Life Sciences

  • September 24, 2024

    Firms Allowed To Exit IP Case After Gaining Philips' Consent

    A North Carolina federal judge allowed Dentons and Morningstar Law Group to withdraw as Transtate Equipment Co. Inc.'s counsel in a copyright and unfair competition case, after a stipulation was struck with opposing attorneys representing a Dutch health technology conglomerate that initially scoffed at the request.

  • September 24, 2024

    8th Circ. Won't Revive Pot Shop's Discrimination Suit

    The Eighth Circuit won't reinstate discrimination and interference claims by a would-be cannabis distributor against a firm contracted to evaluate applicants for Arkansas' dispensary licenses, saying the complaint lacks specificity to support its claims.

  • September 24, 2024

    NJ Judge Leaves J&J Ch. 11 Venue Change To Texas Judge

    A New Jersey bankruptcy judge on Tuesday declined the U.S. trustee's request to move Johnson & Johnson's latest talc-unit Chapter 11 from Texas to the Garden State, saying the issue could be as ably decided by a Texas court while avoiding a thorny issue of authority.

  • September 23, 2024

    J&J Talc Claims Paused In Latest Spinoff Ch. 11

    A Texas bankruptcy judge Monday froze certain talc personal injury litigation against Johnson & Johnson, saying a three-week administrative stay will give the court time to decide key jurisdictional issues in the Chapter 11 case of Red River Talc LLC, a newly created J&J spinoff and the pharmaceutical and cosmetics giant's latest attempt to settle claims in bankruptcy that its baby powder caused cancer.

  • September 23, 2024

    Mallinckrodt Brass Can't Avoid Investor Suit Over 2nd Ch. 11

    A New Jersey federal judge ruled Monday that senior leaders of drugmaker Mallinckrodt cannot escape a lawsuit brought by shareholders alleging the company tricked them into thinking it had recovered from bankruptcy and would make a $200 million payment to opioid claimants, finding the investors sufficiently pleaded securities law violations.

  • September 23, 2024

    Bio Lab Settles Conn. False-Claims Allegations For $1.73M

    Enzo Biochem Inc. and subsidiary Enzo Clinical Labs Inc. will pay nearly $1.73 million to settle accusations that the companies' former Farmingdale, New York, laboratory billed higher rates to the state of Connecticut's Medicaid coffers than it billed to other payers, the state attorney general announced Monday.

  • September 23, 2024

    Fired Sotera Exec's Vesting Suit Goes Forward In Del.

    Delaware's Court of Chancery dismissed on Monday some claims in a former Sotera Health Co. executive's suit accusing the lab-testing and sterilization firm of wrongly refusing to grant him severance benefits and equity awards worth millions, while holding other claims for trial.

  • September 23, 2024

    GSK Claims Pfizer Hasn't Proven Misconduct In Vax IP Fight

    GlaxoSmithKline is urging a Delaware federal judge to block Pfizer and BioNTech's claims that it has misused its patents tied to COVID-19 vaccination technology, or that it and a predecessor acted inappropriately when applying for those patents.

  • September 23, 2024

    Fed. Circ. OKs Novartis Loss In Eye Syringe Patent Feud

    The Federal Circuit has backed a Patent Trial and Appeal Board finding that more than two dozen claims in a Novartis pre-filled eye injection syringe patent weren't patentable.

  • September 23, 2024

    Amneal Latest Generic EpiPen Maker To Fight Colo. Law

    Amneal Pharmaceuticals has sued Colorado in federal court alleging that a state drug affordability program resulted in unconstitutional takings of its generic epinephrine auto-injectors.

  • September 23, 2024

    Cancer Test Cos. Strike Deal For Partial End To Patent Row

    Natera Inc. and Neogenomics Laboratories Inc. said they reached a confidential yet partial settlement Friday in their dispute covering intellectual property for a Natera DNA test meant to detect cancer.

  • September 23, 2024

    Insurer Freed From Damaged Blood Plasma Suit

    A supplier of blood plasma can't secure coverage for a nearly $820,000 blood plasma shipment declared a total loss because of excessive temperature variation and shipping delays, a Georgia federal court ruled, finding the supplier failed to abide by separate temperature and delay warranties in its policy.

  • September 23, 2024

    J&J Accuses Beasley Allen Of Casting Bogus Talc Ballots

    Johnson & Johnson has accused the Beasley Allen Law Firm of casting about two dozen false ballots against the company's latest talc bankruptcy plan without voters' consent and urged a New Jersey federal court to remove the firm from the plaintiff's steering committee as a consequence.

  • September 23, 2024

    RSV Vaccine Biz Secures $100M For Series B Funding Round

    Biopharmaceutical company Vicebio Ltd. on Monday announced that it secured its Series B funding round after securing $100 million led by science-focused investment firm TCGX.

  • September 23, 2024

    Kratom Co. Gets Claims Trimmed In Addiction False Ad Row

    A California federal judge has tossed four out of six claims from a proposed class action alleging Ashlynn Marketing Group Inc. hid from buyers the addictive qualities of its kratom products, leaving only fraud and Consumer Legal Remedies Act claims.

  • September 20, 2024

    House To Weigh Patent Bill Aimed At Cutting Drug Prices

    The U.S. House of Representatives is expected to consider a bill soon that has already cleared the Senate and could streamline patent litigation by curbing the number of patents that makers of biologic drugs can assert over biosimilar drugs.

  • September 20, 2024

    ITC Has Been Launching Fewer Section 337 Investigations

    Intellectual property activity at the U.S. International Trade Commission has "decreased somewhat," the agency said in a report Friday.

  • September 20, 2024

    Alnylam Seeks To End Inventorship Suit Tied To COVID Vax

    Alnylam Pharmaceuticals, which alleges that COVID-19 vaccines made by Pfizer and Moderna infringe its patents, has moved in Delaware federal court to dismiss a suit by former collaborator Acuitas Therapeutics Inc. seeking to have its scientists added as inventors on the patents.

  • September 20, 2024

    3rd Circ. Rejects 'Close' Case For Preemption In Fosamax MDL

    A U.S. Food and Drug Administration letter denying changes to the label of Merck's osteoporosis drug Fosamax does not count as a final agency action triggering federal preemption of state law "failure to warn" claims, the Third Circuit ruled Friday in a precedential decision.

  • September 20, 2024

    Del. Justices Uphold Toss Of AmerisourceBergen Syringe Suit

    Delaware's Supreme Court upheld with little comment Friday a lower court dismissal of a nearly 5-year-old shareholder derivative suit accusing AmerisourceBergen Corp. directors of failing to investigate and stop illegal repackaging of cancer drugs.

  • September 20, 2024

    IPO Trio Looks To Raise $536M Combined As Autumn Begins

    Three companies spanning the energy, healthcare and life sciences industries are preparing initial public offerings that could raise $536 million combined in the coming week, guided by six law firms, signaling an upturn in IPOs as autumn begins.

  • September 20, 2024

    DuPont Cos. Can't Escape Cape Fear River PFAS Suit

    A North Carolina federal judge said DuPont and several corporate spin-offs can't escape a lawsuit brought by four Tar Heel State residents who claim the companies knowingly poisoned the Cape Fear River with toxic forever chemicals pollution.

  • September 20, 2024

    Lawmakers Ask USPTO To Fix Patent Calculation Problem

    Federal patent officials need to change standards that could let drug companies hold on to patent rights beyond the time frame they are entitled to, according to federal lawmakers.

  • September 20, 2024

    Plaintiffs Firms Battle Over Proposed $9B Deal In J&J Talc Suit

    Two leading plaintiffs law firms in the multibillion-dollar litigation over Johnson & Johnson's tainted talcum powder are now warring among themselves, with Smith Law Firm PLLC suing Beasley Allen Law Firm for defamation after Beasley Allen accused the former of selling out clients to pay off litigation funders.

  • September 20, 2024

    Ex-Healthcare Exec Can't Sue GC Over Probe Advice

    A former Baxter International treasurer who was fired amid an investigation into improper foreign exchange transactions was correctly blocked from pursuing claims against the healthcare company and its general counsel over advice he received on navigating the probe, an Illinois appellate panel said Friday.

Expert Analysis

  • E-Discovery Quarterly: Rulings On Hyperlinked Documents

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    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.

  • Loper Bright Limits Federal Agencies' Ability To Alter Course

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    The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.

  • A Primer On EU's Updated Human Substance Regulations

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    The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

  • Series

    Teaching Scuba Diving Makes Me A Better Lawyer

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    As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.

  • The Road Ahead For Regulation Of Digital Twins In Healthcare

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    Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.

  • Lawyers Can Take Action To Honor The Voting Rights Act

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    As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.

  • 3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy

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    The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.

  • Opinion

    Unclear Intellectual Property Laws Are Stifling US Innovation

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    U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.

  • The Fed. Circ. In June: More Liability For Generic-Drug Makers

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    The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.

  • Opinion

    Expert Witness Standards Must Consider Peer Review Crisis

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    For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.

  • Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days

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    In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.

  • How To Grow Marketing, Biz Dev Teams In A Tight Market

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    Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.

  • Patent Lessons From 5 Federal Circuit Reversals In June

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    A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • Unpacking HHS' Opinion On Cell Therapy Refund Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

  • Series

    Rock Climbing Makes Me A Better Lawyer

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    Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.

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