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Life Sciences
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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.
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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.
Expert Analysis
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A Look At The PTAB's Assessment Of Prior Art Exceptions
The Patent Trial and Appeal Board's approach over the last 10 years to assessing Section 102(b) prior art exceptions reveals a few trends, including that evidence of common ownership may have a higher likelihood of successfully disqualifying prior art under Section 102(b)(2)(C) at the institution stage, say Louis Panzica and David Holman at Sterne Kessler.
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Series
Playing Diplomacy Makes Us Better Lawyers
Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.
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How Patent Litigation Is Changing Amid Decline In Filings
Marked by a notable decline in case filings and preferred venue shifts, patent litigation has undergone significant changes over the last decade and litigation hot spots have shifted, encouraging a more strategic approach to patent disputes, says Saishruti Mutneja at Winston & Strawn.
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Mental Health First Aid: A Brief Primer For Attorneys
Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.
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Opinion
FTC's Report Criticizing Drug Middlemen Is Flawed
The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.
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Series
Collecting Art Makes Me A Better Lawyer
The therapeutic aspects of appreciating and collecting art improve my legal practice by enhancing my observation skills, empathy, creativity and cultural awareness, says attorney Michael McCready.
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Del. Dispatch: Cautionary Tales Of 2 Earnout Effort Breaches
The Delaware Court of Chancery's tendency to interpret earnout provisions precisely as written, highlighted in two September rulings that found buyers breached their shareholder obligations when they failed to make reasonable efforts to hit certain product development milestones, demonstrates the paramount importance of precisely wording these agreements, say attorneys at Fried Frank.
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Takeaways From Novo Nordisk's Fight For Market Exclusivity
Generic competitors’ challenge to Novo Nordisk’s patents in hopes of capturing a portion of the rapidly expanding Type 2 diabetes and obesity treatment market highlights the role of abbreviated new drug application litigation, inter partes review and multidistrict litigation in patent defense, says Pedram Sameni at Patexia.
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Using Primacy And Recency Effects In Opening Statements
By understanding and strategically employing the primacy and recency effects in opening statements, attorneys can significantly enhance their persuasive impact, ensuring that their narrative is both compelling and memorable from the outset, says Bill Kanasky at Courtroom Sciences.
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Secret Service Failures Offer Lessons For Private Sector GCs
The Secret Service’s problematic response to two assassination attempts against former President Donald Trump this summer provides a crash course for general counsel on how not to handle crisis communications, says Keith Nahigian at Nahigian Strategies.
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Opinion
Bill Is Key To Protecting US Economy From Patent Piracy
It is critical that Congress pass a recently introduced bill that would protect U.S. investors from intellectual property theft by restoring court-ordered injunctions as the default remedy in patent infringement cases to ensure inventors get the justice they deserve, says Andrei Iancu at Sullivan & Cromwell.
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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.
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Litigation Inspiration: Honoring Your Learned Profession
About 30,000 people who took the bar exam in July will learn they passed this fall, marking a fitting time for all attorneys to remember that they are members in a specialty club of learned professionals — and the more they can keep this in mind, the more benefits they will see, says Bennett Rawicki at Hilgers Graben.
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From Concept To Capital: 5 Stages Of Evolving IP Needs
Companies must understand the shifting intellectual property needs throughout an organization’s life cycle in order to protect innovation, which can be done by fortifying the IP portfolio, expanding and leveraging IP assets, and more, says Keegan Caldwell at Caldwell Law.
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.