In the debate among lawmakers over generic biotech drugs, the disagreement comes down to this: How many years should makers of the brand-name biologics be protected from generic competition?

Too short an exclusivity period will decrease companies’ motivation to innovate, supporters of the branded drug makers say. But biologics are expensive and the longer the exclusivity period, the longer patients have to wait for affordable drugs, say others, including the Federal Trade Commission.

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This week, the Senate Health, Education, Labor and Pensions Committee will be considering a bill introduced by Sen. Edward Kennedy that proposes 13 ½ years of protection, notes the WSJ. That’s nearly twice as long as the seven years recommended by the White House, and appears to support the industry’s position of at least 12 years of exclusivity. However, BIO, the biotech industry trade group, points out that the plan would offer protection only to new biologics approved after the passage of the bill.

Two other bills introduced earlier in the year — one from Senators Sherrod Brown and Chuck Schumer and the other from Rep. Henry Waxman — propose a five-year period of exclusivity with a possibility of an extension.

“Biotechnology start-up involves high risk and high cost, but you can’t give these companies open-ended protection from generics,” Sen. Brown told the WSJ.

The generic drug industry trade group says that the seven-year compromise is what is needed.

Source: The Wall Street Journal

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According to a brief filed with a federal appeals court in New York, the Department of Justice (DOJ) said that pharmaceutical patent settlements that delay the introduction of generic drugs to the market are “presumptively unlawful.” The appeals court had invited the DOJ to submit comments on such deals as the court considers whether to allow a challenge to a $398-million patent settlement between Bayer and Teva’s Barr unit over the antibiotic Cipro (ciprofloxacin).

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The head of the department’s antitrust division, Christine Varney, stated in the brief that agreements involving payments by the drug manufacturer to the patent challenger to delay a generic launch “requires the defendant to offer justifications in order to avoid antitrust liability.” In addition, the DOJ remarked that the resulting decrease in drug costs after a generic product is introduced, as well as the terms of federal drug law, “create unique incentives and opportunities for settlements that threaten the public interest, incentives and opportunities apparently not found elsewhere.” The DOJ declined to take a position on the litigation launched by drug purchasers against Bayer and Barr over the drugmakers’ 1997 settlement to delay the introduction of a generic version of Cipro.

The DOJ’s statements follow a recent Federal Trade Commission analysis that suggested prohibiting patent settlements between brand-name manufacturers and generic drugmakers could result in reduced spending on prescription drugs by $3.5 billion annually in the US.

Source: FirstWord

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The Health Blog has a word of warning for Andrew Bodnar, a former senior executive vice president at Bristol-Myers Squibb: Writing is a tough gig.

A federal judge yesterday sentenced Bodnar to write the story of how he came to give false information to the feds about Bristol’s 2006 efforts to delay generic competition for its blood thinner Plavix.

“I would like to see you write a book” so other people “don’t find themselves in a similar situation,” the judge told Bodnar, Bloomberg News reports. “Who knows, it may even be inspirational.”

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Bodnar pleaded guilty in April to a single count of lying to the Federal Trade Commission, Bloomberg says. He was also sentenced to two years of probation and ordered to pay a $5,000 fine. (For more on the case against him, see our post from when he was indicted.) The case was part of a broader Bristol imbroglio that also led the company to oust its CEO, plead guilty to a federal charge pay a $1 million fine.

Bodnar doesn’t object to the terms and is “gratified” that the matter is behind him, his attorney told Bloomberg News. A Bristol spokesman declined to comment, Bloomberg said.

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