Latest news with #ALJ
Yahoo
04-05-2025
- Business
- Yahoo
DEA Diversion in Cannabis Chaos: MMJ Urges Terrance Cole, President Trump DEA Nominee to Dismantle Biden Era Cannabis Obstructors
Message to President Trump's Appointee: Terrance Cole Must Act on Cannabis Scientific Reform. "Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional marijuana bias, and restore lawful science-based regulatory practices." WASHINGTON, DC / / May 4, 2025 / MMJ BioPharma Cultivation announced it will file an emergency motion and lawsuit in the U.S. District Court for the District of Rhode Island following a controversial ruling by DEA Administrative Law Judge (ALJ) Teresa Wallbaum. Judge Wallbaum recently issued a ruling to vacate a previously granted stay-clearing the path for a DEA ALJ hearing before what MMJ asserts is a constitutionally defective tribunal. Judge Wallbaum retired immediately after issuing the ruling. The company's forthcoming legal action seeks to block the DEA's internal administrative hearing process, which MMJ argues violates the Supreme Court's landmark ruling in Axon Enterprise, Inc. v. FTC, and inflicts irreparable harm on its constitutional rights and medical mission. MMJ Direct Challenge to DEA Overreach The Axon decision, issued by the Supreme Court in 2023, affirmed that entities subject to unconstitutional agency proceedings can challenge them in federal court before being forced through the flawed administrative process. MMJ contends that the DEA's ALJ system, where judges are insulated from presidential oversight, runs afoul of Article II of the Constitution. "We are not just challenging DEA policy; we are defending the rule of law," said Duane Boise, CEO of MMJ BioPharma Cultivation. "The DEA cannot ignore Supreme Court precedent and funnel applicants into hearings that are constitutionally invalid." From Regulatory Delay to Constitutional Injury MMJ's application to grow pharmaceutical-grade marijuana for FDA-sanctioned clinical trials was filed in 2018. Since then, the company has: Built and passed inspection of a DEA-compliant facility Received a DEA Schedule I analytical registration Filed two FDA Investigational New Drug (IND) applications Been awarded FDA Orphan Drug Designation for Huntington's Disease Despite these milestones and the 60-day processing deadline set by the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), MMJ has waited over 2,300 days. "The damage done by these delays is not just procedural-it's personal," Boise added. "Patients living with Huntington's and MS deserve answers and access, not bureaucratic purgatory." Biden's Failed Cast of Characters: Milgram, Garland, Thomas Prevoznik, Matthew Strait For years, DEA Administrator Anne Milgram, Attorney General Merrick Garland, and the broader Biden administration have stood idle-overseeing a federal agency that continues to delay and deny legitimate medical cannabis research. Despite bipartisan legislation and judicial precedent, no meaningful reform has occurred. "The Biden administration had every opportunity to fix this. Instead, they turned a blind eye to patients and the Constitution," said Boise. Message to President Trump's Appointee: Terrance Cole Must Act Now, all eyes turn to Terrance Cole, President Trump's nominee for DEA Administrator, who MMJ urges to dismantle the obstructionist legacy left behind by the Biden-era leadership. "Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional bias, and restore lawful science-based regulatory practices." MMJ emphasized that Cole's leadership can mark a turning point: not just for the agency, but for tens of thousands of patients across the country. "This is about reclaiming the DEA from the grip of politics and putting patients first," Boise added. "Terrance Cole can either reform the agency-or risk continuing the shameful legacy of his predecessors." Federal Court Relief Sought MMJ's legal filing will request: A preliminary and permanent injunction halting the ALJ proceeding A declaration that the DEA's ALJ process violates the Constitution Expedited federal review in accordance with the Axon precedent "We are not seeking special treatment," Boise concluded. "We are demanding a fair, lawful process-something every American is entitled to. The DEA must be held accountable." MMJ is Represented by Attorney Megan Sheahan and Associates CONTACT:Madison Hiseymhisey@ SOURCE: MMJ International Holdings View the original press release on ACCESS Newswire
Time of India
02-05-2025
- Business
- Time of India
Oura scores initial win in US patent case against Ultrahuman
Indian smart ring maker Ultrahuman and Chinese rival RingConn may have infringed patents held by Finnish wearable tech startup Oura , according to an initial determination by a US International Trade Commission (ITC) administrative law judge (ALJ). #Pahalgam Terrorist Attack Pakistan reopens Attari-Wagah border to allow stranded citizens in India to return Key Jammu & Kashmir reservoirs' flushing to begin soon Air India sees Pakistan airspace ban costing it $600 mn over 12 months In a blog post, Oura said the ALJ conducted a claim-by-claim analysis and found that both Ultrahuman and RingConn's products infringe every element of every asserted claim of its patent. A smart ring is a wearable device embedded with sensors that track health metrics such as heart rate, sleep patterns, activity levels, and body temperature, typically syncing with a smartphone app. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo Oura alleged that the Ultrahuman Ring and RingConn Smart Ring copied not only its ring form factor but also the core technology behind its patented sleep and health tracking capabilities. Ultrahuman denied the allegation. 'We respectfully but firmly disagree with the recent initial determination and remain confident in our position,' the Bengaluru-based company said in a statement. Live Events The ALJ's findings will be reviewed by the US ITC, which determines whether goods being imported into the US meet various standards including existing US patents. Discover the stories of your interest Blockchain 5 Stories Cyber-safety 7 Stories Fintech 9 Stories E-comm 9 Stories ML 8 Stories Edtech 6 Stories Ultrahuman currently manufactures around 40% of its volumes in the US there – putting the remaining 60% at risk should the US ITC rule against it, people aware of the matter said. 'Ultrahuman has a facility in Texas and can ramp it up to de-risk, but this will entail additional costs making its products costlier to manufacture,' one of them said. The startup is in talks to raise $100-120 million in funding from WestBridge Capital , and plans to use these funds to fuel its international expansion, the sources said. Oura had filed its complaint against Ultrahuman and RingConn in August 2023, citing multiple US patents covering hardware design, sensor integration, and signal processing algorithms. According to the Finnish firm, the ALJ also found Ultrahuman's claims of its Texas facility to be 'falsified' – but this was opposed by the Indian startup. 'Our fast-scaling Texas facility is set to cover 100% of US demand within the next two to three months – underscoring our commitment to domestic operations and customer-first innovation,' Ultrahuman said in its statement. 'This category has enormous potential to transform human health, but it has too often been shaped by companies that rely on legal intimidation, legacy patent acquisitions, and questionable procurement tactics rather than innovation,' it said. 'We will continue to challenge anti-competitive behaviour, defend real innovation, and fight for a more transparent and merit-driven future in this industry – regardless of how long it takes or who's on the other side.' The development was first reported by digital tech publication ZDNet . Oura had also filed a case in 2023 against Ultrahuman in a US District Court of Texas but those proceedings were stayed pending the US ITC investigation. In its annual report released in January, Ultrahuman said it recorded a 6X growth in revenue year-on-year in 2024, with an average profit before tax (PBT) of 11%. The company expects PBT margins to rise to around 20% over time, as it invests in expanding its product line up—including new wearable form factors, fertility and cardiovascular health clinical trials, experience centres, and its Texas UltraFactory .
Yahoo
30-03-2025
- Business
- Yahoo
DEA Forces Marijuana Pharma Drug Industry Offshore: A Symbol of DEA Systemic Obstruction Against Trump Administration Directives
"The DEA's marijuana approach is stuck in an outdated 'war on drugs' mentality," said Duane Boise CEO of MMJ International Holdings. "While lawmakers push for medical progress, the DEA's red tape is suffocating innovation." DEA officials, including Matt Strait and Thomas Prevoznik, have been accused of imposing unnecessary hurdles, such as slow-walking API Bulk Manufacturing registrations, and imposing opaque approval processes while patients continue to suffer. WASHINGTON, DC / / March 30, 2025 / As the Trump administration pushes to reshore pharmaceutical manufacturing through aggressive tariffs and trade policies, a less visible but equally critical challenge persists: the Drug Enforcement Administration's (DEA) stringent regulations. Critics argue that the agency's bureaucratic delays and restrictive oversight are not only hindering medical research but also driving pharmaceutical companies overseas , undermining domestic innovation and economic goals. The MMJ Marijuana Case: A Symbol of DEA Systemic Obstruction At the heart of this debate is a high-stakes legal battle between MMJ International Holdings and the DEA . The company, which specializes in cannabis-based treatments for conditions like multiple sclerosis and Huntington's disease , alleges that the DEA has unlawfully delayed approvals for cultivating proprietary marijuana strains needed for research and drug development. These delays, MMJ claims, have delayed FDA clinical trials for its flagship drug, MMJ-002, and reflect a broader bias against cannabis-derived medicines. The lawsuit also challenges the constitutionality of protections for Administrative Law Judges (ALJs), who oversee DEA cases. MMJ argues that these protections insulate ALJs from accountability, allowing inefficiency and bias to fester. The Department of Justice (DOJ) recently backed this view, declaring ALJ removal safeguards unconstitutiona l - a move that will force the DEA to operate with greater transparency and responsiveness. Regulatory Delays vs. Legislative Progress The DEA's actions stand in stark contrast to recent legislative efforts aimed at advancing medical research. Laws like the Right to Try Act and the Medical Marijuana Research Expansion Act were designed to streamline access to experimental treatments and expand cannabis studies. However, DEA officials, including Matt Strait and Thomas Prevoznik , have been accused of imposing unnecessary hurdles, such as slow-walking cultivation licenses and imposing opaque approval processes. "The DEA's approach is stuck in an outdated 'war on drugs' mentality," said Duane Boise CEO of MMJ International Holdings. "While lawmakers push for medical progress, the agency's red tape is suffocating innovation." DEA Driving Pharma Offshore The DEA's sluggish processes are exacerbating a growing trend: pharmaceutical companies relocating operations to countries with friendlier regulatory climates. Canada, Germany, and Israel-nations with clearer pathways for cannabis research-have emerged as hubs for drug development, luring American firms deterred by U.S. bureaucracy. "Every month of delay costs millions and risks losing talent overseas," noted a CEO of a biotech startup. "The DEA's inefficiency is a competitive disadvantage for the U.S." Broader Implications for DEA Accountability MMJ's case could set a precedent for reforming how federal agencies operate. If the court sides with MMJ, agencies like the DEA will face increased executive oversight, potentially dismantling systemic inefficiencies. This shift could revitalize sectors reliant on timely approvals, including pharmaceutical manufacturing, and biotechnology. The Cannabis Conundrum Critics argue that the DEA's resistance to cannabis research is particularly shortsighted. With 38 states legalizing medical marijuana and global markets for cannabis-based therapies projected to reach $55 billion by 2027, the U.S. risks ceding leadership in a burgeoning industry. "The DEA is clinging to stigma over science," said Duane Boise an advocate for Pharmaceutical marijuana. "Patients are paying the price." A Crossroads for U.S. Pharma and Marijuana Drug Development The outcome of MMJ's lawsuit could determine whether the U.S. retains its edge in pharmaceutical innovation. A win for MMJ International Holdings will catalyze regulatory reforms, aligning the DEA with legislative and public sentiment. Conversely, a loss could accelerate the offshoring of research and production, leaving American patients dependent on foreign-developed treatments. As the Trump administration champions "America First" trade policies, the DEA's role as an inadvertent roadblock highlights a stark contradiction . Without regulatory modernization, tariffs alone may fail to reverse the pharmaceutical exodus-or unlock the potential of groundbreaking therapies. The Bottom Line: The DEA's regulatory inertia is more than a bureaucratic hiccup; it's a critical threat to U.S. medical innovation and economic competitiveness. As legal and political battles unfold, the agency's ability to adapt may well decide the future of American pharmaceutical leadership. For updates on this evolving story and its impact on cannabis research and federal accountability, follow our ongoing coverage. MMJ is represented by attorney Megan Sheehan . CONTACT: Madison Hisey mhisey@ 203-231-8583 SOURCE: MMJ International Holdings View the original press release on ACCESS Newswire
