When faced with determined opponents, sports teams sometimes work the referees to win the game. A victory based on an interpretation of the rules is a victory nonetheless. The team of Warner Chilcott (Rockaway, NJ), Medicis Pharmaceutical (Scottsdale, AZ), Roche (Basel), and Stiefel Laboratories (Coral Gables, FL) recently used this tactic in their competition with generic drugmakers. The companies filed citizen petitions with the US Food and Drug Administration in an attempt to delay the approval of generic versions of their antibiotics.
The innovators’ argument is based on several laws that were modified over time. Warner Chilcott and the others complied with the relevant patent law, but generics manufacturers submitted abbreviated new drug applications (ANDAs) before the patents were officially listed. FDA’s approval process for antibiotics subsequently changed, and Congress granted Hatch–Waxman protections to antibiotics in October 2008. In light of the new protections, the petitions asked FDA to stay approval of the generics companies’ ANDAs for 30 months.
FDA didn’t buy the argument, saying that it was based on law that no longer applied. Although Hatch–Waxman initially allowed the approval of generic ANDAs to be stayed for 30 months at a petitioner’s request, the Medicare Prescription Drug, Improvement, and Modernization Act limited the availability of the stays when it was enacted in December 2003.
These petitions strike me as ill conceived. Although the evolving law can admittedly be confusing, the companies’ case seems to have been doomed from the start. Their lawyers likely realized that the argument was not based on current regulations and would not hold water. Without a clear case of patent violation, the companies would compete better with generics companies by investing in research or reformulating their existing products.