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Life Sciences
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June 20, 2024
HHS Drug Pricing Program Flouts Constitution, Boehringer Says
An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.
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June 20, 2024
11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement
The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.
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June 20, 2024
Theravance, Mylan Say Chinese Co. Copied COPD Drug
Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.
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June 20, 2024
USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section
The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."
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June 20, 2024
11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit
The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.
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June 18, 2024
High Court Petition Asks Justices: What's A 'Willful' Kickback?
Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.
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June 18, 2024
Company, States Battle In Court Over At-Home Rape Kits
A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.
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June 20, 2024
CORRECTED: Drug Cos., PBMs Score Win In Calif. AG's Insulin Price Suit
A Los Angeles judge ruled Tuesday that the statute of limitations bars the California Attorney General's unfair competition law and unjust enrichment claims against drugmakers and pharmacy benefit managers over an alleged conspiracy to spike insulin costs, but granted leave to amend the allegations.
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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.
Expert Analysis
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.
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The Legal Industry Needs A Cybersecurity Paradigm Shift
As law firms face ever-increasing risks of cyberattacks and ransomware incidents, the legal industry must implement robust cybersecurity measures and privacy-centric practices to preserve attorney-client privilege, safeguard client trust and uphold the profession’s integrity, says Ryan Paterson at Unplugged.
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Fed. Circ. In Jan.: One Word Can Affect Claim Construction
The Federal Circuit's recent Pacific Biosciences v. Personal Genomics decision highlights how even construction of a simple term can be dispositive, and thus disputed, in view of the specific context provided by the surrounding claim language, say Jeremiah Helm and Sean Murray at Knobbe.
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5 Reasons Associates Shouldn't Take A Job Just For Money
As a number of BigLaw firms increase salary scales for early-career attorneys, law students and lateral associates considering new job offers should weigh several key factors that may matter more than financial compensation, say Albert Tawil at Lateral Hub and Ruvin Levavi at Power Forward.
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How Biotech Deals May Help Competition, Despite FTC View
The Federal Trade Commission's complaint against Sanofi's proposed partnership with Maze Therapeutics highlights increasing skepticism of so-called killer acquisitions, but a closer look reveals potentially legitimate reasons behind why entities might decide to delay or abandon the development of acquired products, say consultants at Analysis Group.
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Expediting Psychedelics Approvals In The US And Canada
Accelerated regulatory pathways for psychedelics in the U.S. and Canada play a pivotal role in the progression of drugs, devices and novel therapies toward commercialization, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
Playing Competitive Tennis Makes Me A Better Lawyer
My experience playing competitive tennis has highlighted why prioritizing exercise and stress relief, maintaining perspective under pressure, and supporting colleagues in pursuit of a common goal are all key aspects of championing a successful legal career, says Madhumita Datta at Lowenstein Sandler.
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Series
The Pop Culture Docket: Judge Djerassi On Super Bowl 52
Philadelphia Court of Common Pleas Judge Ramy Djerassi discusses how Super Bowl 52, in which the Philadelphia Eagles prevailed over the New England Patriots, provides an apt metaphor for alternative dispute resolution processes in commercial business cases.
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Reverse Merger Tips For Biotechs After SEC's Recent Actions
Several recent U.S. Securities and Exchange Commission developments could limit the viability of reverse mergers for biotech companies, and will require additional creativity and analysis for private companies looking to go public, say attorneys at Orrick.
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Opinion
Proposed Rule Misses The Mark On Improving MDLs
The Advisory Committee on Civil Rules' recently proposed rule on multidistrict litigation would provide some guidance for courts on managing MDLs — but without any requirement for the early vetting of claims, it is particularly unhelpful for defendants in pharmaceutical and product liability cases, say attorneys at Crowell & Moring.