By Julian Pecquet - 08/06/11 06:56 PM EDT
The generic medicines industry is up in arms about an amendment in pending patent reform legislation tailored to benefit a Massachusetts pharmaceutical company.
The provision, dubbed the “Dog Ate My Homework Act” by critics - would redefine the deadline for filing a patent extension. It would benefit The Medicine Company, which missed a filing deadline for the anticoagulant Angiomax by two days a decade ago and has been trying to fix things ever since, as well as other drugmakers.
The company and its supporters in Congress say drugmakers’ lifesaving research shouldn’t be imperiled by confusing filing deadlines. Generic drugmakers retort that rejecting the patent extension would allow them to offer patients - and the government - a 70 percent discount on the cost of the drug.
The House passed the bill, 304-117, in June. Now generic drugmakers are drawing renewed attention to the provision after Senate Majority Leader Harry Reid (D-Nev.) filed for cloture Tuesday on the patent reform bill, setting up a vote in September.
"This amendment is an egregious example of an earmark designed to benefit a single brand pharmaceutical company at significant expense to American consumers and the generic pharmaceutical industry," said Generic Pharmaceutical Association Executive Director Bob Billings in a recent statement.
“If enacted, it would make the deadline for filing a patent term extension essentially meaningless, and treat patentees differently than anyone else to whom statutory deadlines apply. And all to benefit one company that, by choice, waited until the last minute to file a simple form that hundreds of other companies have timely filed since 1984.”
The Medicines Company says it's not the only company that stands to benefit from the change; Bayer and AstraZeneca, for example, have asked to have their rejected patent extension requests reconsidered under a recent court ruling.
A federal judge ruled last year that regulators were wrong in their interpretation of the deadline and that the company’s lawyers didn't actually miss it. A generic drugmaker, APP Pharmaceuticals, has appealed the ruling and oral arguments are pending.
Generic drugmakers are also worried about a slippery slope if the amendment passes.
In June, for example, Harvard’s Massachusetts General Hospital wrote to Sens. Herb Kohl (D-Wis.) and Michael Lee (R-Utah), the top Democrat and Republican on the Judiciary Committee’s antitrust panel - asking them to give the hospital a pass for missing the extension deadline on its respiratory drug INOMAX.
“We know that Congress is very sensitive to this problem and that it has given serious consideration to legislation that would solve a very similar problem for a pharmaceutical manufacturer that mistakenly failed to file for its patent term restoration within the 60-day statutory period,” hospital president Peter Slavin wrote.
“The availability of additional royalties to [the hospital] during this period of economic stress and budget cuts will enable us to continue important research in discovering treatments and cures for some of our country's most challenging medical conditions,” Slavin wrote.
Massachusetts senators John Kerry (D) and Scott Brown (R) are copied on the letter.
Update: This post was updated Aug. 8 with comment from The Medicines Company.