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Life Sciences
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May 31, 2024
New Antibody IP Ruling Still Needs To Be Tested In Courts
A May decision from top U.S. Patent and Trademark Office officials is giving some attorneys renewed hope that they'll be able to secure antibody patents, but they say the agency's ruling may not be enough to overcome courts that have been hostile toward these patents.
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May 31, 2024
In Rarity, 1 Party's Judges Gain 100% Control Of Circuit Bench
At the First Circuit, the judges' robes are all black, but the judges are all blue. It's a new and unusual instance of one political party's judicial picks controlling each active seat on a federal appeals court, and the Democratic dominance could prove magnetic for ideologically charged litigation.
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May 31, 2024
FDA Seeks Fines Over Elf Bar E-Cigarette Sales
The U.S. Food and Drug Administration on Thursday said that it is seeking civil money penalties from nine stores and one online retailer for selling Elf Bar e-cigarettes, after previously warning them about sales of unauthorized tobacco products.
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May 30, 2024
Warren Pushes To Clinch 'Popular' Drug Patent 'March-In' Plan
Sen. Elizabeth Warren, D-Mass., and Rep. Lloyd Doggett, D-Texas, Thursday urged the U.S. Department of Commerce to finalize a proposal that would allow the government to take possession of "taxpayer-funded" patents on drugs and lease them to generic-drug makers, saying the "popular framework will help reduce exorbitant drug costs."
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May 30, 2024
Exec Found Liable For 'Shadow Trading' Seeks New Trial
A former executive of biopharmaceutical company Medivation Inc. whom a jury found liable for using inside information from his company when he purchased stock in a rival pharmaceutical maker has moved for a new trial in the U.S. Securities and Exchange Commission's novel "shadow trading" case.
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May 30, 2024
Rite Aid Ch. 11 Timeline Extended To Allow More Plan Review
A New Jersey judge on Thursday lengthened the timeline for Rite Aid to seek an exit from its Chapter 11 bankruptcy, pushing the confirmation hearing date out by seven days after insurers and others said the company's schedule would not provide enough time to review its restructuring plan.
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May 30, 2024
'South Park'-Quoting Judge Says CEO Can't 'Blame Canada'
In a ruling drawing on the show about four foul-mouthed boys from Colorado, a Pennsylvania federal judge said a CEO who sued his former company could not blame Canada for an unfavorable arbitration ruling in a case where he claimed he was wrongly fired from his post.
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May 30, 2024
What To Watch As The FTC Targets Drug Patent Listings
The Federal Trade Commission has been scrutinizing patents listed by drugmakers on a key federal database, warning several companies that their listings are improper and drive up drug prices. Here's a look at what the agency and others could do next.
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May 30, 2024
Pa. Court Blocks State's Recall Over Cannabis Vape Additives
The Pennsylvania Commonwealth Court has permanently blocked the state Department of Health from enforcing a 2022 recall of medical cannabis products containing certain additives, on the grounds that the department's reversal on the additives' approval was a "de facto regulation" that was enacted without the proper procedures.
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May 30, 2024
Ozempic Maker Says Texas Pharmacy Selling Knockoff Drug
The manufacturer behind the Ozempic weight loss drug has asked a federal court to prohibit a Houston-area pharmacy from selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient.
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May 30, 2024
3M Nixes Teva Inhaler Patent On Appeal At EPO
3M Innovative Properties Co. has convinced European officials to ax a patent owned by Israeli generic-drug maker Teva for an inhaler that relieves pulmonary disease symptoms, arguing that other scientists would have eventually figured out its special formula.
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May 30, 2024
Ex-Sidley Atty To Lead Faegre's West Coast Class Action Team
Faegre Drinker Biddle & Reath LLP is boosting its litigation team, announcing Wednesday it is bringing in a Sidley Austin LLP class action ace as a partner in its Los Angeles office.
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May 29, 2024
NY Attys Back Bid For Justices To Hear Double-Patenting Row
A petition looking to persuade the U.S. Supreme Court to wade into a double-patenting dispute has received support from a trade group of New York patent lawyers.
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May 29, 2024
South Baltimore Citizens Call On EPA For Incinerator Relief
Baltimore has turned a blind eye to South Baltimore residents suffering from respiratory diseases and persistently urging the city to transition away from Maryland's largest trash incinerator to zero-waste infrastructure for dealing with refuse, two environmental groups and a residents group say in an administrative complaint Wednesday.
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May 29, 2024
FDA Sued Over Controversial Lab Test Rule
A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.
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May 29, 2024
Israeli Nanotech Startup, Canadian Biotech Plot US IPOs
An Israeli nanotech startup launched plans Wednesday for an estimated $75 million U.S. initial public offering, while a Canadian-listed biotechnology company also filed documents to tap U.S. markets, adding to a recent spate of cross-border listings.
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May 29, 2024
Chicago IP Firm Accused Of Botching Fetal Biotech Patent
A company that makes technology that can detect fetal asphyxia and distress has alleged in Illinois state court that Chicago law firm Fitch Even Tabin & Flannery LLP cost it millions when it registered the company's patents under one of its former employees, who then used its intellectual property to launch a competing company.
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May 29, 2024
Wilson Sonsini Adds 2 Attys In Salt Lake City From Kirkland
Wilson Sonsini Goodrich & Rosati PC has continued to expand its growing, three-year-old Salt Lake City, Utah, office with the recent addition of two experienced litigators who moved their practices from Kirkland & Ellis.
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May 29, 2024
Gibson Dunn, Skadden Guide $3B Merck-EyeBio Deal
Gibson Dunn-led Merck said Wednesday it has agreed to purchase ophthalmology-focused biotech company Eyebiotech Ltd., or EyeBio, which is represented by Skadden, for up to $3 billion.
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May 29, 2024
3 Firms Build $627M Take-Private Sale Of Medical Device Biz
Medical device company Surmodics Inc. on Wednesday revealed it has agreed to be bought by private equity giant GTCR for $627 million in a take-private deal built by Kirkland & Ellis, Faegre Drinker and Cleary Gottlieb.
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May 29, 2024
Greenberg Traurig Adds IP Atty From Eversheds Sutherland
Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.
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May 29, 2024
Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee
A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.
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May 28, 2024
Abbott, Dexcom Call For New Glucose Monitor Patent Trial
Just over two months after a jury in Wilmington, Delaware, handed down a mixed verdict in a patent lawsuit over glucose monitors, both sides are now asking the judge to give them another trial.
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May 28, 2024
J&J To Pay $1.25B For Global Rights To Eczema Treatment
Johnson & Johnson has agreed to buy the rights to an experimental treatment for eczema from Baker McKenzie-advised Numab Therapeutics for approximately $1.25 billion, the companies announced on Tuesday.
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May 28, 2024
HIV Drug Buyers Fight Bid To Combine 9th Circ. Appeal Briefs
Drug buyers that allege Gilead Sciences Inc. and Teva Pharmaceuticals delayed generic versions of HIV medications told the Ninth Circuit it would be unfair to grant the companies' call for a single brief addressing the 17 appeals filed after a jury rejected the claims last year.
Expert Analysis
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.
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Lessons From Country Singer's Personal Service Saga
Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.
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A Potential Proactive Tool For Public-Private Joint Ventures
In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.
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Patent Prosecution Carries Consequences For Later Litigation
The Federal Circuit's recent Mylan v. Actelon holding, along with three other 2023 decisions, underscores the continued need for patent prosecutors to make note of potential claim construction issues that may arise in subsequent litigation, says Steven Wood at Hunton.
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10 Global Antitrust Trends To Anticipate In 2024
Proactive navigation of the antitrust enforcement environment remains crucial this year as legal policy and tools evolve to meet intensifying global economic complexity, including geopolitical tensions, trade realignment, market volatility and inflation, say attorneys at Freshfields.
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Global Cartel Enforcement Looks Set To Intensify In 2024
The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.
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Series
Baking Bread Makes Me A Better Lawyer
After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.
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Supreme Court Amgen Ruling's Major Effect On Enablement
The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.
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Federal Courts And AI Standing Orders: Safety Or Overkill?
Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.
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7 E-Discovery Predictions For 2024 And Beyond
The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.
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Top Considerations For Retailers Using AI To Combat Theft
The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.
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5 Litigation Funding Trends To Note In 2024
Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.
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Medtronic's Cautionary Tale Of Fed. Circ. Word Limits
The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.