Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.
On July 2, 2018, the Federal Circuit Court of Appeals affirmed the decision of the Patent Trial and Appeal Board holding that some of the claims relating to artificial glands…
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently being launched in Europe and…
Before Dyk, Clevenger, and Chen. Appeal from the United States District Court for the Northern District of California.
Summary: In order to rely on the entire market value rule to calculate damages, a patentee must prove that the unpatented features in the accused product did not influence consumer demand.
The United States Patent and Trademark Office (USPTO) recently issued a memo providing examination guidance on the subject matter eligibility of the method of treatment claims. The memo discussed the recent Federal Circuit decision in Vanda Pharmaceutical Inc. v. West-Ward Pharmaceuticals, 887 F. 3d 1117 (Fed. Cir. 2018) and addressed the question of how to evaluate the patent eligibility of method of treatment claims in view of Vanda.
Before Moore, Wallach, and Taranto. Appeal from the Patent Trial and Appeal Board.
Summary: The Supreme Court’s decision in SAS Institute Inc. v. Iancu requires the Board in an instituted IPR proceeding to address all grounds for unpatentability raised in the IPR petition in its final written decision.
On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”
On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition, Platinum Equity Chairman and CEO Tom Gores said
The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.
Before Lourie, Dyk, and Taranto. Appeal from the District Court for the District of Delaware.
Summary: A passing reference in the prior art to a formulation containing the claimed active ingredient and the claimed administration route may not be sufficient to invalidate a claim.
