In re Biogen 755 Patent Litig.
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Opinion
CECCID, District Judge.
The Court held a five-week jury trial in this patent infringement action beginning on January 18, 2018. On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe claims 1 and 2 of United States Patent No. 7,588,755 (the "'755 patent") when they administer or self-administer the product Rebif ® for the treatment of multiple sclerosis ("MS"), that Defendants EMD Serono, Inc. ("Serono") and Pfizer Inc. ("Pfizer") (collectively, "Defendants") have contributed to the infringement of claims 1 and 2 by selling or offering to sell Rebif ®, that neither Serono nor Pfizer has actively induced the infringement of claims 1 or 2, that claims 1, 2, and 3 of the '755 patent are not invalid for obviousness, lack of adequate written description, or lack of enablement, and that claims 1, 2, and 3 are invalid for anticipation. ECF No. 977 ("Verdict Form").
Now pending before the Court are renewed motions for judgment as a matter of law ("JMOL") pursuant to Federal Rule of Civil Procedure 50(b) by Plaintiff Biogen MA Inc. ("Biogen") and Defendants. ECF Nos. 980, 982. Specifically, Biogen moves for JMOL on the issues of anticipation, induced infringement by Serono and Pfizer, certain defenses that were not litigated at trial, and certain subsidiary damages-related issues. Biogen also moves conditionally and in the alternative for a new trial as to certain issues pursuant to Federal Rules of Civil Procedure 50(c) and 59, respectively. Defendants move for JMOL on the issues of patent eligibility, obviousness, enablement, written description, contributory infringement by Pfizer, and lost profits damages.
The Court heard oral argument on June 6, 2018. The parties also submitted letters following oral argument. ECF Nos. 1010, 1011, 1012, 1014, 1015, 1017, 1018. Having considered the parties' written submissions and oral presentations, and for the reasons discussed below, Biogen's JMOL motions with respect to anticipation, induced infringement against Serono and Pfizer, and certain non-litigated defenses are hereby GRANTED. The Court also conditionally orders a new trial on anticipation and induced infringement against Serono and Pfizer pursuant to Rule 50(c), and orders a new trial on all damages issues pursuant to Rule 59. Biogen's remaining JMOL motions and each of Defendants' JMOL motions are hereby DENIED.
I. BACKGROUND
On May 28, 2010, Biogen filed this patent infringement suit asserting claims of the '755 patent against Defendants, Bayer HealthCare Pharmaceuticals Inc. ("Bayer"), and Novartis Pharmaceuticals Corp. ("Novartis"). C.A. No. 10-2760, ECF No. 1 ("Compl."). Prior to trial, Biogen's infringement claims against Serono and Pfizer were severed from Biogen's infringement *697claims against Bayer and Novartis.1 ECF No. 743. Thus, only Biogen's claims against Serono and Pfizer (and Serono and Pfizer's defenses thereto) were tried before the jury and are the subject of the instant motions.
The '755 patent claims a method for immunomodulation, or treating viral diseases, cancers, or tumors, by administering to a patient a recombinant polypeptide-human interferon beta2 -that is produced by a non-human host transformed by a recombinant DNA molecule. The '755 patent includes three claims, of which only claim 1 is independent.3
Claim 1 of the '755 patent recites:
1. A method for immunomodulation or treating a viral conditions [sic ], a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
(a) DNA sequences which are capable of hybridizing to any of the DNA inserts of G-pBR322(Pst)/HFIFI, G-pBR322(Pst)/HFIF3 (DSM 1791), G-pBR322(Pst)/HFIF6 (DSM 1792), and G-pBR322(Pst)/HFIF7 (DSM 1793) under hybridizing conditions of 0.75 M NaCl at 68° C. and washing conditions of 0.3 M NaCl at 68° C., and which code for a polypeptide displaying antiviral activity, and
(b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a);
said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.
The Court previously construed claim 1 of the '755 patent as reciting a "one-step method of 'administering' to a patient in need the specified recombinant HuIFN-ß." ECF No. 403 ("Markman Op.") at 17. The Court also determined that the "produced" and "transformed" limitations of claim 1 are "merely descriptive of the recombinant polypeptide to be administered" as opposed to separate steps that must be shown to prove infringement. Id. at 14-15.
Biogen's infringement claims against Serono and Pfizer are based on the sale of recombinant interferon-ß product Rebif® in the United States for the treatment of MS. Compl. ¶¶ 32-49; Am. Compl. ¶¶ 42-59. In their Answers, Defendants assert *698that the '755 patent claims are invalid, not infringed, and/or unenforceable. C.A. No. 10-2760, ECF Nos. 56, 57, 75; ECF Nos. 44, 71. The issues of infringement, validity, and damages were tried to a jury for a number of weeks in January and February of 2018.4 With respect to infringement, the jury was asked to decide whether Serono and Pfizer were each liable for induced and contributory infringement of claims 1 and 2 of the '755 patent (the "asserted claims"). With respect to validity, the jury was asked to decide whether claims 1, 2, and 3 were invalid for obviousness, lack of adequate written description, lack of enablement, or anticipation. Before the case was submitted to the jury, Biogen and Defendants each moved for JMOL on a number of issues pursuant to Federal Rule of Civil Procedure 50(a).5 2/9/18 Tr. at 168:21-169:15, 170:18-171:8, 172:4-18, 179:7-23; 2/21/18 Tr. at 20:23-22:3, 52:9-53:24, 62:23-64:5, 67:19-69:16. The Court reserved decision on all of the parties' Rule 50(a) motions. 2/9/18 Tr. at 183:11-12; 2/21/18 Tr. at 75:26-77:4.
On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe the asserted claims of the '755 patent when they administer or self-administer Rebif ® for the treatment of MS. Verdict Form at 1, Q. 1. The jury also found that neither Serono nor Pfizer has actively induced the direct infringement of the asserted claims. Id. at 2-3, Qs. 2, 6. The jury further found that both Serono and Pfizer have contributed to the direct infringement of the asserted claims by selling or offering to sell Rebif® in the United States. Id. at 3, Qs. 7, 8.
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CECCID, District Judge.
The Court held a five-week jury trial in this patent infringement action beginning on January 18, 2018. On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe claims 1 and 2 of United States Patent No. 7,588,755 (the "'755 patent") when they administer or self-administer the product Rebif ® for the treatment of multiple sclerosis ("MS"), that Defendants EMD Serono, Inc. ("Serono") and Pfizer Inc. ("Pfizer") (collectively, "Defendants") have contributed to the infringement of claims 1 and 2 by selling or offering to sell Rebif ®, that neither Serono nor Pfizer has actively induced the infringement of claims 1 or 2, that claims 1, 2, and 3 of the '755 patent are not invalid for obviousness, lack of adequate written description, or lack of enablement, and that claims 1, 2, and 3 are invalid for anticipation. ECF No. 977 ("Verdict Form").
Now pending before the Court are renewed motions for judgment as a matter of law ("JMOL") pursuant to Federal Rule of Civil Procedure 50(b) by Plaintiff Biogen MA Inc. ("Biogen") and Defendants. ECF Nos. 980, 982. Specifically, Biogen moves for JMOL on the issues of anticipation, induced infringement by Serono and Pfizer, certain defenses that were not litigated at trial, and certain subsidiary damages-related issues. Biogen also moves conditionally and in the alternative for a new trial as to certain issues pursuant to Federal Rules of Civil Procedure 50(c) and 59, respectively. Defendants move for JMOL on the issues of patent eligibility, obviousness, enablement, written description, contributory infringement by Pfizer, and lost profits damages.
The Court heard oral argument on June 6, 2018. The parties also submitted letters following oral argument. ECF Nos. 1010, 1011, 1012, 1014, 1015, 1017, 1018. Having considered the parties' written submissions and oral presentations, and for the reasons discussed below, Biogen's JMOL motions with respect to anticipation, induced infringement against Serono and Pfizer, and certain non-litigated defenses are hereby GRANTED. The Court also conditionally orders a new trial on anticipation and induced infringement against Serono and Pfizer pursuant to Rule 50(c), and orders a new trial on all damages issues pursuant to Rule 59. Biogen's remaining JMOL motions and each of Defendants' JMOL motions are hereby DENIED.
I. BACKGROUND
On May 28, 2010, Biogen filed this patent infringement suit asserting claims of the '755 patent against Defendants, Bayer HealthCare Pharmaceuticals Inc. ("Bayer"), and Novartis Pharmaceuticals Corp. ("Novartis"). C.A. No. 10-2760, ECF No. 1 ("Compl."). Prior to trial, Biogen's infringement claims against Serono and Pfizer were severed from Biogen's infringement *697claims against Bayer and Novartis.1 ECF No. 743. Thus, only Biogen's claims against Serono and Pfizer (and Serono and Pfizer's defenses thereto) were tried before the jury and are the subject of the instant motions.
The '755 patent claims a method for immunomodulation, or treating viral diseases, cancers, or tumors, by administering to a patient a recombinant polypeptide-human interferon beta2 -that is produced by a non-human host transformed by a recombinant DNA molecule. The '755 patent includes three claims, of which only claim 1 is independent.3
Claim 1 of the '755 patent recites:
1. A method for immunomodulation or treating a viral conditions [sic ], a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
(a) DNA sequences which are capable of hybridizing to any of the DNA inserts of G-pBR322(Pst)/HFIFI, G-pBR322(Pst)/HFIF3 (DSM 1791), G-pBR322(Pst)/HFIF6 (DSM 1792), and G-pBR322(Pst)/HFIF7 (DSM 1793) under hybridizing conditions of 0.75 M NaCl at 68° C. and washing conditions of 0.3 M NaCl at 68° C., and which code for a polypeptide displaying antiviral activity, and
(b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a);
said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.
The Court previously construed claim 1 of the '755 patent as reciting a "one-step method of 'administering' to a patient in need the specified recombinant HuIFN-ß." ECF No. 403 ("Markman Op.") at 17. The Court also determined that the "produced" and "transformed" limitations of claim 1 are "merely descriptive of the recombinant polypeptide to be administered" as opposed to separate steps that must be shown to prove infringement. Id. at 14-15.
Biogen's infringement claims against Serono and Pfizer are based on the sale of recombinant interferon-ß product Rebif® in the United States for the treatment of MS. Compl. ¶¶ 32-49; Am. Compl. ¶¶ 42-59. In their Answers, Defendants assert *698that the '755 patent claims are invalid, not infringed, and/or unenforceable. C.A. No. 10-2760, ECF Nos. 56, 57, 75; ECF Nos. 44, 71. The issues of infringement, validity, and damages were tried to a jury for a number of weeks in January and February of 2018.4 With respect to infringement, the jury was asked to decide whether Serono and Pfizer were each liable for induced and contributory infringement of claims 1 and 2 of the '755 patent (the "asserted claims"). With respect to validity, the jury was asked to decide whether claims 1, 2, and 3 were invalid for obviousness, lack of adequate written description, lack of enablement, or anticipation. Before the case was submitted to the jury, Biogen and Defendants each moved for JMOL on a number of issues pursuant to Federal Rule of Civil Procedure 50(a).5 2/9/18 Tr. at 168:21-169:15, 170:18-171:8, 172:4-18, 179:7-23; 2/21/18 Tr. at 20:23-22:3, 52:9-53:24, 62:23-64:5, 67:19-69:16. The Court reserved decision on all of the parties' Rule 50(a) motions. 2/9/18 Tr. at 183:11-12; 2/21/18 Tr. at 75:26-77:4.
On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe the asserted claims of the '755 patent when they administer or self-administer Rebif ® for the treatment of MS. Verdict Form at 1, Q. 1. The jury also found that neither Serono nor Pfizer has actively induced the direct infringement of the asserted claims. Id. at 2-3, Qs. 2, 6. The jury further found that both Serono and Pfizer have contributed to the direct infringement of the asserted claims by selling or offering to sell Rebif® in the United States. Id. at 3, Qs. 7, 8. With respect to validity, although the jury found that the '755 patent claims were not invalid for obviousness, lack of adequate written description, or lack of enablement, (id. at 3-4, Qs. 9-11), it found that the claims were anticipated by prior-art uses of naturally-occurring (or native), human interferon-ß (id. at 4, Q. 12). Accordingly, the jury did not reach the issue of damages, leaving the damages questions on the Verdict Form blank. Id. at 5-6, Qs. 13-18.
Following the verdict, on March 16, 2018 the Court held a telephone conference with the parties to discuss a schedule for filing post-trial motions pursuant to Rule 50(b). In its Rule 50(b) JMOL motions, Biogen asks the Court to enter judgment that the '755 patent claims are not anticipated by prior-art uses of native, human interferon-ß and that Serono and Pfizer have each induced infringement of the asserted claims. ECF No. 980-1 ("Biogen Br."). Biogen also seeks a judgment in its favor on certain damages-related issues and as to certain non-litigated defenses. Biogen further asks the Court to conditionally grant a new trial under Rule 50(c) for each of those issues except for the non-litigated defenses, and alternatively moves for a new trial under Rule 59 for any of those issues on which the Court does not grant JMOL. Defendants oppose each of Biogen's motions. ECF No. 991 ("Defs. Opp."). In their Rule 50(b) JMOL motions, Defendants ask the Court to enter judgment that Pfizer has not contributed to the infringement of the asserted claims, that the '755 patent claims are patent ineligible, that the '755 patent claims are invalid on the grounds of obviousness, lack of enablement, *699and lack of adequate written description, and that Biogen is not entitled to lost profits damages. ECF No. 983 ("Defs. Br."). Biogen opposes each of Defendants' motions. ECF No. 989 ("Biogen Opp."). The Court heard oral argument on June 6, 2018 ("6/6/18 Tr.").
II. LEGAL STANDARDS
A. Motion for Judgment as a Matter of Law
Judgment as a matter of law is appropriate if "the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party" on an issue. Fed. R. Civ. P. 50(a)(1). "If the court does not grant a motion for judgment as a matter of law made under Rule 50(a), the court is considered to have submitted the action to the jury subject to the court's later deciding the legal questions raised by the motion." Fed. R. Civ. P. 50(b). In ruling on a Rule 50(b) motion, "the court may: (1) allow judgment on the verdict, if the jury returned a verdict; (2) order a new trial; or (3) direct the entry of judgment as a matter of law." Id.
To prevail on a renewed motion for JMOL under Rule 50(b) following a jury trial and verdict, the moving party "must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) implied by the jury's verdict cannot in law be supported by those findings." Power Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc. ,
In the Third Circuit, JMOL "should be granted only if, viewing the evidence in the light most favorable to the nonmovant and giving it the advantage of every fair and reasonable inference, there is insufficient evidence from which a jury reasonably could find" for the nonmovant. Lightning Lube, Inc. v. Witco Corp. ,
*700Reeves ,
B. Motion for a New Trial
Rule 59(a) provides, in pertinent part, "[t]he court may, on motion, grant a new trial on all or some of the issues-and to any party-as follows:... after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court." Fed. R. Civ. P. 59(a)(1)(A). The most common reasons for granting a new trial include: (1) the verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice; (2) newly discovered evidence exists that would likely alter the outcome of the trial; (3) improper conduct by an attorney or the court unfairly influenced the verdict; or (4) the verdict was facially inconsistent. See Zarow-Smith v. N.J. Transit Rail Operations, Inc. ,
Moreover, "[w]here the subject matter of the litigation is simple and within a layman's understanding, the district court is given less freedom to scrutinize the jury's verdict than in a case that deals with complex factual determinations."
Pursuant to Rule 50(c), "[i]f the court grants a renewed motion for judgment as a matter of law, it must also conditionally rule on any motion for a new trial by determining whether a new trial should be granted if the judgment is later vacated or reversed." Fed. R. Civ. P. 50(c)(1). In addition, the court "must state the grounds for conditionally granting or denying the motion for a new trial."
III. DISCUSSION
A. Biogen's Post-Trial Motions
Biogen moves for JMOL under Rule 50(b) as to (1) anticipation; (2) induced infringement by Pfizer; (3) induced infringement by Serono; (4) certain non-litigated defenses; and (5) certain subsidiary damages-related issues. Biogen also moves conditionally for a new trial under Rule 50(c), and alternatively for a new trial under Rule 59, on anticipation, induced infringement by Pfizer and Serono, and the subsidiary damages issues. The Court addresses each of Biogen's motions in turn with the exception of Biogen's JMOL motion as to Defendants' patent-ineligibility defense, which the Court addresses with Defendants' JMOL motion on that defense in Section III.B.1 below.
1. Anticipation
(a) Applicable Legal Principles for Anticipation
A patent claim is invalid by reason of anticipation if "the invention was *701known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent."
Moreover, anticipation "requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim. A prior art disclosure that 'almost' meets that standard may render the claim invalid under [ 35 U.S.C.] § 103 ; it does not 'anticipate.' " Connell v. Sears, Roebuck & Co. ,
The jury was instructed that "[f]or a claim to be invalid because it is not new" Defendants "must show by clear and convincing evidence that all of the requirements of that claim were present in a single previous device or method that was known of, used, or described in a single previous printed publication or patent." ECF No. 968 ("Final Jury Instructions") at 29. The jury instructions also provide that "[t]o anticipate the invention, the prior art does not need [to] use the same words as the claim, but all the requirements of the claim must have been disclosed, either stated expressly or implied to a person of ordinary skill in the art in the technology of the invention, so that looking at that one reference, that person could make and use the claimed invention."
(b) Parties' Contentions
The jury found that the '755 patent claims were anticipated by prior-art uses *702of native, human interferon-ß. Verdict Form at 4, Q. 12 ("Do you find, by clear and convincing evidence, that the claims of the '755 patent are invalid as anticipated by prior art uses of native human interferon-beta?"). Biogen contends that the verdict cannot stand because no reasonable jury could have found by clear and convincing evidence that the '755 patent claims were anticipated by the prior art. According to Biogen, JMOL of no anticipation under Rule 50(b) is appropriate because Defendants failed to identify a single prior-art reference that discloses all of the elements of the '755 patent claims. Biogen Br. at 13. Specifically, Biogen asserts that no reference discloses treatment with a "therapeutically effective amount" (or any amount) of a composition comprising "recombinant" interferon-ß made in a "non-human host" that had been "transformed by a recombinant DNA molecule." Id. at 13-14. Instead, all therapeutic uses of interferon-ß before the priority date of June 6, 1980 employed the native protein.6 Biogen further observes that, in stark contrast to Defendants' trial presentation of their obviousness defense, Defendants did not bring a Rule 50(a) motion on anticipation at trial, "barely alluded to anticipation at trial," and did not raise anticipation in their summation. Id. at 5; see also 6/6/18 Tr. at 168:17-169:8. In Biogen's view, because the jury "did not focus on, and did not understand, the anticipation question," as evidenced by a jury question asked only one hour before the jury returned its verdict, the verdict represents a "miscarriage of justice" warranting a new trial under Rule 59.7 Biogen Br. at 6.
By contrast, Defendants contend that the evidence presented at trial supports the jury's verdict of anticipation. Defendants rely on the legal principle that a new source or process (i.e., recombinant DNA technology) for making an old product (i.e., interferon-ß) in and of itself is insufficient to confer novelty on the product, unless the new source or process confers both structural and functional differences distinguishing the product from the prior art. Defs. Opp. at 1. Product claims that define a product by a particular process are referred to as "product-by-process" claims.8 Defendants contend that this principle applies to all types of claims having source limitations, including the method of treatment claims of the '755 patent. 6/6/18 Tr. at 63:7-64:2. Defendants further assert that evidence of either structural or functional identity between native and recombinant *703interferon-ß can support the jury's anticipation verdict, and that there is more than sufficient evidence of both in the record. See id. at 65:18-66:11.
Defendants principally rely on two allegedly-anticipatory publications, Kingham et al. , Treatment of HBsAg-positive chronic active hepatitis with human fibroblast interferon, Gut. 19(2):91-4 (1978) ("Kingham") (STX-1596) and Sundmacher et al. , Human Leukocyte and Fibroblast Interferon in a Combination Therapy of Dendritic Keratitis, Albrecht Von Graefes Arch Klin Exp Ophthalmol. 208(4):229-33 (1978) ("Sundmacher") (STX-1810). Defendants contend that these publications disclose all of the elements of claim 1, specifically, the administration of therapeutically effective amounts of native, human interferon-ß proteins-which, in Defendants' view, are identical to the recombinant interferon-ß proteins of claim 1-to treat viral diseases. Defs. Opp. at 7-8; 6/6/18 Tr. at 61:6-18.
In addition, Defendants rely on two comparative studies that, while not prior art, allegedly demonstrate that the native interferon-ß administered in Kingham and Sundmacher is structurally identical to interferon-ß made recombinantly in Chinese Hamster Ovary ("CHO") cells: a study by InterPharm Laboratories Ltd. entitled "Comparative Biochemical Analysis of Native Human Fibroblast Interferon and Recombinant Beta Interferon Expressed by Chinese Hamster Ovary Cells" (the "InterPharm Study") (STX-1259),9 and Kagawa et al. , Comparative Study of the Asparagine-linked Sugar Chains of Natural Human Interferon-ß1 and Recombinant Human Interferon-ß1 Produced by Three Different Mammalian Cells, J Biol Chem. 263(33): 17508-15 (1988) ("Kagawa") (STX-1587). In support of their position that native and recombinant interferon-ß are functionally identical, Defendants rely on the InterPharm Study, along with a publication co-authored by Michel Revel, M.D., Ph.D., Professor Emeritus retired from the Weizmann Institute of Science, entitled Chernajovsky et al. , Efficient Constitutive Production of Human Fibroblast Interferon by Hamster Cells Transformed with the IFN-ß1 Gene Fused to An SV40 Early Promoter, DNA 3(4):297-308 (1984) ("Chernajovsky") (STX-1439), and Dr. Revel's United States Patent No. 4,808,523 (the "Revel '523 patent") (STX-1314). Defs. Opp. at 13. As with the InterPharm Study and Kagawa, neither Chernajovsky nor the Revel '523 patent is prior art.
Finally, Defendants rely on the expert testimony of Harvey Lodish, Ph.D., a Professor of Biology and Biological Engineering at the Massachusetts Institute of Technology and member of the Whitehead Institute for Biomedical Research. 2/8/18 PM Tr. at 48:21-49:1. Defendants offered Dr. Lodish as an expert in the field of recombinant DNA technology and the production of recombinant therapeutic proteins. Id. at 57:9-16. In Defendants' view, JMOL is inappropriate because there was sufficient evidence in the record for the jury to conclude that native interferon-ß administered before June 6, 1980 and recombinant interferon-ß made in CHO cells are structurally identical, functionally identical, or both.
(c) Biogen Is Entitled to JMOL of No Anticipation
In assessing the sufficiency of the evidence, the Court gives Defendants, as the verdict winners, "the benefit of all logical inferences that could be drawn from the evidence presented, resolve[s] all *704conflicts in the evidence in [Defendants'] favor and, in general, view[s] the record in the light most favorable to [Defendants]." Williamson ,
(1) Defendants Failed to Present as Evidence a Prior-Art Reference Disclosing Each and Every Element of the '755 Patent Claims
The Court concludes that because Defendants failed to present as evidence a single prior-art reference that describes the therapeutic use of a recombinant interferon-ß polypeptide made in a non-human host, the jury could not have reasonably reached its verdict of anticipation. As discussed above, the '755 patent claims are method claims that require therapeutic use of a recombinant interferon-ß polypeptide made in a non-human host. The Court instructed the jury that a "recombinant polypeptide" is "a polypeptide produced by recombinant DNA engineering," that a "recombinant DNA molecule" must include "DNA from different genomes," and that "produced in a nonhuman host transformed by a recombinant DNA molecule" requires production within "a transformed cell line that is not a human cell line." Final Jury Instructions at 17. Defendants failed to identify a single prior-art reference that discloses all of the elements of the '755 patent claims. Specifically, no reference in the record discloses treatment with a "therapeutically effective amount" of a composition comprising a "recombinant" interferon-ß polypeptide produced in a "non-human host" that had been "transformed by a recombinant DNA molecule."
Instead, the expert testimony presented to the jury, including testimony by Defendants' experts Dr. Lodish and Jordan Gutterman, M.D., the latter a Professor of Medicine at the University of Texas MD Anderson Cancer Center, showed that all therapeutic uses of interferon-ß before the priority date of June 6, 1980 employed native, human interferon-ß.10 See 2/13/18 AM Tr. at 35:4-37:5 (Lodish) (explaining that before June 6, 1980, no one had made enough recombinant interferon-ß to treat a patient); 2/7/18 PM Tr. at 85:7-86:7 (Gutterman) (explaining that studies of interferon-ß in MS in the 1970s did not use "recombinant interferon" but instead used "the native interferon produced from fibroblasts"); 2/15/18 PM Tr. at 66:12-16 (Garcia) (agreeing that no prior-art publications "talked about the activity of recombinant beta interferon"). The '755 patent itself discloses that therapeutic use of native, human interferon-ß was known in the prior art, and describes how compositions of the native protein had been prepared. PTX0001 ( '755 patent) at 2:53-4:22, 4:49-5:3. Although Defendants cite prior-art publications disclosing therapeutic uses of interferon-ß, those uses were limited to the native protein. See STX-1596 (Kingham) at 1 (disclosing use of native, human interferon-ß for the treatment of hepatitis B virus); STX-1810 (Sundmacher) at 1 (disclosing use of native, human interferon-ß for the treatment of dendritic keratitis virus). Defendants did not present any evidence or testimony as to the presence in the prior art of therapeutic uses of recombinant interferon-ß.
*705Accordingly, since Defendants failed to present as evidence a single prior-art reference that discloses each and every element of the '755 patent claims, no reasonable jury could have found by clear and convincing evidence that the claims were anticipated by the prior art. See Summit 6 ,
(2) JMOL of No Anticipation Is Appropriate Even Applying Product-By-Process Law
Even if the Court were to agree with Defendants that method of treatment claims having source limitations should be analyzed in the same way as product-by-process claims for purposes of anticipation, or that the Court should at least be guided by product-by-process law, the jury's verdict of anticipation still cannot stand. Giving Defendants the benefit of every fair and reasonable inference that can be drawn from the record, as discussed below, there is insufficient evidence to support a finding that the product of the '755 patent claims (i.e., recombinant interferon-ß made, for example, in CHO cells) is the same as the product known and used in the prior art (i.e., native interferon-ß).
(i) Native and Recombinant Interferon-ß Are Not Structurally Identical
The evidence presented at trial demonstrates that native interferon-ß and recombinant interferon-ß are not structurally identical. As discussed above, "strict identity" is a requirement for anticipation; that the prior art is "substantially identical," "extremely similar," or "very similar" to the claimed invention is not enough. See Trintec ,
Although Defendants contend that the "most basic and obvious identicality between [native and recombinant interferon-ß] proteins is in the DNA," (6/6/18 Tr. at 74:23-24), and that the "amino acid sequence of both proteins is identical," (id. at 75:20-21), the record evidence shows that the proteins differ structurally in terms of their attached carbohydrate (or sugar) groups, also referred to as glycosylation patterns. In denying Bayer's Motion for Summary Judgment of Invalidity No. 2 (Anticipation by the Treatment References), which Defendants joined, the Court declined to find as a matter of law that "their shared amino acid sequence renders native interferon-ß and recombinant interferon-ß the same for purposes of anticipation." ECF No. 892 ("Summ. J. Op.") at 28. In reading the term "polypeptide" in the context of claim 1, the Court determined that claim 1 requires the recombinant polypeptide to display "antiviral activity" and be administered in a "therapeutically effective amount."
*706Moreover, Defendants' expert, Dr. Lodish, testified during his direct examination that the native and recombinant proteins' structures are not identical with respect to their carbohydrate groups. Among the several opinions Dr. Lodish discussed during the three days on which he testified was the brief statement that, in his view, native interferon-ß and recombinant interferon-ß are, at best, "substantially identical." 2/8/18 PM Tr. at 50:11-12. Specifically, during a short portion of one afternoon session at trial, he testified that, based on his reading of the InterPharm Study, "[t]here were minor differences in the structures of the sugars" of native and recombinant interferon-ß, "but I wouldn't call them identical, I would call the sugars extremely similar."11 2/9/18 Tr. at 87:24-88:7; see also id. at 87:3-9 (explaining that although he did not perform a comparison of native interferon-ß in the prior art with recombinant interferon-ß made in CHO cells, he would characterize the amino acid sequences as "exactly" the same but the carbohydrates as "virtually identical"); STX-1259 (InterPharm Study) at 94 (concluding that the sugar structures of native and recombinant interferon-ß are merely "very similar"). Additional expert testimony in the record offered a consistent interpretation of the InterPharm Study. See 2/15/18 PM Tr. at 101:9-102:15 (Garcia) (stating that with respect to the glycosylation patterns of the native and recombinant proteins, "[i]n some cases they're close, but they're never identical," and that it is "pretty clear that the[ ] glycans have some significant differences"). Dr. Lodish also testified that Kagawa showed that the sugar groups of the native and recombinant proteins in the study had "small differences" that made them "extremely similar." 2/9/18 Tr. at 88:9-25. These "minor" and "small" differences matter for purposes of anticipation. See Net MoneyIN ,
In their opposition brief, Defendants explain that Dr. Lodish's testimony was "not that the individual polypeptides differed, but instead that the proportions of polypeptides containing identical sugar structures in IFN-ß made naturally and recombinantly were 'extremely similar.' " Defs. Opp. at 14 (quoting 2/9/18 Tr. at 87:14-88:25, 103:6-10 (Lodish) ) (emphasis in original). Defendants assert that the "prior *707art mixtures" of native interferon-ß proteins encompass species of proteins that are identical to species of recombinant interferon-ß proteins covered by the '755 patent claims. See
Even if the Court were to accept Defendants' anticipation theory, the anticipation evidence remains critically deficient. Defendants have not cited any testimony, from Dr. Lodish or otherwise, stating that as between two populations-native interferon-ß proteins in the prior art and recombinant *708interferon-ß proteins-there is a molecule or subset of molecules that is identical between them. See id. at 120:7-23, 123:7-22, 130:9-132:23, 133:7-136:13, 139:4-140:24, 143:25-145:16. The few lines of trial testimony from Dr. Lodish upon which Defendants rely neither expressly nor implicitly elucidate this theory for the jury. Based on a review of the record, it does not appear that the particular arguments that Defendants have raised post-trial to uphold the anticipation verdict were, in fact, presented to the jury either through expert testimony, during summation, or otherwise. Although Defendants assert that "the InterPharm report and the Kingham or Sundmacher papers ... would be sufficient in and of itself to support this jury verdict," (id. at 77:3-8), neither Dr. Lodish nor any other witness at trial testified as to the presence in the prior art of the particular protein structures identified in the InterPharm Study or any of the other post-June 6, 1980 references. In other words, there was no evidence presented to the jury "linking" the prior-art use of native, human interferon-ß as disclosed in Kingham, Sundmacher, or any other prior-art reference with the InterPharm Study, Kagawa, Chernajovsky, or the Revel '523 patent. See id. at 22:12-23:3. Without any evidence or testimony in the record mentioning, let alone explaining, that there is a molecule that exists in both the prior-art native interferon-ß population and the recombinant interferon-ß population, it cannot fairly be concluded that the jury drew such an inference in reaching its verdict.
The evidence Defendants cite in support of their anticipation theory is deficient in other respects as well. For instance, there appears to be no evidence or testimony that the native interferon-ß proteins used in the prior art are the same as the native proteins studied in the post-June 6, 1980 publications. Absent from the record is any evidence of the carbohydrate structure of a single native interferon-ß protein used for treatment in the prior art. Sundmacher does not disclose the structure of the native interferon-ß material, including its glycosylation pattern, nor is it clear what cell lines were used in the study. Kingham similarly does not disclose the glycosylation pattern of the native interferon-ß produced from the human fetal lung fibroblast cells used in the study. Moreover, there was no testimony from any witness regarding the structures of the native proteins discussed in either of those prior-art publications. Also absent from the record is any testimony that all native, human interferon-ß proteins are structurally identical. Indeed, the InterPharm Study and Kagawa disclose different compositions for native, human interferon-ß proteins. See 6/6/18 Tr. at 104:14-106:9; STX-1587 (Kagawa) at 4; STX-1259 (InterPharm Study) at 67 (stating that "[a]n analysis of oligosaccharide [or carbohydrate] structures on the same protein from different species and even different tissues reveals that major variations frequently exist" and that "a homogeneous cell population" produces "an astonishing array of different oligosaccharide structures"). Furthermore, the InterPharm Study offers almost no information about the precise native, human interferon-ß proteins used in the study, whether those proteins pre-dated the priority date, or whether the study used the same cell line or cell type as that used in either Kingham or Sundmacher.
In sum, Defendants bore the burden of proving by clear and convincing evidence that the native, human interferon-ß in the prior art was in fact identical to the recombinant interferon-ß of the '755 patent claims. Given the above-mentioned deficiencies in the evidence, no reasonable jury could find that Defendants met their burden.
*709(ii) Native and Recombinant Interferon-ß Are Not Functionally Identical
The evidence presented at trial also demonstrates that native, human interferon-ß and recombinant interferon-ß are not functionally identical. Although Dr. Lodish testified that the functional characteristics of native interferon-ß and recombinant interferon-ß made in CHO cells are "very similar, if not identical," (2/9/18 Tr. at 87:10-13), as discussed above, "strict identity" is required for anticipation. Defendants rely on the InterPharm Study, Chernajovsky, and the Revel '523 patent as evidence of functional identity. See Defs. Opp. at 13; STX-1439 (Chernajovsky) at 2 (stating that recombinant interferon-ß "appears identical in size, activity, and immunospecificity to the native human IFN-ß1 glycoprotein"); STX-1314 (Revel '523 patent ) at 10 (stating that "expression of the DNA coding for pre-IFN-ß1 in hamster cells leads to the secretion of a protein which is electrophoretically identical to the natural glycoprotein and which gives, upon purification by immunoaffinity on monoclonal antibodies, the same specific activity as the IFN-ß1 purified from human fibroblasts"). As discussed above, however, there was no evidence presented to the jury "linking" the prior-art use of native, human interferon-ß disclosed in Kingham and Sundmacher with the InterPharm Study, Chernajovsky, or the Revel '523 patent.
Moreover, the jury heard fact and expert testimony regarding the different biological effects that native interferon-ß and recombinant interferon-ß have on the human body. Biogen's expert, Revere Kinkel, M.D., a neurologist at the University of California San Diego, testified regarding the role of neutralizing antibodies in interferon-ß treatment. 1/29/18 PM Tr. at 12:16-15:18. Dr. Kinkel explained that neutralizing antibodies are proteins that bind to interferon and prevent it from binding to its receptor and having its intended effect. Id. at 14:3-8. Dr. Kinkel opined that the closer a recombinant protein resembles the native protein, the lower the development of neutralizing antibodies. Id. at 13:1-10. Dr. Kinkel also testified about the differences among the various recombinant interferon-ß drug products Betaseron ®, Extavia®, Rebif ®, Avonex®, and Plegridy® in terms of the incidence of neutralizing antibodies. Id. at 14:9-15:18.
The evidence presented at trial also showed that recombinant interferon-ß can be made in much larger quantities and much more easily than native, human interferon-ß can be obtained. See, e.g. , PTX0001 ( '755 patent) at 4:10-13, 4:49-61, 6:64-67. In particular, the '755 patent explains that interferon-ß "produced by human cell lines grown in tissue culture" resulted in a "low yield, expensive process." Id. at 4:49-50; see also id. at 4:11-13 (noting that "the antitumor and anticancer applications of IFN-ß have been severely hampered by lack of an adequate supply of purified IFN-ß"). This problem was eventually solved by
locating and separating DNA sequences that code for the expression of HuIFN-ß in an appropriate host thereby providing DNA sequences, recombinant DNA molecule and methods by means of which a host is transferred to produce a polypeptide displaying an immunological or biological activity of human fibroblast interferon.
Id. at 6:48-53. By virtue of this discovery, it was "possible to obtain polypeptides displaying an immunological or biological activity of HuIFN-ß for use in antiviral, antitumor *710or anticancer agents and methods," and the invention "allow[ed] the production of these polypeptides in amounts and by methods" that were not previously available "for use in antiviral and antitumor or anticancer agents and methods and immunomodulation." Id. at 6:54-7:7; see also Amgen Inc. v. F. Hoffman-La Roche Ltd. ,
Furthermore, although the evidence establishes functional differences, it appears that structural differences alone may suffice to impart novelty. This case is similar to Amgen, Inc. v. F. Hoffman-La Roche Ltd. ,
Notably, the Federal Circuit made no mention of functional differences in affirming the anticipation rulings. After analyzing and finding sufficient bases to uphold those rulings, the Federal Circuit then addressed the defendant Roche's challenge to the district court's decision to construe the source limitations differently in the validity and infringement contexts.
(3) Product-By-Process Law Should Not Apply in Analyzing the Validity of the '755 Patent Method of Treatment Claims
The Court has addressed the issues raised in Biogen's JMOL motion under the framework proposed by Biogen. The Court has also addressed those issues under the framework proposed by Defendants. Under either approach, the Court has concluded that there is legally insufficient evidence to support the jury's verdict of anticipation. Nevertheless, for the following reasons, the Court concludes that Biogen's proposed framework is more appropriate in this case.
As an initial matter, there appears to be no binding precedent supporting Defendants' position that the anticipation inquiry of product-by-process claims governs the analysis of method of treatment claims *712that include source limitations, such as claim 1 of the '755 patent. The parties agree that claim 1 includes a source limitation, i.e., the interferon-ß protein is made by recombinant DNA technology. In its claim construction Opinion, this Court stated that it was "unclear that [the] method of treatment claim can be treated as a product-by-process claim," and that it was "aware of no binding precedent requiring method of treatment claims to be treated as product-by-process claims in the claim construction context."Markman Op. at 14. Since the Court's claim construction ruling, Defendants have not identified cases that would warrant this Court to apply the framework for assessing novelty of product-by-process claims to method of treatment claims.16
Even beyond the absence of binding precedent, the Court is persuaded by Biogen's argument that given the particular principles underlying product-by-process law, the framework Defendants propose should not apply to assessing the validity of the '755 patent method of treatment claims.17 The product-by-process doctrine allows patentees to draft claims to a product by reference to the process by which the product is made where the product's characteristics are unknown or otherwise cannot be described. See In re Thorpe ,
Product-by-process claims are not specifically discussed in the patent statute. The practice and governing law have developed in response to the need to enable an applicant to claim an otherwise patentable product that resists definition by other than the process by which it is made. For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.
Claim 1 of the '755 patent, by contrast, is not directed to a product that the inventor, Dr. Walter Charles Fiers, was unable to describe in words or where the product's structure was not sufficiently understood. Rather, the purpose of the invention, consistent with the stated goal of the '755 patent, was to solve the problem in the prior art that the viability of certain medical treatments was hindered by insufficient supply. See PTX0001 ( '755 patent) at 4:10-13; 6:54-7:7. The principles that inform product-by-process law as set forth in Thorpe , SmithKline , and Amgen do not apply in this context. See 6/6/18 Tr. at 12:10-11 (explaining that the '755 patent"is not taking advantage of a legal procedure to overcome a lack of information"). The Court agrees with Biogen that since the source limitation of claim 1 "lies at the heart of the benefit of this invention," it should be given "force and effect in the anticipation analysis." Id. at 12:7-10.
The procedural posture dictates that the Court may only consider whether Defendants presented sufficient evidence to support the jury's conclusion. Even viewing the evidence in the light most favorable to Defendants, the Court concludes that there is insufficient evidence from which the jury reasonably could have found that the '755 patent claims were anticipated by the prior-art uses of native, human interferon-ß. Accordingly, the Court grants Biogen's Rule 50(b) JMOL motion of no anticipation and vacates the jury's verdict in favor of Defendants.
(d) Biogen Is Entitled to a Conditional New Trial on Anticipation
For the same reasons the Court grants Biogen's JMOL motion, the Court conditionally orders a new trial on anticipation pursuant to Rule 50(c)(1). Additional considerations warrant granting Biogen's request for a new trial on the issue of anticipation. The Court recognizes that the five-week trial in this case was "long and complicated," required complex factual determinations on multiple infringement, validity, and damages issues, was noticeably focused on issues other than anticipation, and involved scientific concepts that are not the "subject matter ... lying within the ordinary knowledge of jurors." Lind ,
Upon consideration of the overall setting of the trial, the character of the evidence, and the complexity of the legal principles that the jury was asked to apply to the facts, the Court concludes that the jury's determination that the '755 patent claims are invalid for anticipation is against the weight of the evidence and therefore warrants the conditional grant of a new trial on the issue of anticipation pursuant to Rule 50(c)(1). Biogen's alternative request for a new trial under Rule 59 is denied as moot.
2. Induced Infringement By Pfizer and Serono
Biogen seeks JMOL of induced infringement against Pfizer and Serono. As to the *714questions of direct infringement by healthcare professionals and/or patients and contributory infringement by Pfizer and Serono, the jury found in favor of Biogen. Defendants have not challenged the jury's finding of direct infringement or its finding of contributory infringement by Serono. Nevertheless, because the legal principles for, and specific elements of, each type of infringement are instructive to the following analysis regarding the issue of induced infringement, the Court discusses those principles and elements below.
(a) Applicable Legal Principles for Direct, Induced, and Contributory Infringement
Section 271(a) of the Patent Act governs direct infringement and provides that "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States ... during the term of the patent therefor, infringes the patent."
In addition, a reasonable, good-faith belief in noninfringement can negate the specific intent required for induced infringement. See Commil USA, LLC v. Cisco Sys., Inc. ,
Section 271(c) of the Patent Act governs contributory infringement and provides that:
[w]hoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.
*715
(b) Induced Infringement By Pfizer
(1) Parties' Contentions
The jury found that Pfizer has not "actively induced healthcare professionals and/or patients to directly infringe the asserted claims of the '755 patent." Verdict Form at 3, Q. 6. Biogen seeks to overturn the verdict of no induced infringement by emphasizing the jury's direct infringement and contributory infringement verdicts. Specifically, Biogen argues that in finding direct infringement, the jury inherently found that Rebif ® (interferon-ß) treats MS through immunomodulation, an element of claim 1, because MS is indisputably an autoimmune disease and is not a viral condition, a viral disease, a cancer, or a tumor. See Biogen Br. at 23 (citing 1/29/18 AM Tr. at 102:22-103:21 (Kinkel) ); 6/6/18 Tr. at 238:8-10; see also PTX0001 ( '755 patent) at 49:59-60 ("A method for immunomodulation or treating a viral condition[ ], a viral disease, cancers or tumors ...." (emphasis added) ). Biogen also contends that in finding contributory infringement, the jury necessarily found that Pfizer "knew that Rebif was being used by healthcare professionals and/or patients in a manner that infringes a claim of the '755 patent" and that "Rebif has no substantial, non-infringing use." Final Jury Instructions at 24 (emphasis added); see also 6/6/18 Tr. at 238:15-21. Biogen argues that, when considered together, these two findings indicate that the jury agreed with Biogen that Pfizer knows how Rebif ® works and that Pfizer knows it works through immunomodulation. According to Biogen, with respect to inducement, the only question remaining for the jury to decide was whether Pfizer intended for Rebif ® to work through immunomodulation. See Final Jury Instructions at 22 (instructing jury that to be liable for induced infringement, Pfizer must have "specifically intend[ed] to cause the infringing acts by healthcare professionals and/or patients").
In Biogen's view, the verdict in Pfizer's favor cannot stand because no reasonable jury could have concluded that Pfizer lacked the specific intent to induce infringement. Biogen contends that the jury heard ample evidence that Pfizer had the specific intent to induce the direct infringement of the '755 patent claims-i.e., Pfizer specifically intended that Rebif ® be used to treat MS through immunomodulation, as opposed to through some other way. Biogen Br. at 21-27. In particular, Biogen cites the testimony of its expert Dr. Kinkel, who opined that there is a consensus in the scientific community that Rebif ® works through immunomodulation to treat MS.
Defendants nevertheless contend that the Court should not disturb the verdict of no inducement by Pfizer. Defendants reiterate that it is Biogen, not Defendants, who bore the burden of proving inducement. Defs. Opp. at 22. While Defendants do not dispute that interferon-ß has immunomodulatory properties, in their view, "Biogen had to prove that [Defendants] specifically intended immunomodulation to be that mechanism of action" by which interferon-ß treats MS. 6/6/18 Tr. at 258:7-15. To support the jury's finding that Pfizer lacked the specific intent to induce infringement, Defendants cite the Rebif ® package insert label, which states that the "mechanism(s) by which REBIF (interferon beta-1a ) exerts its therapeutic effects in patients with multiple sclerosis is unknown," (PTX0582 at 11), and Dr. Kinkel's testimony that "all of the labels for the FDA-approved interferon beta drugs, [Biogen's interferon-ß product] Avonex included, state that the mechanism of action is unknown" (1/29/18 PM Tr. at 49:16-50:5, 55:18-56:2). Defs. Opp. at 23. Defendants characterize this evidence as proof that it is unknown whether the various immunomodulatory properties of interferon-ß work to treat MS, and that Biogen's cited evidence "actually emphasizes the uncertainty in the field as to what causes MS and how IFN-ß treats it." Id. at 22. Defendants also rely on the testimony of Giampiero De Luca, Serono's former Chief Intellectual Property Counsel, in which he questions whether patients know that interferon-ß immunomodulates when it treats MS. Id. at 23 (citing 8/15/12 De Luca Dep. Tr. at 168:25-169:6, 169:13-23). Defendants argue that the jury was entitled to credit this testimony and evidence and conclude that Biogen failed to meet its burden of establishing Pfizer's specific intent.
(2) Biogen Is Entitled to JMOL of Induced Infringement By Pfizer
Having reviewed the record under the appropriate standard, including drawing all reasonable inferences in favor of Defendants as the non-movants, the Court concludes that no reasonable jury could *717have found that Pfizer lacked the specific intent to induce infringement. In reviewing the entirety of the record evidence, the Court has "give[n] credence to the evidence favoring" Defendants as well as evidence supporting Biogen that is "uncontradicted and unimpeached." Reeves ,
Whether Pfizer "took action after the time the '755 patent issued specifically intending to cause the infringing acts by healthcare professionals and/or patients" is the only element in the inducement inquiry that does not overlap with direct or contributory infringement. Final Jury Instructions at 22. Defendants' argument in support of the inducement verdict, which relies primarily on the language in the Rebif ® label and other interferon-ß product labels, goes to a different question that the jury resolved against Pfizer. Specifically, in finding contributory infringement, the jury rejected Defendants' argument that Pfizer does not know that Rebif ® works through immunomodulation to treat MS.19 Moreover, the language in the interferon-ß product labels cited by Defendants regarding interferon-ß's mechanism of action is far outweighed by and, in fact, is consistent with the record evidence of intent; what is "unknown" is only the precise mechanism(s) involved. See 1/29/18 AM Tr. at 122:21-23 (Kinkel) ("A mechanism of action is the precise way that a particular drug has its effect."). When asked: "[I]s there any serious debate in the scientific community about whether interferon-beta is immunomodulatory in treating multiple sclerosis?" Dr. Kinkel answered: "No, there is not." Id. at 127:6-9. While it is true that the jury may disregard evidence on disputed propositions, see Reeves ,
Accordingly, the Court grants Biogen's Rule 50(b) JMOL motion as to induced infringement by Pfizer and vacates the jury's verdict in favor of Pfizer. For the same reasons that the Court grants Biogen's JMOL motion, the Court concludes that the jury's verdict is against the clear weight of the evidence and conditionally orders a new trial on induced infringement by Pfizer pursuant to Rule 50(c)(1). Biogen's alternative request for a new trial under Rule 59 is denied as moot.
(c) Induced Infringement By Serono
The jury found that Serono has not "actively induced healthcare professionals and/or patients to directly infringe the asserted claims of the '755 patent." Verdict Form at 2, Q. 2. As with Pfizer, Biogen seeks to overturn the verdict of no induced infringement by emphasizing the jury's direct *718infringement and contributory infringement verdicts. The Verdict Form, as prepared and supplied by the parties, included the following four questions with regard to Serono's alleged inducement, which have been conformed to show the jury's response:
2. Do you find, by a preponderance of the evidence, that Serono has actively induced healthcare professionals and/or patients to directly infringe the asserted claims of the '755 patent ?
Yes ____ (for Biogen) No ? (for Serono)
If your answer to Question 2 is "Yes", continue to Question 3. If your answer is "No", do not continue to Question 3, but instead proceed to Question 6 .
3. Do you find, by a preponderance of the evidence, that it is. unreasonable to read the '755 patent claims to require three steps (transformation of the non-human host cell, production of the recombinant polypeptide, and administration) as opposed to only a single step (of administration)?
Yes ____ (for Biogen) No ____ (for Serono)
4. Do you find, by a preponderance of the evidence, that for at least some time period Serono lacked a good faith belief that its acts did not induce direct infringement of the asserted claims of the '755 patent ?
Yes ____ (for Biogen) No ____ (for Serono)
5. If you find that Serono lacked a (1) reasonable and (2) good faith belief that its acts did not induce direct infringement, over what span of time do you find that Serono lacked such a belief?
Please specify: _____________
Verdict Form at 2. The Verdict Form instructed the jury to skip Questions 3, 4, and 5 if it answered "No" to Question 2.
As with the jury's inducement verdict in favor of Pfizer, Biogen contends that the jury's verdict of no inducement by Serono cannot stand because no reasonable jury could have concluded that Serono lacked the specific intent to induce infringement. In Biogen's view, the jury's answer of "No" to Question 2 indicates that it ruled on Defendants' immunomodulation theory as it did for Pfizer, and did not reach Serono's reasonable, good-faith belief defense. Biogen contends that the latter theory cannot support a verdict of no inducement in any case, given that Serono conceded during trial that it relinquished its belief of noninfringement following the Court's March 28, 2016 claim construction ruling. ECF No. 1003 ("Biogen Reply") at 12-13; 6/6/18 Tr. at 247:8-9, 248:4-18, 250:8-12, 287:21-288:21. With respect to Defendants' immunomodulation *719theory, Biogen argues that in finding contributory infringement by Serono, as it did with Pfizer, the jury rejected Defendants' argument that Serono does not know that Rebif ® works through immunomodulation to treat MS. As affirmative evidence supporting an inducement finding, Biogen cites (i) the Rebif ® BLA's sections that Biogen cited in challenging the inducement verdict for Pfizer; (ii) Serono's internal presentation entitled "Interferon-ß Pharmacokinetics, Pharmacodynamics and Mechanism of Action," which recounts seven facets of "Immunomodulatory Activity of IFN" and diagrams how interferon-ß affects the immune response in MS (PTX0227 at 26-29); (iii) an article by Dr. Revel, who was involved in the development of Rebif ® on behalf of Serono, entitled Interferon-ß in the treatment of relapsing-remitting multiple sclerosis, Pharmacol Ther. 100(l):49-62 (2003), which states that the "anti-inflammatory and immunomodulatory effects of interferon-ß are the predominant mechanisms responsible for its effectiveness as a MS [disease-modifying drug]" (PTX1055 at 4); and (iv) Serono's failure to call an expert witness to present any alternative, non-immunomodulatory hypothesis for interferon-ß's mechanism of action in treating MS. Biogen Br. at 31-32.
In response, Defendants assert that sufficient evidence supports the verdict of no inducement by Serono. Specifically, Defendants contend that the jury heard evidence that Serono (i) did not believe that interferon-ß treats MS through immunomodulation, based on the same evidence discussed above with respect to Pfizer's intent, including the testimony of Mr. De Luca; and (ii) reasonably believed that the '755 patent claims require multiple steps that Serono never carried out, based on the independent assessments of the claims by Mr. De Luca and Henry Einav, the latter an Israeli patent attorney employed by, and responsible for patent prosecution and patent licensing for, Serono (2/8/18 AM Tr. at 7:12-14, 8:16-25 (Einav) ), and the advice of United States patent attorneys Roger Browdy and John White. Defs. Opp. at 23-27. In Defendants' view, Question 2 of the Verdict Form is not limited to any particular noninfringement theory. Defendants also contend that, contrary to Biogen's assertion, Serono did not relinquish its belief in noninfringement after the Court's claim construction decision, and the jury could have concluded that Serono's belief was reasonable. 6/6/18 Tr. at 265:9-18, 267:6-10. According to Defendants, a reasonable jury considering this evidence could have concluded that Biogen failed to meet its burden of establishing that Serono specifically intended to cause direct infringement.
(2) Biogen Is Entitled to JMOL of Induced Infringement By Serono
Having reviewed the record under the appropriate standard, including drawing all reasonable inferences in favor of Defendants as the non-movants, the Court concludes that no reasonable jury could have found that Serono lacked the specific intent to induce infringement. As discussed above with respect to Pfizer, by finding direct infringement of the '755 patent claims, the jury found that Rebif ® treats MS through immunomodulation. By finding that Serono contributed to the infringement of the '755 patent claims, the jury necessarily found that Serono "knew that Rebif was being used by healthcare professionals and/or patients in a manner that infringes a claim of the '755 patent" and that "Rebif has no substantial, non-infringing use." Final Jury Instructions at 24 (emphasis added). As discussed above with respect to Pfizer, because no other mechanism of action was suggested in the record, the jury could not therefore have *720reasonably inferred any other mechanism of action by which Rebif ® treats MS. Accordingly, JMOL of inducement against Serono is appropriate because no reasonable jury could have concluded that Serono did not intend that Rebif ® be used for immunomodulation in the treatment of MS.
The Court therefore turns to Defendants' other basis to uphold the verdict. As discussed above, the parties offer competing interpretations of Verdict Form Questions 2 through 5. On the one hand, Biogen reads the jury having not answered Questions 3, 4, and 5 as showing that the jury did not reach the issue of Serono's reasonable, good-faith belief of noninfringement in making its determination of induced infringement. The jury was directed by the Verdict Form to answer Question 3, 4, and 5 only if it answered "Yes" to Question 2. See Verdict Form at 2. In other words, only if the jury found that Serono induced infringement did it then need to decide whether, and for what period of time, Serono had a valid defense to rebut such a finding of liability. See
The Court is disinclined to give credence to non-answers by the jury. In addition, the directive on the Verdict Form to bypass Questions 3,4, and 5 essentially instructed the jury to only consider Serono's reasonable, good-faith belief defense in the event it found that Serono had actively induced infringement. However, even if the Court were to agree with Defendants' interpretation of the Verdict Form-that the jury did, in fact, conclude that Serono did not induce infringement because the jury found that Serono held a reasonable, good-faith belief in noninfringement-the jury's verdict still cannot stand because it is not supported by substantial evidence. The jury heard evidence that as of March of 2016, when the Court issued its claim construction decision construing claim 1 as a one-step method, Serono no longer believed in its three-step claim construction. See 2/8/18 AM Tr. at 73:11-74:21 (Einav); 2/8/18 PM Tr. at 15:4-21 (Einav) (testifying that prior to the Court's claim construction ruling, Serono "believed for all that time that we are talking about a three-step process," and that subsequent to the Court's claim construction it acknowledged that this ruling "is the law and this is what we accept and this is what we understand"). Thus, substantial evidence does not support a finding that Serono held its belief of noninfringement at all times following the issuance of the '755 patent on September 15, 2009.
Accordingly, the Court grants Biogen's Rule 50(b) JMOL motion as to induced infringement by Serono and vacates the jury's verdict in favor of Serono. For the same reasons that the Court grants Biogen's JMOL motion, the Court concludes that the jury's verdict is against the clear weight of the evidence and conditionally orders a new trial on induced infringement by Serono pursuant to Rule 50(c)(1). Biogen's alternative request for a new trial under Rule 59 is denied as moot.
3. Invalidity Defenses Not Litigated
(a) Applicable Legal Principles
"Under Rule 50, a court should render judgment as a matter of law when 'a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue.' " Reeves ,
"While waiver, as a general principle, is not unique to patent law," courts in the Third Circuit have applied Federal Circuit precedent to the question of whether a patent-law-specific defense is waived. See, e.g., Cubist Pharms., Inc. v. Hospira, Inc. ,
Biogen seeks a judgment as to certain affirmative defenses that Defendants included in their Answers but purportedly "discarded" at trial: (1) obviousness-type double patenting; (2) anticipation based on United States Patent No. 5,460,811 (the "Goeddel patent") ; and (3) improper inventorship under
In response, Defendants concede that they did not present any evidence in support of these defenses at trial. However, Defendants contend that Biogen's request is inappropriate because a Rule 50 JMOL motion is limited to issues on which "a party has been fully heard ... during a jury trial." Defs. Opp. at 28 (quoting Fed. R. Civ. P. 50(a)(1) ). According to Defendants, Biogen improperly seeks an advisory opinion on issues that were not litigated.
(c) Defendants Waived Their Non-Litigated Defenses
Given that Defendants had the opportunity to either present evidence on their invalidity defenses or else withdraw these defenses, and yet chose inaction, a finding of waiver is appropriate. See Acorda Therapeutics, Inc. v. Roxane Labs., Inc. , No. 14-882,
The Federal Circuit has explained that "[i]t is a claimant's burden to keep the district court clearly apprised of what parts of its claim it wishes to pursue and which parts, if any, it wishes to reserve for another day." Silicon Graphics, Inc. v. ATI Techs., Inc. ,
The Court also finds in the alternative that, even if Defendants had not waived their defenses of obviousness-type double patenting and anticipation by the Goeddel patent, Defendants failed to present clear and convincing evidence that the '755 patent claims are invalid on either of those two grounds. The Court has "assessed both what the parties expected to try given their statements and conduct and what they actually litigated at trial." Alcon Research ,
Contrary to Defendants' assertion, Alcon Research does not preclude the Court deciding the merits of their non-litigated defenses. In Alcon Research , the defendant sought JMOL of noninfringement for two patents where the plaintiff "neither put forward evidence of infringement nor formally obtained a dismissal of the claims involving those patents from its complaint prior to trial."
Unlike the plaintiff in Alcon Research , Defendants (i) did not provide pre-trial notice to their adversary that they were withdrawing any of the challenged defenses; and (ii) included their obviousness-type double patenting and anticipation by the Goeddel patent defenses in their pretrial submissions to the Court. Alcon Research does not appear to preclude the entry of JMOL where a defendant chooses not to adduce evidence in such circumstances. Indeed, courts have stated that entry of judgment would be appropriate in these circumstances. See, e.g., Innogenetics, N.V. v. Abbott Labs. ,
With respect to Defendants' improper inventorship defense, as with their defenses of obviousness-type double patenting and anticipation by the Goeddel patent, Defendants pled this defense in their Answers but did not request a jury instruction or Verdict Form question on this defense, did not move for JMOL on this defense, did not seek to withdraw this defense before trial, and did not present any evidence of this defense during trial. Unlike the other challenged defenses, however, Defendants did not identify their inventorship defense in the Joint Pretrial Statement or their Trial Brief. Given that Defendants did not raise this defense in their pretrial submissions and did not otherwise pursue this defense in the case, the Court considers Defendants' improper inventorship defense abandoned but finds that an entry of judgment on this defense based on an alleged failure of proof is inappropriate. See Apple, Inc. v. Samsung Elecs. Co. ,
In sum, the Court concludes that the defenses of obviousness-type double patenting, anticipation by the Goeddel patent, and improper inventorship that Defendants could have asserted against the '755 patent claims but did not litigate at trial, as indicated above, are deemed waived.
4. Subsidiary Damages Issues
(a) Applicable Legal Principles for Patent Damages
A patent owner, upon a finding that a patent is infringed, is entitled to recover "damages adequate to compensate for the infringement, but in no event less than a reasonable royalty."
There is "no particular required method to prove but for causation" in patent cases. Mentor Graphics ,
The Federal Circuit has instructed that the "but for" inquiry "requires a reconstruction of the market, as it would have developed absent the infringing product, to determine what the patentee 'would ... have made.' " Grain Processing Corp. v. Am. Maize-Prods. Co. ,
"The goal of lost profit damages is to place the patentee in the same position it would have occupied had there been no infringement." Mentor Graphics ,
The jury did not reach the damages questions on the Verdict Form because it found that the '755 patent claims were invalid as anticipated over the prior-art uses of native, human interferon-ß. See Verdict Form at 5-6, Qs. 13-18. Rule 50(b) permits post-trial JMOL motions as to issues "not decided by a verdict." Fed. R. Civ. P. 50(b). Biogen requests that if the Court enters JMOL in its favor on anticipation, the Court should schedule a new trial on damages. In addition, Biogen asks that the Court either (1) enter judgment in its favor as to three subsidiary damages-related issues and conditionally grant a new trial under Rule 50(c); or (2) in the alternative, grant a new trial on all damages issues under Rule 59. Biogen Br. at 35.
With respect to the first subsidiary damages issue, in seeking JMOL, Biogen reiterates *726essentially the same argument it made in opposition to Defendants' motion for partial summary judgment as to Biogen's claim of lost profits. As discussed in the Court's Opinion denying Defendants' summary judgment motion, the parties' dispute with respect to Biogen's entitlement to lost profits damages concerns a Nonsuit and Option Agreement, entered into by Serono and Biogen in October of 2000 (STX-0166). ECF No. 884 at 2. That agreement gave Serono certain rights, including an option to obtain a license to the patent application that later issued as the '755 patent. Serono's option to obtain a license to the '755 patent was available to Serono when the '755 patent issued in September of 2009. It appears that, to date, Serono has not exercised its option, and the option remains available.
As it did on summary judgment, Biogen contends that exercising the option under the Nonsuit and Option Agreement is not an "alternative action," and that "licensed Rebif" is not a non-infringing alternative. Biogen Br. at 35-37. Biogen asserts that "the Federal Circuit and various district courts have rejected the notion that the mere right to take a license precludes recovery of lost profits." Id. at 36 (citations omitted). Biogen cites Immersion Corp. v. HTC Corp. , No. 12-259,
In opposition, Defendants contend that none of Biogen's cited cases "involved a unilateral 'right' to participate in the market," and disagree with Biogen's interpretation of the Immersion court's decision, which, in Defendants' view, merely "rejected as 'too far' the argument that the defendant would have taken a license not only to the patents, but to non-infringing products as well." Defs. Opp. at 29 (citing Immersion ,
(c) Biogen Is Not Entitled to JMOL as to Subsidiary Damages Issues
The Court declined to conclude on summary judgment that the Nonsuit and Option Agreement precludes Biogen's claim of lost profits as a matter of law. In particular, the Court determined that Serono's motion raised genuine issues of material fact that were appropriate for a jury's consideration. ECF No. 884 at 10-12. As observed in this Court's prior decision, other district courts faced with arguments similar to those Defendants raised have sent the issue to the jury for resolution. See Cardiac Pacemakers, Inc. v. St. Jude Med., Inc. ,
B. Defendants' Post-Trial Motions
Defendants move for JMOL under Rule 50(b) as to (1) patent ineligibility; (2) obviousness; (3) lack of enablement and lack of adequate written description; (4) contributory infringement by Pfizer; and (5) lost profits damages. The Court addresses each of Defendants' motions in turn. The Court also addresses Biogen's JMOL motion as to Defendants' patent-ineligibility defense, specifically, Biogen's contention that Defendants waived their defense and that, even absent waiver, Defendants' defense fails on the merits.
1. Patent Eligibility (Defendants' and Biogen's Motions)
(a) Applicable Legal Principles for Patent Eligibility
Section 101 of the Patent Act states that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof" may obtain a patent.
In Mayo Collaborative Services v. Prometheus Laboratories, Inc. ,
The Supreme Court has explained that laws of nature, natural phenomena, and abstract ideas are not patentable because "they are the basic tools of scientific and technological work," Mayo ,
In addition, the Supreme Court has described the second step of the Alice inquiry as a search for an "inventive concept"-i.e., an element or combination of elements that is "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself." Alice , 134 S.Ct. at 2355 (quoting Mayo ,
(b) Waiver of Defendants' Patent-Ineligibility Defense
As a threshold matter, Biogen contends, that the Court need not reach the merits of Defendants' patent-ineligibility challenge on the ground that the defense, which allegedly rests on disputed facts, was never presented to the jury and is therefore waived. Biogen points out that while the Joint Pretrial Statement lists patent eligibility among the issues of law to be litigated, (ECF No. 916 at 13), and Defendants' Trial Brief similarly contends that the '755 patent claims are patent ineligible, (ECF No. 901 at 2), Defendants did not seek resolution before or during the trial of disputed facts upon which the defense rests.24 Biogen Opp. at 8-11. Specifically, Biogen asserts that Defendants did not move for summary judgment on this defense, nor did they present this defense to the jury. Biogen further contends that Defendants' decision to raise their patent-ineligibly defense in a Rule 50(a) motion is prejudicial to Biogen because it deprived Biogen of the ability to develop a record to effectively respond to Defendants' arguments. See 6/6/18 Tr. at 187:15-19.
By contrast, Defendants contend that questions of law such as patent eligibility are "regularly vetted in a Rule 50 motion when not presented to the jury" and that any facts underlying the legal defense are undisputed. ECF No. 1017 at 3. In Defendants' view, the " Section 101 issue is a straightforward legal issue for the Court that can be determined on the face of the patent and the patent claims alone." 6/6/18 Tr. at 199:22-25; see also id. at 199:6-9 (disputing that there are "facts that need to be adjudicated in connection with" determining whether the claims are patent eligible). Defendants also point out that "well-known model jury instructions lack any mention of eligibility." ECF No. 1002 ("Defs. Reply") at 4; see also 6/6/18 Tr. at 197:15-18.
The Court declines to preclude Defendants from raising a patent-eligibility challenge *730based on an alleged waiver. Unlike their defenses of obviousness-type double patenting, anticipation by the Goeddel patent, and improper inventorship, Defendants moved under Rule 50(a) for JMOL as to patent ineligibility during trial. The cases Biogen cites do not appear to compel a finding of waiver under these circumstances, given that in those cases either the movant had not moved for JMOL during trial or its Rule 50(a) motion provided insufficient notice of the precise legal challenge, an argument that Biogen does not appear to make.25 Moreover, as Defendants note, "as a procedural matter, the Federal Circuit has observed frequently that § 101 disputes may be amenable to resolution on motions for judgment on the pleadings, motions to dismiss, or summary judgment." TriPlay, Inc. v. WhatsApp Inc. , No. 13-1703,
Given these circumstances, the Court is disinclined to deny Defendants' motion on the ground that it is procedurally improper. The Court therefore addresses Biogen's alternative argument that, even if Defendants' defense were properly preserved, entry of JMOL that the '755 patent claims are patent eligible is appropriate because Defendants have not carried their burden of proving, by clear and convincing evidence, that the '755 patent claims are patent ineligible.
(c) Parties' Contentions on Patent Eligibility
Defendants contend that the '755 patent claims are ineligible under
With respect to the second step of the Alice inquiry, Defendants assert that the claims do not contain an inventive concept because they add no improvement or anything else new in terms of treatment. Id. at 7-10. In Defendants' view, the concept of administering a therapeutically effective amount of a "preexisting polypeptide" to a patient in need of treatment for certain diseases does not render the claims patent eligible because "practitioners had long administered native human IFN-ß to patients to treat these diseases." Id. at 1-2; see also Defs. Reply at 3 (arguing that the claims lack an inventive concept because they "provide no unconventional manipulation of or improvement to the known methods of treating viruses with IFN-ß").
In response, Biogen argues that Defendants' § 101 challenge lacks legal support. With respect to the first step of the Alice inquiry, according to Biogen, method of treatment claims, including those involving the administration of naturally-occurring products, have consistently been held patent eligible. Biogen Opp. at 12-17. Biogen also asserts that the claims exclude treatment with native interferon-ß and are instead limited to treatment with recombinant interferon-ß made in a non-human host, and thus "pose[ ] no Section 101 concerns." Id. at 6; see also id. at 14-16. Biogen further contends that there is no legal support for Defendants' proposition that a method of treatment with a man-made protein is ineligible for patenting if that protein is identical to a naturally-occurring protein, and that even if there were support for such a proposition, the undisputed trial evidence shows that the three-dimensional proteins of native and recombinant interferon-ß are not identical. Id. at 16-17.
With respect to step two of the Alice inquiry, Biogen contends that a jury could have reasonably found based on the record evidence that determining whether recombinant interferon-ß made in a non-human host had biological activity akin to that of the native protein and could thus be used as a therapeutic agent was anything but "routine and conventional." Id. at 2, 17-19. On this point, Biogen argues that the jury heard ample evidence that the "best molecular biologists labored-in a worldwide, round-the-clock race" to express recombinant interferon-ß and to "prove that the expressed protein had biological activity *732like native interferon-beta and thus could be used as a therapeutic treatment." Id. at 18 (citations omitted). In Biogen's view, "routine and conventional is a harder standard to meet than obvious," (6/6/18 Tr. at 219:7-8), and here, the jury heard ample evidence on, and rejected, Defendants' obviousness defense. Biogen Opp. at 19 ("[I]t is simply not possible for the subject matter of a patent claim to be both non-obvious but yet sufficiently well known to be 'routine and conventional.' "). Thus, according to Biogen, even if the evidence and arguments Defendants raise in their JMOL motion were presented to the jury, a reasonable jury could conclude that Defendants failed to establish by clear and convincing evidence that the '755 patent claims are patent ineligible.
(d) The '755 Patent Claims Are Patent Eligible
Under step one of the Alice inquiry, the Court determines whether the '755 patent claims are directed to a patent-ineligible concept. In doing so, the Court looks at the "focus" of the claims and their "character as a whole." Elec. Power ,
Underlying Defendants' patent-ineligibility argument is the premise that naturally-occurring interferon-ß and recombinant interferon-ß share the same linear sequence of amino acids. In Defendants' view, under Myriad II and Roslin , this shared amino-acid sequence alone renders recombinant interferon-ß ineligible under § 101. See Defs. Br. at 6 (Defendants contending that "like the clones in Roslin and the DNA strands in Myriad II , the recombinant IFN-ß whose use the '755 patent covers is an 'exact genetic cop[y] of patent ineligible subject matter' that is not 'distinct in any relevant way' from its native counterpart" (quoting Roslin ,
Moreover, there is a distinction in the case law with regard to the patentability of method of treatment claims on the one hand and product claims and claims directed to methods of diagnosis on the other. As discussed above, the '755 patent claims a method for immunomodulation, or treating viral diseases, cancers, or tumors, by administering to a patient a "therapeutically effective amount" of a composition comprising a "recombinant" interferon-ß polypeptide produced in a "non-human host" that had been "transformed by a recombinant DNA molecule." The Court previously construed claim 1 of the '755 patent as reciting a "one-step method of 'administering' to a patient in need the specified recombinant HuIFN-ß." Markman Op. at 17. Recent decisions by the Supreme Court and Federal Circuit addressing § 101 in the contexts of genetics and medical treatment inform this Court's analysis. With respect to the distinction drawn in the case law between method of treatments claims and other types of claims and its impact on this case, this Court looks first to the Supreme Court's Mayo decision. The Supreme Court in Mayo held that a claim directed to a diagnostic method for "optimizing" the dosage of certain drugs by administering those drugs to a patient and measuring the level of metabolites in the blood, wherein the level of metabolites indicated whether to adjust the dosage, recited a natural law.
Earlier this year, the Federal Circuit in Vanda examined the Supreme Court's Mayo and Myriad I decisions in determining the patent eligibility of a method of treatment claim involving the step of "determining" with a genotyping assay, and then "administering" a certain amount of drug based on that determination in order to "treat a particular disease."
Defendants attempt to analogize claim 1 of the '755 patent to the claims at issue in Mayo , (6/6/18 Tr. at 230:12-25), but the claims in Mayo were directed to a diagnostic method and not to the application of a drug to treat a particular disease. While the Mayo claims recited a step of administering a drug to a patient, that step was performed in order to gather data about the natural relationships, and thus was ancillary to the overall diagnostic focus of *734the claims.28 As the Federal Circuit recognized in Vanda , method of treatment claims (which apply natural relationships as opposed to being "directed to" them) were identified by the Supreme Court as not being implicated by its Mayo and Myriad decisions because they "confine their reach to particular applications."
The method claims at issue in this case are thus also distinguishable from the claims held ineligible in Myriad II and Roslin . Myriad II and Roslin involved claims not to methods of treatment but rather to man-made, physical things that were identical to products of nature. For example, in Myriad II , the Federal Circuit held that the claimed single-stranded DNA primers, which had the same structure and function as naturally-occurring primers, were not patent eligible.
*735The Court has undertaken step one of the Alice inquiry as a legal issue based on a review of the '755 patent claims, as Defendants propose, and concludes that the claims are not directed to a patent-ineligible concept. Therefore, the Court need not reach step two of the Alice inquiry. See Vanda ,
Even if the Court were to proceed to step two of the Alice inquiry, for example, based on a finding that the '755 patent claims are directed to a product of nature, it would still deny Defendants' motion. The dispute at step two turns on whether the elements or combination of elements of the claims were "well-understood, routine, and conventional" as of June 6, 1980. The Court agrees with Biogen that the evidence presented at trial, even if not adduced for the specific purpose of establishing that step two was met, nonetheless bears on this question. See 6/6/18 Tr. at 218:14-220:1, 219:7-13; see also Exergen Corp. v. Kaz USA, Inc. ,
*7362. Obviousness
(a) Applicable Legal Principles for Obviousness
A patent claim is invalid if "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains."
A person shall be entitled to a patent unless ... before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
The jury was instructed that it "must determine the date of the invention for the alleged prior art" which "can be the date when the invention of the prior art was reduced to practice or when the invention was conceived provided the inventors were diligent in reducing the invention to practice." Final Jury Instructions at 29. The jury was also instructed that:
Conception is the mental part of an inventive act, i.e., the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention, enough that one skilled in the art could understand the invention as it is thereafter to be applied in practice. An idea is definite and permanent when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan he hopes to pursue. Where the idea is in constant flux, it is not definite and permanent. A conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor's idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice.
Finally, "because obviousness, like any other ground of invalidity, must be established by clear and convincing evidence," the defendant's burden on a JMOL motion is "doubly high: it must show that no reasonable jury could have failed to conclude that [the defendant's] case had been established by clear and convincing evidence."
*737Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp. ,
The jury found that the '755 patent claims were not "invalid as obvious in view of the activities of Dr. Tadatsugu Taniguchi, Dr. Jan Vilcek, Dr. David Goeddel, or other prior art." Verdict Form at 3, Q. 9. Defendants assert that there is an insufficient evidentiary basis to uphold the jury's finding that the '755 patent claims are not invalid for obviousness, and that Defendants "presented largely uncontested evidence" that the claims would have been obvious to a POSA as of June 6, 1980.30 Defs. Br. at 11.
Defendants identify three "separate and independent" grounds on which they contend the jury should have found the '755 patent claims invalid for obviousness. Id. at 10. First, Defendants rely on the scientific work of Tadatsugu Taniguchi, Ph.D. at Harvard University prior to June 6, 1980. Specifically, Defendants rely on Dr. Taniguchi's synthesis of the "117 plasmid" that was designed to produce mature, biologically-active, recombinant human interferon-ß in Escherichia Coli ("E. coli ") bacteria cells, and they identify "at least three occasions" before June 6, 1980 on which the 117 plasmid purportedly "produced positive results demonstrating the production of biologically active recombinant JPN-ß in E. coli in controlled experiments." Id. at 11-12. Defendants cite New York University School of Medicine Professor Jan Vilcek, M.D., Ph.D.'s trial testimony that his blinded cytopathic effect assay of Dr. Taniguchi's plasma samples provided "ultimate proof" that Dr. Taniguchi had produced biologically-active recombinant interferon-ß in E. coli in May of 1980. Id. at 12.
Second, Defendants rely on the scientific work of David Goeddel, Ph.D. at Genentech, Inc. prior to June 6, 1980. Specifically, Defendants rely on Dr. Goeddel's synthesis of the "Trp-69 plasmid" designed to produce mature, biologically-active recombinant interferon-ß in E. coli , and they identify "at least three occasions" before June 6, 1980 on which Dr. Goeddel purportedly "observed biological activity in experiments testing the product of this plasmid." Id. at 14. According to Defendants, the uncontroverted evidence at trial showed that Dr. Taniguchi's and Dr. Goeddel's plasmids could be "scaled up, purified, formulated, and administered using techniques well known by 1980." Id. at 15.
Third, Defendants rely on the publication of the DNA sequence for interferon-ß and the alleged admissions made by Biogen in an affidavit by '755 patent inventor Dr. Fiers, dated November 19, 2001, which Biogen submitted to the Canadian Patent Office during a conflict proceeding involving Dr. Fiers's Canadian Application No. 374,378 (the "Fiers Affidavit") (STX-0002). In particular, Defendants contend that Biogen admitted that, with the interferon-ß DNA sequence in hand, as of June 6, 1980 a POSA would have expected to be able to produce mature, biologically-active, recombinant human interferon-ß in E. coli that could be used for treating tumors and viruses in humans. Id. at 16-17.
In response, Biogen argues that none of the three grounds identified by Defendants merit overturning the verdict, and that Defendants' cited evidence is far from uncontested.
*738Biogen contends that there is more than sufficient evidence to support the jury's finding that neither Dr. Taniguchi nor Dr. Goeddel had made the claimed invention prior to June 6, 1980 and, consequently, a POSA would not have found the '755 patent claims obvious in light of the work of these scientists. Biogen Opp. at 20-23. Biogen also asserts that the jury was free to credit the evidence presented by Biogen, including testimony by its experts Michael Green, M.D., Ph.D., a Professor and Chair of the Department of Molecular, Cell, and Cancer Biology at the University of Massachusetts Medical School and Director of the school's Cancer Center (ECF No. 916 at 16; 1/29/18 AM Tr. at 18:15-22), and Christopher Garcia, Ph.D., a Professor of Molecular and Cellular Physiology and a Professor of Structural Biology at Stanford University (ECF No. 916 at 21-22; 2/15/18 PM Tr. at 41:22-25). In Biogen's view, the jury was free to believe Dr. Green's and Dr. Garcia's testimony that a POSA would not have known or reasonably expected that recombinantly-produced interferon-ß would be biologically active. Biogen Opp. at 24. Biogen further contends that Defendants walked the jury through the Fiers Affidavit on multiple occasions and in great detail during the trial, and that the jury was free to reject Defendants' obviousness arguments based thereon. Id. at 24-25.
(c) Defendants Are Not Entitled to JMOL of Obviousness
The Court finds that substantial evidence supports the jury's verdict that the '755 patent claims are not invalid for obviousness. The jury was presented with ample fact testimony, expert testimony, and exhibits pertaining to Defendants' obviousness defense. In particular, the jury heard testimony and evidence concerning Dr. Taniguchi's series of experiments carried out prior to June 6, 1980 to test for biological activity of recombinant human interferon-ß made in E. coli . In making its obviousness determination, the jury was free to weigh the evidence of Dr. Taniguchi's individual experiments that Defendants highlight in their brief against the contrary evidence that certain of Dr. Taniguchi's other experiments yielded false positives, inconclusive results, or results showing no biological activity. See, e.g. , Dr. Taniguchi's Laboratory Notebook (PTX0411) at 6-33, 36-63; 2/5/18 Tr. at 142:2-144:4, 160:5-166:16, 167:1-20 (Taniguchi); 1/24/12 Weissmann Dep. Tr. at 138:2-139:5 (Dr. Taniguchi's mentor testifying that Dr. Taniguchi "did not get expression of biologically-active protein"). For instance, as recorded in Dr. Taniguchi's laboratory notebook page dated June 4 and 5, 1980, one of Dr. Taniguchi's experiments yielded a false positive where the result was marked "should be negative." PTX0411 at 53; see also 2/13/18 AM Tr. at 25:24-28:13 (Lodish) (testifying that false positives can be due to contaminants). In addition, the jury reasonably could have discounted Dr. Vilcek's testimony concerning Dr. Taniguchi's allegedly favorable results in light of this contrary evidence, and/or credited Dr. Vilcek's other testimony that it was "very possible" that they were still testing for biological activity of recombinant interferon-ß after June 6, 1980. 2/6/18 PM Tr. at 51:13-18.
Similarly, the jury was free to weigh the evidence of Dr. Goeddel's three pre-June 6, 1980 experiments that purportedly confirmed biological activity against the contrary evidence that over 100 of Dr. Goeddel's assays, conducted before and after June 6, 1980, were inconclusive or yielded negative results. See 2/20/18 AM Tr. at 64:22-65:7, 65:16-68:17, 69:21-70:4 (Green). For instance, in an experiment on May 20, 1980 upon which Defendants rely and about which Dr. Goeddel had recorded "Looks good!" in his laboratory notebook, *739Dr. Goeddel detected activity only in a mixed pool of clones that would require further, clone-by-clone testing. See Dr. Goeddel's Laboratory Notebook (STX-0053) at 16; 2/20/18 AM Tr. at 65:12-66:17 (Green) (testifying that Dr. Goeddel's written comment about his preliminary result when read in the context of the laboratory notebook page was merely an "instruction to keep working" rather than a "declaration of victory"). Dr. Green testified that these results were not conclusive, (2/20/18 AM Tr. at 66:12-24), and in fact, when Dr. Goeddel assayed individual clones eight days later, all of his results were negative, (id. at 66:25-67:4; STX-0053 at 20). The jury also saw evidence that in later experiments in May of 1980, Dr. Goeddel noted that his assay was "not a good assay," (STX-0053 at 20), and that the "cells look unhealthy," (PTX0029A at 3375). See 2/20/18 AM Tr. at 67:5-11 (Green); see also id. at 71:20-22 (Green) (testifying that there was "no doubt in [his] mind" that Dr. Goeddel did not possess recombinant interferon-ß prior to June 6, 1980). Thus, there was sufficient evidence for a reasonable jury to find that Dr. Taniguchi and Dr. Goeddel had not made biologically-active, recombinant interferon-ß by June 6, 1980.31
Defendants contend, however, that the testimony of their experts Dr. Lodish and Dr. Gutterman "provided substantial evidence" that a POSA would have reasonably expected to be able to produce recombinant interferon-ß in E. coli and that the protein produced would have the biological activity of native interferon-ß. Defs. Br. at 16. Contrary to Defendants' assertion, on a Rule 50(b) JMOL motion, the question is not whether substantial evidence supports the moving party's position, but rather whether substantial evidence supports the jury's verdict. See Power Integrations ,
"[F]aced with competing expert testimony," the jury was free to disbelieve Defendants' experts and credit Biogen's experts. Intellectual Ventures I LLC v. Motorola Mobility LLC ,
Furthermore, as the Court stated in its decisions denying Defendants' Motion for Summary Judgment of Invalidity Under
Viewing the evidence in the light most favorable to Biogen, the Court finds that substantial evidence supports the jury's finding that the '755 patent claims are not invalid for obviousness. Accordingly, the Court denies Defendants' Rule 50(b) JMOL motion as to obviousness.
3. Enablement and Written Description
(a) Applicable Legal Principles for Enablement and Written Description
The first paragraph of
The written description requirement mandates that "the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co. ,
Consistent with the Court's rulings denying Defendants' Motion for Summary Judgment of Invalidity Under
The jury found that the '755 patent claims were neither invalid for lack of enablement nor for lack of adequate written description. Verdict Form at 4, Qs. 10-11. Defendants contend that judgment of invalidity for lack of enablement and lack of adequate written description should be entered. Specifically, Defendants assert that the evidence and testimony presented at trial established that the '755 patent fails to enable and describe expression of recombinant interferon-ß polypeptides in the full range of "non-human hosts" for administration to human patients. Defs. Br. at 19-21. Defendants also contend that the '755 patent fails to enable and describe the claimed methods of treatment "using the wide scope of the claimed variant polypeptides."
Biogen contends, in response, that sufficient evidence supports the jury's verdict that the claims were neither invalid for lack of enablement nor for lack of adequate written description, and that Defendants merely rehash the arguments raised (and rejected) on summary judgment. Biogen Opp. at 26. Biogen also asserts that Defendants recount their own experts' testimony but omit the contrary evidence on which the jury was entitled to rely. Id , at 26-32.
(c) Defendants Are Not Entitled to JMOL of Lack of Enablement or Lack of Adequate Written Description
The Court finds that substantial evidence supports the jury's verdict that the claims are not invalid for lack of enablement or lack of adequate written description. Defendants' motion appears to focus on the scope of the non-human hosts and recombinant polypeptides. As this Court stated in its decision denying Defendants' Motion for Summary Judgment of Invalidity Under
(1) Non-Human Hosts
With respect to Defendants' contention as to the '755 patent's purported failure to enable expression of recombinant polypeptides in non-human hosts other than E. coli for administration to a patient, Defendants cite Dr. Lodish's trial testimony. They omit, however, the fact that the jury also heard testimony from Biogen's expert, Dr. Green, regarding the availability of non-human hosts other than E. coli as of June 6, 1980 as identified in the literature and the '755 patent itself. See 2/20/18 AM Tr. at 26:21-27:8, 106:25-111:13; PTX0001 ( '755 patent) at 13:54-64. Additionally, the jury heard evidence that Defendants' own expert, Dr. Lodish, previously testified in a separate lawsuit that "[b]y February 25, 1980 many types of cells had been used as *743host cells, and workers of ordinary skill in the art had various types of cultured cells that could be used as host cells in transformation experiments." Initial Expert Report of Harvey F. Lodish, Ph.D. dated August 27, 2004 in In re Columbia University Patent Litigation , No. 04-MD-01592 (D. Mass.) (PTX1069) at 24; see also 2/20/18 AM Tr. at 109:3-110:18 (Green). Citing various pre-1980 publications, Dr. Lodish had testified in the prior lawsuit that "[s]everal types of human, mouse, and Chinese hamster cell lines, including Chinese Hamster Ovary cells lines, were in routine use." PTX1069 at 24; see also
With respect to written description, although Defendants again rely on Dr. Lodish's testimony regarding the '755 patent's purported failure to adequately describe methods of treatment using recombinant polypeptides produced in hosts other than E. coli , the jury also heard Dr. Green's testimony that the '755 patent specification expressly describes other host cells that could be used besides E. coli , including Pseudomonas, Bacillus subtilis, Bacillus stearothermophilus and other bacilli, yeasts and other fungi, and plant and animal cells. See
(2) Recombinant Polypeptides
With respect to Defendants' argument that the '755 patent fails to enable and describe the full range of claimed recombinant interferon-ß polypeptides, Biogen's expert, Dr. Garcia, testified that the '755 patent describes the structures likely to be common to the polypeptides meeting the limitations of claim 1, informs the reader "what kinds of changes you can make to the polypeptides while staying within the scope of the patent," including "common optimization" techniques, and "discloses a whole montage of possible tests that one could use to assess the function and the activity of the beta interferon." 2/15/18 PM Tr. at 86:9-89:2. In addition, Dr. Green and Dr. Garcia each described to the jury the various tests for biological activity disclosed in the '755 patent. See 2/20/18 AM Tr. at 30:23-33:5 (Green); 2/15/18 PM Tr. at 88:5-89:2 (Garcia); see also 2/7/18 PM Tr. at 62:15-18 (Gutterman) (agreeing that the '755 patent offers "extensive teaching" about how to *744test whether any individual polypeptide has the required biological activity). Moreover, Dr. Green opined that the patent describes and enables the therapeutic use of recombinant interferon-beta-like proteins. 2/20/18 AM Tr. at 23:8-12. Again, while Defendants cite expert testimony favorable to their § 112 invalidity defenses, as discussed above with respect to the jury's obviousness determination, faced with competing expert testimony, the jury was free to disbelieve Defendants' experts and credit Biogen's experts. See Intellectual Ventures , 870 F.3d at 1327 ; MobileMedia ,
(3) Immunomodulation
Sufficient evidence also supports the jury's finding that the '755 patent enables and describes the use of recombinant interferon-ß polypeptides for immunomodulation. The Court provided the jury with its definition of the term "immunomodulation" as "regulation of the immune system by immunopotentiation (up-regulation) or immunosuppression (down-regulation)." Final Jury Instructions at 17. The '755 patent discloses that interferon-ß may "play a role in regulation of the immune response" and "can be both immunopotentiating and immunosuppressive in vivo and in vitro." PTX0001 ( '755 patent) at 3:33-36. The jury was free to reject Dr. Gutterman's testimony that "a clinician would need to know how to 'selectively obtain' upregulation or downregulation of the immune system in order to use IFN-ß in a therapeutically effective manner." Defs. Br. at 22 (citing 2/7/18 AM Tr. at 75:13-19 (Gutterman) ). Contrary to Defendants' assertion, there is no requirement that immunomodulation means exclusively up-regulation or exclusively down-regulation, and the jury was not asked to determine whether, in treating MS, interferon-ß acts by only up-regulation or only down-regulation. Moreover, the jury heard expert testimony and was presented with evidence, including Pfizer's and Serono's own internal presentations and statements to the FDA, showing that interferon-ß upregulates some parts of the immune system and downregulates others in treating MS. See, e.g. , 1/29/18 PM Tr. at 22:17-19, 23:17-29:11, 32:14-33:24, 38:19-24, 40:9-42:2 (Kinkel); PTX0059 (Rebif ® BLA) at 163; PTX0061 (Rebif ® BLA) at 19-20; PTX0227 (Serono presentation) at 1, 26-29; PTX0659 (Pfizer presentation) at 14, 87; PTX0056 (Betaseron ® Product License Application) at 77-78, 922. The jury was free to believe this evidence and testimony in reaching its verdict on Defendants' § 112 defenses. Finally, a reasonable jury could have also credited the evidence that the issue of whether the patent sufficiently describes and enables the full scope of the claims was before the PTO when it issued the patent. See, e.g. , 2/15/18 PM Tr. at 99:2-11 (Garcia); 2/20/18 AM Tr. at 111:9-13 (Green); 2/7/18 AM Tr. at 94:24-95:24 (Gutterman); see also Microsoft ,
Viewing the evidence in the light most favorable to Biogen, the Court finds that substantial evidence supports the jury's finding that the '755 patent claims are not invalid for lack of enablement or lack of adequate written description. Accordingly, the Court denies Defendants' Rule 50(b) JMOL motion as to enablement and written description.
4. Contributory Infringement By Pfizer
(a) Applicable Legal Principles for Contributory Infringement
Section 271(c) of the Patent Act deems a "contributory infringer" one who "offers to sell or sells" within the United States a "component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in *745practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use."
The Federal Circuit has explained that the "ordinary meaning of a sale" under Section 271"includes the concept of a transfer of title or property" and may be determined by "the agreement by which such a transfer takes place." Halo Elecs., Inc. v. Pulse Elecs., Inc. ,
In addition, an "offer to sell is a distinct act of infringement separate from an actual sale" and "differs from a sale in that an offer to sell need not be accepted to constitute an act of infringement." Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc. ,
The jury found that Pfizer "has contributed to the direct infringement of the asserted claims of the '755 patent by healthcare professionals and/or patients by selling or offering to sell Rebif." Verdict Form at 3, Q. 8. Defendants contend that there is no legally sufficient evidentiary basis on which the jury could have found that Pfizer has contributorily infringed the asserted claims of the '755 patent under 35 U.S.C § 271(c).33 According to Defendants, while Pfizer has previously co-promoted Rebif ® with Serono, Pfizer did not and does not sell, offer to sell, or import Rebif® into the United States.34 Defs. Br. at 23. Defendants assert *746that the jury heard evidence that while Pfizer has the right to promote (or detail) Rebif ®, it does not have the right to sell Rebif ®, as reflected in Serono and Pfizer's collaboration agreement dated July 10, 2002 (STX-946). Id. at 23-24. The collaboration agreement provides that Serono "grants to Pfizer the exclusive right, together with SERONO, to promote and Detail (but not to sell) the Product in the Territory in the Field." STX-946 at 10. Defendants also cite deposition testimony of Pfizer's corporate representatives in arguing that "Pfizer indisputably has no title or property interest in Rebif to transfer." Defs. Br. at 23-24. Moreover, in Defendants' view, "Pfizer cannot offer to sell what it does not have the right or ability to sell." Id. at 24.
Biogen contends, in opposition, that sufficient evidence supports the jury's determination that Pfizer sells Rebif ®, offers to sell Rebif ®, or both. Biogen Opp. at 32. With respect to Pfizer purportedly selling Rebif ®, Biogen asserts that Defendants' brief omits the collaboration agreement's provision requiring Serono and Pfizer to "work diligently and use reasonable efforts to promote the sale of" Rebif® in the United States. Id. at 33-34; STX-946 at 22, § 5.1. Biogen also contends that the jury heard evidence regarding Pfizer's efforts to support the sale and marketing of Rebif ® in exchange for a share of the net sales of Rebif ®, and that Serono and Pfizer do not know whether any given sale of Rebif ® is due to Serono's or Pfizer's detailing efforts. Biogen Opp. at 34-35. Moreover, Biogen asserts, in support of its argument that Pfizer offers to sell Rebif ®, that Pfizer's sales representatives visit thousands of doctors and nurses each year to "encourage them to prescribe Rebif ®," and that Defendants' argument that Pfizer cannot "offer to sell" Rebif ® because Pfizer cannot "sell" Rebif ® "blinks reality." Id. at 37-38.
(c) Defendants Are Not Entitled to JMOL of No Contributory Infringement By Pfizer
The Court finds that substantial evidence supports the jury's verdict that Pfizer is liable for contributory infringement. In particular, substantial evidence supports a finding that Pfizer at least "offers to sell" Rebif® within the United States.
Defendants contend that Pfizer cannot, as a matter of law, "offer to sell" Rebif ® within the meaning of § 271(c) because Pfizer merely details Rebif ® and Serono, not Pfizer, is the company that manufactures Rebif ® and ultimately transfers title to the drug. See, e.g. , Defs. Br. at 24 ("Pfizer cannot offer to sell what it does not have the right or ability to sell."); id. at 24 n.5 (Pfizer "could not enter into any bargain regarding the sale of Rebif"). Defendants do not appear to cite authority that supports such a proposition. Nor have Defendants persuaded this Court to hold as a matter of law that a contractual provision granting a company the right to promote (or detail) "but not to sell" a product singularly shields that company from liability for "offering to sell" a product under § 271. Rather, determining whether there has been an "offer to sell" requires applying traditional contract law principles to the particular facts of the case, taking into account the circumstances in which such offers are made. In this case, the jury heard testimony regarding the "structure and realities of the heavily regulated pharmaceutical industry." Christopher v. SmithKline Beecham Corp. ,
The evidence presented at trial, from which the Court draws all reasonable inferences in favor of Biogen, demonstrates that Pfizer's conduct at least constitutes an "offer to sell" Rebif ® within the meaning of § 271(c). For instance, Defendants' collaboration agreement explicitly requires that both Serono and Pfizer "work diligently and use reasonable efforts to promote the sale of" Rebif® in the United States. STX-946 at 22, § 5.1. The agreement also requires Serono to make "commission payments" to Pfizer based on a percentage of the net sales of Rebif ® and requires Pfizer to make sales of Rebif ® "a factor in the determination of the incentive compensation for its Sales Representatives."
In addition, Pfizer's sales team, comprised of about 75,000 sales representatives, visits healthcare professionals across the country to persuade them to prescribe Rebif ® to their patients. 1/31/13 Mehl Dep. Tr. at 21:13-22:15, 23:7-15, 31:3-6. Indeed, various Serono and Pfizer representatives testified regarding Pfizer's efforts to support the sale and marketing of Rebif ® in exchange for a share of the net sales of Rebif ®. See, e.g. , 1/25/13 Gans Dep. Tr. at 23:8-24:3 (stating that both Serono and Pfizer are "involved in the ... actual sale of - or the promotion of Rebif to physicians at the ... sales level or the field level"); id. at 34:6-20 (Pfizer gets "a share of the net sales" of Rebif ®); 1/11/13 Huycke Dep. Tr. at 65:8-24 (explaining that Serono and Pfizer each deploys a salesforce across the United States and have a "shared responsibility" over the sale of Rebif ®); 2/13/13 Moore Dep. Tr. at 21:17-22:8, 22:10-21 (stating that "detailing is intended to lead to greater prescription, which would lead to sales"); 1/31/13 Mehl Dep. Tr. at 21:13-22:15, 23:7-15, 31:3-6 (explaining that there is a "sales team on both sides" and agreeing that Pfizer "sell[s] Rebif" by helping "promote the product through a contract with" Serono). Based on this evidence and testimony, a reasonable jury could have determined that Pfizer could, in fact, "enter into a bargain" regarding the sale of Rebif ®, and that a pharmacy would thereafter fill a prescription for Rebif ® from a physician visited by a Pfizer sale representative. See 1/11/13 Huycke Dep. Tr. at 74:21-75:13 (explaining that after a successful detail, typically "the prescription will be written in the form of an SRF, which can, one means, be faxed to the MS Lifelines or the prescription could be given to a specialty pharmacy, and that will trigger the reimbursement, the verification and eventually the product shipment").
*748Indeed, the evidence showed that neither Serono nor Pfizer knows whether any given sale of Rebif ® is due to Serono's or Pfizer's sales team's detailing efforts. See 1/25/13 Gans Dep. Tr. at 36:21-24 (explaining that there is "no mechanism" to track sales due to either company's marketing efforts); id. at 25:5-16 (stating that "[m]ost territories are shared by Pfizer and Serono" sales representatives and an individual doctor may get called on by a sales representative from both companies). That Serono is the source of Rebif ® and ultimately transfers title to Rebif ® does not preclude the jury's having found that Pfizer "offers to sell" Rebif ®.36 Sufficient evidence supports such a finding, and Defendants have not cited authority that warrants disrupting that finding.
Viewing the evidence in the light most favorable to Biogen, a reasonable jury could have found by a preponderance of the evidence that Pfizer is liable for contributory infringement. Accordingly, the Court denies Defendants' Rule 50(b) JMOL motion as to contributory infringement by Pfizer.
5. Lost Profits Damages
(a) Legal Principles for Lost Profits Damages
The legal principles for lost profits damages are set forth in the Court's discussion in Section III.A.4 above regarding Biogen's JMOL motion as to subsidiary damages issues.
As discussed above, the jury did not reach the damages questions on the Verdict Form, having concluded that the '755 patent claims are invalid as anticipated over the prior-art uses of native interferon-ß. Defendants seek a judgment that Serono's right to license the '755 patent forecloses Biogen's lost profits claim because "no reasonable jury could conclude that Serono would ever be off the market." Defs. Br. at 25. According to Defendants, Biogen's own witnesses testified that a market without Rebif ® is "inconceivable" and that the evidence showed that Serono would have exercised its unilateral right to sell Rebif ® under license rather than leave the market. Id. Defendants also reiterate the arguments in their Daubert motion to preclude Biogen's damages expert Kevin Murphy, Ph.D.'s testimony, arguing that his damages analysis improperly disregarded Serono's non-infringing alternative action and suggested that patent damages are intended to punish Serono rather than compensate Biogen. Id. at 26.
In response, Biogen contends that Defendants merely restate their arguments *749that the Court rejected in denying their summary judgment motion, in denying their Daubert motion against Dr. Murphy, and during the crafting of the jury instructions. Biogen Opp. at 38. Biogen also argues that contrary to Defendants' assertion, there was substantial evidence that Serono believed that the Nonsuit and Option Agreement did not even apply to sales of Rebif ®, and that this was the same evidence the Court considered when it denied Defendants' summary judgment motion. Id. at 39-40 (citing 7/22/16 Newland Dep. Tr. at 18:18-19:22, 42:20-44:4, 60:21-61:4, 61:7-61:24, 70:17-72:20, 72:22-24; 1/31/18 Tr. at 53:5-17 (De Luca); 3/22/16 Brudnick Dep. Tr. at 14:17-15:10).
(c) Defendants Are Not Entitled to JMOL as to Lost Profits Damages
As discussed above, the Court orders a new trial on all damages issues, including the issue of whether licensed Rebif ® constitutes a non-infringing alternative. Again, the Court declined to conclude on summary judgment that the Nonsuit and Option Agreement precludes Biogen's claim of lost profits as a matter of law. ECF No. 884. In particular, the Court determined that Serono's motion raised genuine issues of material fact that were appropriate for a jury's consideration. Id. at 10-12. In instructing the jury on the law of damages, the Court stated that the jury "must take into account, where relevant, alternative actions that Serono would have undertaken had it not infringed." Final Jury Instructions at 43. During the trial both sides presented expert testimony in support of their positions on this issue, and the jury did not reach the question of damages. Defendants largely reiterate the same case law they cited in their summary judgment motion as to Biogen's claim of lost profits, and have not cited new authority that would compel this Court to rule as a matter of law that the Nonsuit and Option Agreement forecloses Biogen's lost profits claim. Accordingly, the Court denies Defendants' Rule 50(b) JMOL motion as to lost profits damages.
IV. CONCLUSION
For the reasons discussed above, Biogen's JMOL motions with respect to anticipation, induced infringement against Pfizer and Serono, and certain non-litigated defenses are hereby GRANTED. The Court also conditionally orders a new trial on anticipation and induced infringement against Pfizer and Serono pursuant to Rule 50(c), and orders a new trial on all damages issues pursuant to Rule 59. Biogen's remaining JMOL motions and each of Defendants' JMOL motions are hereby DENIED. An appropriate Order will be entered.
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