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Life Sciences
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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.
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December 20, 2024
Top Privacy & Cybersecurity Developments Of 2024
The state data privacy law patchwork continued to add new and varied pieces in 2024, while major hacks shook up the healthcare industry and other critical sectors, and the first U.S. laws setting guardrails for the use of artificial intelligence technologies emerged.
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December 20, 2024
7th Circ. Upholds $900K Punitive Damages Award In TM Case
The Seventh Circuit has affirmed $900,000 in punitive damages against a nutritional company and its owners for infringing the "Diesel Test" trademark of a testosterone-boosting product from a former competitive body builder, saying the defendant's conduct merited the award.
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December 20, 2024
Capital Markets Attorneys Ready For Reset After Bumpy 2024
Capital markets activity — initial public offerings especially — posted a hesitant recovery in 2024, marginally increasing over prior-year levels before pausing altogether during a heated presidential election and postponing attorneys' hopes for a stronger rebound until 2025.
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December 19, 2024
Ex-Biopharma Exec Settles SEC Insider Trading Claim
A former biopharmaceutical executive will pay nearly $156,000 to end U.S. Securities and Exchange Commission claims that he bought up shares of his employer's acquisition target and the target's shareholder ahead of the announcement of the acquisition.
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December 19, 2024
Judge Says Some Paraquat Plaintiffs Being Left In Dark
Amid a hearing targeting fall 2025 for a first bellwether trial over the alleged link between the pesticide paraquat and Parkinson's disease, an Illinois federal judge told plaintiffs' lawyers to keep in better touch with their clients after her chambers received calls from plaintiffs wondering what's happening with their cases.
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December 19, 2024
PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law
The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."
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December 19, 2024
FTC Says PBMs Can't Get Preliminary Block In Insulin Case
The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.
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December 19, 2024
Foley Adds Tech, Life Sciences Partner From IP Boutique
Foley & Lardner LLP has hired a longtime partner from intellectual property boutique Lerner David LLP to strengthen both the transactional and litigation arms of its technology and life science practices in New York.
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December 19, 2024
Judge Wrongly Axed $107M IP Verdict, Pfizer Tells Fed. Circ.
A Pfizer unit has told the Federal Circuit that a federal judge got it wrong when he overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents.
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December 19, 2024
Biotech Co. Hid Eye Drug's Safety Risks, Investor Says
A biotech company concealed the potential risks that emerged during clinical trials of a drug meant to treat age-related vision degradation, according to an investor complaint filed in Massachusetts federal court Thursday.
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December 19, 2024
Medical Supplies Giant, Drone Operator File Confidential IPOs
Private equity-backed medical supplies giant Medline Inc. and drone operator Airo Group Holdings Inc. said Thursday that they confidentially filed plans for initial public offerings with regulators, joining a growing pipeline of IPO prospects for 2025.
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December 19, 2024
McKesson Urges Justices To Keep Hobbs Act's 'Exclusivity'
McKesson Corp. is urging the U.S. Supreme Court to preserve circuit courts' "exclusive" jurisdiction for Federal Communications Commission orders, warning that regulatory consistency nationwide could be undermined if lower courts are allowed to step in.
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December 19, 2024
Medical Device Investors Get Final OK On $15M Deal
A North Carolina federal judge has given final approval to a $15.25 million settlement that will resolve a suit claiming Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices, along with $5 million in attorney fees.
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December 19, 2024
Generic-Drug Cos. Get State AGs' Trial Order Flipped
A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.
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December 19, 2024
Labcorp Settles Competition Suit Against Ex-Sales Exec
Less than two weeks after Laboratory Corp. of America Holdings sued its former sales marketing executive and his new employer in North Carolina federal court for allegedly violating noncompete and nonsolicitation agreements, a deal has been reached to end the lawsuit.
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December 19, 2024
FDA Declaration May Restart Compounders' Shortage Suit
Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.
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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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.
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Series
Group Running Makes Me A Better Lawyer
The combination of physical fitness and community connection derived from running with a group of business leaders has, among other things, helped me to stay grounded, improve my communication skills, and develop a deeper empathy for clients and colleagues, says Jessica Shpall Rosen at Greenwald Doherty.
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Opinion
6 Changes I Would Make If I Ran A Law School
Reuben Guttman at Guttman Buschner identifies several key issues plaguing law schools and discusses potential solutions, such as opting out of the rankings game and mandating courses in basic writing skills.
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Predictions For Trump Antitrust Enforcement Of Life Sciences
Key life sciences antitrust issues of the past two administrations may indicate the direction of enforcement during President-elect Donald Trump's second term, including in areas such as drug prices, killer acquisitions and merger remedies, say attorneys at Ropes & Gray.