Life Sciences

  • August 14, 2024

    J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival

    Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.

  • August 14, 2024

    NC Judge OKs $15.2M Deal For Medical Device Investors

    A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.

  • August 14, 2024

    Grassley Asks HHS For Clarity On Cannabis Position

    Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.

  • August 14, 2024

    Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says

    A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.

  • August 14, 2024

    AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case

    A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.

  • August 14, 2024

    HHS Calls For More Research, Planning To Combat Heat Risks

    Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.

  • August 14, 2024

    Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs

    The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.

  • August 14, 2024

    Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit

    A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.

  • August 14, 2024

    Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda

    A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.

  • August 14, 2024

    Zantac Judge Won't Step Aside Over Wife's Reed Smith Role

    A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.

  • August 13, 2024

    SEC Drops Insider Trading Suit Against Ex-Mylan Exec

    The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case. 

  • August 13, 2024

    Entresto Release Delayed As Novartis Goes To Fed. Circ.

    A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.

  • August 13, 2024

    Mother Can't Revive Suit Against GE For Child's Brain Damage

    A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.

  • August 13, 2024

    Spinal Implant Patents Verdict Must Stand, Pa. Judge Says

    A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.

  • August 13, 2024

    NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach

    Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.

  • August 13, 2024

    Janssen Wants New FCA Trial As Relators Seek $1.85B Win

    Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.

  • August 13, 2024

    Fed. Circ. Restores J&J, Allergan's Viberzi IP After Del. Loss

    The Federal Circuit fully revived claims of patents covering Allergan's bowel treatment drug Viberzi on Tuesday, overruling a Delaware federal judge who said the claims don't meet obviousness-type double patenting or written description requirements.

  • August 13, 2024

    Former Sprinter Eyes Plea Deal In 2020 Olympics Doping Case

    A onetime world-class sprinter from the Atlanta area is in talks to resolve charges that he illegally provided banned performance-enhancement drugs while training other athletes ahead of the 2020 Tokyo Olympic Games, a Manhattan federal judge heard Tuesday.

  • August 13, 2024

    DC Circ. Backs EPA's Ethylene Oxide Cancer Risk Value

    The D.C. Circuit on Tuesday upheld federal environmental regulators' assessment of the cancer risk from exposure to certain chemical manufacturers' ethylene oxide emissions, rejecting a challenge from a chemical company and two chemical associations that argued the risk assessment was arbitrary and capricious.

  • August 13, 2024

    FTC Makes 2nd Request In Review Of Medical Device Co. Deal

    Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.

  • August 13, 2024

    'Clever' Scheme Is Concealing Talc Litigation Funding, J&J Says

    The Beasley Allen Law Firm needs to disclose alleged litigation funding fueling its litigation over Johnson & Johnson's talcum powder even if that funding was not given directly to the firm since the disclosure rules apply to "parties" and not "law firms," J&J has told a New Jersey federal court.

  • August 13, 2024

    Ex-McCarter & English Client Wants To Undo Malpractice Loss

    A New Jersey pharmaceutical business is urging a New Jersey state court to reconsider its decision to throw out the company's malpractice case against McCarter & English LLP, saying the firm "brazenly" misstated part of the timeline of the case's lengthy history.

  • August 13, 2024

    Conn. Trial Attys Back McCarter's Bid For Punitive Award

    The Connecticut Trial Lawyers Association has asked the state Supreme Court for permission to file a friend-of-court brief supporting McCarter & English LLP's bid for a punitive payout after winning multimillion-dollar judgments in a contract dispute with a former client.

  • August 13, 2024

    3 Firms Drive $3.8B Carlyle-Baxter Kidney Care Deal

    Kirkland & Ellis LLP-led private equity firm Carlyle on Tuesday agreed to acquire the kidney care unit of Baxter International Inc., represented by Sullivan & Cromwell LLP and Baker McKenzie, for $3.8 billion, Baxter said in a statement Tuesday.

  • August 12, 2024

    Accused Accounting Prof Is No Tax Expert, NJ Jury Told

    New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.

Expert Analysis

  • The Art Of Asking: Leveraging Your Contacts For Referrals

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    Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.

  • Trending At The PTAB: Permissible New Reply Arguments

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    In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.

  • Wave Of Final Rules Reflects Race Against CRA Deadline

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    The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.

  • 'Beauty From Within' Trend Poses Regulatory Risks For Cos.

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    Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.

  • McKesson May Change How AKS-Based FCA Claims Are Pled

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    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.

  • Series

    Being An Equestrian Makes Me A Better Lawyer

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    Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.

  • 7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits

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    On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.

  • Fintiv Denials Are On The Rise At PTAB

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    Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.

  • 4 Ways To Refresh Your Law Firm's Marketing Strategy

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    With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.

  • Cos. Must Prepare For Calif. Legislation That Would Ban PFAS

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    Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • Practical Pointers After Fed. Circ. Double-Patenting Decision

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    With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.

  • Highlights From The 2024 ABA Antitrust Spring Meeting

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    U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.

  • Strategies For Challenging A Fla. Grand Jury Report's Release

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    A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

  • Patent Lessons From 8 Federal Circuit Reversals In March

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    A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

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