Ferring B v. v. Watson Laboratories, Inc.
764 F.3d 1401
Fed. Cir.2014Background
- Ferring owns U.S. Patents 7,947,739; 8,022,106; and 8,273,795 claiming modified-release oral tranexamic acid (about 650 mg per tablet) with specified amounts of a "modified release material" and defined USP dissolution profiles. Lysteda® practices the patents.
- Watson filed ANDA No. 20-2093 seeking to market generic 650 mg tranexamic acid tablets; its cores contain ~6.52% hypromellose and finished tablets have a pH-dependent film coating. Watson amended ANDA hardness specs from 13–20 kp to 13–17 kp and later to 13–16.5 kp (FDA‑approved). Biobatch data in the ANDA showed coated-tablet dissolution in water well below the claimed release percentages for most samples.
- Ferring sued under 35 U.S.C. § 271(e)(2)(A), alleging infringement by Watson’s ANDA product (both uncoated cores and finished coated tablets). District court construed “modified release material” and “about,” held claims nonobvious, and found infringement by uncoated cores and by coated tablets with core hardness ≥17 kp; it entered an injunction and ordered the FDA to reset Watson’s approval date.
- On appeal, the Federal Circuit affirmed nonobviousness but reversed the infringement finding, holding infringement must be assessed against the ANDA‑approved finished product (not uncoated cores or pre‑approval development data) and that the ANDA‑compliant finished tablets did not meet the claimed dissolution limits or show the required functioning modified‑release materials.
- As a result, the court vacated the district court’s order resetting the FDA approval date and vacated the permanent injunction; costs were awarded to Watson.
Issues
| Issue | Ferring's Argument | Watson's Argument | Held |
|---|---|---|---|
| Obviousness of asserted patents under 35 U.S.C. § 103 | Claims nonobvious; patents solve a long‑felt need with clinical benefit (fast‑track FDA status) | Prior art (EMA report, Nakagami) would have suggested raising dose to 650 mg and using modified‑release excipients | Affirmed nonobvious: prior art did not teach/suggest 650 mg with claimed polymer amounts and dissolution profiles; evidence insufficient to overcome presumption of validity |
| Infringement based on ANDA filing (§ 271(e)(2)(A)) | ANDA and development data show cores and finished product infringe (contain required polymer amounts and meet dissolution limits) | Infringement must be assessed against FDA‑approved finished product; uncoated cores/dev data are not the marketed product; ANDA shows coated tablets generally do not meet claimed dissolution limits | Reversed: infringement not proven by preponderance; ANDA biobatch data and tested coated tablets mostly fall outside claim dissolution limits |
| Relevance of pre‑approval development data (e.g., PTX 381) | Such data show uncoated cores meet claim limits and thus support infringement | Developmental data are not evidence of the ANDA‑approved, marketable coated product and may be subject to the § 271(e)(1) experimental use context | Development data not dispositive: PTX 381 does not show finished coated tablets would infringe; court did not need to decide § 271(e)(1) applicability |
| Role of claim construction for “modified release material” | Material lists/percentages in ANDA demonstrate claimed modified release material is present | Even if polymer is present, testing is required to show it actually modifies tranexamic acid release; ANDA lacks such evidence for finished product | Reversed: Ferring failed to show by testing that ANDA product’s excipients actually functioned as the claimed modified‑release material; district court misapplied its own construction |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (obviousness framework and motivation-to-combine analysis)
- Graham v. John Deere Co., 383 U.S. 1 (factors for obviousness analysis)
- Microsoft Corp. v. i4i Ltd., 564 U.S. 91 (clear-and-convincing evidence required to overcome patent validity presumption)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (ANDA filing creates artificial act of infringement for jurisdiction; infringement ultimately judged against ANDA product)
- Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (infringement analysis under Hatch-Waxman compares claims to the product likely to be sold under the ANDA)
- Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367 (ANDA specification governs infringement inquiry; sale limited to products described in ANDA)