On June 13, 2018, Senator Orrin Hatch (R-UT) introduced to the Senate Judiciary Committee an amendment to restore the careful balance sought in the Hatch-Waxman Act, which provided incentives for both pharmaceutical innovation and drug affordability. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would modify the IPR process for pharmaceuticals—under Hatch-Waxman and the BPCIA—and would amend sections of the Federal Food, Drug and Cosmetic Act that provide abbreviated pathways for generic drug and biosimilar product approval.
Continue Reading Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics

The Federal Circuit upheld the PTAB’s mixed decisions in IPRs filed by Google to challenge claims of two Personal Audio LLC patents asserted against Apple, Samsung, Amazon and Research in Motion, in addition to Google. Google LLC v. Personal Audio LLC, Nos. 2017-1162, -1166, -2110, -2111 (Fed. Cir. Aug. 1, 2018) (non-precedential).
Continue Reading Mixed Result Upheld in Personal Audio IPRs

In Application in Internet Time v. RPX Corp., Nos. 2017-1698, -1699, -1701 (Fed. Cir. July 9, 2018), the Federal Circuit decided that the Patent Trial and Appeal Board “applied an unduly restrictive test for determining whether a person or entity is a ‘real party in interest’ within the meaning of [35 USC] § 315(b) and failed to consider the entirety of the evidentiary record in assessing whether § 315(b) barred” IPRs petitioned by RPX more than one year after one of its clients, Salesforce.com, Inc. (Salesforce), was served with a complaint for infringing the challenged patents. Based on these decisions, the court vacated the Board’s final written decisions that canceled the challenged claims. The court’s decision is important if only because it offers guidance in determining how a non-party may be a real party in interest or in privity with a petitioner.
Continue Reading Federal Circuit Admonishes PTAB for Taking Short-cuts

In affirming a PTAB IPR decision canceling claims for obviousness, the Federal Circuit concluded that the PTAB’s reliance on references not included in the original petition did not violate due process or the patent owner’s procedural rights under the Administrative Procedure Act (APA).  Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372 (Fed. Cir. 2018).

Citing Genzyme Therapeutic Products Ltd. v. Biomarin Pharmaceutical. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016) (discussed here), the court stated that new evidence was to be expected during an IPR and was permissible under the APA provided the opposing party receives notice and an opportunity to reply. 
Continue Reading PTAB May Cite New References Not Cited in the IPR Petition

Update: On September 26, 2019, the court vacated and remanded the PTAB’s decision.

Next trip to the grocery store, stop in the canned soup aisle and take a closer look at how the canned soups are displayed on the shelves. You may notice a gravity feed dispenser with a label area. Between 2002 and 2009, Petitioner Campbell Soup Co. purchased $31 million of Patent Owner Gamon’s gravity feed display racks protected by design patent D621,645 (“the ‘645 patent”).
Continue Reading Contour of Soup Can Saves Gravity Feed Display Design Patent

The Federal Circuit’s recent decision in Sirona Dental Systems GMBH v. Institut Straumann AG, Appeals 2017-1341, 2017-1403 (Fed. Cir. June 19, 2018) tasked the PTAB with reconciling the Supreme Court’s SAS Institute decision (discussed here) with its en banc decision in Aqua Products regarding the burden of proof on motions to amend (discussed here).
Continue Reading Federal Circuit Remands Decision on Motion to Amend to Board to Apply and Interpret Aqua Products and SAS Institute

PTAB Failed to Properly Apply Incorporation by Reference Doctrine

In Paice LLC, The Abell Foundation, Inc., v. Ford Motor Company, Appeal No. 2017-1406 (Fed. Cir. Feb. 1, 2018), the Federal Circuit reversed a PTAB decision for failing to properly apply the doctrine of incorporation by reference, thereby reminding the PTAB as well as practitioners alike of the proper standard for invoking and applying that doctrine.
Continue Reading PTAB Failed to Properly Apply Incorporation by Reference Doctrine

The Federal Circuit vacated and remanded the PTAB’s decision that a video demonstration and slides distributed by Petitioner Medtronic at three industry meetings and conferences were not publicly accessible and, thus, were not “printed publications.” Medtronic, Inc. v. Barry, Case no. 17-1169, 2018 WL 2769092 (Fed. Cir. June 11, 2018). Recent Board decisions have set a high bar for proving that materials were publicly accessible. We have previously discussed examples here, here, and here. In Medtronic, the Federal Circuit provides factors that the Board should consider in these determinations.
Continue Reading PTAB Failed to Properly Apply Test for Printed Publication

On June 7, 2018, the Federal Circuit in Wi-Fi One, LLC v. Broadcom Corp. requested that intervenor, Patent Office director Andrei Iancu, and appellee Broadcom, file a response to Wi-Fi One’s second petition for rehearing.  Wi-Fi One, Case No. 2015-1944, Docket No. 212 (June 7, 2018).  At issue was whether the court should grant Wi-Fi One’s second petition for panel or en banc rehearing regarding 35 U.S.C. § 315 (b) time-bar challenges.  See Wi-Fi One, LLC v. Broadcom Corp., Case No. 2015-1944, Doc. No. 210 (May 21, 2018).
Continue Reading Federal Circuit Requests Briefing from Patent Office Regarding § 315(b) Time-Bar Determinations

Left in the wake of the Supreme Court’s SAS decision (discussed here) are a number of appeals pending before the Federal Circuit concerning Patent Trial and Appeal Board final written decisions in inter partes review (IPR) proceedings administered on a subset of claims and grounds presented in the IPR petition. While litigants before the Board scramble to reassess strategies, the Board itself has been offering guidance, including its publication on June 5 of an updated FAQ on how it will administer pending IPRs and decide petitions pending when the Court decided SAS. As for pending appeals, the Federal Circuit explained that it has jurisdiction to address appeals of PTAB final written decisions that have “SAS transition issues.” PGS Geophysical AS v. Iancu, Appeals 2016-2470, -2472, -2474, Slip Op. at 9–11 (Fed. Cir. June 7, 2018). And the court further explained that future appellants will need to request relief regarding those issues, as the court will not act sua sponte. Id. at 11–13.
Continue Reading No SAS-based Relief on Appeal, Unless Requested