Genzyme Corporation v. Dr. Reddy's Laboratories, Ltd
16-2206
| Fed. Cir. | Dec 18, 2017Background
- Genzyme holds U.S. Patent No. 7,897,590 (the ’590 Patent) claiming a three-step method: administer G‑CSF, administer plerixafor (or salt) in an amount effective to mobilize progenitor/stem cells, then harvest the cells.
- Plerixafor (AMD‑3100) is a CXCR‑4 antagonist; CXCR‑4 binds SDF‑1 in bone marrow and was theorized to help retain stem cells.
- DRL (generic challengers) asserted claim 19 is obvious under 35 U.S.C. § 103, relying on prior art including Hendrix (pharmacology/safety study of plerixafor), WO ’814, and U.S. Patent No. 5,824,304 (the ’304 Patent) (teaching VLA‑4 blockade mobilizes stem cells and that G‑CSF mobilizes via increased production).
- At bench trial the district court found DRL failed to prove obviousness, concluding a person of ordinary skill would not have had a reasonable expectation that plerixafor would mobilize stem cells for harvest; the court entered an injunction against DRL’s generic activity.
- On appeal, the Federal Circuit reviewed factual findings for clear error and legal conclusions de novo and affirmed the district court, emphasizing lack of reasonable expectation of success and unpredictability in stem cell mobilization at the time.
Issues
| Issue | Genzyme's Argument | DRL's Argument | Held |
|---|---|---|---|
| Whether claim 19 is invalid for obviousness under § 103 | Claim 19 is not obvious because prior art did not provide a reasonable expectation that plerixafor would mobilize stem cells sufficiently for harvest | Hendrix/WO ’814 (showing WBC elevation and CXCR‑4 antagonism) combined with the ’304 Patent (VLA‑4 mobilization and G‑CSF co‑use) would have made claim 19 obvious | Affirmed: not obvious — district court’s finding that there was no reasonable expectation of success was not clearly erroneous |
| Whether Hendrix/WO ’814 are analogous art to stem cell mobilization | Prior art focused on mobilizing stem cells; skilled artisan would not reasonably rely on HIV/WBC studies for stem cell harvest use | Hendrix/WO ’814 were reasonably pertinent because they disclosed plerixafor’s CXCR‑4 antagonism and WBC effects | Held Hendrix/WO ’814 were not sufficiently analogous or persuasive to supply reasonable expectation of success |
| Whether combining teachings of VLA‑4 blockade and CXCR‑4 antagonism would have been predictable | The mechanisms differ (VLA‑4 vs CXCR‑4/SDF‑1); no evidence they would behave similarly for mobilization | The ’304 Patent’s VLA‑4 teaching plus Hendrix/WO ’814 would have suggested plerixafor as a viable CXCR‑4 mobilizer | Held the structural/mechanistic differences and lack of in vivo evidence defeated a reasonable expectation of success |
| Role of secondary considerations (e.g., failure of others, unpredictability) | Secondary considerations support nonobviousness and corroborate lack of reasonable expectation | DRL argued primary references suffice; secondary evidence less relevant | Court did not need to resolve all secondary issues but found district court’s consideration supported nonobviousness |
Key Cases Cited
- Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed. Cir. 2013) (describing factual inquiries for obviousness analysis)
- Honeywell Int’l, Inc. v. United States, 609 F.3d 1292 (Fed. Cir. 2010) (standard of review for bench trial factual findings and legal conclusions)
- Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91 (2011) (patent invalidity must be proved by clear and convincing evidence)
- Insite Vision Inc. v. Sandoz Inc., 783 F.3d 853 (Fed. Cir. 2015) (discussing reasonable expectation of success and how research focus affects obviousness)