These are but two examples. There are numerous others. Even drug products that were approved by FDA just prior to enactment of the Hatch-Waxman Act received better treatment than many of the outlier pipeline drugs covered under S.1172. While these already approved drugs did not receive any patent extension, they did receive 10 years of market exclusivity under other provisions of that Act. Thus, they received ten years of protection against generic drug competition.
Pharmaceutical companies are under tremendous competitive pressure.
Companies that do not discover and develop new products oftentimes do not survive. The number of pharmaceutical companies that have disappeared through mergers and acquisitions in recent years is evidence of this fact. Given this environment, and because so few compounds ever make it through the development process and to the market, it is critical that the rare successful product receive fair patent protection. Solution to the Outlier Pipeline Drug Problem Senator Torricelli has introduced legislation that would create a process by which the PTO could consider applications for patent term restoration for seven outlier pipeline drugs. The bill, S.1172, would authorize the PTO to determine whether pipeline drugs that were subjected to more than five years of NDA review by FDA should be awarded patent term restoration of up to three years.