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Life Sciences
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January 22, 2025
Fed. Circ. Stays Order Delisting Teva Inhaler Patents
Federal Circuit judges have agreed to hold off on immediately delisting patents that cover components of a Teva asthma inhaler from the U.S. Food and Drug Administration's Orange Book after the Israeli drugmaker said doing so would have "seismic" legal consequences and should be reviewed by the full court.
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January 22, 2025
Vanda Loses Takings Clause Arguments In Trade Secret Fight
A Court of Federal Claims judge has held that specifications on how fast Vanda Pharmaceuticals' drugs dissolve do not count as property interest under the Fifth Amendment, handing a loss to the pharmaceutical company in its trade secrets case against the federal government.
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January 22, 2025
No New Trial For Tevra's Flea, Tick Meds Suit Against Bayer
A California federal judge refused to give Tevra Brands LLC a do-over on allegations that Bayer used exclusive contracts to anticompetitively lock up the market for flea and tick treatments for dogs, finding the veterinary drugmaker was just rehashing previously rejected arguments attacking a key expert witness.
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January 22, 2025
Pharma Co. Says Ex-CEO's Alleged Misconduct Is Not Fraud
Artificial intelligence-driven pharmaceutical company Exscientia PLC has asked a New Jersey federal court to toss a suit alleging it is responsible for share price declines following the termination of its CEO after claims emerged he participated in inappropriate relationships with employees, arguing the alleged misconduct is not securities fraud.
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January 22, 2025
Fed. Circ. Backs Ravgen's Genetic Testing Patent
The Federal Circuit has refused to undo the Patent Trial and Appeal Board's rejection of biotechnology company Streck's challenge to numerous claims in a Ravgen genetic testing patent, which is tied to a $372 million judgment Ravgen won in a separate case against Labcorp.
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January 22, 2025
Benzene Suits Against Retailers Not Covered, Insurer Says
An insurer doesn't have to cover claims that CVS, Walmart, Walgreens and others sold products linked to a carcinogen, benzene, because the customers making the underlying allegations sought only reimbursement for the products they bought, the carrier told a California state court.
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January 22, 2025
9th Circ. Won't Revive Express Scripts Generics Dispute
A Ninth Circuit panel won't renew a suit accusing Express Scripts of shortchanging a Seattle pharmacy on reimbursements for the generic version of HIV/AIDS drug Truvada, finding that only the name-brand prescription was listed in their contract as a "covered specialty medication" entitled to a higher payback rate.
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January 22, 2025
Wyden Urges National Standard For Hemp Regulation
Sen. Ron Wyden, D-Ore., rallied on Wednesday for his bill that would beef up regulation of products with hemp-derived cannabinoids in order to protect consumers, particularly children.
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January 22, 2025
Cooley-Led Insulin Device Maker Preps $113M IPO
Insulin delivery system maker Beta Bionics on Wednesday announced the terms for its initial public offering, planning to raise $113 million.
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January 22, 2025
Nixed Invitae Asset Buyer Asks Ch. 11 Court To Stop Litigation
Genetic testing company Natera has launched an adversary lawsuit against Invitae, a competitor that sought insolvency protection last year, asking a New Jersey bankruptcy judge to stop Invitae's Chapter 11 plan administrator from collecting payments owed under a rejected contract.
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January 21, 2025
Key Justices Stay Quiet As High Court Weighs FCC Deference
Several U.S. Supreme Court justices on Tuesday appeared open to giving district courts more leeway to review the Federal Communciations Commission's tome of regulations under the Telephone Consumer Protection Act, although the two justices expected to cast pivotal votes refrained from posing questions.
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January 21, 2025
Intuitive Seeks Midtrial End To Robo-Surgery Antitrust Suit
Before calling its first defense witness Tuesday, Intuitive Surgical urged a federal judge to find in its favor in a trial over claims that it abused its market dominance by blocking third parties from refurbishing a component of its da Vinci surgery robot, saying there's no evidence of an unlawful tying arrangement.
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January 21, 2025
The Legal And Practical Questions Around Trump's WHO Exit
President Donald Trump’s first-day order setting in motion the United States’ withdrawal from the World Health Organization could leave the nation less prepared for global health threats and trigger legal clashes over the president’s authority to act unilaterally.
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January 21, 2025
Last Sackler Family Members Join Purdue Draft Deal
The final holdouts among two branches of Sackler family members are ready to join a settlement in the bankruptcy of OxyContin maker Purdue Pharma LP, a business owned by the family, according to a report from the co-mediators handling negotiations.
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January 21, 2025
Bacon Giant Smithfields Leads 3 IPOs Primed To Exceed $1B
Bacon maker Smithfields Foods Inc. led a trio of companies unveiling price ranges for initial public offerings Tuesday that could raise $1.3 billion combined over the next week, with 10 law firms guiding the IPOs in various capacities.
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January 21, 2025
Trump Taps Pot Legalization Opponent As Acting DEA Head
A stalled effort to loosen federal restrictions on marijuana will be overseen, at least temporarily, by a former U.S. Drug Enforcement Administration agent who has previously spoken out against marijuana reform and specifically criticized the former administration's bid to recategorize the drug.
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January 21, 2025
Justices Doubt Retailers Are 'Bystanders' In FDA Challenge
Several U.S. Supreme Court justices appeared to agree Tuesday that Texas and Mississippi retailers could join a North Carolina e-cigarette manufacturer in challenging the U.S. Food and Drug Administration's denial of its marketing application, and Justice Clarence Thomas questioned the agency's motivation to argue otherwise.
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January 21, 2025
Firm Slams Beasley Allen's Bid To Nix Suit Over Talc Team-Up
Smith Law Firm PLLC is urging a Mississippi federal court to reject Beasley Allen Law Firm's bid to dismiss or transfer a defamation and breach of contract lawsuit over their joint venture agreement for talc litigation against Johnson & Johnson, saying the case shouldn't be thrown out in favor of Beasley Allen's Alabama suit.
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January 21, 2025
What IP Attorneys Need To Know From Trump's First Days
Since the Trump administration took over on Monday, a new acting director for the U.S. Patent and Trademark Office has been sworn in, federal workers have been mandated to return to working in person and the Biden administration's artificial intelligence executive order has been rescinded. Here's what IP attorneys should know.
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January 17, 2025
Law360 Names Practice Groups Of The Year
Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2024, which honor the attorney teams behind litigation wins and significant transaction work that resonated throughout the legal industry this past year.
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January 17, 2025
Law360 Names Firms Of The Year
Eight law firms have earned spots as Law360's Firms of the Year, with 54 Practice Group of the Year awards among them, steering some of the largest deals of 2024 and securing high-profile litigation wins, including at the U.S. Supreme Court.
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January 20, 2025
Trump, Musk Sued By Nonprofits Over DOGE Transparency
Public Citizen and other nonprofits hit the Trump administration with multiple lawsuits seeking to shut down the new Department of Government Efficiency in D.C. federal court Monday, alleging the Elon Musk-led advisory committee targeting government waste lacks requisite transparency guardrails to prevent DOGE from solely advancing private interests.
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January 17, 2025
Walgreens Knowingly Filled Invalid Prescriptions, Feds Say
The U.S. Department of Justice has accused Walgreens of knowingly filling millions of prescriptions for opioids and other controlled substances that did not have a legitimate medical purpose or were not valid, intervening in cases brought by four whistleblowers in Illinois federal court.
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January 17, 2025
MSN Wants Generic Entresto Launch After Patent Expired
MSN Pharmaceuticals asked the Federal Circuit Friday to let it launch its generic version of Novartis' blockbuster heart drug Entresto while the drugmakers continue their litigation over a newly expired patent, by lifting a temporary injunction barring that launch.
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January 17, 2025
Bayer, J&J Minimized Drug Reaction Data, 3rd Circ. Told
A doctor urged the Third Circuit on Friday to revive his whistleblower suit against Bayer Corp. and Johnson & Johnson, arguing that the drugmakers' regulatory approval applications played down the side effects of the antibiotics Cipro and Levaquin.
Expert Analysis
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.
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Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB
Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.
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IP Ruling Likely To Limit Arguments Against Qualified Experts
The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.
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How Boards And Officers Should Prep For New Trump Admin
In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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Series
Flying Makes Me A Better Lawyer
Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.
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9th Circ.'s High Bar May Limit Keyword Confusion TM Claims
A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.
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Trump Patent Policy May Be Headed In Unexpected Direction
While commentators have assumed that the patent policy of President-elect Donald Trump's second administration will largely mirror the pro-patent policy of his first, these predictions fail to take into account the likely oversized influence of Elon Musk, says Jorge Contreras at the University of Utah.
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What Trump's Next Term May Mean For Biz Immigration
Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.