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Life Sciences
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July 23, 2024
4 Firms Guide SPAC Mergers Targeting AI, Cannabis Sectors
An AI-powered startup that vows to combat "disinformation" and a medical cannabis developer have agreed to go public by merging with special purpose acquisition companies through separate deals unveiled this week, guided by four law firms and a law office.
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July 22, 2024
GSK Inks $4.5M Deal Resolving 'Non-Drowsy' Robitussin Suit
GlaxoSmithKline has agreed to pay $4.5 million as well as remove the "non-drowsy" label from its Robitussin cough medicine to put to rest allegations it mislabeled the medicine, which consumers claim does cause drowsiness, according to a motion filed Monday in New York federal court.
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July 22, 2024
AbbVie Challenges Mo. Drug Discount Program Requirements
AbbVie Inc. on Monday asked a Missouri federal court to block a state law that adds requirements to participate in the federal drug discount program, claiming that the measure violates both the federal and Missouri constitutions.
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July 22, 2024
USPTO Wins Dismissal Of Danish Co.'s PTSD Drug Lawsuit
A Virginia federal judge has ruled that the U.S. Patent and Trademark Office appropriately rejected drugmaker Lundbeck's request for three additional months of patent exclusivity for a PTSD drug, saying the agency could dock those days due to the impermissible gray shading of some text in the company's patent application.
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July 22, 2024
Tevra Says Bayer Owes Millions As Antitrust Trial Opens
Tevra Brands LLC told a California federal jury during antitrust trial openings Monday that Bayer owes millions of dollars for allegedly cutting anticompetitive deals with retailers to undermine competition from anti-flea-and-tick treatment generics, while Bayer defended its "reasonable" and optional retailer discounts and criticized Tevra's "astronomical" damages demand.
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July 22, 2024
Allarity Warns Of SEC Suit Over Cancer Drug Statements
Clinical stage pharmaceutical company Allarity Therapeutics informed investors Monday that the U.S. Securities and Exchange Commission is preparing to sue following an investigation into statements the company made as it sought approval for a new cancer treatment.
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July 22, 2024
Michigan's Cases To Watch 2024: A Midyear Report
Michigan's highest court is preparing to take on cases that could restore imperiled PFAS regulations, prevent employers from cutting short employees' window to file civil rights claims and expand the reach of Michigan's consumer protection law. Here are some of Michigan's most important cases to watch for the rest of the year.
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July 22, 2024
Price-Fixing Claims Against Par Pharma On Chopping Block
A Connecticut federal judge has asked a coalition of states to explain why he shouldn't toss two price-fixing lawsuits against Par Pharmaceutical Companies Inc., noting that the defendant and its parent, Endo International PLC, recently filed Chapter 11 reorganization plans shielding them from the cases.
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July 22, 2024
DuPont, NC To Drop Docs Dispute In 'Forever Chemicals' Case
North Carolina and DuPont have come to terms in a dispute over allegedly missing documents as part of the state's lawsuit alleging the predecessor of Chemours and other chemical companies poisoned North Carolina's environment with "forever chemicals."
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July 22, 2024
Groups Ask 3rd Circ. To Reverse Medicare Drug Price Rulings
A conservative group was one of several organizations to file amicus curiae briefs with the Third Circuit on Friday urging it to reverse a lower court's finding that Medicare's ability to negotiate drug prices with pharmaceutical companies does not run contrary to the companies' constitutional rights.
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July 22, 2024
Anthem Blue Cross Wants Lab's $3.8M Suit Tossed
Anthem Blue Cross Blue Shield of Connecticut has asked a federal judge to toss a medical lab's lawsuit seeking nearly $3.8 million from it for refusing to pay for or underpaying for lab work and COVID-19 tests, arguing the claims are "baseless."
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July 22, 2024
1st Circ. Hints At Higher Bar For Feds In Anti-Kickback Cases
The First Circuit on Monday questioned the government's assertion that Congress intended to broaden the standard for liability in False Claims Act kickback cases when it passed a key amendment in 2010.
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July 22, 2024
Lack Of 'Smoking Gun' Sinks J&J's Bid To DQ Beasley Allen
The Beasley Allen Law Firm may represent plaintiffs in multicounty talc injury litigation in New Jersey state court, after a judge found Johnson & Johnson failed to show a former Faegre Drinker outside counsel shared information he learned representing the company in earlier talc litigation.
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July 22, 2024
Catching Up With Delaware's Chancery Court
A $6 million bank fee, a $42.5 million shopping mall deal, some questionable Amazon deliveries and long-ago expired ketchup: it was all part of the comings and goings in Delaware's Court of Chancery last week. New cases involved mining and cybersecurity companies, board takeovers, "weaponized" director election provisions, and legal fees following a $3.1 billion telecom merger. In case you missed it, here's the latest from the Chancery Court.
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July 19, 2024
Jazz Says Narcolepsy Drug Charge MDL Should Be Tossed
Jazz Pharmaceuticals urged a California federal judge to toss claims from insurers and consumers pursuing multidistrict litigation accusing the drugmaker of staving off generic competition to its blockbuster narcolepsy medicine Xyrem through antitrust conduct and deals with other drugmakers, saying the company engaged in "permissible competition."
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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.
Expert Analysis
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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.
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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.