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Life Sciences
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January 03, 2025
Natera Loses New Trial Bid After Winning $96M Patent Verdict
A Delaware federal judge denied Natera's bid for a new trial in a case where a jury awarded the DNA test company $96 million in damages after finding rival CareDx stole from one of its patents but didn't infringe a second patent, saying Friday that sufficient evidence backed the verdict.
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January 03, 2025
Aetna Says Takeda Inked Deal To Block Generics, Keep Profits
Takeda Pharmaceuticals struck an anticompetitive deal with Par Pharmaceutical to keep a cheaper, generic version of its anticonstipation drug Amitiza off the market after the drug's compound patent expired, Aetna claimed Friday in a Massachusetts lawsuit, with the insurer alleging it overpaid millions of dollars for the brand name drug.
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January 03, 2025
DOJ Wants Oct. Amedisys Trial, UnitedHealth Wants Aug.
The U.S. Department of Justice sparred with UnitedHealth Group in a Maryland federal court filing Friday over when to hold a trial on the government challenge to the $3.3 billion purchase of home health and hospice services company Amedisys Inc.
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January 03, 2025
PBMs 'Wasting' Time in Opioid MDL Discovery Spat: Judge
An Ohio federal judge overseeing multidistrict opioid litigation on Friday denied pharmacy benefit managers a stay to appeal a discovery order and said he believed the PBMs were "wasting" the court's time.
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January 03, 2025
Cancer Drug Co. Revives Bid To Go Public Via Direct Listing
Brain cancer-focused drug developer NeOnc Technologies Holdings Inc. filed plans on Friday to go public through a direct listing, represented by Manatt Phelps & Phillips LLP, as it pursues an alternative to an initial public offering after canceling a prior IPO attempt.
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January 03, 2025
Pfizer Partner Targets GSK In COVID Vax Patent Suit
A drug developer that Pfizer and BioNTech partnered with to develop their COVID-19 vaccine has opened up another legal front in a dispute over allegations that the Pfizer vaccine infringes patents issued to U.K. drugmaker GlaxoSmithKline.
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January 03, 2025
Fed. Circ. Upholds Cancellation Of TMs On Pink Hip Implants
The Federal Circuit on Friday said a trademark panel correctly canceled a German medical supplier's trade dress protections for the color pink in a hip joint implant part because the color is functional, citing the company's previous patents and public statements to support that conclusion.
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January 03, 2025
$15M Flea Collar MDL Deal Scores Swift Approval By Ill. Judge
An Illinois federal judge gave his final blessing on Friday to a $15 million settlement in multidistrict litigation targeting adverse side effects that Bayer and other companies behind certain flea and tick collars allegedly failed to warn about.
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January 03, 2025
Biogen Not On Hook For Disruptions Caused By Landlord
Biogen Inc. did not breach the terms of a sublease with biopharma components manufacturer Brammer Bio and bears no responsibility for any claimed losses suffered by Brammer during a construction project by the building's owner, a Massachusetts judge has concluded.
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January 03, 2025
Research Co. Can't Ax Affair Harassment Suit, Ex-Worker Says
A former worker for a clinical research company asked a Georgia federal judge to deny the company's bid to toss her harassment suit claiming a co-worker made sexual comments about her father and started sleeping with him, arguing the conduct was severe enough to keep her case alive.
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January 02, 2025
Eye Drug Study Blindsided Pharma Co. Investors, Suit Says
The CEO and directors of biopharmaceutical company Apellis Pharmaceuticals Inc. face shareholder derivative claims they failed to monitor clinical study participants for a serious side effect, leading to plummeting trading prices after a medical association sounded an alarm about the company's drug candidate.
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January 02, 2025
Fox Rothschild Atty Beats Trade Secret Theft Allegations
A federal judge in New Jersey says a company trying to develop cancer drugs had waited too long to sue its former patent lawyer after he allegedly "confessed" over five years ago to helping a Chinese rival file a patent application that allegedly misappropriated trade secrets.
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January 02, 2025
Edwards Brass Face Investor Suit Over Heart Valve Sales
The executives and directors of medical device maker Edwards Lifesciences have been hit with a shareholder derivative suit in California federal court alleging the company understated how industry trends and macroeconomic factors would impact the success of its mainstay device.
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January 02, 2025
Issa Again Selected To Lead House IP Subcommittee
Rep. Darrell Issa, R-Calif., will again lead the House subcommittee overseeing intellectual property in the upcoming Congress, a role in which he has sponsored bills seeking to limit how many patents can be asserted in biosimilar cases and require disclosure of litigation funding.
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January 02, 2025
1st Private Co. Joins Insulin Price-Fixing MDL
A Florida-based car dealer is the first private company to join a multidistrict litigation accusing Novo Nordisk, Eli Lilly and Sanofi-Aventis of fixing the prices of insulin and other drugs to treat diabetes.
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January 02, 2025
A-Rod's SPAC Deal Seeks Extra Innings, Plus More IPOs Filed
The period between Christmas Eve and Jan. 1 wasn't completely quiet on the capital markets deals front, with A-Rod's special purpose acquisition company seeking an extension to complete its merger and several new IPOs being filed. Here, Law360 looks at the capital markets news from the holiday break.
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January 02, 2025
Ozempic Caused Severe Pain And Hospitalization, Suit Says
Pharmaceutical giant Novo Nordisk has been sued in Connecticut federal court by a 67-year-old woman claiming it did not properly disclose the risk of gastroparesis associated with its popular weight loss drug Ozempic, which allegedly caused her severe stomach pain and vomiting that led to a 10-day hospitalization.
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January 02, 2025
Eli Lilly Slams Suit Alleging Shortage Of Weight-Loss Drug
Eli Lilly is seeking permission to join a legal fight over whether compounding pharmacies can keep making copycat versions of the company's lucrative weight-loss and diabetes drug, telling a federal court Wednesday that its interests aren't adequately represented by federal regulators.
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January 02, 2025
Hikma Wants Extension At High Court In Skinny Label Case
Hikma Pharmaceuticals USA Inc. wants an extra month to file its petition challenging the Federal Circuit's revival of a suit claiming the company induced physicians to infringe patents covering Amarin Pharma Inc.'s blockbuster cardiovascular drug Vascepa, citing the case's importance and the busy schedules of attorneys.
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January 02, 2025
Roche Strikes $80M Oncology Drug Deal With Chinese Biotech
A multimillion-dollar agreement kicked off biotech deals in the new year when Swiss pharma giant Roche and Chinese biotech Innovent Biologics announced Wednesday that they had entered into an exclusive licensing agreement focused on a new oncology drug.
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January 02, 2025
'Crush-Resistant' OxyContin Patents Fail At Fed. Circ.
In one of its last major moves in 2024, the Federal Circuit decided to reject an appeal from the bankrupt maker of OxyContin, which is trying to use patent laws to block the release of a competing "crush-resistant" generic painkiller.
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January 02, 2025
Aetna Sues Drugmakers In Conn., Alleging Generics Price-Fixing
Health insurer Aetna has sued 23 drugmakers, including Novartis and Pfizer, over an alleged scheme to fix the prices of 111 generic medications, citing information gleaned from a congressional probe, lawsuits by state attorneys general, a Pennsylvania multidistrict litigation proceeding, and U.S. Department of Justice findings.
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January 02, 2025
Beasley Allen Aims To Toss Suit From Ex-Ally Firm
Beasley Allen has called on a Mississippi federal court to dismiss or transfer a defamation and breach of contract lawsuit from The Smith Law Firm PLLC over their joint venture agreement for talc litigation against Johnson & Johnson, arguing the case should be tossed in favor of its own suit filed earlier in Alabama.
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January 02, 2025
IRS, Treasury Float Regs On Excise Taxes For Drugmakers
The IRS and Treasury proposed rules for charging excise taxes to drugmakers that refuse to negotiate drug prices with Medicare under requirements of the 2022 tax and climate law, saying the tax only would apply to manufacturers and importers that initially sell the drugs.
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January 01, 2025
Healthcare and Life Science Deals Attys Expect In 2025
As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House.
Expert Analysis
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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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.