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Life Sciences
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April 25, 2025
Judge Says FDA Can Take Ozempic Off Shortage List
A Texas federal judge has sided with arguments from Ozempic maker Novo Nordisk A/S not to block the U.S. Food and Drug Administration from moving forward with an administrative decision stopping "unsafe, knockoff versions" of the blockbuster diabetes and weight loss drug from flooding the market.
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April 25, 2025
J&J Unit Sees Claims Trimmed In Engineer's Bias Suit
A Johnson & Johnson-owned prosthetics company does not have to face claims that an engineer filed his lawsuit, alleging violations of the Family and Medical Leave Act, too late, a Massachusetts federal judge ruled Friday, but determined some of the allegations are timely and can proceed.
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April 25, 2025
Aggressive USPTO Policy Push Suggests 'It's Lutnick's Show'
U.S. Patent and Trademark Office acting Director Coke Morgan Stewart's three months in charge have featured an unprecedented level of policymaking for an interim leader, suggesting that Secretary of Commerce Howard Lutnick has a vision for the agency and he's not waiting for the U.S. Senate to confirm a new director to pursue it.
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April 25, 2025
Ozempic Maker Settles Infringement Claims With Atlanta Clinic
Novo Nordisk, the pharmaceutical manufacturer behind Ozempic and other weight loss drugs, said Friday it has reached a settlement to end a series of claims that a Georgia anti-aging clinic was using the company's name and reputation to sell off-brand versions of its treatments.
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April 25, 2025
Insulet's $452M Trade Secrets Award Reduced To $59.4M
A $452 million trade secrets jury award for Insulet Corp. has been cut to $59.4 million by a Massachusetts federal judge who said the reduction is necessary to avoid double recovery and to comply with the law, following a trend where courts have reduced large jury awards in trade secret cases.
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April 25, 2025
11th Circ. Backs FDA In Denial Of Bidi's Vape Application
The Eleventh Circuit has affirmed the denial of a marketing application for a tobacco-flavored electronic cigarette made by Bidi Vapor LLC, finding that the U.S. Food and Drug Administration did not act arbitrarily or capriciously in finding that the company failed to show the product would promote public health.
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April 24, 2025
Circuit-By-Circuit Guide As Justices Confront Class Cert. Split
The U.S. Supreme Court is set for climactic arguments over class certification standards that have cleaved circuits from coast to coast for much of the past two decades, teeing up a make-or-break ruling for many class actions and a transformative event for legal practice in the swelling litigation realm.
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April 24, 2025
Biz Court Questions What Ties TikTok To NC In Addiction Case
A North Carolina business judge grappled Thursday with the limits of personal jurisdiction in the internet age in the state's case alleging TikTok addicts young users, questioning whether a digital app is different from a physical good regarding where a lawsuit can be filed.
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April 24, 2025
DOJ Probing Disney-FuboTV Deal, And Other Rumors
The DOJ is investigating Disney's proposed FuboTV acquisition, Merck is close to a $3.5 billion deal for SpringWorks, and U.S. investor James Cameron offered $5 billion for a Luxembourg-based mining enterprise. Here, Âé¶¹´«Ã½360 breaks down these and other notable deal rumors from the last week.
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April 24, 2025
Polsinelli Gains 2 Healthcare Shareholders In Denver
Polsinelli PC announced this week that it has brought two Denver-based attorneys from Husch Blackwell LLP and the U.S. Food and Drug Administration to its healthcare practice, which the firm says gained six new shareholders in the past 12 months, not including these most recent additions.
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April 24, 2025
Harvard Seeks To Move 'Swiftly' In $2B Fund Freeze Suit
Harvard University is seeking to move as quickly as possible to get to the merits of its suit challenging the Trump administration's $2.2 billion funding freeze, asking a Massachusetts federal judge to expedite discovery and briefing.
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April 24, 2025
UPS Paying $1.6B For Andlauer's Healthcare Logistics Co.
UPS said Thursday it has agreed to acquire Andlauer Healthcare Group Inc. for approximately 2.2 billion Canadian dollars ($1.6 billion) in cash, expanding its global healthcare logistics footprint with a particular focus on so-called cold chain capabilities.
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April 24, 2025
Latham-Led LLR Clinches 7th Fund With $2.45B Committed
Latham & Watkins LLP-advised LLR Partners on Thursday announced that it wrapped its seventh private equity fund with $2.45 billion in tow.
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April 23, 2025
11th Circ. Considers Timeliness Of J&J Pelvic Mesh Claims
An Alabama couple urged the Eleventh Circuit on Wednesday to revive their lawsuit over injuries allegedly caused by pelvic mesh manufactured by Ethicon Inc. and its parent Johnson & Johnson, arguing that a district court wrongly found their claims were time-barred.
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April 23, 2025
FDA Warns Of Health Risks In Topical Hair Loss Drug
The U.S. Food and Drug Administration on Wednesday alerted healthcare providers, pharmaceutical compounders and consumers about potential safety risks tied to certain hair loss treatment products, citing reports of persistent adverse side effects, including sexual dysfunction, depression and suicidal thoughts.
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April 23, 2025
Curaleaf Sues Ex-VP For Alleged Breach Of Noncompete
Cannabis company Curaleaf sued a former executive in Florida federal court Wednesday, alleging she breached her employment agreement and may have shared confidential information when she jumped ship to competitor Jushi.
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April 23, 2025
Fed. Circ. Agrees MS Generic Drug Didn't Infringe Metacel IP
The Federal Circuit on Wednesday backed a New Jersey federal judge's finding that Rubicon Research's generic version of Metacel's drug Ozobax does not induce doctors and patients to infringe a Metacel patent.
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April 23, 2025
Ex-Sprinter Turned Track Coach Cops To Olympic Doping Rap
A onetime world-class sprinter from Georgia on Wednesday admitted to illegally providing banned performance-enhancement drugs while training athletes to compete in the 2020 Tokyo Olympic Games.
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April 23, 2025
Âé¶¹´«Ã½ Firm Fights Sanctions Bid In Mootness Fee Row
Attorneys at Monteverde & Associates PC urged an Illinois federal judge not to order certain sanctions against them in a challenge to so-called mootness fees paid to settle and dismiss allegedly baseless merger disclosure suits, saying more sanctions would be inconsistent with "well-established" pleading and sanctions standards.
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April 23, 2025
Ex-Exec Says Centene Harassed Him Over Void Noncompete
A former vice president at Centene claims in a new Illinois federal court lawsuit that the company has engaged in a campaign of harassment, threats and bullying directed at him and his new employer, based on a noncompete agreement he alleges is void.
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April 23, 2025
Judge Lifts Biocon Eye Med Biosimilar Ban After Settlement
A West Virginia federal judge has vacated a permanent injunction that had blocked Biocon Biologics Inc. from selling a biosimilar to Regeneron's blockbuster eye medication Eylea in the U.S., citing a settlement agreement in the patent litigation allowing sales of the biosimilar in 2026.
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April 23, 2025
Sandoz, Novartis Cut Price-Fixing Deal With South Carolina
Sandoz Inc. and Fougera Pharmaceuticals Inc. have struck a deal with the state of South Carolina to resolve claims that they and Sandoz's former parent company, Novartis AG, engaged in a price-fixing conspiracy to inflate the price of certain generic drugs.
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April 23, 2025
Genetic Testing Co., Marketer Settle FCA Case For $6M
A genetic testing company, marketing firm, and their top executives have agreed to pay $6 million to resolve the government's allegations that they billed Medicare for unnecessary medical tests, in violation of the False Claims Act.
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April 23, 2025
FCA Suit Over Allergan's Alleged Kickbacks Trimmed
An Illinois federal judge on Wednesday pared down a lawsuit by former Allergan USA pharmaceutical sales reps claiming the company engaged in a scheme to provide kickbacks to doctors in exchange for prescribing more gastrointestinal drugs, saying they largely failed to show enough of a link between the alleged kickbacks and any false claims to the government for prescriptions.Â
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April 23, 2025
Eli Lilly Sues 4 Telehealth Cos. For Weight Loss Drug Copies
Eli Lilly filed a new round of lawsuits Wednesday over the compounding of its popular weight loss drugs Mounjaro and Zepbound, accusing four telehealth companies of making copies of the medications while alleging that two companies violated laws requiring doctors to make medical decisions, not corporations.Â
Expert Analysis
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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 Âé¶¹´«Ã½yer
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.
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Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons
As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.
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Series
Circus Arts Make Me A Better Âé¶¹´«Ã½yer
Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.