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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 05, 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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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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.