Posts Tagged ‘biotechnology law’

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

Monday, June 29th, 2015

horses2After 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 policy.”

In AMP v. Myriad, Justice Roberts joined in a unanimous opinion holding that segments of DNA are patent-ineligible “natural products,” reversing a Fed. Cir. panel decision that held DNA to be patent-eligible as a novel chemical molecule.

But what if Justice Roberts disagreed with his brethren and penned a dissent? I have repeatedly taken the position that Myriad was decided on policy grounds, which required the Justices to decide that a novel chemical compound is not a “composition of matter” under s. 101, but is something else.

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Teva v. Sandoz – “Strange Brew” Boils Over

Monday, June 22nd, 2015

iStock_000008592211_SmallOn 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 – once because of lack of deference to the district court’s fact-finding (135 S. Ct. 831) in this suit, and once because the indefiniteness standard applied by the Fed. Cir. in Nautilus v. Biosig was incorrect (134 S. Ct. 2120). (A copy of the decision can be found at the end of this post.)

Commentators have rushed lots of notes on this decision onto the web (Teva Parma. USA v. Sandoz, Inc., Appeal no. 2012-1567 et al. (Fed. Cir., June 18, 2015) – possibly because the central issue was comprehensible without an advanced degree – so I will not spend more time on the history of the decision. The outcome is what matters after all, and I think it can be summed up in one sentence: Deference to a district court’s fact-finding still leaves the Fed. Cir. free to determine if the question of law “indefiniteness” was decided properly. In other words – and there always are – there is no presumption that the ultimate question of law was decided correctly, even if there was no clear error in the lower court’s fact finding.

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Product-by-process claims are product claims

Tuesday, June 9th, 2015

This is being published with the permission of Kawaguti & Partners.

Kawaguti   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 Irrespective of Process, But …

Teva Gyogyszergyar Zartkoruen Mukodo Rt. (Patentee) v. Kyowa Hakko Kirin Co., Ltd. (Accused Infringer), Case No. 2012 (Jyu) 1204 (Decision rendered on June 5, 2015)

The Supreme Court overturned a decision of the Grand Panel1) of the Intellectual Property High Court (IPHC) relating to the construction of the scope of a “product-by-process” claim2) rendered in 2012, and ruled that the scope of a “product-by-process” claim should be determined as products having the same structure, properties and the like as a product produced by the process defined in the claim, even though the process of producing the product is defined in the claim. Namely, the Supreme Court admitted that a “product-by-process” claim covers all the products having the same structure or properties as a product produced by the process defined in the claim even if the actual process for producing the product is different from the process in the claim.

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FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

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.