(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.
Double Standard: The majority found that an injunction is overbroad if it includes non-adjudicated products, but that an injunction is not overbroad if it includes prohibitions against a non-adjudicated party.
- Where are those Principles of Equity: Interestingly, the injunction portion of the decision did not discuss the Supreme Court’s recent case of eBay v. MercExchange. EBay focused on the language of the statute typically associated with patent infringement injunctive relief – 35 USC 283. Here, the law supporting the IVAX injunction is found at 35 USC 271(e)(4). There are some differences between those two statutes, although both are written in the permissive form – that courts “may” grant injunctions or injunctive relief. It is clear that the traditional equitable relief test should apply to Section 283 injunctions since the statute calls for use of “the principles of equity.” Another difference is that no money damages are available for Section 271(e) infringement. Are those differences sufficient enough to allow the court to issue an injunction under 271(e)(4) without considering the principles of equity required by the Supreme Court in EBay?