Lialda ruling overturned


Shire plc (SHPG -1.6%) drops modestly after its favorable judgement against Watson Pharmaceuticals (now Actavis) (ACT) blocking a generic competitor to Lialda is overturned according to market chatter.

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Comments (6)
  • Daniel B. Ravicher
    , contributor
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    $SHPG v $ACT Lialda Court of Appeals opinion is here: http://1.usa.gov/1hidbWi. I see it highly unlikely Shire wins on remand given this decision.
    28 Mar 2014, 11:53 AM Reply Like
  • autofocus111
    , contributor
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    In the end, SHPG won the case, contrary to your assertion, as a patent lawyer, that it was 'highly unlikely' to do so. Go figure.

     

    @Mon Mar 28, 2016 12:02pm EDT Shire gets favorable ruling against Allergan in Lialda patent case A U.S. district court on Monday ruled in favor of Shire Plc, preventing Allergan Plc from selling generic versions of Lialda, the ulcerative colitis drug, in the United States until 2020. Judge Donald Middlebrooks of the Southern Florida district court said that Allergan's Watson unit had infringed on two claims of the Lialda drug patent. Lialda, which was approved in 2007 by the U.S. Food and Drug Administration, brought in $684.4 million in sales for the year ended Dec. 31, contributing 11 percent to Shire's total sales of $6.1 billion. The U.S. Supreme Court last year sent back Shire's Lialda drug patent case to a lower court for further proceedings. The appeals court had in a March 2014 ruling thrown out a lower court decision in Shire's favor over the drug that treats inflammatory bowel conditions. The district court had found that a competing product manufactured by Allergan's Watson unit had infringed on Shire's patent.
    14 Aug, 01:33 PM Reply Like
  • Daniel B. Ravicher
    , contributor
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    The case has been appealed to the Court of Appeals, so the case has not come to an end.
    15 Aug, 05:41 PM Reply Like
  • autofocus111
    , contributor
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    Why do you believe Shire is unlikely to win on remand? The issue is what appears to be poor claim construction of two specific terms by the district court. The patent itself remains valid. Surely these terms can be re-worded to more accurately reflect the application of the patented invention to the disputed drug.
    30 Mar 2014, 03:26 AM Reply Like
  • Daniel B. Ravicher
    , contributor
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    Claim terms can NOT be "re-worded" on remand. They are what they are and Shire has to live with them and how the Court of Appeals interpreted them on Friday. It is my expectation that Actavis will be able to show on remand that its product does NOT have separate matrices as required by the patent under the Court of Appeals decision Friday. So long as Actavis' generic does not do one thing required by the claims, they do not infringe. Without sounding disrespectful, it seems you know absolutely nothing about patent law. Thus, you may be better off asking questions of a professional than making completely incorrect assumptions such as "surely these terms can be re-worded".
    30 Mar 2014, 09:42 AM Reply Like
  • autofocus111
    , contributor
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    Indeed, I am not a patent expert or lawyer, and was simply trying to understand why they were unlikely to win, since the patent seems straightforward in concept... create matrix1, break it up into fine particles, then create a second matrix containing these particles. Is that not correct? Does the Actavis drug not use this sequence of manufacture? Thanks for any further insights on this.
    28 Apr 2014, 06:33 PM Reply Like
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