Life Sciences

  • December 04, 2024

    Withers IP Partners Hop To Sullivan & Worcester

    Sullivan & Worcester LLP has said the Boston firm picked up a team of five intellectual property lawyers, including two partners, from Withers who have expertise in filing patents and working on deals for biotech startups. 

  • December 04, 2024

    Novartis Fails To Stop Generic Drug Release At Fed. Circ.

    Novartis could not persuade Federal Circuit judges to grant an injunction Wednesday protecting its blockbuster heart failure medication from facing generic competition, with the appeals court backing a Delaware federal judge's opinion that it was unlikely that one of the generic drug's ingredients is "amorphous."

  • December 04, 2024

    Jackson's 'Quite Worried' About Equal Protection Precedent

    The U.S. Supreme Court's Republican-appointed justices' apparent willingness Wednesday to rule that a Tennessee law banning gender-affirming healthcare for transgender minors didn't rely on sex-based classifications worried Justice Ketanji Brown Jackson, who warned that such a decision would undermine decades of the court's equal protection clause precedent.

  • December 04, 2024

    JSR Wins As Fed. Circ. Axes Cytiva Antibody Isolation Patents

    In a precedential opinion, the Federal Circuit held Wednesday that all the claims that JSR Corp. challenged in three Cytiva Bioprocess antibody isolation patents are invalid as obvious, backing the Patent Trial and Appeal Board's invalidation of many claims while reversing its decision to uphold others.

  • December 04, 2024

    Colo. Co's Alleged Kickback Scheme Ends In $2M Settlements

    A Colorado neuromonitoring company, its founder and two others have agreed to pay more than $2 million to end a False Claims Act lawsuit alleging they participated in a kickback scheme to get surgeons to order neuromonitoring services covered by federal programs.

  • December 04, 2024

    DEA Judge Sets Pot Rescheduling Hearings

    The Drug Enforcement Administration will kick off six weeks of hearings in late January on the merits of the attorney general's proposal to loosen restrictions on marijuana, an agency administrative law judge said Wednesday.

  • December 04, 2024

    Fed. Circ. Judge Condemns 'Nonsense' Law In Antibody Fight

    U.S. Circuit Judge Todd Hughes called the Federal Circuit's case law on interpreting preambles in patent claims "nonsense" on Wednesday, expressing frustration as a panel tried to work through whether Xencor Inc.'s antibody patent application was too broad.

  • December 04, 2024

    Takeda Exec Duped Beau Into $2M Fraud, Jury Told

    A Massachusetts man is accusing his wife, a former Takeda Pharmaceuticals vice president, of playing "puppet master" by tricking him into joining a scheme to steal millions from the drug company through fake invoices.

  • December 04, 2024

    Justices Clash Over Tenn. Transgender Care Ban

    The U.S. Supreme Court justices, including members of the conservative majority, appeared to sympathize Wednesday with transgender minors unable to access gender-affirming medical treatments banned by a Tennessee law.

  • December 03, 2024

    Mich. AG Deal, NIH 4th Circ. Win And X Corp Bid In HIPAA Row

    Michigan's attorney general has agreed not to hold a Christian healthcare provider accountable to certain antidiscrimination protections related to gender and sexuality while the provider challenges them in court. Meanwhile, a New York federal judge decided to keep the largest anesthesiology provider in the U.S. on the hook for antitrust claims over its noncompete agreements with clinicians.

  • December 03, 2024

    Calif. Unveils Reproductive Rights Bills To Prep For Trump

    California lawmakers plan to introduce a pair of bills aimed at protecting access to abortion in the Golden State as Donald Trump returns to office, according to an announcement made Monday, the first day of a special legislative session called by Gov. Gavin Newsom.

  • December 03, 2024

    SEC Says Biopharma's Cooperation Helped It Avoid Penalty

    A Houston biopharmaceutical company accused of misleading investors about the regulatory status of two cancer drugs agreed to settle the U.S. Securities and Exchange Commission's action against it on Tuesday without paying a dime, in recognition of what the SEC said was the company's self-reporting and cooperation with investigators.

  • December 03, 2024

    J&J's Neosporin Forever Discolored Man's Groin, Suit Says

    Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.

  • December 03, 2024

    $1B Sandoz Placeholder Bid Needs More Support, Judge Says

    A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.

  • December 03, 2024

    USPTO Abandons Polarizing Proposal Over Double Patenting

    The U.S. Patent and Trademark Office has withdrawn an extremely controversial proposal tied to double patenting, citing "resource constraints" in a Federal Register notice set to be published Wednesday.

  • December 03, 2024

    Vidal Aimed To Put USPTO Rulemaking In The Spotlight

    Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.

  • December 03, 2024

    FDA Issues Guidance On Potential Infant Formula Shortages

    The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.

  • December 03, 2024

    4 Mass. State Court Rulings You May Have Missed In Nov.

    An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.

  • December 03, 2024

    VA Announces Study On MDMA-Assisted Therapy For Vets

    The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.

  • December 02, 2024

    House COVID-19 Probe Points to China 'Lab Leak'

    The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.

  • December 02, 2024

    Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud

    A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.

  • December 02, 2024

    Justices Seem Inclined To Back FDA Block Of Flavored Vapes

    U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.

  • December 02, 2024

    Investor Alleges Medical Device Co. Misled On FDA Clearance

    The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.

  • December 02, 2024

    Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal

    A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.

  • December 02, 2024

    Chancery OKs $21M Deal To End Gene Co. Class Suit

    A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.

Expert Analysis

  • Litigation Inspiration: Reframing Document Review

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    For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.

  • Key Takeaways From FDA's Latest Social Media Warnings

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    The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.

  • Expect More State Scrutiny Of PE In Healthcare M&A

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    While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.

  • Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB

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    Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.

  • IP Ruling Likely To Limit Arguments Against Qualified Experts

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    The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.

  • How Boards And Officers Should Prep For New Trump Admin

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    In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.

  • Dissecting The Obviousness-Type Double Patenting Debate

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    The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.

  • Service Providers Must Mitigate 'Secondary Target' Risks

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    A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.

  • Health Policy Predictions For Trump's Second Administration

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    As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

  • Series

    Flying Makes Me A Better Lawyer

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    Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.

  • 9th Circ.'s High Bar May Limit Keyword Confusion TM Claims

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    A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.

  • Trump Patent Policy May Be Headed In Unexpected Direction

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    While commentators have assumed that the patent policy of President-elect Donald Trump's second administration will largely mirror the pro-patent policy of his first, these predictions fail to take into account the likely oversized influence of Elon Musk, says Jorge Contreras at the University of Utah.

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

  • Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons

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    As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.

  • Series

    Circus Arts Make Me A Better Lawyer

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    Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.

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