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Life Sciences
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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.
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November 15, 2024
Attys Get 'Final Warning' In Tepezza Hearing Loss MDL
A magistrate judge has chastised attorneys on both sides of multidistrict litigation involving claims that a thyroid eye disease treatment manufactured by Horizon Pharmaceuticals Inc. causes hearing loss, calling for an end to their "improper" conduct during depositions.
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November 15, 2024
HOA's Insurer Says Pool Chemical Injury Suits Aren't Covered
A homeowners association's insurer told a Virginia federal court it needn't cover underlying lawsuits alleging a lifeguard employed by the association's contractor allowed hazardous chemicals to spread and hurt pool patrons, arguing that its commercial general liability policy excluded bodily injury as a result of pollutants.
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November 15, 2024
Orrick Trial Partner Joins Morgan Lewis In Boston
Morgan Lewis & Bockius LLP announced that an experienced litigator from Orrick Herrington & Sutcliffe LLP joined the firm's Boston office as a partner, enhancing its capacity in areas such as life sciences and regulatory compliance.
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November 15, 2024
Pharma Biz To Pay $47M To Settle Feds' Kickback Claims
A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.
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November 15, 2024
Sterilization Co. Cosmed Hits Ch. 11 Amid Cancer Claims
Sterilization company Cosmed Group Inc. filed for Chapter 11 protection in a Texas bankruptcy court Thursday with over $100 million in liabilities, much of it related to cancer claims over the gas that it uses for sterilization.
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November 14, 2024
Trump's RFK Jr. Pick For HHS Draws Its Share Of Critics
The nomination of Robert F. Kennedy Jr. — well-known for his opposition to vaccines — as the secretary of the U.S. Department of Health and Human Services is President-elect Donald Trump's latest controversial pick for his administration, and one that could disrupt the U.S. Food and Drug Administration and its mission.
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November 14, 2024
Senate Panel Delays Votes On Patent Eligibility And PTAB Bills
The Senate Judiciary Committee on Thursday postponed planned votes on legislation aimed at reducing decisions that inventions are ineligible for patents and setting new limits on Patent Trial and Appeal Board challenges, but approved a bill to let the patent office collect demographic data on inventors.
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November 14, 2024
Judge Finds Dexcom Infringed Abbott Patent That Hung Jury
A judge has found that Dexcom Inc. infringed a glucose monitor patent owned by an Abbott Laboratories unit, with the ruling coming after a Delaware federal jury in March said it was hung on the issue.
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November 14, 2024
Takeda Rips Cert. Order's 'Whale Of Assumption' At 9th Circ.
Takeda Pharmaceutical urged the Ninth Circuit on Thursday to reverse a ruling certifying a class of third-party payors who allege Takeda and Eli Lilly & Co. hid their anti-diabetes drug's bladder-cancer risks, arguing the lower court erroneously made a "whale of an assumption" that 56.7% of prescriptions wouldn't have been written with disclosures.
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November 14, 2024
Boehringer Says Inhaler Antitrust Suit 'Fails On Its Face'
Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH have urged a Connecticut federal judge to dismiss a proposed class action brought by health funds accusing it of monopolizing the inhaler market with improper patent listings, arguing the suit fails to allege any competitors were actually hindered by those patents.
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November 14, 2024
Boeing Could Sell Navigation Unit For $6B, And More Rumors
Boeing is mulling a sale of its Jeppesen navigation unit at potential $6 billion price tag, Pfizer may be seeking billions for its hospital drug unit, and a U.S. gas station and convenience store business could be sold at a $1.5 billion value. Here, Law360 breaks down these and other notable deal rumors from the past week.
Expert Analysis
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The Shifting Role Of Patent Attorneys In The Age Of AI
The integration of artificial intelligence into patent drafting represents a significant change in how legal work is performed, and patent attorneys must shift from manual drafting to a strategy-oriented approach, says Ian Schick at Draft Builders.
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8 Childhood Lessons That Can Help You Be A Better Attorney
A new school year is underway, marking a fitting time for attorneys to reflect on some fundamental life lessons from early childhood that offer a framework for problems that no legal textbook can solve, say Chris Gismondi and Chris Campbell at DLA Piper.
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Opinion
This Election, We Need To Talk About Court Process
In recent decades, the U.S. Supreme Court has markedly transformed judicial processes — from summary judgment standards to notice pleadings — which has, in turn, affected individuals’ substantive rights, and we need to consider how the upcoming presidential election may continue this pattern, says Reuben Guttman at Guttman Buschner.
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A Look At The PTAB's Assessment Of Prior Art Exceptions
The Patent Trial and Appeal Board's approach over the last 10 years to assessing Section 102(b) prior art exceptions reveals a few trends, including that evidence of common ownership may have a higher likelihood of successfully disqualifying prior art under Section 102(b)(2)(C) at the institution stage, say Louis Panzica and David Holman at Sterne Kessler.
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Series
Playing Diplomacy Makes Us Better Lawyers
Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.
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How Patent Litigation Is Changing Amid Decline In Filings
Marked by a notable decline in case filings and preferred venue shifts, patent litigation has undergone significant changes over the last decade and litigation hot spots have shifted, encouraging a more strategic approach to patent disputes, says Saishruti Mutneja at Winston & Strawn.
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Mental Health First Aid: A Brief Primer For Attorneys
Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.
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Opinion
FTC's Report Criticizing Drug Middlemen Is Flawed
The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.
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Series
Collecting Art Makes Me A Better Lawyer
The therapeutic aspects of appreciating and collecting art improve my legal practice by enhancing my observation skills, empathy, creativity and cultural awareness, says attorney Michael McCready.
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Del. Dispatch: Cautionary Tales Of 2 Earnout Effort Breaches
The Delaware Court of Chancery's tendency to interpret earnout provisions precisely as written, highlighted in two September rulings that found buyers breached their shareholder obligations when they failed to make reasonable efforts to hit certain product development milestones, demonstrates the paramount importance of precisely wording these agreements, say attorneys at Fried Frank.
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Takeaways From Novo Nordisk's Fight For Market Exclusivity
Generic competitors’ challenge to Novo Nordisk’s patents in hopes of capturing a portion of the rapidly expanding Type 2 diabetes and obesity treatment market highlights the role of abbreviated new drug application litigation, inter partes review and multidistrict litigation in patent defense, says Pedram Sameni at Patexia.
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Using Primacy And Recency Effects In Opening Statements
By understanding and strategically employing the primacy and recency effects in opening statements, attorneys can significantly enhance their persuasive impact, ensuring that their narrative is both compelling and memorable from the outset, says Bill Kanasky at Courtroom Sciences.
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Secret Service Failures Offer Lessons For Private Sector GCs
The Secret Service’s problematic response to two assassination attempts against former President Donald Trump this summer provides a crash course for general counsel on how not to handle crisis communications, says Keith Nahigian at Nahigian Strategies.
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Opinion
Bill Is Key To Protecting US Economy From Patent Piracy
It is critical that Congress pass a recently introduced bill that would protect U.S. investors from intellectual property theft by restoring court-ordered injunctions as the default remedy in patent infringement cases to ensure inventors get the justice they deserve, says Andrei Iancu at Sullivan & Cromwell.
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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.