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Life Sciences
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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.
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August 16, 2024
Avantor Sells Clinical Services Biz To PE Shop In $650M Deal
Life sciences tools company Avantor Inc., advised by Arnold & Porter Kaye Scholer LLP, on Friday announced plans to sell its clinical services business to Ropes & Gray LLP-advised Audax Private Equity for $650 million.
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August 16, 2024
Psilocybin Right-To-Try Petition To Get 9th Circ. Hearing
A Ninth Circuit panel will hear oral arguments Monday in an appeal brought by a Seattle doctor seeking to administer psilocybin to terminal cancer patients under state and federal right-to-try laws.
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August 16, 2024
Taxation With Representation: Cleary, Kirkland, Skadden
In this week's Taxation with Representation, Mars Inc. sets a 2024 record with its $36 billion acquisition of Kellanova, Carlyle inks a $3.8 billion purchase with Baxter International Inc., and Performance Food Group Co. agrees to a $2.1 billion cash deal with Cheney Bros. Inc.
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August 16, 2024
NC Litigation Highlights Of 2024: A Midyear Report
Several-high profile cases in North Carolina came to a close in the first half of the year, from a second bribery conviction against an insurance magnate beset by legal woes, to the anticlimactic withdrawal of a state Supreme Court justice's much-watched free speech suit. Here, Law360 looks at those and other notable rulings so far in North Carolina.
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August 16, 2024
New Jersey Litigation Highlights Of 2024: A Midyear Report
A court's upheaval of New Jersey's longstanding "county line" ballot layout for the Democratic primary fueled both sides of the lively political aisle this year, while the same federal judge also riled the state's pharmaceutical hotbed by ending two challenges to Medicare's ability to negotiate drug prices. Here, Law360 looks at some of the notable cases so far in New Jersey.
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August 15, 2024
Talc Jury Delivers $63M Verdict Against J&J, Beauty Care Co.
A South Carolina jury awarded a cancer patient more than $63 million Thursday after he said he developed terminal lung cancer from breathing in asbestos during daily use of Johnson & Johnson's talc-based baby powder.
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August 15, 2024
NIH Accused Of Wrongly Eliminating Cos. From $50B IT Deal
Two companies have disputed their exclusion from the National Institutes of Health's pending $50 billion CIO-SP4 information technology procurement, saying they were qualified for the contract and the NIH hasn't explained its decisions.
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August 15, 2024
Matthew Perry's Assistant And 2 Drs. Charged In Actor's Death
The former personal assistant for actor Matthew Perry and two doctors have been criminally charged in connection with the "Friends" star's death last year from an overdose of ketamine, according to a criminal complaint unsealed Thursday in California federal court.
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August 15, 2024
LA Times Owner Sued Over Control Of Biotech Nonprofit
A biotech research institute has sued board member Dr. Patrick Soon-Shiong, the billionaire owner of the Los Angeles Times, in Washington federal court alleging entities controlled by him contractually owe the institute millions, even as Soon-Shiong is demanding the institute reallocate resources to fund pet projects unrelated to its mission.
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August 15, 2024
Monsanto Gets 3rd Circ. Win In Roundup Failure-To-Warn Case
The Third Circuit ruled Thursday that a Pennsylvania state law failure-to-warn claim in a suit alleging the weed killer Roundup caused a Keystone State man's cancer is preempted by federal law, creating a circuit split on central issues in multidistrict litigation over the Monsanto product.
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August 15, 2024
Pharmacy Can't Dodge Novo Nordisk's Diabetes Drug Suit
A Tennessee federal judge on Thursday declined to throw out a suit by Novo Nordisk Inc. alleging that DCA Pharmacy is selling drugs with the same active ingredient as its Ozempic diabetes medicine without U.S. Food and Drug Administration authorization.
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August 15, 2024
CMS Posts Final Costs For 1st Set Of Drugs After Negotiations
The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.
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August 15, 2024
Price-Fixing Claims Against Par Pharma Tossed After Ch. 11
A Connecticut federal judge on Thursday tossed Par Pharmaceutical Cos. Inc. from two price-fixing lawsuits after the defendant and its parent, Endo International PLC, recently filed the Chapter 11 reorganization plans that they said shielded them from the cases.
Expert Analysis
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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.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.