[Ip-health] ''Dog Ate My Homework Act'' would grant MDCO 5 year extension of patent on heart drug Angiomax

[James Love]

* 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 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.

http://www.nytimes.com/aponline/us/AP-Drugs-Patent-Problem.html

Missed Deadline Causes Jam for Drug Maker

By THE ASSOCIATED PRESS
Published: June 17, 2006

Filed at 3:51 a.m. ET

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.


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James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton