Merck v Apotex and its aftermath: Did Apotex have the last laugh?

摘要

In Merck & Co., Inc. y Apotex, Inc., 292 Fed. Appx. 38 (Fed. Cir. 2008), the US Court of Appeals for the Federal Circuit (Federal Circuit) affirmed a decision of the US District Court for the District of New Jersey dismissing declaratory judgment counterclaims of Apotex, Inc. (Apotex) because Merck & Co., Inc. (Merck), the patentee, had filed disclaimers as to the patents in question. As a result, Apotex was unable to obtain a decision of invalidity or non-infringement with respect to those disclaimed patents for which another company, Hi-Tech Pharmacal Co., Inc. (Hi-Tech), was first to file an abbreviated new drug application (ANDA) containing paragraph IV certifications. Consequently, Apotex was unable to cause Hi-Tech to forfeit its 180-day exclusivity as a first filer. Following the Federal Circuit's decision, the US Food and Drug Administration (FDA) determined that Hi-Tech had forfeited its exclusivity because Merck had earlier requested delisting of the disclaimed patents. Hi-Tech unsuccessfully challenged the FDA's forfeiture determination in the US District Court for the District of Columbia. Thus, Apotex got what it ultimately wanted - forfeiture of Hi-Tech's exclusivity - due to Merck's delisting of the disclaimed patents in question and not due to its attempt to get a court decision on those patents (which was thwarted by virtue of Merck's disclaimer).