Since 2014, the USPTO has periodically issued examination guidance, analysis examples, and other insights to guide evaluation of patent subject matter eligibility under 35 U.S.C. § 101.  These documents are available on the USPTO’s website and can be helpful in crafting arguments for or against the patent eligibility of claims during examination or in litigation.  The summary below is intended to assist the reader in locating relevant materials for a particular eligibility inquiry.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa under Accelerated Approval, Priority Review, and Orphan Drug designations. These designations indicate that Aliqopa is a drug for treating serious conditions, fills an unmet medical need, and provides incentives to encourage the development of drugs for rare diseases.

The Federal Circuit issued an en banc decision instructing the PTAB to assess patentability of amended claims in IPR proceedings without placing the burden of persuasion on the patent owner.  Aqua Products, Inc. v. Matal, No. 2015-1177 (Fed. Cir. Oct. 4, 2017) (en banc, Stoll not participating).

On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products release, Bloomberg reports. According to the Bloomberg article, this program operates as a “fast track” for these technology companies, which amongst others include Apple, Fitbit, Samsung, Johnson & Johnson, and Verily Life Science (an arm of Google parent Alphabet Inc.), and is said to allow them to develop technologies rapidly, while allowing the FDA to maintain oversight over those projects.

The U.S. District Court for the District of Delaware recently handed down two important decisions on motions to transfer for improper venue. Judge Stark presided over both cases, transferring one case and ordering further discovery in the other. See Boston Sci. Corp. et al. v. Cook Grp. Inc. et al., Case No. 1:15-cv-00980-LPS-CJB (D. Del. 2017); Bristol-Myers Squibb Co. et al. v. Mylan Pharms., Inc., Case No. 17-379-LPS (D. Del. 2017). These decisions show how the Supreme Court’s recent TC Heartland decision is reshaping venue rules for patent cases, particularly in Hatch-Waxman litigation.  These cases also foreshadowed how the Federal Circuit would authoritatively interpret the relevant venue statute in its September 21, 2017 In re Cray order.

A magistrate judge in the Eastern District of Texas recommended in Network-1 Technologies, Inc. v. Alcatel-Lucent USA, Inc. Case No. 6:11-cv-492 (E.D.Tex. September 25, 2017) that Hewlett-Packard (“HP”) should be estopped from asserting invalidity grounds that HP did not raise, but reasonably could have raised, during IPR proceedings.

The PTAB denied institution of Covered Business Method (CBM) Review, finding that the parties’ license agreement and covenant not to sue removed any “imminent” threat of an infringement suit. MasterCard International Inc., v. Alexam, Inc., CBM2017-00041, Paper 12 (P.T.A.B. September 21, 2017).

The PTAB’s Chief Administrative Patent Judge and Deputy Chief Administrative Patent Judge joined an expanded PTAB panel that adopted the seven NVIDIA factors and denied institution of the Petitioner’s follow-on petitions in General Plastic Industrial Co., Ltd., v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 (P.T.A.B. September 6, 2017). The PTAB designated the decision as “Informative” on September 18, 2017.

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system.  The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy.

The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD).