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Life Sciences
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January 02, 2025
'Crush-Resistant' OxyContin Patents Fail At Federal Circuit
In one of the court's last major moves last year, Federal Circuit judges decided to turn down 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.
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January 01, 2025
Product Liability Cases To Watch In 2025
Cases that attorneys will be keeping an eye on in the coming year involve Monsanto and a circuit rift over preemption regarding Roundup cancer claims, as well as mass torts over claims that social media harm minors' mental health.
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January 01, 2025
Patent Policy To Watch In 2025
Patent attorneys are awaiting new leadership at the U.S. Patent and Trademark Office and the U.S. International Trade Commission, and are tracking several bills in Congress. Here's what else they should be following in the new year.
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January 01, 2025
IPO Outlook Brightens As More Companies Eye 2025 Listings
Capital markets attorneys are preparing to advise more companies toward initial public offerings in 2025, given evidence that a rising number of candidates are joining the pipeline in expectation of a long-awaited resurgence in new listings. Here, Law360 looks at what deals attorneys and market participants expect.
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January 01, 2025
Patent Cases To Watch In 2025
The Federal Circuit has taken on a rare en banc patent case looking at damages, while the U.S. Supreme Court has been asked to review when foreign damages can be incorporated into patent awards. Here's what you need to know about these cases and others that attorneys are keeping an eye on in 2025.
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January 01, 2025
Top Federal Tax Cases To Watch In 2025
Over the next year, tax practitioners will be closely monitoring suits that challenge the IRS' use of the economic substance doctrine, take advantage of the U.S. Supreme Court's landmark decision curbing federal agencies' regulatory authority and dispute the government's handling of worker retention credits. Here, Law360 looks at key federal tax cases to follow in 2025.
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January 01, 2025
Patent Litigation Trends To Watch In 2025
Litigation funding resulting in more heated disputes, artificial intelligence tools becoming a fact of life for patent attorneys and increased use of patent reexaminations are among the trends attorneys will be keeping tabs on in the coming year.
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December 23, 2024
Ex-Pharma Exec Charged With $38M Insider Trading Scheme
A former chief science officer of pharmaceutical company Humanigen faces charges in New Jersey federal court that he dumped shares of the company before it publicly announced its potential COVID-19 drug did not receive federal approval, according to an indictment unsealed Monday.
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December 23, 2024
HHS Can't Enforce Abortion Privacy Rule Against Texas Doctor
A Texas federal judge has granted a Lone Star State doctor a reprieve from a new U.S. Department of Health and Human Services rule that aims to protect the privacy of abortion providers and patients, saying that the rule likely exceeds the Health Insurance Portability and Accountability Act's statutory authority.
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December 20, 2024
Sens. Aim To Protect Generics With Skinny Labels In New Bill
A bipartisan group of senators from Colorado, Arkansas, Vermont and Maine have introduced a bill that would shield generic-drug and biosimilar manufacturers from infringement liability when using approved "skinny labels."
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December 20, 2024
South Korean Needle Operation Secures Patent Win At ITC
The U.S. subsidiary of a South Korean dermatologist's needle business has convinced a judge at the U.S. International Trade Commission that several rivals in the marketplace for selling microneedles to plastic surgeons are infringing patents.
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December 20, 2024
Fed. Circ. Says Teva Inhaler Patents Can't Be In Orange Book
The Federal Circuit on Friday upheld a decision that Teva Pharmaceuticals improperly listed its asthma inhaler patents in the U.S. Food and Drug Administration's Orange Book, saying that only patents that claim a drug's active ingredient can be included in the database.
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December 20, 2024
Hagens Berman Settles Suit Over Effexor Deal Atty Fees
A pharmaceutical reseller's in-house counsel and founder moved Friday to drop a Mississippi federal court breach of contract suit accusing Hagens Berman Sobol Shapiro LLP of stiffing him on his share of a $13 million attorney fees award from an antitrust class settlement, citing a resolution to the dispute.
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December 20, 2024
Nippon Owes $115M In Muscular Dystrophy IP Fight, Jury Says
Nippon Shinyaku Co. Ltd. owes more than $115 million for infringing a patent owned by Massachusetts-based Sarepta Therapeutics, a federal jury in Delaware said Friday after finding that the Japanese company failed to prove the patent was invalid.
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December 20, 2024
The Most Significant Trade Secrets Cases Of 2024
Insulet Corp. became the latest company to notch a colossal trade secrets award, and a new presidential administration has attorneys wondering what will become of the Federal Trade Commission's pending proposal to ban employee noncompete agreements. Here's a look at trade secrets cases that defined 2024 and what to expect from the FTC in the coming year.
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December 20, 2024
Top Product Liability Cases Of 2024
Some of the top cases for product liability for 2024 include an Ohio Supreme Court ruling on opioids and public nuisance, baby formula trials and an appellate decision in Fosamax litigation.
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December 20, 2024
Psychedelics Law Reformers Hit Multiple Setbacks In 2024
In 2024, advocates, physicians and researchers attempted to broaden lawful access to federally illegal psychedelic drugs through a variety of avenues — the new drug approval process, litigation and a ballot initiative — with the upshot that the law remains largely unchanged and, for the most part, still restricts legal use and possession of these substances.
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December 20, 2024
Fla. Labs Appeal $7.3M Conn. Jury Verdict Favoring Cigna
Three Florida substance abuse testing laboratories filed notice Thursday promising to appeal a $7.3 million loss to Cigna Health and Life Insurance Co. over billings for recurring tests on drug treatment patients the insurer said were not medically necessary.
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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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.
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The State Of USPTO Rulemaking At The End Of Vidal's Term
As U.S. Patent and Trademark Office director, Kathi Vidal placed a particular emphasis on formal rulemaking — so as she returns to private practice this week, attorneys at Irell take stock of which of her proposals made it across the finish line, and where the rest stand on the cusp of a new administration.
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2024 IPO Market Trends, And What To Expect Next Year
The initial public offering market returned to historically typical levels on a deal count basis in 2024 but continued to lag based on proceeds raised due to a larger number of smaller IPOs this year, and signs point to continued ongoing momentum in the next year, say attorneys at Paul Hastings.
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What 2024 Trends In Marketing, Comms Hiring Mean For 2025
The state of hiring in legal industry marketing, business development and communications over the past 12 months was marked by a number of trends — from changes in the C-suite to lateral move challenges — providing clues for what’s to come in the year ahead, says Ben Curle at Ambition.
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How Trump's Tariff Promises May Play Out In 2nd Term
While it is unclear which of President-elect Donald Trump's promised tariffs he intends to actually implement in January, lessons from his first administration, laws governing executive action and U.S. trade agreements together paint a picture of what may be possible, say attorneys at Butzel.