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Life Sciences
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March 20, 2024
How The Supreme Court Could Narrow Chevron
After hours of oral argument in a closely watched administrative law case, it appeared that some U.S. Supreme Court justices could be open to limiting the opportunities for lower courts to defer to federal agencies' legal interpretations in disputes over rulemaking — and legal experts said there are a number of ways they could do it.
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March 20, 2024
2 Biotechs Unveil Separate Fundings Totaling $325M
Life sciences companies Clasp Therapeutics and Cooley-advised Capstan Therapeutics, which develop treatments for a range of health conditions including cancer and autoimmune diseases, separately announced funding rounds Wednesday that together total $325 million.
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March 20, 2024
Law360 Announces The Members Of Its 2024 Editorial Boards
Law360 is pleased to announce the formation of its 2024 Editorial Advisory Boards.
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March 20, 2024
US Chamber's Litigation Funding Concerns Spur 2 State Laws
Amid concerns from the U.S. Chamber of Commerce about third-party litigation funding, including from potentially hostile foreign entities, state legislatures in Indiana and West Virginia have recently passed bills imposing restrictions on the practice.
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March 19, 2024
Healthcare Policy Roundup: HHS Budget, Telehealth, PBMs
Amid a government funding battle, work of interest to healthcare lawyers and agency watchers was getting done on federal legislation and policy in recent days.
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March 19, 2024
Schumer Scolds McConnell For Judge-Shopping Policy Rebuff
Senate Majority Leader Chuck Schumer on Tuesday lauded the Judicial Conference's updated policy on random case assignments to prevent litigants from judge-shopping, saying that Senate Minority Leader Mitch McConnell is pushing back against the policy since it'd make it tough for hard-right partisans "to hijack our courts for their purposes."
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March 19, 2024
Acorda Says Tribunal Ignored Patent Law In MS Drug Feud
Acorda Pharmaceuticals is pressing the Federal Circuit to award it nearly $66 million more than the $16.5 million it won in arbitration against Irish biopharmaceutical company Alkermes in a licensing fight over a multiple sclerosis drug, arguing that the tribunal disregarded clear patent law.
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March 19, 2024
Law Firm Hit With Suit Over Abandoned Patent Application
A Louisiana-based medical software company has sued a law firm that was hired to help it with an application for a patent for its platform, saying the firm's alleged negligence led to the application being abandoned.
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March 19, 2024
NBA Fraudster Dodges Prison After Cooperation, Testimony
A former NBA shooting guard avoided prison Tuesday for participating in a $5 million retiree healthcare fraud scheme after Manhattan federal prosecutors lauded his assistance and testimony at a trial this past fall.
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March 19, 2024
Skin Care Drug Co. Can Ask Creditors To OK Ch. 11 Plan
A Delaware bankruptcy judge said Tuesday she will give a debtor formerly known as Timber Pharmaceuticals Inc. permission to send its Chapter 11 plan out for a vote by the dermatology drug developer's creditors, after counsel for the company explained it had expanded the creditors' ability to opt out of the plan's claim releases.
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March 19, 2024
Cancer Patient Fights Monsanto's Philadelphia Roundup Win
A cancer patient alleging that he developed his illness after using the weed killer Roundup wants to overturn Bayer AG unit Monsanto's first win in Philadelphia's Roundup mass tort, arguing that the judge's erroneous evidentiary rulings caused him to lose the case.
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March 20, 2024
Future Of Judge-Shopping Reform Hazy After Rule Proposal
The policymaking body for U.S. courts provoked a stir last week when it proposed a rule designed to curb "judge shopping," with observers saying that the policy does address one type of the practice but that it remains to be seen if individual federal district courts will be willing to adopt even that limited reform.
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March 19, 2024
OptumRx Can't Get Motley Rice Disqualified From Opioid MDL
An Ohio federal judge has denied a bid by pharmacy benefit manager OptumRx to disqualify Motley Rice LLC from representing plaintiffs in the national opioid litigation, saying the company hasn't shown that the firm's prior representation of states investigating opioids puts the company at a disadvantage in the multidistrict litigation.
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March 19, 2024
IFF Selling Pharma Unit To French Co. Roquette In $2.85B Deal
IFF, a maker of ingredients and additives for food, health and home-based products, said Tuesday it has agreed to sell its Pharma Solutions business to French plant-based ingredient maker Roquette at an enterprise value of up to $2.85 billion.
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March 18, 2024
Patent Suit Over AstraZeneca's Tagrisso Heads To Jury
A Delaware federal judge said Monday that there are too many "genuine factual disputes" to end a lawsuit from a Pfizer brand claiming it developed a cancer treatment that's being infringed by a drug that has racked up billions in sales for rival AstraZeneca.
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March 18, 2024
2nd Circ. Rejects 'New Standard' Of Patent Monopolies
A Second Circuit panel on Monday revived antitrust allegations accusing Novartis of concealing the true history of an eye syringe treatment's development from the U.S. Patent and Trademark Office to edge Regeneron out of the market, faulting a district court for holding that antitrust markets can't be "coextensive" with the patent.
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March 18, 2024
4th Circ. Sends Opioid 'Nuisance' Question To W.Va. Top Court
The Fourth Circuit asked West Virginia's high court Monday to determine whether the state's public nuisance law can be used to target companies that shipped drugs to pharmacies in a community ravaged by addiction, a crucial question in litigation spawned by the opioid crisis.
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March 18, 2024
Conn. Pharmacy, FDA Say They've Settled Suit Over Probe
Medication compounding firm SCA Pharmaceuticals and the U.S. Food and Drug Administration together have asked a Connecticut federal judge to dissolve an emergency temporary restraining order blocking the agency from publishing comments related to its contested investigation of the pharmacy, with the parties saying they have executed a settlement.
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March 18, 2024
Biotech Ardelyx Beats Shareholder Suit Over Kidney Drug
Biotechnology company Ardelyx Inc. has for now beaten a shareholder class action alleging the company and its top brass made false and misleading statements about regulatory approval of Ardelyx's drug for patients with chronic kidney disease.
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March 18, 2024
High Court Doubts Feds Coerced Social Media Cos.
A majority of the U.S. Supreme Court appeared unconvinced Monday that the Biden administration violated the First Amendment by working with social media platforms to combat the spread of misinformation, often chiding Louisiana's solicitor general for presenting confusing and overly expansive arguments.
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March 18, 2024
Kimberly-Clark Gets OK For $6M Deal Over Tainted Wipes
A Texas federal court has granted final approval to a deal worth as much as $17 million — with $3.6 million going to plaintiff attorney fees — that would resolve claims that paper products manufacturer Kimberly-Clark sold flushable wipes contaminated with a bacteria particularly dangerous to those with weak immune systems.
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March 18, 2024
Leerink Enticed Goldman Exec With False Promises, Suit Says
An investment banker says she was lured away from a senior position at Goldman Sachs to Boston-based Leerink Partners with what turned out to be a meaningless job title and false promises of guaranteed bonuses, according to a lawsuit filed Monday in Massachusetts state court.
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March 18, 2024
Amyris Gets OK To Settle Pot Co.'s $15M Trade Secret Suit
A Delaware bankruptcy judge has approved biotechnology company Amyris' $15.1 million settlement with cannabinoid manufacturer Lavvan, resolving yearslong litigation and arbitration proceedings alleging the debtor misused its then-business partner's trade secrets.
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March 18, 2024
Catching Up With Delaware's Chancery Court
Multimillion-dollar e-cigarette settlements, $4 billion in stock buybacks and a $6.1 million appraisal tweak were among the big-dollar items logged in the Delaware Court of Chancery's ledger last week. Also on the docket: a Panama port project, a news outlet's defamation case, drone disputes and a flood of mail from Tesla shareholders. In case you missed it, here's all the latest from the Chancery Court.
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March 18, 2024
Pfizer To Reduce Stake In Haleon To 24% Through Share Sale
Haleon PLC said Monday that U.S. pharmaceutical titan Pfizer Inc. will reduce its stake in the British consumer healthcare company to 24%.
Expert Analysis
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.
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How Biden's AI Order Stacks Up Against Calif. And G7 Activity
Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.
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ITC Ban On Apple Watch Could Still Be Reversed
The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.
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Incontinence Drug Ruling Offers Key Patent Drafting Lessons
In a long-awaited decision in Astellas v. Teva and Sandoz, an English court found that the patent for a drug used to treat overactive bladder syndrome had not been infringed, highlighting the interaction between patent drafting and litigation strategy, and why claim infringement is as important a consideration as validity, says George McCubbin at Herbert Smith.
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Why Hemp-Synthesized Intoxicants Need Uniform Regs
State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.
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Opinion
Life Sciences Regulators Must Write Cloud-Specific Guidance
As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.
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Fed. Circ. Elekta Holding May Make Patent Prosecution Harder
The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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Series
ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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Boeing Opinion Strikes Blow Against Overpayment Theory
The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.