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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended primarily for other attorneys. Orange Book Blog is not edited by McDonnell Boehnen Hulbert & Berghoff LLP ("MBHB") or its clients. Therefore, no part of Orange Book Blog--whether information, commentary, or other--may be attributed to MBHB or its clients. Readers should be aware that MBHB represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MBHB clients. Orange Book Blog will always strive to be unbiased in its reporting. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-08

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May 04, 2008

OBB News Briefs

  • Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday.  The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product.
  • In what is being reported as a setback for the prospects of a biosimilars industry in the United States, the FDA recently denied Genzyme's request to change the manufacturing site of its drug Myozyme.  For more: Boston Globe, Pharmalot, WSJ Health Blog.
  • The L.A. Times published an interesting op-ed last week about safety concerns with biotech drugs.
  • The New York Times reported last week on a lobbying fight between the brand-name and generic drug industries over inequitable conduct provisions in patent reform legislation.
  • FDA Law Blog recently updated their coverage of two interesting cases: Teva vs. FDA, concerning 180-day exclusivity on Risperdal, in which Apotex filed a motion to intervene; Nu-Pharm v. FDA, Nu-Pharm's ANDA for generic Depakote, in which the D.C. Circuit summarily affirmed the district court's decision in favor of FDA.
  • On April 16, a district court denied Perrigo's motion for summary judgment that its generic version of Olux (clobetasol propionate foam), a treatment for scalp psoriasis, does not infringe Connetics' U.S. Patent No. 6,126,920.
  • On March 19, a district court denied Ranbaxy's motion for summary judgment that Roche's patent on Valcyte (valganciclovir HCl), U.S. Patent No. 6,083,953, is invalid due to incorrect inventorship.  Numerous other summary judgment motions are still outstanding in the case.

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