Sunday, June 18, 2006

Congress doing the people's work

Well, the people who run this particular drug company.

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 Medicines Co. for a patent extension on its heart drug Angiomax.

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.
I seem to remember the issue of deadline extensions coming up recently. What was it George Bush said?

"Deadlines help people understand there's finality, and people need to get after it, you know?"
When you have money and lobbyists at your disposal, there's apparently more than one way to "get after it."

ps. Don't hold your breath waiting for a pool reporter to ask Bush about his feelings concerning deadlines in relation to this bill, or to explain any inconsistency or changes in his position.

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