Last week, we wrote about Arthrex, Inc. v. Smith & Nephew, Inc. and described recent developments that suggested the Federal Circuit was leaning toward holding that all current PTAB judges had been unconstitutionally appointed in violation of the Appointments Clause of Article II. The Federal Circuit has now done just that
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An order from the Federal Circuit on October 15 suggests the court may be close to holding that the PTAB has been operating in violation of the Appointments Clause, which could significantly disrupt PTO operations.  The case presents important questions: whether the PTAB’s judges have been lawfully appointed, and if not, what happens to decisions that have been issued by panels of those judges?
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On July 30, the Federal Circuit issued a decision in Celgene Corporation v. Peter (Nos. 2018-1167, -1168, -1169, and -1171), where the patent owner argued that the PTAB’s authority to cancel claims through IPR amounted to an unconstitutional taking as applied to pre-AIA patents. Numerous patent owners have raised similar challenges since the Supreme Court expressly reserved judgment on the issue in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 138 S. Ct. 1365, 1379 (2018). The Federal Circuit’s decision puts that issue to rest (at least for now) and confirms that all issued patents remain subject to IPR.

Background

The Celgene appeal arose
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In Amerigen Pharmaceuticals v. UCB Pharmaceuticals, the Federal Circuit held that a generic Abbreviated New Drug Application (“ANDA”) filer with a Paragraph III certification to an Orange Book-listed patent has standing to appeal decisions from the Patent Trial and Appeal Board (“the Board”). Case No. 17-2529, Doc. 54, January 11, 2019 (the “Decision”). In this case, Amerigen was a Petitioner in inter partes review proceedings involving U.S. Patent No. 6,858,650 (“the ’650 patent”). The Board found the challenged claims not unpatentable, and Amerigen appealed. On appeal, UCB argued that Amerigen lacked standing to appeal because Amerigen had filed a Paragraph III certification with its ANDA. The Federal Circuit disagreed.

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In the chemical and biological arts, it is common for patent challengers to allege obviousness based upon prior art disclosures of ranges combined with “routine optimization” by one skilled in the art.  In E.I. du Pont de Nemours & Co. v. Synvina C.V., No. 17-1977 (Fed. Cir. Sept. 17, 2018), the Federal Circuit reversed the PTAB’s (“Board”) final written decision upholding Synvina’s U.S. Patent No. 8,865,921 (“’921 patent”) as non-obvious, in response to du Pont’s inter partes review (“IPR”) challenge on such grounds.  In particular, in E.I. du Pont, the Court found that the patentee failed to demonstrate that 1) the claimed range produced a new and unexpected result, different in kind and not merely in degree from the prior art, 2) the optimized parameter was not recognized as a result-effective variable, 3) the disclosure of broad ranges did not invite more than routine optimization, or 4) that the prior art taught away from the range.

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The Federal Circuit recently held that a product catalog distributed at a trade show was “publicly accessible,” and therefore qualified as prior art. In Nobel Biocare Services AG, v. Instradent USA, Inc., decided on September 13, 2018, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) finding that a catalog distributed at the International Dental Show (“IDS”) Conference in Cologne, Germany was publicly accessible. The court’s decision in Nobel hinged largely on the testimony of two declarants, one who went to the conference (Zvi Chakir), and another who Chakir gave the catalog to upon his return (Yechiam Hantman).
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On August 27, 2018, the Federal Circuit in Ericsson Inc. v. Intellectual Ventures I LLC, vacated the Patent Trial and Appeal Board’s (“PTAB”) final written decision in an inter partes review (IPR) and remanded for the PTAB to properly consider all portions of the petitioner’s reply.  No. 17-1521, slip op. at 13 (Aug. 27, 2018).
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The “on-sale bar” deems that certain sales of an invention that occur more than one year before a patent application is filed are a bar to patentability.  See 35 U.S.C. § 102(b) (pre-America Invents Act (“AIA”)); 35 U.S.C. § 102(a)(1) (AIA).  On Monday, June 25, 2018, the Supreme Court granted Helsinn’s petition for certiorari in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., to interpret the on-sale bar provision of 35 U.S.C. § 102 in the AIA.  Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., — S. Ct. —, 2018 WL 1142984 (2018) [SCOTUSblog case file].  The question presented to the Supreme Court is: “Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”  Petition for Certiorari, Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., No. 17-1229, 2018 WL 1168243 (Feb. 28, 2018).

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In view of the Federal Circuit’s April 13, 2018 decision in Vanda Pharms. Inc. v. West-Ward Pharms., 877 F.3d 1117(Fed. Cir. 2018), regarding subject matter patent eligibility, the USPTO issued a memorandum on June 7, 2018, to “address[] the limited question of how to evaluate the patent eligibility of ‘method of treatment’ claims” and announce modifications to life sciences example 29 of the PTO’s current patent-eligibility guidance. Memo at 3.

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