Webdog - the dog ate my homework!

WASHINGTON (AP) -- A day late and possibly several millions of dollars short. That's the scenario facing one 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 strange events leading to the bill's introduction began on Feb. 14, 2001, when the U.S. Patent and Trademark Office received The Medicines Company's application 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 three from Massachusetts which is the company's home state,have co-sponsored a bill that could reverse that decision. The bill gives the director of the patent office the discretion to accept an application if filed less than five days after the deadline. The applicant also needs to show that missing the window was unintentional.

The stakes for The Medicines Company are huge. The company 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.

''Neither Congress, nor taxpayers and consumers, should be used to cover up and correct any company's errors,'' the watchdog group's president, Thomas Schatz, said in a letter Friday to Rep. Jim Sensenbrenner, the Republican chairman of the House Judiciary Committee.

''Pursuing this legislation sets a dangerous precedent as it starts our nation on the slippery slope of politicizing the patent office,'' Schatz wrote.

The four original co-sponsors of the law are Reps. Bill Jenkins, R-Tenn., John Duncan, R-Tenn., William Delahunt, D-Mass., and Marty Meehan, D-Mass. None of the lawmakers would comment; their aides either declined to comment or did not return telephone calls.

A patent extension is designed to compensate companies for the extensive amount of time used to test the drug for safety and effectiveness. The federal government provides the extensions because it wants to stimulate product development and innovation.

In the company's most recent quarterly public filing, it acknowledged the patent mess and the pending legislation: ''We are exploring alternatives to extend the term of the patent, but we can provide no assurance that we will be successful.''

Asked for comment, company spokesman Michael Mitchell said in a statement, ''We support HR 5120 since, if it becomes law, it will make clear the Patent Office could review our patent restoration application on its merits.''

However, some in the generic drug industry, believe the bill is another example of the brand-name drug industry's clout on Capitol Hill.

''As generic companies, we aren't afforded such treatment, nor are other entities that make a mistake like that. Deadlines are deadlines and though unfortunate for the company, it's just too bad,'' said Greg Howard, a Washington-based consultant for the generic drug industry.

Source: NY Times