The Federal Circuit’s decision in Shaw Indus. Grp., Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293 (Fed. Cir. 2016) raised the possibility that the inter partes review (IPR) estoppel of 35 U.S.C. § 315(e) might not do much to narrow patent invalidity cases in district courts. A recent decision out of the Western District of Wisconsin, however, gives real teeth to the IPR estoppel provision and incentivizes IPR petitioners to raise every possible ground of invalidity in their IPR petitions.
Under 35 U.S.C. § 102, the on-sale bar generally holds that the sale of a patented invention more than one year before the filing date invalidates the patent. Before the America Invents Act (AIA), courts held that confidential sales of the patented invention triggered the on-sale bar—no public disclosure of the invention or the sale was required. The AIA—which applies to patents filed after March 16, 2013—amended §102 to state that a patent is invalid if it was “in public use, on sale, or otherwise available to the public before the effective filing date.” In Helsinn Healthcare v. Teva Pharmaceuticals, interpreting the on-sale provision under the AIA for the first time, the Federal Circuit held that the AIA’s on-sale bar similarly does not require that the sale of the patented invention publicly disclose the details of the invention if the existence of the sale is public.
The Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s finding that claims to a graphical user interface (GUI) were patent-eligible under 35 U.S.C. § 101.
On January 13, 2017, the Supreme Court granted certiorari to two related petitions brought by Amgen, Inc. and Sandoz, Inc. to resolve disputes regarding the interpretation of the Biologics Price Competition and Innovation Act (BPCIA). In 2009, Congress passed the BPCIA to create an abbreviated regulatory pathway through which the Food and Drug Administration (FDA) can approve a biological pharmaceutical product as a “biosimilar.” 42 U.S.C. § 262(a), (k). A biosimilar is a drug product that is highly similar to an approved biological product or “reference product.” 42 U.S.C. § 262(i)(2).
In this case, the Federal Circuit determined that in its nearly 35-year history, it had not established the legal standard for demonstrating standing in an appeal from a final agency action. The underlying dispute arose from an appeal by Phigenix, Inc. (“Phigenix”) of the Patent Trial and Appeal Board (PTAB) decision that the challenged claims of U.S. Patent No. 8,337,856 (the “’856 patent”), which is assigned to ImmunoGen, Inc. (“ImmunoGen”), were not obvious in view of the prior art. Genentech Inc. (“Genentech”) has an exclusive license to the ’856 patent, which Genentech uses to produce the drug Kadcyla®TM. Phigenix, a research company that focuses on the use of therapeutics designed to fight cancer, does not manufacture any products, but has an intellectual property portfolio that includes U.S. Patent No. 8,080,534 (the “’534 patent”), which Phigenix claims is infringed by Genetech based on its activities related to Kadcyla®TM. After Genentech refused to take a license to the ’534 patent, Phigenix filed a petition for an inter partes review (“IPR”) against ImmunoGen’s ’856 patent. After Phigenix appealed the PTAB’s decision on its IPR petition, ImmunoGen filed a motion to dismiss claiming that Phigenix lacks standing to appeal the PTAB’s decision.
Demonstrating again that the “broadest reasonable interpretation” standard has limits, the Federal Circuit reversed the Patent Trial and Appeal Board’s decision that claims of two patents were unpatentable due to anticipation and obviousness. The dispute arose when MasterCard International filed two inter partes review petitions on the ’486 and ’988 patents—both owned by D’Agostino. Both patents related to methods of effecting secure credit card purchases by minimizing merchant access to credit card numbers. The issue on appeal was the proper construction of the “single merchant” limitation, which required that a transaction code from the account holder be limited to a single merchant. The PTAB determined that the term was broad enough to apply to credit card transactions identifying a particular chain of stores and, on that basis, held the patent claims anticipated and obvious in view of Cohen.
On December 6, 2016, the Federal Circuit remanded, in part, a district court’s grant of a permanent injunction in order to develop additional facts relating to the appropriate reach and scope of the injunction. Asetek Danmark A/S v. CMI USA Inc. (16-1026).
Plaintiff FairWarning sued defendant Iatric Systems for infringement of U.S. Patent No. 8,578,500 (the “’500 patent”), titled “System and Method of Fraud and Misuse Detection”. The ’500 patent discloses ways to detect fraud and misuse by identifying unusual patterns in users’ access of sensitive data, including detecting fraud by an otherwise-authorized user of a patient’s protected health information (PHI). The claimed systems and methods record data of users’ access to PHI, analyze it against a rule and provide a notification if the analysis detects misuse. The district court granted defendant’s 12(b)(6) motion to dismiss and held that the claims of the ’500 patent were invalid for being directed to patent-ineligible subject matter. FairWarning appealed.