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Life Sciences
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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.
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November 07, 2024
Ex-Natera VP Defends Ad Campaign Against Rival Guardant
A former Natera Inc. marketing vice president defended the company Thursday in a false advertising case launched by Guardant Health Inc., testifying that there was a sales and marketing campaign against Guardant's Reveal colorectal cancer test, but its aim was to address Guardant's "misleading" claims.
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November 07, 2024
3rd Circ. Says Tainted Bayer Antifungals Clearly 'Worth Less'
Four of the nine named plaintiffs in a proposed class action over Bayer's 2021 recall of potentially benzene-tainted antifungal sprays can revive their claims against the company on the grounds that they'd paid for an effectively worthless product, a Third Circuit panel ruled Thursday.
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November 07, 2024
FDA Wants Ineffective Decongestant Removed From Market
The U.S. Food and Drug Administration on Thursday suggested removing the widely used decongestant phenylephrine as an active ingredient in over-the-counter cold and allergy medicines after an agency review determined that the drug is ineffective when taken orally.
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November 07, 2024
Ill. Judge Anticipates 'Massive' Outcome Investor Restitution
An Illinois federal judge signaled Thursday that he anticipates three former Outcome Health executives will pay a "massive" amount in restitution to investors such as Goldman Sachs and CapitalG that were persuaded to give Outcome money in a fraudulent effort to grow the company.
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November 07, 2024
Researcher Sues DEA Over Pot Rescheduling Process
A psychedelic researcher has asked a Washington federal judge to block the Drug Enforcement Administration from proceeding with its plan to hold administrative hearings on a proposal to reclassify marijuana, alleging various breaches of administrative law.
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November 07, 2024
Eye Drop Maker To Pay $3.6M To Settle Class Claims
A maker of homeopathic eye drops has agreed to pay nearly $3.6 million to settle claims its products are being sold as drugs without U.S. Food and Drug Administration approval and don't meet manufacturing safety standards, according to a preliminary settlement agreement filed Wednesday.
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November 07, 2024
Teva Can't End Inhaler Antitrust Suit But Gets Claim Nixed
A Massachusetts federal court refused Teva Pharmaceutical Industries Ltd.'s attempt to end a case accusing it of orchestrating a decade-long scheme to delay generic competition for its QVAR asthma inhalers, but cut allegations that Teva paid Amneal Pharmaceuticals Inc. not to launch its version.
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November 07, 2024
Same PBM Conduct Means Same Insulin Price Trial, FTC Says
Federal Trade Commission staffers want Caremark Rx, Express Scripts and OptumRx kept together in a single in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices through unfair rebate schemes, arguing they are all "accused of violating the same laws by engaging in the same type of conduct."
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November 07, 2024
LeBron Eyes Media Merger, AI Startup IPO, And More Rumors
Basketball star LeBron James wants to merge his TV and film production company with a British studio, while AI-focused startup CoreWeave has selected investment banks to manage an initial public offering planned for 2025, plus a women's clothing retailer and a generic-drug maker are planning a pair of listings that could revive Canada's dormant IPO market.
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November 06, 2024
Masimo Expert Cites LED And Foam As Evidence Apple Stole IP
Apple misappropriated Masimo's pulse oximetry trade secrets and used them to improve its Apple Watch, a Masimo expert witness testified in California federal court Wednesday, pointing to Apple's use of a short circuit LED and a black foam test.
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November 06, 2024
Natera Declared 'War' On Guardant, Jury Told At Trial's Start
Guardant on Wednesday told a California federal jury during opening statements in its false advertising lawsuit that rival Natera saw Guardant's competing colorectal cancer detection test as "an existential threat" and declared "war" while Natera maintained that its ads to doctors comparing the tests were meant "to educate, not deceive."
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November 06, 2024
Trump's Win Likely To Spur Deals For Capital Markets Attys
Former President Donald Trump's decisive win in Tuesday's presidential election will enable deals to proceed on a more certain basis, capital markets advisers said Wednesday, citing pent-up demand to restart capital raising after a long period of subdued activity.
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November 06, 2024
After Electoral Defeats, Cannabis Advocates Eye Next Steps
Cannabis industry advocates and reform activists struck a note of cautious optimism Wednesday following an expected Republican electoral sweep of the federal government, while opponents of legalization touted the defeat of multiple statewide ballot measures as proof of their position that marijuana reform efforts were losing support.
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November 06, 2024
Sanctioned Supplier, Abbott Strike Deal Over TM Judgment
Abbott Laboratories has resolved a dispute with a diabetes test-strip wholesaler that was ordered to pay Abbott $33.4 million after committing discovery misconduct, with the parties saying they've agreed to a settlement after a federal appeals court upheld Abbott's default win in September.
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November 06, 2024
Medtronic Says Axonics Misled Jury To Beat Patent Case
Medtronic is seeking a new trial after a California federal jury two months ago found that Axonics did not infringe three of its patents related to its bladder and bowel control device, while Axonics wants the court to find that one of those patents wasn't valid to begin with.
Expert Analysis
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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.
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3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy
The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.
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Opinion
Unclear Intellectual Property Laws Are Stifling US Innovation
U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.
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The Fed. Circ. In June: More Liability For Generic-Drug Makers
The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.