Warner Chilcott Laboratories Ireland Ltd. v. Mylan Pharmaceuticals Inc.
451 F. App'x 935
Fed. Cir.2012Background
- Mylan filed ANDA in 2008 to produce a 150 mg Doryx generic; Mayne owns the '161 patent covering Doryx and licenses to Warner Chilcott for U.S. markets.
- Warner Chilcott filed suit in 2009 alleging Mylan infringing the '161 patent; district court stayed FDA approval for 30 months.
- Claim at issue is claim 21 of the '161 patent, concerning a stabilizing coat between core elements and coating in a delayed-release doxycycline tablet.
- The district court construed the term stabilizing coat to mean a layer reducing interaction between core and coating to limit migration of core materials.
- At a September 2011 hearing the court did not hold an evidentiary hearing and did not make findings on Mylan’s invalidity defense, reserving matters for trial.
- The district court granted a preliminary injunction in September 2011 based on disputed facts, later vacated and remanded by this court.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the district court properly handled disputed facts at the preliminary-injunction stage. | Warner Chilcott contends disputed expert issues require an evidentiary hearing. | Mylan argues the record supports grant given irreparable harm and likely infringement despite disputed facts. | Abuse of discretion; evidentiary hearing required; vacate for proper proceedings. |
| Whether the district court properly weighed the validity defense and made findings on validity. | Warner Chilcott urges court to weigh evidence for/against validity. | Mylan asserts invalidity defenses (anticipation/obviousness) must be considered and findings made. | District court failed to weigh validity or make findings; remand for proper Rule 52 findings. |
| Whether the district court’s decision can be sustained without addressing the four Winter factors given disputed factual record. | Warner Chilcott asserts likelihood of success/irreparable harm shown under disputed facts. | Mylan argues the injunction should be denied absent clear findings on merits and validity. | Remand to allow proper assessment of all factors with appropriate record. |
Key Cases Cited
- Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372 (Fed. Cir. 2009) (trial court must weigh evidence for and against validity at preliminary stage)
- Elliott v. Kiesewetter, 98 F.3d 47 (3d Cir. 1996) (evidentiary hearing required if genuine issues of material fact exist)
- Ty, Inc. v. GMA Accessories, Inc., 132 F.3d 1167 (7th Cir. 1997) (undisputed facts not controlling when material facts in dispute)
- Kos Pharms., Inc. v. Andrx Corp., 369 F.3d 700 (3d Cir. 2004) (weighing validity evidence at preliminary stage; need for balancing)
- Mayo v. Lakeland Highlands Canning Co., 309 U.S. 310 (U.S. 1940) (requirement to explain factual findings under Rule 52(a))
- Pretty Punch Shoppettes, Inc. v. Hauk, 844 F.2d 782 (Fed. Cir. 1988) (remand when district court fails to explain findings)
- Sabinsa Corp. v. Creative Compounds, LLC, 609 F.3d 175 (3d Cir. 2010) (remand for proper analysis when findings are inadequate)
- Winter v. NRDC, 555 U.S. 7 (U.S. 2008) (four-factor test for preliminary injunction)