Late Patent Extension Request Spurs Proposed Legislation in House
20 Jun 2006
On February 14, 2001, a patent extension request by The Medicines Company on its heart medication Angiomax arrived at the U.S. Patent and Trademark office (USPTO)—one day after the application deadline. The USPTO rejected the application. However, that decision may be overturned if a bill giving the patent office the discretion to accept applications up to five days late is passed.
By law, pharmaceutical manufacturers have 60 days to apply for a patent extension after their drug is approved by the Food and Drug Administration for commercial use. The bill—H.R. 5120—is sponsored by 10 House representatives. Three of those representatives are from Massachusetts, where The Medicines Company is based. The Medicines Company is seeking to extend its patent for exclusive rights to Angiomax (an anti-clotting drug used during angioplasty) until December 15, 2014. It projects that Angiomax will generate over $500 million in the United States by 2010.
The legislation is being opposed by generic drug companies, which argue that it is intended to benefit one particular drug company and that generic manufacturers would not be “afforded such treatment.” The watchdog group Citizens Against Government Waste is criticizing the legislation on similar grounds. However, The Medicines Company has defended H.R. 5120 by arguing that it is meant to atone for drug manufacturers whose late patent applications were unintentional. If passed, H.R. 5120 would give the USPTO the authority to accept an application within five days following the deadline. Additionally, the patent applicant would have to demonstrate that the late request was unintentional.
Source: Missed deadline causes jam for drug maker. The Associated Press. June 17, 2006.
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