The narrowly tailored provision, first added to the bill by Sen. Edward Kennedy, D-Mass., is the fruit of an impressive $4.6 million lobbying campaign featuring an all-star cast of former lawmakers and government officials from both parties.
Medicines Company, or MDCO, a pharmaceutical maker, has dispatched this full-court lobbying press in hopes of extending by 56 months its patent on a heart medication, preventing competition from generics in that period and boosting company earnings by $1 billion. To this end, the company’s lobbyists have crafted a change to patent law that would apply, in fact, only to MDCO.
The story line begins Dec. 15, 2000, when the Food and Drug Administration approved sale of Angiomax, the prescription heart medication on which MDCO held the patent. Because the FDA approval process took some time, MDCO was entitled to a 56-month extension of its Angiomax patent past the March 2010 expiration. However, MDCO didn’t apply for this extension until Feb. 14, 2001, 61 days after FDA approval, and thus one day past the deadline clearly set in law for such applications.
This meant generic versions of Angiomax would hit shelves in 2010 rather than in 2014 — good news for Angiomax patients and generic drugmakers, but bad news for MDCO. That one-day tardiness cost the company an estimated $500 million to $1 billion. MDCO begged for forgiveness, but the law doesn’t grant the U.S. Patent and Trademark Office any flexibility when it comes to this deadline.
Rather than forgo half a billion dollars, MDCO did what any company in its position would do — it started lobbying Congress to change the law. MDCO, however, assembled an unusually impressive lineup of lobbyists. The company hired at least eight lobbying firms and retained the biggest names available.
MDCO’s lobbyists on this one issue have included: former Sen. and Ambassador to Germany Daniel Coats; former House Majority Leader Dick Armey; former spokesman for Vice President George H.W. Bush and former Ambassador to Canada Peter Teeley; Philip Kiko, former counsel to former House Judiciary Committee Chairman James Sensenbrenner; Mac Bernstein, an aide to former Democratic Sen. Howard Metzenbaum and currently a HillRaiser — $100,000 bundler for Hillary Clinton; Tom Korologos, who served in the Nixon and Ford administrations and was recently the ambassador to Belgium; and Steve Elmendorf, top adviser to John Kerry and Richard Gephardt.
With this team, it’s no wonder MDCO shelled out $4.6 million on lobbying last year, much more than either the National Rifle Association or Wal-Mart.
The full-court press began in late 2006, when the company crafted a bill that would grant the PTO director authority to accept late applications. How widespread was this problem? Jon Dudas, director of the PTO, testified to Congress that the bill would apply only to the Medicines Company. Considering the narrow application, it’s hard to argue the measure would “promote the Progress of Science,” the Constitution’s justification for federal patent authority.
At first, the company couldn’t get its way. Despite the cast of Republican stars, MDCO couldn’t persuade jittery Republicans, on the eve of the 2006 election, to insert its provision. One Senate staffer told me that Republicans were not about to pass a bill narrowly crafted to help one drug company, thus setting themselves up for corporate-cronyism attacks by Democrats. “This was nothing more than a naked bailout of one company,” the staffer said.
Last fall, however, Kennedy inserted the provision into the Patent Reform Act of 2007 bill while the Judiciary Committee was debating it. The bill, with Kennedy’s provision, is now before the full Senate.
Earlier this month, the Congressional Budget Office estimated the MDCO provision, by keeping cheap generic versions of Angiomax off the market longer, would increase government spending on health care by $19 million from 2011 to 2018.
The generic drug industry is lobbying against the provision for obvious reasons, but MDCO has more to gain here than any rival has to lose. Unless something changes, it looks like once again, he with the biggest lobbying budget wins.
Examiner columnist Timothy P. Carney is senior reporter for the Evans & Novak Political Report.
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