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Life Sciences
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December 19, 2024
PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law
The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."
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December 19, 2024
FTC Says PBMs Can't Get Preliminary Block In Insulin Case
The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.
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December 19, 2024
Foley Adds Tech, Life Sciences Partner From IP Boutique
Foley & Lardner LLP has hired a longtime partner from intellectual property boutique Lerner David LLP to strengthen both the transactional and litigation arms of its technology and life science practices in New York.
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December 19, 2024
Judge Wrongly Axed $107M IP Verdict, Pfizer Tells Fed. Circ.
A Pfizer unit has told the Federal Circuit that a federal judge got it wrong when he overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents.
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December 19, 2024
Biotech Co. Hid Eye Drug's Safety Risks, Investor Says
A biotech company concealed the potential risks that emerged during clinical trials of a drug meant to treat age-related vision degradation, according to an investor complaint filed in Massachusetts federal court Thursday.
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December 19, 2024
Medical Supplies Giant, Drone Operator File Confidential IPOs
Private equity-backed medical supplies giant Medline Inc. and drone operator Airo Group Holdings Inc. said Thursday that they confidentially filed plans for initial public offerings with regulators, joining a growing pipeline of IPO prospects for 2025.
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December 19, 2024
McKesson Urges Justices To Keep Hobbs Act's 'Exclusivity'
McKesson Corp. is urging the U.S. Supreme Court to preserve circuit courts' "exclusive" jurisdiction for Federal Communications Commission orders, warning that regulatory consistency nationwide could be undermined if lower courts are allowed to step in.
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December 19, 2024
Medical Device Investors Get Final OK On $15M Deal
A North Carolina federal judge has given final approval to a $15.25 million settlement that will resolve a suit claiming Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices, along with $5 million in attorney fees.
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December 19, 2024
Generic-Drug Cos. Get State AGs' Trial Order Flipped
A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.
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December 19, 2024
Labcorp Settles Competition Suit Against Ex-Sales Exec
Less than two weeks after Laboratory Corp. of America Holdings sued its former sales marketing executive and his new employer in North Carolina federal court for allegedly violating noncompete and nonsolicitation agreements, a deal has been reached to end the lawsuit.
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December 19, 2024
FDA Declaration May Restart Compounders' Shortage Suit
Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.
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December 19, 2024
Fresenius Loses Invalidity Argument In Nausea Drug IP Fight
Fresenius Kabi USA LLC has lost its arguments in Delaware federal court that claims in a pair of Heron Therapeutics patents for a nausea drug were invalid, keeping Fresenius' generic from entering the market for around a decade.
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December 19, 2024
Philips CPAP Suits Against SoClean Tossed From MDLs
A Pennsylvania federal judge has tossed two complaints from Philips RS North America against SoClean Inc. from multidistrict litigation stemming from a CPAP machine recall, saying one would disrupt the wrap-up of the MDL surrounding Philips' products, while the other should not have been filed directly into the SoClean MDL.
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December 18, 2024
Pharma Trial Consultant To Pay SEC $3M Over Insider Trading
An oncologist and clinical professor at the University of California, Irvine agreed to pay the U.S. Securities and Exchange Commission $3 million to resolve allegations he purchased shares in a Massachusetts biotech company based on insider information regarding a clinical trial he was overseeing, the SEC announced Wednesday.
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December 18, 2024
Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try
A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
J&J Unit Beats Schizophrenia Drug IP Challenge On Remand
Teva Pharmaceuticals USA Inc. has failed to invalidate claims in a patent for a Johnson & Johnson unit's blockbuster schizophrenia medicine, according to a New Jersey federal judge who rejected the generic-drug maker's assertions that the formula was obvious.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
RJ Reynolds Asks Justices To Toss Forum Shopping Argument
R.J. Reynolds Vapor Co. is urging the U.S. Supreme Court to reject the U.S. Food and Drug Administration's argument that the vape company engaged in forum shopping when it challenged denial of one of its applications in the Fifth Circuit, saying its Texas- and Mississippi-based co-petitioners make the Fifth Circuit the proper venue.
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December 18, 2024
SiteOne Gets $100M To Advance Non-Opioid Pain Treatments
SiteOne Therapeutics Inc., a biopharmaceutical company focusing on pain treatment, on Wednesday announced that it clinched a Series C funding round after securing $100 million from investors.
Expert Analysis
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The Bar Needs More Clarity On The Discovery Objection Rule
Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.
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How Patent Landscape Analysis Drives Business Growth
Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.
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In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling
When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.
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Marching In On Orange Book Drugs May Have Limited Effect
Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.
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Series
Being A Navy Reservist Makes Me A Better Lawyer
Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Next Steps In The $2.8B Blue Cross Payout To Providers
Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.
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So You Want To Move Your Law Practice To Canada, Eh?
Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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Trump Rollback Of Biden Enviro Policies: What To Expect
Donald Trump's upcoming second presidential term will usher significant shifts in U.S. environmental and natural resource law and policy — and while the Biden administration is racing to secure its legacy, the incoming Trump administration is making plans to dramatically roll back most, if not all, of Biden's environmental initiatives, say attorneys at Beveridge & Diamond.
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Takeaways From State Votes On Abortion In The 2024 Election
Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.
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Key Territory-Split Licensing Lessons For Life Sciences Cos.
Territory-split deals can allow life sciences companies to maximize products' potential across a range of geographic areas, but these deals also present unique challenges requiring highly bespoke structures that can make or break the value of an asset, say attorneys at Covington.
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Legislation Most Likely To Pass In Lame Duck Session
As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.
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Justices Must Weigh Reach Of Civil RICO In Cannabis Case
Oral arguments in Medical Marijuana Inc. v. Horn suggest that a majority of the U.S. Supreme Court may agree that a truck driver's losing his job after unknowingly ingesting THC and failing a drug test does not merit a racketeering claim — but the court may not buy the other side's theory of the case either, say attorneys at Lewis Baach.
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Litigation Strategies In View Of New Double Patenting Rulings
Recent Federal Circuit decisions, including in Allergan v. MSN, raise several issues that patent owners should understand and consider addressing proactively regarding obviousness-type double patenting, at least in their prosecution strategies, say attorneys at Dentons.