medicine

Delhi High Court Restrains Dr. Reddy’s, OneSource in Novo Nordisk’s Weight Loss Drug Patent Dispute

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In a significant legal development, the Delhi High Court has issued an interim injunction restraining Indian pharmaceutical major Dr. Reddy’s Laboratories and OneSource Nutra from manufacturing, selling, or distributing generic versions of a weight loss drug patented by Danish pharmaceutical company Novo Nordisk.

The dispute centers around semaglutide, the active ingredient in Novo Nordisk’s blockbuster drug Wegovy, which is used for chronic weight management and has gained global popularity due to its high efficacy in combating obesity. Semaglutide, also used in the diabetes medication Ozempic, has seen skyrocketing demand, making it a highly valuable asset for the company.

The Court’s Interim Order

On Thursday, Justice Sanjeev Narula of the Delhi High Court granted an ex parte ad interim injunction in favor of Novo Nordisk, barring Dr. Reddy’s and OneSource from infringing on the company’s patent rights related to semaglutide. The order came in response to a lawsuit filed by Novo Nordisk India Pvt. Ltd. and Novo Nordisk A/S, which alleged unauthorized use and commercialization of the patented compound by the defendants.

The court observed that a prima facie case of patent infringement had been established and that irreparable harm could be caused to Novo Nordisk if interim relief was not granted. The order restrains the defendants from importing, manufacturing, marketing, or offering for sale any product containing semaglutide until the matter is fully adjudicated.

Background of the Dispute

Novo Nordisk holds a valid Indian patent for semaglutide, which is protected until 2033. The company claimed that Dr. Reddy’s and OneSource had begun producing and marketing unauthorized generic versions of the compound in violation of its intellectual property rights.

In its petition, Novo Nordisk argued that such actions not only amounted to infringement but also posed a serious threat to its commercial interests and research investments in India and globally.

The Danish drugmaker submitted evidence including product listings and promotional material from the defendants, suggesting active commercialization efforts despite the subsistence of the patent.

Industry Impact

The injunction is likely to have far-reaching implications for the Indian pharmaceutical sector, particularly in the context of patent law enforcement and the growing market for obesity treatment drugs. With semaglutide-based therapies becoming a major growth driver for Novo Nordisk, the ruling underscores the increasing significance of patent protection in high-value therapeutic categories.

While Indian generic manufacturers have historically played a critical role in making affordable medications accessible, this case reaffirms the judiciary’s stance on respecting patent laws, particularly when infringement is clearly established.

Responses from the Parties

As of the time of publication, Dr. Reddy’s Laboratories has not issued an official statement on the court’s order. OneSource Nutra also remains silent on the issue.

Novo Nordisk, on the other hand, welcomed the decision, stating it was a “vindication of our ongoing commitment to protecting innovation and ensuring patient safety.” The company emphasized that unregulated generics could compromise treatment efficacy and patient outcomes.

Next Steps

The matter is scheduled for further hearing in July 2025, during which the defendants are expected to present their responses. Legal experts suggest that the final outcome could set a precedent for similar cases involving high-demand biologics and patented pharmaceuticals.

As India continues to balance public health interests with intellectual property rights, the resolution of this case will be closely monitored by stakeholders in the pharmaceutical and healthcare sectors both domestically and internationally.

Delaware Court Upholds Acadia’s Patent Rights, Secures Protection for Nuplazid Formulation

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In a significant legal victory for Acadia Pharmaceuticals Inc., a Delaware district court has ruled in favor of the company’s arguments concerning patent infringement and validity, providing crucial protection for its flagship product, Nuplazid. The ruling reinforces Acadia’s intellectual property rights and ensures continued exclusivity for the formulation of the drug, which is widely used in the treatment of Parkinson’s disease-related psychosis.

The decision, issued earlier this week by the U.S. District Court for the District of Delaware, concluded that Acadia’s patent covering the specific formulation of Nuplazid is both valid and enforceable, and that a proposed generic version would infringe on this patent. The case centered around challenges brought by a generic drug manufacturer seeking to introduce a competing product ahead of patent expiration.

Chief Executive Officer Catherine Owen Adams welcomed the ruling, stating, “This decision is a critical validation of our intellectual property strategy and our commitment to protecting innovations that bring value to patients. Patent protection for Nuplazid’s formulation is essential to ensuring we can continue investing in research and development to address unmet medical needs.”

Nuplazid, approved by the U.S. Food and Drug Administration in 2016, is known for Its unique formulation has been central to its clinical effectiveness and commercial success, making the preservation of its patent rights a top priority for Acadia.

The court’s ruling effectively blocks the launch of a generic version until the expiration of Acadia’s patent, currently set for 2030. Legal analysts noted that the decision could have broader implications for similar cases involving branded pharmaceuticals defending their market exclusivity against generic challengers.

Investors responded positively to the news, with Acadia’s shares rising in after-hours trading. The company reaffirmed its financial guidance for the year, citing confidence in the continued revenue stream from Nuplazid.

This ruling is expected to bolster confidence among stakeholders and reinforces the legal protections afforded to novel pharmaceutical formulations under U.S. patent law.

Nobel Prize Winners Convince Court to Revive CRISPR Patent Dispute

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In a significant legal development with profound implications for the future of genetic engineering, a U.S. federal appeals court has agreed to revisit a high-stakes patent battle over CRISPR-Cas9 gene-editing technology. This decision follows a petition spearheaded by Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier, who are seeking to reclaim intellectual property rights over one of the most groundbreaking discoveries in modern biology.

The CRISPR Breakthrough

CRISPR-Cas9, a revolutionary tool that enables precise editing of DNA, has transformed the field of genetics since its development in the early 2010s. The technology allows scientists to alter genes with unprecedented ease and accuracy, offering promise in treating genetic diseases, improving crops, and even combating climate change. In 2020, Doudna and Charpentier were awarded the Nobel Prize in Chemistry for their pioneering work on CRISPR.

A Complex Legal Landscape

The CRISPR patent battle has pitted the University of California, Berkeley—where Doudna conducted much of her research—against the Broad Institute of MIT and Harvard. In 2022, the U.S. Patent and Trademark Office (USPTO) ruled in favor of the Broad Institute, recognizing its claim over the use of CRISPR in eukaryotic cells, including human cells.

UC Berkeley had earlier filed for the foundational CRISPR patent, but the Broad Institute’s expedited filing and specific focus on eukaryotic applications earned it a separate, and so far, legally upheld claim. The dispute centers on whether the Broad’s innovations were obvious extensions of the original CRISPR work or merited independent patent protection.

The Revival of the Case

In a rare move, the U.S. Court of Appeals for the Federal Circuit has agreed to review the previous ruling, citing newly presented arguments and scientific evidence by the UC Berkeley team and their legal representatives. Doudna and her colleagues argue that the Broad Institute’s patents should be invalidated on the grounds that the underlying concept of CRISPR in eukaryotic cells was an “obvious” step from their foundational research.

“The decision to revisit the case acknowledges the evolving understanding of CRISPR’s development and the need to fairly assign credit for its invention,” said a UC Berkeley spokesperson.

Legal analysts believe that the court’s decision could reshape the landscape of biotechnology patents. “This is not just about who owns CRISPR,” said Lisa Morgan, a biotech patent attorney in Washington. “It’s about how intellectual property is awarded in rapidly advancing scientific fields.”

Scientific and Commercial Stakes

The implications of the patent dispute are enormous. CRISPR-based therapies are currently in clinical trials for conditions such as sickle cell anemia, cancer, and blindness. With billions of dollars in potential revenue at stake, the ownership of key CRISPR patents determines who can license the technology and at what cost.

The legal battle has also sparked concern within the scientific community over how intellectual property law intersects with collaborative research and open science. Many researchers argue that patent disputes could stifle innovation and slow the development of life-saving treatments.

What’s Next?

The appeals court is expected to hear oral arguments later this year, with a decision anticipated in early 2026. Until then, the scientific community, biotech firms, and investors will be closely watching the proceedings.

As the legal saga unfolds, the core of the dispute remains a fundamental question about innovation in science: Who truly owns a discovery when multiple researchers contribute to a single transformative breakthrough?

Indian Pharma Stocks Tumble Amid Trump’s Drug Price Cut Order: Industry Braces for Patent Clampdown

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In a significant development that sent shockwaves across global pharmaceutical markets, U.S. President Donald Trump signed an executive order aimed at drastically reducing prescription drug prices in the United States. The move has triggered a sharp decline in Indian pharmaceutical stocks, raising concerns about the future of generic drug exports and the potential tightening of global patent regimes.

Trump Pushes for Global Price Parity

President Trump’s executive order, signed on Monday, mandates that U.S. drug prices should align with the lowest prices paid by other developed nations. Under the proposed “Most Favoured Nation” policy, the U.S. would no longer pay more for prescription medicines than any other country. The administration has given pharmaceutical companies 30 days to propose pricing solutions. Should they fail to deliver “significant progress” within six months, further government intervention is expected.

In a social media post, Trump argued that American consumers were unfairly burdened by high drug prices, noting that medicines manufactured in the same facilities are sold for significantly less in other countries. He emphasized that the United States bears a disproportionate share of global research and development costs, indirectly subsidizing affordable drugs for the rest of the world.

Indian Pharma Sector Reacts

The announcement caused immediate ripples in Indian stock markets. Shares of major pharmaceutical firms such as Sun Pharma plunged nearly 7% during early trading, while others including Lupin, Aurobindo Pharma, Divi’s Laboratories, and Glenmark Pharma also experienced a selloff.

Although Trump’s pricing directive primarily targets patented and branded drugs, experts warn of indirect consequences for India’s generic drug industry, which is heavily reliant on the U.S. market for exports.

“The concern lies in the potential policy response from multinational pharma companies,” said P.V. Appaji, former Director General of the Pharmaceuticals Export Promotion Council (Pharmexcil).

Threat of Patent Barriers Looms

Industry analysts believe that global drugmakers may respond to the price caps by tightening intellectual property regulations to prolong their market exclusivity and recover R&D investments. Potential measures include data exclusivity, automatic patent term extensions, patent linkage mechanisms, broader patentability criteria, and evergreening tactics.

Such practices, if adopted widely, could delay the entry of generic drugs into global markets and restrict the availability of off-patent drugs for Indian manufacturers. “These moves threaten to shrink the pipeline of medicines going off-patent, directly impacting India’s generic export prospects,” warned Ravi Uday Bhaskar, another former Pharmexcil chief.

India’s Stance on Patent Flexibilities

India has historically resisted stringent patent norms in trade negotiations, advocating for access to affordable medicines as a public health priority. The country does not recognize data exclusivity and maintains that regulatory authorities can rely on existing clinical trial data to approve generics. It also rejects patent linkage, preventing unnecessary legal hurdles that could delay the launch of affordable versions.

“India blocks evergreening by disallowing patents for minor modifications to existing drugs,” said Ajay Srivastava, founder of the Global Trade Research Initiative (GTRI).

However, if global pharmaceutical giants succeed in influencing trade agreements to include such provisions, Indian generic drug manufacturers may face significant challenges. The development and export of specialty generics—high-value, complex generics—could particularly be affected.

The Road Ahead

While the immediate impact of Trump’s executive order may be limited to branded drugs, the broader implications could be far-reaching for India’s pharmaceutical industry. Any moves to fortify global patent laws or extend exclusivity periods could undermine India’s position as the “pharmacy of the world” and disrupt access to affordable medications in many countries.

As the U.S. pushes forward with its aggressive drug pricing reforms, industry stakeholders and policymakers in India will need to closely monitor international negotiations and advocate for a balanced approach that safeguards innovation without compromising global health access.

Clearmind Medicine Secures European Patent Publication for Psychedelic-Based Cocaine Addiction Therapy

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Clearmind Medicine Inc. (Nasdaq: CMND, FSE: CWY0), a clinical-stage biotechnology firm focused on the development of next-generation psychedelic-based treatments, has officially announced the publication of a European patent application for its novel cocaine addiction therapy. The patent, filed with the European Patent Office (EPO) under number EP 4531826, represents a critical milestone in the company’s mission to address substance use disorders with innovative, non-addictive therapeutic solutions.

A Groundbreaking Therapeutic Combination

The newly published patent centers around a proprietary formulation that combines MEAI (5-methoxy-2-aminoindane) with N-Acylethanolamines (NAEs), including Palmitoylethanolamide (PEA). This unique combination aims to reduce cocaine cravings and prevent relapse by targeting the neurological pathways associated with drug addiction, without negatively impacting the natural reward systems in the brain.

These studies showed that animals treated with MEAI experienced a significant reduction in drug-seeking behavior. Notably, the research also found that the treatment did not impair the animals’ motivation for natural rewards such as sucrose, indicating the therapy’s ability to specifically address compulsive drug use without affecting healthy reward mechanisms.

Enhancing Global IP Protection

The European patent publication marks a key development in Clearmind’s broader strategy to strengthen its global intellectual property portfolio. The company has filed similar patent applications in multiple jurisdictions, and this European recognition further validates its proprietary approach to addiction therapy.

“This milestone reinforces our commitment to protecting the science behind our innovative treatments,” said Adi Zuloff-Shani, Ph.D., CEO of Clearmind Medicine. “Securing intellectual property rights in major global markets is essential for supporting the future commercialization of our psychedelic-based therapeutics and ensuring continued leadership in this evolving field.”

Strategic Collaboration and Expansion

The patent is also part of an ongoing collaborative effort with SciSparc Ltd. (Nasdaq: SPRC). The partnership is exploring the combined potential of Clearmind’s MEAI compound with SciSparc’s PEA-based technologies to develop advanced treatments for a range of central nervous system (CNS) disorders. This alliance is expected to further accelerate the development of therapies targeting addiction, anxiety, depression, and other mental health conditions.

About Clearmind Medicine Inc.

Clearmind Medicine is a clinical-stage psychedelic pharmaceutical company dedicated to creating transformative solutions for pressing and under-treated health conditions. Its research and development efforts focus primarily on psychedelic-derived compounds, with the goal of advancing them through the regulatory pipeline for use as pharmaceutical treatments, functional supplements, or food-grade therapies.

The company currently manages an expansive IP portfolio comprising 19 patent families and 31 granted patents, and continues to pursue additional filings to protect its proprietary formulations and discoveries.

The publication of this European patent application represents a significant leap forward in Clearmind’s pursuit of effective therapies for cocaine addiction. By combining rigorous scientific research with strategic global partnerships and IP protection, the company continues to establish itself as a leader in the emerging field of psychedelic-based mental health treatments.

ABVC BioPharma Secures Japanese Patent for Botanical Depression Drug ABV-1504, Strengthens Global IP Portfolio

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In a significant boost to its intellectual property portfolio, U.S.-based clinical-stage biopharmaceutical company ABVC BioPharma has received a key patent grant in Japan for its novel antidepressant candidate, ABV-1504. The newly issued patent secures exclusive rights in Japan for the innovative botanical-based treatment through 2040, reinforcing the company’s commitment to addressing global mental health challenges with plant-derived therapies.

ABV-1504, currently under clinical development for Major Depressive Disorder (MDD), is formulated from PDC-1421, a proprietary compound extracted from the traditional medicinal herb Polygala tenuifolia. This active ingredient acts as a Norepinephrine Transporter (NET) inhibitor and has shown encouraging safety and efficacy in Phase II clinical trials, offering a potentially safer and non-addictive alternative to conventional treatments like selective serotonin reuptake inhibitors (SSRIs).

The Japanese patent adds to ABVC’s existing IP protections in the United States, Australia, and Taiwan, ensuring broad international coverage for PDC-1421. With depression affecting more than 280 million people globally, and the antidepressant market projected to reach $20 billion by 2030, ABV-1504 positions itself as a differentiated and promising therapy in a growing global landscape.

“Securing patent protection in Japan is a critical achievement for ABV-1504 and reflects our broader strategy to provide innovative, plant-based solutions for central nervous system disorders,” said a company representative. “Japan’s healthcare system, which has long embraced botanical therapies, represents an ideal market for introducing this novel treatment.”

Japan presents strong commercial potential for ABV-1504. With over 5 million people suffering from depression and the country’s antidepressant market expected to surpass $1.25 billion by 2025, ABVC sees the region as a vital part of its global expansion strategy. The integration of herbal medicine into Japan’s modern healthcare practices further enhances market readiness for scientifically validated botanical alternatives.

To accelerate market access and local engagement, ABVC established BioLite Japan K.K., a joint venture led by a former Pfizer executive with deep experience in the Asia-Pacific pharmaceutical industry. Through this entity, ABVC is actively collaborating with regulatory bodies, academic institutions, and local industry leaders to prepare for future clinical and commercial developments in the region.

In a parallel development, ABVC signed a global licensing deal in November 2023 with AiBtl BioPharma Inc., valued at $667 million. The agreement includes milestone payments and royalties based on future commercialization success, underscoring investor confidence in the compound’s potential.

The issuance of the Japanese patent represents a major milestone for ABVC BioPharma as it continues its mission to redefine the treatment landscape for mental health disorders. By advancing a botanical-based solution with proven clinical promise, ABVC aims to offer patients a new path toward safer and more sustainable depression management.

Catheter Precision Secures First U.S. Patent for Surgical Closure Device, LockeT

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Catheter Precision, Inc. (NYSE American: VTAK), a leading U.S.-based developer of advanced medical devices in the cardiac electrophysiology field, has received a significant boost to its intellectual property portfolio. The company announced today that the United States Patent and Trademark Office has issued a notice of allowance for its first U.S. patent for LockeT, a specialized surgical closure device designed for orthoscopic entry wounds. The patent application was originally filed in December 2022.

LockeT, a Class 1 device registered with the U.S. Food and Drug Administration (FDA), is a suture retention product aimed at facilitating wound closure following percutaneous venous procedures. This latest patent strengthens Catheter Precision’s competitive position in the U.S. market and builds upon its growing foundation of international intellectual property protections.

“This first U.S. patent for LockeT complements our portfolio of international patents already granted in China, Europe, and the United Kingdom,” said David Jenkins, Chief Executive Officer of Catheter Precision. “Securing IP protection in the U.S. is particularly meaningful as we continue discussions for product distribution in key global markets, including China and Europe.”

The company is also anticipating regulatory clearance in the form of a CE mark within the current quarter, which would authorize LockeT’s commercial use across European markets. According to Jenkins, this approval is expected to open new revenue opportunities and accelerate market entry efforts abroad.

“We’re encouraged by the reception LockeT has received since its limited rollout in the U.S. late last year,” Jenkins added. “Healthcare systems globally are increasingly looking for devices that can improve clinical outcomes while also reducing overall procedural costs. LockeT is well-positioned to meet these dual objectives.”

LockeT represents a key addition to the company’s product lineup, especially as hospitals and surgical centers seek more effective wound management solutions that minimize complications and enhance recovery.

About Catheter Precision
Based in the United States, Catheter Precision, Inc. is a medical technology company dedicated to improving the treatment of cardiac arrhythmias. The company collaborates closely with clinicians to design and deliver innovative electrophysiology devices that raise the standard of care in cardiac procedures.

Forward-Looking Information
This news article contains statements that may be considered forward-looking under the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties, including those related to product approvals, market adoption, and commercial success. Actual results may differ materially due to various factors, including those detailed in the company’s filings with the Securities and Exchange Commission (SEC).

Conduit Pharmaceuticals Receives Additional Patent Approval for Lead Autoimmune Disease Asset

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Conduit Pharmaceuticals Inc. (NASDAQ: CDT), a biopharmaceutical company focused on developing treatments for autoimmune and inflammatory diseases, announced today that it has received further patent approval for its lead therapeutic asset targeting autoimmune conditions. The newly granted patent strengthens the company’s intellectual property portfolio and provides added protection for its innovative approach to treating autoimmune diseases such as sarcoidosis and lupus.

The patent, issued by the United States Patent and Trademark Office (USPTO), covers key methods of use and compositions relating to Conduit’s investigational drug, which is designed to modulate the immune response in patients with chronic autoimmune disorders. According to company officials, the approval not only broadens the existing patent family but also enhances the commercial potential of the lead compound as it advances through clinical development.

“This new patent grant is a major milestone for Conduit Pharmaceuticals, as it secures crucial proprietary rights over our lead autoimmune asset,” said Dr. David Tapolczay, Chief Executive Officer of Conduit Pharmaceuticals. “Our mission is to bring safe and effective treatments to patients suffering from complex autoimmune conditions, and this patent approval is a significant step forward in protecting the innovation that underpins our approach.”

The company’s lead asset, originally acquired from a major pharmaceutical partner, has demonstrated promising results in preclinical and early clinical studies. The drug works by selectively targeting pathways involved in the overactive immune response characteristic of autoimmune diseases, while minimizing systemic immunosuppression.

Conduit Pharmaceuticals has emphasized its strategy of revitalizing underutilized assets from larger pharmaceutical companies and accelerating them through late-stage development. The expanded patent protection ensures a longer runway for exclusivity, which could facilitate future licensing agreements or commercial partnerships.

Industry analysts view the patent approval as a positive development that enhances Conduit’s valuation and strengthens its position in the competitive autoimmune drug market, projected to surpass $150 billion globally by 2030.

The company plans to continue progressing its lead candidate through clinical trials, with additional updates expected later this year regarding regulatory filings and potential Phase 2 study initiations.

For more information, visit www.conduitpharma.com.

Government can invoke section 100 of Patent for Rare Disease Medicine

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In a recent news MP Haris Beeran (Rajya Sabha) wrote to the Minister of Health and Family Welfare on December 20, 2024, urging the Central Government to invoke Section 100 (1) of the Patents Act with respect to local production of the rare disease Spinal Muscular Atrophy (SMA) treating drug Risdiplam. SMA is a genetic disease affecting the nerve cells that control voluntary muscle movement. SMA incidence in India is one in 10,000 live-born babies. Risdiplam is currently under patent protection in India till May 11, 2035 (subject to payment of Patent renewal fees) and is Patented as Indian Patent No. IN 334397.

Key Points:

High Treatment Costs: The annual cost of Risdiplam treatment is approximately ₹1 crore, which is huge and unaffordable for patients.

Government Intervention: Section 100 of the Patents Act empowers the government of India to authorize the local manufacturing of patented drugs in the extreme urgency, potentially reducing costs significantly.

Public Health Impact: SMA affects thousands of children in India annually, and the high cost of treatment has led to calls for government action to ensure access to essential medications.

By invoking Section 100, the government can enable local production of Risdiplam, potentially reducing the annual treatment cost to around ₹3,024, thereby improving access for patients in need. Section 100 empowers the central government to use, or authorise to use, an invention (application or grant) for the purposes of the government, on a non-commercial basis. Importantly, this is not a provision that requires abuse of patent by the patentee. This includes but is not limited to using the invention in case of national emergency or other situations of extreme urgency.

Patent granted for a herbal medicine to manage diabetes

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Dr. Bharti Goyal, a research scholar at the Government College of Education (GCE) in Chandigarh, has received a patent for her innovative herbal formulation aimed at managing diabetes and its related complications. Dr. Goyal developed the formulation in collaboration with Professor Sapna Nanda, utilizing natural traditional herbs as a promising alternative to synthetic diabetic medications, which often have side effects.

The patent, titled “An oral synergistic formulation for the management of diabetes and related complications,” was granted in just two years, setting a record time for such patents. The National Biodiversity Authority (NBA) has recognized and approved the formulation, and the patent is valid for 20 years, starting from December 30, 2022, in accordance with the Patents Act, 1970.

This achievement emphasizes the potential of traditional herbal medicine in modern scientific research. The formulation provides a safer, effective, and sustainable option for managing diabetes, highlighting the importance of integrating traditional knowledge with contemporary scientific advancements.