The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more
The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2016. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more
Eight years ago, in Conte v. Wyeth, the California Court of Appeals shocked brand prescription drug manufacturers when it held that they could be liable for injuries caused by generic versions of their medications — an...more
The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more
Last month, in Pfizer, Inc. v. Lee, the Federal Circuit determined that the District Court for the Eastern District of Virginia did not err in granting summary judgment in favor of the U.S. Patent and Trademark Office on the...more
In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more
The Patent Trial and Appeal Board (PTAB or Board) interpreted the estoppel provision of 35 U.S.C. § 315(e)(1) to deny institution of inter partes review in a second petition by the same petitioner against the challenged...more
In a recent Inter Partes Review (“IPR”) institution decision, Apotex v Wyeth (IPR2015-00873, Paper No. 8), the USPTO’s Patent Trial and Appeal Board (the “Board”) found that some previously-asserted grounds of invalidity were...more
Addressing the U.S. Patent Office’s (USPTO) discretion in connection with patent term adjustments, the U.S. Court of Appeals for the Federal Circuit agreed with the district court that the USPTO acted within its discretion in...more
In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to...more
Earlier this month, the Supreme Court of Alabama confirmed its January 2013 holding in Weeks v. Wyeth Inc. that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Though the recent ruling puts...more
On August 15, 2014, the Alabama Supreme Court held for the second time in Wyeth v. Weeks, No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless...more
Lst Thursday, a jury in the Southern District of New York convicted Mathew Martoma in what is in dollar terms the largest insider trading case in captivity. As we’ve discussed before, Martoma had been accused of paying a...more
Issuing an opinion over two years after oral argument, the Pennsylvania Supreme Court ruled last week in Lance v. Wyeth that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs....more
Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more
In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112....more
When is it undue experimentation in practicing the full scope of a claim that contains a genus of chemical compounds and a functional limitation of activity, when the specification provides a method to assess the claimed...more
Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more
Executive Summary: Three years removed from the Federal Circuit’s decision in Wyeth v. Kappos, patentees are seeking additional extensions of patent term based on the recent decision issued in Exelixis v. Kappos, which could...more