Patent law in the life sciences industry evolves rapidly, with several recent Federal Circuit decisions showing how those shifts can impact intellectual property strategy. The cases discussed below touch on everything from...more
A recent judgment of the U.K. High Court (Patents Court) has clarified the scope of the notification requirements for the supplementary protection certificate (SPC) manufacturing waiver in the U.K. ...more
On December 2, 2025, Bayer announced that the Solicitor General of the United States, D. John Sauer1 has recommended the United States Supreme Court take up the Monsanto Co. v. Durnell2 appeal on the Roundup product...more
Life sciences and biopharma companies often rely on clinical trial results and "clinically proven effective" language in patent claims, but this approach carries significant risks if key details are publicly disclosed before...more
On June 3, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) began a public comment period on a draft plant pest risk assessment (PPRA) and draft environmental assessment (EA)...more
A new trend is emerging among corporations to seek immunity from prosecution and prevent consumers from suing after the corporation’s product injures a consumer. As an example, Bayer/Monsanto1 is currently seeking legislative...more
Exposure to the weedkiller Roundup (glyphosate) has been linked to an increased risk of non-Hodgkin's lymphoma....more
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more
Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and...more
Federal environmental regulators are taking action that eventually could transform the way motor vehicle tires are manufactured to reduce toxic runoff from 6PPD, a substance used in tire production that kills or harms some...more
The future of California water storage reached a major milestone on Thursday with the finalization of plans for the Sites Reservoir in Northern California. The reservoir would be the second largest off-stream reservoir in the...more
The High Court has made a Group Litigation Order (GLO) in the class action proceedings of Tongue & Ors v Bayer Public Ltd Company & Ors [2023] EWHC 1792 (KB). This appears to be only the second GLO made by the High Court in...more
In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging...more
In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more
The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases. The Justice Department is executing on that promise and doing so with great success. Week after week, we read about...more
Commercial transactions often involve parties from different states. When a dispute arises between diverse parties, the question of whether a party can obtain personal jurisdiction over a defendant becomes critical. This...more
Bayer bid to end Roundup suits draws U.S. Supreme Court inquiry - Bloomberg – December 13 - The U.S. Supreme Court signaled interest in Bayer AG’s bid to stop thousands of lawsuits claiming that its top-selling...more
A regional hospital system in Akron, Ohio, Akron General Health System (AGHS) reached a $21.25 million settlement over allegations that an improper physician referral arrangement violated the Anti-Kickback Statute, Physician...more
Last year Bayer announced a plan to settle lawsuits alleging injury due to exposure to Roundup™. Lawsuits alleging injuries related to pesticide exposure, such as the lawsuits involving Roundup™, are not new, and they are...more
From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more
PE-backed Inspire Brands is in negotiations to take over Dunkin’ Brands Group, the parent of both Dunkin’ and Baskin-Robbins, in a deal valued at nearly $9 billion. Inspire includes Buffalo Wild Wings and Jimmy John’s among...more
A California appeals court has affirmed a lower court decision requiring Uber and Lyft to “treat their California drivers as employees, providing them with the benefits and wages they are entitled to under state labor law.”...more
In hotly anticipated comments on Thursday—and yes, such a designation applies to a speech on monetary policy—Federal Reserve Chair Jay Powell “announced a major shift in how the central bank guides the economy, signaling it...more
A state appeals court in California has preempted Uber and Lyft’s threatened state-wide shutdown over a new state law ordering them to reclassify their drivers as employees by “allowing them to continue operating [under their...more
Welcome to 2020's second edition of Product Lines, our e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal issues. As you will...more