Source: https://www.1600ptab.com/category/appeals/
Timestamp: 2019-04-20 15:09:10+00:00

Document:
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.
Did the AIA Change the On-Sale Bar Standard? The Supreme Court Will Decide.
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).
USPTO’s Subject Matter Eligibility Guidance Evolves After Vanda Pharms. Inc. v. West-Ward Pharms.
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 v. Iancu – What Now?
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.

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