Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
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 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 199: Bringing Awareness to Organ and Tissue Donation with Dave DeStefano of We Are Sharing Hope
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 198: Artificial Intelligence in Healthcare and Life Sciences with hosts Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh and Randi Branham of Elliott Davis
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 191: South Carolina Lowcountry Healthcare with Walter Bennet, MUSC Orangeburg CEO
The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v....more
In Amgen Inc. v. Sanofi, the Supreme Court unanimously held that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent specification must enable a person skilled in...more
Can a patentee really just take a pass on alleging that an accused product meets a limitation in an asserted claim, even where the case involves complex technology? That's the upshot of the court's decision in Lindis Biotech,...more
The Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...more
Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more
With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by...more
Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more
Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more
What do telegraphic communications, incandescent lamps, wood veneering glues, and antibodies have in common? Nothing. That is of course, until May 18, 2023, when the Supreme Court ruled that Amgen’s antibody claims, like...more
In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more
Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) - The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more
The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more
The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid,...more
The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more
On May 18, the Supreme Court sided with Sanofi in Amgen v. Sanofi, 598 U.S. ____ (2023), a dispute concerning broad functional genus claims for antibodies. The ruling affirmed the Federal Circuit’s reading of the Patent Act’s...more
A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection....more
The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more
This morning, the US Supreme Court issued its opinion in Amgen v. Sanofi, a closely watched case concerning patent law’s enablement requirement. Under that requirement, codified at 35 U.S.C. § 112(a), a patent specification...more
On March 27, the U.S. Supreme Court heard oral argument in Amgen v. Sanofi, a closely watched case concerning the appropriate legal standard for patent law's enablement requirement. That requirement is found in Title 35...more
The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more
On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more
U.S. Supreme Court Will Decide This Year - In this year’s foray into patent law, the Supreme Court will decide whether Amgen’s patent that claims antibodies by functional antigen binding and does not disclose the full...more