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Life Sciences
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July 29, 2024
Genzyme Says Sarepta's Dystrophy Gene Therapy Infringes IP
Sanofi's biotechnology company Genzyme Corp. hauled Sarepta Therapeutics into Delaware federal court on Friday, alleging Sarepta's gene therapy treatment for Duchenne muscular dystrophy infringed two of its patents for manufacturing certain therapeutics.
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July 29, 2024
Medical Co. Can't Get Alleged Fraudulent Arbitral Award Nixed
A New York federal judge has declined to vacate an arbitral award issued by a Swiss tribunal to a Singapore company in a dispute over a medical imaging joint venture, rejecting arguments that an agreement struck by the parties meant that a New York court could decide the issue.
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July 29, 2024
NIST Lays Out 200+ Ways To Tackle Generative AI Risks
The National Institute of Standards and Technology has recommended hundreds of actions that can be taken to address issues of data privacy, intellectual property, environmental impact and more raised by generative artificial intelligence.
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July 29, 2024
Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech
Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.
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July 29, 2024
Gilstrap Finds Nothing Between The Lines Of Barcode Patents
A handful of barcode scanning patents issued to prolific litigant Leigh Rothschild met their fate in Texas, with U.S. District Judge Rodney Gilstrap deciding they "recite no more than generic computer operations."
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July 29, 2024
Vaccine Co. Was Sanctioned For Deliberately Hiding Testing
U.S. Patent and Trademark Office Director Kathi Vidal backed sanctions for Longhorn Vaccines & Diagnostics' "egregious abuse" of the Patent Trial and Appeal Board system because of the patent owner's "deliberate scheme to hide" harmful evidence from the board, she said in an opinion made public Friday.
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July 29, 2024
Boehringer Appeals HHS Win In Medicare Drug Price Suit
Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.
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July 29, 2024
Kirkland-Led Amulet Closes $1.2B Health-Focused Fund
Kirkland & Ellis LLP-advised private equity shop Amulet Capital Partners LP on Monday announced that it successfully closed its third healthcare-focused private equity fund with roughly $1.2 billion in tow.
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July 29, 2024
Legalization Org Taps Cannabis Atty As New Treasurer
The pro-legalization advocacy organization Marijuana Policy Project announced Monday that a preeminent member of the cannabis bar had been tapped as the group's newest treasurer.
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July 29, 2024
GSK Settles Ill. Zantac Cancer Suit
GlaxoSmithKline said Monday it has settled a lawsuit brought by an Illinois man who took the heartburn medication Zantac or its generic counterpart for more than 20 years and claimed the drug caused his prostate cancer.
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July 29, 2024
Firm, Ex-Client Brief Conn. High Court In Punitive Award Case
McCarter & English LLP and ex-client Jarrow Formulas Inc. are weighing in as the Connecticut Supreme Court decides whether a federal court can award law firms punitive damages in suits for breach of contract, as the firm seeks a punitive payout after winning multimillion-dollar judgments in a contract dispute.
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July 29, 2024
Catching Up With Delaware's Chancery Court
Litigation linked to Elon Musk sparked several filings in Delaware's Court of Chancery last week, including a call for sanctions and hand-wringing about a proposed multibillion-dollar attorney fee. Here, Law360 looks at this and other highlights from last week in Delaware's Chancery Court.
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July 29, 2024
Ex-Pharma Exec Seeks Leniency After SEC Contempt Plea
A former pharmaceutical executive is hoping to avoid jail after his use of an alias to circumvent a U.S. Securities and Exchange Commission ban on finance work landed him a criminal contempt conviction, while Boston federal prosecutors are seeking up to 10 months in prison.
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July 26, 2024
'Low-Grade Lawyering': Quinn Emanuel Attys Draw Judge's Ire
A California federal judge considering Guardant Health's sanctions bid in a false advertising case against rival Natera said Friday that representations to the court by Natera's attorneys from Quinn Emanuel Urquhart & Sullivan LLP regarding a proposed expert witness were "less than forthright" and "pretty low-grade lawyering."
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July 26, 2024
Apple Commits To White House Guidelines For Responsible AI
Apple Inc. has signed onto the Biden administration's voluntary guidelines for "responsible" artificial intelligence innovation, joining the likes of Amazon.com Inc., Google LLC, Microsoft Corp. and a dozen other leading tech companies, the White House announced Friday.
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July 26, 2024
Product Liability Cases To Watch 2024: A Midyear Report
Litigation over claims that social media addict children and harm mental health continues to hold attorneys' attention, along with claims that "forever chemicals" are a source of cancer.
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July 26, 2024
Del. Court Won't Let Generic Co. Walk Back Invalidity Promise
Generic-drug maker Mankind Pharma is bound to its promise not to challenge the validity of a patent covering Allergan's glaucoma drug Lumigan after a federal judge in Delaware shot down its argument that recent rulings on obviousness-type double patenting altered the litigation landscape.
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July 26, 2024
Indivior To Pay $86M To Settle Opioid Claims By 5 States
Indivior will pay $86 million to settle claims by a group of state attorneys general over the drugmaker's alleged contributions to the American opioid crisis.
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July 26, 2024
Hearing Set Over Bid To Recuse Judge In Philly Zantac Cases
A Philadelphia judge will hear arguments next month over a recusal motion filed by plaintiffs' counsel in the city's Zantac mass tort program that argues the judge should remove himself from the proceedings after he disclosed his wife is a partner at Reed Smith, which represents GlaxoSmithKline, a manufacturer of the drug.
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July 26, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen U.K. band The 1975 face action by Future Sound Asia after its performance in Malaysia resulted in a festival's cancelation, Spectrum Insurance hit by The Motoring Organization following their dispute over information misuse, and a former police constable pursue defamation against a colleague for allegedly instigating a campaign of harassment against her. Here, Law360 looks at these and other new claims in the U.K.
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July 25, 2024
3rd Circ. Again Tosses J&J Talc Unit's 'Texas Two-Step' Ch. 11
The Third Circuit on Thursday affirmed the dismissal of the reworked Chapter 11 case of Johnson & Johnson's talc unit that used a controversial "Texas two-step" maneuver, saying the company still hasn't displayed the financial distress required to justify bankruptcy protection.
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July 25, 2024
Seattle, Monsanto Ink $160M Deal Over PCBs In Duwamish
Bayer AG's Monsanto Co. has agreed to pay $160 million to resolve allegations that it contaminated Seattle's stormwater and drainage systems as well as the Lower Duwamish Waterway with polychlorinated biphenyls, the city attorney's office announced Thursday.
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July 25, 2024
Pfizer Calls GSK Patents In COVID Vax Case Unenforceable
Pfizer and BioNTech have fired back at GlaxoSmithKline's patent suit against them over the COVID-19 vaccine, saying GSK's patents are unenforceable because the company delayed in filing its applications and then crafted them to cover the blockbuster vaccine after it became available.
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July 25, 2024
DC Panel Upholds FDA's Win Against Ipsen's Generics Suit
A D.C. panel declined to revive Ipsen's challenge to regulators' refusal to classify its acromegaly drug as a biologic, which would have blocked generic versions of it, finding Thursday the drug's active ingredient doesn't meet the Food, Drug and Cosmetic Act's definition of a protein to be considered a biologic.
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July 25, 2024
Shkreli Says He Has Right To Use Wu-Tang Clan Album Copies
Martin Shkreli pushed back on a crypto project's bid to force him to hand over copies of the one-of-a-kind Wu-Tang Clan album he once owned, saying his original purchase agreement of the album entitled him to make the copies and the album's current crypto owner hasn't shown how Shkreli's duplicates irreparably harm the value of the original.
Expert Analysis
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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3 Infringement Defenses To Consider 10 Years Post-Nautilus
In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.
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9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense
The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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Investors Can Aid In The Acceptance Of Psychedelic Medicine
Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.