Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards. The study includes aggregate and anonymized data from 31 large medical companies, including Fisher & Paykel Healthcare, ResMed, Smith & Nephew, and Medtronic, among others. The majority of the surveyed companies operate primarily in the medical device field, but the data also includes results from diagnostic and pharmaceutical companies.
The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third. The pilot, dubbed as “a Turbo Tax for information submitted in 510(k)s,” by FDA Commissioner Scott Gottlieb, will allow device manufacturers to submit premarket notifications electronically using “eSubmitter” software, as long as the device is classified under one of the specific product codes included in the pilot program and is not a combination product. In addition to lower risk devices, the pilot program includes some higher risk Class II devices, such as surgical lasers, certain endoscopic equipment, and certain imaging devices (e.g., MRI and stationary X-rays).
Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner case, a new interface, and, according to Apple “revolutionary health capabilities.” These health capabilities include electrocardiogram (ECG) functionality, which has been granted approval by the U.S. Food and Drug Administration. Also incorporated into the latest version of the Watch, according to Apple, are a new accelerometer and gyroscope that allow for fall detection.
The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United States. The announcement notes that Epidiolex contains a highly purified form of cannabidiol (CBD), one of many cannabinoids derived from cannabis plants. CBD, however, lacks the psychoactive properties of its more famous cousin, tetrahydrocannabinol (THC). The FDA approved the use of Epidiolex for the treatment of seizures associated with several rare forms of epilepsy in patients 2 years and older.
On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows Apple to provide its Series 4 Apple Watches as an over-the-counter ECG-monitoring device.
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.
Before Judges Reyna, Bryson, and Stoll. Appeal from the United States District Court for the District of Delaware.
Summary: A claim that recites a specific method for navigating through three-dimensional electronic spreadsheets is not directed to an abstract idea.
Before O’Malley, Reyna, and Hughes. Appeal from the District Court for the Northern District of California.
Summary: Testing for the presence of a bacterium that causes tuberculosis and the primers used in that testing were directed to patent-ineligible subject matter because the primers were indistinguishable from naturally occurring DNA.
Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields. The Federal Circuit recently addressed this issue in E.I. DuPont De Nemours & Co. v. Synvina C.V., reversing the Patent Trial and Appeal Board’s (PTAB’s) finding that Synvina’s patent was non-obvious, in view of close prior art references and little to no additional evidence of non-obviousness.
