In General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., Case No. 2017-1012 (Fed. Cir. May 4, 2018), the Federal Circuit affirmed the PTAB’s August 2016 decision that General Hospital Corporation’s (GHC) claims involved in an interference proceeding (that GHC requested) failed to meet the written description requirement. But the court also vacated the PTAB’s denial of GHC’s contingent motion to add a new claim as arbitrary and capricious because the PTAB did not follow its own Standing Order. The court therefore remanded the case to the PTAB to decide remaining issues in the interference. Continue Reading
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
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
In Unwired Planet, LLC v. Google Inc., 841 F.3d 1346 (Fed. Cir. 2016) (discussed here), the Federal Circuit determined that the PTAB was using an overly-broad standard for CBM eligibility. Specifically, the PTAB was administering CBM review of patents if they included claims directed to activities that are “incidental to” or “complementary to” a financial activity. Continue Reading
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
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
In Altaire Pharm., Inc. v. Paragon Biotek, Inc., Case No. 2017-1487 (Fed. Cir. May 2, 2018), the Federal Circuit reversed in part a PGR final written decision that upheld the patentability of challenged claims, and determined that a risk of a future lawsuit for patent infringement may be sufficient to establish Article III standing for the appeal.
Under Supreme Court precedent, Article III standing requires: (1) a concrete and particularized injury, (2) caused by the challenged conduct, (3) which can be redressed by a judicial decision. Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016). Ironically, a party that has not been charged with infringement may have sufficient standing to file a petition with the PTAB, but lack standing to appeal the PTAB’s final decision to an Article III court. Continue Reading
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
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
In Hologic, Inc. v. Smith & Nephew Inc., No. 2017-1389 (Fed. Cir. Mar. 14, 2018), the Federal Circuit concluded that disclosure of a species provides written descriptive support for a claimed genus where the invention was in a predicable field of art, the species was a well-known member of the genus, and other members of the genus were also well known. As a result, the court affirmed the PTAB’s decision that Smith & Nephew’s PCT application (the “Emanuel PCT”) had sufficient written description to qualify as a priority document, and therefore was not prior art. In reaching this decision, the court relied heavily on the fact that the field of the invention was a predictable art. Continue Reading