In a significant ruling that underscores the importance of transparency, reasoned decision-making, and procedural fairness in patent examination, the Calcutta High Court has set aside a refusal order issued by the Patent Office in the case of Takeda Pharmaceutical Co. Ltd. v. Controller of Patents and Designs & Ors. The Court found that the Patent Office’s failure to consider crucial post-filing data demonstrating technical advancement violated the principles of natural justice and remanded the matter for fresh consideration.
Facts of the Case
Takeda Pharmaceutical Co. Ltd. (“Takeda”) filed a patent application in 2010 for a novel class of protein kinase inhibitors intended for treating cancers associated with abnormal kinase activity. The application specifically claimed Brigatinib, a compound designed to selectively inhibit Anaplastic Lymphoma Kinase (ALK) over closely related kinases, including the insulin receptor (Ins-R). This selective inhibition was critical to Brigatinib’s therapeutic efficacy, as it reduced side effects that typically arise from off-target binding to Ins-R.
During the course of prosecution, Takeda submitted experimental data demonstrating Brigatinib’s enhanced selectivity for ALK, as evidenced by reduced IC50 values (the concentration needed to inhibit 50% of kinase activity). Additionally, Takeda provided expert affidavits, comparative data with other marketed drugs, and evidence of industrial acclaim to substantiate the compound’s technical advancement and superior efficacy.
Refusal Order by the Controller
Despite the supporting data, the Controller of Patents rejected Takeda’s application on three grounds:
Lack of Inventive Step under Section 2(1)(ja)
Non-patentability under Section 3(d) of the Patents Act, which prevents the patenting of mere derivatives of known substances unless they show significant improvement in therapeutic efficacy
Insufficiency of Disclosure under Section 10(4), alleging that Takeda had not adequately described the invention.
Furthermore, the Controller contended that the application lacked any evidence of technical advancement or enhanced efficacy at the time of filing the specification.
Arguments by Takeda
They argued that the Controller had disregarded supplementary data and expert affidavits that demonstrated Brigatinib’s superior selectivity and efficacy. Takeda claimed that the inventive step analysis was flawed, arguing that the Controller had used hindsight to select prior art compounds and had wrongly assumed that a minor structural modification (the sulfonyl-phosphoryl substitution) would not have a significant effect on the compound’s performance.
Takeda further pointed out that the Controller had failed to consider the post-filing data submitted during prosecution, which demonstrated Brigatinib’s enhanced selectivity for ALK over Ins-R, reducing off-target effects and improving the drug’s therapeutic profile. According to Takeda, the hasty rejection failed to account for the complexity and novelty of their invention.
Court’s Findings
The Calcutta High Court sided with Takeda, finding that the Controller’s refusal was unreasoned and erroneous. In its judgment, the Court emphasized that the inventive step must be assessed in the context of the entire invention, and prior art should not be merely compared to isolated features of the invention. The Court specifically noted that the mere presence of structurally similar elements in the prior art does not make an invention obvious. The invention must be evaluated as a whole, considering its technical merits and novel contributions.
The Court also found that the Controller had misinterpreted the concept of bioisosterism and failed to consider that Brigatinib’s modification—substituting a sulfonyl group with a phosphoryl group—was not obvious in the context of the prior art. It emphasized that there was no teaching in the prior art to modify the structure of TAE684 in the way required to produce Brigatinib, particularly with regard to selective inhibition between ALK and Ins-R.
Regarding the issue of technical advancement, the Court pointed out that Takeda had submitted critical data, including experimental results showing Brigatinib’s superior selectivity for ALK and reduced off-target effects. The Court noted that the Controller had improperly disregarded this data, which was directly relevant to proving therapeutic efficacy.
Key Legal Principles: Procedural Fairness and Transparency
The Court ruled that the Controller had violated the principles of natural justice by failing to adequately consider all material facts and evidence submitted by Takeda, including post-filing data. The Court emphasized that under Indian patent law, post-filing data demonstrating technical advancement is not prohibited and must be duly considered by the examining authorities.
Furthermore, the Court held that the refusal was not supported by adequate reasoning and that the Controller’s decision-making process lacked clarity and fairness. The judgment highlighted the need for a reasoned order, one that addresses all relevant factors and provides a comprehensive explanation of why certain evidence is accepted or rejected.
Conclusion
By setting aside the refusal order, the Court has provided a clear directive to the Patent Office to re-evaluate the application in light of all available evidence, including post-filing data, and to ensure that all parties are given an adequate opportunity to be heard.
The Court has also remanded the case to the Patent Office for fresh consideration, with a mandate to complete the process within three months from the date of communication of the order. This ruling not only benefits Takeda but also reinforces the importance of ensuring fairness and accountability in the patent grant process, particularly in high-stakes pharmaceutical and biotechnology patents.
Impact on Patent Law in India
This judgment is expected to have far-reaching implications for patent law practice in India, especially in complex patent cases involving pharmaceutical and biotechnology inventions. It reinforces the need for patent examiners to engage thoroughly with the evidence presented, ensuring that decisions are based on substantive and comprehensive analyses rather than superficial assessments. This decision could also encourage more transparency in the examination process, ultimately fostering an environment that supports innovation and fair competition in the Indian patent ecosystem.
infringement
Patent Applicants Face Tighter Deadlines: What the New USPTO Rule Means for Continuation and Divisional Applications
Starting May 13, 2025, patent applicants will experience a significant change in the timeline for filing continuation and divisional applications with the U.S. Patent and Trademark Office (USPTO). Under the new rule, the window between paying the issue fee and a patent officially issuing will shrink dramatically—from about three weeks to just one week.
For those familiar with the process, this may feel like a significant shift. Previously, applicants had a comfortable amount of time to make key decisions regarding the filing of continuation or divisional applications after paying the issue fee. This period, although not extensive, offered ample opportunity to consider further filings and get the necessary paperwork in order. Now, with the new timeline, applicants will have to act quickly or risk missing the opportunity to file these crucial applications before the parent patent officially issues.
A Major Change for Continuation and Divisional Filings
For those in the patent world, continuation and divisional applications are powerful tools used to refine, expand, or protect different aspects of an invention disclosed in the original patent application. These tools allow applicants to pursue additional claims or protect additional inventions within the same family of patents.
This might happen if an applicant wants broader protection or if new claims emerge that were not included in the original application. A continuation application essentially gives the applicant another opportunity to further develop the patent without starting the process from scratch.
Divisionals, on the other hand, are filed when the USPTO requests the applicant to divide the original application into separate filings because the application covers more than one invention. This is typically seen in cases where the original application is too broad or contains more than one distinct invention.
The critical detail here is that both continuation and divisional applications must be filed before the parent patent is granted. Once the patent issues, the opportunity to file such applications is largely closed, and reopening prosecution after issuance can be costly and difficult.
The New Deadline: A Week to Act
Historically, applicants had about three weeks, sometimes longer, to file continuation or divisional applications after paying the issue fee. This gave them time to review their options, consult with colleagues or patent attorneys, and finalize their strategy before the patent officially issued.
However, with the new rule coming into effect on May 13, 2025, applicants will have only one week between paying the issue fee and the patent issuing. This means the timeline for making decisions has been drastically compressed. The issue fee, which is typically paid after receiving a Notice of Allowance from the USPTO, serves as an indication that the patent is about to be granted. With the tighter timeline, applicants must be ready to act quickly to file continuation or divisional applications—or risk missing the opportunity altogether.
For patent professionals who file these types of applications regularly, this change represents a considerable shift in workflow. The new rule is likely to require better planning, quicker decision-making, and perhaps even a shift in internal procedures to ensure applications are filed on time.
Best Practices for Navigating the Change
While the new rule presents challenges, there are several best practices that applicants can adopt to ensure they stay ahead of the game:
File Before Paying the Issue Fee
This gives ample time to review the strategy and decide on any additional filings. Filing before paying the issue fee ensures that applicants can secure their desired protection without the stress of a shortened timeline.
Incorporate Continuation and Divisional Discussions into the Review Process
Patent applicants should include discussions of continuation and divisional strategies as part of their regular Notice of Allowance review. This can involve consulting with patent attorneys, revisiting claims, and carefully evaluating whether additional applications are necessary.
Set Internal Deadlines
This gives teams time to deliberate and take a more measured approach to filings, without the added pressure of an approaching deadline.
Treat the Issue Fee as a Warning Signal
The issue fee payment should be viewed as a signal to take immediate action, not as a last-minute task. Instead of waiting until the last moment, applicants should be proactive and take time to file any necessary applications well ahead of the fee payment deadline. Procrastination can lead to missed opportunities.
Why the Change Matters
The USPTO’s decision to tighten this filing window is likely a response to the growing complexity of the patent process and the increasing speed at which innovation is occurring.
For applicants, however, this presents a new set of challenges. The need for quick decision-making and a more nimble approach to patent strategy has never been more important. Companies will need to ensure their patent portfolios are managed with greater efficiency and foresight. In particular, patent attorneys and in-house counsel will need to be highly organized to ensure that crucial filings are made within the shortened timeline.
The Bottom Line: Speed and Preparation Are Key
The new rule that takes effect on May 13, 2025, is a significant change that will impact the way patent applicants file continuation and divisional applications. With only one week between paying the issue fee and the patent issuing, applicants must be prepared to act quickly to protect additional claims or inventions.
The smartest strategy is to file continuation and divisional applications before paying the issue fee, giving applicants more time to review and finalize their filing strategy. By setting internal deadlines, planning ahead, and treating the issue fee payment as a cue to take immediate action, patent applicants can ensure they are not caught off guard by the new, shorter timeline.
In the world of patent law, timing is everything—and starting May 2025, those who act early will be best positioned to navigate the new filing requirements.
For those familiar with the process, this may feel like a significant shift. Previously, applicants had a comfortable amount of time to make key decisions regarding the filing of continuation or divisional applications after paying the issue fee. This period, although not extensive, offered ample opportunity to consider further filings and get the necessary paperwork in order. Now, with the new timeline, applicants will have to act quickly or risk missing the opportunity to file these crucial applications before the parent patent officially issues.
A Major Change for Continuation and Divisional Filings
For those in the patent world, continuation and divisional applications are powerful tools used to refine, expand, or protect different aspects of an invention disclosed in the original patent application. These tools allow applicants to pursue additional claims or protect additional inventions within the same family of patents.
This might happen if an applicant wants broader protection or if new claims emerge that were not included in the original application. A continuation application essentially gives the applicant another opportunity to further develop the patent without starting the process from scratch.
Divisionals, on the other hand, are filed when the USPTO requests the applicant to divide the original application into separate filings because the application covers more than one invention. This is typically seen in cases where the original application is too broad or contains more than one distinct invention.
The critical detail here is that both continuation and divisional applications must be filed before the parent patent is granted. Once the patent issues, the opportunity to file such applications is largely closed, and reopening prosecution after issuance can be costly and difficult.
The New Deadline: A Week to Act
Historically, applicants had about three weeks, sometimes longer, to file continuation or divisional applications after paying the issue fee. This gave them time to review their options, consult with colleagues or patent attorneys, and finalize their strategy before the patent officially issued.
However, with the new rule coming into effect on May 13, 2025, applicants will have only one week between paying the issue fee and the patent issuing. This means the timeline for making decisions has been drastically compressed. The issue fee, which is typically paid after receiving a Notice of Allowance from the USPTO, serves as an indication that the patent is about to be granted. With the tighter timeline, applicants must be ready to act quickly to file continuation or divisional applications—or risk missing the opportunity altogether.
For patent professionals who file these types of applications regularly, this change represents a considerable shift in workflow. The new rule is likely to require better planning, quicker decision-making, and perhaps even a shift in internal procedures to ensure applications are filed on time.
Best Practices for Navigating the Change
While the new rule presents challenges, there are several best practices that applicants can adopt to ensure they stay ahead of the game:
File Before Paying the Issue Fee
This gives ample time to review the strategy and decide on any additional filings. Filing before paying the issue fee ensures that applicants can secure their desired protection without the stress of a shortened timeline.
Incorporate Continuation and Divisional Discussions into the Review Process
Patent applicants should include discussions of continuation and divisional strategies as part of their regular Notice of Allowance review. This can involve consulting with patent attorneys, revisiting claims, and carefully evaluating whether additional applications are necessary.
Set Internal Deadlines
This gives teams time to deliberate and take a more measured approach to filings, without the added pressure of an approaching deadline.
Treat the Issue Fee as a Warning Signal
The issue fee payment should be viewed as a signal to take immediate action, not as a last-minute task. Instead of waiting until the last moment, applicants should be proactive and take time to file any necessary applications well ahead of the fee payment deadline. Procrastination can lead to missed opportunities.
Why the Change Matters
The USPTO’s decision to tighten this filing window is likely a response to the growing complexity of the patent process and the increasing speed at which innovation is occurring.
For applicants, however, this presents a new set of challenges. The need for quick decision-making and a more nimble approach to patent strategy has never been more important. Companies will need to ensure their patent portfolios are managed with greater efficiency and foresight. In particular, patent attorneys and in-house counsel will need to be highly organized to ensure that crucial filings are made within the shortened timeline.
The Bottom Line: Speed and Preparation Are Key
The new rule that takes effect on May 13, 2025, is a significant change that will impact the way patent applicants file continuation and divisional applications. With only one week between paying the issue fee and the patent issuing, applicants must be prepared to act quickly to protect additional claims or inventions.
The smartest strategy is to file continuation and divisional applications before paying the issue fee, giving applicants more time to review and finalize their filing strategy. By setting internal deadlines, planning ahead, and treating the issue fee payment as a cue to take immediate action, patent applicants can ensure they are not caught off guard by the new, shorter timeline.
In the world of patent law, timing is everything—and starting May 2025, those who act early will be best positioned to navigate the new filing requirements.
Patent Dispute Erupts Over Scavenger Robots: Kerala’s Genrobotics Files Lawsuit Against IIT Madras Startup
A legal battle has broken out in the field of sanitation technology as Genrobotics, a Kerala-based robotics company known for its sewer-cleaning robot ‘Bandicoot’, has taken legal action against a startup incubated at IIT Madras. The dispute centers on alleged patent infringement involving robotic systems designed to eliminate manual scavenging.
The company argues that its patented design and mechanism have been replicated without authorization, potentially undermining years of research and development.
The case highlights growing tensions in India’s deep tech and robotics sectors, where startups and research institutions are increasingly innovating but also entering complex territory involving patents and proprietary technologies.
According to Genrobotics, its invention was created specifically to address the inhumane practice of manual scavenging, offering a safer and more dignified alternative through automation. The company has received widespread recognition and government support for deploying its technology across multiple states.
The IIT Madras startup, whose identity has not been officially disclosed in legal documents, reportedly launched a robotic solution with functions and features that Genrobotics claims are too similar to be coincidental. Genrobotics has approached the courts seeking an injunction against the manufacture, sale, and promotion of the allegedly infringing product.
Industry observers note that this case could set a precedent for how intellectual property rights are enforced in India’s emerging robotics industry. It also raises broader questions about the balance between innovation, open research, and patent protection, particularly in sectors aimed at solving critical social issues.
Neither side has made a detailed public statement yet, but the case is expected to draw attention as it unfolds, especially given the increasing focus on technology-driven solutions in public sanitation.
The company argues that its patented design and mechanism have been replicated without authorization, potentially undermining years of research and development.
The case highlights growing tensions in India’s deep tech and robotics sectors, where startups and research institutions are increasingly innovating but also entering complex territory involving patents and proprietary technologies.
According to Genrobotics, its invention was created specifically to address the inhumane practice of manual scavenging, offering a safer and more dignified alternative through automation. The company has received widespread recognition and government support for deploying its technology across multiple states.
The IIT Madras startup, whose identity has not been officially disclosed in legal documents, reportedly launched a robotic solution with functions and features that Genrobotics claims are too similar to be coincidental. Genrobotics has approached the courts seeking an injunction against the manufacture, sale, and promotion of the allegedly infringing product.
Industry observers note that this case could set a precedent for how intellectual property rights are enforced in India’s emerging robotics industry. It also raises broader questions about the balance between innovation, open research, and patent protection, particularly in sectors aimed at solving critical social issues.
Neither side has made a detailed public statement yet, but the case is expected to draw attention as it unfolds, especially given the increasing focus on technology-driven solutions in public sanitation.
High Courts Should Not Intervene in SARFAESI Proceedings Unless Actions Are Clearly Illegal or Mala Fide: Allahabad High Court
In a recent judgment, the Allahabad High Court emphasized that judicial intervention in matters governed by the Securitisation and Reconstruction of Financial Assets and Enforcement of Security Interest (SARFAESI) Act, 2002, should be limited to instances where banks have acted either unlawfully or with mala fide intent.
The division bench, comprising Justice Shekhar B. Saraf and Justice Dr. Yogendra Kumar Srivastava, cited the Supreme Court’s ruling in United Bank of India vs. Satyawati Tondon & Others to support its stance. The bench noted, “Interference by this Court in SARFAESI-related issues is not warranted unless a clear case of illegality or bad faith is established on the part of the bank authorities.”
This section empowers financial institutions to recover dues by enforcing security interests if a borrower fails to repay within 60 days after receiving a demand notice under Section 13(2).
The petitioner argued that the bank did not respond to their objection filed under Section 13(3A) before initiating recovery action under Section 13(4). However, upon reviewing the documents submitted, the court found that the bank had issued an order addressing the objection and attempted to serve it via post. Though delivery to two of the petitioners was unsuccessful due to the premises being locked, the court acknowledged that proper service to one petitioner may not have occurred. Despite this, the petitioners had received the Section 13(4) notice and had subsequently challenged it before the Debts Recovery Tribunal (DRT).
The High Court pointed out that the petitioners initially failed to inform the court that they had already approached the DRT. This fact only came to light through a supplementary affidavit filed later. The court observed that since the petitioners had already sought remedy before the DRT, pursuing the same grievance through a writ petition constituted a case of attempting to “sail in two boats.”
“The existence of an order under Section 13(3A), the efforts made to deliver it, and the petitioners’ acknowledgment of the Section 13(4) notice suggest that they had the opportunity to raise their concerns before the appropriate forum. Having done so, they cannot now bypass that process by invoking the writ jurisdiction of this Court,” the bench observed.
The court further highlighted that the petitioners had already raised the same objections regarding Section 13(3A) in their application before the DRT, rendering their writ plea redundant.
Reaffirming the precedent set by the Supreme Court in Satyawati Tondon, the High Court stressed that although the Constitution allows for writ petitions even where alternate remedies exist, such discretion should be exercised sparingly when an effective statutory mechanism is available.
With no evidence of mala fide conduct by the bank and considering that the asset sale had already occurred, the court found no reason to intervene. Consequently, the writ petition was dismissed.
The division bench, comprising Justice Shekhar B. Saraf and Justice Dr. Yogendra Kumar Srivastava, cited the Supreme Court’s ruling in United Bank of India vs. Satyawati Tondon & Others to support its stance. The bench noted, “Interference by this Court in SARFAESI-related issues is not warranted unless a clear case of illegality or bad faith is established on the part of the bank authorities.”
This section empowers financial institutions to recover dues by enforcing security interests if a borrower fails to repay within 60 days after receiving a demand notice under Section 13(2).
The petitioner argued that the bank did not respond to their objection filed under Section 13(3A) before initiating recovery action under Section 13(4). However, upon reviewing the documents submitted, the court found that the bank had issued an order addressing the objection and attempted to serve it via post. Though delivery to two of the petitioners was unsuccessful due to the premises being locked, the court acknowledged that proper service to one petitioner may not have occurred. Despite this, the petitioners had received the Section 13(4) notice and had subsequently challenged it before the Debts Recovery Tribunal (DRT).
The High Court pointed out that the petitioners initially failed to inform the court that they had already approached the DRT. This fact only came to light through a supplementary affidavit filed later. The court observed that since the petitioners had already sought remedy before the DRT, pursuing the same grievance through a writ petition constituted a case of attempting to “sail in two boats.”
“The existence of an order under Section 13(3A), the efforts made to deliver it, and the petitioners’ acknowledgment of the Section 13(4) notice suggest that they had the opportunity to raise their concerns before the appropriate forum. Having done so, they cannot now bypass that process by invoking the writ jurisdiction of this Court,” the bench observed.
The court further highlighted that the petitioners had already raised the same objections regarding Section 13(3A) in their application before the DRT, rendering their writ plea redundant.
Reaffirming the precedent set by the Supreme Court in Satyawati Tondon, the High Court stressed that although the Constitution allows for writ petitions even where alternate remedies exist, such discretion should be exercised sparingly when an effective statutory mechanism is available.
With no evidence of mala fide conduct by the bank and considering that the asset sale had already occurred, the court found no reason to intervene. Consequently, the writ petition was dismissed.
India Sees 310% Rise in Patent Filings by Startups and MSMEs in Last Five Years
India has witnessed an extraordinary increase in patent filings by startups and micro, small, and medium enterprises (MSMEs), with data revealing a 310% growth over the past five years. This surge underscores the country’s growing focus on innovation, research, and intellectual property protection among emerging businesses.
According to recent government and industry data, this dramatic rise in patent activity reflects the effectiveness of initiatives aimed at nurturing a robust innovation ecosystem. Supportive policies, such as reduced filing fees, fast-track examination processes, and government-backed awareness programs, have played a critical role in encouraging smaller enterprises and startups to safeguard their inventions.
Experts believe that the increasing participation of startups and MSMEs in patenting not only signals a maturing entrepreneurial landscape but also positions India as a rising innovation hub on the global stage.
Government officials have noted that this trend aligns with the vision of making India self-reliant and technology-driven. The growing number of intellectual property filings by smaller players is also contributing to job creation, export potential, and overall economic growth.
The momentum is expected to continue as more early-stage ventures recognize the strategic value of protecting their intellectual property, particularly in sectors such as artificial intelligence, healthcare, clean energy, and digital technologies.
According to recent government and industry data, this dramatic rise in patent activity reflects the effectiveness of initiatives aimed at nurturing a robust innovation ecosystem. Supportive policies, such as reduced filing fees, fast-track examination processes, and government-backed awareness programs, have played a critical role in encouraging smaller enterprises and startups to safeguard their inventions.
Experts believe that the increasing participation of startups and MSMEs in patenting not only signals a maturing entrepreneurial landscape but also positions India as a rising innovation hub on the global stage.
Government officials have noted that this trend aligns with the vision of making India self-reliant and technology-driven. The growing number of intellectual property filings by smaller players is also contributing to job creation, export potential, and overall economic growth.
The momentum is expected to continue as more early-stage ventures recognize the strategic value of protecting their intellectual property, particularly in sectors such as artificial intelligence, healthcare, clean energy, and digital technologies.
India Strengthens Its Global Standing in AI and Patent Innovation: Nasscom’s Patent Pulse 2025 Report
As World Intellectual Property (IP) Day is observed globally, India has emerged as a prominent player in the international innovation ecosystem.
India maintained its rank as the fifth-largest patent filer worldwide in FY24, with over 90,000 patents submitted—a milestone marking seven consecutive years of growth. A notable portion of these patents, more than 25%, are linked to AI technologies, underlining India’s growing reputation as a center for advanced technological development.
The report also reveals a steady rise in the country’s innovation output. India’s patent-to-GDP ratio more than doubled in a decade, increasing from 144 in 2013 to 381 in 2023. Additionally, India’s share in global patent grants grew from 1.7% in 2022 to 3.8% in 2023—a 149% year-on-year increase.
For the first time, the number of granted patents in India crossed 100,000 in FY24, indicating both enhanced operational efficiency at the Indian Patent Office and an improvement in the quality of applications. A growing share of these filings—over 55%—were submitted by Indian residents, compared to 52.3% the previous year. Contributions from startups, academic institutions, and small and medium enterprises (SMEs) are playing an increasingly vital role, showing a broadening base of innovation.
Artificial Intelligence remains a major driver of this progress. Since 2010, India has filed more than 86,000 AI-related patents, with filings between 2021 and 2025 rising seven times compared to the 2010–2015 period. Indian entities were responsible for 63% of these filings, signaling strong domestic innovation leadership in AI.
Machine Learning (ML) continues to dominate AI-related patents, accounting for over half of them. Within ML, Generative AI (GenAI) has become a significant focus area. In India, GenAI makes up 28% of AI patents, far exceeding the global average of just 6%, placing the country among the top five globally in this space.
Key sectors driving AI patent activity include transportation, which accounts for more than 70% of AI filings, as well as computer vision and natural language processing, which together represent over 90% of India’s AI-related patents.
India’s grant rate for AI patents stands at only 0.37%, significantly behind global leaders such as the United States and China. The gap is even wider in academia, where the approval rate is just 1%, compared to 40% for corporate applicants.
This gap reflects the need for improved research capabilities, stronger institutional support, and a greater emphasis on producing high-quality intellectual property.
Rajesh Nambiar, President of Nasscom, recognized India’s progress but emphasized that more work is needed. “While the increase in filings and patent office responsiveness are encouraging, delays in approvals and inconsistent patent quality remain barriers to matching global benchmarks,” he stated.
To support ongoing improvements, Nasscom has introduced the IP Enablement Initiative. This program aims to boost IP literacy and infrastructure across academia, startups, and industry. It also calls for policy reforms and a cultural shift to encourage innovation and higher-quality IP creation nationwide.
India maintained its rank as the fifth-largest patent filer worldwide in FY24, with over 90,000 patents submitted—a milestone marking seven consecutive years of growth. A notable portion of these patents, more than 25%, are linked to AI technologies, underlining India’s growing reputation as a center for advanced technological development.
The report also reveals a steady rise in the country’s innovation output. India’s patent-to-GDP ratio more than doubled in a decade, increasing from 144 in 2013 to 381 in 2023. Additionally, India’s share in global patent grants grew from 1.7% in 2022 to 3.8% in 2023—a 149% year-on-year increase.
For the first time, the number of granted patents in India crossed 100,000 in FY24, indicating both enhanced operational efficiency at the Indian Patent Office and an improvement in the quality of applications. A growing share of these filings—over 55%—were submitted by Indian residents, compared to 52.3% the previous year. Contributions from startups, academic institutions, and small and medium enterprises (SMEs) are playing an increasingly vital role, showing a broadening base of innovation.
Artificial Intelligence remains a major driver of this progress. Since 2010, India has filed more than 86,000 AI-related patents, with filings between 2021 and 2025 rising seven times compared to the 2010–2015 period. Indian entities were responsible for 63% of these filings, signaling strong domestic innovation leadership in AI.
Machine Learning (ML) continues to dominate AI-related patents, accounting for over half of them. Within ML, Generative AI (GenAI) has become a significant focus area. In India, GenAI makes up 28% of AI patents, far exceeding the global average of just 6%, placing the country among the top five globally in this space.
Key sectors driving AI patent activity include transportation, which accounts for more than 70% of AI filings, as well as computer vision and natural language processing, which together represent over 90% of India’s AI-related patents.
India’s grant rate for AI patents stands at only 0.37%, significantly behind global leaders such as the United States and China. The gap is even wider in academia, where the approval rate is just 1%, compared to 40% for corporate applicants.
This gap reflects the need for improved research capabilities, stronger institutional support, and a greater emphasis on producing high-quality intellectual property.
Rajesh Nambiar, President of Nasscom, recognized India’s progress but emphasized that more work is needed. “While the increase in filings and patent office responsiveness are encouraging, delays in approvals and inconsistent patent quality remain barriers to matching global benchmarks,” he stated.
To support ongoing improvements, Nasscom has introduced the IP Enablement Initiative. This program aims to boost IP literacy and infrastructure across academia, startups, and industry. It also calls for policy reforms and a cultural shift to encourage innovation and higher-quality IP creation nationwide.
AI Boom: Over 86,000 AI Patents Filed Between 2010–2025, Representing Over a Quarter of All Tech Patents
The rapid ascent of artificial intelligence (AI) is not only transforming industries but is also reshaping the intellectual property landscape. Recent data reveals that more than 86,000 AI-related patents have been filed globally between 2010 and 2025, marking a dramatic surge in innovation and investment in the field. These AI patents now account for over 25% of all technology-related patent filings during the same period, underscoring AI’s central role in shaping the future of technology.
Accelerated Growth in AI Innovation
The number of AI patent filings has seen exponential growth, especially in the last five years, driven by breakthroughs in machine learning, natural language processing, computer vision, and generative AI. The surge reflects both the maturity of AI research and its widespread commercial adoption across industries ranging from healthcare and finance to automotive and entertainment.
Leading patent offices, including the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), and the China National Intellectual Property Administration (CNIPA), have all reported significant increases in AI-related submissions. China and the United States are at the forefront of this trend, with companies like IBM, Microsoft, Google, Baidu, and Alibaba leading the charge in filing AI innovations.
Key Areas of AI Patent Activity
The 86,000+ patents span a wide range of applications, including:
Autonomous vehicles and driver-assistance systems
AI-powered healthcare diagnostics and drug discovery tools
Smart assistants and voice recognition platforms
AI in cybersecurity, including threat detection and automated response
The expansion of AI into nearly every facet of modern life has fueled demand for proprietary protection, as businesses race to secure their intellectual property in a competitive and fast-moving market.
Implications for the Tech Industry
The fact that more than a quarter of all tech patents in the past 15 years are AI-related signals a major paradigm shift. According to intellectual property analysts, this shift highlights both the strategic importance of AI and the increasing complexity of patent landscapes, which may lead to a rise in patent disputes and licensing negotiations in the near future.
Legal experts warn that the rush to patent AI innovations also raises questions about patent quality, the scope of protection, and ethical considerations, particularly when it comes to inventions generated by AI itself.
The Road Ahead
With ongoing advancements in generative AI, robotics, and quantum computing, the number of AI-related patent filings is expected to keep climbing. Governments and regulatory bodies are also paying closer attention to how AI patents are evaluated, ensuring that innovation is balanced with responsibility and legal clarity.
Accelerated Growth in AI Innovation
The number of AI patent filings has seen exponential growth, especially in the last five years, driven by breakthroughs in machine learning, natural language processing, computer vision, and generative AI. The surge reflects both the maturity of AI research and its widespread commercial adoption across industries ranging from healthcare and finance to automotive and entertainment.
Leading patent offices, including the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), and the China National Intellectual Property Administration (CNIPA), have all reported significant increases in AI-related submissions. China and the United States are at the forefront of this trend, with companies like IBM, Microsoft, Google, Baidu, and Alibaba leading the charge in filing AI innovations.
Key Areas of AI Patent Activity
The 86,000+ patents span a wide range of applications, including:
Autonomous vehicles and driver-assistance systems
AI-powered healthcare diagnostics and drug discovery tools
Smart assistants and voice recognition platforms
AI in cybersecurity, including threat detection and automated response
The expansion of AI into nearly every facet of modern life has fueled demand for proprietary protection, as businesses race to secure their intellectual property in a competitive and fast-moving market.
Implications for the Tech Industry
The fact that more than a quarter of all tech patents in the past 15 years are AI-related signals a major paradigm shift. According to intellectual property analysts, this shift highlights both the strategic importance of AI and the increasing complexity of patent landscapes, which may lead to a rise in patent disputes and licensing negotiations in the near future.
Legal experts warn that the rush to patent AI innovations also raises questions about patent quality, the scope of protection, and ethical considerations, particularly when it comes to inventions generated by AI itself.
The Road Ahead
With ongoing advancements in generative AI, robotics, and quantum computing, the number of AI-related patent filings is expected to keep climbing. Governments and regulatory bodies are also paying closer attention to how AI patents are evaluated, ensuring that innovation is balanced with responsibility and legal clarity.
SK bioscience Claims Final Victory in mRNA Patent Dispute Against Moderna
South Korea’s SK bioscience, the biopharmaceutical subsidiary of SK Group, announced on Wednesday that it has secured a decisive win in a patent dispute against U.S.-based biotechnology company Moderna, known globally for its development of mRNA COVID-19 vaccines.
The legal challenge, initiated in 2023, contested Moderna’s South Korean patent concerning the use and modification of nucleosides, nucleotides, and nucleic acids in mRNA technology. According to SK bioscience, the patent posed a significant barrier to domestic research and innovation by granting what it called “unjust priority rights.” This patent, reportedly the only one of its kind registered in South Korea related to mRNA production, was viewed as crucial to SK bioscience’s ongoing projects, including its experimental mRNA vaccine for Japanese encephalitis, GBP560.
The vaccine project is being conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), a global health organization supported by funding from philanthropist Bill Gates.
A spokesperson for the company highlighted that, if successful, its mRNA-based vaccines could be distributed in developing regions such as Africa, Southeast Asia, Latin America, and the Middle East—areas where Moderna has not yet secured intellectual property rights for its mRNA technology.
The ruling in SK bioscience’s favor came from the Intellectual Property Trial and Appeal Board last month, and with Moderna opting not to appeal within the designated timeframe, the decision stands as final. The company believes this outcome will accelerate its ambitions to become a key player in the mRNA vaccine space, which analysts project could surpass 84 trillion won (around $58.9 billion) in market value by 2033.
SK bioscience now aims to develop a robust mRNA platform that can be used to combat not just pandemics, but a broader array of infectious diseases worldwide.
The legal challenge, initiated in 2023, contested Moderna’s South Korean patent concerning the use and modification of nucleosides, nucleotides, and nucleic acids in mRNA technology. According to SK bioscience, the patent posed a significant barrier to domestic research and innovation by granting what it called “unjust priority rights.” This patent, reportedly the only one of its kind registered in South Korea related to mRNA production, was viewed as crucial to SK bioscience’s ongoing projects, including its experimental mRNA vaccine for Japanese encephalitis, GBP560.
The vaccine project is being conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), a global health organization supported by funding from philanthropist Bill Gates.
A spokesperson for the company highlighted that, if successful, its mRNA-based vaccines could be distributed in developing regions such as Africa, Southeast Asia, Latin America, and the Middle East—areas where Moderna has not yet secured intellectual property rights for its mRNA technology.
The ruling in SK bioscience’s favor came from the Intellectual Property Trial and Appeal Board last month, and with Moderna opting not to appeal within the designated timeframe, the decision stands as final. The company believes this outcome will accelerate its ambitions to become a key player in the mRNA vaccine space, which analysts project could surpass 84 trillion won (around $58.9 billion) in market value by 2033.
SK bioscience now aims to develop a robust mRNA platform that can be used to combat not just pandemics, but a broader array of infectious diseases worldwide.
USPTO Suspends Expedited Examination for Design Applications Amid Fraud Concerns and Case Backlog
In a decisive move aimed at improving efficiency and safeguarding the integrity of the U.S. intellectual property system, the United States Patent and Trademark Office (USPTO) has announced the suspension of expedited examination for design patent applications, effective April 17, 2025. The policy change was officially detailed in a notice published in the USPTO’s Official Gazette on April 14.
The decision comes in response to a 560% surge in requests for expedited design application reviews—a trend the USPTO attributes in large part to a rise in fraudulent filings. This suspension is part of a broader strategy to reduce the growing inventory of unexamined design applications, curb misuse of the system, and ensure accurate and fair processing for legitimate applicants.
Key Reasons Behind the Suspension
According to the USPTO, the unexpected spike in expedited examination requests has placed significant pressure on examiners and contributed to increased backlogs in the design application pipeline. Much of this rise, the agency notes, is linked to fraudulent filings, which not only distort processing timelines but also pose risks to the integrity of the U.S. intellectual property system.
The USPTO also cites a rise in erroneous micro entity certifications—false claims to fee discounts intended for small applicants—as a factor in its decision. These certifications have become a growing concern in recent years, complicating the patent review process and necessitating additional scrutiny.
What the Suspension Means for Applicants
Starting April 17, 2025, the USPTO will no longer grant requests for expedited examination of design applications, including any renewed or pending requests submitted on or after that date. In line with this change:
Associated fees will be refunded in full for requests made after the effective date.
The USPTO will continue to examine design applications under its standard timeline, as it works to reduce overall pendency and inventory.
Impact on the Design Patent Community
The suspension will have a notable impact on companies and individuals relying on faster design patent protection for products with short market cycles, particularly in sectors like fashion, consumer electronics, and packaging design. However, the USPTO maintains that ensuring quality and transparency in the application process outweighs the short-term disruption caused by the policy shift.
Industry analysts suggest that while the suspension may create delays for some innovators, the move is likely to improve the reliability and credibility of granted design patents in the long run, which is critical for both domestic and international enforcement.
Broader Reform Efforts
This policy change is one component of the USPTO’s wider agenda to combat abuse and strengthen the integrity of the IP system. The office has been ramping up enforcement against fraudulent filings, improving data analytics to detect suspicious activity, and refining procedures for certifying applicant eligibility for reduced fees.
The USPTO also continues to explore new technologies and staffing solutions to address examination delays and ensure legitimate applications are processed efficiently.
Delhi High Court Denies Roche Injunction Against Natco, Puts Public Health Over Patent in Rare Disease Drug Case
The case, centered on Roche’s high-priced drug risdiplam used to treat Spinal Muscular Atrophy (SMA), brought public health and drug affordability to the forefront of the legal discourse.
Justice Mini Pushkarna, delivering the verdict on March 24, underscored the primacy of public health in patent litigation involving critical medications. “Public health is not something that should be dealt with lightly,” she wrote, adding that when a drug is the only available treatment for a rare disease in India, its affordable availability to the public becomes a “material factor” in deciding whether to grant an injunction. Notably, she emphasized that while pharmaceutical companies can be compensated monetarily, the public “has no such right to compensate itself.”
Roche vs Natco: The Core Dispute
Roche had filed a patent infringement suit seeking to block Natco from manufacturing a generic version of risdiplam, marketed by Roche as Evrysdi. The oral medication is the only approved treatment for SMA in India, a rare and progressive genetic disorder that impairs motor function and eventually leads to loss of movement and breathing capability.
Roche argued that Natco’s generic infringed on its Indian species patent, valid until 2035. Natco, however, challenged the legitimacy of the patent, citing an earlier genus patent filed internationally, claiming Roche was attempting to extend its monopoly illegitimately.
The Affordability Crisis
One of the case’s most compelling elements was the stark reality of Evrysdi’s cost. For an SMA patient weighing over 20 kg, that equates to ₹1.8 crore annually—a prohibitive amount for most Indian families.
Seba P. A., an SMA patient, and Purva Mittal, who is awaiting treatment at Lok Nayak Jai Prakash Hospital in Delhi, both intervened in the suit, highlighting the devastating impact of the drug’s unaffordability.
Roche’s Limited Patient Assistance Programme Rejected
Roche, like many multinational pharmaceutical firms, proposed offering risdiplam at a subsidized rate under a Patient Assistance Programme (PAP). But the court found this insufficient. The judge noted that the programme was too limited in scope, benefiting only a select group of patients, and would still exclude a significant number of SMA sufferers.
Furthermore, Roche’s plan to work with the National Rare Diseases Committee was seen as impractical, given limited funding under the National Policy for Rare Diseases (NPRD). The court referenced a 2024 government release stating that while up to ₹50 lakh is allocated per patient, only 1,118 patients had received support for any rare disease, despite 63 such diseases being recognized.
Court Favors Balance of Convenience
In assessing whether to grant the injunction, the court applied the principle of balance of convenience—weighing which party would suffer more harm from the interim decision. Justice Pushkarna concluded that Natco stood on stronger ground, especially since damages could compensate Roche if it ultimately prevailed, whereas denying access to a life-saving drug could not be reversed for patients.
The judge also drew parallels to a prior case in 2008, where Roche had sought to block Cipla’s generic version of the cancer drug erlotinib (marketed as Tarceva). That case also emphasized affordability, with the court refusing an injunction because Cipla’s generic cost ₹48,000 per month, while Roche’s version was priced at ₹1.4 lakh.
A Global Legal Battle
While Natco has prevailed in India for now, the battle over risdiplam continues elsewhere. In the United States, Roche is pursuing legal action against Natco and other generic makers who have filed Abbreviated New Drug Applications (ANDAs) with the FDA. Despite SMA being a rare condition, Evrysdi’s U.S. sales hit $1.8 billion in 2024, bolstered by its oral formulation, which provides a less invasive option compared to competitor drugs that require spinal injections.
Patent Complexity: Genus vs. Species
At the heart of the legal challenge is the distinction between genus and species patents. Roche holds a species patent for risdiplam in India, valid until 2035, while the earlier genus patent—covering a broader class of compounds—expires in 2033. Natco argues that risdiplam was already disclosed in the genus patent and that Roche is attempting to unfairly extend patent protection through strategic filings. Similar allegations of patent misuse have emerged against Roche in other international jurisdictions.
A Turning Point for Access and IP Law?
Justice Pushkarna’s ruling is being hailed as a significant judicial stance on the issue of drug affordability, especially in the context of rare diseases. While Indian courts have occasionally refused to grant injunctions against generic firms in the past, few have spoken as plainly about the right to health and the public’s interest in affordable medicine.
The case is far from over—trial proceedings will continue to decide the validity of Roche’s patent. However, the court has made it clear: innovation must not come at the cost of accessibility.
As the world grapples with balancing intellectual property rights and public health imperatives, this decision may serve as a legal and moral benchmark—especially for lower-income countries navigating similar dilemmas.
Justice Mini Pushkarna, delivering the verdict on March 24, underscored the primacy of public health in patent litigation involving critical medications. “Public health is not something that should be dealt with lightly,” she wrote, adding that when a drug is the only available treatment for a rare disease in India, its affordable availability to the public becomes a “material factor” in deciding whether to grant an injunction. Notably, she emphasized that while pharmaceutical companies can be compensated monetarily, the public “has no such right to compensate itself.”
Roche vs Natco: The Core Dispute
Roche had filed a patent infringement suit seeking to block Natco from manufacturing a generic version of risdiplam, marketed by Roche as Evrysdi. The oral medication is the only approved treatment for SMA in India, a rare and progressive genetic disorder that impairs motor function and eventually leads to loss of movement and breathing capability.
Roche argued that Natco’s generic infringed on its Indian species patent, valid until 2035. Natco, however, challenged the legitimacy of the patent, citing an earlier genus patent filed internationally, claiming Roche was attempting to extend its monopoly illegitimately.
The Affordability Crisis
One of the case’s most compelling elements was the stark reality of Evrysdi’s cost. For an SMA patient weighing over 20 kg, that equates to ₹1.8 crore annually—a prohibitive amount for most Indian families.
Seba P. A., an SMA patient, and Purva Mittal, who is awaiting treatment at Lok Nayak Jai Prakash Hospital in Delhi, both intervened in the suit, highlighting the devastating impact of the drug’s unaffordability.
Roche’s Limited Patient Assistance Programme Rejected
Roche, like many multinational pharmaceutical firms, proposed offering risdiplam at a subsidized rate under a Patient Assistance Programme (PAP). But the court found this insufficient. The judge noted that the programme was too limited in scope, benefiting only a select group of patients, and would still exclude a significant number of SMA sufferers.
Furthermore, Roche’s plan to work with the National Rare Diseases Committee was seen as impractical, given limited funding under the National Policy for Rare Diseases (NPRD). The court referenced a 2024 government release stating that while up to ₹50 lakh is allocated per patient, only 1,118 patients had received support for any rare disease, despite 63 such diseases being recognized.
Court Favors Balance of Convenience
In assessing whether to grant the injunction, the court applied the principle of balance of convenience—weighing which party would suffer more harm from the interim decision. Justice Pushkarna concluded that Natco stood on stronger ground, especially since damages could compensate Roche if it ultimately prevailed, whereas denying access to a life-saving drug could not be reversed for patients.
The judge also drew parallels to a prior case in 2008, where Roche had sought to block Cipla’s generic version of the cancer drug erlotinib (marketed as Tarceva). That case also emphasized affordability, with the court refusing an injunction because Cipla’s generic cost ₹48,000 per month, while Roche’s version was priced at ₹1.4 lakh.
A Global Legal Battle
While Natco has prevailed in India for now, the battle over risdiplam continues elsewhere. In the United States, Roche is pursuing legal action against Natco and other generic makers who have filed Abbreviated New Drug Applications (ANDAs) with the FDA. Despite SMA being a rare condition, Evrysdi’s U.S. sales hit $1.8 billion in 2024, bolstered by its oral formulation, which provides a less invasive option compared to competitor drugs that require spinal injections.
Patent Complexity: Genus vs. Species
At the heart of the legal challenge is the distinction between genus and species patents. Roche holds a species patent for risdiplam in India, valid until 2035, while the earlier genus patent—covering a broader class of compounds—expires in 2033. Natco argues that risdiplam was already disclosed in the genus patent and that Roche is attempting to unfairly extend patent protection through strategic filings. Similar allegations of patent misuse have emerged against Roche in other international jurisdictions.
A Turning Point for Access and IP Law?
Justice Pushkarna’s ruling is being hailed as a significant judicial stance on the issue of drug affordability, especially in the context of rare diseases. While Indian courts have occasionally refused to grant injunctions against generic firms in the past, few have spoken as plainly about the right to health and the public’s interest in affordable medicine.
The case is far from over—trial proceedings will continue to decide the validity of Roche’s patent. However, the court has made it clear: innovation must not come at the cost of accessibility.
As the world grapples with balancing intellectual property rights and public health imperatives, this decision may serve as a legal and moral benchmark—especially for lower-income countries navigating similar dilemmas.