Ferring B v. v. Watson Laboratories, Inc.
764 F.3d 1382
Fed. Cir.2014Background
- Ferring owns three patents covering a modified‑release 650 mg tranexamic acid oral dosage (Lysteda) with specified in‑vitro dissolution limits at 15, 45, 90 minutes.
- Apotex filed an ANDA in 2010 seeking approval for a Lysteda generic; the 2010 ANDA specified only NLT 80% dissolution at 60 minutes and was silent on the claimed timepoints/weight‑percent limits.
- Ferring sued Apotex under 35 U.S.C. § 271(e)(2) after Apotex submitted paragraph IV certifications for the patents; the district court held a Markman and a bench trial on infringement.
- At trial the district court found Apotex’s actual product samples did not literally infringe, but initially concluded the 2010 ANDA nonetheless permitted sale of an infringing product under Sunovion.
- Apotex amended its ANDA in Feb. 2014 to specify NLT 75% dissolved at 45 minutes; FDA approved the amendment and Apotex agreed to notify the court/Ferring before any further change.
- The district court dismissed as moot after concluding the 2014 ANDA did not infringe; Ferring appealed.
Issues
| Issue | Plaintiff's Argument (Ferring) | Defendant's Argument (Apotex) | Held |
|---|---|---|---|
| Whether the 2010 ANDA infringes under Sunovion/§271(e)(2) | The 2010 ANDA permits marketing of an infringing product and Sunovion requires looking to ANDA language | Sunovion applies only when ANDA clearly describes an infringing product; the 2010 ANDA is silent on claimed limits so Glaxo standard governs | No infringement: 2010 ANDA is silent; under Glaxo plaintiff must prove likelihood of marketing an infringing product, and evidence showed Apotex’s bio‑batches were non‑infringing |
| Construction of the claim term “about” (dissolution percentages) | “About” should be ±10% based on USP guidance (e.g., 63–77% at 45 min), making 75% infringing | “About” means approximately; no fixed numerical tolerance in the spec; USP guidance does not create a ±10% allowance on the calculated result | Affirmed: court adopted “about” = “approximately” and refused to read a numerical tolerance into the claims |
| Whether the 2014 ANDA (NLT 75% @45 min) infringes | Under Ferring’s ±10% construction the 2014 ANDA falls within claimed range and infringes | The 2014 ANDA affirmatively specifies a non‑infringing dissolution (outside the claimed approximate limit); amendment precludes infringement | No infringement: 2014 ANDA specification is non‑infringing under the district court’s claim construction |
| Whether the amendment mooted the case / whether court could consider amended ANDA & enter §271(e)(4) relief | Amendment after finding of infringement cannot bar entry of a §271(e)(4) resetting order; district court should have ordered relief based on initial ANDA | Statute and precedent permit consideration of amended ANDA; courts may reconsider in light of amendments and Bayer permits dismissal when amendment removes infringement risk | Affirmed: district court appropriately considered the amended ANDA; amendment mooted claim because Apotex made it unlikely infringing conduct would recur; §271(e)(4) resetting not required absent judgment based on operative ANDA |
Key Cases Cited
- Sunovion Pharm. Inc. v. Teva Pharms. USA, 731 F.3d 1271 (2013) (ANDA that clearly defines an infringing product cannot be avoided by applicant’s contrary certification)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (1997) (when ANDA is silent on claimed features patentee must show the applicant is likely to market an infringing product)
- Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241 (2000) (amended ANDA that removes infringement risk can be dispositive; courts may consider amendments)
- Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364 (2005) (term “about” given ordinary meaning of approximately unless patentee clearly redefines it)
- Already, LLC v. Nike, Inc., 133 S. Ct. 721 (2013) (voluntary cessation moots a case only when it is absolutely clear the wrongful behavior will not recur)