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Life Sciences
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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%.
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March 16, 2024
Up Next At High Court: Gov't Jawboning & Retaliatory Arrests
The U.S. Supreme Court has a packed oral arguments calendar this week that includes disputes over the Biden administration's work with social media companies to combat misinformation, the appropriate evidence standard for bringing retaliatory arrest claims and whether the federal government can object to a consent decree entered into by three states.
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March 15, 2024
Judiciary Clarifies Judge Shopping Policy After Senator Letter
The Judicial Conference of the United States said Friday that its updated policy aimed at preventing litigants from shopping for the judge of their choice is not intended to overstep judges' authority or discretion under the law, issuing guidance one day after Republican senators pushed back against the policy.
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March 15, 2024
8th Circ. Nixes Arbitration Bid In $9M Chinese PPE Fight
The Eighth Circuit on Thursday refused to force a Chinese manufacturer of personal protective equipment to arbitrate its $9 million dispute over unpaid invoices with a U.S. distributor, ruling in a published opinion that the underlying pact containing an arbitration clause was never consummated.
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March 15, 2024
'Cobra Venom' Painkiller Co. Inks Deal To Settle SEC Claims
A penny stock company that previously held itself out as a maker of cobra venom-infused pain drugs has agreed to resolve U.S. Securities and Exchange Commission fraud claims, according to court filings that note the company's two principals have also reached a settlement.
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March 15, 2024
Enfamil Maker Hit With $60M Jury Verdict In Infant Death Suit
An Illinois jury has awarded $60 million to the mother of an infant who died after using Mead Johnson's Enfamil formula, a loss for the company in the first of hundreds of suits to go to trial alleging certain cow's milk-based formulas cause a fatal illness in premature infants.
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March 15, 2024
Hospitals Say Constitutional Defenses Valid In FTC Merger Row
Two North Carolina hospital systems shot back at the Federal Trade Commission's contention that constitutional defenses are immaterial to the agency's challenge of a $320 million merger plan, arguing that case law shows that striking the positions would be premature.
Expert Analysis
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How Legal Teams Can Prep For Life Sciences' Tech Revolution
The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.
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Series
ESG Around The World: South Korea
Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.
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General Counsel Need Data Literacy To Keep Up With AI
With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.
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Trending At The PTAB: Administrative Procedure
A pair of recent Federal Circuit rulings on Patent Trial and Appeal Board inter partes review shed light on applications of the Administrative Procedure Act, adding to an ever-growing body of case law showing the board's final written decision must be based on arguments clearly put forth by the parties, say Robert High and Benjamin Saidman at Finnegan.
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Rite Aid's Reasons For Ch. 11 Go Beyond Opioid Suits
Despite opioid-related lawsuits being the perceived reason that pushed Rite Aid into bankruptcy, the company's recent Chapter 11 filing reveals its tenuous position in the pharmaceutical retail market, and only time will tell whether bankruptcy will right-size the company, says Daniel Gielchinsky at DGIM Law.
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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A Look At DOJ's New Nationwide Investment Fraud Approach
Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.
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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.