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On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more
Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone was originally approved in 2000 by the U.S. Food and...more
On March 26, 2024, the Supreme Court heard arguments in the two consolidated cases concerning access to mifepristone pending before the Court, FDA v. Alliance for Hippocratic Medicine, Case No. 23-235 and Danco Laboratories,...more
8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...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
On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more
Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more
Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., Appeal No. 2018-2273 (Fed. Cir., April 23, 2020). Argentum and other petitioners filed IPRs against Novartis’ patent related to methods of treating...more
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more
Last week, the State of Arizona made an interesting litigation decision. As part of the ongoing litigation over the opioid crisis, Arizona filed a complaint against Purdue Pharmaceuticals and its owners, the Sackler...more
A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board....more
The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta’s appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar...more
Takeaway: There are two ways to beat a class action – defeat class certification or defeat the class claims on the merits. Individual RICO actions tend to be complex and expensive to defend, and they increase a defendant’s...more
On February 7, 2019, in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed an appeal brought by a petitioner in an inter partes review (IPR) for lack of standing and mootness because...more
The Federal Circuit has on several occasions taken the opportunity to address (and in doing so, flesh out) the requirements for Article III standing to appeal an adverse determination in a post-grant review proceeding...more
The Federal Circuit just issued a decision that confirms its stance on Article III standing for appeals from inter partes reviews (IPRs), making it tougher for unsuccessful IPR petitioners to obtain judicial review of U.S....more
Mylan Pharmaceuticals, Inc. petitioned for inter partes review (IPR) of U.S. Patent No. 6,858,650 (the “‘650 Patent”), which is owned by UCB Pharma GmbH (“UCB”) and is directed to chemical derivatives of a drug for treating...more
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more
Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...more
Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more
In recent years, courts have reached divergent conclusions about the circumstances in which a damages class containing uninjured persons can be certified. Although there is some room to debate what constitutes injury, it is...more
In his October 17th post, Josh Dunlap describes in detail the First Circuit’s landmark ruling in In re Asacol Antitrust Litigation concerning classes that include uninjured members. ...more