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Life Sciences
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July 19, 2024
House IP Committee Heads Unveil Drug Pricing Bill
Reps. Darrell Issa, R-Calif., and Hank Johnson, D-Ga., respectively the chair and top Democrat of the House intellectual property subcommittee, on Friday introduced a new bill that would change patent law to increase competition in the prescription drug market in order to lower patient costs.
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July 19, 2024
Splenda Must Face False Ad Suit Over Diabetes Benefits
The maker of Splenda cannot escape a proposed class action alleging that it has falsely advertised its products as healthy and "suitable for people with diabetes" after a California federal judge found that federal law does not preempt any of claims the consumers made under state laws.
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July 19, 2024
Conn. Hospital Didn't Heed Insulin Pen Warnings, Maker Says
A Connecticut hospital "ignored" clear warnings from the manufacturer of insulin pens and federal regulators to avoid using the devices on multiple patients, leading to a $1 million class settlement, Novo Nordisk Inc. told a federal judge in urging the dismissal of a lawsuit against the pharma giant.
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July 19, 2024
Boehringer Looks To Toss Inhaler Antitrust Case
Boehringer Ingelheim Pharmaceuticals Inc. urged a Massachusetts federal court to toss a proposed class action accusing it of blocking generic versions of two inhaler medications, saying it has valid patents protecting the products.
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July 19, 2024
Boehringer Long Ignored Zantac's Cancer Signs, Jury Hears
Boehringer Ingelheim had the warning signs for years suggesting Zantac's active ingredient degraded into a carcinogen but "purposefully ignored" them to market the drug as a safe and effective heartburn treatment, a prostate cancer patient told a Cook County, Illinois, jury Friday.
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July 19, 2024
Amazon Gets Tainted Eye Drop Suit Pared Down
A Pennsylvania federal judge has trimmed claims from a woman's lawsuit against Amazon and multiple drug companies alleging she had to have her left eye surgically removed after using EzriCare eye drops linked to an outbreak of an infectious bacteria.
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July 19, 2024
A Guide To The USPTO's Long List Of Requests For Comment
The U.S. Patent and Trademark Office has kept attorneys busy this year by seeking input on numerous patent issues and proposed rules. Here's a cheat sheet to the topics where feedback has been collected, from fee hikes to director reviews, and those with upcoming comment deadlines, including artificial intelligence.
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July 19, 2024
McCarter & English Pushes To End Biotech Malpractice Row
McCarter & English LLP faced accusations Friday in New Jersey state court that it was making "fictitious" defenses in a malpractice suit by a biotechnology company, saying in response that it was being treated as a "scapegoat."
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July 19, 2024
Gout-Focused Biotech Raises $60M In Latest Funding Round
Biotechnology company GRO Biosciences Inc. on Friday revealed that it clinched its oversubscribed Series B funding round after raising $60.3 million from investors, which will be used to help push the company's refractory gout treatments to clinic.
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July 19, 2024
Ex-Pharma Sales Exec Denies Fake Prescription Scheme
The former vice president of sales for pharmaceutical company U.S. Compounding Inc. pled not guilty in Manhattan federal court Friday to forging fake horse drug prescriptions in order to juice revenues.
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July 19, 2024
Regeneron Rips DOJ's FCA Suit As 'Divorced From Reality'
Regeneron Pharmaceuticals Inc. has told a Massachusetts federal judge that a False Claims Act suit brought by the U.S. Department of Justice claiming the company withheld information about a drug's average sales price was "divorced from reality" and the practice the government was complaining about was commonplace.
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July 19, 2024
Cooley, Latham Lead Biotech Firm Artiva's Upsized $167M IPO
Venture-backed Artiva Biotherapeutics Inc. rallied in debut trading Friday after the drug developer priced an upsized $167 million initial public offering below its price range, represented by Cooley LLP and underwriters' counsel Latham & Watkins LLP.
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July 18, 2024
DaVita To Pay $34M In Medicare Kickback Whistleblower Suit
Dialysis company DaVita will pay more than $34 million to settle a Medicare fraud case over alleged kickbacks doctors received in exchange for patient referrals, after a whistleblower from the company's C-suite came forward, the U.S. Attorney's Office for the District of Colorado announced Thursday.
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July 18, 2024
Abbott Wins Trust Asset Freeze To Collect $33M In TM Fight
A New York federal judge has agreed to freeze trusts tied to a couple who owe Abbott Laboratories $33.4 million in sprawling trademark litigation over gray-market diabetes test strips, finding an asset freeze is necessary due to the defendants' "pervasive and repeated" use of the trusts for personal expenses and gambling.
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July 18, 2024
Apple Wants 2 Trials In Masimo Trade Secrets And Patent Row
Apple has told a California federal judge that a November retrial in Masimo's suit against it should only cover claims including trade secrets that led to a mistrial last year after Masimo sought $1.85 billion, and that Masimo's patent claims should be tried later.
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July 18, 2024
Vidal Backs 'Egregious Abuse' Findings Against Vaccine Maker
U.S. Patent and Trademark Office Director Kathi Vidal has upheld a Patent Trial and Appeal Board decision to punish Longhorn Vaccines & Diagnostics for "egregious abuse of the PTAB process," a status report in a Utah federal case indicates.
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July 18, 2024
Biopharma Shareholder Sues In Del. For Docs On Akeso Deal
A shareholder of Summit Therapeutics Inc. sued the Florida biopharmaceutical company in Delaware's Court of Chancery on Thursday, seeking corporate records to investigate whether a $520 million financing arrangement connected to a partnership with Akeso Inc. benefited the company's co-CEOs at the expense of public stockholders.
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July 18, 2024
LegitScript Asks 9th Circ. To Ax Price-Checker Antitrust Suit
LegitScript has told the Ninth Circuit that PharmacyChecker cannot bring antitrust claims for allegedly having its price-checking website blacklisted because the bulk of its business is geared towards helping people illegally import prescription drugs.
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July 18, 2024
Ocugen Execs Hit With Derivative Suit Over Shoddy Controls
The top brass at biopharmaceutical company Ocugen Inc. were hit with a derivative suit alleging the company's lack of effective internal financial controls caused it to be misvalued and allowed shareholders to approve proposals based on incomplete information.
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July 18, 2024
GSK, Boehringer Face Jurors Again On Zantac Cancer Claims
GlaxoSmithKline and Boehringer Ingelheim returned to Illinois state court Thursday, where they face separate juries to defend against Zantac users' claims that the drug caused them to develop cancer.
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July 18, 2024
Docs Get Same Hefty Opioid Sentences Despite Top Court Win
Two Alabama doctors accused of unlawfully prescribing patients fentanyl and other opioids failed to shave time off their lengthy prison sentences despite a landmark U.S. Supreme Court decision that raised the bar for such prosecutions.
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July 18, 2024
Pharma Biz Buys Animal Medicine Co. For Up To $520M
Latham & Watkins LLP-advised animal health therapeutics company Invetx, which is currently owned by life sciences-focused investment management firm Novo Holdings, on Thursday announced plans to be bought by veterinary pharmaceuticals company Dechra Pharmaceuticals Ltd., advised by Kirkland & Ellis LLP, for up to $520 million.
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July 18, 2024
Ga. Mineral Co. Can't Nab Win In Row Over Talc Suit Coverage
A Georgia federal judge declined to grant a win to a mineral products company trying to compel a Travelers unit to defend it against an underlying suit claiming that it supplied asbestos-containing talc products.
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July 18, 2024
PharMerica Inks $100M Deal In 13-Year-Old Whistleblower Suit
PharMerica Corp. has agreed to pay $100 million to settle a former New Jersey nursing home owner's long-running whistleblower litigation over an alleged drug kickback scheme, according to the plaintiff's law firm.
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July 17, 2024
ITC Affirms Lab Equipment Co.'s Patent Wasn't Infringed
The U.S. International Trade Commission has upheld an administrative law judge's finding that a California biotechnology outfit did not infringe a German laboratory equipment supplier's patent.
Expert Analysis
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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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.