On September 10, 2018, the international convenience store chain 7-Eleven filed suit in the United States District Court for the Northern District of Texas against Perry Ellis Menswear, LLC d/b/a OriginalPenguin.com (“Defendant”). 7-Eleven’s complaint alleges trademark infringement, dilution, unfair competition, counterfeiting, and unjust enrichment under the Lanham Act as well as trademark infringement, unfair competition, dilution, and unjust enrichment under Texas state law.
The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.”
In the recent decision of Data Engine Technologies LLC v. Google LLC, the Federal Circuit may have expanded how factual questions underpin subject matter eligibility analysis under Section 101. Since the two-part eligibility analysis was established by Alice v. CLS Bank,[1] courts have repeatedly emphasized that eligibility is a question of law, not fact.[2] Courts have used this rationale to justify holding claims patent-ineligible without considering extrinsic evidence.[3] Often, this leads to early dismissals of infringements suits, which limit patent holders’ ability to present evidence in support of their patents.
Over the last year, several Federal Circuit judges have filed opinions lamenting the state of the case law that interprets the abstract idea exception to patent eligibility under 35 U.S.C. § 101. For example, Judge Linn wrote in Smart Systems that the “problem” with the Supreme Court’s test “is that it is indeterminate.”[i] Similarly, Judge Plager wrote in Interval Licensing that the “incoherent body of doctrine” applying Alice makes it “near impossible to know with any certainty whether the invention is or is not patent eligible.”[ii] Many practitioners agree that § 101 decisions are difficult to predict and the state of the case law exacerbates this difficulty. This article considers affirmance data to explore whether it supports the premise that § 101 decisions are not just difficult but fundamentally “indeterminate” or “near impossible” to resolve.
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.
