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.
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.
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). Continue Reading Federal Circuit again finds product catalog distributed at trade show to be “publicly accessible”
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). Continue Reading Arguments in Reply that Expand on Previously Argued Rationale Should Be Considered by the PTAB
Today the Federal Circuit (Judges Moore, Dyk, and Reyna) ruled in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. that tribal sovereign immunity does not apply in IPR proceedings. The appeal represented the first opportunity for the Federal Circuit to address the issue of sovereign immunity in IPR proceedings. Continue Reading Federal Circuit Affirms that Tribal Sovereign Immunity Does Not Apply in IPRs
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).
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.
SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), established a clear rule requiring institution on all challenged claims in future IPR proceedings. But the Supreme Court’s April 24 decision created immediate uncertainty regarding the hundreds of IPRs in which the PTAB had already instituted review or issued a final written decision on fewer than all claims and all grounds presented in the petition. The Federal Circuit’s immediately apparent interest in SAS transitional issues has led to swift action—the court’s precedential decision in PGS Geophysical AS v. Iancu explains that (1) SAS requires institution on all claims and all grounds presented in a petition for IPR, (2) the Federal Circuit can exercise appellate jurisdiction in pre-SAS cases where the Board granted only partial institution, and (3) parties can waive requests for SAS-based relief on appeal. Continue Reading Federal Circuit Rules that Pre-SAS Appeals from Partially Instituted IPRs Can Proceed
On May 14, 2018, the Federal Circuit (Judge Linn, with Judges Reyna and Hughes) ruled on mandamus to address two important issues related to proper venue in a patent infringement case: 1) whether regional or Federal Circuit law governs the analysis of proper venue under 28 U.S.C. § 1400(b), and 2) which party bears the burden of persuasion on the issue when a defendant challenges proper venue. The court held that Federal Circuit law applies, and the plaintiff bears the burden of persuasion. In re: ZTE (USA) Inc., No. 2018-113 (Fed. Cir. May 14, 2018).
The Supreme Court’s recent decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), has bred considerable uncertainty about what to do with the multitude of pending inter partes review (IPR) cases that were instituted under pre-SAS standards. The adjudicators tasked with applying SAS in those cases—at the PTAB and the Federal Circuit—are now sorting through the fallout.
The PTAB reacted quickly by releasing guidance two days after SAS that outlined the agency’s initial response: (1) future institution decisions will be decided on an all-or-nothing basis as to all claims and all grounds in the petition, (2) panels presiding over pending trials that were instituted on fewer than all claims and grounds in the petition are issuing orders to supplement the institution decision and institute on all claims and grounds, and (3) panels may take further actions in individual pending cases, such as allowing supplemental briefing or extending trial deadlines, depending on factors such as the particulars of the case, the stage of proceedings, and input from the parties. The PTAB noted that it will continue to assess its response to SAS and may issue additional guidance in the future.
The Federal Circuit is likewise wrestling with SAS. Continue Reading SAS Institute v. Iancu – What Now?