Method of Treatment Efficacy Benchmarks Avoid Inherency Attack

In Galderma Labs. v. Teva Pharm. USA, Inc., Appeal Nos. 2019-2396 and 2020-1213 (Fed. Cir,. January 29, 2020), a Fed. Cir. panel of Judges Moore, O’Malley and Stoll reversed a district court finding that three Galderma patents (US Pat. Nos. 9,809,587, 9,223,117 and 9,223,118) on methods for treating inflammatory lesions of acne with a 1% ivermectin formulation, Soolantra© were invalid as inherently anticipated by a patent (McDaniel) disclosing the use of a 1-5% ivermectin formulation to treat acne, that was enabled “as to the formulation” by a patent disclosing the Soolantra© composition (Manetta).

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Trump Signs Economic and Trade Agreement with China

On January 15, 2020, President Trump signed a lengthy “Economic and Trade Agreement Between the Government of the [US] and the Government of [P. R. of China].” Chapter 1 is entitled “Intellectual Property”  that contains Sections on trade secrets, pharmaceuticals, patents, piracy and counterfeiting, geographical indications (involving TM disputes), manufacture and export of pirated and counterfeit goods (including counterfeit medicines), bad faith trademarks, judicial enforcement (e.g., via criminal proceedings), bilateral cooperation and implementation.

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Supreme Court Denies Cert. in Vanda, Berkheimer and Athena

This morning, the Supreme Court denied the petitions for cert. filed in the Vanda, Berkheimer and Athena appeals. While the Court had requested and received amici briefs from the Solicitor General that opined that the Court should not grant cert. in Vanda (genotyping to identify appropriate amounts of drug to administer and then administering it) and Berkheimer (Is patent eligibility, e.g., “inventive step” a question of law or fact?), because they were correctly decided, the briefs also strongly suggested that the Court should revisit Prometheus v. Mayo and the patent eligibility of diagnostic tests. Of course, this is not the question that the Court asked the SG to opine on, but the patent bar had some hope that Athena might provide a vehicle for the Court to distinguish Mayo.

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Hulu v. Soundview Innovations – the Shifting Sands of Printed Publications

In Hulu v Soundview Innovations, IPR2018-01039, the PTAB was faced with the question of whether or not a certain textbook was a “printed publication” that was “publicly available” and so qualified as prior art against U.S. Pat. No. 5,806,062 – Patent Owner, Soundview. At the institution phase of the IPR, the Board had found that the textbook (“Dougherty”) had not been adequately shown to be “publicly accessible” enough to qualify as prior art. Because prior Board decisions were in conflict on this issue, a Precedential Opinion Panel (“POP”) review was granted.

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