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Life Sciences
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April 18, 2024
USPTO Reveals Scaled-Back Plan For New Patent Board Rules
The U.S. Patent and Trademark Office unveiled proposed Patent Trial and Appeal Board rules Thursday that would codify current policies on when multiple challenges to one patent are permitted and set a new briefing process about discretionary denials, which attorneys say should add clarity.
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April 18, 2024
NY Fertility Clinic Must Face Lost, Damaged Embryos Suit
A New York appellate panel issued a published opinion Thursday reviving a suit over the loss or damage of embryos due to a fertility clinic's alleged negligence, saying the routine storage and maintenance of frozen embryos can be considered ordinary negligence rather than medical malpractice.
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April 18, 2024
EU Antitrust Chief Says Merger Tool Not A 'Power Grab'
The European Commission's top competition enforcer said Thursday the agency has taken a measured approach to using its newly asserted power to review mergers that fall short of local thresholds, as the European trading bloc's high court mulls a challenge of that authority from DNA sequencing company Illumina.
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April 18, 2024
Pharma Ex-Exec Can't Revive $12M Underpayment Suit in US
A Manhattan federal judge has refused to rethink her decision tossing a $12 million suit accusing Altum Pharmaceuticals Inc. and its cannabis-focused parent company, BetterLife Pharma Inc., of stock dilution and underpaying a former executive chairman of the board of directors, saying the claims are better suited for Canadian courts.
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April 18, 2024
J&J Notches Win In Fla. Talcum Powder Trial
A Florida state jury returned a verdict for Johnson & Johnson on Thursday, finding the company's talcum-based baby powder had not been shown to cause the ovarian cancer of a longtime user of the product.
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April 18, 2024
Pharma Co. Wants Tribe's Opioid Suit To Stay In Federal Court
A pharmaceuticals distributor has asked an Oklahoma federal court to reject a magistrate judge's recommendation to move to state court a suit accusing it of flooding the Cherokee Nation's communities with opioids, saying the tribe's complaint raises a substantial question of federal law.
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April 18, 2024
Endo Pleads Guilty To Marketing Opioids As 'Crush Proof'
Endo Health Solutions Inc. pled guilty Thursday in Michigan federal court to putting out a drug it falsely advertised as being "crush proof" and "abuse deterrent," part of its larger agreement with the government to resolve nearly $2 billion in civil and criminal claims against the company.
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April 18, 2024
23andMe Taps Dechert To Review CEO Buyout Proposal
A special committee of genetic testing company 23andMe has engaged Dechert LLP as its legal adviser and Wells Fargo as its financial adviser as it looks to review an anticipated buyout offer from its co-founder and CEO Anne Wojcicki, according to a statement Thursday.
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April 18, 2024
FDA Head Gets GOP Rep.'s Rebuke Over Pot Rescheduling
The Republican chair of a U.S. House of Representatives Appropriations subcommittee on Thursday chided the commissioner of the U.S. Food and Drug Administration for the agency's recommendation last year to loosen restrictions on marijuana.
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April 18, 2024
Biotech Co. NanoString Lands $393M Bid At Ch. 11 Auction
Scientific instrument maker Bruker Corp. is set to acquire insolvent biotechnology company NanoString for roughly $393 million in cash that would be used to repay creditors under the debtor's recently proposed Chapter 11 plan, a notice filed in Delaware's bankruptcy court shows.
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April 17, 2024
Trial-Ready Paraquat MDL Cases Tossed After Testimony Axed
An Illinois federal judge on Wednesday threw out the first group of trial-ready cases over the herbicide paraquat, agreeing with Syngenta and Chevron that the plaintiffs' expert testimony must be excluded and finding that the cases fail without that testimony.
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April 17, 2024
Walgreens Investors' $36M Deal In Opioid Suit Gets First OK
An Illinois federal judge on Wednesday granted his initial approval of a $36 million settlement to end a stockholder's derivative suit accusing Walgreens and its leadership of failing to limit retail pharmacies from dispensing unreasonable amounts of opioids.
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April 17, 2024
PTC Therapeutics Settles Shareholder Suit Over Director Pay
PTC Therapeutics Inc. has agreed to corporate governance reforms to settle a derivative shareholder lawsuit challenging its allegedly "lavish" non-employee director compensation awards, according to a stipulation of settlement filed Wednesday in Delaware's Court of Chancery.
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April 17, 2024
United Therapeutics Can't Bar Rival Lung Disease Drug
Repeating himself for the second time in the last several weeks, a federal judge in Delaware on Wednesday said he won't stop a biochemical startup from launching a drug that would compete directly with one of United Therapeutics' biggest pharmaceutical products.
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April 17, 2024
Kraft Sued Over Lead Contamination In Lunchables
Kraft has been slapped with a proposed class action over its popular Lunchables snack kits after independent testing of the kits allegedly found that they contained high, though legally allowable, levels of lead and other harmful substances.
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April 17, 2024
J&J Tells Jurors To Look To Evidence And Science In Talc Trial
Johnson & Johnson's attorney urged a Florida jury Wednesday to look beyond the emotion in the case of a longtime baby powder user who died from cancer and to the science and the evidence, which he said fail to show a causal link between talcum powder and ovarian cancer.
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April 17, 2024
Karuna Investor Ends Suit After Bristol-Myers Seals $14B Deal
A Karuna Therapeutics shareholder has dropped her proposed class action after Bristol-Myers Squibb Co. completed its $14 billion purchase of the biotechology company, a deal the suit alleged was brought about by misrepresentations to investors to gain their support.
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April 17, 2024
Jury To Decide Fault Of Driver In Spray-Huffing DUI Death
A Minnesota federal judge on Wednesday said it's up to a jury to decide whether a driver acted intentionally or negligently when he allegedly huffed a compressed gas spray and killed a woman in a collision, in a trial against the spray's manufacturer over the death.
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April 17, 2024
3 Takeaways From Revived Obviousness Case On J&J Patent
A Federal Circuit ruling from earlier this month that told a judge to reconsider upholding a Johnson & Johnson schizophrenia drug patent emphasizes that analyzing whether a patent is invalid as obvious requires focusing on what it actually claims and an inventor's creativity, attorneys said.
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April 17, 2024
FDA's Foot-Dragging On Menthol Ban Sparks Frustration
The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.
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April 17, 2024
FDA Denies Marketing For 65 MNGO Disposable E-Cigarettes
The latest action by the U.S. Food and Drug Administration on e-cigarettes was to tell a Chinese company to take its range of 65 e-cigarette products in a variety of flavors from menthol to pink lemonade and watermelon off the market.
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April 17, 2024
FDA Tells Justices It Has A Better Vape Case In Mind
The U.S. Food and Drug Administration has told the U.S. Supreme Court that if it wants to address the agency's decision not to approve applications for flavored e-cigarettes, there is a better case in the pipeline than the appeal lodged by Lotus Vaping Technologies that the justices should choose instead.
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April 17, 2024
SEC Has Careful Eye On Disclosures Amid Israel-Hamas War
Against the backdrop of protracted war, the U.S. securities watchdog is urging U.S.-listed Israeli companies to disclose more details describing how the Israel-Hamas conflict is affecting their operations in order to keep investors apprised of risks, lawyers say.
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April 17, 2024
'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years
A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.
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April 17, 2024
Manatt Adds NY Bankruptcy, Financial Regulatory Partners
Manatt Phelps & Phillips LLP announced that it hired a pair of experienced New York-based attorneys who focus their practices on regulatory matters as partners in its bankruptcy and financial regulatory practices.
Expert Analysis
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How AI May Be Used In Fintech Fraud — And Fraud Detection
Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.
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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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Business Litigators Have 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.