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Life Sciences
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December 05, 2024
Fed. Circ. Grapples With Injunctions On Eylea Biosimilars
Regeneron Pharmaceuticals Inc. faced a two-pronged challenge before a Federal Circuit panel Thursday as two companies sought to undo a court order prohibiting them from releasing their biosimilar versions of Regeneron's Eylea eye medication.
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December 05, 2024
IP Forecast: PTAB To Hear Pfizer Fight Over COVID-19 Patents
Pfizer heads to an administrative board at the U.S. Patent and Trademark Office next week to argue Moderna should not have been issued patents covering "a basic idea" like using mRNA to fight the COVID-19 virus. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.
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December 05, 2024
Fla. Labs Say Cigna's Trial 'Confession' Erases $7.3M Verdict
Three Florida drug testing laboratories have urged a Connecticut federal court to undo a $7.3 million jury verdict for Cigna Health and Life Insurance Co. over unjustified billings, arguing a new trial is warranted after the insurer allegedly made a "confession" during opening statements that it wasn't seeking damages for itself.
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December 05, 2024
Gov't Efficiency Push Is A 'New Day,' House Speaker Says
House Speaker Mike Johnson, R-La., spoke excitedly Thursday about the new government efficiency operation helmed by billionaire Elon Musk and former presidential candidate Vivek Ramaswamy and touted the budding bipartisan lineup of a congressional caucus that will work with it.
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December 06, 2024
FINRA Fines Firm $900K Over SPAC Underwriting Fee Issues
The Financial Industry Regulatory Authority has fined New York-based LifeSci Capital LLC nearly $1 million over claims that it received and failed to disclose unfair and unreasonable fees for an initial public offering it underwrote.
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December 05, 2024
Abbott Accused Of 'Last-Ditch Effort' To Halt Formula Suit
Investors accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula urged an Illinois federal judge to reject the company's bid to stay the case because it belatedly formed a special litigation committee to investigate the allegations two years into the litigation.
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December 05, 2024
Quest Ex-Workers Ask 3rd Circ. To Revive 401(k) Suit
Ex-workers for Quest Diagnostics Inc. urged the Third Circuit to revive their suit alleging mismanagement of their $5 billion 401(k) retirement plan, arguing a lower court shouldn't have handed Quest an early win on claims the company failed to properly monitor investment offerings.
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December 05, 2024
SpaceX Seeks Astronomical $350B Value, And More Rumors
SpaceX is in discussions for a transaction that could value the rocket and spacecraft maker at about $350 billion, the private equity owner of Crunch Fitness could sell the health club at a $1.5 billion value, and the management group looking to buy the Japanese owner of 7-Eleven may launch an IPO. Here, Law360 breaks down these and other notable deal rumors from the past week.
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December 05, 2024
FDA Warns 115 Retailers Over Unauthorized E-Cigarettes
The U.S. Food and Drug Administration has issued warning letters to 115 retailers across the country for selling unauthorized e-cigarettes that appeal to youths, the agency said Thursday.
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December 05, 2024
Insulet Wins $452M In Trade Secret Theft Trial
A Massachusetts federal jury has awarded Insulet Corp. $452 million after concluding that a South Korean company stole its trade secrets for a wearable insulin patch pump, marking one of the largest trade secrets verdicts of the decade.
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December 04, 2024
Withers IP Partners Hop To Sullivan & Worcester
Sullivan & Worcester LLP has said the Boston firm picked up a team of five intellectual property lawyers, including two partners, from Withers who have expertise in filing patents and working on deals for biotech startups.
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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.
Expert Analysis
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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.
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New HHS Research Misconduct Rules Bring Seismic Changes
The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.
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State Of The States' AI Legal Ethics Landscape
Over the past year, several state bar associations, as well as the American Bar Association, have released guidance on the ethical use of artificial intelligence in legal practice, all of which share overarching themes and some nuanced differences, say Eric Pacifici and Kevin Henderson at SMB Law Group.
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How Biden Admin Has Used Antitrust Tools, And What's Next
The last four years have been marked by an aggressive whole-of-government approach to antitrust enforcement using a broad range of tools, and may result in lasting change regardless of the upcoming presidential election result, say attorneys at Norton Rose.
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Defining All-Risk: Despite $30M Loss, Loose Bolt Not 'Damage'
A Massachusetts federal court’s recent ruling in AMAG Pharmaceuticals v. American Guarantee and Liability Insurance Co., denying coverage for $30 million in damages claimed when a loose bolt caused an air leak, highlights an ongoing debate over the definition of “direct physical loss or damage,” say Josh Tumen and Paul Ferland at Cozen O'Connor.
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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.