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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.
Expert Analysis
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.