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

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

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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Allvoice Decision Provides Roadmap For Software-based Inventions

May 29th, 2015

iStock_000034528996_SmallGuest post from Greg Stark, attorney at Schwegman Lundberg & Woessner.

In a refreshing break from Alice/Mayo abstract idea based 35 U.S.C. § 101 rejections, the Federal Circuit released a decision invalidating certain claims of U.S. Patent No. 5,799,273 as not being directed to one of the four statutory categories of inventions (see Allvoice Developments US, LLC, v. Microsoft Corp., CAFC 2014-1258, decided May 22, 2015 – a copy is available at the end of this post). The matter was on appeal, by Allvoice, from a district court decision invalidating claims 60-68 as non-statutory subject matter. The decision also affirms a non-infringement decision by the district court, while interesting that that portion of the decision is not the focus of this post.

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Apotex Petitions Supreme Court to Review Therasense Standards

May 21st, 2015

Magnesium SaltIn Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court’s ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court found was a perfect storm of misrepresentations during the prosecution of U.S. Pat. No. 6,767,566 that claimed a method to make the magnesium (Mg) salt of Moexipril. The Fed. Cir. found that Dr. Sherman, the named inventor on the application withheld prior art, mischaracterized the cited art in arguments and via a Rule 132 Declaration, and included examples in the application that had not been performed. In fact, this was characterized as an attempt to patent a competitor’s drug.  The  competitor, UCB, had listed in the Orange Book, as the hydrochloride salt – although the court found that Dr. Sherman was aware that the process disclosed in the listed patent, U.S Patent No. 4,743,450, would yield the Mg salt of Moexipril, which imparted substantial stability. The Fed. Cir. agreed with Apotex that Dr. Sherman had no duty to disclose his own suspicions or beliefs regarding the prior art (that he suspected that the ‘450 process would in fact yield the stable Mg salt) but rested its holding on its opinion that Dr. Sherman “affirmatively and knowingly misrepresented material facts regarding the prior art.” Slip op. at 15.

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