Back grey_arrow_rt.gif
US Department of Justice says drug patent settlements,
delaying generics may be illegal
  by Anna Bratulic
July 07, 2009
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).
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 Commissionanalysis 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.
Reference Articles
Drug settlements may be illegal, US Justice Department says - (Bloomberg)
DOJ changes policy on pharma pacts that delay generics - (CNN Money)
Justice Dept says reverse payments illegal - (Forex)
DOJ changes policy on pharma pacts that delay generics (free preview) - (The Wall Street Journal)
  icon paper stack View Older Articles   Back to Top