In 1984, the “Drug Price Competition and Patent Term Restoration Act,” more commonly known as the “Hatch-Waxman Act” after its sponsors, established the modern regime for resolving pharmaceutical patent infringement disputes between generic and branded drug manufacturers in situations in which a generic maker seeks Food and Drug Administration (FDA) approval to market a drug that is bioequivalent to an approved branded drug. The Patent Act, 35 U.S.C. §271(e)(2), establishes that submission of an abbreviated new drug application (ANDA) by a generic pharmaceutical maker to the FDA constitutes patent infringement (even though such an application technically is not a use of the patented invention). Upon such a filing, the brand manufacturer can then commence a patent infringement suit, commonly known as ANDA litigation.
One issue that the branded manufacturer must consider in these circumstances is the venue in which to bring suit. The Federal Circuit’s precedential decision earlier this month in Celgene v. Mylan Pharmaceuticals, No. 20-1154 (Fed. Cir. Nov. 5, 2021) provided further guidance regarding what constitutes an act of infringement for venue purposes in the ANDA context.