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Life Sciences
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October 07, 2024
AbbVie's Top Brass Escape Suit Over Rinvoq Claims, For Now
An Illinois federal judge Friday tossed AbbVie investors' suit challenging directors' statements about the potential for its rheumatoid arthritis drug Rinvoq to be approved for other conditions, a possibility that collapsed over safety risks with Pfizer's competing drug Xeljanz, finding the investors don't allege the directors knew Xeljanz's results would affect Rinvoq.
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October 07, 2024
Boehringer Defends Zantac As Cancer Jury Trial Kicks Off
Boehringer Ingelheim Pharmaceuticals defended the company's heartburn medication Zantac during the defense's opening statements in a product liability trial Monday, telling California jurors that trial evidence will show the plaintiff never used Boehringer's over-the-counter Zantac products, and that other risk factors put him at risk of developing bladder cancer.
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October 07, 2024
ITC Judge Pushes For Import Ban In Liver Drug Secrets Row
The U.S. International Trade Commission's chief judge is recommending the agency block a Hong Kong-listed drug developer from potentially marketing unapproved treatments for a type of liver disease for the next seven years, a win for another company behind a different unapproved treatment for the same type of liver disease.
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October 07, 2024
Fed. Circ. Questions If Safer OxyContin Profits Came From IP
An attorney for Purdue Pharma didn't seem to find much purchase at the Federal Circuit on Monday as he argued that the company's patents for abuse-deterrent OxyContin weren't obvious, claiming other companies had ample opportunity to reach a solution and failed to do so.
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October 07, 2024
Merck Immune For 'Inflated' Vax Claims To FDA, 3rd Circ. Says
A divided Third Circuit panel inoculated Merck from claims that it tried to prevent competition by making inflated declarations to federal regulators about its mumps vaccine, with the majority ruling Monday that because Merck convinced federal regulators it had extended the vaccine's long-term potency, those assertions can't have been an anticompetitive "sham."
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October 07, 2024
Biotech, Medical Device Firms Prep Three IPOs Totaling $376M
Two venture-backed biotechnology startups and a medical device maker launched plans on Monday for three initial public offerings projected to raise about $376 million combined, adding to a busy schedule of IPOs this week.
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October 07, 2024
Mich. Supreme Court Snapshot: Insulin Prices, Disney Audit
The Michigan Supreme Court's first oral argument session of the 2024-25 term promises to be a busy one, involving an investigation into Eli Lilly's insulin prices with big implications for the scope of Michigan's consumer protection law and Disney's appeal of an order to turn over decades-old uncashed checks to the state treasurer.
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October 07, 2024
Mylan, Novo Nordisk Settle Ozempic Patent Dispute
Mylan Pharmaceuticals and Novo Nordisk have asked the Patent Trial and Appeal Board to terminate Mylan's request to review whether a patent covering Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic holds up, telling the board the two sides have resolved their dispute.
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October 07, 2024
5 Decisions To Know By Outgoing Mass. Chief Judge
Chief Massachusetts U.S. District Judge F. Dennis Saylor IV, who announced Monday that he will step back from full-time judicial service next summer, has presided over numerous significant cases in recent years, including a dispute over the U.S. Securities and Exchange Commission's disgorgement powers and a birth defects suit against GlaxoSmithKline.
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October 07, 2024
Trio Of 1st Circ. Criminal Cases Turned Away By Top Court
The U.S. Supreme Court on Monday declined to review three white collar cases on appeal from the First Circuit, including challenges to a cryptocurrency founder's conviction for investor theft and an Illinois attorney's fraud and money laundering conspiracy verdict.
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October 07, 2024
Justices Won't Hear Kickback Statute 'Willfulness' Case
The U.S. Supreme Court on Monday declined to consider whether a "willful" act under federal anti-kickback law requires a defendant to know their actions violate the law.
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October 07, 2024
High Court Rejects Pleas To Hear 7 Patent Cases
The U.S. Supreme Court on Monday turned down seven petitions seeking review of decisions in patent cases, including appeals dealing with double patenting, patent eligibility and Patent Trial and Appeal Board procedures.
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October 07, 2024
High Court Won't Look At Alabama Frozen Embryo Decision
The U.S. Supreme Court on Monday said it won't consider a challenge to a first-of-its-kind Alabama state court ruling that frozen embryos are legally children.
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October 07, 2024
Justices Won't Hear Shkreli's Bid To Undo $64M Disgorgement
The U.S. Supreme Court refused Monday to review former pharmaceutical executive Martin Shkreli's challenge of a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%.
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October 04, 2024
Top 5 Supreme Court Cases To Watch This Fall
The U.S. Supreme Court will hear several cases in its October 2024 term that could further refine the new administrative law landscape, establish constitutional rights to gender-affirming care for transgender minors and affect how the federal government regulates water, air and weapons. Here, Law360 looks at five of the most important cases on the Supreme Court's docket so far.
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October 04, 2024
NJ, Ethics Board Must Hand Over Docs In Retaliation Fight
A New Jersey state judge has ordered the state and its ethics commission to hand over to an ex-state health official internal documents in his lawsuit alleging that he was wrongly fired in 2020 for raising concerns about the earmarking of COVID-19 tests for relatives of another state official.
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October 04, 2024
DOJ Charges Execs, Sales Reps Over Texas 'Pill Mills' Sales
Tens of millions of opioid pills ended up in the black market by way of pharmaceutical distribution executives and sales representatives who targeted a Houston "hot zone" for drug diversion, the U.S. Department of Justice said in unsealing several indictments in Texas, Florida, Missouri and North Carolina.
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October 04, 2024
Regeneron Can't Ax Willful Infringement In COVID Patent Case
Regeneron Pharmaceuticals Inc. cannot boot a willful infringement claim from Allele Biotech's patent suit over the development of COVID-19 vaccines and treatments, a New York federal judge ruled Friday, saying it was up to Regeneron to establish that Allele failed to show the defendant had presuit knowledge of the patent.
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October 04, 2024
Healthcare Co. Inks Deal In DOL Equal Pay Investigation
A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.
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October 04, 2024
There May Not Be Life On Mars, But There Could Be IP
The rapidly expanding space tourism industry is raising a vast universe of potential intellectual property issues. Experts say most of the laws governing extraterrestrial IP are as unexplored as space itself.
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October 04, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen GMB Union sued by the makers of Tetley Tea after a staff walkout in September, boxer Mike Tyson hit with legal action from a marketing company and the Met Police face a misuse of private data claim from a woman who had a relationship with an undercover police officer. Here, Law360 looks at these and other new claims in the U.K.
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October 04, 2024
High Court Takes Up E-Cig 'Forum Shopping' Appeal
The U.S. Supreme Court on Friday agreed to review a Fifth Circuit ruling that allowed out-of-circuit e-cigarette manufacturers to seek judicial review before the New Orleans-based court so long as the petition is joined by a seller located in the circuit.
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October 04, 2024
High Court Will Hear TCPA Case Over Online Junk Faxes
The U.S. Supreme Court said Friday it will review whether district courts must follow a Federal Communications Commission ruling that the Telephone Consumer Protection Act does not prohibit junk faxes that are received only via electronic inboxes.
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October 03, 2024
Gilead Makes Generic HIV Drug Plan, Advocates Urge Expansion
Gilead Sciences Inc. this week announced a plan to allow six drugmakers to produce generic lenacapavir to help combat the HIV pandemic in 120 lower-income countries, an initiative that won praise as a welcome step Thursday, although advocacy groups urged the company to expand the effort.
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October 03, 2024
Boston Pharma Co. Drops Another Moderna Patent Suit
A Boston pharmaceutical developer once again has agreed to drop a patent lawsuit against Moderna over its popular coronavirus vaccines after losing a claim construction ruling in front of Delaware's top judge.
Expert Analysis
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.