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Life Sciences
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June 07, 2023
Judge Reverses Course On Jurisdiction In False Ad Suit
An Illinois federal judge on Wednesday reversed his prior order dismissing on jurisdictional grounds a false advertising suit over non-drowsy cough and flu medicine, saying while it is odd for the Class Action Fairness Act to change how a court determines a limited liability company's citizenship, the case can move forward under that law.
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June 07, 2023
Pot Cos., Advocates Partner To Push Cannabis Rescheduling
Some of the country's largest multistate cannabis companies have formed a group of law firms, legalization advocates and industry trade organizations to push the executive branch to rethink cannabis' status as a Schedule I drug.
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June 07, 2023
Amazon Teams Up With Canon, Yeti On Joint Counterfeit Suits
Amazon has launched joint lawsuits with camera maker Canon and cooler maker Yeti against counterfeiters on the marketplace, but it's hardly the first time the e-commerce giant has teamed up with a big-name player to crack down on fake goods.
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June 07, 2023
Crowell & Moring Blasted Over Fees Clause In Walgreens Suit
A D.C. federal judge tore into Crowell & Moring LLP attorneys at a Wednesday hearing, demanding to know why she wasn't told about contractual language that seemingly means Crowell could forfeit its fees if the firm is conflicted out of representing Humana in bitter litigation against Walgreens — an outcome that now appears increasingly likely.
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June 07, 2023
SPAC Extends Merger Timeline After Investors Redeem $11M
Special purpose acquisition company OceanTech Acquisition I Corp. said on Wednesday that stockholders had redeemed over $11 million in shares two days before the SPAC announced it would push its deadline to merge with pharmaceutical company Regentis Biomaterials Ltd.
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June 07, 2023
Ultrasound Tech Co. Must Face Fujifilm's Patent Claims
A Delaware federal judge has shot down an ultrasound technology developer's bid to trim a suit accusing it of infringing various patents owned by a Fujifilm subsidiary, keeping intact arguments that the seven patents were allegedly infringed willfully.
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June 07, 2023
Biopharma Co. Hit With Firing Bias Suit Over COVID Vax Rules
A biopharmaceutical services company illegally targeted employees with disabilities and religious beliefs for termination after they refused to get vaccinated against COVID-19 under the company's mandate, according to a proposed class action filed in North Carolina federal court.
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June 07, 2023
Biden Names Louisiana District, Federal Claims Court Picks
President Joe Biden announced four new judicial nominees Wednesday, including two for vacancies in Louisiana — one of which would be the first person of color to serve on the district's bench — and one nominee each for the Federal Claims Court and D.C. Superior Court.
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June 06, 2023
Pfizer, Moderna Sued Over MRNA Tech In COVID Vaccines
Biotech company Promosome LLC on Tuesday sued Pfizer, BioNTech and Moderna in California federal court, alleging the trio's COVID-19 vaccines infringe a patent related to messenger RNA technology that helps teach the body's immune system to recognize and attack disease-causing viruses.
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June 06, 2023
Merck Brings Jones Day Brawler & Punchy Tone To HHS Fight
Pharmaceutical giant Merck picked the first legal fight over landmark legislation letting Medicare negotiate drug prices, and the company showed up with bare-knuckle rhetoric and a Jones Day partner who told Law360 on Tuesday that the litigation "fits perfectly" into his mission of battling Uncle Sam's excesses.
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June 06, 2023
Providers Challenge Kansas Abortion Restrictions
The largest provider of reproductive services in Kansas slapped the state government with a suit Tuesday over legally mandated abortion counseling and related notification requirements, arguing alongside a group of physicians that the laws spread medically inaccurate information and must be barred.
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June 06, 2023
Ex-Gilead GC Says He Didn't Calculate Teva's Gain In IP Deal
Gilead's ex-general counsel testified Tuesday in a "pay for delay" antitrust trial over its HIV drug patent deal with Teva, saying he never calculated a dollar value for the royalty-free license Gilead gave Teva, which ultimately gave Teva six months on the generics market ahead of competitors.
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June 06, 2023
Judge Hesitant To Advise Michigan Justices On Insulin Probe
A Michigan appellate judge seemed loath Tuesday to grant the state attorney general's request to criticize Michigan Supreme Court precedent exempting certain business activities from consumer protection law, saying the state was asking him to be the Supreme Court's law clerk in its bid to investigate Eli Lilly and Co.'s insulin prices.
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June 06, 2023
Alkermes Raises Revenue Forecast After Arbitration Award
Biopharmaceutical company Alkermes PLC on Tuesday boosted its financial forecast for 2023 by $425 million after the company said it wrapped arbitration proceedings with Johnson & Johnson subsidiary Janssen Pharmaceutica NV over two license agreements for small particle pharmaceutical compound technology that Janssen uses in antipsychotic, schizophrenia and HIV drugs.
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June 06, 2023
Wash. Panel Disputes J&J Analysis On Protecting Health Data
Washington appellate judges on Tuesday called out a Johnson & Johnson statistician who claimed the company could protect Medicaid patients' identities if it is allowed to get their medical records as part of Washington's lawsuit over the opioid epidemic, saying the expert had failed to rigorously analyze the potential risk.
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June 06, 2023
TRIPS Vaccine Waiver Was A Bad Call, GOP Reps. Say
Republicans on the U.S. House of Representatives' intellectual property subcommittee on Tuesday took issue with the Biden administration's endorsement of a deal two years ago at the World Trade Organization that created an emergency COVID-19-related carve-out for patent rights, raising complaints that China would eventually take advantage of it.
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June 06, 2023
Case Against Takeda, Eli Lilly Gets Partial Class Cert.
A California federal judge has certified a class of at least hundreds of third-party payors who ponied up money for anti-diabetes drug Actos as part of a suit accusing Takeda Pharmaceutical Co. and Eli Lilly & Co. of hiding the risks associated with the treatment.
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June 06, 2023
Talc Claimants Object To Fee Deal For J&J Plan Supporters
The official committee of talc claimants in the Chapter 11 case of LTL Management asked a New Jersey bankruptcy judge Tuesday to deny LTL's request to pay the professional expenses of a claimant group that supports its proposed settlement, saying the deal is unnecessary.
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June 06, 2023
Illumina Tells 5th Circ. Grail Case 'Flagrant' Overreach
Illumina told the Fifth Circuit that the Federal Trade Commission's case challenging its $8 billion repurchase of cancer testing company Grail is "flagrant" overreach that is costing lives and highlights constitutional problems with the agency.
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June 06, 2023
Fate Execs Sued After $50M Deal With J&J Unit Falls Apart
Executives of biopharmaceutical company Fate Therapeutics Inc. have been hit with a shareholder derivative suit alleging they misled investors about the feasibility of a $50 million collaboration agreement with a Johnson & Johnson unit, leading to a stock price decline when the agreement was later terminated.
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June 06, 2023
AI-Focused Biotech Seeks Chapter 11 To Rework $9M Debt
Life science company HTG Molecular Diagnostics Inc. has sought Chapter 11 protection in Delaware, citing a string of failed drug development partnerships followed by the COVID-19 pandemic putting a damper on its research.
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June 06, 2023
Judge Blocks Fla. Ban On Trans Health Care
A Florida federal judge on Tuesday blocked the enforcement of a state ban on medical care for transgender adolescents, ruling that a law that prevents parents from making informed decisions on their children's medical treatment and receiving doctor-recommended health care is likely unconstitutional.
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June 06, 2023
3 Firms Build $462M Sale Of Paratek Pharmaceuticals
Commercial-stage biopharmaceutical company Paratek Pharmaceuticals Inc. said Tuesday that it will become a private company after agreeing to a purchase by Gurnet Point Capital and Novo Holdings A/S in a deal valued at roughly $462 million and steered by three firms.
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June 05, 2023
Ex-Gilead VP Says Execs Gamed Out Truvada Generic Date
A former Gilead executive testifying Monday in an antitrust trial over claims Gilead and Teva illegally delayed generic versions of its blockbuster HIV drugs until 2020 told jurors that before the pharmaceutical makers' deal, Gilead executives discussed the possibility that generic competition for Truvada could come as early as 2017.
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June 05, 2023
Circuits 'Didn't Get The Memo' On Opioid Cases, Justices Told
A doctor who persuaded the U.S. Supreme Court to demand stronger proof of intentional misconduct in prosecutions of opioid prescribers is seeking a sequel to his triumph last year, accusing federal appeals courts of widely flouting the demand and effectively allowing regulators to invent felony offenses.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Firm Tips For Helping New Lawyers Succeed Post-Pandemic
Ten steps can help firms significantly enhance the experience of attorneys who started their careers in the coronavirus pandemic era, including facilitating opportunities for cross-firm connection, which can ultimately help build momentum for business development, says Lana Manganiello at Equinox Strategy Partners.
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What To Know About Recent Trends In PTAB Sanctions
Hilary Gerzhoy at HWG discusses recent Patent Trial and Appeal Board trends in sanctioning and how to handle a discipline complaint from the U.S. Patent and Trademark Office in the wake of the PTAB's recent cancellation of multiple biological specimen collection patents.
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Prepping Your Business Ahead Of Affirmative Action Ruling
The U.S. Supreme Court's upcoming ruling on whether race should play a role in college admissions could potentially end affirmative action, and companies will need a considered approach to these circumstances that protects their brand power and future profits, and be prepared to answer tough questions, say Nadine Blackburn at United Minds and Eric Blankenbaker at Weber Shandwick.
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4 Emerging Risks For US Insurance Markets
Both insureds and insurers in the U.S. must be aware of significant inbound exposures — including the issues arising from opioids, climate change and artificial intelligence — that could lead to continued volatility in insurance markets, say Aidan McCormack and Wes Reichart at DLA Piper.
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Tackling Judge-Shopping Concerns While Honoring Localism
As the debate continues over judge-shopping and case assignments in federal court, policymakers should look to a hybrid model that preserves the benefits of localism for those cases that warrant it, while preventing the appearance of judge-shopping for cases of a more national or widespread character, says Joshua Sohn at the U.S. Department of Justice.
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No Easy Out For FCA Defendants After Justices' Ruling
The U.S. Supreme Court’s June 1 decision in U.S. v. SuperValu puts an end to the defense that a federal contractor's belief and in-house debates about problematic conduct are irrelevant to False Claims Act liability, says R. Scott Oswald at The Employment Law Group.
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How Telemedicine Providers Can Adapt To Post-COVID Rules
Telemedicine providers should pay close attention to the U.S. Drug Enforcement Administration's temporary rule extending pandemic-era flexibilities for prescribing controlled substances and utilize this brief reprieve to prepare for significant changes in the final permanent rules to come, say Chris Eades and Mayo Alao at Hall Render.
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Perspectives
How Attorneys Can Help Combat Anti-Asian Hate
Amid an exponential increase in violence against Asian American and Pacific Islander communities, unique obstacles stand in the way of accountability and justice — but lawyers can effect powerful change by raising awareness, offering legal representation, advocating for victims’ rights and more, say attorneys at Gibson Dunn.
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Opinion
Congress Needs To Enact A Federal Anti-SLAPP Statute
Although many states have passed statutes meant to prevent individuals or entities from filing strategic lawsuits against public participation, other states have not, so it's time for Congress to enact a federal statute to ensure that free speech and petitioning rights are uniformly protected nationwide in federal court, say attorneys at Skadden.
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Global Issues In EU's Licensing Plans For Essential Patents
Consultants at Analysis Group explore questions surrounding the recently announced EU licensing framework for standard-essential patents, and how the European Commission's goals may influence discussions of issues like procedure, efficiency and transparency in the U.S. and elsewhere.
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Why Fed. Circ. Should Explain Treatment Of Prior Art Ranges
The Federal Circuit in UCB v. Actavis recently cited previous cases in holding that prior art disclosure of a range is not a disclosure of its endpoints, but the appeals court needs to more thoroughly explore the basis for this decades-old patentability precedent, say Ben Katzenellenbogen and Paul Stewart at Knobbe Martens.
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A Watershed Moment For Microbiome-Based Therapy
While there has been limited microbiome patent enforcement so far, the regulatory approvals of three microbiome-related products and the case of Ferring v. Finch indicate that microbiome patent litigation could take off, and may spur greater investment in this space, say Mark FitzGerald and Alissa Young at Nixon Peabody.
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Legal Pitfalls To Watch For When Advertising Psychedelics
As psychedelic products and related therapeutic services make their way into the mainstream, companies engaged in creating or publishing ads for such products and services should consider several legal implications on federal, state and local levels, says Dorian Thomas at Frankfurt Kurnit.
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Trending At The PTAB: IPR Estoppel After Ironburg
The Federal Circuit's recent Ironburg v. Valve decision does not make clear how patent owners could attempt to meet the burden of abiding by its rules for litigating inter partes review estoppel for references not asserted in a petition, but arguments in the case offer a clue, say attorneys at Finnegan.
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Takeaways From New Fla. Pharmacy Benefit Manager Rules
A recently passed Florida law imposes several new requirements on pharmacy benefit managers, necessitating practical considerations that range from potential license application delays to possible trade secret exposure, say Thomas Range and Bruce Platt at Akerman.