PATENT ISSUES IN ANDA APPROVAL

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  Merck  Sharp  &  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.