Intendis Gmbh v. Glenmark Pharmaceuticals Inc.
822 F.3d 1355
| Fed. Cir. | 2016Background
- Bayer’s Finacea® Gel (NDA No. 21470) is a 15% azelaic acid hydrogel and is claimed in U.S. Patent No. 6,534,070, which recites azelaic acid plus specific excipients including a triglyceride (triacylglyceride) and lecithin.
- Glenmark filed an ANDA seeking to market a generic Finacea® Gel substitute that uses isopropyl myristate in place of the claimed triglyceride and lecithin and submitted a Paragraph IV certification asserting invalidity/noninfringement.
- Appellees (patent owner/licensees) sued under 35 U.S.C. § 271(e)(2); the district court held a bench trial and found claims 1–12 infringed under the doctrine of equivalents and not invalid.
- For infringement the court found isopropyl myristate equivalent to the claimed triglyceride/lecithin because it performed substantially the same function (penetration enhancement), in substantially the same way (disrupting stratum corneum lipids), to achieve substantially the same result (therapeutic skin penetration). The court relied in part on Glenmark’s own ANDA statements calling these ingredients penetration enhancers.
- The court rejected defenses that the doctrine of equivalents would ensnare prior art (Gasco) and that prosecution-history estoppel or obviousness invalidated the claims, finding no clear-and-unmistakable surrender in prosecution, no motivation/expectation of success to combine the cited art, and supportive objective indicia of nonobviousness (unexpected results, commercial success).
- The Federal Circuit affirmed the district court on all issues.
Issues
| Issue | Glenmark's Argument | Appellees' Argument | Held |
|---|---|---|---|
| Infringement under doctrine of equivalents (function prong) | Claimed triglyceride/lecithin do not function as penetration enhancers in the claimed composition; lack of support in the patent and literature; district court erred. | Claimed excipients perform as penetration enhancers; Glenmark’s ANDA repeatedly called them penetration enhancers; extrinsic evidence supports function. | Affirmed: fact finding not clearly erroneous — claimed excipients function as penetration enhancers and are equivalent to isopropyl myristate. |
| Ensnaring the prior art (scope of equivalents) | Finding equivalents would cover all penetration enhancers and thus read on prior art like Gasco. | Hypothetical claim should include only triglyceride/lecithin or alternatively isopropyl myristate; not all penetration enhancers. | Affirmed: district court’s narrower hypothetical claim was proper and does not ensnare Gasco. |
| Prosecution-history estoppel | Applicants disavowed lecithin-free formulations during prosecution, so equivalents covering Glenmark’s lecithin-free product are barred. | Amendments were clarifying (dependent claims always required lecithin); no clear and unmistakable surrender. | Affirmed: no amendment- or argument-based estoppel; amendments were clarifying, not narrowing to surrender equivalents. |
| Obviousness | Prior art (Skinoren® + non-azelaic acid and azelaic acid references) would have motivated a skilled artisan to combine and would yield the claimed compositions with reasonable expectation of success. | No adequate motivation to combine or reasonable expectation of success; formulation substitutions are not routine; objective indicia support nonobviousness. | Affirmed: district court’s finding of nonobviousness not clearly erroneous. |
Key Cases Cited
- Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (doctrine of equivalents framework)
- Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605 (function-way-result and equivalence principles)
- Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (prosecution-history estoppel rules)
- DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (ensnarement/prior art limits on equivalents)
- Ultra-Tex Surfaces, Inc. v. Hill Bros. Chem. Co., 204 F.3d 1360 (hypothetical claim analysis for ensnarement)