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Life Sciences
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November 19, 2024
10th Circ. Iffy On Colo.'s Remedy To Generic EpiPen Takings
A Tenth Circuit panel on Tuesday pressed Colorado regulators on whether requiring epinephrine auto-injector makers to repeatedly sue over the cost of complying with a state program provides an adequate legal remedy, with one judge saying that that route offers no finality for manufacturers.
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November 19, 2024
J&J Wants Beasley Allen Atty Sanctioned For Depo No-Show
Johnson & Johnson's talc unit called on a Texas bankruptcy court to sanction a Beasley Allen Law Firm attorney for "unilaterally" deciding not to attend a scheduled deposition in the company's bankruptcy case.
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November 19, 2024
McGuireWoods Lands Health Ace, Former GC From Akin In NY
A veteran healthcare and life sciences attorney who previously served as general counsel at pharmaceutical companies Novo Nordisk and Daiichi Sankyo has made the move from Akin Gump Strauss Hauer & Feld LLP to McGuireWoods LLP.
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November 19, 2024
Akin Adds Another Healthcare Expert To DC Lobbying Team
The former chief health adviser for the Senate Finance Committee's majority has joined Akin Gump Strauss Hauer & Feld LLP's lobbying team in Washington, D.C., weeks after the firm added another healthcare advocate from the national association representing pharmacy benefit managers.
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November 19, 2024
MVP: Covington's Catherine Dargan
Catherine Dargan of Covington & Burling LLP represented Bristol Myers Squibb Co. in its $14 billion acquisition of the company that developed Cobenfy — the first new drug in 35 years to be approved by the Food and Drug Administration for treating schizophrenia — earning her a spot among the 2024 Law360 Life Sciences MVPs.
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November 19, 2024
McDermott Adds IP Pro From Gibson Dunn In Los Angeles
McDermott Will & Emery LLP announced Tuesday that it has hired partner Timothy Best from Gibson Dunn & Crutcher LLP to help bolster its intellectual property practice group, especially its efforts serving life sciences and biotechnology clients.
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November 18, 2024
'You Stepped Over The Line': Judge Rips Quinn Emanuel Atty
A California federal judge told a Quinn Emanuel partner defending Natera Inc. at trial Monday in Guardant Health Inc.'s false advertising case that she'd be sanctioned over her questioning of a Natera expert about Guardant's alleged damages, saying, "You stepped over the line, and you did it several times."
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November 18, 2024
J&J Posts $1.17B Bond For Del. Merger Milestone Appeal
Johnson & Johnson Inc. has posted a $1.167 billion surety-backed bond ahead of its planned appeal challenging a Delaware Chancery Court's finding that it owes more than $1 billion to a medical robotics developer's former shareholders caught up in a post-acquisition dispute.
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November 18, 2024
Melinta Obtains Ban On Generic Antibiotic Injections In IP Row
A drugmaker that recently sold a manufacturing facility to Eli Lilly for nearly $1 billion has failed to persuade a federal judge in Chicago to wipe out patents covering a line of injections that treat infections developed by a recently bankrupt antibiotic developer.
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November 18, 2024
Pa. Lab Seeks Ad Coverage For Libel Suit Over COVID Tests
A Pennsylvania laboratory told a federal court Monday that its insurer must cover it in an underlying lawsuit brought by a COVID-19 test manufacturer in which the manufacturer alleged that the lab sent 19,000 letters to test kit users wrongfully stating that the tests were unreliable.
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November 18, 2024
$100M Deal In Suit Over Walgreens Rx Prices Gets First OK
An Illinois federal judge gave an initial blessing Monday to a $100 million deal resolving claims from consumers and unions that Walgreens unlawfully overcharged insured consumers for prescription drugs while allowing members of its cost savings club to pay less.
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November 18, 2024
Medical Group Wants Justices To Review IP Safe Harbor Fight
A medical device trade group has said the U.S. Supreme Court should take up an appeal of a Federal Circuit decision Edwards Lifesciences said broadened a drug-development safe harbor to avoid patent infringement, saying the circuit court misread the provision.
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November 18, 2024
Biopharm Co. Seelos Files For Ch. 11 After Nasdaq Delisting
Publicly traded biopharmaceutical company Seelos Therapeutics Inc. sought Chapter 11 protection in New York on Saturday, citing between $10 million and $50 million in estimated liabilities.
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November 18, 2024
MVP: Ropes & Gray's Amanda Austin
Amanda Austin of Ropes & Gray's life sciences practice guided Pfizer through its $7 billion deal with Flagship Pioneering, advised Fulcrum Therapeutics in its blockbuster collaboration with Sanofi, and was lead counsel to Ginkgo Bioworks, earning her a spot as one of the 2024 Law360 Life Sciences MVPs.
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November 18, 2024
Supreme Court Turns Down 3 Patent Cases
The U.S. Supreme Court on Monday refused to hear three patent cases dealing with patent eligibility, standing to bring infringement suits and the rules surrounding the launch of generic drugs.
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November 15, 2024
Eli Lilly Says HHS Ignores Drug Discount Double-Dipping
Eli Lilly & Co. claims the U.S. Department of Health and Human Services is unlawfully blocking its efforts to crack down on hospitals the company alleges are double-dipping on medication discounts that are meant to benefit low-income patients, according to a lawsuit filed in D.C. federal court.
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November 15, 2024
Natera Exec Calls Guardant's Cancer Test Claims 'Dangerous'
Natera's president of clinical diagnostics testified at trial Friday in a California federal false advertising case that Guardant Health's claims about Guardant's competing colorectal cancer test were "false and misleading" and also "dangerous."
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November 15, 2024
SEC-Sanctioned Accounting Firm Sued Over Pre-IPO Work
The former public company accounting firm BF Borgers is facing a California state lawsuit by an ex-client that says it was forced to scuttle its plans for an initial public offering after the U.S. Securities and Exchange Commission accused the firm of being a "sham auditing mill."
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November 15, 2024
PBMs Denied Breakup Of Combined FTC Insulin Price Trial
The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.
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November 15, 2024
Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'
Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.
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November 15, 2024
Ariz. Judge Will Decide Proper Venue For CVS Antitrust Suit
A federal judge concluded Thursday that he must decide whether a proposed class action accusing CVS of exploiting a Medicare loophole to charge independent pharmacies exorbitant fees belongs in arbitration, after scolding CVS's attorneys for failing to adequately develop their arguments defending an underlying delegation clause.
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November 15, 2024
DEA Judge Nixes Vet Group's Bid To Take Part In Pot Hearings
An administrative law judge with the U.S. Drug Enforcement Administration on Friday denied a veterans group's bid to participate in upcoming hearings on a proposal to loosen federal restrictions on marijuana.
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November 15, 2024
Abbott Inks $8M Deal With Healthcare Fraudster In TM Suit
A New York federal judge on Thursday green-lit a trademark infringement settlement in which Abbott Laboratories will receive $8 million from a Florida businessman who recently pled guilty to healthcare fraud for his role in a sprawling gray market scheme to profit off of Abbott's line of diabetic test strips meant to be sold internationally.
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November 15, 2024
Ayahuasca Church Urges Justices To Hear Discovery Case
An Arizona church that uses a psychedelic substance in its ceremonies has asked the U.S. Supreme Court to reconsider lower courts' rulings directing the church to turn over members' personal information to federal drug enforcement authorities.
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November 15, 2024
Teva Defends Mifepristone Antitrust Case Against Corcept
Teva Pharmaceuticals has asked a California federal judge to reject a bid to dismiss its lawsuit against the maker of a brand-name drug used to treat a rare cortisol disorder, contending its complaint plausibly alleges an illegal scheme to suppress generic competition.
Expert Analysis
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.