Morgan Lewis on Life Sciences
August/September 2005

In this Issue:

• Medicare Amendments Preserve Strategic Obstacles for Generics:
  In the 2003 Medicare Prescription Drug, Improvement and Modernization Act (the “Medicare Amendments”), Congress addressed a “critical” issue for generic drug companies — when a company that files an abbreviated new drug application (ANDA) seeking to market a generic formulation can bring an action against the innovator company for a declaratory judgment of patent noninfringement or invalidity. Despite an explicit provision in the legislation authorizing declaratory judgment actions as well as presumed congressional intent to foster such actions, the Federal Circuit, in Teva v. Pfizer, found that Congress did not intend to modify the jurisdictional test applied in a traditional patent infringement suit. Accordingly, the court held that no declaratory judgment action could be brought by the generic company absent a traditional threat of suit for patent infringement.
• Drug Patents May Not Bar Rival Research after Merck v. Integra:
  In June 2005, the U.S. Supreme Court issued the long-awaited ruling on the dispute between Merck KGaA and Integra Life Sciences Holdings Corp. over the unlicensed use of patented compounds in research and development. While the Supreme Court affirmed the position that many drug developers had adopted years ago — that they are free to use patented compounds in development without a license — it also extended this right upstream from clinical development to earlier-stage research, while at the same time expressly avoiding any discussion about the application of the exemption to “research tools.”
• Speeches

For the full story, please view the PDF.