Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Regular consumers now enjoy a front-row seat to the long-running intellectual property dispute between Apple, the tech giant based in Cupertino, California, and Masimo, a medical device company based in Irvine, California....more
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...more
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies....more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more
On February 10, 2022, in Junker v. Medical Components, Inc., the U.S. Court of Appeals for the Federal Circuit reversed the Eastern District of Pennsylvania’s grant of summary judgment of no invalidity under the “on-sale bar”...more
Patent protection, regulatory exclusivity and product life cycle management should be at the core of any company’s life science development strategy. A well-integrated strategy will be critical to securing investments,...more
The U.S. Supreme Court’s June 29 decision in Minerva Surgical, Inc. v. Hologic, Inc. has important implications for inventors who assign patent rights, employers to whom employees assign patent rights, other assignees, and...more
Teladoc has sued competitor Amwell over patent claims in the U.S. District Court for the District of Delaware. Teladoc is accusing Amwell of infringing on its patents related to telehealth carts, a digital scope and...more
Rapid advancements in medical device technology have brought unprecedented changes to the industry. Increasingly, innovative medical devices also combine developments from other industries such as software, hardware,...more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
Two recent letters to the US Senate stand on opposite sides of the debate over patent subject matter eligibility. Proposed legislation could reform Sections 101 and 112 of the US Patent Act, changing the way patent subject...more
Patent activity provides an important signal that is helpful in identifying and forecasting industry trends including the development of new products and services. It can predict the future focus of individual competitors...more
3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D...more
On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more
KFx Medical Corp. filed its patent applications like any startup would and with the same goal: protecting its intellectual property. Sometimes, that’s not an easy thing to do, especially if the infringing company is...more
Intellectual property (IP) law is undergoing a major transformation just as additive manufacturing? or 3D printing? has begun to revolutionize the manufacturing industry. The interplay between these two forces could end up...more
Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more
In Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., the Federal Circuit agreed with the district court that Ethicon’s prototype constituted prior art under 35 USC § 102(g) based on its earlier date of conception, but...more