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Life Sciences
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October 17, 2024
Justices Urged To Fix 'Novel Misreading' Of IP Safe Harbor
Edwards Lifesciences is asking the U.S. Supreme Court to rein in what's covered under a drug-development safe harbor to avoid patent infringement, saying the Federal Circuit wrongfully expanded it in a "novel misreading" of the law.
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October 17, 2024
Northwestern Hits Moderna With Patent Suit Over COVID Vax
Northwestern University has launched a patent infringement lawsuit in Delaware federal court accusing Moderna of wrongly taking research that the school did when the company was making its COVID-19 vaccine.
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October 17, 2024
Amgen Faces Derivative Suit In Del. Over Tax Disclosures
An Amgen Inc. stockholder has sued the company in Delaware's Court of Chancery seeking derivative recoveries for the multinational biopharmaceutical company from its directors and officers based on allegedly false and misleading statements regarding $10.7 billion in federal tax bills and penalties.
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October 17, 2024
Oregon Appeals Court Says E-Cig Rules Violate Free Speech
Oregon's intermediate appellate court ruled Wednesday that a state law governing how e-cigarettes and cannabis vapes can be packaged violated guarantees of free speech enshrined in the state's constitution.
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October 17, 2024
$20B Verizon-Frontier Deal Faces Scrutiny, And Other Rumors
A growing list of Frontier Communications' largest shareholders are concerned about its planned $20 billion takeover by Verizon Communications, and a group of former professional athletes are in talks to buy a stake in the NFL's Buffalo Bills. Here, Law360 breaks down these and other notable rumors from the past week.
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October 17, 2024
Ex-Genzyme Exec Says Anxiety Disclosure Led To Firing
A former marketing director for Sanofi subsidiary Genzyme says he was fired on a pretext after disclosing that he suffers from anxiety, according to a lawsuit filed Wednesday in Massachusetts state court.
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October 17, 2024
Moderna Wants Fees For 'Frivolous' COVID-19 Vax Suit
Moderna is asking a Delaware federal judge to award it about $2.8 million in legal costs for its defense of claims in a patent suit brought by Alnylam Pharmaceuticals over its coronavirus vaccine, arguing the Boston-based company pursued "frivolous" claims that wasted court resources.
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October 16, 2024
Philips Says $12M Sanction Needed For Evidence Destruction
A spoliation sanctions hearing for around $12 million in royalty damages turned terse when the owner of a medical device equipment sale and servicing company seemingly hedged his statements, with a Texas federal judge saying, "Oh my gosh, just answer the question," during the Wednesday hearing.
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October 16, 2024
Apple Heart Rate Monitor Patent Survives PTAB
An administrative patent board has decided not to invalidate an Apple patent that the tech giant once asserted in its ongoing fight with a company in the smartwatch space.
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October 16, 2024
Direct Buyers Get Final OK For $44M Drug Price-Fixing Deal
A Pennsylvania federal court has granted final approval to $44.4 million in settlements between drugmakers Apotex, Breckenridge and Heritage and direct purchasers in a multidistrict litigation over alleged price-fixing in the generic-drug industry.
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October 16, 2024
Pharma Co. Contractor Settles SEC Insider Trading Claim
An information technology consultant for a Massachusetts biopharmaceutical company will pay the U.S. Securities and Exchange Commission over $28,000 to resolve claims he immediately dumped shares of his client when he got wind of its yet-to-be announced plans for major layoffs.
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October 16, 2024
Ex-Pharma Co. Employee Traded On GSK Deal Info, SEC Says
The former director of analytical development at Canada-based drug company Bellus Health Inc. has agreed to pay the U.S. Securities and Exchange Commission over $120,000 to settle claims that he sold shares on nonpublic information about pharma giant GSK's impending takeover of his company, according to court filings.
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October 16, 2024
SEC To Settle Claims CBD Exec Took $13M From Hospital
The U.S. Securities and Exchange Commission is ready to make a deal with a former cannabidiol products executive accused of taking $13 million from a hospital after falsely promising to deliver urgently needed masks during the height of the pandemic.
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October 16, 2024
Caremark, Optum Say FTC Insulin Case Gets PBMs All Wrong
Caremark Rx, Express Scripts and OptumRx continue to attack the Federal Trade Commission's in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes, arguing the agency's case lacks authority, facts and the right targets.
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October 16, 2024
Houston Pharma Exec Found Guilty In $160M Health Fraud
A Houston man was convicted on 15 criminal charges in connection with orchestrating a massive healthcare scheme that defrauded the government out of $160 million, following a 10-day trial in which prosecutors said doctors were "bamboozled" by the conspiracy.
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October 16, 2024
AAM, Alvogen Back Sun Pharma In Double Patenting Row
A trade group representing generic-drug makers, a generic-drug company and a plant-breeding technology business have all thrown their support behind Sun Pharmaceutical Industries' bid for the full Federal Circuit to take a closer look at the issue of double patenting.
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October 16, 2024
M&A Pros Cautious About Expected Private Equity Surge
It's an oft-repeated line that private equity activity is set to surge amid pressure to exit older investments and deploy record stores of dry powder, but mergers and acquisitions professionals recently surveyed by Dykema were cautious when asked if they expect private equity to boost deal flow in the next 12 months, with a majority saying they only "somewhat agree."
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October 15, 2024
Horizon Lodges 4-Fold Attack On Tepezza MDL Bellwethers
Horizon Therapeutics argued Tuesday that an Illinois federal judge should toss out nine of the dozen cases selected as bellwethers in multidistrict litigation targeting hearing loss issues with its biologic Tepezza, saying they're preempted because the label was approved with those problems in mind.
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October 15, 2024
Judge Backs Exelixis Cancer Drug Patent Claims
A Delaware federal judge on Tuesday rejected invalidity arguments against three Exelixis patents that MSN Laboratories Private Ltd. said it would be infringing with a proposed generic of blockbuster drug Cabometyx, while also finding that a fourth patent wasn't invalid nor was it infringed.
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October 15, 2024
Motley Rice May Avoid DQ In Boston Opioid Case, Judge Hints
A Massachusetts federal judge on Tuesday appeared skeptical of a bid by pharmacy benefit manager OptumRX to disqualify Motley Rice LLC from representing the city of Boston in a lawsuit over the company's alleged role in the opioid crisis.
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October 15, 2024
GSK Says Moderna's COVID, RSV Vax Infringe MRNA Patents
Moderna's breakthrough COVID-19 vaccine and a related respiratory syncytial virus, or RSV, vaccine were built on mRNA technology discovered by researchers whose patents are owned by GlaxoSmithKline, the latter company alleged in a pair of Delaware lawsuits.
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October 15, 2024
Justices Mull RICO's Scope In Trucker's CBD Case
U.S. Supreme Court justices on Tuesday appeared conflicted whether to sanction a commercial trucker's attempt to bring a racketeering claim against CBD companies, whose allegedly mislabeled products the trucker claims led to his firing.
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October 15, 2024
Walmart, Execs Settle Chancery Opioid Suit For $123M
Walmart and its directors and officers have agreed to a $123 million deal to end a stockholder class derivative lawsuit in Delaware's Court of Chancery that accused the nationwide retailer of multiyear opioid prescription oversight failures, potentially resolving class claims dating to early 2020.
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October 15, 2024
Novartis To Appeal Ruling In Entresto Generic Drug Fight
Swiss drugmaker Novartis said Tuesday that it plans to appeal a ruling from over the weekend that scuttled its suit over the U.S. Food and Drug Administration's approval of a generic version of Entresto, the drugmaker's blockbuster heart failure medication.
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October 15, 2024
Feds Cut Whistleblowers Out Of Kickback Deal, Court Told
Whistleblowers who accused a medical device company of a kickback scheme said Tuesday that the government left them out to dry when it settled False Claims Act claims with surgeons for $3.3 million and refused to share any of it with them.
Expert Analysis
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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.
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Class Actions At The Circuit Courts: May Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.
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Perspectives
Trauma-Informed Legal Approaches For Pro Bono Attorneys
As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.
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Series
Playing Music Makes Me A Better Lawyer
My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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How Attys Can Avoid Pitfalls When Withdrawing From A Case
The Trump campaign's recent scuffle over its bid to replace its counsel in a pregnancy retaliation suit offers a chance to remind attorneys that many troubles inherent in withdrawing from a case can be mitigated or entirely avoided by communicating with clients openly and frequently, says Christopher Konneker at Orsinger Nelson.
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Using A Children's Book Approach In Firm Marketing Content
From “The Giving Tree” to “Where the Wild Things Are,” most children’s books are easy to remember because they use simple words and numbers to tell stories with a human impact — a formula law firms should emulate in their marketing content to stay front of mind for potential clients, says Seema Desai Maglio at The Found Word.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.