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Integra and the Burnham (Ps), own five patents related to the tripeptide sequence Arg-Gly-Asp, known in single-letter notation as the 'RGD peptide.' In 1988, D provided funding for angiogenesis research conducted by Dr. Cheresh who worked at Scripps. Angiogenesis is the process by which new blood vessels sprout from existing vessels; it plays a critical role in many diseases. Dr. Cheresh discovered that it was possible to inhibit angiogenesis by blocking the [alpha] [nu] [beta] integrins on proliferating endothelial cells. In 1988, D provided funding for angiogenesis research conducted by Dr. Cheresh. Angiogenesis is the process by which new blood vessels sprout from existing vessels; it plays a critical role in many diseases. Dr. Cheresh discovered that it was possible to inhibit angiogenesis by blocking the [alpha] [nu] [beta] integrins on proliferating endothelial cells. Ibid. In 1994, Dr. Cheresh succeeded in reversing tumor growth in chicken embryos, first using a monoclonal antibody (LM609) he developed himself and later using a cyclic RGD peptide (EMD 66203) provided by D. With his initial success, Dr. Cheresh submitted a detailed proposal for expanded collaboration between Scripps and D on February 1, 1995. The proposal was to culminate with the submission of an IND to the FDA in year three. D pledged $6 million. On July 18, 1996, P filed a patent-infringement suit against D, Scripps, and Dr. Cheresh. P sought damages and a declaratory judgment against Dr. Cheresh and Scripps. D claimed that it did not infringe P's patents and that Ds were protected by the common-law research exemption §271(e)(1). The Court gave the following instruction regarding the §271(e)(1) exemption: 'To prevail on this defense, [petitioner] must prove by a preponderance of the evidence that it would be objectively reasonable for a party in [petitioner's] and Scripps' situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the processes by which the FDA would decide whether to approve the product in question. Each of the accused activities must be evaluated separately to determine whether the exemption applies. [Petitioner] does not need to show that the information gathered from a particular activity was actually submitted to the FDA.' The jury found infringement and awarded P $15 million. The Court dismissed P's suit against Dr. Cheresh and Scripps, but affirmed the jury's damages award against D. It held that §271(e)(1) did not apply because the connection between the infringing Scripps experiments and FDA review was insufficiently direct. The Court of Appeals held that the safe harbor did not apply because the work performed was not clinical testing to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds. The Supreme Court granted certiorari.

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