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Life Sciences
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April 12, 2024
Asbury Park Escapes Pot Co.'s Zoning Board Conspiracy Suit
A New Jersey federal court has dismissed a medical cannabis company's suit alleging Asbury Park and its zoning board conspired with a rival to block it from operating a treatment center, saying the complaint fails to support its allegations of the scheme.
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April 11, 2024
Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'
Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.
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April 11, 2024
Fed. Circ. Blocks Alvogen Generic Of Bausch Diarrhea Drug
The Federal Circuit upheld a decision Thursday that prevents Alvogen from releasing a generic version of Bausch Health's blockbuster diarrhea and brain disease drug Xifaxan until 2029, rejecting Alvogen's bid to launch sooner because it was cleared of infringing some patents.
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April 11, 2024
FDA Commissioner Says Congress Must Act On Hemp, CBD
The commissioner of the U.S. Food and Drug Administration said Thursday that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.
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April 11, 2024
9th Circ. Nixes 'Super Snap Removals' In Dexcom Suits
The Ninth Circuit won't let Dexcom Inc. remove three suits alleging its glucose monitoring system is defective to federal court, saying its "super snap removal" motions were premature as they were filed before any of the cases actually commenced.
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April 11, 2024
Birth Control Injury Claims Barred From Conn., Court Told
Connecticut state courts have no basis to exercise jurisdiction over three of the four companies targeted in product liability lawsuits brought by 103 women who claim their Filshie Clip birth control devices migrated within their bodies and caused injuries, counsel for the defendants told a Waterbury judge Thursday.
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April 11, 2024
Deals Rumor Mill: US Steel, Germany's Stada, Paramount
The DOJ opens a probe into Nippon’s proposed $14.9 billion takeover of US Steel, German drugmaker Stada explores a sale, and Paramount and Skydance are hashing out potential deal terms. Here, Law360 breaks down these and other notable deal rumors from the past week.
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April 11, 2024
Del. Justices OK Denial Of Icahn-Illumina Midcase Appeal Bid
Billionaire investor Carl Icahn may not put his Chancery Court litigation against biotechnology company Illumina Inc.'s board on hold for a review of a decision that struck portions of the complaint that were based on confidential information, Delaware's Supreme Court said Thursday, upholding the lower court's rejection of the midcase appeal.
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April 11, 2024
Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim
Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.
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April 11, 2024
Kirkland, Jones Day Build $787.5M Sale Of Steris' Dental Unit
Medical device company Steris, advised by Jones Day, on Thursday announced plans to sell its dental segment to Kirkland & Ellis LLP-advised middle market private equity shop Peak Rock Capital for $787.5 million.
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April 11, 2024
Life Sciences Group Of The Year: Sullivan & Cromwell
Sullivan & Cromwell LLP helped Bayer defeat Merck in litigation over asbestos-containing talc liability and guided mega pharma deals such as Pfizer's $43 billion acquisition of Seagen and Amgen's $27.8 billion acquisition of Horizon Therapeutics, earning the firm a spot among Law360's 2023 Life Sciences Groups of the Year.
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April 10, 2024
Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims
A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.
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April 10, 2024
DOJ Hits Regeneron With False Claims Act Suit Over Eylea
The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday.
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April 10, 2024
Del. Justices Probe Validity Of Advance Notice Bylaws
The appeal of a Delaware Chancery Court decision voiding a biopharmaceutical company's "onerous" advance notice requirements for director nominations while upholding the rejection of an activist shareholder's nominees boiled down to one basic legal question at Delaware's Supreme Court Wednesday: Is this a facial or an as-applied challenge?
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April 10, 2024
9th Circ. Mostly Affirms Industry Ban For COVID PPE Delays
A Ninth Circuit panel on Tuesday largely upheld a district court's ruling requiring personal protective equipment suppliers to pay over $3 million after finding that they misrepresented the shipping times of hand sanitizer products at the start of the COVID-19 pandemic, while reversing the Federal Trade Commission's injunction against one of the companies' owners.
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April 10, 2024
Dems Introduce Bill To Codify Policy Barring Judge Shopping
Senate Majority Leader Chuck Schumer, D-N.Y., along with 37 other Democratic and two independent senators, introduced legislation on Wednesday to codify the new Judicial Conference of the United States policy against judge shopping after pushback from Republicans and a Texas court.
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April 10, 2024
4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'
The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.
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April 10, 2024
Skadden, Fenwick Lead $4.9B Alpine Immune Sciences Sale
Biotechnology company Alpine Immune Sciences Inc., advised by Fenwick & West LLP, on Wednesday revealed that it has agreed to be bought by Vertex Pharmaceuticals Inc., led by Skadden Arps Slate Meagher & Flom LLP, in a $4.9 billion cash deal.
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April 10, 2024
Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed
A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.
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April 10, 2024
Justices Asked To Ban FCA Suits Relying On Patent Reviews
Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.
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April 10, 2024
Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row
Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.
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April 10, 2024
1st Circ. Says Appellant's Death Erases Conviction
The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.
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April 10, 2024
Life Sciences Group Of The Year: Morrison Foerster
Morrison Foerster LLP successfully beat a preliminary injunction that would have thwarted a Sandoz biosimilar for multiple sclerosis from going to market, one achievement among many that earned the firm a spot among Law360's 2023 Life Sciences Groups of the Year.
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April 10, 2024
Ginkgo Bioworks SPAC Investors Sue In Del. After Stock Drop
Investors in the blank check company that took biotech firm Ginkgo Bioworks Inc. public in September 2021 have sued the venture's founders and insiders for unjust enrichment and fiduciary breaches in Delaware's Court of Chancery, alleging that the deal was propped up by false and misleading claims.
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April 09, 2024
After Uproar, New MDL Rule Advances With Attys Assuaged
Following years of debate and months of outcry, a judicial panel Tuesday approved the first formal rule aimed at improving efficiency and fairness in the nation's burgeoning realm of multidistrict litigation, earning plaudits from placated lawyers in the defense and plaintiffs bars.
Expert Analysis
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FTC Rite Aid Order Holds Biometrics And AI Compliance Tips
The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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SEC Case May Expand Scope Of Insider Trading Liability
The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Fed. Circ. Patent Decisions In 2023: An Empirical Review
The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.
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Digging Into The Debate On FDA's Proposed Lab Test Rule
A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.
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How 2023 Shaped Drug And Medical Device Legal Trends
2023 brought a number of positive developments for the life sciences industry, including great trial and multidistrict litigation outcomes, but also some heavy-handed regulations and other concerning developments that lay the groundwork for significant litigation, say attorneys at Faegre Drinker.
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Opinion
What Insurers Gain When Litigating Coverage Denials
Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.
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Trending At The PTAB: 6 Areas To Watch In 2024
Expect further changes in a half-dozen areas in 2024 following a busy 2023 at the Patent Trial and Appeal Board, including more adjustments to the director review process and the first case to hit the Appeals Review Panel, say attorneys at Finnegan.
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5 Trends That Will Affect Food Litigation In 2024
In 2024, food and beverage companies are likely to continue to face threats of litigation relating to so-called forever chemicals, citric and malic acid, and ESG claims, but recent developments in case law have created potential avenues for defense, say Abby Meyer and Khirin Bunker at Sheppard Mullin.
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Law Firm Strategies For Successfully Navigating 2024 Trends
Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.
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The Most-Read Legal Industry Law360 Guest Articles Of 2023
A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.
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Inside Higher Education's New FCA Liability Challenges
As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.