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
The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role...more
In an ANDA case in the District of Delaware, the court has rejected an obviousness challenge to a patented method of increasing survival in patients having prostate cancer. The court found that early clinical trial results...more
Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more
The Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that...more
In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...more
Earnest v. Sanofi U.S. Services et al, U.S. Circuit Court of Appeals for the Fifth Circuit, No. 20-30184 (Feb. 10, 2022) - The plaintiff sued Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S., LLC in the Eastern District...more
In Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 21-1070, slip op. at 7 (Fed. Cir. Jan. 3, 2022), the defendant posed two distinct written-description challenges to Novartis’s patent claims, regarding (1) a daily...more
In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more
When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim? This is a question that comes readily to mind...more
It’s not easy getting a drug or device to market. From concept to launch, it takes years of work and the involvement of countless professionals from the engineering, medicine and regulatory disciplines. If the product becomes...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more
Applying basic scientific principles to exclude an expert’s unfounded and unsupported opinions, the U.S. District Court for the Northern District of California has granted summary judgment to the maker of the antipsychotic...more
Update: On July 28, 2021, the Federal Court of Appeal dismissed Seedling’s appeal from Justice Grammond’s decision: Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154 (see article here). On January 2,...more
Summer is winding down, and Fall texted to say she is on her way. This means that Pro Te: Solutio is returning for its third edition of 2019. As always, our authors have taken the time to research and address current issues...more
Invoking a newly minted equivalent disclosure doctrine, a panel of the US Court of Appeals for the Federal Circuit found that the written description requirement of § 112 was satisfied in the interest of arriving at a...more
Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more
Until now, the perception that New Jersey law on expert admissibility was weaker than the Daubert standard used in federal courts and many other states - combined with New Jersey being home to so many pharmaceutical and...more
Welcome to our inaugural issue of Product Lines—our e-newsletter focusing on toxic torts and products liability news and issues. As we all know, there are many issues that arise in this complex area of the law every day. We...more
In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more
Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more
To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to...more
On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more
With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit®...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more