Biotech

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).

Navigating the Complexities of Biotech Patent Law: A Look at REGENXBIO v. Sarepta Therapeutics

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The rapidly evolving field of biotech patent law continues to present significant challenges, particularly when it comes to innovations involving recombinant nucleic acids and biological sequences. A recent ruling in REGENXBIO v. Sarepta Therapeutics by the US District Court for the District of Delaware has brought to light critical issues regarding patent eligibility for biotechnological inventions. Judge Richard Andrews ruled that the mere act of combining natural AAV (adeno-associated virus) sequences with heterologous (non-AAV) sequences in a cultured host cell—without further modifications—does not satisfy the requirements for patent eligibility under 35 U.S.C. § 101.

This decision has stirred discussions within the biotech community, as it reflects an ongoing trend of courts scrutinizing the extent of modifications required to make genetic and biological innovations eligible for patent protection. The ruling suggests that simply combining existing natural biological sequences may not meet the necessary standards for patent eligibility unless the innovation includes further modifications that can be considered novel or non-obvious.

What Does the Court’s Ruling Mean for the Biotech Industry?
The REGENXBIO v. Sarepta Therapeutics case builds on the precedent set by Funk Brothers Seed Co. v. Kalo Inoculant Co., where the U.S. Supreme Court ruled that naturally occurring substances could not be patented unless they had been modified in a way that created new and non-obvious properties. In this case, the court applied the same logic, finding that simply combining natural sequences from AAV with other biological materials does not meet the standards of patentability under 35 U.S.C. § 101, which requires inventions to be novel, non-obvious, and useful.

This decision has significant implications for gene therapy innovations and other biotech patent strategies. It raises important questions about the scope of patent protection available for new biotechnologies, especially in cases where the innovation involves natural biological elements. For biotech companies and researchers, this ruling emphasizes the importance of demonstrating how their innovations go beyond simple combinations of natural materials and truly push the boundaries of scientific knowledge and utility.

Join the Discussion: Biotech Patent Eligibility and Innovation
To further explore the impact of this ruling and the broader challenges within the realm of biotech patent law, a key discussion will be held on Tuesday, April 15. WilmerHale Partner Omar Khan will be joined by Christen DiPetrillo, Head of Intellectual Property, and Kevin Marks, Chief Legal Officer at the Parker Institute for Cancer Immunotherapy, at Biocom California’s joint meeting of the IP and Cellular Gene Therapy Committees.

During this session, the panel will explore:

The historical context of biotech patent eligibility.


The implications of the ruling for gene therapy innovations and biotech patent strategies moving forward.

This discussion will offer valuable insights into the complexities of patenting biotechnological innovations and the legal hurdles that companies face when seeking patent protection for cutting-edge research in genetic therapies and biologics.

Conclusion
As the biotech industry continues to push the boundaries of science, navigating the complexities of patent law becomes increasingly critical. The REGENXBIO v. Sarepta Therapeutics decision highlights the challenges companies face when attempting to secure patent protection for genetic and biological innovations. As more companies and researchers grapple with patent eligibility, understanding the intricacies of patent law and its evolving landscape will be essential to fostering continued innovation and growth in the biotech sector.

For those looking to stay at the forefront of these developments, attending the upcoming discussion on biotech patent eligibility is an excellent opportunity to deepen your understanding of the legal challenges and strategies shaping the future of gene therapy and biotechnology.