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Life Sciences
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January 01, 2025
Patent Policy To Watch In 2025
Patent attorneys are awaiting new leadership at the U.S. Patent and Trademark Office and the U.S. International Trade Commission, and are tracking several bills in Congress. Here's what else they should be following in the new year.
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January 01, 2025
IPO Outlook Brightens As More Companies Eye 2025 Listings
Capital markets attorneys are preparing to advise more companies toward initial public offerings in 2025, given evidence that a rising number of candidates are joining the pipeline in expectation of a long-awaited resurgence in new listings. Here, Law360 looks at what deals attorneys and market participants expect.
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January 01, 2025
Patent Cases To Watch In 2025
The Federal Circuit has taken on a rare en banc patent case looking at damages, while the U.S. Supreme Court has been asked to review when foreign damages can be incorporated into patent awards. Here's what you need to know about these cases and others that attorneys are keeping an eye on in 2025.
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January 01, 2025
Top Federal Tax Cases To Watch In 2025
Over the next year, tax practitioners will be closely monitoring suits that challenge the IRS' use of the economic substance doctrine, take advantage of the U.S. Supreme Court's landmark decision curbing federal agencies' regulatory authority and dispute the government's handling of worker retention credits. Here, Law360 looks at key federal tax cases to follow in 2025.
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January 01, 2025
Patent Litigation Trends To Watch In 2025
Litigation funding resulting in more heated disputes, artificial intelligence tools becoming a fact of life for patent attorneys and increased use of patent reexaminations are among the trends attorneys will be keeping tabs on in the coming year.
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December 23, 2024
Ex-Pharma Exec Charged With $38M Insider Trading Scheme
A former chief science officer of pharmaceutical company Humanigen faces charges in New Jersey federal court that he dumped shares of the company before it publicly announced its potential COVID-19 drug did not receive federal approval, according to an indictment unsealed Monday.
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December 23, 2024
HHS Can't Enforce Abortion Privacy Rule Against Texas Doctor
A Texas federal judge has granted a Lone Star State doctor a reprieve from a new U.S. Department of Health and Human Services rule that aims to protect the privacy of abortion providers and patients, saying that the rule likely exceeds the Health Insurance Portability and Accountability Act's statutory authority.
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December 20, 2024
Sens. Aim To Protect Generics With Skinny Labels In New Bill
A bipartisan group of senators from Colorado, Arkansas, Vermont and Maine have introduced a bill that would shield generic-drug and biosimilar manufacturers from infringement liability when using approved "skinny labels."
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December 20, 2024
South Korean Needle Operation Secures Patent Win At ITC
The U.S. subsidiary of a South Korean dermatologist's needle business has convinced a judge at the U.S. International Trade Commission that several rivals in the marketplace for selling microneedles to plastic surgeons are infringing patents.
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December 20, 2024
Fed. Circ. Says Teva Inhaler Patents Can't Be In Orange Book
The Federal Circuit on Friday upheld a decision that Teva Pharmaceuticals improperly listed its asthma inhaler patents in the U.S. Food and Drug Administration's Orange Book, saying that only patents that claim a drug's active ingredient can be included in the database.
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December 20, 2024
Hagens Berman Settles Suit Over Effexor Deal Atty Fees
A pharmaceutical reseller's in-house counsel and founder moved Friday to drop a Mississippi federal court breach of contract suit accusing Hagens Berman Sobol Shapiro LLP of stiffing him on his share of a $13 million attorney fees award from an antitrust class settlement, citing a resolution to the dispute.
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December 20, 2024
Nippon Owes $115M In Muscular Dystrophy IP Fight, Jury Says
Nippon Shinyaku Co. Ltd. owes more than $115 million for infringing a patent owned by Massachusetts-based Sarepta Therapeutics, a federal jury in Delaware said Friday after finding that the Japanese company failed to prove the patent was invalid.
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December 20, 2024
The Most Significant Trade Secrets Cases Of 2024
Insulet Corp. became the latest company to notch a colossal trade secrets award, and a new presidential administration has attorneys wondering what will become of the Federal Trade Commission's pending proposal to ban employee noncompete agreements. Here's a look at trade secrets cases that defined 2024 and what to expect from the FTC in the coming year.
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December 20, 2024
Top Product Liability Cases Of 2024
Some of the top cases for product liability for 2024 include an Ohio Supreme Court ruling on opioids and public nuisance, baby formula trials and an appellate decision in Fosamax litigation.
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December 20, 2024
Psychedelics Law Reformers Hit Multiple Setbacks In 2024
In 2024, advocates, physicians and researchers attempted to broaden lawful access to federally illegal psychedelic drugs through a variety of avenues — the new drug approval process, litigation and a ballot initiative — with the upshot that the law remains largely unchanged and, for the most part, still restricts legal use and possession of these substances.
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December 20, 2024
Fla. Labs Appeal $7.3M Conn. Jury Verdict Favoring Cigna
Three Florida substance abuse testing laboratories filed notice Thursday promising to appeal a $7.3 million loss to Cigna Health and Life Insurance Co. over billings for recurring tests on drug treatment patients the insurer said were not medically necessary.
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December 20, 2024
Top Privacy & Cybersecurity Developments Of 2024
The state data privacy law patchwork continued to add new and varied pieces in 2024, while major hacks shook up the healthcare industry and other critical sectors, and the first U.S. laws setting guardrails for the use of artificial intelligence technologies emerged.
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December 20, 2024
7th Circ. Upholds $900K Punitive Damages Award In TM Case
The Seventh Circuit has affirmed $900,000 in punitive damages against a nutritional company and its owners for infringing the "Diesel Test" trademark of a testosterone-boosting product from a former competitive body builder, saying the defendant's conduct merited the award.
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December 20, 2024
Capital Markets Attorneys Ready For Reset After Bumpy 2024
Capital markets activity — initial public offerings especially — posted a hesitant recovery in 2024, marginally increasing over prior-year levels before pausing altogether during a heated presidential election and postponing attorneys' hopes for a stronger rebound until 2025.
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December 19, 2024
Ex-Biopharma Exec Settles SEC Insider Trading Claim
A former biopharmaceutical executive will pay nearly $156,000 to end U.S. Securities and Exchange Commission claims that he bought up shares of his employer's acquisition target and the target's shareholder ahead of the announcement of the acquisition.
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December 19, 2024
Judge Says Some Paraquat Plaintiffs Being Left In Dark
Amid a hearing targeting fall 2025 for a first bellwether trial over the alleged link between the pesticide paraquat and Parkinson's disease, an Illinois federal judge told plaintiffs' lawyers to keep in better touch with their clients after her chambers received calls from plaintiffs wondering what's happening with their cases.
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December 19, 2024
PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law
The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."
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December 19, 2024
FTC Says PBMs Can't Get Preliminary Block In Insulin Case
The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.
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December 19, 2024
Foley Adds Tech, Life Sciences Partner From IP Boutique
Foley & Lardner LLP has hired a longtime partner from intellectual property boutique Lerner David LLP to strengthen both the transactional and litigation arms of its technology and life science practices in New York.
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December 19, 2024
Judge Wrongly Axed $107M IP Verdict, Pfizer Tells Fed. Circ.
A Pfizer unit has told the Federal Circuit that a federal judge got it wrong when he overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents.
Expert Analysis
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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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.