pharma

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.

Donald Trump Urged to Target ‘Lazy Patent Expansion’ in U.S. Drug Bill Push

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In a significant development in the ongoing debate over U.S. drug pricing, Richard Saynor, CEO of Sandoz, a leading generic pharmaceutical company, has called on former President Donald Trump to address the issue of “lazy patent expansion” in his efforts to reduce prescription drug costs. Saynor’s remarks come as Trump seeks to implement a “most favored nation” policy, aiming to align U.S. drug prices of other nations. While supporting this initiative, Saynor emphasized the need for reform in the generics market to ensure sustainable access to affordable medications.

The Problem: Patent Thickets and Evergreening
Saynor criticized the practice of “evergreening,” where brand-name drug manufacturers file numerous patents on slight modifications of existing drugs to extend their market exclusivity. This strategy, often referred to as creating “patent thickets,” has been used to delay the entry of generic competitors, thereby maintaining high drug prices. For instance, blockbuster drugs like AbbVie’s Humira have been subject to extensive patent filings, with over 140 patents filed per top-selling drug, causing prices to remain high and limiting competition.

Impact on Generic Drug Market
Generic drugs account for approximately 90% of prescriptions in the U.S. and are significantly more affordable than their branded counterparts. However, the proliferation of patent thickets has led to shortages and limited availability of generics. Saynor highlighted that the rebate system, which involves pharmacy benefit managers, further inflates drug costs, making it more challenging for generics to compete.

Proposed Solutions
To address these issues, Saynor advocated for reinstating a six-month exclusivity period for first-to-market generics, a policy that could incentivize the development and availability of affordable alternatives. Additionally, he cautioned against proposed pharmaceutical tariffs, which could disproportionately impact generics due to their low margins and reliance on overseas production.

Legislative Efforts and Challenges
Bipartisan efforts to reform the patent system have been introduced in Congress, targeting practices like patent thickets, product hopping, and pay-for-delay agreements. Despite strong support, these bills have faced obstacles in becoming law, often due to legislative gridlock and opposition from industry stakeholders.

Global Implications
Trump’s “most favored nation” policy, which seeks to align U.S. drug prices with those paid by other countries, has raised concerns internationally. In the UK, for example, where branded drugs cost significantly less than in the U.S., pharmaceutical firms may respond by raising prices elsewhere or withholding drugs from certain markets. This could strain healthcare systems globally and potentially discourage pharmaceutical innovation.

Conclusion
As the U.S. continues to grapple with high drug prices, addressing the issue of “lazy patent expansion” is crucial for fostering a competitive and affordable pharmaceutical market. While Trump’s policy initiatives aim to reduce costs, comprehensive reform of the patent system is necessary to ensure long-term access to essential medications for all Americans.

Biofrontera Inc. Secures Extended Patent Protection for Ameluz® and Completes Patient Enrollment in Phase 2b Acne Study

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Biofrontera Inc. (NASDAQ: BFRI), a biopharmaceutical company specializing in dermatological treatments, has announced two significant milestones: the extension of U.S. patent protection for its flagship product, Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, and the completion of patient enrollment in its Phase 2b clinical trial evaluating Ameluz® for the treatment of moderate to severe acne vulgaris.

Extended Patent Protection for Ameluz®

The U.S. Patent and Trademark Office (USPTO) has granted Biofrontera a new patent related to a photodynamic therapy (PDT) protocol that is expected to be less painful while maintaining efficacy. This patent extends the protection of Ameluz®-PDT through October 2040. Further patents are pending, which may extend protection until 2043 or beyond. 

This extension fortifies Biofrontera’s intellectual property portfolio, ensuring prolonged market exclusivity for Ameluz® and its associated PDT protocols. The company anticipates that this will bolster its competitive position in the dermatological therapeutics market.

Completion of Phase 2b Acne Study Enrollment

In parallel, Biofrontera has successfully completed patient enrollment in its Phase 2b clinical trial assessing the efficacy and safety of Ameluz® for treating moderate to severe acne vulgaris.  This randomized, double-blind study aims to explore the potential of Ameluz® as a novel PDT option for acne, a condition affecting millions worldwide.

The trial’s completion of enrollment marks a significant step toward expanding the indications for Ameluz®.  Pending positive outcomes, Biofrontera plans to advance to Phase 3 trials, with the goal of submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026. 

Strategic Outlook

These developments underscore Biofrontera’s commitment to innovation in dermatological therapies.  By securing extended patent protection and advancing clinical research, the company aims to enhance its product offerings and address unmet needs in skin health.

With the extended patent life of Ameluz® and the progression of its acne treatment program, Biofrontera is poised to strengthen its market presence and deliver value to both patients and shareholders in the coming years.

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.

Delhi High Court Clarifies Patent Law Standards in Landmark Ruling on Section 3(d) of the Indian Patents Act, 1970

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In a landmark judgment, the Delhi High Court has provided critical clarity on the interpretation and application of Section 3(d) of the Indian Patents Act, 1970, particularly in cases concerning pharmaceutical innovations. The decision, rendered in the matter of Ischemix LLC v. The Controller of Patents, emphasizes the standards of patentability and the admissibility of post-filing data in applications involving new forms of known substances.

Section 3(d): A Barrier to Evergreening
Section 3(d) of the Indian Patents Act is a unique provision designed to prevent the “evergreening” of patents—where pharmaceutical companies attempt to extend patent monopolies by making minor modifications to known substances. The provision stipulates that a new form of a known substance is patentable only if it results in a significant enhancement of efficacy. In the context of pharmaceutical inventions, the Supreme Court, in its 2013 ruling in Novartis AG v. Union of India, interpreted “efficacy” to mean “therapeutic efficacy.”

The Ischemix LLC Case: Background
Ischemix LLC filed an appeal against the rejection of its patent application (No. 9739/DELNP/2011) by the Indian Patent Office on the grounds of Section 3(d). The applicant argued that they had submitted robust data—spanning in-vitro, in-vivo, and clinical trial results—along with expert opinions to demonstrate the enhanced therapeutic efficacy of the compound.

The Patent Office, however, rejected the application, noting that while comparative data had been submitted after the oral hearing, the data was not clearly explained or sufficiently correlated to therapeutic enhancement as claimed in the specification.

High Court’s Ruling: Key Takeaways
1. Therapeutic Efficacy as the Benchmark
The Delhi High Court reaffirmed the principle established in Novartis AG v. Union of India—that efficacy in the context of pharmaceutical patents must be understood as therapeutic efficacy. Mere improvements in physicochemical properties like stability or solubility are insufficient unless they translate to demonstrable therapeutic benefits.

2. Comparative Data: A Necessary Requirement
Drawing from its earlier ruling in DS Biopharma Limited v. Controller of Patents, the Court stressed that applicants must furnish comparative efficacy data to demonstrate enhancement over known substances. Importantly, this data should be provided in the form of structured comparative tables and supported by appropriate scientific evidence.

3. Admissibility of Post-Filing Data
The Court recognized the inherent delay in generating empirical efficacy data, especially in the pharmaceutical sector where clinical trials are time-intensive. It ruled that while some indication of efficacy should be included at the time of filing, post-filing data may be considered if it corroborates the technical effects disclosed in the original specification. This position is consistent with the Calcutta High Court’s judgment in Oyster Point Pharma Inc. v. Controller of Patents, which acknowledged the prolonged timeline for drug development.

4. Timing and Explanation of Additional Data
The Court made it clear that post-filing data must be submitted well before the final hearing at the Patent Office and should be clearly explained. Submitting complex efficacy data during written submissions post-hearing without oral explanation could render it ineffective, as the Controller may struggle to appreciate the technical details.

5. Requirement for Correlation with Specification
Referring to AstraZeneca AB v. Intas Pharmaceuticals Ltd., the Court ruled that post-filing data should only confirm technical effects already hinted at or described in the specification. It cannot be used to introduce an entirely new technical effect.

Court’s Direction in Ischemix Case
Recognizing the importance of the data but noting the lack of explanation linking the data to therapeutic efficacy, the Court directed Ischemix LLC to submit an explanatory note correlating the submitted evidence to enhanced efficacy. Upon the Patent Office’s consent, the Court remanded the application for re-examination, thereby allowing a fair opportunity for reconsideration.

Broader Implications for Patent Law
This judgment offers significant guidance to pharmaceutical companies and patent practitioners navigating Section 3(d). It strikes a delicate balance between encouraging genuine innovation and preventing the misuse of the patent system to monopolize marginal improvements. The judgment also reinforces procedural discipline, requiring that critical data be timely, complete, and clearly presented.

Conclusion
The Delhi High Court’s decision in Ischemix LLC v. The Controller of Patents builds upon the jurisprudence laid down in Novartis and contributes to a growing body of case law interpreting Section 3(d). As patent litigation continues to evolve in India’s dynamic pharmaceutical sector, such decisions will serve as important references for determining the scope of patentable subject matter and the treatment of post-filing evidence.

Legal experts expect that the continued engagement of the judiciary with Section 3(d) will bring greater predictability and transparency to India’s patent system, particularly for drug-related inventions.

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.

Navigating the Genomics Revolution: The Evolving Role of Intellectual Property Protection

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More than two decades after the landmark announcement of the Human Genome Project’s completion in 2003, the field of genomics is undergoing a profound transformation. What began as a focus on decoding linear DNA sequences has expanded into a multidisciplinary understanding of the genome’s structural and functional complexity. This includes insights into protein folding, post-translational modifications like glycosylation, and the critical functions of non-coding DNA segments once dismissed as “junk,” such as introns.

In healthcare, personalized medicine, pharmacogenomics, and CRISPR-Cas9 gene editing are transitioning from research to real-world application. Genomic research is also driving the development of disease-resistant crops in agriculture and, in the biotech industry, is converging with artificial intelligence (AI) to accelerate innovations like next-generation sequencing and data interpretation.

This rapid evolution brings renewed focus on how intellectual property (IP) laws can safeguard innovation while keeping pace with scientific complexity. A strategic approach to IP is essential to protect genomics-related breakthroughs across multiple domains.

Patents: The Traditional Tool — and Its Limitations
Utility patents remain a cornerstone of IP strategy in genomics. In the competitive life sciences market, such exclusivity can determine commercial viability. However, the scope of what is patentable, especially in the U.S., is becoming increasingly restrictive.

Key genomic discoveries — like isolated human genes — when naturally occurring, are not patentable under U.S. law. Similarly, diagnostic methods that link biomarkers with disease states often fall outside the scope of patent-eligible subject matter. AI-driven components, such as algorithms used to interpret genomic data, also face hurdles, as abstract ideas and software in isolation typically don’t qualify for patent protection.

Disclosure Challenges in Patent Law
Patents require inventors to fully disclose their invention. This becomes problematic when critical elements of an innovation — like proprietary algorithms or data models — aren’t patentable but are vital to the invention’s function. In such cases, companies may be reluctant to disclose sensitive information that could be exploited by competitors, forcing them to weigh the benefits of limited patent protection against the risk of exposing valuable trade secrets.

Trade Secrets: A Flexible but Fragile Option
When patenting isn’t viable or would reveal too much, trade secrets offer an alternative. This form of protection doesn’t require disclosure and isn’t limited by subject matter rules or duration, as long as the information remains confidential. Genomics-based innovations — such as algorithm development, data modeling, and experimental optimization — are well-suited to trade secret strategies.

However, trade secrets are vulnerable. A single leak — from an employee, partner, or regulatory disclosure — can irreversibly compromise protection. Therefore, robust internal controls, clear access policies, and legal safeguards are essential to maintain secrecy.

Copyright: Protecting the Expression of Genomic Insights
While traditionally associated with creative works, copyright law has found new relevance in the digital era. It now extends to software, source code, and potentially, some aspects of genomics-related data and algorithms. Unlike patents, copyright protects the expression of an idea, not the idea itself — which means competitors can replicate the core concept using different language or methods, provided they don’t copy the exact expression.

For genomics, copyright might apply to algorithmic code, databases, or visualization tools used in analyzing genetic data. However, it is a limited tool that works best in conjunction with other forms of IP protection.

Toward an Integrated IP Strategy for Genomics
As genomics continues to push scientific boundaries, no single form of IP protection is sufficient. A multi-layered approach is often required — combining patents for core inventions, trade secrets for proprietary methods or data, and copyright for software or data presentation.

Careful coordination is essential. Over-disclosure in a patent could undermine trade secret protection, while an overly secretive approach might prevent the grant of a meaningful patent. Developing a clear, strategic IP roadmap that aligns with scientific goals and commercial interests is critical for ensuring innovations are protected without sacrificing competitive advantage.

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.