By Kenneth Horton
Pfizer recently triumphed in a strategy for continuing the exclusivity of its branded drug Neurontin. One avenue for attacking the exclusivity of a branded drug is by obtaining FDA approval of an Abbreviated New Drug Application (ANDA). The ANDA seeks to market and sell a generic drug that is the bioequivalent to a branded drug. The branded drug, however, has previously been approved under a New Drug Application (NDA) which requires expensive and time-consuming clinical trials. Unlike a NDA, an ANDA need not submit clinical evidence of the safety or efficacy of the drug.
The ANDA must certify that the approved product is not protected by a patent, or that the patent is invalid or will not be infringed by the generic drug. The first generic pharmaceutical company that successfully challenges the patent is awarded a 180-day exclusivity period during which no other ANDA may be approved. Thus, other generic pharmaceutical companies cannot file and pursue an ANDA.
Teva obtained an ANDA for a generic version of Neurontin and began to sell the generic version during the 180 day period. During this same period, Pfizer also began to sell a generic version of its own branded drug. Teva filed a “citizen petition” with the FDA and requested that they prohibit Pfizer from selling its generic version during this time period. When that petition was denied by the FDA, Teva sought relief from the courts.
In Teva Pharmaceutical Industries Ltd. v. Lester M. Crawford, Jr., Acting Commissioner of Food And Drugs, et al. (No. 05-5004, June 3, 2005), the U.S. Court of Appeals for the District of Columbia Circuit affirmed a district court’s ruling that while other generic pharmaceutical companies cannot seek approval of their own ANDA (and thereby sell their own generic versions), the holder of an approved NDA is not prohibited from marketing and selling its own generic version of its branded drug.
For more information, contact Kenneth Horton at khorton@kmclaw.com.