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Life Sciences
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January 08, 2025
EPA Slams $535M Talc Settlement In Whittaker's Ch. 11
The U.S. government objected to a $535 million settlement that bankrupt talc supplier Whittaker Clark & Daniels reached regarding talc claims in its New Jersey Chapter 11 case, saying the deal was built on faulty estimates of the company's environmental liabilities.
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January 08, 2025
3 Firms Steer Galapagos' Plan To Spin Off New Drug Company
Belgian biotechnology firm Galapagos NV said Wednesday that it will spin off certain operations into a second company focused on developing innovative medicines with about €2.45 billion ($2.5 billion) in cash to start, while Galapagos in turn focuses on cell therapies, through a deal guided by three law firms.
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January 08, 2025
Ex-Marketing Exec Says J&J Unit Dodging Basic Discovery
An ex-marketing director for Johnson & Johnson's vision unit urged a New Jersey federal judge to order her former employer to produce documents related to its suit alleging she breached a noncompete agreement, arguing its stonewalling of discovery is depriving her of a fair chance to defend herself.
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January 08, 2025
Buchanan Ingersoll Adds Frier Levitt Pharmacy Atty In NJ
Buchanan Ingersoll & Rooney PC added a shareholder this week in its Newark, New Jersey, office from Frier Levitt who specializes in representing various kinds of pharmacies in transactions, litigation, investigations and other matters.
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January 08, 2025
FBI Director's Former Chief Of Staff Joins Fenwick
Weeks after FBI Director Christopher Wray announced that he'll resign at the end of President Joe Biden's term, Fenwick & West LLP said Wednesday that it has hired the FBI director's chief of staff, who joined the team as a white collar defense and investigations partner.
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January 08, 2025
Abbott Beats UC Regents' Probiotic Patent Claims
An Illinois federal judge has found that claims in a pair of patents owned by the University of California related to a baby probiotic were invalid, handing a win to Abbott Laboratories in a suit accusing the company of infringing the patents.
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January 08, 2025
Boston Scientific Paying Up To $664M For Bolt Medical
Boston Scientific Corp. said Wednesday it plans to acquire the remaining stake it does not own in Bolt Medical Inc., the developer of a proprietary laser-based treatment for coronary and peripheral artery disease, for up to $664 million.
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January 07, 2025
Obesity Drug Maker Faces Investor Suit Over IPO Disclosures
Biopharmaceutical company BioAge Labs Inc. is facing a proposed class action alleging investors in its initial public offering were hurt by plummeting share prices after the company unexpectedly hit the brakes on a clinical trial for its lead product candidate.
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January 07, 2025
Robo Surgery Co. Gets Billions From Selling Parts, Jury Told
Surgical Instrument Service accused Intuitive Surgical at the start of a federal trial Tuesday of being a monopolist making billions of dollars by blocking hospitals from extending the life of reusable surgical-robot components, while Intuitive blasted the medical instrument repair company for "trying to misuse antitrust laws to enrich itself."
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January 07, 2025
Alcohol Warnings Unlikely To Bring Same Fate Tobacco Faced
The U.S. surgeon general on Friday recommended that alcohol carry warnings about cancer risks, and attorneys say that while warning labels might be warranted, alcohol is unlikely to become the next tobacco.
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January 07, 2025
Amneal Calls Teva's IP Delisting Panic 'Theatrical Distraction'
The pharmaceutical industry won't fall into "chaos and disruption" if the Federal Circuit doesn't stay an injunction ordering Teva to remove inhaler patents from the Orange Book, and Teva's arguments otherwise are "a mere theatrical distraction" from the weakness of its position, according to Amneal Pharmaceuticals.
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January 07, 2025
New USPTO Advisers Include Mattel, Estee Lauder Attys
The U.S. Patent and Trademark Office on Tuesday welcomed six additions to its patent and trademark advisory committees, including lead intellectual property attorneys at The Estee Lauder Cos. Inc. and Mattel Inc.
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January 07, 2025
Cannabis Reformers Move To Oust DEA From Pot Hearings
The U.S. Drug Enforcement Administration has worked behind the scenes to undermine an administrative process that will determine whether federal restrictions on marijuana are relaxed, a group of reformers alleged in a new filing submitted to an agency tribunal.
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January 07, 2025
Biotech Co. Urges NC Panel To Revive Legal Malpractice Suit
A biotech company that lost a $22 million libel suit brought by a pharmaceutical executive has asked a North Carolina appeals panel for another shot at legal malpractice claims against its former legal counsel, arguing that a savings provision expands the statute of repose for the voluntarily dismissed claim to be revived.
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January 06, 2025
Athira Inks $4M FCA Deal Over Ex-CEO's Research Fraud
Athira Pharma Inc. has agreed to pay $4 million to resolve allegations it used falsified academic research papers on neurological disorders like Alzheimer's to secure federal grants from the National Institute of Health, the U.S. Department of Justice announced Monday.
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January 06, 2025
Sidley, Wachtell Guide Inari Medical's $4.9B Sale To Stryker
Medical technology company Stryker Corp., represented by Sidley Austin LLP, announced Monday that it has inked an agreement to acquire device maker Inari Medical Inc., represented by Wachtell Lipton Rosen & Katz, in a deal worth about $4.9 billion.
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January 06, 2025
High Court Asked To Take Whistleblower Medical Device Row
A former Minerva Surgical Inc. sales representative who says he was mistreated after raising concerns about the safety of certain medical devices wants the U.S. Supreme Court to take up his challenge to an arbitration award given to his former employer in whistleblower proceedings.
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January 06, 2025
Biotech Trade Secrets Case Gets New Punitive Damages Trial
A California federal judge has ordered a new punitive damages trial on how much a former Skye Orthobiologics LLC employee owes in a case where he was found to have breached his fiduciary duties by leveraging Skye's proprietary information, after ruling last year there wasn't enough evidence to support an earlier $25 million award.
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January 06, 2025
Biotech Co. Revance Faces Suit After Tender Offer Weakens
Biotechnology company Revance Therapeutics Inc. and two of its executives face a proposed investor class action alleging the company hurt investors after the value of a take-private tender offer was negotiated down following allegations that Revance had breached a distribution deal with another company.
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January 06, 2025
DOD Adds WeChat Owner, CATL To Chinese Military Co. List
The U.S. Department of Defense added dozens of businesses Monday to its list of companies affiliated with the Chinese military, including electric-car battery maker CATL and Tencent Holdings Ltd. — owner of the popular text-messaging app WeChat — prompting Tencent to slam the designation as "clearly a mistake."
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January 06, 2025
Labcorp Loses Appeal Of Gene-Testing Patent In $372M Case
Labcorp, one of the world's largest chains of clinical lab providers, lost its appeal over a patent tied to a $372 million judgment it is facing in the Western District of Texas, after Federal Circuit judges on Monday upheld an administrative patent board ruling against it two years ago.
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January 06, 2025
Judge Urged To Sit Out Alopecia IP Row Over Ex-Clerk's Role
Sun Pharmaceutical Industries has asked a New Jersey federal judge to recuse himself from a case alleging the company's alopecia drug infringes an Incyte patent, saying Incyte's attorneys hired the judge's former law clerk and put him on the case, creating "an indelible appearance of impropriety."
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January 06, 2025
Teoxane Outbids Crown With New Revance Therapeutics Bid
Teoxane SA said Monday it has submitted a proposal to Revance Therapeutics Inc. to acquire the healthcare biotechnology company for $3.60 per share in cash, one-upping Revance's existing agreement to sell itself to skincare company Crown Laboratories Inc. for $3.10 per share in cash.
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January 06, 2025
Girard Sharp Launches Into New Year With New Leadership
San Francisco-based Girard Sharp has kicked off the new year with a major leadership change, announcing Monday that Daniel C. Girard had stepped down as managing partner of the prominent plaintiffs complex litigation boutique he founded in 1995 and that longtime partner Dena C. Sharp was taking the reins.
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January 03, 2025
Vizgen Loses Antitrust Claims Against 10x In Biotech IP Fight
A Delaware federal court on Friday dropped Harvard's business partners at 10x Genomics Inc. out of some of the antitrust counterclaims by a rival biotech developer that is targeted in a patent lawsuit set for trial next month.
Expert Analysis
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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.
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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.