Schering Corporation and Biogen, Inc. v. Amgen Inc.

222 F.3d 1347, 55 U.S.P.Q. 2d (BNA) 1650, 2000 U.S. App. LEXIS 18360, 2000 WL 1055975
CourtCourt of Appeals for the Federal Circuit
DecidedAugust 1, 2000
Docket99-1251
StatusPublished
Cited by48 cases

This text of 222 F.3d 1347 (Schering Corporation and Biogen, Inc. v. Amgen Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Schering Corporation and Biogen, Inc. v. Amgen Inc., 222 F.3d 1347, 55 U.S.P.Q. 2d (BNA) 1650, 2000 U.S. App. LEXIS 18360, 2000 WL 1055975 (Fed. Cir. 2000).

Opinion

TRADER, Circuit Judge.

Sehering Corporation and Biogen, Inc. (collectively, Sehering) sued Amgen Inc. in the United States District Court for the District of Delaware for infringing U.S. Patent No. 4,530,901 (the ’901 patent). The ’901 patent claims recombinant DNA molecules encoding specific types of human interferon, microorganisms genetically engineered to produce that interferon, and methods of producing interferon with recombinant technology. The district court conducted a pre-trial Markman hearing to construe the patent’s claims. After the district court announced its claim construction decision, see Schering Corp. v. Amgen, Inc., 18 F.Supp.2d 372 (D.Del.1998) (Sehering I), Sehering moved for entry of summary judgment of nonin-fringement in Amgen’s favor, explaining that it could not prevail at trial under the district court’s interpretation of the claims. The district court granted Schering’s motion, and dismissed without prejudice Am-gen’s motions for summary judgment of patent invalidity and misuse, concluding that those motions are moot in light of the district court’s noninfringement judgment. See Schering Corp. v. Amgen, Inc., 35 F.Supp.2d 375, 50 USPQ2d 1051 (D.Del. 1999) (Sehering II). Sehering appeals only the district court’s claim construction. Because this court concludes that the district court correctly construed the claims, and because Sehering conceded nonin-fringement under that claim construction, this court affirms the district court’s judgment of noninfringement.

I.

Biogen, Inc. is the assignee of the ’901 patent; Sehering Corp. is Biogen’s exclusive licensee under the patent. The ’901 patent resulted from the pioneering work of Dr. Charles Weissmann in the fields of immunology and molecular biology in the late 1970s. Dr. Weissmann’s work focused on certain human polypeptides, known as interferons. Since the late 1950’s, immunologists knew that interfer-ons have important anti-viral and anti-tumor properties. They studied interferons by extracting and purifying blood samples from human subjects. Scientists now appreciate that different cells of the human immune system produce many interferon subtypes. However, at the time of Dr. Weissmann’s work, scientists had conclusive evidence of only two varieties: interferon produced by cells known as fibroblasts, and interferon produced by cells known as leukocytes. No one had successfully characterized the specific genes that code for interferon polypeptides, nor had anyone developed a means for producing substantial quantities of interferon. Dr. Weissmann, through a series of elegant experiments, isolated pieces of DNA that code for one of the leukocyte interferon polypeptides, the interferon now referred to in the scientific community as “IFN-a-1.”

The ’901 patent claims the recombinant DNA molecules containing the structural *1350 genes isolated by Dr. Weissmann. As originally filed, the claims referred to leukocyte interferon, instead of IFN-a. The patent also claims genetically engineered micro-organisms containing these recombinant DNA molecules. Finally, the ’901 patent claims a method for producing interferon polypeptides by transforming microorganisms with Dr. Weissmann’s recombinant DNA molecules, culturing the transformed microorganisms, and then collecting the interferon produced by the cells. Examples of each type of claim, claims 1, 5, and 9, state:

1. A recombinant DNA molecule consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and which have the capacity to infect some host and to be maintained therein, and the progeny thereof, comprising a DNA sequence selected from the group consisting of:
(a) the DNA inserts of Z-pBR322(Pst)/HcIF-2h (DSM 1700), Z-pBR322(Pst)/HcIF-SN35 (DSM 1701), Z-pBR322(Pst)/HcIF-SN42 (DSM 1702) and Z-pKT287(Pst)/HcIF-2h-AH6 (DSM 1703),
(b) DNA sequences which hybridize to any of the foregoing DNA inserts and which code on expression for a polypeptide of the IFN- ¥ type, and
(c) DNA sequences which code on expression for a polypeptide of the IFN-a type coded for on expression by any of the foregoing DNA sequences and inserts,
said DNA sequences and inserts being operatively linked to an expression control sequence in said recombinant DNA molecule.

’901 patent, col. 36,11. 4-23.

5. A unicellular host transformed with at least one recombinant DNA molecule, said molecule, consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and which have the capacity to infect some host and to be maintained therein, and the progeny thereof, comprising a DNA sequence selected from the group consisting of:
(a) the DNA inserts of Z-pBR322(Pst)/HcIF-4c. (DMS 1699), Z-pBR322(Pst)/HcIF-2h (DSM 1700), Z-PBR322(Pst)/HcIF-SN35 (DSM 1701), Z-pBR322(Pst)/HcIF-SN42 (DSM 1702) and Z-pKT287(Pst)/HcIF-2h-AH6 (DSM 1703),
(b) DNA sequences which hybridize to any of the foregoing DNA inserts and which code on expression for a polypeptide of the IFN- ¥ type, and
(c) DNA sequences which code on expression for a polypeptide of the IFN-a type coded for on expression by any of the foregoing DNA sequences and inserts.

Id. at col. 36,11. 39-59

9. A method for producing a polypeptide comprising the steps of preparing a recombinant DNA molecule, consisting of segments of DNA from diffex-ent genomes which have been joined end-to-end outside of living cells and which have the capacity to infect some host and to be maintained therein, and the progeny thereof, comprising a DNA sequence selected from the group consisting of:
(a) the DNA inserts of Z-pBR322(Pst)/HcIF-2h (DSM 1700), Z-pBR322(Pst)/HcIF-SN35 (DSM 1701), Z-pBR322(Pst)/HcIF-SN42 (DSM *1351 1702) and Z-pKT287(Pst)/HcIF-2h-AH6 (DSM 1703),
(b) DNA sequences which hybridize to any of the foregoing DNA inserts and which code on expression for a polypeptide of the IFN- ¥ type, and
(c) DNA sequences which code on expression for a polypeptide of the IFN-a type coded for on expression by any of the foregoing DNA sequences or inserts,
and having operatively linked thereto an expression control sequence; transforming an appropriate host with said recombinant DNA molecule; culturing said host; and collecting said polypeptide.

Id. at col. 37, 11. 18-40. Even a cursory review of the claims reveals that they recite the specific recombinant DNA inserts isolated by Dr. Weissmann, and their use. Many years later, scientists sequenced Dr. Weissmann’s DNA inserts and discovered that they code for a subtype of leukocyte interferon known as IFN-a-1.

Schering sued Amgen, alleging that Am-gen’s consensus interferon product infringes the ’901 patent. Amgen’s product is a synthetic polypeptide that does not correspond to any naturally occurring interferon subtype.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

ModernaTX, Inc. v. Pfizer Inc.
D. Massachusetts, 2023
Zak v. Facebook, Inc.
E.D. Michigan, 2021
Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co.
240 F. Supp. 3d 605 (E.D. Texas, 2017)
Cipher Pharmaceuticals Inc. v. Actavis Laboratories FL, Inc.
99 F. Supp. 3d 508 (D. New Jersey, 2015)
Broussard v. Go-Devil Manufacturing Co. of LA., Inc.
29 F. Supp. 3d 753 (M.D. Louisiana, 2014)
Harari v. Hollmer
602 F.3d 1348 (Federal Circuit, 2010)
Nextec Applications v. BROOKWOOD COMPANIES, INC.
703 F. Supp. 2d 390 (S.D. New York, 2010)
Sepracor Inc. v. Dey, L.P.
590 F. Supp. 2d 649 (D. Delaware, 2008)
In Re Paul Lew
257 F. App'x 281 (Federal Circuit, 2007)
Chic Optic, Inc. v. E'Lite Optik, Inc.
524 F. Supp. 2d 794 (N.D. Texas, 2007)
PolyVision Corp. v. Smart Technologies Inc.
501 F. Supp. 2d 1042 (W.D. Michigan, 2007)
NEUTRINO DEVELOPMENT CORP. v. Sonosite, Inc.
423 F. Supp. 2d 673 (S.D. Texas, 2006)
Phillips v. Awh Corporation
Federal Circuit, 2005

Cite This Page — Counsel Stack

Bluebook (online)
222 F.3d 1347, 55 U.S.P.Q. 2d (BNA) 1650, 2000 U.S. App. LEXIS 18360, 2000 WL 1055975, Counsel Stack Legal Research, https://law.counselstack.com/opinion/schering-corporation-and-biogen-inc-v-amgen-inc-cafc-2000.