In a July 16, 2013 ruling, Judge Katherine B. Forrest dismissed two patent infringement cases brought by Teva Pharmaceuticals USA, Inc. against Sandoz Inc. and Mylan Pharmaceuticals Inc. under Rule 12(6). The four patents-in-suit relate to methods of characterizing the active pharmaceutical ingredient in a drug for treating relapsing-remitting multiple sclerosis. Half of Teva's claims in each complaint related to the defendants' alleged infringement of the patents-in-suit while generating information for their Abbreviated New Drug Applications to make generic forms of the drug, and the other half of the claims were declaratory judgment claims that the defendants would infringe the patents-in-suit in their future production of the drug.
As to the alleged infringement in connection with preparing the ANDAs, Judge Forrest considered whether the allegedly infringing conduct fell within the safe harbor provision, 35 U.S.C. § 271(e)(1), which insulates infringing conduct "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." Relying on recent Federal Circuit, Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348 (Fed. Cir. 2012), Judge Forrest ruled that the "holding of Momenta -- combined with its fact pattern -- supports dismissal here. Momenta allows for the elective use of patented technology as long as it serves to produce information required under a federal law. Here, the complaints allege that Sandoz and Mylan have done no more than just that." After considering, and rejecting, case law cited by Teva, the Court concluded:
The statutory safe harbor is clear. It applies to precisely that activity alleged here to be infringing. both the Mylan and Sandoz defendants used the patented product solely for uses reasonably related to the development and submission of information under a federal law. The parties do not dispute that this is the case.
As to the declaratory judgment claims concerning future use, Judge Forrest dismissed them for lack of subject matter jurisdiction after both defendants unequivocally represented to the Court that they had changed their processes to avoid the patents-in-suit. The Court thus found no case or controversy, and dismissed these claims.
