Before Judges Reyna, Bryson, and Stoll. Appeals from the Patent Trial and Appeal Board and the United States District Court for the District of Delaware.
Summary: Non-prior art evidence may be considered when evaluating the knowledge, motivations, and expectations of a POSITA regarding the prior art. In addition, there is no categorical rule in pharmaceutical patent cases precluding obviousness determinations in the absence of a pharmacokinetic and pharmacodynamics profile. Finally, it is not error to apply an “obvious to try” analysis where there are a limited number of permutations of dose and frequency not already disclosed in the prior art.
Fashion Week San Diego is this weekend—one of the few fashion shows open to the fashion industry and the general public! Fashion shows are exhilarating. As an intellectual property (“IP”) attorney, however, fashion shows are also nerve-racking. Fashion shows mean designers are showing their designs publicly. Some designs are brand new, never-been-seen-before lines. And to make sure the designs are protected to the maximum extent possible, it is essential to take certain steps with your IP attorney before they are disclosed publicly.
In BSG Tech LLC v. BuySeasons, Inc., the Federal Circuit held that a patent claim is ineligible under § 101 when its only allegedly unconventional feature is an abstract idea.[1] The Federal Circuit affirmed the judgment of the U.S. District Court for the Eastern District of Texas that the claims are ineligible because they claim nothing more than the abstract idea of considering historical usage information while inputting data.[2]
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.
