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Life Sciences
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March 07, 2025
FDA Can Take Eli Lilly Weight Loss Drug Off Shortage List
A Texas federal judge has refused to issue an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, ruling that the U.S. Food and Drug Administration was within its authority when it removed the medication from the drug shortage list.
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March 07, 2025
AGs Say Anti-Trans Admin Puts $367M Hospital Grants At Risk
Attorneys general from Washington and three other states told a federal court that the Trump administration has canceled thousands of dollars in grant funding for gender-affirming care — and threatened to strip up to nearly $370 million more — in violation of court injunctions.
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March 07, 2025
Hints Of A New High Court Majority Emerge In Trump Cases
The U.S. Supreme Court's recent rejection of President Donald Trump's bid to keep frozen nearly $2 billion in foreign aid funding gave court watchers a glimpse of a coalition majority that could end up thwarting some of the president's more aggressive and novel attempts to expand executive power.
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March 07, 2025
Ohio, PBMs Say High Court Ruling Didn't End Pricing Appeal
Ohio state enforcers have told the Sixth Circuit an appeal in their case accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices was not resolved by a U.S. Supreme Court decision dealing with federal versus state jurisdiction.
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March 07, 2025
New Bellwethers Score Cert. In Generic Drug Price-Fixing MDL
The Pennsylvania federal court overseeing sprawling multidistrict litigation springing from claims that pharmaceutical giants worked together to hike the cost of off-brand drugs has certified several sets of classes for the cases for the MDL's latest bellwethers.
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March 07, 2025
Apple Prevails In Watch Tech Patent Fight At Fed. Circ.
The Federal Circuit handed Apple a significant victory Friday in a dispute that might have led to a ban on imports of its smartwatches, affirming that a competing company's heart monitor patents are invalid and vacating a conflicting U.S. International Trade Commission decision that found the watches infringed those patents.
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March 07, 2025
Ex-Novo Nordisk Worker Can't Reopen Harassment Suit
A former employee of Novo Nordisk can't revive her lawsuit claiming she was let go because she is a Jewish woman and had a back and hip injury, a California state appeals court ruled, finding no issue with a trial court tossing the case after she failed to oppose the move.
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March 07, 2025
Tariffs, Diversity And DOGE Dominate Trump 2.0 'Risk Factors'
Public companies are busily reworking risk disclosures since the arrival of President Donald Trump's second administration, seeking to walk a fine line of being upfront with investors about potential threats to business despite vast legal and policy uncertainties.
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March 07, 2025
Husband Of Ex-Takeda VP Gets 2½ Years For Invoice Scam
The husband of a former Takeda Pharmaceuticals vice president was sentenced in Massachusetts federal court Friday to two and a half years in prison for his role in a scheme to dupe the drug giant out of $2.3 million through bogus invoices.
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March 07, 2025
Taxation With Representation: Kirkland, Wachtell, Skadden
In this week's Taxation With Representation, Walgreens Boots Alliance goes private via a deal with Sycamore Partners, Honeywell buys Sundyne from Warburg Pincus, and Jazz Pharmaceuticals acquires Chimerix.
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March 06, 2025
Don't Give Teva 'Eighth Bite' At $235M Patent Trial, GSK Says
GlaxoSmithKline has told a Delaware federal judge that Teva's request for a new trial in the drugmakers' decade-long, $235 million "skinny label" patent fight over heart failure medication is an "eighth bite at the same apple."
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March 06, 2025
Pfizer Failed To Warn Of Depo-Provera's Tumor Risk, Suit Says
A woman who claims she developed a brain tumor after years of taking the contraceptive Depo-Provera is suing Pfizer and other pharmaceutical companies who manufacture the drug, claiming in Washington federal court they failed to tell patients of the danger even though it is standard on warning labels in Europe and Canada.
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March 06, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Believe it or not, there's still important litigation happening that doesn't involve President Donald Trump, and the proof exists in this month's circuit court calendars. During the remaining weeks of March, arguments will explore numerous high-profile topics, including a law firm's severe punishment for alleged misconduct in 9/11 litigation and a judicial rebuke of Trader Joe's for "an attempt to weaponize the legal system."
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March 06, 2025
FTC Challenges PE Firm's Medical Device Coatings Deal
The Federal Trade Commission moved Thursday to block private equity firm GTCR BC Holdings LLC's planned $627 million acquisition of Surmodics Inc. over concerns about competition for medical device coatings.
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March 06, 2025
Walgreens Boots Inks $24B Go-Private Deal With Sycamore
Walgreens Boots Alliance said Thursday it has agreed to be purchased by private equity firm Sycamore Partners in a transaction with a total value of up to $23.7 billion, as the storied retailer looks to reverse years of financial declines by going private.
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March 06, 2025
No Cancer Therapy Patent For AbbVie, Says Federal Circuit
The Federal Circuit declined on Thursday to second-guess a Virginia federal judge who sided with the U.S. Patent and Trademark Office in refusing to issue a patent requested to cover a purportedly new way of administering a clinical stage cancer treatment to an AbbVie unit.
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March 06, 2025
Attys Seek $30M Fees In Walgreens Rx Overcharge Deal
Attorneys for unions and consumers who struck a $100 million settlement of Walgreens prescription overcharge fee claims asked an Illinois federal judge for a $30 million cut of that pot, arguing the amount would pay for seven years of meaningful work they put into the case.
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March 06, 2025
FDA Nominee Hedges On Job Cuts, Abortion Drug In Hearing
The nominee to lead the U.S. Food and Drug Administration, Dr. Marty Makary, repeatedly hedged about whether he would reconvene a flu vaccine committee, maintain access to the abortion drug mifepristone or control future job cuts during his confirmation hearing in front of a Senate panel on Thursday.
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March 06, 2025
Kirkland-Led Medical Device Firm Prices Upsized $202M IPO
Shares of Kestra Medical Technologies Ltd. soared in debut trading Thursday after the maker of wearable defibrillators priced an upsized $202 million initial public offering above its range, represented by Kirkland & Ellis LLP and underwriters' counsel Allen Overy Shearman Sterling LLP.
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March 06, 2025
Trump Administration Ordered To Release Funds To States
A Rhode Island judge on Thursday ordered the Trump administration to stop withholding funds from states, saying an executive order freezing federal grants, loans and other payments approved by Congress "fundamentally undermines" the separation of powers and is causing irreparable harm.
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March 05, 2025
Celltrion Can't Undo Eye Med Biosimilar Injunction On Appeal
The Federal Circuit on Wednesday affirmed a lower court's preliminary injunction barring South Korea-based Celltrion Inc. from launching a biosimilar version of Regeneron's blockbuster eye disease treatment Eylea, rejecting Celltrion's argument that it has shown a patent on the drug may be invalid.
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March 05, 2025
Teva Wants Pause Of Patent Delisting For High Court Appeal
Israeli drugmaker Teva Pharmaceuticals is hoping the Federal Circuit will keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold while it appeals the matter to the U.S. Supreme Court.
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March 05, 2025
Pfizer Beats Claims Of Copay Aid Scheme For Good
Litigation firms accusing Pfizer of a scheme to inflate drug prices for Medicare and Medicaid plans saw their suit dismissed permanently, with a Washington, D.C., federal judge ruling they had been given "enough chances" to remedy pleading deficiencies in their claims.
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March 05, 2025
Nationwide Block Of Trump Trans Healthcare Orders Extended
A Maryland federal judge has extended a nationwide injunction that was set to expire this week prohibiting the Trump administration from enforcing executive orders banning federal funding for gender-affirming care for people under the age of 19, finding the harm inflicted by the orders is "non-speculative, concrete, and potentially catastrophic."
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March 05, 2025
Biotech Co. Maravai Hit With Investor's Internal Controls Suit
Health research tools company Maravai LifeSciences Holdings Inc. has been hit with a proposed shareholder class action alleging it failed to report that it had issues with its internal reporting controls ahead of its announcement that an inaccurate report led to the misallocation of $3.9 million.
Expert Analysis
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.
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Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB
Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.
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IP Ruling Likely To Limit Arguments Against Qualified Experts
The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.
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How Boards And Officers Should Prep For New Trump Admin
In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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Series
Flying Makes Me A Better Lawyer
Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.
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9th Circ.'s High Bar May Limit Keyword Confusion TM Claims
A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.
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Trump Patent Policy May Be Headed In Unexpected Direction
While commentators have assumed that the patent policy of President-elect Donald Trump's second administration will largely mirror the pro-patent policy of his first, these predictions fail to take into account the likely oversized influence of Elon Musk, says Jorge Contreras at the University of Utah.
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What Trump's Next Term May Mean For Biz Immigration
Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.
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Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons
As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.