The US Department of Agriculture (USDA) is expected to vote in the next few weeks on a Senate bill that would extend the patent life of some biotechnology process patents held by nonprofit organizations. The legislation is designed to extend the life of a Columbia University (New York) process patent on fundamental recombinant protein technology. Several biotechnology companies currently pay Columbia University a royalty of about 1% on sales of products made using the process—over $100 million a year collectively—but the patent expires next month. If passed, the extension could prolong these payments and open the possibility of extended patent royalties to other nonprofit institutions in the future. Supporters of the bill say it would effectively offer universities the same compensation for regulatory delays that biotech companies currently enjoy. However, industry organizations are worried that the bill is open to misinterpretation and could make it difficult to predict future royalty obligations to non-profits.
The Drug Price Competition and Patent Term Restoration Act (35 U.S.C. §156), commonly known as the Hatch–Waxman Act, allows any US patent owner to extend the life of a patent covering drug products (or a method of making and using the drugs) that were the subject of direct regulatory review by the Food and Drug Administration before market approval. The patent extension is designed to restore part of the patent term eroded by the lengthy regulatory review process. To be eligible, a request for extension must be filed within 60 days of the drug's regulatory approval and the patent must not yet be expired. The extension, however, applies only to a limited number of patents and products. For example, a patent can only be extended once, regardless of how many drugs make use of the patented technology, and only one patent per product can be extended regardless of how many patents cover the drug product, its use, and/or its manufacture. The life of patents that meet these criteria can be extended a maximum of 5 years, but not longer than 14 years from the date of FDA approval.
This is a preview of subscription content, access via your institution