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Life Sciences
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April 10, 2024
Justices Asked To Ban FCA Suits Relying On Patent Reviews
Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.
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April 10, 2024
Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row
Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.
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April 10, 2024
1st Circ. Says Appellant's Death Erases Conviction
The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.
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April 10, 2024
Life Sciences Group Of The Year: Morrison Foerster
Morrison Foerster LLP successfully beat a preliminary injunction that would have thwarted a Sandoz biosimilar for multiple sclerosis from going to market, one achievement among many that earned the firm a spot among Law360's 2023 Life Sciences Groups of the Year.
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April 10, 2024
Ginkgo Bioworks SPAC Investors Sue In Del. After Stock Drop
Investors in the blank check company that took biotech firm Ginkgo Bioworks Inc. public in September 2021 have sued the venture's founders and insiders for unjust enrichment and fiduciary breaches in Delaware's Court of Chancery, alleging that the deal was propped up by false and misleading claims.
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April 09, 2024
After Uproar, New MDL Rule Advances With Attys Assuaged
Following years of debate and months of outcry, a judicial panel Tuesday approved the first formal rule aimed at improving efficiency and fairness in the nation's burgeoning realm of multidistrict litigation, earning plaudits from placated lawyers in the defense and plaintiffs bars.
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April 09, 2024
Investor Can't Get Approval Of Hong Kong Award In Calif.
A California judge has thrown out a petition filed by a biotechnology company investor seeking to enforce a Hong Kong arbitral award that found she is the proper owner of the company's shares, saying the case has an insufficient connection to the Golden State.
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April 09, 2024
Philips, Feds Enter Consent Decree Over Sleep Apnea Devices
Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.
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April 09, 2024
Pfizer Cancer Drug Way Too Expensive, Biden Told
The U.S. government is being asked yet again to use patent laws to lower the price of a prostate cancer drug that was developed at UCLA and is being sold by Pfizer for $136 a pill in the U.S.
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April 09, 2024
HK Arbitrator Halts Commercialization Of Leukemia Treatment
A Cayman Islands pharmaceutical company has announced that an emergency arbitrator in Hong Kong has ordered a Chinese biopharma firm to stop commercializing a treatment for leukemia as the two companies arbitrate a dispute over a terminated license agreement.
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April 09, 2024
Former Pharma Exec Can't Oust Judge In Contempt Case
A federal judge in Massachusetts on Tuesday denied what he called a "frivolous" motion to recuse himself from a criminal contempt proceeding against a former pharmaceutical executive who has acknowledged using an alias to flout an injunction banning him from working in the securities field.
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April 09, 2024
Endo Sues FDA Over Generic Adrenalin Approvals
Endo has filed a lawsuit against federal health regulatory authorities, alleging that they are wrongfully giving the go-ahead for a generic version of the Adrenalin epinephrine injection, asking for a stay of the decision.
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April 09, 2024
Biotech Co. Insiders Sued In Del. Over $200M PIPE Deal Gain
Investors of clinical-stage pharmaceutical company Taysha Gene Therapies Inc. sued the company's directors and officers in Delaware Chancery Court to recover more than $200 million in damages on behalf of the company after its insiders allegedly wrongfully profited from a public equity sale.
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April 09, 2024
Tech M&A Reigns Supreme In Q1 After Rare Hiccup In Q4
The technology sector logged the greatest total value of global mergers and acquisitions in the first quarter of 2024, following a rare quarter that saw the industry fall out of the top spot and into third place, data from Dealogic shows.
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April 09, 2024
Life Sciences GCs On Tighter Regs, Outside Counsel Advice
General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.
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April 09, 2024
Jenner & Block Recruits Ex-Sheppard Mullin IP Litigator In SF
Jenner & Block LLP is boosting its intellectual property practice with the addition of a veteran trial lawyer as of counsel in its San Francisco office who was most recently with Sheppard Mullin Richter & Hampton LLP.
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April 09, 2024
Court OKs Decision Clearing Contractor Of Missed IP Deadline
A patent docketing contractor used by major remote law firm FisherBroyles can't be held liable for a "clerical mistake" that led to a missed patent application deadline and then a neurosurgeon's lawsuit potentially seeking nearly $102 million, with a Georgia appeals court affirming a lower court decision that the surgeon never should have relied on those dates in the first place.
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April 08, 2024
Target's Acne Treatments Contain Benzene, Customer Says
A Target customer in Illinois has launched consumer protection claims in federal court targeting acne treatments the retail giant allegedly manufactures and markets without disclosing benzene among their active ingredients.
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April 08, 2024
Walmart Beats Investor Suit Over Opioid Probe Disclosures
Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.
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April 08, 2024
SEC 'Shadow Trading' Victory Could Bring DOJ Knocking
Now that the U.S. Securities and Exchange Commission has convinced a jury that a pharmaceutical executive committed insider trading by purchasing a competitor's stock in a practice often referred to as "shadow trading," attorneys say federal prosecutors might be tempted to dip their toe into the waters of the previously untested legal theory.
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April 08, 2024
Roche Again Beats Ex-Service Members' Antimalarial Drug Suit
A California federal judge on Monday tossed a second suit alleging Roche Inc. and its affiliates failed to warn service members that their antimalarial drug could have permanent psychiatric side effects, saying such claims are preempted by federal law.
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April 08, 2024
9th Circ. Urged To Revive J&J, Bausch Talc False Ad Suit
An attorney for a proposed class alleging they were misled by Johnson & Johnson and Bausch Health about their talc products' safety urged a Ninth Circuit panel on Monday to revive the suit, saying a lower court erred in finding his clients needed to point to specific advertisements that misled them.
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April 08, 2024
La. Drug Caps Conflict With Federal Law, AbbVie Says
Drugmaker AbbVie is asking a Louisiana federal judge to grant its summary judgment motion and block new state-level pharmaceutical caps for the federal 340B drug discount program, calling the state's competing summary judgment motion arguments "legally and factually wrong."
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April 08, 2024
PE Firm Calls FTC's Antitrust Claims 'Many Yesterdays' Old
A Texas anesthesiology company and the private equity firm that created it told a Houston federal judge Monday that the Federal Trade Commission has gone back "many yesterdays ago" in making its antitrust case, arguing that there's no imminent threat of a monopoly in an attempt to get the case dismissed.
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April 08, 2024
Catching Up With Delaware's Chancery Court
Last week, a much-watched Chancery Court Match.com decision got reversed, a Philip Morris motion got stubbed out, and a long-frozen Blue Bell Creameries suit started churning again. Delaware's Court of Chancery also saw new suits filed for legal fees, arguments over multibillion-dollar pay packages, and a judge flummoxed over Truth Social.
Expert Analysis
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.
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The Legal Industry Needs A Cybersecurity Paradigm Shift
As law firms face ever-increasing risks of cyberattacks and ransomware incidents, the legal industry must implement robust cybersecurity measures and privacy-centric practices to preserve attorney-client privilege, safeguard client trust and uphold the profession’s integrity, says Ryan Paterson at Unplugged.