India has reaffirmed its commitment to affordable medicines and public health safeguards in its latest Free Trade Agreement (FTA), signed on **July 24**. The government announced that the deal does **not include provisions** for **patent term extensions** or **data exclusivity**, commonly sought by multinational pharmaceutical companies to extend their market monopolies.
The **Ministry of Commerce and Industry** clarified that critical sections of the **Indian Patents Act, 1970** — notably **Section 3(d)** and **Section 3(b)** — will remain fully protected under the FTA. These provisions are key to India’s rejection of “**evergreening**” practices, which involve patenting minor modifications of existing drugs to delay generic competition.
> 🔗 [Section 3(d) – Indian Patents Act](https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Patent_Amendment_Act_2005.pdf)
**Section 3(d)** allows patents only for new drug forms that demonstrate **enhanced efficacy**, while **Section 3(b)** restricts patents for inventions that are **contrary to public interest** or lack significant therapeutic benefit.
> “India’s patent regime remains intact. There is no obligation under the new agreement to extend patent terms or introduce data exclusivity for pharmaceuticals or agrochemicals,” the ministry said in an official release.
The government emphasized that the FTA **does not include**:
* **Patent term extensions** to compensate for regulatory delays.
* **Data exclusivity** that would prevent Indian regulators from using innovator data to approve generics.
* **Patent linkage**, which ties drug approval to patent status.
* **Automatic injunctions** that delay generic entry during litigation.
> 🔗 [Understanding Data Exclusivity – WHO](https://www.who.int/news-room/questions-and-answers/item/intellectual-property-data-exclusivity)
These exclusions are a win for India’s **USD 25 billion generic drug industry**, which supplies nearly **50% of its pharmaceutical output** to global markets, including **life-saving drugs for HIV/AIDS, tuberculosis, and cancer** in low- and middle-income countries.
> 🔗 [India’s Generic Pharmaceutical Sector – Brookings](https://www.brookings.edu/articles/the-indian-pharmaceutical-industry/)
The deal follows similar resistance by India during talks with the **European Free Trade Association (EFTA)** — comprised of **Switzerland, Norway, Iceland, and Liechtenstein** — where India successfully opposed attempts to insert stricter IP protections in their FTA finalized in **March 2023**.
> 🔗 [EFTA–India FTA Overview](https://www.efta.int/free-trade/Free-Trade-Agreement/India)
Pressure to include such IP provisions often comes from countries with large pharmaceutical industries, including the **UK** and **Switzerland**, home to global players like **AstraZeneca**, **GlaxoSmithKline (GSK)**, **Novartis**, and **Roche**.
However, India’s stance remains consistent with its obligations under the **World Trade Organization’s (WTO) TRIPS Agreement**, which does not require countries to implement **data exclusivity** or **patent extensions**. Experts argue that such measures are “**TRIPS-plus**” provisions that go beyond international norms.
> 🔗 [WTO TRIPS Agreement](https://www.wto.org/english/tratop_e/trips_e/trips_e.htm)
India also draws strength from the **Doha Declaration on TRIPS and Public Health (2001)**, which affirms the right of WTO members to protect public health and promote access to medicines.
> 🔗 [Doha Declaration – WTO](https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm)
“This agreement reinforces India’s role as the ‘pharmacy of the developing world’ by ensuring that domestic laws prioritize **access to affordable medicines** over extended monopolies,” said a Delhi-based trade policy expert.
The FTA will undergo legislative procedures before coming into effect, expected within the next year. For now, the government’s firm stance is seen as a strategic move to protect its pharmaceutical export economy and uphold public health imperatives.
drug
India Reiterates Ban on Patent Evergreening: Piyush Goyal Emphasizes Public Health Over Pharma Profits
Union Commerce and Industry Minister Piyush Goyal has reiterated that India will not allow evergreening of pharmaceutical patents. Speaking at a recent trade event, Goyal highlighted India’s commitment to affordable healthcare and equitable access to medicines. He firmly stated that evergreening contradicts Indian law and undermines public health.
🔍 What Is Evergreening?
Evergreening is a strategy where pharmaceutical firms seek new patents for minor changes to existing drugs. These changes often include alterations in formulation, dosage, or delivery methods. The intent is to extend monopoly rights and delay generic drug entry.
India’s Patents Act, 1970, under Section 3(d), prohibits such practices unless the new version offers significantly enhanced therapeutic efficacy.
👉 Read Section 3(d) of the Indian Patents Act
👉 What is Evergreening – WHO Definition
🗨️ Goyal’s Firm Stand Against Evergreening
Piyush Goyal emphasized that India has faced repeated pressure from multinational pharmaceutical companies to weaken its IP laws. He stated:
“India does not permit evergreening. We protect genuine patents. But we will not let companies misuse the system to maintain monopolies.”
He challenged critics to show a single instance where India violated intellectual property rights. According to Goyal, none have been able to do so.
⚖️ The Legal Foundation: Section 3(d)
India’s Section 3(d) is a globally recognized provision. It has prevented the misuse of the patent system and has been upheld by the Supreme Court of India in the Novartis vs. Union of India case.
In 2013, India’s top court rejected Novartis’ patent for a modified version of the cancer drug Glivec, ruling it lacked increased efficacy.
👉 Learn more about the Novartis Case
This ruling became a milestone in India’s public health jurisprudence and strengthened the nation’s stance on patent quality over quantity.
🌍 Public Health Over Profits
Goyal underlined that India’s patent system aims to balance innovation with access. He noted:
“Our goal is to make life-saving medicines available at affordable rates—not to support super-profits for a few companies.”
India’s approach supports global healthcare. The country is known as the “Pharmacy of the Global South”, supplying low-cost generics to over 200 nations.
The government also runs Ayushman Bharat, one of the world’s largest public health programs, covering more than 620 million people.
👉 Visit Ayushman Bharat official website
🌐 Global Support and Recognition
India’s position has gained support from global health advocates. Organizations like Médecins Sans Frontières (MSF) have praised Section 3(d) for preventing abusive patent extensions.
International forums including the World Trade Organization (WTO) have acknowledged India’s right to use TRIPS flexibilities to protect public health.
🧾 Summary Table: India’s Policy on Patent Evergreening
| Issue | India’s Position |
|---|---|
| Evergreening | Strictly prohibited under Section 3(d) |
| Valid Patents | Fully respected during legal term |
| TRIPS Compliance | Yes, with use of flexibilities |
| Pressure to Amend IP Laws | Resisted to safeguard public health |
| Generic Medicine Promotion | Encouraged for affordable drug access |
🔑 Key Takeaways
- India will not compromise its patent law to favor big pharma.
- Section 3(d) remains the cornerstone of India’s patent policy.
- The government remains committed to TRIPS-compliant innovation and global medicine accessibility.
Big Pharma Faces $180 Billion ‘Patent Cliff’ Threat by 2028
Global pharmaceutical giants are preparing for a major challenge as patents on many best-selling drugs near expiration. Analysts warn of a looming “patent cliff” set to hit the industry between 2027 and 2028. This wave of expirations could erase $180 billion in annual revenues, or about 12% of global pharma sales.
What is a Patent Cliff?
A patent cliff refers to a sharp revenue drop that occurs when patents on high-earning drugs expire. Once exclusivity ends, generic and biosimilar competitors can enter the market, driving prices down rapidly.
One of the biggest drugs facing expiry is Keytruda, a cancer therapy by Merck. The drug earned nearly $30 billion in 2024, making it the world’s top-selling drug. Keytruda’s patent is set to expire in 2028, opening the floodgates to biosimilars.
Pharma’s Strategic Shift
To offset future losses, Big Pharma is shifting away from mega-mergers and embracing targeted acquisitions.
For instance, Merck recently acquired Verona Pharma for $10 billion. Verona’s lead drug, Ohtuvayre, treats chronic obstructive pulmonary disease (COPD) and recently received FDA approval. Analysts project this therapy could generate $4 billion in annual sales by the mid-2030s.
Read more: Merck’s Verona Pharma deal – FT
More than Just Mergers
Beyond acquisitions, companies are also using patent-extension tactics. This includes reformulating drugs or introducing new delivery systems to create fresh patents — a controversial method often called “patent thicketing.”
Some firms are also accelerating R&D, especially in oncology, immunotherapy, and gene editing. Despite the uncertainty, the industry sits on $1.3 trillion in deal-making capital.
Risks on the Horizon
The path ahead is not without risk.
- Regulatory uncertainty in the U.S. and Europe could impact drug pricing and market access.
- Investor sentiment is also shifting. Shareholders now favor innovation-led growth over cost-cutting from large-scale mergers.
- Biosimilar competition is rising slowly but surely, particularly for complex biologics like Humira and Keytruda.
The Road Ahead
Industry leaders must act fast. Without fresh blockbusters, companies could lose tens of billions in yearly revenue.
Pharma is in a race — not only to find the next big drug — but also to navigate a complex legal and regulatory environment. The next 12 to 18 months could determine which companies stay ahead and which fall behind.
Disclaimer:
This article is based on publicly available information sourced from the Financial Times. For the full original article, visit FT.com.
ICMR Sets Ambitious Goal to File 10,000 Patents to Boost MedTech Innovation
In a bold move to advance India’s healthcare innovation, the Indian Council of Medical Research (ICMR) has launched two new initiatives—Patent Mitra and MedTech Mitra. These programs aim to simplify patent filing and promote indigenous medical technologies.
ICMR plans to file 10,000 patents in three years, a tenfold increase from the current average. To achieve this, it has hired 10 top legal firms to guide researchers in patent assessments, filings, and long-term IP support.
Patent Mitra offers services for end-to-end patent handling—from initial evaluation to prosecution and five-year maintenance. MedTech Mitra will assist innovators with clinical validation, regulatory approvals, and connecting with industry for tech transfer.
ICMR will act as a facilitator between researchers and the MedTech industry, ensuring practical use of patented technologies. This approach is expected to reduce India’s reliance on imported devices and foster cost-effective healthcare solutions.
Additionally, ICMR is setting up regional Health Technology Assessment (HTA) units. These will analyze the cost-effectiveness of new health products, helping shape state and national healthcare policies.
ICMR’s Director General, Dr. Rajiv Bahl, emphasized the vision to turn intellectual property into market-ready solutions. The move supports the broader goal of making India a global leader in affordable MedTech innovation.
Japan Grants Patent for Non-Invasive Endometriosis Test
Proteomics International Laboratories Ltd (ASX: PIQ), a global leader in predictive diagnostics, has announced that it has been granted its first patent in Japan for Pro marker Endo—a world-first, non-invasive blood test developed to diagnose endometriosis. This strategic patent grant represents a major milestone in the company’s global intellectual property (IP) rollout and sets the stage for accelerated commercialization across key markets.
Groundbreaking Diagnostic Solution
Endometriosis is a chronic inflammatory condition affecting roughly 1 in 9 women of reproductive age, characterized by the growth of tissue similar to the uterine lining outside the uterus. It causes severe pelvic pain, infertility, and impacts mental and physical well-being. Current diagnostic methods—mainly laparoscopic surgery—are invasive, expensive, and result in diagnostic delays of 7 to 10 years on average.
PromarkerEndo offers a revolutionary alternative. Using a simple blood sample, the test applies a biomarker-based algorithm to detect the presence of endometriosis and deliver results in the form of a “traffic light” system:
Green: Low likelihood of endometriosis
Amber: Moderate likelihood
Red: High likelihood
This intuitive format provides clinicians with actionable insights, greatly improving early-stage detection and treatment planning.
Strong Clinical Results
The PromarkerEndo test has demonstrated outstanding clinical performance in both research and real-world settings. Results from a landmark clinical study involving 704 participants—recently presented at the 16th World Congress on Endometriosis (May 2025)—highlighted the test’s exceptional diagnostic accuracy. The area under the curve (AUC), a measure of diagnostic performance, ranged from 0.89 to 0.94, particularly excelling in early-stage (I-II) detection.
These outcomes surpass many traditional diagnostic approaches and emphasize the test’s utility as a first-line screening tool in both primary and specialist care.
Strategic Importance of the Japanese Patent
The patent granted by the Japan Patent Office significantly enhances Proteomics International’s global IP portfolio. Japan, with a population of over 125 million and an advanced healthcare system, represents a high-value market for women’s health diagnostics. The new patent strengthens the company’s freedom to operate in Asia and supports upcoming commercial launches.
Proteomics International now holds patents or patent applications for PromarkerEndo in Australia, China, Europe, and the United States, with the Japanese grant adding further momentum to its global rollout.
Managing Director Dr. Richard Lipscombe commented:
“The Japanese patent is a critical milestone in protecting our proprietary technology in one of the world’s most sophisticated healthcare markets. It reinforces the strength of our innovation and supports our mission to bring non-invasive, accessible diagnostics to women suffering from endometriosis worldwide.”
Path to Commercialization
Proteomics International is actively working towards the initial commercial launch of PromarkerEndo in Australia by Q3 2025, with other markets such as Japan, the EU, and the U.S. expected to follow. The company is in discussions with diagnostic partners and health providers to integrate PromarkerEndo into standard clinical pathways.
The potential market for the test is vast. With endometriosis affecting over 190 million women globally, and with growing public and clinical awareness, demand for improved diagnostics is surging.
Broader Implications
Beyond offering a non-invasive alternative to laparoscopy, PromarkerEndo has the potential to reshape how healthcare systems approach chronic women’s health conditions. By enabling earlier diagnosis:
Patient outcomes can improve dramatically
Healthcare costs associated with delayed diagnosis and invasive procedures may be reduced
Physicians gain a powerful tool for faster triage and referral
Additionally, this development aligns with global policy shifts focused on addressing historical gaps in women’s health research and diagnostics.
Conclusion
The Japanese patent marks a crucial step forward for Proteomics International and its pioneering PromarkerEndo test. With clinical validation, global IP protection, and a clear path to market, the company is well-positioned to transform endometriosis diagnosis—bringing hope to millions of women who have long faced delays, misdiagnosis, and inadequate care
🔖 Disclaimer:
This article is based on publicly available information provided by Proteomics International Laboratories and related sources.
How Indian Drugmakers Can Capitalize on Patent Expiry
India’s pharmaceutical industry is preparing to tap into a massive global opportunity. A patent cliff worth $63.7 billion is set to hit the U.S. drug market. Experts say Indian drugmakers are well-positioned to benefit.
What Is a Patent Cliff?
A patent cliff occurs when major drugs lose their patent protection. This allows other companies to produce generic versions. In the U.S., several blockbuster drugs are nearing the end of their exclusivity.
From 2025 to 2030, drugs worth $236 billion globally will lose patent rights. Of this, the U.S. accounts for $63.7 billion. This opens the door for generic manufacturers, especially from India.
Why Indian Pharma Has an Edge
India is a global leader in generic drug manufacturing. It supplies around 30% of generic medicines to the U.S. market.
Indian companies like Sun Pharma, Biocon, Cipla, and Lupin have FDA-approved facilities. These firms are investing in research and biosimilars to seize the moment.
They offer affordable alternatives at scale. This makes them attractive in both the U.S. and other global markets.
Analysts See Huge Potential
Analysts expect Indian firms to earn $8–10 billion annually from this patent cliff. With the right strategy, this number could grow even more.
India’s cost advantage, skilled workforce, and regulatory knowledge make it a key player in this shift.
Key Strategies for Indian Companies
Fast-track development of generics and biosimilars
File early for U.S. FDA approvals
Challenge patents through Paragraph IV filings
Form partnerships with global drug firms
Expand production to meet new demand
These steps will help Indian pharma capitalize on the coming wave of drug expiries.
Risks to Watch
While the opportunity is big, there are challenges too. These include:
Price competition
Regulatory delays
Market saturation
High development costs for biosimilars
Still, the overall outlook is positive. Indian pharma is expected to play a leading role.
Conclusion
The $63.7 billion U.S. patent cliff is a game-changer. It creates a golden chance for India’s generic and biosimilar companies. If executed well, Indian pharma could dominate the global generics space in the next five years.
📌 Disclaimer
This article is for informational purposes only. It is based on publicly available data and expert analysis.
Conduit Pharmaceuticals Receives Additional Patent Approval for Lead Autoimmune Disease Asset
Conduit Pharmaceuticals Inc. (NASDAQ: CDT), a biopharmaceutical company focused on developing treatments for autoimmune and inflammatory diseases, announced today that it has received further patent approval for its lead therapeutic asset targeting autoimmune conditions. The newly granted patent strengthens the company’s intellectual property portfolio and provides added protection for its innovative approach to treating autoimmune diseases such as sarcoidosis and lupus.
The patent, issued by the United States Patent and Trademark Office (USPTO), covers key methods of use and compositions relating to Conduit’s investigational drug, which is designed to modulate the immune response in patients with chronic autoimmune disorders. According to company officials, the approval not only broadens the existing patent family but also enhances the commercial potential of the lead compound as it advances through clinical development.
“This new patent grant is a major milestone for Conduit Pharmaceuticals, as it secures crucial proprietary rights over our lead autoimmune asset,” said Dr. David Tapolczay, Chief Executive Officer of Conduit Pharmaceuticals. “Our mission is to bring safe and effective treatments to patients suffering from complex autoimmune conditions, and this patent approval is a significant step forward in protecting the innovation that underpins our approach.”
The company’s lead asset, originally acquired from a major pharmaceutical partner, has demonstrated promising results in preclinical and early clinical studies. The drug works by selectively targeting pathways involved in the overactive immune response characteristic of autoimmune diseases, while minimizing systemic immunosuppression.
Conduit Pharmaceuticals has emphasized its strategy of revitalizing underutilized assets from larger pharmaceutical companies and accelerating them through late-stage development. The expanded patent protection ensures a longer runway for exclusivity, which could facilitate future licensing agreements or commercial partnerships.
Industry analysts view the patent approval as a positive development that enhances Conduit’s valuation and strengthens its position in the competitive autoimmune drug market, projected to surpass $150 billion globally by 2030.
The company plans to continue progressing its lead candidate through clinical trials, with additional updates expected later this year regarding regulatory filings and potential Phase 2 study initiations.
For more information, visit www.conduitpharma.com.
WHO and Medicines Patent Pool Support Nigerian Innovation in Health Diagnostic
In a landmark step towards strengthening healthcare innovation in Africa, the World Health Organization (WHO) and the Medicines Patent Pool (MPP) have announced strategic support for Nigerian-led advancements in health diagnostics. This collaboration is aimed at fostering local innovation, improving access to affordable diagnostic tools, and enhancing the country’s capacity to respond to pressing public health challenges.
The initiative comes under WHO’s Global Initiative on Digital Health and the MPP’s commitment to equitable access to medical innovations. Nigeria has been identified as a critical partner due to its growing innovation ecosystem and urgent need for scalable, cost-effective diagnostic solutions for diseases such as malaria, tuberculosis, hepatitis, and HIV/AIDS.
Speaking at a press briefing in Abuja, WHO Nigeria Country Representative, Dr. Walter Kazadi Mulombo, emphasized the importance of locally developed technologies in transforming health outcomes. “Nigeria has demonstrated significant potential in biomedical innovation,” he stated. “By supporting homegrown diagnostic solutions, we aim to empower Nigerian researchers and entrepreneurs to develop tools that are not only technologically sound but also contextually appropriate for local health challenges.”
The partnership will provide technical assistance, funding opportunities, and pathways to intellectual property management through the MPP. Nigerian innovators will gain access to international patent licensing frameworks, regulatory support, and opportunities for technology transfer. This is expected to facilitate the development, manufacturing, and distribution of diagnostics that meet global standards while remaining affordable for local healthcare systems.
“Affordable diagnostics are a cornerstone of universal health coverage,” he said. “Through this collaboration, we aim to bridge the gap between innovation and access, ensuring that promising technologies from Nigeria can benefit both the country and the wider global South.”
Among the early beneficiaries of the initiative is a Lagos-based biotech startup that has developed a rapid point-of-care diagnostic test for tuberculosis, which uses AI-powered image recognition. Another group from Ahmadu Bello University is working on a low-cost paper-based testing kit for hepatitis B and C, tailored for use in rural and underserved communities.
Health experts have welcomed the announcement, noting that empowering local solutions can reduce dependency on imported diagnostics and improve response times during outbreaks. Dr. Amina Balogun, a public health analyst, noted: “This kind of support is crucial for building a self-reliant health system. It’s not just about the tools, but about building confidence and capacity in our institutions and scientists.”
As part of the next phase, WHO and MPP plan to host a regional innovation forum in Nigeria later this year to showcase emerging diagnostic technologies and connect local developers with global health agencies and funders.
This partnership marks a significant step in aligning Nigeria’s innovation capacity with global health goals and demonstrates how strategic international collaboration can empower local solutions to meet both national and international health needs.
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.