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Life Sciences
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August 12, 2024
States Want Teva Generic Price Fixing Case Tried 1st
A coalition of state attorneys general suing a slew of generic drugmakers are asking for a Connecticut federal court to proceed with one of the two cases before the other, saying the outcome in that case will have a "significant impact" on settlement talks with other pharmaceutical company plaintiffs.
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August 12, 2024
Glass Tempering Co. Loses Early Exit Bid In NC Patent Fight
A glass processing equipment distributor can't ditch a Finnish competitor's patent infringement suit, a North Carolina federal judge has ruled, finding its rival has sufficiently alleged "exclusionary rights" to the patents for glass tempering.
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
States Oppose Shkreli High Court Bid For $64M Disgorgement
State enforcers are opposing a petition from ex-pharmaceutical executive Martin Shkreli asking the U.S. Supreme Court to review a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%
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August 12, 2024
Pacira Patent On Surgery Pain Drug Voided In Win For Generic
Pacira Pharmaceuticals Inc.'s patent on a nonopioid painkiller is invalid, a New Jersey federal judge has ruled, opening the way for generic versions of Exparel, a long-acting injectable for managing postsurgical pain.
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August 12, 2024
King & Spalding Adds Freshfields M&A Ace In Silicon Valley
King & Spalding LLP is expanding its corporate team, announcing Monday it is bringing in a Freshfields Bruckhaus Deringer LLP mergers and acquisitions expert as a partner in its Silicon Valley office.
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August 12, 2024
Del. Judge Says Vaccine IP Claim Actually Mandates Vaccine
Delaware's chief judge was baffled by Alnylam Pharmaceuticals' argument that the word "vaccine" in a patent it claims Pfizer and BioNTech have infringed doesn't actually require a vaccine, leading him to reject the trip down the rabbit hole presented by the company in exchange for "common sense."
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August 12, 2024
The Biggest Georgia Rulings Of 2024 So Far
From upholding a win for a transgender sheriff's deputy who challenged a county health plan's refusal to pay for gender-affirmation surgery, to ruling that a judicial emergency order issued during the pandemic can be used to toll the state's medical malpractice statute of repose, Georgia courts have been busy in the first half of 2024.
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August 12, 2024
Catching Up With Delaware's Chancery Court
Multimillion-dollar share conversions, power struggles in a classic rock band, a good deal for fandom collectibles, and a pindown by two heavyweights were all part of the spectacle in Delaware's Court of Chancery last week. New cases involved pharmaceutical companies, cannabis, drones and liquid-gas exports. In case you missed it, here's the latest from the Chancery Court.
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August 12, 2024
3 Firms Rep As Crown Buys Revance In $924M Deal
Skincare company Crown Laboratories Inc. on Monday announced that it has agreed to merge with aesthetic healthcare biotechnology company Revance Therapeutics Inc. in a $924 million deal built by three law firms.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Delaware Jury Says Fecal Treatment Patents Are Worth $25M
A Delaware federal jury decided Friday that a Swiss drugmaker owes a smaller drug rival at least $25 million in a patent case involving an experimental enema used to treat a particularly deadly form of diarrhea.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
Biotech Firms Mull Acquisition Offers Amid Shaky IPO Climate
Amid a shaky outlook for initial public offerings, more private biotechnology firms are exploring acquisition offers from larger pharmaceutical companies as a more certain exit strategy, according to experts who advise emerging drug developers.
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
Biopharm Co. Alector Sued In Del. For Docs On Director Pay
A stockholder of small cap biopharmaceutical venture Alector Inc has sued the business in Delaware's Court of Chancery for books and records releases, citing company payment of directors at rates roughly twice the amount paid to nonemployee directors of large cap companies in the same sector.
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August 09, 2024
Novartis Wants DC Judge To Quickly Block Entresto Generic
Novartis Pharmaceuticals urged a D.C. federal judge Friday to temporarily restrain the U.S. Food and Drug Administration from officially approving a generic version of the company's blockbuster heart failure medication Entresto.
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August 09, 2024
Pharmacy Escapes Recklessness Claim In Septic Shock Suit
A Pennsylvania federal judge has dismissed a claim seeking punitive damages from a northern Pennsylvania pharmacist brought by a patient who alleges that her endocrinologist and the pharmacy overprescribed corticosteroids that opened holes in her intestines and subsequently made her go into septic shock and become suicidal.
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August 09, 2024
Vidal's Sanctions Make It Clear: Don't Mess With The PTAB
The Patent Trial and Appeal Board has only faced a handful of instances where sanctions took center stage, but the U.S. Patent and Trademark Office director's rulings have made attorneys increasingly aware that pushing ethical boundaries at the board could put their cases and their careers at risk.
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August 09, 2024
Wash. AG Says Kroger Refusing To Delay Merger For Ruling
The Washington Attorney General's Office told a state court that Kroger will not agree to put off closing its planned merger with Albertsons until after a final ruling in the state's merger challenge, but the companies say they've already agreed not to finalize the deal until litigation plays out in another state.
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August 09, 2024
Merck To Buy Autoimmune Treatment Drug For Up To $1.3B
Pharmaceutical giant Merck, advised by Hogan Lovells, said Friday it has agreed to buy a novel, investigational, clinical-stage, bispecific antibody used to treat B cell-associated diseases from Goodwin Procter LLP-led Curon Biopharmaceutical for up to $1.3 billion.
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August 09, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen China Evergrande Group file a commercial fraud claim against its founder's ex-wife, legal action by Manolete Partners against the directors of an insolvent construction company, VietJet tackle a claim by French banking group Natixis and more developments in the "Dieselgate" scandal. Here, Law360 looks at these and other new claims in the U.K.
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August 08, 2024
Mass. Atty, 2 Others Settle SEC Insider Trading Claims
A Massachusetts business lawyer, his friend and his friend's father have agreed to collectively pay more than $230,000 to settle the U.S. Securities and Exchange Commission's allegations they used intel to trade ahead of an announcement made by the biotechnology company Frequency Therapeutics Inc., the SEC said Thursday.
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August 08, 2024
Pot Cos. Get Creative To Boost Brands Despite Feds' TM Ban
The marijuana industry still lives in the shadows of trademark law while the drug remains federally illegal, leaving businesses and their lawyers to seek workarounds to protect their brands.
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.