Amgen Inc. v. Apotex Inc.
712 F. App'x 985
| Fed. Cir. | 2017Background
- Amgen owns U.S. Patent No. 8,952,138 claiming a method to refold recombinant proteins expressed in non-mammalian systems at relatively high protein concentrations; Amgen markets filgrastim/pegfilgrastim (Neupogen/Neulasta).
- Apotex filed abbreviated Biologics License Applications under the BPCIA to market biosimilars for filgrastim and pegfilgrastim and engaged in the statute’s information exchange with Amgen.
- Amgen identified the ’138 patent; Apotex provided a detailed non-infringement statement and pre‑litigation letters stating “inclusion body concentration” of 0.9–1.4 g/L in its refold buffer.
- District court construed the claim to require (1) protein present in a volume at ≥2.0 g/L as measured before contacting refold buffer and (2) a refold mixture protein concentration of at least about 1.0 g/L.
- At trial Apotex’s witness (Dr. Dowd) testified that inclusion bodies are wet pastes and the actual protein concentration in Apotex’s refold mixtures would be ≤0.708 g/L (batch records showed ~0.56 g/L), below the court’s 1.0 g/L requirement.
- The district court found Amgen failed to prove literal infringement; Amgen appealed and the Federal Circuit affirmed.
Issues
| Issue | Amgen's Argument | Apotex's Argument | Held |
|---|---|---|---|
| Probative value of Apotex’s pre‑litigation BPCIA letters | Letters show Apotex represented higher concentrations and should be credited | Letters are party admissions but factually incorrect and not dispositive in light of trial evidence | Court may consider letters but properly credited Dr. Dowd; letters lacked probative weight here; not clearly erroneous to discount them |
| Whether “protein concentration” equals “washed‑inclusion‑body concentration” | Claims should treat inclusion body concentration as identical to protein concentration | Specification distinguishes proteins (inside) from inclusion bodies (aggregates/wet paste); concentrations differ | Rejected Amgen’s construction; protein concentration is not interchangeable with inclusion‑body concentration |
| Whether Apotex’s FDA applications authorize infringing processes (Sunovion issue) | Applications permit up to 1.4 g/L; court must consider full range authorized by the application | Applications’ key process parameters and batch records constrain the process to non‑infringing levels; applications and records interpreted as limiting | Sunovion not controlling; court reasonably found applications and batch records constrain process below infringing levels; affirmed |
Key Cases Cited
- Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286 (Fed. Cir.) (standard of review for factual findings of noninfringement)
- Jack Guttman, Inc. v. Kopykake Enters., Inc., 302 F.3d 1352 (Fed. Cir.) (de novo review for legal claim‑construction issues)
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (clarifies standard for reviewing claim construction involving subsidiary factfindings)
- Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (describing the BPCIA information exchange and its role)
- Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271 (Fed. Cir.) (applicant’s ANDA can authorize infringing activity; court must consider scope of application)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir.) (look to extrinsic submissions and data when an abbreviated application is silent on an infringement issue)