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.
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.
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.