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.
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“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.
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.
Oral Biopsy Device technology Granted a Patent in USPTO
An automated oral biopsy device which is invented by a professor of Siksha ‘O’ Anusandhan (SOA) Deemed to be University in Bhubaneswar has been granted a Patent by United States patent office.
This device is pen-like shape and user-friendly, it simplifies the biopsy process, eliminating the need for extensive instrumentation and incorporating features like tele-screening and fiber-optic lighting.
This device enhance the accuracy and efficiency of oral disease diagnoses, particularly oral cancer, by enabling early detection and treatment without compromising expert opinion. Professor Mohanty had previously secured two Indian patents for the same product in 2023 and 2024, and a design patent in 2019. She filed for the U.S. patent in 2019, which was granted recently.
The research was funded by the Department of Science and Technology for prototype development, with support from Startup Odisha for need-based assistance. This innovation has garnered recognition, including the Global Outreach Dental Innovation Award in 2021, and was showcased at the Global Bio India 2024 in New Delhi.
This useful invention will help the patients immensely with early diagnosis and treatment of oral diseases without compromising on the expert opinion and reducing the burden of oral diseases, specially oral cancer.
Patent granted for a herbal medicine to manage diabetes
Dr. Bharti Goyal, a research scholar at the Government College of Education (GCE) in Chandigarh, has received a patent for her innovative herbal formulation aimed at managing diabetes and its related complications. Dr. Goyal developed the formulation in collaboration with Professor Sapna Nanda, utilizing natural traditional herbs as a promising alternative to synthetic diabetic medications, which often have side effects.
The patent, titled “An oral synergistic formulation for the management of diabetes and related complications,” was granted in just two years, setting a record time for such patents. The National Biodiversity Authority (NBA) has recognized and approved the formulation, and the patent is valid for 20 years, starting from December 30, 2022, in accordance with the Patents Act, 1970.
This achievement emphasizes the potential of traditional herbal medicine in modern scientific research. The formulation provides a safer, effective, and sustainable option for managing diabetes, highlighting the importance of integrating traditional knowledge with contemporary scientific advancements.