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Life Sciences
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June 18, 2024
Fla. Immune To Contract Suit Over COVID Tests, 4th Circ. Says
The Fourth Circuit reversed on Tuesday a district court decision denying a motion to dismiss by a Florida state agency in a breach of contract case involving COVID-19 tests, finding the lower court erred in ruling that the state did not have sovereign immunity and remanding the case for further proceedings.
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June 18, 2024
11th Circ. Orders New Shrimp Secrets Trial Over Judge's Exit
The Eleventh Circuit ordered a new trial in a trade secrets dispute involving breeders of disease-resistant shrimp, saying Tuesday that a magistrate judge who oversaw the trial's conclusion so that a federal judge could catch a flight exceeded his authority by answering jury questions and rejecting a defense counsel's request for clarification on damages awarded.
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June 18, 2024
COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit
A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.
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June 18, 2024
J&J Fights Law Firm's Bid To Nix Subpoenas In Talc Brawl
Information about the Beasley Allen Law Firm's litigation funding and settlement communications is relevant and necessary to resolving long-running multidistrict litigation over Johnson & Johnson's talcum powder products and so should be turned over, the pharmaceutical giant has told a New Jersey federal court.
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June 18, 2024
Restitution Plan For Lead-Test Defects Leaves Judge Uneasy
A Massachusetts federal judge on Tuesday questioned the legality of a plan to have a claims administrator, rather than the court, oversee victim compensation in a criminal case alleging Magellan Diagnostics hid information about inaccurate results in its lead-testing devices.
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June 18, 2024
Latham Leads Boston Scientific On $1.16B Silk Road Deal
Latham & Watkins-advised Boston Scientific Corp. said Tuesday it has agreed to acquire medical device maker Silk Road Medical Inc., represented by Wilson Sonsini, at an enterprise value of approximately $1.16 billion.
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June 18, 2024
Cancer Test Company DermTech Hits Ch. 11, Seeking Sale
California-based dermatologic test maker DermTech Inc. hit Chapter 11 Tuesday in Delaware and said it would be laying off about 20% of its workforce as it seeks to sell its assets.
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June 18, 2024
Samsung Bioepis Denies Infringing Blood Treatment Patent
Samsung Bioepis has fought back against a bid by Alexion to prevent it from selling a biosimilar version of a patented blood treatment drug by a rival, telling a court that this will not infringe the protections of an AstraZeneca subsidiary over the medicine.
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June 17, 2024
Teva, DOJ Signal Key Kickback Case May Fizzle At 1st Circ.
A U.S. Department of Justice kickback case against Teva Pharmaceuticals — closely watched by False Claims Act lawyers because of its multibillion-dollar stakes and its link to a major circuit split — is poised for settlement, according to a new First Circuit filing ahead of eagerly awaited oral arguments.
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June 17, 2024
NJ Firm Defends Lien On Ex-Client's Patents After Unpaid Bills
A major New Jersey law firm said it has a "common law" right to place a lien on its former client's patents without telling it, after the "failed" biopharmaceutical startup fired the firm and stopped paying its outstanding legal bills.
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June 17, 2024
USC Allegedly Used 'Junk Science' On Black Kidney Patients
The University of Southern California secretly has been using a "junk science" scoring formula that hurts Black patients' eligibility to receive kidney transplants, according to a putative class action in California federal court.
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June 17, 2024
Mifepristone Ruling Means End Of Texas DACA Suit, Feds Say
A Texas-led coalition of states doesn't have standing to challenge the Deferred Action for Childhood Arrivals program after the U.S. Supreme Court's blockbuster decision rejecting a challenge to the abortion drug mifepristone, the Biden administration told the Fifth Circuit on Monday.
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June 17, 2024
DOJ Wants 15 Years For Outcome CEO's $1B Fraud
Federal prosecutors said former Outcome Health CEO Rishi Shah should serve 15 years in prison while Outcome's co-founder and ex-financial chief each serve 10 years following their convictions for running a $1 billion fraud that affected lenders, investors and clients.
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June 17, 2024
Top Patent Eligibility Rulings In The Decade Since Alice
The U.S. Supreme Court's Alice v. CLS Bank decision 10 years ago this week led to scores of inventions being found ineligible for patenting, and rulings since then have fleshed out the law on the contentious topic. Here's a look at the most notable patent eligibility decisions after Alice.
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June 17, 2024
Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme
The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.
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June 17, 2024
HUD Freed From Pa. Pot Patients' Suit Over Housing Rebuff
Unless the U.S. Department of Housing and Urban Development fulfills its threat to withhold a Pennsylvania county housing agency's funding for complying with a state court order to admit licensed medical marijuana patients, a lawsuit by the county agency and two potential tenants is premature, a federal judge ruled Monday.
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June 17, 2024
Drugmaker, PE Investor Sued In Del. Over 'Unfair' Deal Terms
Clinical-stage biotechnology firm Omega Therapeutics' board entered into an "unfair" agreement to develop a new drug with the company's controlling private equity stockholder that was heavily tilted in favor of the majority equity holder and Omega insiders, an investor alleged in a lawsuit in Delaware's Chancery Court.
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June 17, 2024
Zantac Suits Must Exit State Court, Conn. Judge Told
A Connecticut state court judge must relinquish jurisdiction over two lawsuits claiming that generic versions of the heartburn drug Zantac caused cancer because state statutes do not subject entities with foreign business registrations to the auspices of Constitution State judges, a pharmaceutical industry attorney argued at a hearing Monday morning.
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June 17, 2024
Fed. Circ. Says Errors Led To Injunction In Trade Secrets Suit
A Federal Circuit panel on Monday overturned a preliminary injunction against a South Korean insulin pump patch manufacturer that allegedly stole trade secrets from a rival, saying a Massachusetts federal court made a series of errors in its determination to grant an injunction.
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June 17, 2024
Catching Up With Delaware's Chancery Court
Proposed amendments to Delaware's General Corporation Law that were prompted by several recent Chancery Court rulings sailed through the state Senate last week despite loud opposition from corporate law professors and other Chancery Court watchers, and Tesla shareholders filed two new suits against CEO Elon Musk.
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June 17, 2024
Talc Claimants Want Documents In Fight Over J&J Unit Venue
Cancer patients with talc damage claims against Johnson & Johnson have urged a New Jersey federal court to give them access to transcripts and exhibits from depositions of top executives at the company's talc unit, saying the information will aid their effort to bar the J&J spinoff from filing a third Chapter 11 outside the Garden State.
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June 14, 2024
Justices Are Asked To Wade Into Blood Pressure Drug IP Fight
United Therapeutics is taking its patent case seeking to stop a rival from selling a drug that competes with its blockbuster treatment for high blood pressure to the U.S. Supreme Court.
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June 14, 2024
Janssen Hit With $150M Verdict In HIV Drug False Claims Suit
A New Jersey federal jury hit Janssen with a $150 million False Claims Act verdict in a 12-year-old whistleblower suit, finding that the drugmaker violated the federal law as well as 27 related state FCA statutes by illegally profiting from the off-label marketing of two popular Janssen HIV medications.
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June 14, 2024
3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks
The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.
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June 14, 2024
Judge Won't Undo Save Of J&J Patent After Fed. Circ. Ruling
A federal court has refused to reconsider a March decision finding Tolmar failed to show a patent on Janssen's blockbuster schizophrenia drug Invega Sustenna was invalid as obvious.
Expert Analysis
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What Recent Study Shows About AI's Promise For Legal Tasks
Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.
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Fed. Circ. Patent Lesson: No Contradiction, No Indefiniteness
The Federal Circuit’s recent ruling in Maxwell v. Amperex Technology highlights the complexities of construing patent claims when seemingly contradictory limitations are present, and that when a narrowing limitation overrides a broader one, they do not necessarily contradict each other, says Roy Wepner at Kaplan Breyer.
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11th Circ. FMLA Ruling Deepens Divide Over Causation
The Eleventh Circuit's recent ruling in Lapham v. Walgreen distinguishes the circuit as the loudest advocate for the but-for causation standard for assessing Family and Medical Leave Act retaliation claims, though employers in other jurisdictions may encounter less favorable standards and the U.S. Supreme Court will likely have to address the circuit split eventually, say attorneys at Benesch.
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Decline In Same-Industry M&A Tells A Nuanced Policy Story
In light of newly available Hart-Scott-Rodino Act data suggesting that intraindustry mergers are down overall and pharmaceutical and hospital intraindustry transactions tend to face greater antitrust scrutiny than in the past, attorneys at Morgan Lewis explore whether Biden administration enforcement policies may be curbing pro-competitive strategic M&A.
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What's At Play In Rising Lanham Act Cases At The ITC
Amid an uptick in Lanham Act claims involving false advertising related to medical devices at the U.S. International Trade Commission, Brian Busey and Maryrose McLaughlin at MoFo discuss recent ITC complaints from Eli Lilly and R.J. Reynolds, Lanham Act claim limits under the Federal Food, Drug, and Cosmetic Act, and the issues practitioners face in this realm.
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BIPA's Statutory Exemptions Post-Healthcare Ruling
The Illinois Supreme Court's November opinion in Mosby v. Ingalls Memorial Hospital, which held that the Biometric Information Privacy Act's healthcare exemption also applies when information is collected from healthcare workers, is a major win for healthcare defendants that resolves an important question of statutory interpretation, say attorneys at Quinn Emanuel.
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Key Factors In Establishing Compelling Merits At The PTAB
A look at over 450 Patent Trial and Appeal Board decisions between June 2022 and now provides insights into strategies for petitioners and patent owners in establishing compelling merits arguments in post-grant proceedings, say David Holman and Tyler Liu at Sterne Kessler.
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Litigation Inspiration: A Source Of Untapped Fulfillment
As increasing numbers of attorneys struggle with stress and mental health issues, business litigators can find protection against burnout by remembering their important role in society — because fulfillment in one’s work isn’t just reserved for public interest lawyers, say Bennett Rawicki and Peter Bigelow at Hilgers Graben.
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What FTC's 'Killer Acquisition' Theory Means For Pharma Cos.
The Federal Trade Commission's recent lawsuit to block Sanofi's acquisition of a pharmaceutical treatment developed by Maze Therapeutics builds on previous enforcement actions and could indicate the agency's growing willingness to use its so-called killer acquisition theory against perceived attempts to eliminate nascent competition, say attorneys at Morgan Lewis.
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Series
Skiing Makes Me A Better Lawyer
A lifetime of skiing has helped me develop important professional skills, and taught me that embracing challenges with a spirit of adventure can allow lawyers to push boundaries, expand their capabilities and ultimately excel in their careers, says Andrea Przybysz at Tucker Ellis.
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The Road Ahead For Florida's Drug Importation Program
Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.
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Assessing CDC's Revised Guideline On Opioid Prescriptions
Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.
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Think Like A Lawyer: Forget Everything You Know About IRAC
The mode of legal reasoning most students learn in law school, often called “Issue, Rule, Application, Conclusion,” or IRAC, erroneously frames analysis as a separate, discrete step, resulting in disorganized briefs and untold obfuscation — but the fix is pretty simple, says Luke Andrews at Poole Huffman.
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Valeant Ruling May Pave Way For Patent-Based FCA Suits
The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.
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Opinion
Suits Against Insulin Pricing Are Driven By Rebate Addiction
A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.