Tag Archives: biotechnology law

“If Wishes Were Horses” – Roberts’ Dissent from Myriad

After reading Obergefell v. Hodges, 576 U.S.___(2015), (a copy is found at the end of this post) I was struck by Justice Robert’s dissent – which excoriates the majority for legislating from the bench and basing its opinion on “social … Continue reading

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Teva v. Sandoz – “Strange Brew” Boils Over

On June 18, 2015, a divided Fed. Cir. panel reaffirmed that the key claim of a Teva patent, U.S. Pat. No. 5,800,808, was invalid as indefinite, although the Fed. Cir. had previously been reversed twice by the Supreme Court – … Continue reading

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Product-by-process claims are product claims

This is being published with the permission of Kawaguti & Partners.    K&P’s Court Decision Report in 2015 <<<Special News Flash>>>   Supreme Court Overturns Grand Panel’s Decision of IPHC and Admits that “Product-by Process” Claim should Cover Same Products … Continue reading

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FDA Finalizes Biosimilar Guidance

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents. You can find the article here.

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