In a significant step forward for next-generation immunotherapy, CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced the allowance of two patent applications by the U.S. Patent and Trademark Office (USPTO). These approvals further strengthen the company’s intellectual property portfolio and advance its mission to revolutionize cancer treatment through engineered T cell technology.
🧬 What the New Patents Cover
The first allowance, Patent Application No. 17/040,472, titled “Cellular Immunotherapy Compositions and Uses Thereof,” provides coverage for both the composition and methods of use for CERo’s lead therapeutic candidate, CER-1236.
This patent secures protection for a combination of phosphatidylserine-targeting CD4+ CER-T cells alongside either CD8+ CAR-T cells or CD8+ recombinant TCR-T cells — a potentially powerful duo in the fight against cancer. The application was allowed on March 13, 2025, and is expected to formally issue as a U.S. patent pending final administrative steps.
The second allowance, Patent Application No. 17/040,317, focuses on the design elements of CER-1236.
Together, these new additions bring CERo’s total IP protection to 17 issued and allowed patents globally, covering 9 patent families and ensuring exclusivity through at least 2039 in the U.S.
🚀 Why This Matters
According to Chris Ehrlich, CEO of CERo Therapeutics:
This announcement comes on the heels of two major developments for CERo — the opening of its first clinical trial site for a Phase 1 trial in Acute Myeloid Leukemia (AML) and the FDA’s clearance of an Investigational New Drug (IND) application to begin human trials targeting ovarian and non-small cell lung cancers.
đź§Ş What Sets CERo Apart
CERo’s platform centers on what it calls Chimeric Engulfment Receptor T cells (CER-T) — a unique blend of adaptive and innate immune functionalities. Unlike traditional CAR-T cells, which rely on antigen recognition and activation, CER-T cells incorporate engulfment pathways that allow them to phagocytose and destroy cancer cells — mimicking a mechanism usually seen in innate immune cells.
This hybrid design could position CER-Ts as a more versatile alternative, with the potential to treat both blood cancers and solid tumors, a key limitation in current CAR-T therapies.
đź§ Looking Ahead
CERo is preparing to initiate clinical trials for CER-1236 in hematologic malignancies in 2025, and with its fortified patent portfolio, the company is well-positioned to push its immunotherapy pipeline forward — both scientifically and commercially.
The additional patent protections will not only support ongoing R&D and commercialization efforts but also provide a competitive moat in an increasingly crowded cell therapy space.
Conclusion:
As CERo advances toward clinical trials, these patent approvals reflect growing validation for its novel T cell engineering approach. With a focus on real innovation and strong IP protection, CERo Therapeutics continues to stake its claim as a leader in the evolving world of cellular immunotherapy.
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Navigating the Complexities of Biotech Patent Law: A Look at REGENXBIO v. Sarepta Therapeutics
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.
Landmark Delhi High Court Ruling Prioritizes Access to Life-Saving Drugs Over Patent Protection
In a powerful judgment that resonates with the ongoing global debate on healthcare access versus intellectual property rights, Justice Mini Pushkarna of the Delhi High Court has delivered a standout ruling that places public health and patient affordability at the heart of India’s patent law jurisprudence.
On March 24, 2025, the Court dismissed a patent infringement suit filed by Swiss pharmaceutical giant Hoffman-La Roche against Hyderabad-based Natco Pharma, in a case involving the prohibitively expensive spinal muscular atrophy (SMA) drug, risdiplam, marketed internationally as Evrysdi.
đź’Š The High Stakes: Life-Saving Medicine or Legal Monopoly?
Spinal muscular atrophy is a rare genetic disorder that progressively weakens muscles used for breathing, walking, and other vital functions. Risdiplam is the only approved oral treatment available in India for SMA, and its cost places it far out of reach for most patients. One bottle reportedly costs ₹6 lakh, with a typical patient requiring 30 bottles a year—a staggering ₹1.8 crore annually.
Natco Pharma has developed a generic version of risdiplam, challenging Roche’s patent rights. Roche, in response, approached the court to halt the sale of Natco’s version, claiming patent infringement and requesting an interim injunction.
⚖️ Justice Pushkarna’s Clear Stand: People First
In a firm and clear ruling, Justice Pushkarna refused the injunction, emphasizing that public health cannot be treated lightly. She wrote:
She also highlighted a critical point in patent law: while pharma companies can be compensated later through damages, there is no mechanism to compensate the public for a lack of access to essential medicine.
This case stands out because the voice of patients was directly heard in court. Two SMA patients intervened to share their lived experiences—stating unequivocally that they could not afford Roche’s drug and had no alternative treatment available.
💸 Big Pharma’s “Patient Assistance” Argument Falls Flat
Roche attempted to soften the blow by pointing to its Patient Assistance Programme (PAP)—an initiative that offers discounted medication to a limited number of patients. But the court saw through the strategy.
Justice Pushkarna called the program “far too limited” and noted that even the proposed reduced prices (revealed in a sealed cover) were insufficient to address widespread affordability. Only a fraction of patients could potentially benefit, leaving many out in the cold.
She also acknowledged budgetary limitations of the National Policy for Rare Diseases (NPRD)—a government scheme that provides up to ₹50 lakh per patient but has only been able to support 1,118 patients, despite India recognizing 63 rare diseases.
🔄 Global Implications & Legal Loopholes
Interestingly, this is not the only battleground for Roche and Natco. In the U.S., Natco is seeking approval to launch its generic risdiplam through an Abbreviated New Drug Application (ANDA), and is currently facing another infringement suit there. Despite being a rare disease drug, Evrysdi clocked $1.8 billion in U.S. sales in 2024, a growth of 18%, thanks to its user-friendly oral format.
Back in India, the patent debate hinges on Roche’s attempt to claim protection under a “species patent”, even though a broader “genus patent” had been filed earlier internationally. Natco argues that Roche is trying to extend its monopoly by segmenting patents, which is not allowed under Indian law if the new invention was already disclosed.
đź§ A Legal Shift in Priorities
The ruling isn’t just about one drug or one company. It signals a broader shift in judicial thinking, where courts are weighing public health more heavily in patent disputes, especially for essential or life-saving medicines.
This isn’t the first time Indian courts have leaned this way. In a 2008 case, Roche sought an injunction against Cipla over its cancer drug erlotinib (Tarceva). The court refused, noting that Cipla’s version was significantly cheaper, and the balance of convenience lay with affordable treatment.
🧬 What This Means for Patients and Policy
This case is likely to become a benchmark in how rare disease drugs are treated in Indian courts, especially when affordability is at stake. It also brings renewed focus on the inadequacy of current government schemes to support patients with ultra-expensive therapies.
For pharmaceutical companies, it’s a wake-up call: patent rights do not guarantee exclusivity if access is denied to the vast majority.
For patients, it is a glimmer of hope—an acknowledgment that their right to live cannot be outweighed by corporate profits.
📝 Final Thoughts
In Justice Pushkarna’s words, “There exists no right for the public to lessen or compensate itself.” This ruling flips the script, putting people before patents, and serves as a reminder that innovation must go hand in hand with access.
India has long been seen as the pharmacy of the developing world, and rulings like this ensure that mantle remains intact.
Could Intellectual Property Retaliation Be the Game-Changer in Trade Wars?
Intellectual property, particularly patents and copyrights, has long been a cornerstone of U.S. economic dominance. In 2024, the United States received nearly $150 billion in royalties and licensing fees alone, which makes up over 5% of total after-tax corporate profits. But these fees represent only the direct payments for IP use; they don’t account for embedded costs in products like software and technology, which are often used globally in consumer goods.
One possible retaliatory strategy involves countries announcing that they will no longer respect U.S. patents and copyrights for as long as Donald Trump continues his tariff policies. This kind of action would target U.S. companies that rely on their intellectual property rights for profit, such as tech giants like Microsoft and pharmaceutical companies like Pfizer and Merck.
The concept of not honoring foreign patents is not without precedent. During World War I, the U.S. invoked the Trading with the Enemy Act to allow the compulsory licensing of patents held by German companies. This measure allowed U.S. businesses to use these patents without permission, as long as they paid a minimal licensing fee set by the U.S. government. Countries like Canada, the EU, and others could implement a similar policy to challenge the United States’ trade practices.
The potential benefits of this type of retaliation are twofold. First, it would allow consumers in the retaliating countries to access cheaper products—such as generic drugs, which could drastically reduce the cost of life-saving medications like those used in cancer and heart disease treatments. Second, it would lower the cost of everyday goods like computers, by bypassing the licensing fees for software from companies like Microsoft.
For consumers, this could mean cheaper access to essential products and technologies, making it a win-win situation. Imagine having access to affordable generics of expensive drugs or the latest software without the added cost of licensing fees. This approach would directly benefit the people in those countries, and it would provide a powerful counterweight to the economic challenges posed by Trump’s tariffs.
Such an approach would also hit U.S. corporations where it hurts—potentially changing the landscape of global trade in ways that tariffs alone may not. If other nations got accustomed to accessing cheap drugs, software, and entertainment content, it could shift global perceptions of U.S. intellectual property practices. This shift could permanently disrupt the revenue models of many major U.S. companies that rely on high licensing fees and patent monopolies. For instance, without the constraints of patent monopolies, Americans themselves could spend far less on prescription drugs—possibly saving around $550 billion annually.
GSK Resolves Patent Lawsuit Against Pfizer Over RSV Vaccines
The lawsuit centered on allegations that Pfizer’s RSV vaccine infringed on patents held by GSK, specifically related to the technology behind the development and production of vaccines targeting the virus. RSV, a major cause of respiratory illness, has long been a focus of vaccine research, especially as both companies have worked to bring their respective RSV vaccines to market.
In a joint statement, both companies confirmed that the settlement would allow them to avoid further litigation and continue their efforts in addressing the global health threat posed by RSV. The terms of the settlement were not disclosed, but both GSK and Pfizer emphasized that the agreement would not affect their ongoing work on RSV vaccines, nor would it impact the availability of these vaccines for public health use.
The resolution of the patent dispute comes at a crucial time as RSV continues to strain healthcare systems worldwide, particularly among vulnerable populations like infants, elderly adults, and individuals with underlying health conditions. Both GSK and Pfizer are major players in the global vaccine market, with their respective RSV vaccines being part of a growing effort to combat the virus.
This settlement marks the end of a significant chapter in the intellectual property conflicts between the two pharmaceutical leaders, allowing both to focus on advancing their respective vaccine candidates in the fight against RSV
Hoth Therapeutics Announces Key Developments in HT-KIT Cancer Fighting Drug Candidate
Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on pioneering therapies for allergic and inflammatory diseases, today revealed two significant advancements in the development of its proprietary antisense oligonucleotide (ASO) cancer-fighting drug candidate, HT-KIT.
The company has filed amended claims with the U.S. Patent and Trademark Office to further strengthen the intellectual property protection for HT-KIT. This ASO technology targets MS4A6A and FcεRIβ—genes that are associated with allergic inflammation and mast cell-related diseases. The updated claims enhance HT-KIT’s intellectual property portfolio, reinforcing its position as a unique therapeutic platform with the potential to treat conditions like anaphylaxis, mastocytosis, and allergic asthma.
In addition, Hoth Therapeutics has initiated a Good Laboratory Practice (GLP)-compliant 4-week intravenous toxicity study with a 14-day recovery period in C57BL/6 mice. Conducted in partnership with OnTargetx R&D Inc. and ITR Laboratories, this preclinical study aims to assess the safety profile of HT-KIT in preparation for future regulatory filings. The study will include multiple dose groups, comprehensive pathology assessments, and pharmacokinetic profiling.
Next Steps in Development
Hoth Therapeutics remains dedicated to advancing HT-KIT toward clinical evaluation. The company is conducting additional preclinical studies to further validate the drug’s efficacy and safety profile, and plans to begin regulatory discussions for first-in-human trials soon.
For more information on Hoth Therapeutics and its innovative pipeline, visit www.hoththerapeutics.com.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company committed to developing groundbreaking treatments aimed at improving patient quality of life. We focus on early-stage pharmaceutical research and development, progressing drugs from the bench to preclinical and clinical testing. By partnering with a team of scientists, clinicians, and key opinion leaders, we aim to discover therapeutics that hold the potential for breakthroughs and offer diverse treatment options. To learn more, visit https://ir.hoththerapeutics.com.
Autonomix Medical, Inc. Awarded U.S. Patent for Advanced Sensing Data Collection and Processing with Proprietary Catheter-Based Technology
Autonomix Medical, Inc., a leader in cutting-edge medical technology, is proud to announce the granting of a new U.S. patent that reinforces the company’s position at the forefront of the healthcare industry. The patent covers the innovative sensing data collection and processing capabilities of the company’s proprietary catheter-based technology, a breakthrough that is set to revolutionize diagnostic procedures.
This newly granted patent enhances the efficiency and accuracy of real-time data capture during medical procedures. The technology provides clinicians with unprecedented insights, improving patient outcomes and streamlining medical interventions. With its ability to capture and process complex sensing data, Autonomix Medical’s catheter-based solution offers significant advantages in precision medicine, diagnostics, and treatment delivery.
The proprietary catheter design integrates advanced sensors that enable dynamic, high-quality data collection with minimal disruption to patients, ensuring a safer, more effective diagnostic experience. This latest patent further solidifies Autonomix Medical’s commitment to innovation and excellence in the medical device field.
“We are thrilled to receive this patent, which underscores the potential of our technology to transform diagnostic practices and enhance the quality of patient care,” said [Name, Title], of Autonomix Medical, Inc. “Our catheter-based solution represents a critical step forward in how medical professionals access and interpret patient data during procedures, ultimately improving treatment strategies and clinical outcomes.”
This patent grant marks another milestone in Autonomix Medical’s ongoing efforts to drive advancements in medical technologies, and it opens the door for future applications of the technology across various healthcare sectors. With its strong intellectual property portfolio, Autonomix Medical is poised to continue leading the way in the development of next-generation medical devices.
About Autonomix Medical, Inc.
Autonomix Medical, Inc. is a pioneering company focused on developing innovative catheter-based medical devices and technologies designed to enhance diagnostic and therapeutic procedures. With a commitment to improving patient outcomes, Autonomix Medical continues to lead in the advancement of precision medicine and healthcare solutions.
“Linezolid” Patent Revoked After Post-Grant Opposition by Symed Labs
Lack of Inventive Step (Obviousness): The controller concluded that the patent was found to lack an inventive step, meaning the claimed invention was obvious to someone skilled in the field.
Non-Patentability Under Section 3(d): The invention also did not meet the criteria for patentability under Section 3(d) of the Patents Act, which states that new forms of known substances that do not result in enhanced efficacy.
Failure to Disclose Information Under Section 8: The patent holder failed to disclose required information as per Section 8 of the Patents Act 1970, which mandates the disclosure of including the disclosure of status of those applications, at the time of filing and during the prosecution of the patent. regarding corresponding foreign applications of this invention.
This patent pertained to Linezolid, an antibiotic used to treat pneumonia, skin infections, and drug-resistant tuberculosis. The earlier patent for Linezolid had expired on January 1, 2012. The revocation of this patent may have implications for the availability and pricing of Linezolid in India. This decision has highlighted the need for quality standards and more careful examination when it is about critical drugs, particularly in light of public health considerations and the potential for monopolistic practices.
Pharma consultant Agrawal filed patent for new anti-ageing drug
The patent application has been submitted to the Indian Patent Office, marking an important step in the development of this novel treatment. If granted, this patent would secure intellectual property rights for the formulation, allowing Agrawal and the associated pharmaceutical group to potentially commercialize the drug and offer it as a solution to slow or reverse cellular aging.
Agrawal, already holds over 42 patents for unique drug formulations. He claims that other than addressing ageing at a cellular level, this drug has the potential to significantly improve skin health and boost energy levels and enhance overall vitality.
He explained that while chronological ageing is inevitable, biological and psychological ageing differ significantly from one individual to another, influenced by intrinsic and extrinsic factors such as hormonal changes, stress, and lifestyle.
Currently the demand for anti-aging treatments is increasing rapidly in market. This development could spark significant interest in the pharmaceutical industry. However, the drug will undergo extensive testing and regulatory approval to be fully realized in the market, which could take several years.
Innocan Pharma secure first patent in India for Liposome Injection
Innocan Pharma Corporation has granted its first patent in India for its Liposomal CBD Injection platform. This patent protects the company’s synthetic Cannabidiol-loaded Liposome Injection Platform (LPT-CBD), designed for precise dosing and sustained release of synthetic CBD into the bloodstream.
The LPT-CBD platform has received positive feedback from the U.S. Food and Drug Administration (FDA) following a successful pre-Investigational New Drug (pre-IND) meeting, advancing its development as a non-opioid alternative for chronic pain management.
Developed in collaboration with Professor Chezy Barenholz and Dr. Ahuva Cern from the Hebrew University in Jerusalem, the liposomal drug delivery platform allows for prolonged exposure and maximizes the bioavailability and therapeutic effects of cannabinoids.
This granted patent enhances Innocan’s proprietary value in India’s $55 billion pharmaceutical market, complementing its global patent applications and strengthening its position in the cannabinoid-based therapeutic sector.
Innocan Pharma’s CEO, Iris Bincovich, expressed his views about the patent grant and highlighted the company’s commitment to innovation and the advancement of non-opioid alternatives for chronic pain management.
This development in IP underscores Innocan Pharma’s dedication to expanding its intellectual property portfolio and advancing cannabinoid-based therapies on a global scale.