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At the intersection of Patent and FDA Law

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Pharma News Briefs

  • FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website.  The comments come in response to FDA's request last month.  A summary of the new comments is in the works.
  • FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues.  This too follows an FDA request made last month.
  • Yesterday, the WSJ Health Blog had two pessimistic reports on the pharmaceutical industry: "Drug Drought Deepens as FDA Approvals Lag" and "Pharma Woes Won't Let Up Soon."
  • Also on Halloween, the New York Time published a spooky article entitled "Chinese Chemicals Flow Unchecked Onto World Drug Market."  Reuters published a similar article the next day.  This can't be good publicity for pharmaceutical companies–both innovators and generics alike–who are increasingly outsourcing production of key ingredients to China.
  • On Tuesday, the Federal Circuit denied rehearing of BIO and PhRMA v. District of Columbia, in which the court previously found Washington, D.C.'s drug price control law to be unconstitutional (see Patently-O).
  • Last week, Sen. Bernie Sanders (D-VT) introduced a new bill that would scrap patent and market exclusivity for drugs and replace it with a "medical innovation prize fund" (see FDA Law Blog and Pharmalot).  I suspect that this bill is DOA, and therefore nothing to fear.
  • Also last week, the WSJ Health Blog reported on Amgen's big win in its patent infringement suit against Roche's Mircera drug.
  • A couple weeks ago, BioPharma Reporter published an interesting article, "U.S. Dragging its Heels on Biosimilars, Report Says."
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One response to “Pharma News Briefs”

  1. Sandeep K. Rathod Avatar
    Sandeep K. Rathod

    Dear Aaron,
    I have put up a very brief summary of all the comments on my blog here:
    http://genericpharmaceuticals.blogspot.com/2007/11/ramipril-documents-recd-at-fda.html
    Hope you find them a good start.
    I know, your analysis as a US Attorney will be much more cogent and focussed.
    Sincerely,
    Sandeep,
    Matrix.

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