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Life Sciences
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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.
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July 17, 2024
Many AI Patent Eligibility Issues Still Hazy After Guidance
The U.S. Patent and Trademark Office's new guidance on patent eligibility for inventions involving artificial intelligence provides some helpful details for patent applicants, but attorneys say it leaves unanswered questions that will likely require court decisions or legislation to sort out.
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July 17, 2024
Pharma Co. Slams Magistrate's Venue Report In Opioid Suit
A pharmaceuticals distributor is objecting to an Oklahoma federal magistrate judge's recent recommendation to deny as moot the company's bid to dismiss a Cherokee Nation suit accusing it of flooding tribal communities with opioids, saying the case shouldn't be sent to state court.
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.