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Life Sciences
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April 03, 2025
Senate Panel Advances Bills Tackling Drug Patents, Pricing
A U.S. Senate panel on Thursday approved a group of bills tackling pharmaceutical patents and drug pricing, including measures that claim to address so-called patent thickets and an industry practice called "product hopping."
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April 03, 2025
2nd Circ. Judge Thinks Drug Price Fight Sounds Like Antitrust
A Second Circuit judge on Thursday suggested that the federal government may be insulated from claims over its demand for lower prices for Medicare and Medicaid recipients, musing that Boehringer Ingelheim Pharmaceuticals Inc.'s constitutional challenge to an Inflation Reduction Act provision sounds more like an antitrust allegation.
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April 03, 2025
Nestlé, Other Parent Cos. Freed From Baby Food Metals MDL
Overseas food giants Nestlé, Danone and Hero can exit a multidistrict litigation alleging baby food tainted with toxic metals caused children to develop autism, a California federal judge has ruled, but domestic subsidiaries who manufactured the products, such as Gerber, Nurture and Beech-Nut, must remain as defendants.
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April 03, 2025
Amazon, Biotech Net $1.9M Win Against Fake Supplement Sellers
A Washington federal judge has awarded biotechnology company Quincy Biosciences and Amazon a combined total of $1,895,375.40 in default judgments against several individuals who hawked counterfeit Prevagen brain health products through Amazon's marketplace, after the sellers failed to appear or participate in the case.
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April 03, 2025
Texas Appeals Court Backs UT Royalty Award In Pet Co. Suit
A Texas appellate court on Thursday refused to undo a lower court's ruling over the amount a pet healthcare company owes in unpaid royalties to the Board of Regents of The University of Texas System for veterinary testing products.
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April 03, 2025
RI Judge Hits Pause On Billions In Health Grant Funding Cuts
A Rhode Island federal judge on Thursday barred the Trump administration from moving forward, for now, with the termination of billions of dollars in grants supporting state public health programs.
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April 03, 2025
Justices' Ruling Empowers FDA To Rein In Vapes, Experts Say
A unanimous U.S. Supreme Court decision affirming federal regulators' authority to deny marketing applications for flavored vapes was noted as a victory for federal agency autonomy, but vaping industry interests said it could remove a crucial harm reduction tool.
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April 03, 2025
$10M Heritage Pharma Price-Fixing Deal Gets Final OK
A Connecticut federal judge granted final approval to a $10 million deal between Heritage Pharmaceuticals Inc., its parent company Emcure Pharmaceuticals Ltd. and Emcure's founder Satish Mehta to resolve claims from a coalition of states accusing them of conspiring with other companies to inflate generic drug prices.
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April 02, 2025
5 Fed. Circ. Clashes To Watch This Month
The Federal Circuit will hear arguments this month in patent cases involving Moderna's COVID-19 vaccine and a blockbuster Johnson & Johnson schizophrenia drug, and the court will itself be the subject of a case at another appeals court as Judge Pauline Newman seeks to end her suspension.
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April 02, 2025
NIH Sued By Researchers Over 'Ideological Purge' On Grants
The American Public Health Association and others sued the federal government in Massachusetts federal court on Wednesday over the cancellations of billions of dollars worth of National Institutes of Health research grants on such issues as gender identity, diversity, vaccine hesitancy and climate change, claiming the "ideological purge" is illegal.
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April 02, 2025
With Dems Fired, GOP Recused, FTC Pauses PBMs Case
The Federal Trade Commission has stayed its insulin price-fixing case against pharmacy benefit managers for more than three months, saying it does not have any commissioners to hear it after two Republican members recused themselves and the two Democratic commissioners were removed from their posts by President Donald Trump last month.
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April 02, 2025
PE Firm TPG Wants Endo Trust's Transfer Suit Tossed
Private equity firm TPG Capital is seeking the dismissal of a lawsuit that aims to claw back billions of dollars reaped in an allegedly unfair deal with Endo International PLC before the drugmaker went bankrupt.
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April 02, 2025
Zoll Gets Parts Of Data Breach Class Action Tossed
A Massachusetts federal judge released Zoll Medical Corp. from some claims brought by a proposed class of medical device customers whose personal data was released after two ransomware attacks, but kept alive claims of negligence, unjust enrichment and others.
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April 02, 2025
MSN Denied More Relief For 'Falling Sky' In Entresto Dispute
A Delaware federal judge on Wednesday denied MSN Pharmaceuticals Inc.'s effort to pause a judgment delaying its generic version of a blockbuster Novartis heart medication, finding the court had already granted the company's previous request for relief and wouldn't do so again "for essentially the same falling sky."
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April 02, 2025
Garmin Beats Fitness Tracker Patent Suit, For Now
A Michigan federal judge has tossed, for now, a suit accusing Garmin International Inc. of infringing a CardiacSense Ltd. fitness tracker patent after finding the claims aren't eligible for patent protection, but the judge left room for an amended complaint to be filed.
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April 02, 2025
CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts
CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.
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April 02, 2025
Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful
Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.
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April 02, 2025
Orthodontic Software Co. Hit With Data Breach Class Action
An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.
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April 02, 2025
Justices Broaden RICO Reach To Personal Injuries
The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.
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April 02, 2025
Supreme Court Backs FDA Block Of Flavored Vapes
The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.
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April 01, 2025
FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug
The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.
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April 01, 2025
Takeda Antitrust Trial Over Actos Generics Set For July
A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.
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April 01, 2025
Fla. Defends Sandoz Price-Fixing Settlement Terms
Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.
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April 01, 2025
Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits
Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.
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April 01, 2025
No Inequitable Conduct From Fresenius Foe, Judge Says
German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia.
Expert Analysis
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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.
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Series
Circus Arts Make Me A Better Lawyer
Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.
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3 Ways To Train Junior Lawyers In 30 Minutes Or Less
Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.
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How AstraZeneca Ruling Could Change Dosage Patent Claims
If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.