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Life Sciences
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December 03, 2024
Vidal Aimed To Put USPTO Rulemaking In The Spotlight
Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.
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December 03, 2024
FDA Issues Guidance On Potential Infant Formula Shortages
The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.
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December 03, 2024
4 Mass. State Court Rulings You May Have Missed In Nov.
An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.
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December 03, 2024
VA Announces Study On MDMA-Assisted Therapy For Vets
The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.
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December 02, 2024
House COVID-19 Probe Points to China 'Lab Leak'
The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.
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December 02, 2024
Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud
A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.
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December 02, 2024
Justices Seem Inclined To Back FDA Block Of Flavored Vapes
U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.
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December 02, 2024
Investor Alleges Medical Device Co. Misled On FDA Clearance
The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.
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December 02, 2024
Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal
A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.
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December 02, 2024
Chancery OKs $21M Deal To End Gene Co. Class Suit
A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.
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December 02, 2024
Fla. Tribe Sues Eli Lilly, CVS, Others Over Insulin Price-Fixing
The Miccosukee Tribe in Florida is alleging drugmakers like Eli Lilly & Co. and pharmacy benefit managers like CVS illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a new lawsuit filed in New Jersey federal court.
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December 02, 2024
Heritage's $10M Generic Drugs Deal With AGs Gets 1st OK
A Connecticut federal judge gave his initial approval on Monday to Heritage Pharmaceuticals Inc.'s $10 million settlement agreement with state attorneys general to resolve allegations it took part in an anticompetitive, price-fixing scheme focused on generic drugs.
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December 02, 2024
DEA Asserts Its Role As Proponent Of Pot Rescheduling Plan
The Drug Enforcement Administration on Monday affirmed it was acting as the proponent of a proposal to loosen federal restrictions on marijuana, and the administrative law judge said supporters of rescheduling would not get an opportunity to cross-examine DEA witnesses.
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December 02, 2024
Ex-Parexel Worker Says Vax Rule Lacked 'Informed Consent'
A former employee of clinical research firm Parexel International says the company's COVID-19 vaccine requirement was a breach of contract because she and other workers did not have the option of giving informed consent for what she calls an "experimental medical treatment," according to a lawsuit filed in Massachusetts state court.
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December 02, 2024
Shipping Industry Braces For Waves Of New Trump Tariffs
After a holiday weekend marked by a fresh round of tariff threats from President-elect Donald Trump, the shipping and logistics industry is beginning to feel the heat, warning companies to prepare for massive upheaval if Trump follows through.
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December 02, 2024
Co-Worker's Affair Isn't Harassment, Research Co. Tells Court
A clinical research company urged a Georgia federal judge to toss a former employee's suit claiming the business failed to take action when a co-worker made sexual comments about her father and began an affair with him, arguing the conduct isn't protected by federal civil rights law.
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November 27, 2024
A Look Back At Years Of Zantac Litigation: Timeline
After the U.S. Food and Drug Administration raised a red flag five years ago that heartburn drug Zantac and its generics contained levels of a chemical that could cause cancer, litigation kicked off in federal and state courts. Here, Law360 presents a timeline of the lawsuits, trials and settlements that ensued.
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November 27, 2024
PTAB Finds Hormone Treatment Patent Claims Invalid
The Patent Trial and Appeal Board has found Neurocrine Biosciences Inc. was able to show that all the claims in a patent owned by biotechnology company Spruce Biosciences Inc. relating to the treatment of a hormonal disorder were invalid.
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November 27, 2024
Deloitte Posed As Consultant To Steal Vax Software, Suit Says
An inventor has accused Deloitte Consulting LLP in New York federal court of stealing her proprietary vaccination management system and securing a multimillion-dollar government contract for rolling out COVID-19 vaccines, saying the firm colluded with the Centers for Disease Control and Prevention to pilfer the technology.
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November 27, 2024
PBM Says Opioid Ruling Ignored High Court's Privilege Stance
A special master's ruling that internal audit records from Express Scripts Inc. are not protected by attorney-client privilege should be overturned because it contradicts nearly 40 years of U.S. Supreme Court precedent, the pharmacy benefit manager told an Ohio federal court overseeing multidistrict opioid litigation.
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November 27, 2024
Nonprofit Warns 3rd Circ. Against 'Abuse' In Merck Vax Case
The anti-monopoly think tank Open Markets Institute urged the full Third Circuit to rethink a panel's immunization of Merck & Co. Inc. from antitrust claims over its mumps vaccine, arguing in an amicus brief that the doctrine cementing the right to petition the government doesn't justify the use of courts and administration as a "competitive weapon."
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November 27, 2024
Amid Claims Of Bias, DEA To Kick Off Historic Pot Hearing
The Drug Enforcement Administration's administrative law tribunal will hold a preliminary hearing Monday on the U.S. Department of Justice's proposal to relax restrictions on marijuana, kicking off a historic process that has already been marked by allegations of agency bias.
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November 27, 2024
Up Next At The High Court: Transgender Care, Holocaust Art
The U.S. Supreme Court will return to the bench Monday for its December arguments session, which will include blockbuster questions about the constitutionality of state laws banning gender-affirming care for transgender minors and whether Hungary can be held liable for property stolen during World War II.
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November 27, 2024
Hospital Sued For Firing Tech Who Reported Lax Drugmaking
A pharmacy technician claims in Illinois state court that she was fired from Lurie Children's Hospital in Chicago for making complaints both internally and to state regulators that the medications for pediatric patients were being compounded in an unsanitary manner and that the facilities weren't being properly cleaned.
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November 27, 2024
Congressional Dems Urge Biden For More Cannabis Reform
Congressional Democrats are urging President Joe Biden to use his executive authority to take further action on marijuana reforms during the waning weeks of his administration.
Expert Analysis
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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Trending At The PTAB: Obviousness In Director Reviews
Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.
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Opinion
Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Firms Must Offer A Trifecta Of Services In Post-Chevron World
After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.
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Takeaways From UPC's Amgen Patent Invalidity Analysis
The Unified Patent Court Central Division's decision in Regeneron v. Amgen to revoke a patent for lack of inventive step is particularly clear in its reasoning and highlights the risks to patentees of the new court's central revocation powers, say Jane Evenson and Caitlin Heard at CMS.
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5 Ways Life Sciences Cos. Can Manage Insider Trading Risk
In light of two high-profile insider trading jury decisions against life sciences executives this year, public companies in the sector should revise their policies to account for regulators' new and more expansive theories of liability, says Amy Walsh at Orrick.
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5 Tips To Succeed In A Master Of Laws Program And Beyond
As lawyers and recent law school graduates begin their Master of Laws coursework across the country, they should keep a few pointers in mind to get the most out of their programs and kick-start successful careers in their practice areas, says Kelley Miller at Reed Smith.
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Bayer Antitrust Case Hinged On Evolving Market Definition
Generic flea and tick medication manufacturer Tevra's evolving market definition played a key role in the development and outcome of its five-year antitrust litigation against Bayer Healthcare, highlighting challenges that litigants may face when a proposed definition is assessed at trial, say Amy Vegari and Colleen Anderson at Patterson Belknap.
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IP Hot Topic: The Intersection Of Trademark And Antitrust Law
Antitrust claims – like those in the U.S. Department of Justice’s recent case against Apple – are increasingly influencing trademark disputes and enforcement practices, demonstrating how antitrust law can dilute the power of a trademark, say attorneys at Dentons.
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Series
Being An Opera Singer Made Me A Better Lawyer
My journey from the stage to the courtroom has shown that the skills I honed as an opera singer – punctuality, memorization, creativity and more – have all played a vital role in my success as an attorney, says Gerard D'Emilio at GableGotwals.
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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How Law Firms Can Avoid 'Collaboration Drag'
Law firm decision making can be stifled by “collaboration drag” — characterized by too many pointless meetings, too much peer feedback and too little dissent — but a few strategies can help stakeholders improve decision-making processes and build consensus, says Steve Groom at Miles Mediation.
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What BIPA Reform Law Means For Biometrics Litigation
A recently signed Illinois law amending the Biometric Information Privacy Act limits defendants' liability exposure on a per-scan basis and clarifies that electronic signatures constitute a valid written release, establishing additional issues that courts will need to address in future BIPA litigation, say attorneys at Faegre Drinker.
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Opinion
Litigation Funding Disclosure Key To Open, Impartial Process
Blanket investor and funding agreement disclosures should be required in all civil cases where the investor has a financial interest in the outcome in order to address issues ranging from potential conflicts of interest to national security concerns, says Bob Goodlatte, former U.S. House Representative for Virginia.