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Life Sciences
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January 29, 2025
Labcorp Can't Flip Patent Board Loss At Fed. Circ.
Labcorp had no luck Wednesday trying to convince Federal Circuit judges to overturn a patent board decision that refused to invalidate a host of claims in a patent covering a way of detecting genetic disorders.
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January 29, 2025
Farmers' Antitrust Claims Trimmed In Pesticides Case
A North Carolina federal court has cut one set of federal antitrust claims from a suit brought by farmers accusing major pesticide manufacturers Syngenta AG and Corteva Inc. of blocking competition but allowed a slew of other claims to proceed.
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January 29, 2025
Full Fed. Circ. Won't Allow MSN To Launch Generic Entresto
The Federal Circuit is standing by its decision to bar MSN Pharmaceuticals from launching a generic version of Novartis' bestseller, the cardiovascular drug Entresto, as Novartis tries to persuade the court that it deserves an injunction through July.
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January 29, 2025
Chinese Co. Execs Convicted Over Fentanyl Chemical Imports
Two former executives of a Chinese chemical company were convicted Wednesday of charges related to a purported scheme to import fentanyl precursor chemicals in order to manufacture large quantities of the drug, as well as laundering funds.
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January 29, 2025
9th Circ. Affirms Ax Of Patent Atty's Allergan FCA Fight
A Ninth Circuit panel on Wednesday affirmed the dismissal of a patent attorney's False Claims Act lawsuit alleging Allergan and Adamas Pharma fraudulently obtained patents to block generic competition for two Alzheimer's drugs, finding the information he disclosed was already publicly available and so his FCA claims are barred.
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January 29, 2025
4 Questions About Trump's Federal Worker Resignation Policy
President Donald Trump’s offer of letting federal workers resign with several months of paid administrative leave raises questions about its legality and whether workers will actually get paid, attorneys said. Here, Law360 explores four questions that stem from the policy.
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January 29, 2025
White House Rescinds Trump's Spending Freeze
The White House on Wednesday rescinded a directive freezing federal funding, saying it wants to end litigation and confusion, but said the move will not end a review of spending to ensure compliance with a series of executive orders by the president.
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January 29, 2025
RFK Jr. Disputes Anti-Vax Label In HHS Confirmation Hearing
Robert F. Kennedy Jr. attempted Wednesday morning to convince Republican and Democratic lawmakers that he is not anti-vaccine, despite many of his past comments to the contrary, as he hopes to convince them to confirm his appointment as head of the U.S. Department of Health and Human Services.
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January 28, 2025
Trump Targets Gender-Affirming Care For Minors In New Order
President Donald Trump ordered federal agencies late Tuesday to take steps to halt gender-affirming care for minors, including by cutting off Medicaid and military health coverage for what he called a "stain on our nation's history."
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January 28, 2025
Minn. AG Settles Novo Nordisk Insulin Claims With Price Cap
Minnesota's attorney general has reached a settlement resolving a long-running lawsuit accusing Novo Nordisk of inflating insulin prices, with the company agreeing to a $35 per month cap on out-of-pocket costs for state residents.
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January 28, 2025
GSK Urges Del. Judge To Enhance $235M Skinny Label Win
GlaxoSmithKline LLC is urging a Delaware federal judge to enhance the $235 million damages award a jury issued against Teva Pharmaceuticals USA Inc. in 2017, now that the dispute over skinny label infringement has returned to district court.
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January 28, 2025
Founder Can't Explain Hedge Fund's Filing Mismatch To Jury
A hedge fund founder told a Denver jury Tuesday that he doesn't know why some of the fund's regulatory filings don't identify it as a director for a Colorado biopharmaceutical company, in a suit brought by stockholders who claim the fund must return $11 million earned from short-swing trades.
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January 28, 2025
Drugs Made In America SPAC Nets $200M To Buy Pharma Biz
Blank-check company Drugs Made In America Acquisition Corp. began trading Tuesday after completing a downsized $200 million initial public offering with the intention of acquiring a U.S.-based pharmaceutical business, represented by Loeb & Loeb LLP and underwriter's counsel Winston & Strawn LLP.
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January 28, 2025
Pharma Co. Gets Final Shot To Ax NC Contract Breach Suit
A pharmaceutical company can make another attempt to escape a software developer's suit alleging he was duped into selling his technology to the company, the North Carolina Business Court has said, months after the state's top court revived the software maker's breach of contract claims.
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January 28, 2025
Questions To Watch For In RFK Jr.'s Confirmation Hearing
Robert F. Kennedy Jr. is set to appear on Capitol Hill as he tries to secure the top position at the U.S. Department of Health and Human Services. Here are some of the questions healthcare lawyers and others want to see addressed about his "Make America Healthy Again" pledge.
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January 28, 2025
7th Circ. Considers Faith Of 2-Step Collective Certification
A Seventh Circuit panel considered Tuesday whether to keep or ditch the two-step certification process for collectives, with one judge calling Eli Lilly & Co.'s decertification argument in an age discrimination suit "spectacularly wrong" and another asking how tolling could change.
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January 28, 2025
Bain Capital Seeks Surgery Partners Buyout At $3.3B Value
Tennessee-based short-stay surgical facility operator Surgery Partners Inc. disclosed Tuesday that its board received a nonbinding proposal the prior day from Bain Capital Private Equity LP that values the company at close to $3.3 billion.
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January 28, 2025
Trump Pledges Tariffs On Semiconductors, Chips, Drugs
The U.S. will soon place tariffs on foreign-manufactured semiconductors, computer chips and pharmaceuticals in an effort to convince foreign companies to move their manufacturing operations stateside, President Donald Trump told House Republicans at a conference.
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January 28, 2025
North Carolina Drug Testing Lab Inks $850K False Billing Deal
A North Carolina laboratory on Tuesday agreed to pay $850,000 to settle acting U.S. Attorney Randall Galyon's claims it was overbilling the Tar Heel State's Medicaid program for urine tests that were not medically necessary in violation of the False Claims Act.
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January 28, 2025
Chinese Pair Sought To Fuel Fentanyl 'Grand Lab,' Feds Say
Prosecutors told a Manhattan federal jury Tuesday that two Chinese nationals sought to furnish chemicals for what they thought would be a huge fentanyl hub in New York City, pointing to what they called damning evidence such as recordings, texts and cryptocurrency transfers.
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January 28, 2025
Creditors Can Join Nostrum Sale Talks, Ch. 11 Judge Rules
A bankruptcy judge on Tuesday approved a bid from the official committee of unsecured creditors in drugmaker Nostrum Laboratories Inc.'s Chapter 11 case to help investment bank Raymond James find a buyer for the debtor's assets.
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January 28, 2025
4 Firms Look To Build $1B Sale Of Evergreen Theragnostics
Radiopharmaceutical-focused healthcare company Lantheus Holdings Inc. on Tuesday announced plans to buy Evergreen Theragnostics Inc. for up to $1 billion or more in a deal steered by four law firms.
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January 27, 2025
Fund Tells Jury No Need To Return $11M Short-Swing Profits
A hedge fund told a Denver federal jury Monday that the $11 million it earned from the short-swing sales of a biopharmaceutical company's stock doesn't need to be returned because the transactions fall under an exception to securities law on insider trading.
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January 27, 2025
Takeda Pushes Meijer Antitrust Suit Into Arbitration
Meijer is going to have to arbitrate its claims that Takeda Pharmaceutical broke antitrust law by cutting a pay-for-delay deal with Par Pharmaceuticals to keep a generic version of Takeda's anti-constipation drug Amitiza off the market for several years.
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January 27, 2025
Jury Will Decide $140M Intuitive Robo-Surgery Antitrust Case
A federal judge on Monday rejected dueling requests for directed verdicts at the wrap of a $140 million antitrust trial over claims that Intuitive Surgical abused its market power in barring a repair provider's refurbished part for Intuitive's surgery robot, saying there's "substantial evidence" for jurors to decide on the parties' claims and counterclaims.
Expert Analysis
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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Trending At The PTAB: Obviousness In Director Reviews
Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.