Yeda Research & Development Co. v. Abbott GmbH & Co. KG
837 F.3d 1341
Fed. Cir.2016Background
- Abbott holds U.S. Patent No. 5,344,915 (the ’915 patent) claiming a TNF‑α–binding protein (TBP‑II) with a specific N‑terminal amino‑acid sequence; U.S. filing date May 4, 1990, claiming priority to two German applications: P39 15 072 (’072, filed May 9, 1989) and P39 22 089 (’089, filed July 5, 1989).
- Engelmann (published Jan. 1990) describes TBP‑I and TBP‑II; if the ’915 patent lacks the earlier priority date, Engelmann anticipates the claims.
- Neither the ’072 nor the ’089 application discloses the full N‑terminus sequence later claimed; they disclose a partial sequence plus biological properties, source, molecular weight, activity, and degradation characteristics.
- The Board initially held the ’915 patent invalid as anticipated; district court (2008) vacated in part, later proceedings led the Board (2010) and the district court (2015) to find the ’072 application provides adequate written description such that the ’915 patent benefits from the ’072 priority date.
- The central factual premise: no known protein other than TBP‑II matches the partial sequence plus the biological characteristics disclosed in the ’072 application.
Issues
| Issue | Plaintiff's Argument (Yeda) | Defendant's Argument (Abbott) | Held |
|---|---|---|---|
| Whether the ’072 application provides adequate written description to support the ’915 claims (priority to ’072) | The partial N‑terminus in ’072 does not show that a person of ordinary skill would understand it includes the additional amino acids claimed | The ’072 need only describe/enable TBP‑II; inherent disclosure of the remaining amino acids is adequate when the earlier app discloses the same protein and its biological traits | Held: ’072 provides adequate written description via inherent disclosure; priority to ’072 affirmed |
| Whether inherent disclosure doctrine applies here | Inherent disclosure cannot be used unless the missing limitation would have been understood as present | Inherent disclosure applies where the earlier application necessarily describes the identical invention (same protein) | Held: doctrine applies because only TBP‑II fits the combination of partial sequence and biological traits disclosed |
| Whether prosecution history estops Abbott from relying on inherent disclosure | Abbott previously emphasized absence of certain amino acids to distinguish prior art, so it should be estopped from asserting those amino acids were inherently disclosed | Abbott’s prosecution arguments also relied on other disclosed amino acids and distinctions; prosecution history does not contradict reliance on inherent disclosure | Held: prosecution history does not preclude Abbott’s reliance on inherent disclosure |
| Whether the Board’s factual finding of adequate written description is supported by substantial evidence | The Board lacked sufficient factual basis to infer the complete sequence from the partial disclosure and characteristics | There is substantial evidence: ’072 disclosed 9 of 15 N‑terminal residues plus multiple biological characteristics and no other known protein fits | Held: Board’s finding is supported by substantial evidence; affirmed |
Key Cases Cited
- Kennecott Corp. v. Kyocera Int’l, Inc., 835 F.2d 1419 (Fed. Cir.) (inherent properties disclosed in an earlier specification can support later claims)
- Ariad Pharm. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.) (written description requires showing inventor possessed claimed subject matter at filing)
- In re Gartside, 203 F.3d 1305 (Fed. Cir.) (substantial‑evidence standard for reviewing PTO fact findings)
- Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir.) (limitations on finding inherent disclosure in certain contexts)
- In re Wallach, 378 F.3d 1330 (Fed. Cir.) (written description and inherent disclosure analysis for biological sequences)
- Hitzeman v. Rutter, 243 F.3d 1345 (Fed. Cir.) (priority/prosecution‑history estoppel principles)