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Life Sciences
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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.
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October 15, 2024
Skadden Picks Up Arbitration Co-Head From Sidley In Asia
The co-leader of Sidley Austin LLP's global arbitration, trade and advocacy group has been tapped to lead Skadden Arps Slate Meagher & Flom LLP's international litigation and arbitration group in Asia, the firm announced on Monday.
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October 15, 2024
Law Firms Diverge As Anti-ESG Pushback Continues
A continuing onslaught of legislation and litigation opposing corporate environmental, social and governance actions has created a fork in the road for law firms, with some choosing to scale back efforts and others pushing ahead with their internal ESG and diversity, equity and inclusion goals.
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October 15, 2024
The 2024 Law360 Pulse Social Impact Leaders
Check out our Social Impact Leaders ranking, analysis and interactive graphics to see which firms stand out for their engagement with social responsibility and commitment to pro bono service.
Expert Analysis
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.
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3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy
The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.
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Opinion
Unclear Intellectual Property Laws Are Stifling US Innovation
U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.
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The Fed. Circ. In June: More Liability For Generic-Drug Makers
The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.