"Patent Fight Tests Drug Firm's Clout" [front page, Oct. 30] outlined a drug company's lobbying efforts without focusing on why politicians might conclude that the company had a point.
Patent laws offer an inventor the exclusive right to sell a product for a limited period. Until recently, this period ended 17 years after the patent was issued. A drug company, however, cannot sell its product until it obtains Food and Drug Administration approval. The patent term ticks away until the company is able to prove to the FDA's satisfaction that the product is safe and effective.
The Post's article said that patent extensions of up to five years can be obtained for drugs, and pointed out that the drug in question, Schering-Plough's Claritin, received a two-year extension that is scheduled to expire in 2002. Delayed FDA approval meant that the company could sell Claritin under patent protection for only nine years. Eight years of patent protection were effectively lopped off due to FDA delays.
The article said that the drug company is lobbying for a bill to create a special patent review board that would have authority to grant the full five-year extension for drug patents. Even if the new review board is created, and even if the company also wins its case before the new board, the result would be only 12 years of effective patent protection.
As a patent lawyer, I believe that a drug company that has lost almost half of its patent term due to bureaucratic delays has a right to petition Congress to establish a patent review board with authority to restore part of the lost term.