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Life Sciences
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June 27, 2024
Fed. Circ. Backs Ax Of United Therapeutics' Drug Patent
The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that claims in a United Therapeutics Corp. high blood pressure drug patent challenged by Liquidia Technologies were invalid as obvious, even though Liquidia's petition included an expert declaration that did not have a required oath.
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June 27, 2024
Titanic Purdue Ruling Shifts The Balance Of Power In Ch. 11
The U.S. Supreme Court's decision to strike down the Sackler family's liability shield in the Chapter 11 plan of Purdue Pharma LP not only eliminates a key tool to resolve mass tort liabilities through bankruptcy, it gives claimants more leverage and fundamentally changes the insolvency landscape in future cases, experts tell Law360.
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June 27, 2024
EU High Court Upends Servier Decrease Of Pay-For-Delay Fine
French pharmaceutical giant Servier is back on the hook for all but €2.4 million ($2.57 million) of a more than €300 million European Union antitrust fine after the European Court of Justice upended a lower court decision that had reduced the penalty by over €100 million.
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June 27, 2024
Ex-Exec Fights Sotera's Bid To Toss Del. Stock Vesting Suit
An attorney representing a former Sotera executive said Thursday in Delaware's Court of Chancery that the lab testing and industrial sterilization firm failed to justify its request for dismissal of a lawsuit alleging the company wrongly refused to vest his purported right to 620,000 shares in the business after his departure.
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June 27, 2024
Judge OKs $10M Deal In Generic Price-Fixing MDL
Heritage Pharmaceuticals has secured a Pennsylvania federal court's blessing on the second $10 million deal it has inked this year in hopes of extricating itself from multidistrict litigation accusing the generic-drug maker of working with others to hike up the cost of off-brand drugs.
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June 27, 2024
AbbVie Buys Bowel Disease Biotech Celsius For $250M
Chicago-based pharmaceutical company AbbVie said Thursday it has acquired Celsius Therapeutics Inc., a privately held clinical-stage biotechnology company developing therapies for patients with inflammatory disease, for $250 million.
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June 27, 2024
Calif. Justices Say Patient's Choice A Factor In Product Cases
The California Supreme Court has sided with a woman alleging that a shock therapy device made by Somatics LLC caused her permanent injuries, saying she can establish that her injuries were caused by a lack of warning as long as she shows that a prudent patient would have declined treatment upon hearing a warning.
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June 27, 2024
Poor Governance Tanked Genomic Co.'s Stock, Investor Says
Poor corporate governance led to Sema4 Holdings Corp., now named GeneDx Holdings Corp., nixing hundreds of jobs and failing the Nasdaq requirement for common stock to close above $1 per share for 30 consecutive trading days, a derivative shareholder suit filed Tuesday against the genomics company's top brass alleges.
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June 27, 2024
Honeywell Says Sourcing Co. Backpedaled On Supply Deal
Honeywell has accused a sourcing company of trying to claw its way out of a contract to buy medical-grade gloves by fabricating quality concerns and launching a bogus recall in an allegedly underhanded way to make itself more appealing to potential buyers.
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June 27, 2024
Justices Nix 3rd-Party Liability Releases In Purdue Ch. 11 Plan
The U.S. Supreme Court shot down the validity of nonconsensual third-party releases in an opinion issued Thursday in the case of bankrupt drugmaker Purdue Pharma LP, potentially exposing the Sackler family members who own the company to personal liability for the company's role in the opioid crisis.
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June 26, 2024
Ex-Outcome CEO Gets 7½ Years For Fraud Conviction
Former Outcome Health CEO Rishi Shah was sentenced to 7½ years in prison Wednesday for engaging in a massive fraud through which he grew the health advertising company by lying to investors, lenders and customers about its value and capabilities.
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June 26, 2024
Biotech Co. Allowed To Appeal Red Cross Antitrust Immunity
The American Red Cross' immunity from antitrust allegations that it smothered competition for testing platelets for bacteria is back in play after a Massachusetts federal judge agreed Wednesday to let the biotech company suing the blood donation giant ask the First Circuit to revive its claims.
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June 26, 2024
Conn. Zantac Ruling To Include Sanofi As Settlement Looms
A Connecticut state judge will include Sanofi-Aventis US LLC and a related corporate entity in a forthcoming decision on whether Zantac makers must face novel innovator liability claims in the Constitution State, the judge revealed after the pharmaceutical giant suggested a ruling would help finalize a nascent settlement.
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June 26, 2024
Justices Leave Blurry Line In Place On Misinformation Fight
The U.S. Supreme Court's decision Wednesday to reverse a Fifth Circuit order prohibiting the Biden administration from joining with social media platforms to fight misinformation leaves an important First Amendment question unanswered and left Missouri's attorney general promising a continuing fight against what he called a "censorship regime."
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June 26, 2024
Moms For America Sues Biden Admin Over Vax Liability Law
Conservative nonprofit Moms for America has sued the Biden administration over a law that shields companies from COVID-19 vaccine injury lawsuits, saying the law is unconstitutional because it circumvents judicial review and violates fundamental rights, including due process and trial by jury.
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June 26, 2024
Design Patent Attys Wary Of Applicant Disclosure Proposal
Various intellectual property trade groups are expressing some skepticism toward a proposal over the United Nations using a new treaty to force design patent applicants to disclose more details in their applications.
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June 26, 2024
Justices Chide 5th Circ. In Biden Social Media Case
The Fifth Circuit relied on "clearly erroneous" facts and an overgeneralized view of standing when it ordered the Biden administration to stop working with social media platforms to combat COVID-19 and election misinformation, the U.S. Supreme Court ruled Wednesday as it threw out a challenge to the government's actions.
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June 26, 2024
Ga. High Court Told To Skip Inventor's 'Clerical Mistake' Fight
A unit of the analytics giant Clarivate is telling Georgia's highest court that a neurosurgeon's $102 million legal malpractice case over "a clerical mistake" in a patent filing from an aggrieved former FisherBroyles client is definitely "not a cert-worthy case."
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June 26, 2024
State Data Privacy Law Patchwork: Midyear Report
States jumped on the consumer data privacy law bandwagon at a brisk clip in the first half of 2024, although it remains unclear if this push will be enough to encourage Congress to finally enact a nationwide framework this year.
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June 26, 2024
Choctaw Nation Wants 9th Circ. Rehearing In CVS Arb. Dispute
The Choctaw Nation has asked the Ninth Circuit for a rehearing in an effort to undo the court's decision forcing it to arbitrate a dispute over prescription drug reimbursements with subsidiaries of CVS Health Corp., arguing it never waived sovereign immunity and did not agree to such proceedings on its Recovery Act claims.
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June 26, 2024
Apple Watch Improvement Is 'Inferior,' Docs Tell 9th Circ.
Four cardiac specialists backed medical monitoring startup AliveCor against Apple in a Ninth Circuit amicus brief Tuesday arguing a district court wrongly nixed antitrust claims by crediting the phaseout of a heart rate monitoring algorithm as an improvement when all it did was deny patient access to "potentially life-saving" technology.
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June 26, 2024
House GOP Gears Up For The End Of Chevron Deference
A new memo outlines how House Republicans are gearing up for the U.S. Supreme Court to potentially overturn the decades-old precedent that courts defer to agencies' interpretations of ambiguous statutes, as an opportunity to roll back the Biden administration's policies and reclaim Congress' power.
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June 26, 2024
Squire Patton Adds Epstein Becker Healthcare Atty In DC
An experienced healthcare and life sciences industries attorney has jumped from Epstein Becker Green PC to Squire Patton Boggs LLP in Washington, D.C., the latter firm has announced.
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June 26, 2024
Pharma Co. PhaseBio Can Exit Ch. 11 With Wind-Down Plan
A Delaware bankruptcy judge on Wednesday gave her blessing for pharmaceutical developer PhaseBio Pharmaceuticals Inc. to liquidate its assets and wind down after settlement agreements with creditors and a business partner cleared a path for it to exit Chapter 11 after roughly 19 months.
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June 26, 2024
High Court 'Inadvertently' Posts Order Punting Abortion Case
The U.S. Supreme Court mistakenly released a draft order Wednesday that would allow emergency abortions in Idaho, with a majority saying the court was wrong to consider a state challenge at this time.
Expert Analysis
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.