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Life Sciences
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August 13, 2024
DC Circ. Backs EPA's Ethylene Oxide Cancer Risk Value
The D.C. Circuit on Tuesday upheld federal environmental regulators' assessment of the cancer risk from exposure to certain chemical manufacturers' ethylene oxide emissions, rejecting a challenge from a chemical company and two chemical associations that argued the risk assessment was arbitrary and capricious.
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August 13, 2024
FTC Makes 2nd Request In Review Of Medical Device Co. Deal
Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.
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August 13, 2024
'Clever' Scheme Is Concealing Talc Litigation Funding, J&J Says
The Beasley Allen Law Firm needs to disclose alleged litigation funding fueling its litigation over Johnson & Johnson's talcum powder even if that funding was not given directly to the firm since the disclosure rules apply to "parties" and not "law firms," J&J has told a New Jersey federal court.
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August 13, 2024
Ex-McCarter & English Client Wants To Undo Malpractice Loss
A New Jersey pharmaceutical business is urging a New Jersey state court to reconsider its decision to throw out the company's malpractice case against McCarter & English LLP, saying the firm "brazenly" misstated part of the timeline of the case's lengthy history.
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August 13, 2024
Conn. Trial Attys Back McCarter's Bid For Punitive Award
The Connecticut Trial Lawyers Association has asked the state Supreme Court for permission to file a friend-of-court brief supporting McCarter & English LLP's bid for a punitive payout after winning multimillion-dollar judgments in a contract dispute with a former client.
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August 13, 2024
3 Firms Drive $3.8B Carlyle-Baxter Kidney Care Deal
Kirkland & Ellis LLP-led private equity firm Carlyle on Tuesday agreed to acquire the kidney care unit of Baxter International Inc., represented by Sullivan & Cromwell LLP and Baker McKenzie, for $3.8 billion, Baxter said in a statement Tuesday.
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August 12, 2024
Accused Accounting Prof Is No Tax Expert, NJ Jury Told
New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.
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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.
Expert Analysis
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Class Actions At The Circuit Courts: June Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.
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Tracking Implementation Of IRA Programs As Election Nears
As the Biden administration races to cement key regulations implementing the Inflation Reduction Act, a number of the law's programs and incentives are at risk of delay or repeal if Republicans retake control of Congress, the White House or both — so stakeholders should closely watch ongoing IRA implementation and guidance, say attorneys at Squire Patton.
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Unpacking The Circuit Split Over A Federal Atty Fee Rule
Federal circuit courts that have addressed Rule 41(d) of the Federal Rules of Civil Procedure are split as to whether attorney fees are included as part of the costs of a previously dismissed action, so practitioners aiming to recover or avoid fees should tailor arguments to the appropriate court, says Joseph Myles and Lionel Lavenue at Finnegan.
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Del. Bankruptcy Ruling Will Give D&O Insureds Nightmares
In Henrich v. XL Specialty Insurance, the Delaware Bankruptcy Court recently found that a never-served qui tam claim had been "brought" before a D&O policy's retroactive date, thereby eliminating coverage, and creating a nightmare scenario for directors and officers policyholders facing whistleblower claims, says David Klein at Pillsbury.
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Opinion
No Matter The Purdue Ruling, Mass Tort Reform Is Needed
The U.S. Supreme Court will soon issue its opinion in the bankruptcy of Purdue Pharma LP, and regardless of the outcome, it’s clear legal and policy reforms are needed to address the next mass tort, says William Organek at Baruch College.
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After A Brief Hiccup, The 'Rocket Docket' Soars Back To No. 1
The Eastern District of Virginia’s precipitous 2022 fall from its storied rocket docket status appears to have been a temporary aberration, as recent statistics reveal that the court is once again back on top as the fastest federal civil trial court in the nation, says Robert Tata at Hunton.
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Protecting Trade Secrets In US, EU Gov't Agency Submissions
Attorneys at Mintz compare U.S. and European Union trade secret laws, and how proprietary information in confidential submissions to the U.S. Food and Drug Administration and the European Medicines Agency is protected in the face of third-party information requests under government transparency laws.
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Recruitment Trends In Emerging Law Firm Frontiers
BigLaw firms are facing local recruitment challenges as they increasingly establish offices in cities outside of the major legal hubs, requiring them to weigh various strategies for attracting talent that present different risks and benefits, says Tom Hanlon at Buchanan Law.
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4 Tips For Drafting Earnouts To Avoid Disputes
Amid slowed merger and acquisition activity, buyers and sellers are increasingly turning to earnout provisions to get deals done, but these must be carefully drafted to avoid interpretative differences that can lead to later disputes, say attorneys at Cooley.
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Series
Glassblowing Makes Me A Better Lawyer
I never expected that glassblowing would strongly influence my work as an attorney, but it has taught me the importance of building a solid foundation for your work, learning from others and committing to a lifetime of practice, says Margaret House at Kalijarvi Chuzi.
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Opinion
Flawed Fintiv Rule Should Be Deemed Overreach In Tech Suit
A pending federal lawsuit over the U.S. Patent and Trademark Office's unilateral changes to key elements of the America Invents Act, Apple v. Vidal, could shift the balance of power between Congress and federal agencies, as it could justify future instances of unelected officials unilaterally changing laws, say Patrick Leahy and Bob Goodlatte.
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How Associates Can Build A Professional Image
As hybrid work arrangements become the norm in the legal industry, early-career attorneys must be proactive in building and maintaining a professional presence in both physical and digital settings, ensuring that their image aligns with their long-term career goals, say Lana Manganiello at Equinox Strategy Partners and Estelle Winsett at Estelle Winsett Professional Image Consulting.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.
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Emerging Trends In ESG-Focused Securities Litigation
Based on a combination of shareholder pressure, increasing regulatory scrutiny and proposed rulemaking, there has been a proliferation of litigation over public company disclosures and actions regarding environmental, social, and governance factors — and the overall volume of such class actions will likely increase in the coming years, say attorneys at Mintz.
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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.