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Life Sciences
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September 10, 2024
Neb. Midwife Can't Sue For 'Hypothetical' Clients, Judge Rules
A Nebraska midwife who challenged state restrictions on the practice "barely" tried to establish grounds to sue the state over allegations that her would-be clients were being harmed, a federal judge ruled Monday, dismissing the case.
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September 10, 2024
Cybersecurity Co. Beats Suit Over Med Tech Data Breach
A Massachusetts federal judge declined to hold information security technology company Barracuda Networks Inc. liable over a 2018 data breach that exposed the confidential information of more than 277,000 patients of medical device maker Zoll Medical Corp.
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September 10, 2024
House Reps. Float Bill To Limit Patent Invalidations
A bipartisan bill that would reset patent eligibility standards has been introduced in the U.S. House of Representatives, over a year after a similar Senate bill was put forward that drew opposition from much of the tech and retail industry.
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September 10, 2024
Philips Balks At Dentons' Request To Exit IP Case
Dutch health technology conglomerate Philips Medical Systems Nederland BV is balking at Dentons US LLP's request to withdraw as counsel for Transtate Equipment Co. Inc. in a wide-ranging copyright and unfair competition case, insinuating that the move is a stalling tactic to avoid a final judgment.
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September 10, 2024
Free Speech Or Bad Medicine? The Abortion 'Reversal' Battle
The marketing of abortion pill "reversal" — a treatment doubted by medical groups but touted by anti-abortion advocates — is facing increased scrutiny from state attorneys general, triggering legal skirmishes in at least four states centered on First Amendment rights and consumer protection laws.
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September 10, 2024
Swedish Biopharma Vicore Announces Plans To Raise $75M
Vicore said Tuesday that it aims to raise approximately 782 million Swedish kronor ($75 million) to finance projects and operations by issuing shares to investors, advised by Swedish law firm Vinge, with the joint bookrunners led by Baker McKenzie.
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September 17, 2024
Cooley Hires Team For Emerging Companies And VC Practice
Cooley LLP said Tuesday that it has recruited the head of Taylor Wessing LLP's emerging companies and venture capital practice, one of three partner hires as it seeks to boost its transactional ability in London, part of a broader plan for growth in the English capital.
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September 09, 2024
Ex-Outcome CEO Says Issues Warrant Bond Pending Appeal
Former Outcome Health CEO Rishi Shah urged an Illinois federal judge Monday to let him remain on bond while he appeals his fraud conviction and sentence, arguing he has teed up multiple substantial issues that could lead the Seventh Circuit to order a redo.
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September 09, 2024
Pa. Supreme Court Snapshot: Benefits, Cannabis, Taxes
The Pennsylvania Supreme Court's September schedule will have the justices pondering when to cancel tax exemptions for hospitals, if stormwater fees are taxes in disguise, and the potential resurrection of requiring medical marijuana products to be tested and approved by two separate laboratories.
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September 09, 2024
Exec Denied New Trial In 'Shadow Trading' Case, Fined $321K
A California federal judge on Monday denied a new trial request from an ex-Medivation Inc. executive found to have used the pharmaceutical company's inside information when he bought a rival's stock, and also ordered him to pay a $321,000 penalty in the U.S. Securities and Exchange Commission's "shadow trading" case.
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September 09, 2024
Insurer Needn't Cover Lab Fraud Suits, Ill. Judge Rules
An insurer has no obligation to defend or indemnify a property management company or its owner in two underlying lawsuits accusing the owner of concealing financial information from a minority owner in a jointly formed laboratory, an Illinois federal judge said, finding that the underlying suits alleged intentional misconduct.
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September 09, 2024
Ex-Finance Exec To Pay SEC $110K In Insider Trading Action
A former finance director of pharmaceutical company Inhibrx Inc. has agreed to pay over $110,000 to resolve U.S. Securities and Exchange Commission allegations that he bought his employer's shares as it prepared to announce good news about its principal drug candidate.
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September 09, 2024
Purdue Sees Another OxyContin Patent Axed
A Delaware federal court decided on Monday that yet another patent issued to bankrupt OxyContin maker Purdue Pharma is invalid, a year and a half after a similar ruling was issued in another case about the company's efforts to assert different patents to stop the same prospective Indian manufacturer of generic painkillers.
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September 09, 2024
Abbott Says Illinois OT Suit Should Join Similar Case In Ohio
Abbott Laboratories asked an Illinois federal judge Friday to send two workers' dispute over unpaid sanitary gear changes and hand washings to Ohio where a similar suit is pending, arguing that the move would promote consistent judgments across the "nearly identical" claims.
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September 09, 2024
House OKs Bill To Bar Contracts With Chinese Biotech Cos.
Driven by concerns about U.S. genetic data being shared with the Chinese government, House lawmakers passed a bill on Monday to bar federal agencies from buying certain biotechnology linked to the Chinese government or from contracting with firms that use those products.
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September 09, 2024
FTC Backs Teva Orange Book Delisting At Fed. Circ.
The Federal Trade Commission is continuing to back Amneal's efforts to have Teva's inhaler patents delisted from the U.S. Food and Drug Administration's Orange Book, telling the Federal Circuit that a lower court was right in determining that Teva's patents do not satisfy the registry's requirements.
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September 09, 2024
Biotech Execs Face Investor Suit Over Medicare Claims
Executives and directors of biopharmaceutical company Ardelyx have been hit with a shareholder derivative suit in Massachusetts federal court alleging the company misled investors over its intentions and ability to apply for a Medicare reimbursement program for its kidney disease treatment.
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September 09, 2024
Generics Makers Want Mo. Sanctioned In Price-Fixing Case
Teva Pharmaceuticals Inc., Mylan Inc. and other generic-drug makers accused by state enforcers of fixing prices have urged a Connecticut federal judge to punish the state of Missouri for failing to provide information requested by the drug companies.
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September 09, 2024
MBX Biosciences Seeks Up To $136M In Upcoming IPO
Indiana-based clinical-stage biopharmaceutical company MBX Biosciences Inc. on Monday set the terms for its initial public offering, with plans to raise up to $136 million.
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September 09, 2024
Baltimore Strikes $80M Opioid Settlement With Teva
Teva Pharmaceuticals will pay Baltimore $80 million to resolve claims that the company inflamed the city's opioid crisis, the city of Baltimore announced Monday ahead of a trial slated to begin next week against the remaining defendants in the Maryland state court litigation.
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September 09, 2024
Novo Nordisk Sues Over Ads For Diabetes, Weight Loss Drugs
A New Jersey company violated trademark and false advertising laws by promoting drugs without a regulatory green light as being generic versions of Novo Nordisk's Ozempic and Wegovy medications, according to a lawsuit filed in New Jersey federal court.
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September 09, 2024
Novartis Settles Sales Rep.'s Gender Bias Suit
A former sales representative with Novartis Pharmaceuticals Corp. has settled a lawsuit against the company alleging she faced gender-motivated retaliation after reporting a co-worker for falsifying records and hurting her sales numbers.
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September 09, 2024
Catching Up With Delaware's Chancery Court
Delaware's Court of Chancery made some expensive decisions last week, ranging from a $130 million stockholder award and a freeze on $450 million in equity financing to a whopping $1 billion bill for fraud and breach of contract damages. New cases aimed at Virgin Galactic, settlements pulled in Hemisphere Media Group Inc. and court hearings involving Apollo Global Management heated up. In case you missed it, here's the roundup of news from Delaware's Court of Chancery.
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September 09, 2024
2nd Circ. Upholds Regeneron's Win In Remote Work Suit
The Second Circuit rejected a former Regeneron Pharmaceuticals Inc. employee's appeal seeking to revive claims it illegally denied her a remote work situation to care for her daughter while she underwent medical care, ruling Monday that there was no evidence the company had willfully broken the law.
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September 09, 2024
Ore. Seeks Dismissal Of Psilocybin Disabilities Suit
Oregon's health regulator has asked a federal judge to dismiss a lawsuit challenging aspects of the state's pioneering regulated psilocybin treatment program, saying that the program's illegality under federal law makes the lawsuit untenable.
Expert Analysis
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.