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Life Sciences
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August 29, 2024
Comer Tells PBMs 'Correct Record' On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Seattle Biotech Can't Immediately Force Out LA Times Owner
Billionaire and Los Angeles Times owner Dr. Patrick Soon-Shiong will not be forced to recuse himself from a Seattle-based biotech research institute board while the nonprofit's breach-of-fiduciary duty lawsuit against him is pending, a Washington federal judge said on Thursday.
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August 29, 2024
Pacira To Appeal Generic's Win In Pain Drug Patent Fight
Pacira Pharmaceuticals Inc. says it is appealing a New Jersey federal judge's decision invalidating its patent on a nonopioid painkiller and opening the way for generic versions of its drug Exparel, a long-acting injectable for managing postsurgical pain.
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August 29, 2024
Nektar Can't Get Docs It Says Show Lilly As 'Thieves, Liars'
A California federal judge Thursday rejected Nektar Therapeutics' request for internal Eli Lilly documents related to separate litigation as Nektar pursues allegations Eli Lilly ruined prospects for a drug the companies were developing together despite Nektar's counsel saying it would "expose Lilly for being thieves, liars."
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August 29, 2024
Convicted Drexel Prof Says Records Would've Swayed Jury
A Drexel University accounting professor convicted on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy has asked a New Jersey federal judge for a new trial.
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August 29, 2024
Jazz Hits Teva With Patent Suit Over Narcolepsy Drug
Teva Pharmaceuticals Inc. is infringing a patent for the narcolepsy drug Xywav, Jazz Pharmaceuticals Inc. said in a complaint filed in New Jersey federal court.
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August 28, 2024
Merck Must Face Class Claims In Vaccine Antitrust Suit
Merck cannot strike class claims in antitrust litigation over its rotavirus vaccine, a Pennsylvania federal judge ruled Wednesday, while also allowing the city of Baltimore to eliminate redundancies in its complaint.
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August 28, 2024
CyDex Says Bexson Breached Deal By Misusing Pharma IP
CyDex Pharmaceuticals hit Bexson Biomedical with a contract breach suit in Delaware Chancery Court accusing it of misusing a CyDex-designed molecule to develop unauthorized non-ketamine formulations, and subsequently filing a patent for those formulations, in violation of the parties' agreement.
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August 28, 2024
J&J Spinoff Beats Suit Over Tylenol 'Rapid Release' Labels
A New York federal judge tossed Tuesday a proposed class action accusing a Johnson & Johnson spinoff of misleading consumers by falsely claiming Tylenol's "Rapid Release" gelcaps relieved pain faster than alternative acetaminophen pills, finding the consumer's state claims are preempted by federal regulations.
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August 28, 2024
Lipitor Buyers Seek Final OK For $35M Deal In Antitrust Fight
End-payor plaintiffs asked a New Jersey federal judge Tuesday to give final approval of a $35 million settlement resolving their antitrust claims against Pfizer over the cholesterol medication Lipitor.
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August 28, 2024
Walgreens Brass Hid Pharmacy Division Woes, Suit Says
Walgreens' directors and officers have been hit with a derivative suit by a shareholder who says the company and its executives inflated stock value by publicly expressing confidence in the pharmacy division's growth while hiding its struggles adapting to industry hurdles.
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August 28, 2024
Jazz, Hikma Must Face Bulk Of Xyrem Antitrust Suit
Jazz Pharmaceuticals and Hikma Pharmaceuticals appear bound for trial against most solo insurer and class action antitrust claims over alleged efforts to block generic competitors to Jazz's Xyrem narcolepsy drug, under a newly unsealed California federal court order largely rejecting competing motions for summary judgment.
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August 28, 2024
Calif. Couples Drop FujiFilm Suit Over Destroyed Embryos
California couples who sued a manufacturer of oil used in the in vitro fertilization process claiming the product killed their embryos are looking to drop their federal suit.
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August 28, 2024
Del. Justices OK Mid-Case Appeal In Zantac Class Suit
The Delaware Supreme Court on Tuesday said it would hear a mid-case appeal in mass tort litigation over claims that the heartburn drug ranitidine, widely sold under the name Zantac, caused cancer.
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August 28, 2024
High Court Told Tyvaso Row Petition Based On 'False' Premise
A small pharmaceutical startup behind a drug that would compete with the blockbuster high blood pressure treatment Tyvaso says United Therapeutics is making a "fundamentally false" argument to the U.S. Supreme Court about why an appeals court rejected United Therapeutics' case.
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August 28, 2024
Regeneron Sues Sandoz Over Dozens Of Eye Drug Patents
Regeneron Pharmaceuticals Inc. has taken competing biomedical company Sandoz Inc. to New Jersey federal court with an extensive complaint asserting 46 patents and claiming Sandoz infringed them all with a biosimilar alternative to Regeneron's Eylea brand ophthalmic disorder drug.
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August 28, 2024
Biotech Biz Hid Risks Of Gene-Editing Trial, Investor Claims
Biotechnology firm Verve Therapeutics was hit with a proposed class suit alleging it misled investors about the risks associated with a clinical trial of an experimental gene-editing drug that was halted and caused the company's stock to tumble.
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August 27, 2024
Cherokee Nation's Opioid Suit Sent Back To State Court
An Oklahoma federal judge has adopted a magistrate judge's recommendation to send a Cherokee Nation opioid lawsuit against pharmaceuticals distributor Morris & Dickson back to state court, agreeing that the negligence case isn't predicated on a duty arising out of the federal Controlled Substances Act.
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August 27, 2024
USPTO Sued For Rejecting Blood Pressure Drug Patent
A small drug developer has hit the U.S. Patent and Trademark Office with a second lawsuit in Virginia federal court over the agency's latest rejection of the company's efforts to patent a different dosage of a drug the company markets to treat low blood pressure.
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August 27, 2024
NY Pension Funds Join Illumina Deal Suit Pile-On In Del.
New York state's retirement system and fund have added a new derivative suit to widening stockholder litigation over Illumina Inc.'s $8 billion reacquisition of cancer testing company Grail Inc. despite European Commission regulatory agency opposition.
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August 27, 2024
Fed. Circ. Won't Speed Up Apple Watch Ban Appeal
The Federal Circuit on Tuesday denied Apple Inc.'s request to expedite oral arguments in its appeal challenging the U.S. International Trade Commission's decision banning the tech giant from selling Apple Watches with a "blood oxygen" feature in the Masimo patent case.
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August 27, 2024
Connecticut Litigation To Watch In The 2nd Half Of 2024
The Connecticut state and federal courts will grapple with a number of closely watched cases during the second half of 2024, including three key lawsuits by state Attorney General William Tong.
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August 27, 2024
Sheppard Mullin Adds Another McDermott Healthcare Pro
Sheppard Mullin Richter & Hampton LLP has hired a 12-year McDermott Will & Emery LLP healthcare transactions partner in Chicago, making him the latest partner focused on that industry to join the Sheppard Mullin team in the last year.
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August 27, 2024
Vt. High Court Affirms Denial Of Benefits To Marijuana Patient
The Vermont Supreme Court has affirmed an administrative law judge's decision not to issue a declaratory ruling whether off-duty medical cannabis use counts as misconduct for the purposes of terminating and denying benefits to a former transportation company employee.
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August 27, 2024
Freshfields Steers UCB's $680M Sale Of Chinese Portfolio
UCB has said it will sell a portfolio of established products in China to investment firms in Singapore and Abu Dhabi for $680 million so that the Belgian biopharmaceutical company can focus on developing new medicines for the pharma market in the Far East country.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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How Law Firms Can Avoid 'Collaboration Drag'
Law firm decision making can be stifled by “collaboration drag” — characterized by too many pointless meetings, too much peer feedback and too little dissent — but a few strategies can help stakeholders improve decision-making processes and build consensus, says Steve Groom at Miles Mediation.
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What BIPA Reform Law Means For Biometrics Litigation
A recently signed Illinois law amending the Biometric Information Privacy Act limits defendants' liability exposure on a per-scan basis and clarifies that electronic signatures constitute a valid written release, establishing additional issues that courts will need to address in future BIPA litigation, say attorneys at Faegre Drinker.
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Opinion
Litigation Funding Disclosure Key To Open, Impartial Process
Blanket investor and funding agreement disclosures should be required in all civil cases where the investor has a financial interest in the outcome in order to address issues ranging from potential conflicts of interest to national security concerns, says Bob Goodlatte, former U.S. House Representative for Virginia.
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The Licensure Landscape For Psychedelics Manufacturers
As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.
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What NFL Draft Picks Have In Common With Lateral Law Hires
Nearly half of law firm lateral hires leave within a few years — a failure rate that is strikingly similar to the performance of NFL quarterbacks drafted in the first round — in part because evaluators focus too heavily on quantifiable metrics and not enough on a prospect's character traits, says Howard Rosenberg at Baretz+Brunelle.
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Replacing The Stigma Of Menopause With Law Firm Support
A large proportion of the workforce is forced to pull the brakes on their career aspirations because of the taboo surrounding menopause and a lack of consistent support, but law firms can initiate the cultural shift needed by formulating thoughtful workplace policies, says Barbara Hamilton-Bruce at Simmons & Simmons.
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Class Actions At The Circuit Courts: August Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers certification cases touching on classwide evidence of injury from debt collection practices, defining coupon settlements under the Class Action Fairness Act, proper approaches for evaluating attorney fee awards in class action settlements, and more.
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Leveraging Policy Changes To Achieve AI Patent Eligibility
With the latest U.S. Patent and Trademark Office guidance in hand and legislation looming in Congress, innovators should file their artificial intelligence patent applications now — and five strategies can maximize their chances of success, says Nicholas Gallo at Troutman Pepper.
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Planning Law Firm Content Calendars: What, When, Where
During the slower month of August, law firms should begin working on their 2025 content calendars, planning out a content creation and distribution framework that aligns with the firm’s objectives and maintains audience engagement throughout the year, says Jessica Kaplan at Legally Penned.
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Series
Playing Golf Makes Me A Better Lawyer
Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.