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In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s two patents relating to non-radioactive labeling of polynucleotides.  The decision highlights non-enablement issues that may arise with respect to broad functional [...]
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On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6, 2019).  Judge Lourie wrote for the majority in this split decision, expressing some regret but affirming an order invalidating a diagnostic [...]
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On April 17, 2019, several lawmakers from the Senate and House of Representatives released a bipartisan, bicameral framework for statutory reform of 35 U.S.C. § 101.  The framework was released about two months after the revival of the Senate Judiciary Subcommittee on Intellectual Property.  For the past several years, innovators, the Patent Office, and even judges [...]
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On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6, 2019).  Judge Lourie wrote for the majority in this split decision, expressing some regret but affirming an order invalidating a diagnostic [...]
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Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019).  While many had hoped the decision would provide clarity on whether a biosimilar maker who has not yet filed an aBLA has standing to appeal a PTAB decision upholding an [...]
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Last October, the Trump Administration announced its plan to lower prescription drug prices by adopting foreign price controls on certain drugs covered by Medicare Part B.  Many Medicare Part B drugs treat serious illnesses such as cancer. Over the months that have followed, the announcement has stirred debate and led to competing proposals.  Under the [...]
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On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about the perceived lack of predictability and clarity in determining subject matter eligibility under 35 U.S.C. § 101.  See 2019 Revised Patent Subject Matter [...]
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On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day.  If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S. history.  While many federal offices and services are completely closed, agencies that impact biologics—including the FDA, the USPTO, and [...]
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Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing denied, 890 F.3d 1369, address what qualifies as patent-eligible subject matter under 35 U.S.C. § 101 and [...]
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In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners.  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of [...]

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