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Life Sciences
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August 20, 2024
Vax Patent Battles Heat Up As Attention On Pandemic Wanes
It's been over four years since clinical trials began for COVID-19 vaccines, and while the shots have helped the pandemic recede, the lucrative technology has spurred numerous patent suits, many of which are still in the early stages. Here's a look at some of the key cases in the U.S.
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August 20, 2024
Ex-Client Opposes Amicus In McCarter & English Fee Fight
A dietary supplement maker has asked Connecticut's highest court to reject a bid by the Connecticut Trial Lawyers Association to file a friend-of-court brief in a case questioning whether McCarter & English LLP can obtain punitive damages in a fee dispute, saying no additional input is necessary because no tort occurred.
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August 20, 2024
FTC Endorses Push For Broader Access To Biosimilar Drugs
The Federal Trade Commission is backing a proposal that would make it easier for drugmakers to show biosimilar medicines are safe substitutes for their more expensive counterparts, a move the agency says would boost competition and reduce confusion.
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August 20, 2024
Pathology Trade Group 2nd To Sue FDA Over Lab-Test Rule
A molecular pathology trade group has filed a lawsuit against the U.S. Food and Drug Administration, challenging a recent final rule to regulate laboratory-developed tests as medical devices and arguing the agency has abused its power — the second such case filed in recent months.
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August 20, 2024
A Deep Dive Into Law360 Pulse's 2024 Women In Law Report
The legal industry continues to see incremental gains for female lawyers in private practice in the U.S., according to a Law360 Pulse analysis, with women now representing 40.6% of all attorneys and 51% of all associates.
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August 20, 2024
These Firms Have The Most Women In Equity Partnerships
The legal industry still has a long way to go before it can achieve gender parity at its upper levels. But these law firms are performing better than others in breaking the proverbial glass ceiling that prevents women from attaining leadership roles.
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August 20, 2024
J&J Boosting Cardio Portfolio With Up To $1.7B V-Wave Buy
Johnson & Johnson said Tuesday it has agreed to acquire V-Wave Ltd., the maker of an implant device that aims to treat heart failure, for up to $1.7 billion as it looks to bolster its cardiovascular disease portfolio.
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August 19, 2024
TPG Dumped Opioid Co. On 'Unsuspecting' Endo, Suit Says
After pushing Par Pharmaceutical to grow its market share in generic opioids and disregard federal requirements to report suspicious orders, TPG Capital saw other opioid manufacturers being inundated with litigation and sold Par to "an unsuspecting" Endo International PLC, according to a lawsuit filed in New York bankruptcy court.
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August 19, 2024
Biogen Paid To Help Curb Generic Tecfidera Sales, Says Suit
Biogen illegally impaired competition for its multiple sclerosis drug Tecfidera by paying major pharmacy benefit managers to prioritize the brand over generics while it worked to shift the market to a different version of the medication, a multi-employer welfare plan alleged Friday.
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August 19, 2024
NuVasive Beats Fraudulent Inducement Claim At Trial
A Delaware federal jury has rejected a physician's claim that NuVasive Inc. fraudulently induced him to enter into a 2014 agreement related to patents he owns for spinal implant system components — but also rejected the medical device manufacturer's claim that the doctor had breached the deal by suing.
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August 19, 2024
9th Circ. Told Psilocybin Petition Is Backed By Precedent
A Ninth Circuit panel on Monday dissected opposing arguments from the U.S. Drug Enforcement Administration and a Seattle doctor over whether there is precedent to allow the dispensing of psilocybin — a psychedelic compound — to treat terminally ill patients.
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August 19, 2024
Jadex Sells Temperature-Controlled Packaging Biz For $137M
Material sciences company Jadex Inc. is selling its temperature-controlled packaging products business Lifoam Industries LLC to Altor Solutions, led by Gibson Dunn & Crutcher LLP, in a $137 million cash deal, the parties announced in separate Monday statements.
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August 19, 2024
Second Pharmacist To Avoid Meningitis Murder Trial
A pharmacist charged with murder in a deadly fungal meningitis outbreak that killed dozens of people is expected to plead no contest to involuntary manslaughter charges this week, averting a Michigan trial that had been set for November.
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August 19, 2024
Pennsylvania Litigation Highlights Of 2024: A Midyear Report
Pennsylvania courts have been the scene of several explosive cases in the first half of 2024, including one that produced an astronomical $2.25 billion verdict against Bayer AG unit Monsanto in the Roundup mass tort unfolding in the Philadelphia County Court of Common Pleas.
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August 19, 2024
Israeli Co. Sues NC Packaging Firm For Severing $25M Deal
An Israeli smart packaging company is suing North Carolina-based Sealed Air Corp. for allegedly backing out of a $25 million contract for smart sensors, saying Sealed Air lied about their progress developing the product and invented defects to tank the deal.
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August 19, 2024
Biotech Consultant Sues Ex-Partner To Force $2.5M Share Buy
Life sciences consulting firm BioPoint is asking a Massachusetts judge to order a former partner to sell back $2.5 million worth of shares in the closely held company following his ouster, according to a lawsuit filed in state court.
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August 16, 2024
Fed. Circ. Quells Fears Over Double-Patenting Overreach
A recent Federal Circuit decision finding patent claims licensed by Allergan were not invalid for obviousness-type double patenting provided relief to attorneys who were concerned the court had made it easier to invalidate patents that had extended expiration dates to make up for regulatory delays.
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August 16, 2024
Humana To Pay $90M To End 8-Year Medicare Drug FCA Battle
Humana Inc. has agreed to pay the federal government $90 million to settle long-running False Claims Act allegations it submitted fraudulent bids for Medicare prescription drug deals, Phillips & Cohen LLP said Friday in announcing the "first case of its kind" to resolve allegations of fraud in the Medicare Part D contracting process.
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August 16, 2024
Drexel Accounting Prof Convicted Of Evading Tax On $3.3M
New Jersey federal jurors have convicted a Drexel University accounting professor 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.
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August 16, 2024
Baltimore Inks $152.5M Opioid Deal With Cardinal Health
Baltimore announced Friday that it settled claims for $152.5 million with Cardinal Health over its alleged role in helping fuel the city's opioid crisis, reaching the deal with the pharmaceutical distributor ahead of a September trial against five remaining defendants and following separate $45 million settlements with Allergan and CVS.
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August 16, 2024
Birth Control Cos. Say Conn. Injury Suit Must Be Tossed
Several birth control companies have urged a Connecticut state court to toss a lawsuit brought by a woman alleging she was injured by the Filshie Clip contraceptive device, saying there is no jurisdiction because the parties involved in the case have no ties to Connecticut.
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August 16, 2024
States Get Teva Generic Price-Fix Case On Docket As 1st Trial
A Connecticut federal judge has granted a request from a coalition of state attorneys general suing a slew of generic-drug makers to try a case focused on Teva before proceeding with a different case that was first filed.
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August 16, 2024
Walgreens Didn't Disclose PFAS In Bandages, Shopper Says
Walgreens' parent company has been hit with a proposed class suit in Illinois state court claiming the pharmacy retailer illegally markets its flexible fabric bandages as safe while hiding that they contain hazardous "forever chemicals" that are dangerous to human health.
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August 16, 2024
Apple Needs To Wait Its Turn In ITC, Masimo Tells Fed. Circ.
Apple wants to speed up its appeal over a U.S. International Trade Commission patent ruling that forced the company to disable an Apple Watch feature that measures the oxygen in blood, but both its courthouse rival and the agency itself say there's no compelling reason to cut in line.
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August 16, 2024
Ex-CEO Wants Verdict In COVID Test Kit Fraud Case Tossed
A former healthcare software executive found guilty of securities fraud for publicly touting a $670 million COVID test kit deal that ultimately collapsed wants his conviction thrown out, telling a New Jersey federal judge the government failed to establish every element of the crime.
Expert Analysis
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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.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.