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Life Sciences
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November 13, 2024
Biotech Brass Misled Investors About Cancer Drugs, Suit Says
Executives and directors of biotechnology company Agenus Inc. have been hit with a shareholder derivative suit in Massachusetts federal court alleging that the company misled investors about the effectiveness of its mainstay cancer treatments.
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November 13, 2024
Trump's Choice Of Matt Gaetz For AG Hints At Cannabis Policy
President-elect Donald Trump's announcement Wednesday that he would nominate Rep. Matt Gaetz, R-Fla., one of the relatively few Republican proponents of cannabis legalization, to be the next U.S. attorney general marks an early sign of how his administration will consider marijuana policy.
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November 12, 2024
Trump Taps Elon Musk To Head New 'Gov't Efficiency' Dept.
President-elect Donald Trump announced Tuesday that billionaire Elon Musk and former presidential candidate Vivek Ramaswamy will lead a newly created "Department in Government Efficiency" for his administration come January.
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November 12, 2024
Masimo Can't Tie Alleged IP Theft To Apple Profits, Expert Says
An Apple expert witness defended the company Tuesday in a California federal bench trial over Masimo's claim that the tech giant stole pulse oximetry trade secrets for its popular smartwatch, testifying Masimo cannot tie any value to the purported secrets and that Apple's profits can't be attributed to the watch's blood oxygen features.
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November 12, 2024
Guardant CEO Says Rival's False Ads Hurt 'Beautiful Baby'
Guardant Health's CEO testified Tuesday in his company's false advertising suit against Natera Inc. that its rival's "misleading" ad campaign hurt Guardant's colorectal cancer test launch, saying he felt like somebody had taken their "beautiful baby" and "slammed its head against the wall."
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November 12, 2024
Justices Told Fed. Circ. Overstep Claims Are 'Simply Incorrect'
A unit of pharmaceutical company Alvogen on Tuesday urged the U.S. Supreme Court to reject a petition from the company whose blockbuster IBS drug it's hoping to copy, saying the "petition's fundamental premise" that the Federal Circuit went beyond its legal boundaries "is simply incorrect."
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November 12, 2024
HIV Drug Buyers Want Gilead Product Switch Claims Revived
Insurers and benefit plans are asking the Ninth Circuit to revive a chunk of their antitrust case against Gilead, arguing their claims that Gilead delayed generic competition to its HIV drugs by monopolizing the market should have new life.
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November 12, 2024
J&J Says HHS Is Thwarting Transparency Of Drug Discounts
Johnson & Johnson claims the U.S. Department of Health and Human Services is thwarting its efforts to crack down on hospitals the company alleges are "reaping immense profits" on reduced-price medications without passing those discounts on to patients, according to a lawsuit filed Tuesday in D.C. federal court.
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November 12, 2024
Elanco Pays $15M SEC Fine To Settle Sales Incentive Claims
Elanco Animal Health Inc. has agreed to pay a $15 million fine to resolve U.S. Securities and Exchange Commission allegations that it deceptively juiced revenues with distributor sales incentives between 2019 and 2020, the regulator announced Tuesday.
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November 12, 2024
GOP Reps. Propose Another Bill On TRIPS Waivers
A new bill from Republicans in the U.S. House of Representatives seeks to force the Office of the U.S. Trade Representative to file a report "before the negotiation of any international agreement relating to an intellectual property right."
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November 12, 2024
Unsatisfied With $70M UTC Win, Sandoz Appeals To 3rd Circ.
Sandoz Inc. has moved to appeal its already $70 million-plus breach of contract damages win over biopharmaceutical firm United Therapeutics Corp., teeing up a Third Circuit request to ask for more damages and to revive antitrust claims previously tossed by a New Jersey federal court.
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November 12, 2024
Feds Can Hold Proceeds During Chinese Syringe Duties Fight
A U.S. Court of International Trade judge has approved a stipulation between the federal government and a Texas importer allowing the government to hold onto duties collected on Chinese syringes while the importer challenges the amount being charged.
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November 12, 2024
DOJ Suing To Block UnitedHealth Unit's $3.3B Amedisys Deal
The U.S. Department of Justice and four U.S. states filed a lawsuit Tuesday seeking to block UnitedHealth Group's Optum unit from going through with its planned $3.3 billion purchase of Amedisys Inc., arguing the deal will harm competition in the home health and hospice services.
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November 08, 2024
NJ Ethics Board Escapes Contempt Bid In Retaliation Fight
A New Jersey judge Friday denied a former state health official's bid to hold a Garden State ethics agency in contempt over stalled discovery in his wrongful termination suit, ruling there was no basis for the court to conclude there was any type of willful conduct to not comply with a discovery order.
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November 08, 2024
Apple Didn't Hire Cercacor CTO To Steal Watch IP, Ex-VP Says
A retired Apple executive defended the tech giant Friday in Masimo's trade secret suit over pulse oximetry technology, testifying in California federal court that Apple didn't hire a Masimo spinoff's chief technology office in order to obtain confidential information for the Apple Watch and never received any such information.
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November 08, 2024
5th Time Not The Charm For 'Stale' Dow Implant Check Fight
The Sixth Circuit has again rejected an appeal from South Korean claimants who sought replacement checks from a Dow Corning breast implant settlement fund, finding in claimants' fifth trip to the appeals court that they missed their window to cash their duly disbursed settlement checks.
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November 08, 2024
J&J Talc Unit Must Revise Ch. 11 Plan, Insurers Say
A group of Johnson & Johnson insurance carriers urged a Texas judge to reject the Chapter 11 plan disclosure statement for the company's Red River Talc unit as unconfirmable, saying J&J "made it clear that it intends to saddle its insurers with responsibility to pay" for the bankruptcy-related claims.
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November 08, 2024
Fed. Circ. Unclear If Teva Inhaler IP Belongs In Orange Book
A trio of Federal Circuit judges took a complex question tied to whether Teva should be able to include inhaler patents in the U.S. Food and Drug Administration's Orange Book and tried to make it simple: Does owning a patent for a steering wheel mean you claim the whole car?
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November 08, 2024
Ill. Judge Sends Abbott Safety Gear OT Suit To Ohio
Two Abbott Laboratories employees accusing the company of illegally failing to pay them for sanitary gear changes shouldn't litigate their claims in Chicago but rather Ohio, where a similar lawsuit they were previously part of is pending, an Illinois federal judge said.
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November 08, 2024
Ex-Elanco IP Lawyer Lodges Gender Discrimination Suit
A female former in-house intellectual property lawyer at Elanco Animal Health Inc. sued the pharmaceutical company for gender discrimination in Indiana federal court, alleging she was passed over for a promotion in favor of a less qualified man who later mistreated the women on staff.
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November 08, 2024
Judge Lets Plaintiffs Drop Kroger Pain Patch Suit
An Illinois federal judge on Friday allowed two customers who sued supermarket chain Kroger over the effectiveness of lidocaine patches to ditch their class claims after he denied certification last month, and ultimately dismiss the individual claims with prejudice.
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November 08, 2024
White & Case Adds Life Sciences IP Atty From A&O Shearman
A veteran life sciences patent litigator has jumped from Allen Overy Shearman Sterling to White & Case LLP in New York, expanding the firm’s capabilities to represent medical and pharmaceutical industry clients in complex litigation.
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November 07, 2024
Wuhan Chemical Co. Charged In Latest China Fentanyl Bust
California federal prosecutors announced Thursday that a Wuhan, China-based chemical company has been charged with exporting illegal fentanyl precursors and adulterants to the United States and other countries, the latest in a series of recent criminal actions cracking down on Chinese drug manufacturers' role in the opioid epidemic.
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November 07, 2024
Teva Fails To Convince Judge Inhaler Patents Require Drug
Five patents for an inhaler made by Teva Pharmaceuticals Industries Ltd. don't require an active drug's presence in the device, a New Jersey federal judge has ruled, agreeing with Amneal Pharmaceuticals Inc.'s interpretation of claim language in the brand-name drugmaker's infringement suit against Amneal, a generic pharmaceutical firm.
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November 07, 2024
Masimo Spinoff's Ex-CTO Denies Giving Apple Trade Secrets
Cercacor Laboratories' former chief technology officer testified Thursday that he privately emailed Apple CEO Tim Cook offering to help the tech giant become a top health and wellness device brand, but denied accusations that he gave Apple any of the Masimo spinoff's pulse oximetry trade secrets.
Expert Analysis
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.