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Life Sciences
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July 24, 2024
Patent Cap In Drug Pricing Bill Seen As Having Muted Effect
The U.S. Senate recently passed a bill aiming to lower drug prices by limiting the number of patents that can be asserted in cases over biosimilars, but attorneys say the measure's numerous exceptions make it unlikely to have a major effect on litigation or consumer costs.
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July 24, 2024
McCarter & English Beats Biotech Malpractice Suit In NJ
McCarter & English LLP defeated a New Jersey biotechnology company's legal malpractice suit this week, following a New Jersey state judge's finding that the malpractice claims should have been brought in an earlier round of litigation over unpaid legal fees.
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July 24, 2024
Ex-Pharma Exec Gets Jail For Insider Trading On Kodak Loan
A Manhattan federal judge sentenced a former pharmaceutical executive from South Carolina to three months in prison Wednesday for taking over $500,000 of illegal trading profit based on his advance knowledge that Kodak would get a massive pandemic-era government loan.
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July 24, 2024
Priest Loses Fee Bid After 'Split Baby' SEC Verdict
A Greek Orthodox priest and hedge fund founder who largely beat a U.S. Securities and Exchange Commission suit is not entitled to recoup $1.7 million in legal fees because the commission was justified in bringing the case, a Boston federal judge ruled Tuesday.
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July 23, 2024
Meet The Lead Ozempic Lawyers
The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.
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July 23, 2024
Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient
Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.
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July 23, 2024
$680M Allergan FCA Suit Tossed After High Court Revival
A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.
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July 23, 2024
Invitae's Ch. 11 Plan Needs Tweaking, Judge Says
A New Jersey bankruptcy judge said he would confirm the Chapter 11 liquidation plan for genetic testing company Invitae, if it made changes to how it handled distributions to certain creditors.
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July 23, 2024
4th Circ. Says Bad Jury Instructions Gave J&J Win In Mesh Suit
The Fourth Circuit has vacated a judgment in Ethicon Inc. and Johnson & Johnson's favor in a suit from a woman alleging Ethicon's pelvic mesh was defective, saying a federal judge was wrong to limit her expert's opinion based on the so-called elimination mandate.
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July 23, 2024
Ex-Celgene Exec Off The Hook For Statements To Investors
Celgene Corp.'s former chief operating officer on Tuesday escaped some claims in a class action contending that the biopharmaceutical company artificially inflated its share price, with a New Jersey federal court finding that the ex-executive never made nor could he be linked to the statements that were issued by the company.
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July 23, 2024
Feds Urge 6th Circ. To Affirm Pharma Owner's Fraud Sentence
The Sixth Circuit should affirm a district court's fraud convictions, nearly five-year sentence and $7 million restitution order against an Ohio pharmaceutical salesman who underreported his income to reduce his tax liability in a multimillion-dollar scheme involving bogus insurance billings, the federal government said.
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July 23, 2024
Chancery Slams 'Squishy' Deal In 'Tagalong' BioMarin Suit
A visibly irritated Delaware Chancery Court judge on Tuesday rejected a settlement with BioMarin Pharmaceuticals Inc. that would have given shareholder attorneys $1.25 million in exchange for broad releases and "squishy" governance reforms, saying he didn't want to encourage "tagalong litigation" that yielded only "ephemeral" benefits.
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July 23, 2024
Split 2nd Circ. Keeps Zantac Suits In Conn. State Court
A split Second Circuit panel on Tuesday allowed nine consolidated suits over carcinogens in heartburn medication Zantac to remain in Connecticut state court, with the majority ruling that the cases' consolidation is not enough to open up federal jurisdiction.
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July 23, 2024
Senate Dems Roll Out Bill To Codify Chevron Deference
Sen. Elizabeth Warren, D-Mass., led a group of Democratic senators Tuesday in introducing a bill to codify the now-defunct doctrine of Chevron deference after it was struck down by the U.S. Supreme Court last month.
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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."
Expert Analysis
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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Mitigating Incarceration's Impacts On Foreign Nationals
Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.
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Contract Disputes Recap: Saying What Needs To Be Said
Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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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.