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Life Sciences
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June 24, 2024
Justices Pass On Rutgers COVID-19 Vax Mandate Case
The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.
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June 21, 2024
Drug Cos., IP Attys Back Cellect In High Court Efforts
A petition by patent litigation outfit Cellect that is looking to persuade the U.S. Supreme Court to wade into a double patenting dispute has drawn support from even more lawyers as well as a handful of major drugmakers and small tech companies like Sonos.
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June 21, 2024
Drugmakers Decline To Drop Patent Listings After FTC Letters
The eight pharmaceutical companies that the Federal Trade Commission warned in April may have improperly listed patents for its products in a key federal database have chosen not to remove any patents or otherwise alter their listings, according to a document released Friday.
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June 21, 2024
After Fed. Circ. Win, Bausch Sues Alvogen Over Drug Patents
Bausch's Salix Pharmaceuticals has launched a lawsuit against Alvogen's Norwich Pharmaceuticals unit in a New Jersey federal court, claiming that its planned generic version of Xifaxan, a blockbuster diarrhea and brain disorder drug, infringes a set of patents.
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June 21, 2024
Pay-For-Delay Drug Case Not Time-Barred, UK Tribunal Says
The U.K. Competition Appeal Tribunal refused Friday to apply a much more restrictive statute of limitations that would toss government claims that Danish pharmaceutical company Lundbeck Ltd. and generic drug manufacturers anticompetitively agreed to delay generic competition to an antidepressant.
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June 21, 2024
Ex-CEO Found Liable For $1 Now Seeks Atty Fees For Del. Suit
The ex-CEO of a biopharma company who was found liable in 2021 for breaching his fiduciary duties but ordered to pay just $1 in damages after Delaware's Court of Chancery found that no real harm had been done is now suing for his attorney's fees and court costs.
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June 21, 2024
Costco Sued Over PFAS In Kirkland Brand Baby Wipes
Costco is facing a proposed class action over its fragrance-free "natural" baby wipes, which consumers claim are made with toxic levels of forever chemicals, rendering them unsafe for use on children.
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June 21, 2024
8 Firms To Lead 4 IPOs Totaling $806M As Action Heats Up
Eight law firms are slated to guide four initial public offerings estimated to raise a combined $806 million during the week of June 24, potentially closing a slow month for new listings with a bang.
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June 21, 2024
Taxation With Representation: Travers Smith, Potamitis Vekris
In this week's Taxation With Representation, RSK Group Ltd. gets a £500 million ($632 million) investment, Boston Scientific Corp. acquires Silk Road Medical Inc., Masdar takes a part of Terna Energy SA, and Tate & Lyle PLC buys CP Kelco from JM Huber Corp.
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June 20, 2024
Ex-DEA Heads Echo GOP AGs' Call For Pot Rescheduling Hearing
A group of former U.S. Drug Enforcement Administration leaders and Republican attorneys general have formally requested administrative hearings on the U.S. attorney general's proposal to reschedule cannabis, according to separate letters sent this week that distinctly echo each other.
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June 20, 2024
Patent Owners, Challengers Spar Over PTAB Rule Proposal
The U.S. Patent and Trademark Office's scaled-back package of Patent Trial and Appeal Board rules has drawn a mixed reaction from legal and industry groups, which offered praise and concern about both the proposal and the topics it does not address.
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June 20, 2024
Eli Lilly Launches Round Of Diabetes Drug Suits
Eli Lilly on Thursday hit various compounding pharmacies and medical spas in five states and the District of Columbia with suits saying that they trick consumers into thinking that they sell Eli Lilly medications that treat diabetes and obesity when actually they are copycats and are untested by the U.S. Food and Drug Administration.
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June 20, 2024
Spinal Implant Maker Can Liquidate Under Ch. 11 Plan
A Delaware bankruptcy judge agreed Thursday to approve the Chapter 11 liquidation and wind-down plan of biotechnology developer InVivo, which reported it landed a buyer for its spinal cord implant technology following an unsuccessful bankruptcy auction.
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June 20, 2024
11th Circ. Upholds $2.5M Pelvic Mesh Verdict, Rules Suit Timely
The Eleventh Circuit on Thursday refused to throw out a woman's $2.5 million victory against Coloplast Corp. in a suit alleging she was implanted with defective pelvic mesh, saying the evidence does not support a conclusion that her claim was filed too late.
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June 20, 2024
No Access To Ethics Docs For Ex-NJ Official Yet, Judge Rules
A New Jersey judge has rejected a bid by a former Garden State health official asking the court to compel the state and its ethics commission to produce documents related to claims he was fired in 2020 for raising concerns over the earmarking of COVID-19 tests for relatives of a state administration official, according to Wednesday orders.
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June 20, 2024
No Atty, No Case: Judge Tosses Attack On Psychedelics Ban
A federal judge in Washington state threw out a challenge to the U.S. Drug Enforcement Administration's efforts to ban two psychedelic substances in an order Thursday that chided a psychedelic research company for doing "an end run" around requirements that corporations be represented by an attorney.
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June 20, 2024
HHS Drug Pricing Program Flouts Constitution, Boehringer Says
An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.
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June 20, 2024
11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement
The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.
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June 20, 2024
Theravance, Mylan Say Chinese Co. Copied COPD Drug
Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.
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June 20, 2024
USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section
The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."
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June 20, 2024
11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit
The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.
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June 18, 2024
High Court Petition Asks Justices: What's A 'Willful' Kickback?
Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.
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June 18, 2024
Company, States Battle In Court Over At-Home Rape Kits
A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.
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June 20, 2024
CORRECTED: Drug Cos., PBMs Score Win In Calif. AG's Insulin Price Suit
A Los Angeles judge ruled Tuesday that the statute of limitations bars the California Attorney General's unfair competition law and unjust enrichment claims against drugmakers and pharmacy benefit managers over an alleged conspiracy to spike insulin costs, but granted leave to amend the allegations.
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June 18, 2024
Fla. Immune To Contract Suit Over COVID Tests, 4th Circ. Says
The Fourth Circuit reversed on Tuesday a district court decision denying a motion to dismiss by a Florida state agency in a breach of contract case involving COVID-19 tests, finding the lower court erred in ruling that the state did not have sovereign immunity and remanding the case for further proceedings.
Expert Analysis
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.
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The Legal Industry Needs A Cybersecurity Paradigm Shift
As law firms face ever-increasing risks of cyberattacks and ransomware incidents, the legal industry must implement robust cybersecurity measures and privacy-centric practices to preserve attorney-client privilege, safeguard client trust and uphold the profession’s integrity, says Ryan Paterson at Unplugged.
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Fed. Circ. In Jan.: One Word Can Affect Claim Construction
The Federal Circuit's recent Pacific Biosciences v. Personal Genomics decision highlights how even construction of a simple term can be dispositive, and thus disputed, in view of the specific context provided by the surrounding claim language, say Jeremiah Helm and Sean Murray at Knobbe.
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5 Reasons Associates Shouldn't Take A Job Just For Money
As a number of BigLaw firms increase salary scales for early-career attorneys, law students and lateral associates considering new job offers should weigh several key factors that may matter more than financial compensation, say Albert Tawil at Lateral Hub and Ruvin Levavi at Power Forward.
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How Biotech Deals May Help Competition, Despite FTC View
The Federal Trade Commission's complaint against Sanofi's proposed partnership with Maze Therapeutics highlights increasing skepticism of so-called killer acquisitions, but a closer look reveals potentially legitimate reasons behind why entities might decide to delay or abandon the development of acquired products, say consultants at Analysis Group.
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Expediting Psychedelics Approvals In The US And Canada
Accelerated regulatory pathways for psychedelics in the U.S. and Canada play a pivotal role in the progression of drugs, devices and novel therapies toward commercialization, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
Playing Competitive Tennis Makes Me A Better Lawyer
My experience playing competitive tennis has highlighted why prioritizing exercise and stress relief, maintaining perspective under pressure, and supporting colleagues in pursuit of a common goal are all key aspects of championing a successful legal career, says Madhumita Datta at Lowenstein Sandler.
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Series
The Pop Culture Docket: Judge Djerassi On Super Bowl 52
Philadelphia Court of Common Pleas Judge Ramy Djerassi discusses how Super Bowl 52, in which the Philadelphia Eagles prevailed over the New England Patriots, provides an apt metaphor for alternative dispute resolution processes in commercial business cases.
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Reverse Merger Tips For Biotechs After SEC's Recent Actions
Several recent U.S. Securities and Exchange Commission developments could limit the viability of reverse mergers for biotech companies, and will require additional creativity and analysis for private companies looking to go public, say attorneys at Orrick.
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Opinion
Proposed Rule Misses The Mark On Improving MDLs
The Advisory Committee on Civil Rules' recently proposed rule on multidistrict litigation would provide some guidance for courts on managing MDLs — but without any requirement for the early vetting of claims, it is particularly unhelpful for defendants in pharmaceutical and product liability cases, say attorneys at Crowell & Moring.