Abstract

PATENT ISSUES IN ANDA APPROVAL

*Valluri Sowmya

ABSTRACT

The study provides information on the laws governing patents, the revisions made under the Hatch Waxman Act, and the application procedure for US patents. The case 01, involving an ANDA violation brought about by an unlawful venue, involves Valeant Pharmaceuticals and Mylan Laboratories. In the Hatch Waxman instances, the location of the ANDA submission is irrelevant; anybody can submit an ANDA from anywhere in the world. The court took notice of this observation, dismissed Valeant Pharmaceuticals' argument, and authorised Mylan Laboratories to submit an ANDA. Thus, the case gave us the impression that the location of an ANDA filing is irrelevant. The case 02 involving ANDA infringement between MerckSharp & Dohme Corp. and Amneal Pharmaceuticals. The MFM patent is held by the Merck corporation, and when Amneal wishes to submit an ANDA for MFM, Merck claims that this is an act of infringement. Merck testified in court that three peak analyses were required to determine the amount of MFM present in Amneal's product. One peak analysis is also adequate to diagnose MFM, Amneal testified in court. Then the court instructed both firms to form an expert committee, conduct the study, and submit the report. The court dismissed Merck Sharp & Dohme Corp.'s argument after examining the report and concluding that one peak analysis is adequate and that Amneal's ANDA would not violate any patents.

Keywords: Patent, ANDA, Infringement, Case study, Hatch Waxman act.