Janssen Biotech, Inc. v. Celltrion Healthcare Co.
210 F. Supp. 3d 278
D. Mass.2016Background
- Janssen and NYU own patents covering infliximab (Remicade): a genus patent (U.S. Patent No. 6,284,471) and a species patent claiming infliximab specifically (U.S. Patent No. 6,790,444).
- Both patents trace to a 1991 priority application; the ’444 issued later but expired earlier (2011) under the URAA; the ’471 issued earlier but, standing alone, would expire later (2018).
- Celltrion moved for summary judgment that claims 1, 3, 5, 6, and 7 of the ’471 are invalid for obviousness-type double patenting in view of the earlier-expiring ’444.
- Janssen conceded the ’471 claims are not patentably distinct from the ’444 claims.
- The key legal question: whether, given the URAA and Federal Circuit precedent (Gilead), an earlier-expiring patent (the ’444) can serve as a double-patenting reference to invalidate a later-expiring patent (the ’471).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the URAA shields pre-1995-based patents from obviousness-type double patenting | URAA intended to guarantee at least 17 years post-issuance protection for pre-1995 applications, preventing double-patenting invalidation | URAA is silent on double patenting; it did not abolish or limit the judicial doctrine protecting public domain upon patent expiry | Court: URAA did not abrogate the obviousness-type double patenting doctrine; plaintiffs’ reading is incorrect |
| Whether an earlier-expiring later-issued patent can be a double-patenting reference for a later-expiring earlier-issued patent | The earlier-expiring patent should not be allowed to invalidate the later-expiring patent because of URAA protections | An earlier-expiring patent may serve as a reference if the later-expiring patent is not patentably distinct; public free use principle supports this | Court: Applying Gilead and related authority, the earlier-expiring ’444 is a proper double-patenting reference and invalidates the ’471 claims listed |
| Whether the ’471 claims are patentably distinct from the ’444 claims | ’471 is patentably distinct (implicit/argued) | ’471 is not patentably distinct; Janssen conceded indistinctness | Court: Janssen conceded indistinctness; claims 1,3,5,6,7 of the ’471 are invalid for obviousness-type double patenting |
Key Cases Cited
- Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) (holds an earlier-expiring patent can be an obviousness-type double patenting reference; doctrine preserves public freedom to use expired inventions and obvious variants)
- Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014) (confirms continued application of obviousness-type double patenting where patents claiming the same invention have different expiration dates)
- In re Longi, 759 F.2d 887 (Fed. Cir. 1985) (articulates public-use principle that expired patents free the public to practice obvious modifications)