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Life Sciences
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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.
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November 06, 2024
What A Second Trump Term Could Mean For FDA And CPSC
The historic reelection of former President Donald Trump could lead to shake-ups at the U.S. Food and Drug Administration and the U.S. Consumer Product Safety Commission, while questions remain about what policies he will enact.
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November 06, 2024
Tobacco Cos. Side With FDA In Menthol Cigarette Ban Fight
Tobacco giants R.J. Reynolds and Philip Morris have come to the aid of the U.S. Food and Drug Administration in a pair of friend-of-the-court briefs, urging a federal court to toss a suit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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November 05, 2024
How The Patent System May Look After Trump's Return
The U.S. Patent and Trademark Office during Donald Trump's first term as president focused on making the invalidation of patents more difficult, and attorneys say his second administration is likely to do the same following his projected reelection.
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November 05, 2024
Trump Has Official Immunity. What About His Aides?
Whether the U.S. Supreme Court's decision on presidential immunity extends to subordinates who follow a president's orders has become a more pressing question in the wake of Donald Trump's projected election win, according to legal experts.
Expert Analysis
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.