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Life Sciences
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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.
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July 25, 2024
Ex-Pharma Exec's Counsel Accused Of Reading Stolen Emails
A New Jersey pharmaceutical startup wants to disqualify the "tainted" attorneys of a former executive who was allegedly caught spying on the CEO, claiming the attorneys should have immediately shielded their eyes when they realized their client was using stolen, privileged emails to carry out an "attempted shakedown."
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July 25, 2024
Loeb & Loeb Says Ex-GC's Sanctions Motion Is Bogus
Loeb & Loeb LLP urged a Colorado federal judge Wednesday to reject a former general counsel's allegations that it deliberately sent a thumb drive of documents that aren't text searchable, saying they are actually searchable and would have otherwise sent over 64,000 physical pages that weren't.
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July 25, 2024
Deals Rumor Mill: Wiz-Google, Daily Telegraph, Medline IPO
Cybersecurity startup Wiz has rebuffed a buyout offer from Google, former British finance minister Nadhim Zahawi is preparing a $773 million bid for the Daily Telegraph, and medical supplies giant Medline is preparing an initial public offering for 2025. Here, Law360 breaks down these and other notable deal rumors from the past week.
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July 24, 2024
Clinic Drops Case Against Maker Of Body-Sculpting Devices
BTL Industries Inc., a Massachusetts company that sells body-sculpting equipment, and a Connecticut aesthetic clinic have mutually agreed to dismiss a lawsuit accusing the Bay State company of using misleading profit projections and illegal trade restraints that unfairly penalized equipment buyers and caused hefty investments to wither.
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July 24, 2024
Rite Aid's Elixir Buyer Must Pay Additional $50M In Ch. 11 Sale
Prescription benefits group MedImpact owes an extra $50 million on top of $576 million it paid Rite Aid for its former benefits division Elixir, a New Jersey bankruptcy judge ruled Wednesday, saying his earlier ruling on $200 million in disputed liabilities from the sale didn't fundamentally disrupt a post-closing price adjustment.
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July 24, 2024
Patent Cap In Drug Pricing Bill Seen As Having Muted Effect
The U.S. Senate recently passed a bill aiming to lower drug prices by limiting the number of patents that can be asserted in cases over biosimilars, but attorneys say the measure's numerous exceptions make it unlikely to have a major effect on litigation or consumer costs.
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July 24, 2024
McCarter & English Beats Biotech Malpractice Suit In NJ
McCarter & English LLP defeated a New Jersey biotechnology company's legal malpractice suit this week, following a New Jersey state judge's finding that the malpractice claims should have been brought in an earlier round of litigation over unpaid legal fees.
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July 24, 2024
Ex-Pharma Exec Gets Jail For Insider Trading On Kodak Loan
A Manhattan federal judge sentenced a former pharmaceutical executive from South Carolina to three months in prison Wednesday for taking over $500,000 of illegal trading profit based on his advance knowledge that Kodak would get a massive pandemic-era government loan.
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July 24, 2024
Priest Loses Fee Bid After 'Split Baby' SEC Verdict
A Greek Orthodox priest and hedge fund founder who largely beat a U.S. Securities and Exchange Commission suit is not entitled to recoup $1.7 million in legal fees because the commission was justified in bringing the case, a Boston federal judge ruled Tuesday.
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July 23, 2024
Meet The Lead Ozempic Lawyers
The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.
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July 23, 2024
Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient
Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.
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July 23, 2024
$680M Allergan FCA Suit Tossed After High Court Revival
A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.
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July 23, 2024
Invitae's Ch. 11 Plan Needs Tweaking, Judge Says
A New Jersey bankruptcy judge said he would confirm the Chapter 11 liquidation plan for genetic testing company Invitae, if it made changes to how it handled distributions to certain creditors.
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July 23, 2024
4th Circ. Says Bad Jury Instructions Gave J&J Win In Mesh Suit
The Fourth Circuit has vacated a judgment in Ethicon Inc. and Johnson & Johnson's favor in a suit from a woman alleging Ethicon's pelvic mesh was defective, saying a federal judge was wrong to limit her expert's opinion based on the so-called elimination mandate.
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July 23, 2024
Ex-Celgene Exec Off The Hook For Statements To Investors
Celgene Corp.'s former chief operating officer on Tuesday escaped some claims in a class action contending that the biopharmaceutical company artificially inflated its share price, with a New Jersey federal court finding that the ex-executive never made nor could he be linked to the statements that were issued by the company.
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July 23, 2024
Feds Urge 6th Circ. To Affirm Pharma Owner's Fraud Sentence
The Sixth Circuit should affirm a district court's fraud convictions, nearly five-year sentence and $7 million restitution order against an Ohio pharmaceutical salesman who underreported his income to reduce his tax liability in a multimillion-dollar scheme involving bogus insurance billings, the federal government said.
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July 23, 2024
Chancery Slams 'Squishy' Deal In 'Tagalong' BioMarin Suit
A visibly irritated Delaware Chancery Court judge on Tuesday rejected a settlement with BioMarin Pharmaceuticals Inc. that would have given shareholder attorneys $1.25 million in exchange for broad releases and "squishy" governance reforms, saying he didn't want to encourage "tagalong litigation" that yielded only "ephemeral" benefits.
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July 23, 2024
Split 2nd Circ. Keeps Zantac Suits In Conn. State Court
A split Second Circuit panel on Tuesday allowed nine consolidated suits over carcinogens in heartburn medication Zantac to remain in Connecticut state court, with the majority ruling that the cases' consolidation is not enough to open up federal jurisdiction.
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July 23, 2024
Senate Dems Roll Out Bill To Codify Chevron Deference
Sen. Elizabeth Warren, D-Mass., led a group of Democratic senators Tuesday in introducing a bill to codify the now-defunct doctrine of Chevron deference after it was struck down by the U.S. Supreme Court last month.
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July 23, 2024
4 Firms Guide SPAC Mergers Targeting AI, Cannabis Sectors
An AI-powered startup that vows to combat "disinformation" and a medical cannabis developer have agreed to go public by merging with special purpose acquisition companies through separate deals unveiled this week, guided by four law firms and a law office.
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July 22, 2024
GSK Inks $4.5M Deal Resolving 'Non-Drowsy' Robitussin Suit
GlaxoSmithKline has agreed to pay $4.5 million as well as remove the "non-drowsy" label from its Robitussin cough medicine to put to rest allegations it mislabeled the medicine, which consumers claim does cause drowsiness, according to a motion filed Monday in New York federal court.
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July 22, 2024
AbbVie Challenges Mo. Drug Discount Program Requirements
AbbVie Inc. on Monday asked a Missouri federal court to block a state law that adds requirements to participate in the federal drug discount program, claiming that the measure violates both the federal and Missouri constitutions.
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July 22, 2024
USPTO Wins Dismissal Of Danish Co.'s PTSD Drug Lawsuit
A Virginia federal judge has ruled that the U.S. Patent and Trademark Office appropriately rejected drugmaker Lundbeck's request for three additional months of patent exclusivity for a PTSD drug, saying the agency could dock those days due to the impermissible gray shading of some text in the company's patent application.
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July 22, 2024
Tevra Says Bayer Owes Millions As Antitrust Trial Opens
Tevra Brands LLC told a California federal jury during antitrust trial openings Monday that Bayer owes millions of dollars for allegedly cutting anticompetitive deals with retailers to undermine competition from anti-flea-and-tick treatment generics, while Bayer defended its "reasonable" and optional retailer discounts and criticized Tevra's "astronomical" damages demand.
Expert Analysis
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.