Mylan Institutional LLC v. Aurobindo Pharma Ltd.
857 F.3d 858
Fed. Cir.2017Background
- Apicore (licensor Mylan Inst.) owns three patents related to isosulfan blue (ISB): two process patents (’992, ’616) claiming use of silver oxide in synthesizing ISB, and a purity patent (’050) claiming ISB with ≥99.0% purity by HPLC.
- Aurobindo developed an ISB process using manganese dioxide (not silver oxide) and preparatory HPLC to produce ISB >99.5% purity, sought FDA approval, and entered the market in 2016.
- Mylan sued for patent infringement and obtained a district-court preliminary injunction barring Aurobindo’s ISB product based on likely infringement of the process patents under the doctrine of equivalents and validity/irreparable-harm findings for the ’050 purity patent.
- The district court found Aurobindo likely infringing the process patents under equivalents (crediting Mylan’s expert and treating oxidation-strength differences as irrelevant), and found the ’050 patent not invalid (rejection of anticipation, obviousness, and indefiniteness challenges).
- The district court found irreparable harm to Apicore (lost sales, R&D, price erosion, direct competition) with a causal nexus to Aurobindo’s allegedly infringing product.
- On appeal the Federal Circuit affirmed the injunction only as to the ’050 patent, reversed the equivalents finding for the process patents (finding the district court’s FWR analysis deficient), and upheld the district court’s conclusions on ’050 validity and irreparable harm.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Aurobindo infringes the process patents under the doctrine of equivalents | Aurobindo: manganese dioxide oxidizes differently (stronger oxidant; requires acid) so it raises substantial question of non-equivalence | Mylan: manganese dioxide is equivalent to silver oxide in context; yields and function are similar; district court credited its expert | Court: district court’s equivalents analysis under function-way-result (FWR) was incomplete/erroneous; substantial question of infringement exists; injunction cannot rest on process patents |
| Whether the ’050 purity patent is invalid (anticipation, obviousness, indefiniteness) | Aurobindo: Sigma previously produced ≥99% ISB (anticipation); purity >99% would have been obvious from prior art purification techniques; "by HPLC" is indefinite because parameters not specified | Mylan: Sigma evidence unreliable/contradicted; purification to >99% was not enabled or predictable in prior art; "by HPLC" is a well-understood designation to skilled artisans | Court: affirmed district court — no substantial question of invalidity; anticipation evidence unpersuasive; not obvious given inventive purification process; "by HPLC" sufficiently definite |
| Whether Apicore showed irreparable harm and causal nexus | Aurobindo: no evidence consumers demand the patented features (silver oxide or ≥99% purity); harms stem from pricing/competition, not patent features | Mylan: lost sales, R&D, price erosion tied to Aurobindo’s copying of patented process and ANDA promising >99% purity; harms flow from entry of infringing product | Court: affirmed district court — sufficient record support for irreparable harm and causal nexus |
| Whether the preliminary injunction should remain and on what basis | Aurobindo: injunction improper because process-patent infringement raises substantial questions and ’050 validity/irreparable harm challenges succeed | Mylan: injunction appropriate; all four preliminary-injunction factors satisfied | Court: modified injunction — vacated basis under process patents but affirmed injunction premised solely on the ’050 purity patent |
Key Cases Cited
- Graver Tank & Mfg. Co. v. Linde Air Prod. Co., 339 U.S. 605 (Sup. Ct. 1950) (sets out FWR and insubstantial differences frameworks for doctrine of equivalents)
- Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (Sup. Ct. 1997) (doctrine of equivalents requires element-by-element analysis; discusses suitability of FWR in non-mechanical cases)
- Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007) (purified compound not necessarily obvious over prior art mixture if purification process is patentable)
- Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343 (Fed. Cir. 2001) (standards of review for preliminary injunctions)
- Sanofi–Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed. Cir. 2006) (appellate review of preliminary injunction discretion and legal standards)
- Apple, Inc. v. Samsung Elecs. Co., 678 F.3d 1314 (Fed. Cir. 2012) (discusses irreparable harm standard in patent preliminary injunction context)