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Life Sciences
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July 03, 2024
Roche Says Stanford Profs Stole Cancer Detection Tech
Roche Molecular Systems has accused Stanford University and several faculty members of swiping its proprietary cancer detection technology and secretly founding a new company with it, according to a suit filed in California federal court.
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July 03, 2024
Revived Skinny Label Case Is A Warning For Generics
The Federal Circuit has made clear that generic-drug companies need to pay close attention to public statements when advertising drugs that still have patent-protected uses, even if their so-called skinny labels properly avoid references to those carved-out indications, attorneys say.
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July 03, 2024
Appeals Board Tosses Revived License Breach Dispute
The Civilian Board of Contract Appeals has again tossed a dispute, previously revived by the Federal Circuit, alleging the U.S. Food and Drug Administration breached a software company's end-user license agreement, saying it lacks jurisdiction to enforce the agreement.
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July 03, 2024
Cooley DQ'd From IP Case Over Atty's Past Patent Work
Cooley LLP was disqualified on Wednesday from representing a pharmaceutical customer-support software company against patent infringement claims in Delaware, with the district court citing a Cooley partner's prior work representing the plaintiff and Cooley's refusal to screen its attorney.
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July 03, 2024
Penile Implant Doc Seeks $7M Atty Fees, Costs In $18M IP Win
A urologist who won $18.3 million in royalties and damages after a jury found a rival stole his penile implant trade secrets and infringed his intellectual property asked a California federal judge for $6.5 million in attorney fees and $614,000 in costs, saying he is owed the funds as the prevailing party in the litigation.
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July 03, 2024
4 Mass. Rulings You Might Have Missed In June
Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.
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July 03, 2024
1st Circ. Hands Hearing Loss Biotech Win In Stock-Drop Suit
A panel of the First Circuit declined to revive an investor class action alleging that a hearing loss treatment company and some of its executives concealed disappointing clinical trial results, saying there was no evidence the company had knowingly made false statements about the trial.
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July 03, 2024
Cerevel Investors Allege Insider Trades Pre-$8.7B AbbVie Deal
A pension fund shareholder of Cerevel Therapeutics Holdings Inc. has sued the biopharmaceutical company in Delaware's Court of Chancery, seeking documents to investigate potential fiduciary duty breaches and possible insider trading shortly before the company announced its pending $8.7 billion merger with AbbVie Inc.
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July 03, 2024
After Chevron Deference: What Lawyers Need To Know
This term, the U.S. Supreme Court overturned Chevron deference, a precedent established 40 years ago that said when judges could defer to federal agencies' interpretations of law in rulemaking. Here, catch up with Law360's coverage of what is likely to happen next.
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July 03, 2024
Chancery Tosses Challenge To $3B AstraZeneca Viela Bio Sale
AstraZeneca PLC and a U.K. affiliate beat late Tuesday a Delaware Court of Chancery stockholder suit accusing the company of orchestrating an underpriced, $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc. in order to clear the way for AstraZeneca's purchase of a larger competitor.
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July 03, 2024
Quest Diagnostics Paying $985M For OMERS' LifeLabs
Canadian law firm McCarthy Tétrault LLP is guiding New Jersey-based Quest Diagnostics on a newly inked deal to buy LifeLabs from the Ontario Municipal Employees Retirement System, or OMERS, for about $985 million, Quest said Wednesday.
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July 02, 2024
FTC Investigating Teva Inhaler Patent Listings, Report Says
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after it refused to remove inhaler patents from a key federal database, according to a Washington Post report citing confidential agency documents.
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July 02, 2024
Chamber, Pharma Slam Colorado Drug Price Controls
The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.
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July 02, 2024
Biotech Biz Co-Directors Sue Each Other In Del., Cite Breaches
A California-based biotech company once researching a new class of antiviral therapy for COVID-19 is now the subject of dissolution proceedings in Delaware's Court of Chancery, after the company's two directors filed dueling lawsuits alleging fiduciary duty breaches and a board-level stalemate.
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July 02, 2024
Pharma Co. Scores Exit In Investor Suit Over Primate Imports
A Massachusetts federal judge tossed every claim in a proposed class action claiming that pharmaceutical company Charles River Laboratories and its executives concealed their involvement in the illegal importation of nonhuman primates for research, ruling that the disputed statements are not false or misleading.
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July 02, 2024
McKinsey Wants To Arbitrate Ex-Partner's Defamation Suit
McKinsey & Co. has urged a New York state judge to send to arbitration or dismiss a former partner's defamation lawsuit alleging the consulting giant tried to make him a scapegoat for purported evidence destruction amid a U.S. Department of Justice probe into McKinsey's work with opioid makers.
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July 02, 2024
Beasley Allen Slams J&J's DQ Bid 'Check-Up' In Talc Tort
The Beasley Allen Law Firm and Johnson & Johnson continue to spar over the firm and attorney Andy Birchfield's role in long-running federal and state mass torts over talcum powder injuries, with the firm calling out J&J on Tuesday for "prodding" the New Jersey courts to boot the lawyers from the litigation.
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July 02, 2024
High Court Agrees To Review FDA's Flavored E-Cig Denial
The U.S. Supreme Court on Tuesday granted the U.S. Food and Drug Administration's petition to review a Fifth Circuit decision overturning its denial of a flavored e-cigarette marketing application.
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July 01, 2024
High Court's 1-2 Punch Sets Up Long-Standing Regs For KO
By ending its term with a stinging combination against federal agencies, the U.S. Supreme Court's conservative bloc left behind a bruised bureaucracy and a regulatory system that's now vulnerable to a barrage of incoming attacks.
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July 01, 2024
UC Riverside Profs Win Combined $6.1M In Retaliation Trial
Two former University of California, Riverside professors were awarded a total of $6.1 million in damages by a jury that found they were retaliated against in violation of the California Whistleblower Protection Act after making official complaints about alleged misdeeds their supervisor was engaging in, including misuse of government funds.
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July 01, 2024
State AGs Get Stay Lifted In Generic Drug Pricing Litigation
A Connecticut federal judge on Monday agreed to lift a partial discovery stay in a trio of generic drug pricing antitrust suits led by the attorneys general of New York and Connecticut, according to a short, text-only order posted to each of the case dockets.
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July 01, 2024
IPO Rebound Leads Capital Markets Recovery At Midyear
Capital markets activity moderately accelerated in the year's first six months, buoyed by the highest level of initial public offerings in three years, signaling a busy second half for deal-makers at least until the November presidential election.
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July 01, 2024
Caribou Bio Inks $3.9M Deal In Investors' Cancer Therapy Suit
Caribou Biosciences Inc. has agreed to pay $3.9 million to settle a proposed class action alleging it misled investors about the durability of its most advanced cancer-fighting therapy before and after the gene-editing biotechnology company went public, investors told a California federal judge on Friday.
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July 01, 2024
NJ Judge Tosses J&J Unit's Libel Claim Over Talc Study
A New Jersey federal judge has tossed a bankrupt Johnson & Johnson unit's libel suit over a scientific article linking talcum powder to mesothelioma, ruling the challenged statements in the article are scientific conclusions protected by the First Amendment.
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July 01, 2024
Bard, Hernia Mesh Claimants Can't Hide Injury MDL Deal Info
An Ohio federal judge denied a joint bid to seal a forthcoming settlement motion by C.R. Bard Inc. and hundreds of claimants who sued Bard and a subsidiary over their hernia mesh implants Monday, saying the parties had not given a compelling reason their deal should be secret.
Expert Analysis
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.