Merck Sharp & Dohme Corp. v. Microspherix LLC

• Court: Court of Appeals for the Federal Circuit
• Decided: June 9, 2020
• Docket: 19-2197
• Status: Unpublished

Opinion

Case: 19-2197 Document: 45 Page: 1 Filed: 06/09/2020

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

MERCK SHARP & DOHME CORP., MERCK SHARP & DOHME B.V., ORGANON USA, INC., Appellants

v.

MICROSPHERIX LLC, Appellee ______________________

2019-2197, 2019-2200, 2019-2208 ______________________

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2018- 00393, IPR2018-00402, IPR2018-00602. ______________________

Decided: June 9, 2020 ______________________

JESSICA LYNN ELLSWORTH, Hogan Lovells US LLP, Washington, DC, for appellants. Also represented by SEAN MAROTTA, MICHAEL WEST; TRACEY DAVIES, Gibson, Dunn & Crutcher LLP, Dallas, TX; YU-CHIEH ERNEST HSIN, San Francisco, CA.

MARCUS EDWARD SERNEL, Kirkland & Ellis LLP, Chi- cago, IL, for appellee. Also represented by JAMES F. HURST; Case: 19-2197 Document: 45 Page: 2 Filed: 06/09/2020

2 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC

STEFAN MICHAEL MILLER, New York, NY; WILLIAM H. BURGESS, JOHN C. O'QUINN, Washington, DC. ______________________

Before LOURIE, MAYER, and REYNA, Circuit Judges. LOURIE, Circuit Judge. Merck appeals from three decisions of the United States Patent and Trademark Office’s Patent Trial and Ap- peal Board (“the Board”) in three inter partes reviews that Merck Sharp & Dohme Corp., Merck Sharp & Dohme B.V., and Organon USA, Inc. (collectively “Merck”) failed to es- tablish by a preponderance of the evidence that claims 1–5 and 9–25 of U.S. Patent 9,636,401 (“the ’401 patent”), claims 1–19 of U.S. Patent 9,636,402 (“the ’402 patent”), and claims 1–4, 9–12, and 14–20 of U.S. Patent 8,821,835 (“the ’835 patent”) are unpatentable. Merck Sharp & Dohme Corp. v. Microspherix LLC, IPR No. 2019-00402, (P.T.A.B. July 8, 2019) (“401 Decision”); Merck Sharp & Dohme Corp. v. Microspherix LLC, IPR No. 2019-00393, 2019 WL 2932663 (P.T.A.B. July 8, 2019) (“402 Decision”); Merck Sharp & Dohme Corp. v. Microspherix LLC, IPR No. 2018-00602, 2019 WL 2932664 (P.T.A.B. July 8, 2019) (“835 Decision”). Because the Board’s decisions are sup- ported by substantial evidence, we affirm. BACKGROUND Microspherix LLC (“Microspherix”) owns the ’401, ’402, and ’835 patents, which are directed to implantable devices that deliver therapeutics and have a radiopaque marker for detecting the device’s position after insertion. The claimed devices are small strands, open on both ends with a drug contained in the hollow interior. Claim 1 of the ’401 patent is illustrative: 1. A flexible non-radioactive strand for implanta- tion into a subject, comprising: Case: 19-2197 Document: 45 Page: 3 Filed: 06/09/2020

MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 3

a marker component configured to allow for the determination of the position of the strand within a target tissue, the marker component having a length extending along a centerline of the marker component between a first end and a second end and having a substantially continuous wall bounding a hollow interior; a biocompatible component; and a therapeutic, prophylactic, and/or diag- nostic agent, wherein the marker, biocom- patible component and agent are disposed within the hollow interior; wherein the length of the marker compo- nent is greater than the diameter of the hollow interior, and wherein the substantially continuous wall includes at least one opening adapted to al- low the agent to pass out of the hollow in- terior wherein the strand do not contain a radioisotope. ’401 patent col. 25 ll. 2–19. Merck manufactures and markets Nexplanon®, an im- plantable contraceptive containing progestin and marked by a radiopaque medium. Microspherix sued Merck in the United States District Court for the District of New Jersey, alleging that Merck’s product infringes the ’401, ’402, and ’835 patents. Amended Complaint, Microspherix LLC v. Merck Sharp & Dohme Corp., No. 2:17-cv-03984-CCC-MF (D.N.J. Oct. 18, 2017), ECF No. 27. Merck then filed the instant petitions for inter partes review. Merck relied on four U.S. patents as references in the proceedings: (1) U.S. Patent 5,150,718 (“de Nijs”), which discloses contraceptive implants; (2) U.S. Patent 4,012,497 (“Schopflin”), which teaches using barium sulfate as a Case: 19-2197 Document: 45 Page: 4 Filed: 06/09/2020

4 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC

radiopaque marker; (3) U.S. Patent 6,575,888 (“Zamora”), which discloses bioabsorbable brachytherapy devices for treating cancers; and (4) U.S. Patent 5,626,862 (“Brem”), which discloses delivery of chemotherapy drugs using sur- gically implantable discs deposited near tumors. In three decisions, the Board upheld all claims of the three patents except for claims 1–5, 7, 8, 10–19 of the ’402 patent. There are two aspects of the Board’s decisions that are relevant in this appeal. First, the Board rejected Merck’s argument that a skilled artisan would have combined de Nijs and Schopflin. According to the Board, a skilled arti- san would not have been motivated to combine the barium sulfate marker taught in Schopflin with the open-ended tube in de Nijs because barium sulfate was known to be toxic and could leach out. Second, the Board rejected Merck’s argument that the challenged claims would have been anticipated or obvious over Zamora alone or in combination with other references. Acceptance of Merck’s Zamora-based arguments required acceptance of Merck’s arguments regarding Zamora and the Microspherix’s patents’ priority dates. Zamora claims priority from U.S. Provisional App. 60/178,083 (“Zamora provisional”), which was filed in January 2000. The nonprovisional application issued as Zamora was filed in January 2001. All three Microspherix patents claim prior- ity from U.S. Provisional App. 60/249,128 (“Microspherix provisional”), which was filed in November 2000. The ear- liest nonprovisional application in the Microspherix pa- tents’ priority chain was filed in May 2001. A timeline may be instructive. Jan. 2000 Jan. 2001 Zamora provisional filed Zamora nonprovisional filed

Nov. 2000 May 2001 Microspherix provisional filed Microspherix nonprovisional filed Case: 19-2197 Document: 45 Page: 5 Filed: 06/09/2020

MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 5

Based on this timeline, if the Microspherix patents cannot claim priority from the Microspherix provisional, Zamora would qualify as 35 U.S.C. § 102(e) (2006) prior art. Addi- tionally, Zamora would still be prior art to Microspherix’s patents if it was entitled to the date of the Zamora provi- sional. The Board found that neither is the case here. Merck argued that the Microspherix patents were not entitled to the date of the Microspherix provisional appli- cation and that Zamora was entitled to the date of the Za- mora provisional, but the Board rejected both arguments. The Board found that 37 of the 39 claims at issue in these appeals were supported by the Microspherix provisional. For the two unsupported claims, claims 2 and 3 of the ’401 patent, the Board found on the merits that Zamora and Bren failed to disclose open-ended devices because Zamora teaches a device with closed ends, and Bren teaches a tube without specifying whether the ends are open or closed. The Board also found that the Zamora provisional failed to provide written description support for Zamora’s claim 1. Claim 1 of Zamora recites that a “radiopaque me- dium is disposed either on at least a portion of an external surface of the tube, within at least [a] portion of a structure of the tube, or within the radioactive material.” Zamora col. 14 ll. 19–22. According to the Board, the Zamora pro- visional did not disclose coating a radiopaque material on the external surface of the tube, and therefore Zamora was not entitled to the date of its provisional. Merck appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A) and 35 U.S.C. § 141(c). DISCUSSION We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), and its fact findings for substantial evidence, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by sub- stantial evidence if a reasonable mind might accept the Case: 19-2197 Document: 45 Page: 6 Filed: 06/09/2020

6 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC

evidence as sufficient to support the finding. Consol. Edi- son Co. v. NLRB, 305 U.S. 197, 229 (1938). Obviousness is a question of law, supported by under- lying fact questions. In re Baxter Int’l, Inc. 678 F.3d 1357, 1361 (Fed. Cir. 2012). In evaluating obviousness, we con- sider the scope and content of the prior art, differences be- tween the prior art and the claims at issue, the level of ordinary skill in the pertinent art, and any relevant sec- ondary considerations. Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17–18 (1966). Merck argues that two of the Board’s determinations lacked substantial evidence: (1) the Board’s determination that the claims would not have been obvious over the com- bination of de Nijs and Schopflin and (2) the Board’s deter- mination that Zamora was not prior art to the challenged claims. We address each issue in turn. First, Merck argues that the Board erred in holding that the challenged claims would not have been obvious in view of De Nijs and Schopflin. Specifically, Merck contests the Board’s finding that a skilled artisan would not have been motivated to use barium sulfate with an open-ended implant because of toxicity concerns. According to Merck, the Board improperly required that the radiopaque marker used in the device be nontoxic because the claims do not require nontoxicity. Even if toxicity were relevant, Merck submits that the Board’s findings lack substantial evidence and urges us to adopt and credit its view of the facts. We disagree with Merck. The Board’s finding that a skilled artisan would not have been motivated to combine Schopflin’s barium sulfate, a known toxic radiopaque marker, with de Nijs’s open-ended implant is supported by substantial evidence. Specifically, several references in the record teach that barium sulfate leaching was a known problem in the art. See, e.g., U.S. Patent 4,866,132 col. 2 ll. 8–15 (explaining that inorganic barium salts “gradually leached out of the matrix causing discoloration of the Case: 19-2197 Document: 45 Page: 7 Filed: 06/09/2020

MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 7

polymer and release of heavy metal toxins”); U.S. Patent App. 2003/0010929 ¶ [0010] (“Barium sul[f]ate is to be con- sidered as critical for use in a long-term implant, because of the toxicity of barium ions, if it is not sufficiently encap- sulated.”). Although the claims do not require that the im- plant be nontoxic, the Board was permitted to consider the known problem of barium leaching in evaluating whether a person of skill in the art would have been motivated to combine barium sulfate with an open-ended implant. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1368 (Fed. Cir. 2016). Merck also argues that the Board erred in its analysis of Zamora in relation to Microspherix’s patents. For a sub- set of claims, Merck argues that Microspherix’s patents are not entitled to the date of Microspherix provisional appli- cation because the provisional does not reasonably convey to a skilled artisan that the inventor had possession of an implantable unitary seed or strand that could be longer than 10 mm. 1 For claims 10–15 of the ’402 patent, Merck argues that the provisional did not disclose a strand with a biocompatible component comprising a non-biodegradable polymer, and for claims 1–19 of the ’402 patent, Merck ar- gues that the provisional failed to disclose a polymeric coat- ing on a non-radioactive strand. Merck also contends that the Zamora reference is entitled to the filing date of its pro- visional. We disagree with Merck here as well. Microspherix’s claims are entitled to the priority date of the Microspherix provisional if the provisional meets the requirements of

1 Merck’s strand-length arguments concern claims 1, 3, 4, 9–12, 15–19 of the ’835 patent, claims 1, 4, 5, 9–25 of the ’401 patent, and claims 1–6, 9, 10, 13, 16, 17 of the ’402 patent. Appellants’ Br. 43. Case: 19-2197 Document: 45 Page: 8 Filed: 06/09/2020

8 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC

35 U.S.C. § 112 ¶ 1. 35 U.S.C. § 119(e)(1) (2006). 2 Written description is adequate if “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 Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991)). Merck faults the Microspherix provisional for failing to disclose strands of greater than 10 mm, but while there are claims in the Microspherix patents that recite discrete strand lengths, Merck has not challenged those claims as unsupported by the provisional. Instead, Merck has chal- lenged claims without a strand length limitation, and sub- stantial evidence supports the Board’s decision that the claims without explicit strand or seed length requirements are supported by the provisional. The provisional discloses seeds and strands of 2–10 mm with certain needles and 4– 6 mm with other needles and the use of a plurality of spac- ers of between 0.5 mm and 50 mm in length. Microspherix provisional col. 5 ll. 3–17. This description adequately sup- ports the claimed strand recited in Microspherix’s patent claims. As for Merck’s argument about the provisional’s failure to describe a biocompatible component comprising a non- biodegradable polymer, no claim at issue in this appeal re- cites this limitation, and claims 10–15 of the ’402 patent, which do recite the limitation, were ruled invalid on other grounds. Even if Merck were correct that these claims are

2 The application that led to the Microspherix pa- tents was filed before March 16, 2013, and the pre-Leahy– Smith America Invents Act, Pub L. No. 112-29, 125 Stat. 284 (2011), version of § 112 applies. Case: 19-2197 Document: 45 Page: 9 Filed: 06/09/2020

MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC 9

unsupported by the provisional, they have already been held invalid, and this court can provide no additional relief. Finally, the polymeric coating argument for claims 6 and 9 of the ’402 patent was not raised before the Board during the proceedings, and Merck is challenging a finding made only in the institution decision. We need not address Merck’s argument because our review of Board proceedings does not include review of the merits of the institution de- cision. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2141 (2016). Having considered Merck’s arguments re- garding the Microspherix provisional, we conclude that the Board’s decision is correct. Next, we consider whether Zamora is entitled to the fil- ing date of the Zamora provisional. “A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with [the written description require- ment].” Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (citing In re Wertheim, 646 F.2d 527, 537 (CCPA 1981)). On this record, we are not persuaded that Zamora is supported by its provisional. Zamora’s claim 1 explicitly recites three options for radio- paque medium placement: on at least a portion of the ex- ternal surface of the tube, within at least a portion of the structure of the tube, or within the radioactive material. Zamora col. 14 ll. 19–22. The first option—locating the ra- diopaque medium on the external surface of the tube—is absent from the provisional. While the Zamora provisional describes admixing the radiopaque material into the com- plex, Zamora provisional at 5, that disclosure falls short of teaching coating the external surface of the tube. CONCLUSION We have considered the parties’ remaining arguments but find them unpersuasive. Accordingly, the decisions of the Board are affirmed. Case: 19-2197 Document: 45 Page: 10 Filed: 06/09/2020

10 MERCK SHARP & DOHME CORP. v. MICROSPHERIX LLC

AFFIRMED