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Life Sciences
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January 03, 2025
PBMs 'Wasting' Time in Opioid MDL Discovery Spat: Judge
An Ohio federal judge overseeing multidistrict opioid litigation on Friday denied pharmacy benefit managers a stay to appeal a discovery order and said he believed the PBMs were "wasting" the court's time.
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January 03, 2025
Cancer Drug Co. Revives Bid To Go Public Via Direct Listing
Brain cancer-focused drug developer NeOnc Technologies Holdings Inc. filed plans on Friday to go public through a direct listing, represented by Manatt Phelps & Phillips LLP, as it pursues an alternative to an initial public offering after canceling a prior IPO attempt.
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January 03, 2025
Pfizer Partner Targets GSK In COVID Vax Patent Suit
A drug developer that Pfizer and BioNTech partnered with to develop their COVID-19 vaccine has opened up another legal front in a dispute over allegations that the Pfizer vaccine infringes patents issued to U.K. drugmaker GlaxoSmithKline.
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January 03, 2025
Fed. Circ. Upholds Cancellation Of TMs On Pink Hip Implants
The Federal Circuit on Friday said a trademark panel correctly canceled a German medical supplier's trade dress protections for the color pink in a hip joint implant part because the color is functional, citing the company's previous patents and public statements to support that conclusion.
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January 03, 2025
$15M Flea Collar MDL Deal Scores Swift Approval By Ill. Judge
An Illinois federal judge gave his final blessing on Friday to a $15 million settlement in multidistrict litigation targeting adverse side effects that Bayer and other companies behind certain flea and tick collars allegedly failed to warn about.
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January 03, 2025
Biogen Not On Hook For Disruptions Caused By Landlord
Biogen Inc. did not breach the terms of a sublease with biopharma components manufacturer Brammer Bio and bears no responsibility for any claimed losses suffered by Brammer during a construction project by the building's owner, a Massachusetts judge has concluded.
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January 03, 2025
Research Co. Can't Ax Affair Harassment Suit, Ex-Worker Says
A former worker for a clinical research company asked a Georgia federal judge to deny the company's bid to toss her harassment suit claiming a co-worker made sexual comments about her father and started sleeping with him, arguing the conduct was severe enough to keep her case alive.
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January 02, 2025
Eye Drug Study Blindsided Pharma Co. Investors, Suit Says
The CEO and directors of biopharmaceutical company Apellis Pharmaceuticals Inc. face shareholder derivative claims they failed to monitor clinical study participants for a serious side effect, leading to plummeting trading prices after a medical association sounded an alarm about the company's drug candidate.
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January 02, 2025
Fox Rothschild Atty Beats Trade Secret Theft Allegations
A federal judge in New Jersey says a company trying to develop cancer drugs had waited too long to sue its former patent lawyer after he allegedly "confessed" over five years ago to helping a Chinese rival file a patent application that allegedly misappropriated trade secrets.
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January 02, 2025
Edwards Brass Face Investor Suit Over Heart Valve Sales
The executives and directors of medical device maker Edwards Lifesciences have been hit with a shareholder derivative suit in California federal court alleging the company understated how industry trends and macroeconomic factors would impact the success of its mainstay device.
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January 02, 2025
Issa Again Selected To Lead House IP Subcommittee
Rep. Darrell Issa, R-Calif., will again lead the House subcommittee overseeing intellectual property in the upcoming Congress, a role in which he has sponsored bills seeking to limit how many patents can be asserted in biosimilar cases and require disclosure of litigation funding.
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January 02, 2025
1st Private Co. Joins Insulin Price-Fixing MDL
A Florida-based car dealer is the first private company to join a multidistrict litigation accusing Novo Nordisk, Eli Lilly and Sanofi-Aventis of fixing the prices of insulin and other drugs to treat diabetes.
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January 02, 2025
A-Rod's SPAC Deal Seeks Extra Innings, Plus More IPOs Filed
The period between Christmas Eve and Jan. 1 wasn't completely quiet on the capital markets deals front, with A-Rod's special purpose acquisition company seeking an extension to complete its merger and several new IPOs being filed. Here, Law360 looks at the capital markets news from the holiday break.
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January 02, 2025
Ozempic Caused Severe Pain And Hospitalization, Suit Says
Pharmaceutical giant Novo Nordisk has been sued in Connecticut federal court by a 67-year-old woman claiming it did not properly disclose the risk of gastroparesis associated with its popular weight loss drug Ozempic, which allegedly caused her severe stomach pain and vomiting that led to a 10-day hospitalization.
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January 02, 2025
Eli Lilly Slams Suit Alleging Shortage Of Weight-Loss Drug
Eli Lilly is seeking permission to join a legal fight over whether compounding pharmacies can keep making copycat versions of the company's lucrative weight-loss and diabetes drug, telling a federal court Wednesday that its interests aren't adequately represented by federal regulators.
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January 02, 2025
Hikma Wants Extension At High Court In Skinny Label Case
Hikma Pharmaceuticals USA Inc. wants an extra month to file its petition challenging the Federal Circuit's revival of a suit claiming the company induced physicians to infringe patents covering Amarin Pharma Inc.'s blockbuster cardiovascular drug Vascepa, citing the case's importance and the busy schedules of attorneys.
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January 02, 2025
Roche Strikes $80M Oncology Drug Deal With Chinese Biotech
A multimillion-dollar agreement kicked off biotech deals in the new year when Swiss pharma giant Roche and Chinese biotech Innovent Biologics announced Wednesday that they had entered into an exclusive licensing agreement focused on a new oncology drug.
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January 02, 2025
'Crush-Resistant' OxyContin Patents Fail At Fed. Circ.
In one of its last major moves in 2024, the Federal Circuit decided to reject an appeal from the bankrupt maker of OxyContin, which is trying to use patent laws to block the release of a competing "crush-resistant" generic painkiller.
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January 02, 2025
Aetna Sues Drugmakers In Conn., Alleging Generics Price-Fixing
Health insurer Aetna has sued 23 drugmakers, including Novartis and Pfizer, over an alleged scheme to fix the prices of 111 generic medications, citing information gleaned from a congressional probe, lawsuits by state attorneys general, a Pennsylvania multidistrict litigation proceeding, and U.S. Department of Justice findings.
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January 02, 2025
Beasley Allen Aims To Toss Suit From Ex-Ally Firm
Beasley Allen has called on a Mississippi federal court to dismiss or transfer a defamation and breach of contract lawsuit from The Smith Law Firm PLLC over their joint venture agreement for talc litigation against Johnson & Johnson, arguing the case should be tossed in favor of its own suit filed earlier in Alabama.
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January 02, 2025
IRS, Treasury Float Regs On Excise Taxes For Drugmakers
The IRS and Treasury proposed rules for charging excise taxes to drugmakers that refuse to negotiate drug prices with Medicare under requirements of the 2022 tax and climate law, saying the tax only would apply to manufacturers and importers that initially sell the drugs.
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January 01, 2025
Healthcare and Life Science Deals Attys Expect In 2025
As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House.
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January 01, 2025
The Top 5 High Court Cases To Watch This Spring
The U.S. Supreme Court justices will return from the winter holidays to tackle major First Amendment questions and several administrative law disputes — all arising from the Fifth Circuit — that could further change how federal agencies promulgate rules and defend them.
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January 01, 2025
High-Stakes Healthcare Court Battles To Watch In 2025
With pivotal health law cases on the docket in 2025, attorneys will be watching how the incoming Trump administration proceeds in ongoing litigation over abortion care, the Affordable Care Act and the Medicare drug price negotiation program.
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January 01, 2025
Healthcare And Life Science Policies To Watch In 2025
Healthcare and life sciences attorneys will have their eyes on Washington, D.C., in the next few months. They will be keen to understand how a new presidential administration and a new Congress with razor-thin GOP control will approach a bevy of fraught issues.
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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Consultants Should Be Aware Of DOJ's Potential New Reach
The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.
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Lessons Learned From 2024's Top FMLA Decisions
Last year's major litigation related to the Family and Medical Leave Act underscores why it is critical for employers to understand the basics of when leave and accommodations are required, say attorneys at Dechert.
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Product Safety Issues In 2024 Highlight Need For Vigilance
A look at some of the medications and foods that led to significant class actions last year demonstrates the need for robust regulatory systems and proactive measures to protect consumers from defective and harmful products, says Jennifer Taylor at the Law Offices of James Scott Farrin.
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Series
Playing Esports Makes Me A Better Lawyer
Competing in a global esports tournament at Wimbledon last year not only fulfilled my childhood dream, but also sharpened skills that are essential to my day job, including strategic thinking, confidence and networking, says AJ Schuyler at Jackson Lewis.
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Health Tech Regulatory Trends To Watch In 2025
With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.
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An Associate's Guide To Career Development In 2025
As the new year begins, associates at all levels should consider establishing career metrics, fostering key relationships and employing other specific strategies to help move through the complexities of the legal profession with confidence and emerge as trailblazers, say EJ Stern and Amanda George at Fractional Law Firm.
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2025 Patent And TM Policy At USPTO: What We Know So Far
This upcoming year at the U.S. Patent and Trademark Office promises a continued focus on artificial intelligence-related policies, as well as initiatives to drive efficiency and modernize standard processes, say attorneys at Knobbe Martens.
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Reviewing 2024's Crucial Patent Law Developments
As 2024 draws to a close, significant rulings and policies aimed at modernizing long-standing legal practices or addressing emerging challenges have reached patent law, says Michael Ellenberger at Rothwell Figg.
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Series
Fixing Up Cars Makes Me A Better Lawyer
From problem-solving to patience and adaptability to organization, the skills developed working under the hood of a car directly translate to being a more effective lawyer, says Christopher Mdeway at Kaufman Dolowich.
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Making The Pitch To Grow Your Company's Legal Team
In a compressed economy, convincing the C-suite to invest in additional legal talent can be a herculean task, but a convincing pitch — supported by metrics and cost analyses — may help in-house counsel justify the growth of their team, say Elizabeth Smith and Roger Garceau at Major Lindsey.
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Data Privacy Landscape After Mass. Justices' Wiretap Ruling
In Vita v. New England Baptist Hospital, Massachusetts’ highest court recently ruled that the state’s wiretap law doesn’t prohibit all tracking of website user activity, but major financial and reputational risks remain for businesses that aren't transparent about customer’s web data, says Seth Berman at Nutter.
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The Future Of GLP-1 Policy After Drug Shortage Ends
If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.
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Using Contracts As Evidence Of Trade Secret Protection
Recent federal and U.S. International Trade Commission decisions demonstrate an interesting trend of judges recognizing that contracts and confidentiality provisions can serve as important evidence of the reasonable secrecy measures companies must take to prove the existence of protected trade secrets, say attorneys at Finnegan.
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When US Privilege Law Applies To Docs Made Outside The US
As globalization manifests itself in disputes over foreign-created documents, a California federal court’s recent trademark decision illustrates nuances of both U.S. privilege frameworks and foreign evidentiary protections that attorneys must increasingly bear in mind, say attorneys at Hunton.
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Looking For Patterns In Pharmaceuticals' Use Of AI Patents
Merging data from the U.S. Patent and Trademark Office's artificial intelligence patent dataset and the U.S. Food and Drug Administration's Orange Book sheds light on pharmaceutical patents involving AI technology, as well as trends in the industry's use of this technology, says Kiefer Ahn at NERA.