Integra LifeSciences v. Merck
In 1984, a legal “safe harbor” for generic drug makers was created in the patent law (U.S.C. 35 §217(e)(1), also known as the Bolar Amendment). This exempts activities undertaken “solely for uses reasonably related to the development and submission of information” required for FDA drug approval. It is intended to allow generic manufacturers to have their drugs ready to introduce as soon the pioneer drug’s patent expires. In 2003, a federal circuit court upheld a decision that limits what sort of drug research can be considered “reasonably related” to an FDA submission, and therefore immune from infringement claims.
Integra LifeSciences owned several patents on RGD tri-peptides, a type of small protein that binds to integrin molecules on a cell’s surface. Because of this binding property, the RGD peptides can be used to manipulate cell activities in certain useful ways, affecting cell adhesion and blood vessel growth.
Not long after the RGD peptide patents were awarded, Dr. David Cheresch of the Scripps Institute discovered that some RGD-containing compounds can block tumor growth by limiting angiogenesis (growth of blood vessels). Beginning in 1988, Merck began funding Dr. Cheresch’s research to identify cancer drugs that work by this mechanism. By the mid 1990s, his team had found a drug that seemed quite promising: the cyclic RDG peptide 121974.
Believing the drug research infringed on its RDG patents, Integra brought suit against Merck, Scripps, and Cheresch in 1996. Merck claimed that the research was protected from infringement claims under the “safe harbor” provision found in U.S.C. 35 §217(e)(1).
Ultimately, the court decided that the exemption, “simply does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process. The safe harbor does not reach any exploratory research that may rationally form a predicate for future FDA clinical tests.” Neither did the court deem the Merck research to qualify for protection under a common law research exemption.
Judge Neuman dissented, finding Merck’s early stage research to be allowed by the common law research exemption, and the later stage research to be covered by the exemption for generating FDA submissions. She wrote: “The purpose of a patent system is not only to provide a financial incentive to create new knowledge and bring it to public benefit through new products; it also serves to add to the body of published scientific/ technical knowledge… The right to conduct research to achieve such knowledge need not, and should not, await expiration of the patent. That is not the law, and it would a practice impossible to administer.”
| Court: | | Ninth District |
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