Cipla Ltd. v. Amgen Inc., 386 F. Supp. 3d 386

Background

Amgen owns U.S. Patent No. 9,375,405 covering cinacalcet (SENSIPAR). Several generic manufacturers filed ANDAs; litigation ensued. Cipla settled with Amgen in 2018 (Amgen‑Cipla Agreement), conceding infringement and agreeing not to market until the Entry Date (normally 97 days before patent expiration) except in specified circumstances.
Other defendants (Teva, Piramal, Amneal, Zydus) litigated to judgment; Judge Goldberg found Teva and Piramal did not infringe. Teva launched a generic product in December 2018, then on January 2, 2019 entered a settlement (Amgen‑Teva Agreement) stipulating infringement and agreeing to payments and to stop selling.
Cipla launched its generic "at risk" in March 2019 and sued for a declaratory judgment it had the right to launch; Amgen moved for a preliminary injunction to stop Cipla's sales as a breach of the Amgen‑Cipla Agreement.
The pivotal contractual provision is Section 5.6 of the Amgen‑Cipla Agreement: it (inter alia) provides that if a third party that has made an at‑risk launch is "not found to have infringed" or "has not ceased or agreed to cease selling" then Amgen "shall not be entitled to seek or recover any relief" against Cipla for Cipla's at‑risk sales.
The district court found condition [i] of §5.6 satisfied (Teva was "not found to have infringed" at the district‑court level) and, given ambiguities about whether Teva had ceased indirect sales, treated condition [ii] as satisfied as well. Because §5.6 is a "notwithstanding" clause, it overrides other provisions and bars Amgen from seeking any relief (including a preliminary injunction) against Cipla's at‑risk launch.
The court therefore denied Amgen's preliminary injunction motion, although it concluded Amgen had shown irreparable harm and that the balance of equities and public interest slightly favored Amgen; denial rested on Amgen's failure to show likelihood of success on the merits (contract breach) due to §5.6.

Issues

Issue	Amgen's Argument	Cipla's Argument	Held
Whether Cipla breached the Amgen‑Cipla Agreement by launching at risk	Section 5.6(1) and other provisions permit Amgen to seek relief because Teva admitted infringement and agreed to pay damages under the Amgen‑Teva Agreement	Section 5.6(2) (a "notwithstanding" clause) bars Amgen from seeking any relief if a third party that made an at‑risk launch was "not found to have infringed" or "has not ceased or agreed to cease selling"	Court held Cipla likely succeeds: §5.6 sentence [2] applies (Teva was "not found to have infringed"); Amgen cannot show likelihood of success on breach claim
Proper construction of §5.6: whether its disjunctive "or" requires both conditions or either one	"Or" should be read conjunctively (both conditions required); Amgen satisfied conditions so it may seek relief	"Or" is disjunctive; either condition suffices to bar Amgen	Court held "or" is disjunctive: either condition [i] or [ii] triggers the bar, and condition [i] is satisfied
Whether a district‑court non‑infringement judgment qualifies as "not found to have infringed" for §5.6 (or whether an appellate exhaustion is required)	§5.6 requires a "Final Court Decision" (i.e., exhaustion) to trigger third‑party protections	§5.6 uses different language—"not found to have infringed"—which refers to the district court finding and does not require exhaustion	Court held the district court judgment that Teva "does not infringe" satisfies §5.6's "not found to have infringed" phrase; appellate exhaustion not required for §5.6 trigger
Whether Amgen is entitled to preliminary injunctive relief despite showing irreparable harm	Even if irreparable harm exists, contract terms and settlement structure permit emergency relief	Contract §5.6 (and §5.5 ambiguity) preclude any relief; Amgen not likely to prevail on merits so injunction should be denied	Court found Amgen demonstrated irreparable harm but denied the preliminary injunction because Amgen failed to show likelihood of success on the breach claim under §5.6

Key Cases Cited

Novartis Consumer Health, Inc. v. Johnson & Johnson‑Merck Consumer Pharm. Co., 290 F.3d 578 (3d Cir. 2002) (standard for preliminary injunction in Third Circuit)
Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7 (2008) (four‑factor preliminary injunction test)
Bennington Foods LLC v. St. Croix Renaissance Grp., LLP, 528 F.3d 176 (3d Cir. 2008) (movant must show likelihood of success and irreparable harm)
Reilly v. City of Harrisburg, 858 F.3d 173 (3d Cir. 2017) (equitable nature of preliminary injunction and balancing factors)
Macom Tech. Sols. Holdings, Inc. v. Infineon Techs. AG, 881 F.3d 1323 (Fed. Cir. 2018) (causal nexus for irreparable harm in patent cases)
Sanofi‑Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed. Cir. 2006) (irreparable harm to branded drug maker from generic entry)
Cisneros v. Alpine Ridge Group, 508 U.S. 10 (1993) (meaning and effect of "notwithstanding" clauses)
Dawson Chemical Co. v. Rohm & Haas Co., 448 U.S. 176 (1980) (patent misuse relates to unclean hands in equity)
U.S. Philips Corp. v. Int'l Trade Comm'n, 424 F.3d 1179 (Fed. Cir. 2005) (patent misuse as equitable defense)
Lear, Inc. v. Adkins, 395 U.S. 653 (1969) (limitations on contracting away patent challenges)
FTC v. Actavis, Inc., 570 U.S. 136 (2013) (antitrust scrutiny of certain patent settlement agreements)