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
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more
Against the backdrop of a slower M&A market, collaborations between biotech companies and pharma companies have remained robust, particularly those focusing on innovation and collaboration for value creation. According to a...more
Welcome to the Litigation Gazette. Each quarter, BCLP's Paris team will keep you informed of the main litigation news in competition law, commercial litigation, labor law, IP/IT/Data and compliance....more
The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more
The last week has seen crucial developments at the European Commission (EC) and U.S. Federal Trade Commission (FTC) regarding the antitrust review of the $7.1 billion proposed acquisition by Illumina (the leading supplier of...more
In its judgment of 13 July 2022, the EU General Court confirmed that transactions that do not meet EU or Member State thresholds can be referred by national competition authorities to the European Commission (the...more
Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention...more
It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue - In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...more
The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more
Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more
We have been keeping a close eye on the patent suit filed by Canopy Growth against GW Pharma in the Western District of Texas’s Waco Division, a venue that has attained recent fame for its speed to trial in patent litigation....more
In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments...more
Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured,...more
On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to...more
• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more
Earlier last week, a Second Circuit panel resolved a sharp disagreement among district courts regarding the interpretation of the forum defendant rule in the context of a multi-district litigation (“MDL”) involving dozens of...more
As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more
Timing is everything. In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop. On May 4, 2018, the U.S. Court of Appeals heard oral arguments in the expedited appeal of American Hospital...more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...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
Seyfarth Synopsis: In a nationwide consumer fraud class action involving false labeling claims under various state laws, a federal district court in Illinois granted the company’s motion to dismiss claims relative to a...more
The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...more
Every summer vacation (or, at least, the ability to take the weekend off!) should include a good read. Whether your preference runs toward a memoir with words of wisdom, a review of new technical advancements, issues of...more