March 2007 - Pharmaceutical Technology

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March 2007

Pharmaceutical Technology

Pfizer said the court found that Synthon had knowingly failed to disclose to the US Patent and Trademark Office (Washington, DC, Pfizer publications and other information it had in its possession that described the process Synthon sought to patent.

"It's very difficult to meet the standards for establishing inequitable conduct," said Allen Waxman, Pfizer's general counsel, in a company statement. "But in this case it is clear that Synthon improperly used Pfizer's own published material to obtain a patent that it then tried to enforce against us."

Pfizer said it intends to seek attorneys' fees from Synthon. The case may be appealed.

In its statement, Pfizer explained that Synthon had asserted that Pfizer's process for manufacturing Norvasc infringed Synthon patents issued in 2003 and 2005. In August 2006, a federal court ruled that one of those patents was not infringed by Pfizer and was invalid on multiple grounds, principally because it was based on Pfizer's prior published work. Synthon had dropped its claim of infringement on the second patent prior to trial.

-Patricia Van Arnum


User Fees Bolster $2B FDA Budget

Washington, DC (Feb. 1)—The Bush administration's spending plan for 2008 treats the Food and Drug Administration fairly well, considering the cuts directed at Medicare, Medicaid, and children's health programs and flat funding for the National Institutes of Health (NIH). The White House proposes a record $2-billion budget for FDA for the year that starts Sept. 30, 2007. That amount consists of $1.6 billion in appropriated funds, plus some $450 million user fees for drugs, biologics, medical devices, and other products. Even though it's unclear just where the money would come from and just how big the increase really is, the $2-billion total sets a marker for Congress to achieve through some combination of government funding and industry payments.

One problem is that about $45 million in proposed user fees have never been approved by Congress, and may not be this year. The administration wants generic drug makers to pay $16 million in fees to speed up approvals, but industry quickly nixed the idea. They want any fee deal to link to policies halting obstructionist tactics by brands, such as authorized generics.

At the same time, pharmaceutical companies are likely to pay much more than the $340 million user fees in the budget plan for next year. Under the recent proposal for reauthorizing the Prescription Drug User Fee Act (PDUFA), FDA and industry propose to boost fees for drugs and biologics to $400 million per year to support increased oversight of drug safety issues. Congressional leaders plan to address the proposal by summer.

An unusual complication in budget analysis this year is that Congress failed to approve most 2007 spending bills before it adjourned last year, forcing most federal agencies to continue operating at 2006 funding levels. The legislators were still negotiating revised 2007 budget numbers when Bush unveiled the 2008 spending plan, making it difficult to calculate year-to-year increases. Under a Continuing Resolution approved by Congress last month, FDA and NIH were big winners. NIH gained a $600-million budget increase, while FDA was provided $90 million over 2006, for a $1.95 billion total budget for this year. The increase was critical for the agency to continue collecting and increasing user fees and to avoid layoffs of some 650 staffers.

Of almost $50 million in added funds for the Center for Drug Evaluation and Research under the Continuing Resolution for 2007, $35 million goes to the Office of Generic Drugs (OGD) to support faster application approvals. The Bush administration proposes to provide another $5 million next year for OGD, plus the added user fees.


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