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Life Sciences
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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.
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November 06, 2024
Feds Fight Philly Injection Site Group's 3rd Circ. Appeal
The U.S. Department of Justice has urged the Third Circuit to preserve its win in preventing an overdose prevention organization from opening a supervised safe-injection site in Philadelphia, arguing that a lower court correctly ruled that the group is not a religious organization eligible for federal protection.
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November 06, 2024
Insurers Urge Del. Justices To Reverse Drug Co. Policy Ruling
Attorneys for three insurers battling Alexion Pharmaceuticals Inc. over potential director and officer insurance payouts in a securities action launched before Alexion received a separate federal regulator penalty told Delaware's Supreme Court on Wednesday that a lower court decision wrongly sided with the company on coverage worth an additional $20 million.
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November 06, 2024
Feds Look To Halt Vitamin Co. Payouts Amid $1.4M Tax Fight
A couple who bought a vitamin supplement company shouldn't continue to get payments from the business amid a suit claiming they're liable for a previous owner's $1.4 million tax lien, the U.S. Department of Justice told a Connecticut federal court Wednesday.
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November 06, 2024
Business Groups Urge Calif. Justices To Nix HIV Drug Ruling
Business groups led by the U.S. Chamber of Commerce are asking the California Supreme Court to throw out a suit alleging Gilead Sciences Inc. deprived customers of a safer form of its HIV drug for profits, saying the current ruling creates an untenable duty and liability even when there's no harmful defect in a product.
Expert Analysis
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.