The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved test is the first direct-to-consumer test to report on three specific BRCA1 and BRCA2 breast cancer gene mutations.
The Supreme Court has issued two important decisions affecting Inter Partes Review (“IPR”) and other post-grant patent challenges conducted by the Patent Trial and Appeal Board (“PTAB”).
On March 22, 2018, a Texas federal court awarded patent infringement damages totaling over $8 million and ongoing royalties in a case involving multiple patents related to voice over IP technology. The damages award is based on a jury trial that was conducted in January 2016, where the jury found Metaswitch Networks liable for infringing Genband’s seven patents. During trial, Genband requested $9,076,000 in damages based on past sales.
Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants. Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its blessing to combine the companies.
Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services. Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of the University of Tsukub and is traded publicly on the Tokyo Stock Exchange. The press release notes that Medical HAL has received previous marketing approval in Japan and the European Union.
According to Bloomberg, Apple, Inc. is currently developing an electrocardiogram (also known as an EKG or ECG) feature in its smartwatch products. A report from Bloomberg and other sources have stated that the unit in development requires users to squeeze the frame with two fingers to send a weak electrical current to the heart to pick up signals.
Before Dyk, Bryson, and Reyna. Appeal from PTAB, remanded from the Federal Circuit, en banc.
Summary: Time-bar does not apply to IPR petitioner through privity with a district court defendant because the evidence did not show (1) that the petitioner had the right to control the district court litigation nor (2) that the district court defendants were real parties in interest in the IPR proceeding.
Before Newman, Lourie, and Reyna. Appeal from the United States District Court for the Northern District of Florida.
Summary: Collateral estoppel does not apply to a prior decision of no invalidity under § 101, where the issue was not actually litigated.
Before Dyk, O’Malley, and Wallach. Appeal from the PTAB.
Summary: A priority claim must be explicitly stated in the patent and cannot be incorporated by reference from an earlier patent.
Before Prost, Reyna, and Wallach. Appeal from the United States District Court for the Eastern District of Arkansas.
Summary: Pre-reexamination conduct cannot be a basis for equitable estoppel if the asserted claims were substantively amended and narrowed during reexamination.
