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ORPHAN DRUG AMENDMENTS IN LIEU OF BIOTECH EXCLUSIVITY BILL

Executive Summary

ORPHAN DRUG AMENDMENTS IN LIEU OF BIOTECH EXCLUSIVITY BILL were urged by Genetics Institute and Cetus in an April 5 letter to Sen. Orrin Hatch (R-Utah). The companies maintained that "some minor adjustments [of the Orphan Drug Act] would eliminate or greatly reduce the abuses [of the Orphan Drug Act] and bring the orphan drug practices in line with the spirit of this important legislation." Hatch is working on legislation to provide up to 10 years of marketing exclusivity for newly approved biotechnology drugs that under current law would be unpatentable if based on substances produced in the human body ("The Pink Sheet" Feb. 20, p. 3). "We believe such legislation is highly undesirable," the firms' letter states. Among the "adjustments" suggested by the firms was shared exclusivity. "The 'incentive' features of the act can be enhanced and the 'exclusivity' features reduced perhaps in favor of a shared exclusivity approach for developers who are seeking NDA/PLAs and have a current IND in place," the letter states. The companies also suggested that the 200,000 patient threshold for orphan status "could be adjusted." Additionally, they recommended an amendment to the Orphan Drug Act "which removes privileges from an orphaned product if it turns into a blockbuster in the marketplace." Genetics Institute and Cetus have applications pending at FDA for biotech products that are simultaneously being developed by other companies. Genetics Institute is developing erythropoietin (EPO), although it is expected that Amgen will receive the first FDA approval for EPO. Cetus is pursuing marketing approval for its Proleukin interleukin-2 treatment for metastatic kidney cancer. The company is currently involved in a patent dispute with Roche, which also has an interleukin-2 for cancer in clinicals. Hatch's proposed legislation would remove biotech products from coverage under the present Orphan Drug law, while providing an alternative form of market exclusivity. Genetics Institute and Cetus maintain that such an approach "will award market monopolies in a manner that is inherently unfair, inconsistent with sound public policy, and will lead to additional abuses of the drug approval process." The biotech industry is afforded adequate market exclusivity through the current patent system, the firms maintained. "In general," the companies noted, "our current patent system works very well . . . Innovators are being awarded protection for their inventions sufficient to insure a healthy stream of new products to the American public. This system provides 'exclusivity' until a clever competition comes up with a better idea, thus striking the proper balance between protecting creativity and keeping industry on its toes."
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PS015396

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