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Injunction against “any products” that infringe is overbroad; Injunction against potential future contributory infringer is not overbroad
Forest Labs v. IVAX (TEVA) and CIPLA (Fed. Cir. 2007). (Read Part I of this case analysis)
(J.Lourie) IVAX’s infringement began when it filed an abbreviated new drug application (ANDA) with the FDA for approval to manufacture a generic version of Forest Lab’s blockbuster antidepressant Lexapro. Under 35 USC 271(e)(2), the mere submission of the ANDA is considered an “act of infringement.”
At the conclusion of the case, the district court issued an injunction ordering IVAX to refrain from making or using “any products” that infringe Forest’s patent. CIPLA, IVAX’s planned distributor, was also included in the injunction.
IVAX and CIPLA both appealed the injunctions.
Overbroad Injunction: An injunction may only extend to adjudicated products (or methods) and those “not more than colorably different.” In this case, the CAFC found that the injunction language was overbroad because it applied to “any products” that infringe the patent. The court consequently modified the injunction to specifically focus on the products at issue. (Note: Under 271(e)(4), the court may issue injunctive relief to prevent the future manufacture and sale of the infringing product).
Injunction against CIPLA for Potential Contributory Infringement: IVAX is a direct infringer based on its ANDA submission. CIPLA, on the other hand, made no such submission and is not a direct infringer. Likewise, CIPLA is not a contributory infringer based on the ANDA submission. As the majority noted – “Ivax is not currently liable for infringement, as long as it is only pursuing FDA approval.”
Despite any current infringement, the Appellate Panel found that it is proper to issue an injunction to prevent potential future contributory infringement.
“[If the drug were sold] CIPLA would be contributing to the infringement by IVAX, so the injunction should cover both partners.”
Judge Shall dissented – arguing that CIPLA should not suffer under an injunction.
Appellate Panel Upholds Forest’s Lexapro Patent
Forest Labs v. IVAX (TEVA) and CIPLA (Fed. Cir. 2007).
The Court of Appeals for the Federal Circuit today upheld Forest Labs patent on its billion dollar SSRI Lexapro (escitalopram oxalate) — rejecting IVAX’s arguments that the patent is anticipated and obvious. Based on two FDA extensions, the patent is set to expire on March 14, 2012.
This case is an important stepping stone in our new understanding of obviousness. Interestingly, in its multi-page discussion of obviousness, the appellate panel did not mention the Supreme Court’s recent landmark decision of KSR v. Teleflex.
History: Forest holds an expired patent on a racemic form of citalopram. After considerable effort, Forest’s scientists doubled the strength of the drug by isolating the (+) stereoisomer (which turned out to be the only active isomer) and patented that isomer in a “substantially pure” form. A prior art pharmacologic paper had suggested that the (-) stereoisomer would be the potent isomer, but that reference did not describe the preparation of the enantiomer.