The Federal Trade Commission (FTC) has officially challenged more than 100 patents listed by brand name drug manufacturers in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” often known as the “Orange Book.” This action, which took place on November 7, 2023, has drawn considerable attention to listing requirements of…
The world of patent law constantly witnesses shifts and transformations due to the iterative decisions and interpretations of the Supreme Court, the Federal Circuit, and the U.S. Patent and Trademark Office (PTO). To navigate this intricate labyrinth, practitioners need accurate, timely, and relevant guidance. Understanding these requirements, the Practising Law Institute (PLI) is organizing a…
K&L Gates has seen a crucial departure from its team in Tokyo, resulting in a separate legal entity taking the forefront for IP filing capabilities in Japan. Mitsuhiro Imamura, the firm’s only Japan-qualified patent attorney and partner, has reportedly parted ways with K&L Gates. Recent documentation from the Japan Patent Attorneys Association (JPAA) indicates that…
In a recent development, the Federal Trade Commission (FTC) has set its sights on inappropriate listings within the Orange Book – a comprehensive list of FDA approved drugs. The FTC announced in its September 2023 policy statement the intention to “scrutinize improper Orange Book listings” and to employ “its full legal authority” in taking decisive…
The United States Patent and Trademark Office (USPTO) provides significant benefits to patent applicants who qualify as “small entities,” most notably in the form of reduced official fees. However, certain factors can nullify a company’s eligibility for these benefits, and false claims, particularly regarding small or micro entity status, can result in serious penalties including…
The U.S. Food and Drug Administration (FDA) has conferred interchangeable status upon Biogen and Samsung Bioepis’s ranibizumab biosimilar, BYOOVIZ® (Ranibizumab-Nuna). The legal professionals would be cognizant of the fact that BYOOVIZ® has been deemed interchangeable with Genentech’s LUCENTIS for the treatment of several ophthalmic conditions, including neovascular (wet) age-related macular degeneration, macular edema following retinal…
Womble Bond Dickinson, a law firm with a diverse array of legal capabilities has just acquired two key members to their team, Vanessa Hew and Gregory Gulia. Both Hew and Gulia are joining as partners in the trademarks, copyrights, and transactions practice group in the firm’s New York office. The significance of such an event…
In an interesting development for IP professionals, the PTAB has dismissed the institution of inter partes review under Fintiv in a case brought by Zhuhai Cosmx Battery Co., Ltd against Ningde Amperex Technology Limited, IPR2023-00587. This series of decisions provides an insightful look into a lesser-used exercise of discretion by the Patent Trial and Appeal…
The United States Patent and Trademark Office (USPTO), The International Trade Administration (ITA), and National Institute of Standards and Technology (NIST) recently made a call for public comments. This request for public input has given rise to a wealth of dialogue from numerous industry professionals. One such response of note came on November 6, 2023,…
On August 7, 2023, in the case of Axonics, Inc. v. Medtronic, Inc. (Nos. 2022-1532, 2022-1533), the Federal Circuit Court addressed an pivotal issue concerning the ability of a petitioner in an IPR (Inter Partes Review) to present new evidence in a reply brief. This becomes particularly significant when the patent owner proposes a new…
In a recent development, the Federal Circuit has chosen to vacate the Patent Trial and Appeal Board’s (PTAB) decision based on what they deemed to be an overly narrow claim construction. The matter in focus was Apple Inc. v. Corephotonics, LTD., a case that presented two key decisions to analyze. The first issue at hand…
In a recent development, the White House Executive Order on Artificial Intelligence (AI) appears to sidestep some of the more contentious intellectual property (IP) issues. The order, dubbed “EO” in law circles, conducts a broad sweep of AI topics, ranging from risk management to problem-solving methodologies. The EO is most poignant, however, in its discussions…
AbbVie, AstraZeneca, and GSK are part of the 10 companies now on the Federal Trade Commission’s (FTC) radar as it begins challenging more than 100 patents in the “Orange Book.” The FTC alleges that these businesses erroneously or inaccurately listed items on the FDA-approved products list, intending to hold off competition from generic drugs. The…
In the patent case between massage-device companies, Judge Gardephe (S.D.N.Y.) has adopted two recommendations extended by the magistrate judge, as indicated in a recent decision. This marks a significant development in a legal battle involving some key industry players. The first R&R (Report and Recommendation) recommended the denial of Defendant Tzumi’s motion for partial summary…
In a comprehensive ruling on September 20, 2023, Judge McMahon of the U.S. District Court for the Southern District of New York (S.D.N.Y.) decided on a series of pre-trial motions in a complex litigation involving trade dress infringement, unfair competition, and patent infringement. The parties involved were Geigtech East Bay LLC (“Geigtech”) and Lutron Electronics…
Senior U.S. District Judge T.S. Ellis III of Virginia has partially granted Amazon’s motion to dismiss a patent infringement complaint filed by Dialect. The decision, centered on voice recognition technology and natural language understanding used in Amazon’s Echo and Alexa products, particularly affects one of seven patents under contention. The concern raised by Amazon prompted…
In a recent case, Elekta Limited v. Zap Surgical Systems, Inc., the Federal Circuit upheld a PTAB decision that declared some of the claims of a patent owned by Elekta Limited (“Elekta”) to be unpatentable. This decision is notable, as the PTAB did not expressly address the expectation of success for the proposed obviousness combination…
In a notable move by the Federal Trade Commission (FTC), the agency has announced challenges to more than 100 patents held by 10 branded drug firms on November 7. The FTC questions the proper listing of these patents in the Food and Drug Administration’s (FDA) Orange Book, deeming them either inaccurate or irrelevant. The Commission…
Intellectual property (IP) protection is a fundamental tool for emerging companies in the healthy food and beverage (F&B) sector, serving not only to attract investors but also to distinguish their products in an increasingly competitive market. Building a robust IP portfolio, inclusive of patents, trademarks, copyrights, and trade secrets, can be the deciding factor in…
President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, issued on November 1, 2023, has stimulated extensive discussion and anticipation within the legal sector. The firm of Morrison Foerster has extensively reviewed the executive order while dissecting its potential implications across a multitude of legal disciplines. Legal professionals,…
On May 3, 2023, a high-profile case at the Patent Trial & Appeal Board (PTAB) saw Spectrum Solutions LLC being granted a motion for sanctions against Longhorn Vaccines & Diagnostics LLC[ref]. The resulting sanctions order brought about the cancellation of five Longhorn patents in an outcome that stirred the patent law industry. The Board found…
As the nuances of patent law continue to evolve, the US Court of Appeals for the Federal Circuit recently made a significant ruling. In the case of Malvern Panalytical Inc. v. TA Instruments-Waters LLC, Case No. 22-1439, the Federal Circuit vacated a stipulated judgment of noninfringement in a patent infringement dispute after interpreting a contested…
In what can only be defined as a case that hits home for bacon lovers, a recent legal scuffle has emerged around an individual’s claim of being the co-inventor of an innovative method to precook bacon. Although the phrase “Bacon makes everything better”, rings true for most of us, in this particular instance, not all…
The U.S. Federal Trade Commission (FTC) recently issued warning letters to 10 drug manufacturers, challenging approximately a hundred listings in the FDA’s Orange Book as reported by JD Supra. These listings generally refer to patents associated with inhaler devices, multidose ophthalmic bottles, and autoinjectors. FTC’s challenge comes as part of the U.S. Food and Drug…
Working with patent cases often presents an intriguing intersectional challenge due to the inherent necessity for contentions and expert reports to mesh seamlessly. Whether they evolve into a harmonious symphony or a discordant cacophony often rides on a careful judgment call. It seems quite common sense, at first glance, to assert that an expert should…