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Life Sciences
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December 04, 2024
Novartis Fails To Stop Generic Drug Release At Fed. Circ.
Novartis could not persuade Federal Circuit judges to grant an injunction Wednesday protecting its blockbuster heart failure medication from facing generic competition, with the appeals court backing a Delaware federal judge's opinion that it was unlikely that one of the generic drug's ingredients is "amorphous."
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December 04, 2024
Jackson's 'Quite Worried' About Equal Protection Precedent
The U.S. Supreme Court's Republican-appointed justices' apparent willingness Wednesday to rule that a Tennessee law banning gender-affirming healthcare for transgender minors didn't rely on sex-based classifications worried Justice Ketanji Brown Jackson, who warned that such a decision would undermine decades of the court's equal protection clause precedent.
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December 04, 2024
JSR Wins As Fed. Circ. Axes Cytiva Antibody Isolation Patents
In a precedential opinion, the Federal Circuit held Wednesday that all the claims that JSR Corp. challenged in three Cytiva Bioprocess antibody isolation patents are invalid as obvious, backing the Patent Trial and Appeal Board's invalidation of many claims while reversing its decision to uphold others.
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December 04, 2024
Colo. Co.'s Alleged Kickback Scheme Ends In $2M Settlements
A Colorado neuromonitoring company, its founder and two others have agreed to pay more than $2 million to end a False Claims Act lawsuit alleging they participated in a kickback scheme to get surgeons to order neuromonitoring services covered by federal programs.
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December 04, 2024
DEA Judge Sets Pot Rescheduling Hearings
The Drug Enforcement Administration will kick off six weeks of hearings in late January on the merits of the attorney general's proposal to loosen restrictions on marijuana, an agency administrative law judge said Wednesday.
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December 04, 2024
Fed. Circ. Judge Condemns 'Nonsense' Law In Antibody Fight
U.S. Circuit Judge Todd Hughes called the Federal Circuit's case law on interpreting preambles in patent claims "nonsense" on Wednesday, expressing frustration as a panel tried to work through whether Xencor Inc.'s antibody patent application was too broad.
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December 04, 2024
Takeda Exec Duped Beau Into $2M Fraud, Jury Told
A Massachusetts man is accusing his wife, a former Takeda Pharmaceuticals vice president, of playing "puppet master" by tricking him into joining a scheme to steal millions from the drug company through fake invoices.
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December 04, 2024
Justices Seem To Back Ban On Transgender Youth Care
The U.S. Supreme Court's conservative majority on Wednesday seemed poised to greenlight a Tennessee ban on minors receiving gender-affirming care, despite arguments from the court's liberal block that finding the law constitutional would fly in the face of the court's equal-protection precedents.
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December 03, 2024
Mich. AG Deal, NIH 4th Circ. Win And X Corp Bid In HIPAA Row
Michigan's attorney general has agreed not to hold a Christian healthcare provider accountable to certain antidiscrimination protections related to gender and sexuality while the provider challenges them in court. Meanwhile, a New York federal judge decided to keep the largest anesthesiology provider in the U.S. on the hook for antitrust claims over its noncompete agreements with clinicians.
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December 03, 2024
Calif. Unveils Reproductive Rights Bills To Prep For Trump
California lawmakers plan to introduce a pair of bills aimed at protecting access to abortion in the Golden State as Donald Trump returns to office, according to an announcement made Monday, the first day of a special legislative session called by Gov. Gavin Newsom.
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December 03, 2024
SEC Says Biopharma's Cooperation Helped It Avoid Penalty
A Houston biopharmaceutical company accused of misleading investors about the regulatory status of two cancer drugs agreed to settle the U.S. Securities and Exchange Commission's action against it on Tuesday without paying a dime, in recognition of what the SEC said was the company's self-reporting and cooperation with investigators.
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December 03, 2024
J&J's Neosporin Forever Discolored Man's Groin, Suit Says
Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.
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December 03, 2024
$1B Sandoz Placeholder Bid Needs More Support, Judge Says
A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.
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December 03, 2024
USPTO Abandons Polarizing Proposal Over Double Patenting
The U.S. Patent and Trademark Office has withdrawn an extremely controversial proposal tied to double patenting, citing "resource constraints" in a Federal Register notice set to be published Wednesday.
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December 03, 2024
Vidal Aimed To Put USPTO Rulemaking In The Spotlight
Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.
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December 03, 2024
FDA Issues Guidance On Potential Infant Formula Shortages
The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.
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December 03, 2024
4 Mass. State Court Rulings You May Have Missed In Nov.
An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.
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December 03, 2024
VA Announces Study On MDMA-Assisted Therapy For Vets
The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.
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December 02, 2024
House COVID-19 Probe Points to China 'Lab Leak'
The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.
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December 02, 2024
Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud
A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.
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December 02, 2024
Justices Seem Inclined To Back FDA Block Of Flavored Vapes
U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.
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December 02, 2024
Investor Alleges Medical Device Co. Misled On FDA Clearance
The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.
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December 02, 2024
Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal
A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.
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December 02, 2024
Chancery OKs $21M Deal To End Gene Co. Class Suit
A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.
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December 02, 2024
Fla. Tribe Sues Eli Lilly, CVS, Others Over Insulin Price-Fixing
The Miccosukee Tribe in Florida is alleging drugmakers like Eli Lilly & Co. and pharmacy benefit managers like CVS illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a new lawsuit filed in New Jersey federal court.
Expert Analysis
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Series
Beekeeping Makes Me A Better Lawyer
The practice of patent law and beekeeping are not typically associated, but taking care of honeybees has enriched my legal practice by highlighting the importance of hands-on experience, continuous learning, mentorship and more, says David Longo at Oblon McClelland.
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Budding Lessons From Landmark Plant Seed Patent Battle
The Corteva v. Inari case involving intellectual property rights in genetically modified plants is now proceeding through discovery and potentially to trial, and will raise critical questions that could have a major impact on the agriculture technology industry, say Tate Tischner and Andrew Zappia at Troutman Pepper.
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The Key To Solving High Drug Costs Is Understanding Causes
One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.
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Opinion
Legal Institutions Must Warn Against Phony Election Suits
With two weeks until the election, bar associations and courts have an urgent responsibility to warn lawyers about the consequences of filing unsubstantiated lawsuits claiming election fraud, says Elise Bean at the Carl Levin Center for Oversight and Democracy.
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Opinion
Bring Back Patent Models To Shut Down The Patent Trolls
By reintroducing the requirement that inventors submit a miniature working model of their inventions along with their patent, legislators could help to deter patent trolls, reduce frivolous litigation and support legitimate inventors in protecting their innovations, says Darin Gibby at Kilpatrick.
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Strategies To Avoid Patent Issues In AI Drug Discovery
Artificial intelligence has the potential to improve drug discovery and design, but companies should consider a variety of factors when patenting drugs created using AI systems, including guidance from the U.S. Patent and Trademark Office and methods for protecting patent eligibility, say attorneys at Ropes & Gray.
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How Cos. Can Build A Strong In-House Pro Bono Program
During this year’s pro bono celebration week, companies should consider some key pointers to grow and maintain a vibrant in-house program for attorneys to provide free legal services for the public good, says Mary Benton at Alston & Bird.
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Bristol-Myers Win Offers Lessons For Debt Security Holders
A New York federal judge's recent dismissal of a $6.4 billion lawsuit against Bristol-Myers Squibb, due to plaintiff UMB Bank's lack of standing, serves as an important reminder to debt security holders to obtain depositary proxies before pursuing litigation, say attorneys at Milbank.
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Series
Home Canning Makes Me A Better Lawyer
Making my own pickles and jams requires seeing a process through from start to finish, as does representing clients from the start of a dispute at the Patent Trial and Appeal Board through any appeals to the Federal Circuit, says attorney Kevin McNish.
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Navigating The Bankruptcy Terrain After Purdue Pharma
The U.S. Supreme Court’s June ruling in Harrington v. Purdue Pharma is having a significant impact on bankruptcies, with recent cases addressing nonconsensual third-party releases and opt-out mechanisms, and highlighting strategies practitioners can employ to avoid running afoul of the decision, say Brett Axelrod and Agostino Zammiello at Fox Rothschild.
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5 Considerations For Obviousness-Type Double Patenting
The U.S. Supreme Court’s recent denial of certiorari for In re: Cellect highlights the current state of obviousness-type double patenting based on that case and another recent Federal Circuit decision, including that ODP is not fatal, that divisional applications are protected from ODP and more, says Fabian Koenigbauer at Ice Miller.
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Patent Lessons From 7 Federal Circuit Reversals In August
The Federal Circuit’s seven vacated or reversed cases from August provide helpful clarity on obviousness-type double patenting, written description and indefiniteness, and suggest improved practices for petitioners and patent owners in inter partes review, say Denise De Mory and Li Guo at Bunsow De Mory.
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Use The Right Kind Of Feedback To Help Gen Z Attorneys
Generation Z associates bring unique perspectives and expectations to the workplace, so it’s imperative that supervising attorneys adapt their feedback approach in order to help young lawyers learn and grow — which is good for law firms, too, says Rachael Bosch at Fringe Professional Development.
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Opinion
Congress Can And Must Enact A Supreme Court Ethics Code
As public confidence in the U.S. Supreme Court dips to historic lows following reports raising conflict of interest concerns, Congress must exercise its constitutional power to enact a mandatory and enforceable code of ethics for the high court, says Muhammad Faridi, president of the New York City Bar Association.
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Series
The Pop Culture Docket: Justice Lebovits On Gilbert And Sullivan
Characters in the 19th century comic operas of Gilbert and Sullivan break the rules of good lawyering by shamelessly throwing responsible critical thought to the wind, providing hilarious lessons for lawyers and judges on how to avoid a surfeit of traps and tribulations, say acting New York Supreme Court Justice Gerald Lebovits and law student Tara Scown.