Sen. Tom Coburn will look to block the patent reform bill over a funding issue, clouding the legislations future.
Updated: 2:58 p.m.
How does a policy earmark worth more than $214 million garner the votes of conservatives such as GOP Reps. Michele Bachmann (Minn.) and Ron Paul (Texas)?
On Thursday, the House approved an amendment, authored by Rep. John Conyers (D-Mich.), that would change how the Patent and Trademark Office calculates a 60-day period for companies to apply for patent extensions. If signed into law, the language would provide a direct benefit to the Medicines Co., which faces the loss of its patent for its flagship drug, Angiomax, as well as to law firm WilmerHale, which is on the hook for a $214 million settlement with MDCO because it was tardy in submitting the drug’s patent extension request.
That retroactive amendment means the company can keep its patent on Angiomax and WilmerHale is free from the settlement that it agreed to with MDCO in February.
But the amendment could end up being worth much more than the $214 million that MDCO deemed as “fair” in the settlement; the company has said it expects anywhere from $500 million to $1 billion in profits if it retains the patent to the popular anticoagulant past 2014.
At issue is MDCO's 2000 application to maintain its patent over Angiomax. Following approval of the sale of the drug by the Food and Drug Administration in December 2000, the company had 60 days to file for a patent extension, which under the law would have precluded the sale of generic versions of the drug until 2014.
In 2001, the PTO rejected MDCO's application to extend the patent, saying its application was not filed on time. In August 2010, a federal district court agreed with MDCO that the extension was filed in time. The amendment would codify that interpretation.
MDCO and WilmerHale’s success in getting the legislation through the House during a time of deep public cynicism about how Congress works is a testament to the abilities of the companies and their lobbyists’ decision to take the long view.
MDCO, for instance, has spent a total of $16.93 million on lobbying since 2003, according to OpenSecrets.org.
“Why didn’t it get resolved years ago? Clearly they had to work it over and cajole and encourage” lawmakers and their staff to back the bill, said Steve Ellis, vice president of Taxpayers for Common Sense.
Although campaign contributions are the most scrutinized mechanisms for greasing the skids of Washington, Ellis argued that in situations such as MDCO’s, it is the traditional role of lobbyists working Congressional aides and individual Members over time that can count.
“When you hire this much lobbying muscle, a lot of it is dealing with staff,” Ellis said.