Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation

Introducing generic alternatives that compete with previously approved drugs requires market approval through the Food and Drug Administration (“FDA”). To do so, competitors submit an Abbreviated New Drug Application (“ANDA”) that relies on the safety and efficacy data of the previously approved brand name drug. When that previously approved drug is covered by a patent, however, the mere act of filing the required ANDA subjects the competitor to an immediate patent infringement suit by the brand name company. Such suits are common. By filing an infringement action, the brand name company obtains an automatic 30-month stay during which the FDA cannot approve the competitor’s ANDA. The real and immediate risk of an infringement suit extends equally to all members of joint ventures that work towards FDA market approval. Petitioners formed a joint venture with a manufacturing partner to develop a generic alternative to Respondent’s brand name drug. Fearing an infringement suit, Petitioner challenged the validity of Respondent’s patent through an administrative proceeding created by Congress under the Leahy-Smith America Invents Act. Petitioner did not prevail on the challenge and appealed the adverse decision. The questions presented are: Did the Federal Circuit categorically and erroneously preclude redress for injured members of joint ventures in the pharmaceutical industry by only recognizing (1) the manufactuing partner in the joint venture, and (2) the partner applying for FDA marketing approval in the joint venture, as having demonstrable injury-in-fact for Article III standing?