Riskology by Infortal: Episode 34 – The Hezbollah Pager Attack & Supply Chain Compliance
Compliance into the Weeds: Exploring Compliance Data Access and Testing Challenges
All Things Investigations: Anchored in Fraud: Mike DeBernardis and Shayda Vance on Austal USA’s Scandal
#WorkforceWednesday®: What the FTC Non-Compete Ban Block Means for Employers - Employment Law This Week®
Podcasting for Business - The Book: Metrics That Matter, Part 1 - Referrals, Sales Cycle, Promos, SEO and Product Creation
Innovation in Compliance: The Evolution of Compliance and Technology: An Interview with Stuart Breslow
The Magnificent 7 Rides Again: Elaine Capers on Artistic Inspirations from West Texas
Consumer Finance Monitor Podcast Episode: Why do Fintechs Want to Become Banks?
From Paper to Digital: The California DMV's Leap Into Blockchain Technology — The Crypto Exchange Podcast
Compliance Tip of the Day: Bank of America, Culture and Internal Controls
Corruption, Crime and Compliance: SEC Suffers Dismissal of Claims in Solarwinds Securities Fraud Case
Regulatory Ramblings: Episode 51 - The EU AI Act: Why it Matters for Asia and Beyond with Michael Borrelli (AI & Partners) and Anandaday Misshra (AMLEGALS)
The Woody Report: The Solar Winds Dismissal
Life With GDPR: AI Regulation in The EU
The Power of Genuine Networking for Entrepreneurs With OneSixOne Ventures with Pablo Casilimas and Justis Mendez
Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
Corruption, Crime and Compliance: The Boeing Plea Agreement
Riskology by Infortal: Episode 30 – Boeing’s Future: Failure is Not an Option with Tom Fox and Christopher Mason
Daily Compliance News: August 12, 2024 – The Bribery Alleged Edition
2 Gurus Talk Compliance: Episode 34 – The Whistleblower Edition
On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more
The world of intellectual property law is always changing, and it can be difficult to keep up. Here are 13 developments in patent law so far in 2024 to help you stay in the know....more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...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
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more
On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s...more
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more
In H. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, and 2022-1246 (December 7, 2023), the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid...more
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The...more
Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39...more
On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi...more
Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
Case Name: Sanofi-Aventis U.S. LLC v. Sandoz, Inc., No. 20-804-RGA, 2023 WL 4175334 (D. Del. June 26, 2023) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patent No. 10,716,777 (“the ’777...more
The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more
Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market...more
Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in...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
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
On November 4, the U.S. Supreme Court granted Amgen’s petition to review the “enablement requirement” of Section 112 of the Patent Act. See generally Amgen Inc., v. Sanofi, No. 21-757 (U.S. 2022). The Court’s decision will...more
In an 8-1 majority ruling released today, the Supreme Court of Canada (SCC) has affirmed the record-setting $645M patent infringement award in Dow v Nova. The Supreme Court dismissed Nova’s appeal of the earlier decisions of...more
Moderna has sued Pfizer and BioNTech in Massachusetts and Germany (where the defendants are based), claiming that the companies violated three of its patents related to mRNA technology used to develop COVID-19 vaccines....more
On Friday, August 26th, Moderna Tx, Inc. and Moderna US, Inc. filed a complaint for patent infringement in Federal district court for the District of Massachusetts against Pfizer, Inc., BioNTech SE, BioNTech Manufacturing...more
The China National Intellectual Property Administration, a newly established administrative authority on patent infringement disputes, recently issued its first decisions, addressing questions many companies had on the...more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more