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Life Sciences
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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.
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May 28, 2024
Catching Up With Delaware's Chancery Court
Delaware Court of Chancery watchers shifted their focus last week from the courtroom to Dover's legislative hall, as proposed amendments to Delaware's corporate code were finally introduced to state lawmakers. Hearings, decisions and reversals involved Kraft-Heinz, AMC Entertainment and the merger of cryptocurrency companies BitGo and Galaxy. In case you missed it, here's the latest from Delaware's Chancery Court.
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May 28, 2024
Ga. Dental Imaging Co. Fights To Keep X-Ray IP Suit Alive
A dental technology company accusing a competitor of ripping off a 3D imaging system has urged a Georgia federal judge to keep its claims alive, telling the court its rival's defense amounts to a "whitewash" of the patent infringement allegations.
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May 28, 2024
Edwards Urges Full Fed. Circ. To Limit FDA Safe Harbor
Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."
Expert Analysis
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Series
Competing In Triathlons Makes Me A Better Lawyer
While practicing law and competing in long-distance triathlons can make work and life feel unbalanced at times, participating in the sport has revealed important lessons about versatility, self-care and perseverance that apply to the office as much as they do the racecourse, says Laura Heusel at Butler Snow.
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Parsing The USPTO's Guidelines For Assessing Enablement
Ryan Hagglund at Loeb & Loeb details the U.S. Patent and Trademark Office's recent guidelines for assessing enablement principles set forth in the U.S. Supreme Court's 2023 Amgen v. Sanofi decision, including how the guidelines can apply to all fields of technology.
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Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling
Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Precise Advance Notice Bylaws May Help Prevent Disputes
While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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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.