Pharmaceutical giants GSK and Pfizer have reached a settlement to resolve a long-running patent dispute related to respiratory syncytial virus (RSV) vaccines. The legal battle, which revolved around patent infringement claims, has now been brought to a close through an agreement between the two companies.
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
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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.
Madras High Court ruled in favor of Pfizer’s patent rights
In a recent global patent disputes, the Madras High Court has pronounced a ruling concerning the ongoing patent dispute in the United States involving Pfizer’s drug, VYNDAMAX (also known as TAFAMIDIS), which is used to treat a rare heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM).
The case is in focus due to the high stakes involved, as Pfizer holds a patent for VYNDAMAX, which is a formulation of TAFAMIDIS, a drug that stabilizes transthyretin (TTR) protein in the heart, which reduces the life-threatening effects of ATTR-CM. Pfizer’s patent rights on the drug have been contested in several jurisdictions, but this ruling in the Madras High Court is particularly noteworthy, as it reflects the broader international implications of the ongoing patent conflict.
In its order, the Madras High Court emphasized the importance of protecting intellectual property, especially for life-saving drugs like VYNDAMAX in pharma sector. The court ruled that Pfizer’s patent for TAFAMIDIS must be upheld in India, despite challenges from generic manufacturers. This ruling reinforces Pfizer’s exclusive rights over the formulation, production or distribution of VYNDAMAX in the Indian market.
The Madras High Court’s decision is groundbreaking for the global pharmaceutical industry, particularly in the realm of patent enforcement. The ongoing patent dispute in the other countries like United States has sparked heated debates over access to affordable medicines versus protecting the intellectual property rights of pharmaceutical companies. VYNDAMAX is considered a breakthrough in the treatment of a condition that severely impacts the heart, and its exclusivity remains a point of contention in markets where generic alternatives are being sought.
Pfizer has expressed its satisfaction with the ruling, stating that it affirms the company’s commitment to innovation and patient care. The company further emphasized that the decision will help ensure that VYNDAMAX remains available to those who need it while protecting the intellectual property rights of pharmaceutical innovators.
Although, it is expected that this ruling will have limited direct effect on markets outside of India, but it does signify the growing importance of patent protection in the global pharmaceutical landscape. Stakeholders, including patients, healthcare providers, and competitors, are keenly awaiting further developments in this high-profile case.
As the patent battle continues across borders, it remains to be seen how other jurisdictions will respond to similar challenges regarding VYNDAMAX and whether further legal actions will alter the course of the ongoing dispute.
The case is in focus due to the high stakes involved, as Pfizer holds a patent for VYNDAMAX, which is a formulation of TAFAMIDIS, a drug that stabilizes transthyretin (TTR) protein in the heart, which reduces the life-threatening effects of ATTR-CM. Pfizer’s patent rights on the drug have been contested in several jurisdictions, but this ruling in the Madras High Court is particularly noteworthy, as it reflects the broader international implications of the ongoing patent conflict.
In its order, the Madras High Court emphasized the importance of protecting intellectual property, especially for life-saving drugs like VYNDAMAX in pharma sector. The court ruled that Pfizer’s patent for TAFAMIDIS must be upheld in India, despite challenges from generic manufacturers. This ruling reinforces Pfizer’s exclusive rights over the formulation, production or distribution of VYNDAMAX in the Indian market.
The Madras High Court’s decision is groundbreaking for the global pharmaceutical industry, particularly in the realm of patent enforcement. The ongoing patent dispute in the other countries like United States has sparked heated debates over access to affordable medicines versus protecting the intellectual property rights of pharmaceutical companies. VYNDAMAX is considered a breakthrough in the treatment of a condition that severely impacts the heart, and its exclusivity remains a point of contention in markets where generic alternatives are being sought.
Pfizer has expressed its satisfaction with the ruling, stating that it affirms the company’s commitment to innovation and patient care. The company further emphasized that the decision will help ensure that VYNDAMAX remains available to those who need it while protecting the intellectual property rights of pharmaceutical innovators.
Although, it is expected that this ruling will have limited direct effect on markets outside of India, but it does signify the growing importance of patent protection in the global pharmaceutical landscape. Stakeholders, including patients, healthcare providers, and competitors, are keenly awaiting further developments in this high-profile case.
As the patent battle continues across borders, it remains to be seen how other jurisdictions will respond to similar challenges regarding VYNDAMAX and whether further legal actions will alter the course of the ongoing dispute.
“Linezolid” Patent Revoked After Post-Grant Opposition by Symed Labs
The Indian Patent Office has revoked Patent No. 281489 (Application No. 201641013830) following a post-grant opposition filed by Symed Labs. The patent was granted on 20 March, 2017 and the post grant opposition was filed on 5 March, 2018. The patentee had also amended its claims during the opposition proceedings and urged that the application under Form 13 (for amendment of claims) be disposed of so as to be certain of the final set of allowed claims for the hearing. The revocation was based on several grounds:
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.
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.
Government can invoke section 100 of Patent for Rare Disease Medicine
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.
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.
Delhi High Court upheld Controller’s decision under section 10(4)
The Delhi High Court’s decision highlights the importance of fulfilling the detailed disclosure requirements under the Patents Act 1970, particularly in terms of the scope of the claims made in a patent application. The ruling on the patent application by the Regents of the University of California relates to a recombinant Salmonella microorganism-based live vaccine designed to prevent enteric bacterial infections
Key points from the ruling:
Insufficient Disclosure: The court emphasized that the patent application needed for a clear and comprehensive understanding of the invention. This failure resulted in non-compliance with Section 10(4) of the Patents Act, which requires a full description of the invention and the best method of performing it.
Scope of Claims: The Court found that the application broadly claimed the disruption of the gene product in any form, not just through deliberate genetic modifications. This broadness could have led to the inclusion of naturally occurring mutations, which are excluded from patentability under Section 3(c) of the Act. Therefore, the application lacked clarity and precision in defining the scope of what it intended to patent.
Failure to Enable a Skilled Person: The court noted that the patent application did not provide sufficient details for a person skilled in microbiology subject matter to carry out the invention, which is required under Section 10(4)(b) of the Patent Act. The application was seen as incomplete, leaving out important details needed for the invention’s practical implementation.
Incomplete Disclosure: Although the application included examples of deletion mutations in Salmonella, it did not sufficiently cover other forms of mutations, like insertion or substitution. This partial disclosure further contributed to the application’s failure to meet the standards of Section 10(4)(a), which mandates that the invention be fully disclosed.
Impact of the Decision: The Court’s decision focuses the necessity of precise and detailed disclosures in patent applications, particularly when the scope of the invention could potentially cover a wide variety of methods or naturally occurring phenomena. It also highlights the potential issues with vague claims that might lead to patenting something that should not be patentable, such as naturally mutated organisms.
In conclusion, the Delhi High Court upheld the controller’s decision of refusal to grant a patent, reinforcing the importance of clarity and completeness in patent applications for biotechnology-related inventions.
Pharma consultant Agrawal filed patent for new anti-ageing drug
Sanjay Agrawal, a scientific advisor for the US-based Alkomex GBN Pharma Group and an Ahmedabad-based researcher, has filed for a patent for an anti-aging drug formulation aimed at combating aging at the cellular level. The formulation is designed to address the underlying biological processes of aging, potentially offering a groundbreaking approach to age-related issues.
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.
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.