Generic drug manufacturers across the globe, especially from India, experts in making copycat versions, will suffer major losses with the amicus curae of the US Federal Circuit court, Washington Legal Foundation (WLF), urging the court to rehear a case in which Caraco, Sun Pharma’s US subsidiary, is involved. The court’s order last month favouring Caraco in its case with Forest Labs, held back the “declaratory judgment action”, helping generic firms enter the market smoothly. Now, if the Federal Circuit court, acting upon the amicus curae’s request, changes the verdict, it will deal a severe blow to generic firms across the globe, including India.
Caraco had filed paragraph IV ANDA, claiming its abbreviated new drug application (ANDA) for marketing Forest Labs’ Lexapro, $2-billion antidepressant drug, will not infringe Forest’s patents. Forest sued Caraco on the ‘712 patent (expires in 2012) but not on the ‘941 patent (expires in 2023). Following Caraco’s complaint seeking declaratory judgment that its generic version of Lexapro will not infringe the ‘941 patent, Forest granted Caraco an unconditional covenant not to sue for infringement of the ‘941 patent. Due to the covenant, the district court dismissed Caraco’s complaint citing there is no scope for article III (case or controversy). In April, in reversing the district court’s dismissal, the Federal Court held Caraco’s declaratory judgment action, citing that the issues presented are ripe for judicial review, which meets article III, based on a previous verdict by the Supreme Court (SC) in another dispute between MedImmune and Genentech.
Last month, the counsel for WLF as amicus curiae, in its brief in the US Court of Appeals for the Federal Circuit, said, “Rehearing is warranted because subject matter jurisdiction is lacking. In light of Forest’s covenant, there exists no controversy between parties. Also, Caraco has not suffered any injury at the hands of Forest Labs and thus lacks standing.”
Gopakumar Nair, Mumbai-based patent attorney, said, “Though WLF has now moved the Federal Circuit to primarily protect the interests of the innovator companies, the Caraco vs Forest judgment opens a ‘highway’ for all generic companies, especially those who are worried about high litigation costs while filing a Para IV ANDA. The Para IV filer can now approach a court for a declaratory judgment, ahead of an actual suit or absence of a suit by the innovator.” The court decision was termed as a favourable one to generic firms. As Sun Pharma was granted declaratory judgment for non-infringement, other generic firms can claim declaratory judgment to enter the market smoothly. When contacted, Sun Pharma spokesperson refused to comment.
Nair added, “Till the SC judgment in MedImmune and Federal Court judgment in Caraco is maintained and not reversed in response to the suit by WLF, generic companies can ride smoothly with their generic launches through paragraph IV ANDA.”