Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more
Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more
Exploring the applicability of its enablement law to life sciences, the Supreme Court of the United States issued a unanimous opinion, concluding that patent claims covering a genus of antibodies defined in part by functional...more
Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more
Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more
In a rare action by the Supreme Court of the United States, Chief Justice Roberts granted Novartis’s emergency request for a stay of a mandate from the US Court of Appeals for the Federal Circuit, which had found a Novartis...more
A federal district court likely will determine the 340B program definition of “patient” following a decision by the US Court of Appeals for the Fourth Circuit in Genesis Healthcare v. Becerra. The issue was whether the...more
The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more
T-Mobile chief and fan-of-magenta John Legere has announced that he’ll be stepping down in April at the end of his current contract. Legere will be succeeded by Mike Sievert, the carrier’s current president and COO....more
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more
On January 22, 2019, the U.S. Supreme Court affirmed the U.S. Court of Appeals for the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229 (Jan. 22, 2019)....more
Addressing whether the on-sale bar of America Invents Act (AIA) 35 USC § 102(a)(1) applies to confidential sales where specific details are not made public, the Supreme Court of the United States found that the post-AIA...more
If the term "happy hour" in this article's title caught your attention, you may be disappointed by what comes next. This article is actually about limitations on patent protection, which I would argue is just as...more
Originally published in The Journal Record | January 31, 2019. This month, the U.S. Supreme Court issued its opinion in Helsinn Healthcare v. Teva Pharmaceuticals, confirming that private sales of an invention may preclude...more
The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act...more
Prior to the Leahy-Smith America Invents Act (“AIA”), the patent statute (35 U.S.C. § 102(b)) prohibited patenting an invention that was “on sale in this country, more than one year prior to the date of the application for...more
Inventors should not delay the filing of their patent applications, and preferably should file within one year of any commercialization of the invention, as confirmed by the Supreme Court on January 22, 2019....more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court interpreted the “on sale bar” of the America Invents Act (AIA) version of 35 U.S.C. § 102 as unchanged from the pre-AIA version. In so doing, the...more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc, the United States Supreme Court held that a prior public sale of a patented product could destroy the novelty of a patent for that product even though there was no...more
U.S. patent law states that any invention that was “on sale in this country, more than one year prior to the date of the application for patent” is not eligible for patent protection. The Supreme Court recently confirmed...more
The America Invents Act (“AIA”), also called the Patent Reform Act of 2011, was enacted to overhaul the U.S. patent system and harmonize the domestic patent laws with those in the rest of the world. The AIA also created new...more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court affirmed the Federal Circuit’s decision that the sale of an invention to a party who is contractually obligated to keep the invention...more