False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
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 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
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 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
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...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
PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark. Appeal from the Patent Trial and Appeal Board....more
Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more
Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more
The U.S. Supreme Court recently struck down broad patent claims covering a “genus” of antibodies, reaffirming in a 9-0 decision that a patent must “enable” the full scope of its claims (Amgen Inc. v. Sanofi). Amgen, Inc.,...more
This month, the Supreme Court issued its opinion in Amgen Inc. v. Sanofi, the closely watched case involving the enablement standard for patent claims, particularly as applied to functionally defined genus claims. Genus...more
In May, the Supreme Court of the United States handed down its decision in Amgen Inc. v. Sanofi, which addressed the statutory enablement requirement for patents. The decision is consistent with ongoing efforts to strike a...more
A week ago Thursday, the Supreme Court issued its decision in the Amgen v. Sanofi case, affirming the judgment of the Court of Appeals for the Federal Circuit, that the claims of the two patents Amgen asserted against Sanofi...more
On May 18, 2023, the U.S. Supreme Court handed down a unanimous decision in the much-anticipated Amgen Inc. v. Sanofi case. See 598 U.S. ___, No. 21-757, 2023 WL 3511533 (May 18, 2023). In so doing, the Court maintained the...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 case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...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 legal standard for enablement – the statutory requirement under 35 USC § 112 that a patent must enable those skilled in the art to “make and use” the claimed invention – remains unchanged after the US Supreme Court...more
Summary - In Amgen v. Sanofi, the Supreme Court unanimously affirmed the District of Delaware and Federal Circuit findings that Amgen’s functionally defined patent claims to a class of therapeutic antibodies are invalid as...more
Executive Summary - In Amgen Inc. v. Sanofi, the United States Supreme Court affirmed the lower courts’ judgment that the asserted claims of U.S. Patent No. 8,829,165 (“the ’165 Patent”) and U.S. Patent No. 8,859,741 (“the...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
Justice Gorsuch authored a unanimous opinion arching back to precedent from the 1800s and upholding the Federal Circuit’s and district court’s determinations that Amgen’s patent claims are invalid for lack of enablement....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
Earlier today, the Supreme Court issued a unanimous decision in Amgen v. Sanofi, construing the statutory enablement requirement. The case concerns antibodies that help reduce levels of LDL cholesterol....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