The pharmaceutical industry is facing the expiration of patents to more than 30 blockbuster drugs by the year 2002. With the threat of cheaper, generic drugs taking market share, several pharmaceutical companies are implementing various legal strategies to delay the inevitable loss of patent rights. Stop-gap tactics—such as patent infringement litigation, the filing of secondary or blocking patents, and licensing rights to newer, improved drugs—are effectively buying companies more time to continue collecting billions of dollars in revenues. As a result, biotechnology companies, many of which are developing purer forms of drugs, novel forms of drug delivery (Nat. Biotechnol. 16, 115, 1998) or pharmacogenomic-based diagnostic tools (Nat. Biotechnol. 15, 829, 1996), could end up winners.
Eli Lilly & Co. (Indianapolis, IN) is fighting to protect $3 billion annual sales of its selective serotonin re-uptake inhibitor, Prozac (fluoxetine). In a $4 million settlement in January, Lilly won a three-year, two patent infringement, lawsuit against three generic drug companies: Barr Laboratories (Pomona, NY), Apotex (Toronto, Canada), and Geneva Pharmaceuticals (Broomfield, CO). This ensures, in the absence of an appeal and any other litigation, that Prozac will not become a generic drug until December 2003.
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