WASHINGTON -- A day late and possibly several million dollars short. That is the prospect facing one Massachusetts drug manufacturer unless it can get a helping hand from Congress.
Legislation in the House would give the agency overseeing patents discretion in approving late requests for patent extensions. The legislation, which some critics call the ``Dog Ate My Homework Act," is based on a request that arrived one day too late for government consideration.
The events leading to the bill's introduction began Feb. 14, 2001, when the US Patent and Trademark Office received an application from The
That was one day later than the application deadline -- no later than 60 days after the Food and Drug Administration approves the drug for commercial use and sale. There are no exceptions to that window, so patent officials rejected the application.
Ten lawmakers, including at least two from Massachusetts, have cosponsored a bill that could reverse that decision. The bill gives the director of the patent office the discretion to accept an application if filed fewer than five days after the deadline. The applicant also needs to show that missing the window was unintentional.
The stakes are huge. The Medicines Co. recently told stock analysts and investors that it expects Angiomax to generate more than $500 million in sales in the United States by 2010. The drug is an anticoagulant that prevents clot formation during angioplasty.
The company has expanded its lobbying presence on Capitol Hill to push the legislation. It spent $440,000 on lobbying last year -- more than double what it had spent over the three previous years combined, according to FEC Info., a company that tracks lobbying disclosure reports.
The company wants its patent to be extended 1,773 days, giving it exclusive rights to the drug until Dec. 15, 2014.
The legislation has attracted the attention of some generic drug companies and the watchdog group Citizens Against Government Waste, which said it has consistently opposed legislation designed to benefit one company.
The four original cosponsors of the bill are Representatives William L. Jenkins and John J. Duncan Jr., Republicans of Tennessee, as well as William D. Delahunt and Martin T. Meehan, Democrats of Massachusetts. None of the lawmakers would comment.