Posts Tagged ‘biotechnology’

Patent Office Publishes Subject Matter “Update”

Thursday, July 30th, 2015

updateToday (July 30th), the Patent Office released an 11 page “July 2015 Update” on patent-eligible subject matter (or not). (A copy of the update and appendices can be found at the end of this post.) Most of the “Update” focused on clarifying the December 2014 revised guidance. Also released were new examples 21-26–including ones modeled on Flook and Diehr. None of the new examples related to the life-sciences. Also released were an Appendix 2 that indexed all of the examples released since December 2014, and an Appendix 3, summarizing all of the case law discussed.

So if you are a life sciences person, you need only peruse the “Update.” It spends considerable space discussing how to apply the December 2014 Guidance, but the takeaway is that you need to rebut the natural product exception with a showing of markedly difference characteristics (2A) or else you fall into the dreaded “significantly more” circle of Hell called 2B. There is also some attempt to clarify the role of the “Streamlined Analysis” and preemption, that I don’t think clarified anything and that Examiners ignore anyway.

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“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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Ariosa v. Sequenom – Novel Genetic Analysis Fails The Mayo Test

Friday, June 12th, 2015

3d render of dna structure, abstract  backgroundToday, the Fed. Cir. affirmed the district court’s holding that the method for detecting paternally inherited nucleic acid of fetal origin in a sample of the mother’s blood was a patent-ineligible natural phenomenon. Ariosa Diagnostics, Inc. v Sequenom, Inc., Appeal No. 2014-1139, 2014-1144. (Fed. Cir. June 12, 2015). (A copy is available at the end of this post.)  Although commentators have already begun to lament that this decision puts a stake in the heart of claims to diagnostic methods (what I call “If A, then B” claims), I am going to do my best to resist this conclusion.

Of the claims asserted in the case, only one (claim 21) recites “providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid,” and no dependent claim identified what specific diagnosis (e.g., increased likelihood of Down’s syndrome) was provided (or to whom it was provided). Claim 1 was broadly directed to a method for detecting a paternally inherited nucleic acid of fetal original performed on a maternal serum or plasma sample from a pregnant female by amplifying a paternally inherited nucleic acid and detecting its presence in the sample.

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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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