Cybin Inc. has been granted U.S. patent number 12,291,499 by the United States Patent and Trademark Office, bolstering its intellectual property portfolio, which now includes over 80 granted patents and more than 230 active applications. CEO Doug Drysdale underscored the significance of strong patent protections in supporting drug innovation and reaffirmed the company’s dedication to developing new mental health treatments.
Cybin’s lead clinical program, CYB003, is currently being administered to participants in its pivotal Phase 3 trial, known as the APPROACH study, targeting Major Depressive Disorder (MDD) as an adjunctive treatment. A second Phase 3 trial, EMBRACE, is expected to launch in mid-2025. In addition, Cybin is advancing CYB004, a deuterated version of N,N-dimethyltryptamine (DMT), now in Phase 2 development for generalized anxiety disorder.
However, it continues to operate with a negative EBITDA of approximately -$93.87 million over the past 12 months, reflecting the high costs associated with research and development. The company has been rated “FAIR” for overall financial health and appears to maintain enough liquid assets to meet short-term obligations, suggesting operational resilience during its early-stage growth phase.
It is focused on transforming mental healthcare through innovative neuropsychiatric treatments, and has gained recognition for its early clinical data in the field.
The announcement of the new patent was accompanied by a standard disclaimer noting that forward-looking statements involve risks and uncertainties. Cybin emphasized that its products are still undergoing scientific evaluation and must be reviewed and approved by regulatory agencies such as the U.S. FDA and Health Canada before any health claims can be made.
In parallel developments, Cybin has expanded its U.S. clinical trial network to include 18 sites for the ongoing APPROACH study. This move aims to accelerate patient recruitment and improve the efficiency of its Phase 3 trial timeline. Meanwhile, H.C. Wainwright has adjusted its price target for Cybin from $190 to $150, while maintaining a Buy rating, citing updated financials and promising developments in its CYB003 and CYB004 programs. A potential commercial rollout for CYB004 is tentatively projected for fiscal year 2028.
This news is based on a press release from Cybin Inc. and is intended for informational purposes only.
technology
Supreme Court Declines to Hear Patent Officers’ Plea for CBI Probe, Suggests Moving High Court
The Supreme Court has declined to admit a writ petition filed by the All India Patent Officers’ Welfare Association (AIPOWA), which sought a court-monitored investigation and a probe by the Central Bureau of Investigation (CBI) into alleged unauthorized access and data leakage involving sensitive patent and trademark information.
A bench comprising Chief Justice of India Sanjiv Khanna and Justice Sanjay Kumar refused to entertain the petition under Article 32 of the Constitution. However, the Court allowed AIPOWA the liberty to approach the appropriate High Court under Article 226 for further remedies. The Court made it clear that it had not offered any opinion on the merits of the allegations or whether the petition should be admitted by the High Court.
The petition alleged that confidential data from the Indian Intellectual Property Offices (IPO) was improperly accessed and shared with Kaizen Institute, a private multinational consultancy, without following due legal and administrative procedures. According to AIPOWA, this access was facilitated by officials in the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) despite a lack of formal approval from the DPIIT.
The association claimed that Kaizen was allowed to operate within IPO premises based solely on internal email communications, which allegedly misrepresented its links to the Prime Minister’s Office and the Capacity Building Commission (CBC). In contrast, similar access was reportedly denied to a senior government officer.
The petition further argued that this arrangement breached multiple provisions of the Patents Act, 1970, and the Trade Marks Act, 1999. It contended that CGPDTM, being a subordinate office, had no authority to enter into such arrangements without explicit clearance from the Ministry of Commerce and Industry.
Additionally, AIPOWA criticized the process through which Kaizen was engaged, stating that no competitive bidding took place, violating public procurement rules and principles of transparency and accountability. The petition also highlighted an MoU signed among CGPDTM, the CBC, and the Centre for Effective Governance of Indian States (CEGIS), pointing to a clause that indicated CBC’s role in coordinating with Kaizen for process improvements at CGPDTM.
The petition had urged the Court to nullify the MoU, initiate a CBI investigation, and hold those responsible accountable under Indian laws and international agreements, including the Patent Cooperation Treaty and Madrid Protocol.
Senior Advocate Neeraj Kishan Kaul appeared on behalf of AIPOWA. While the Supreme Court declined to intervene directly, it left the door open for the matter to be taken up by a High Court.
A bench comprising Chief Justice of India Sanjiv Khanna and Justice Sanjay Kumar refused to entertain the petition under Article 32 of the Constitution. However, the Court allowed AIPOWA the liberty to approach the appropriate High Court under Article 226 for further remedies. The Court made it clear that it had not offered any opinion on the merits of the allegations or whether the petition should be admitted by the High Court.
The petition alleged that confidential data from the Indian Intellectual Property Offices (IPO) was improperly accessed and shared with Kaizen Institute, a private multinational consultancy, without following due legal and administrative procedures. According to AIPOWA, this access was facilitated by officials in the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) despite a lack of formal approval from the DPIIT.
The association claimed that Kaizen was allowed to operate within IPO premises based solely on internal email communications, which allegedly misrepresented its links to the Prime Minister’s Office and the Capacity Building Commission (CBC). In contrast, similar access was reportedly denied to a senior government officer.
The petition further argued that this arrangement breached multiple provisions of the Patents Act, 1970, and the Trade Marks Act, 1999. It contended that CGPDTM, being a subordinate office, had no authority to enter into such arrangements without explicit clearance from the Ministry of Commerce and Industry.
Additionally, AIPOWA criticized the process through which Kaizen was engaged, stating that no competitive bidding took place, violating public procurement rules and principles of transparency and accountability. The petition also highlighted an MoU signed among CGPDTM, the CBC, and the Centre for Effective Governance of Indian States (CEGIS), pointing to a clause that indicated CBC’s role in coordinating with Kaizen for process improvements at CGPDTM.
The petition had urged the Court to nullify the MoU, initiate a CBI investigation, and hold those responsible accountable under Indian laws and international agreements, including the Patent Cooperation Treaty and Madrid Protocol.
Senior Advocate Neeraj Kishan Kaul appeared on behalf of AIPOWA. While the Supreme Court declined to intervene directly, it left the door open for the matter to be taken up by a High Court.
Flux Power Holdings Secures Patent for Groundbreaking AI-Powered Battery Cycle Life Maximization Algorithm
Flux Power Holdings, Inc. (NASDAQ: FLUX), a pioneering developer of advanced lithium-ion energy storage solutions, today announced that it has been granted a patent for its innovative Intelligent Battery Cycle Life Maximization Algorithm. This proprietary AI-driven technology is designed to optimize the performance and longevity of its battery systems by leveraging machine learning to adapt to real-world usage. With this breakthrough, Flux Power is positioning itself as a leader not only in energy storage but also in the development of software-driven electrification solutions for commercial and industrial sectors.
A Leap Forward in Battery Management
Flux Power’s latest patent reflects a major step forward in the evolution of battery management technologies. The Intelligent Battery Cycle Life Maximization Algorithm uses machine learning to continuously monitor and adjust the charging behavior of lithium-ion battery packs based on real-time usage data. By dynamically optimizing the maximum charge value for each battery pack depending on its actual field usage, the algorithm extends the cycle life of the batteries, improving both efficiency and operational performance.
Paulus Geantil, Chief Technology Officer (CTO) of Flux Power, explained the significance of the development:
“This algorithm uses real-time machine learning to tune battery cycling behavior based on actual usage patterns in the field, significantly extending system life and efficiency,” he said. “We’ve moved beyond conventional battery management systems. This algorithm not only optimizes the performance of each battery pack but learns and evolves with its application over time to deliver superior and sustainable performance.”
The new algorithm is a pivotal component of Flux Power’s broader strategy to evolve from being a battery manufacturer to a technology-driven energy solutions provider. This move aligns with the company’s goal of building smart, connected, and autonomous energy ecosystems that extend far beyond the simple manufacture of energy storage hardware.
Shaping the Future of Energy with AI
As the demand for sustainable and efficient energy solutions grows, Flux Power is looking to meet this demand by incorporating artificial intelligence (AI) and machine learning into its core products. The company’s CEO, Krishna Vanka, highlighted the shift towards AI-driven solutions, emphasizing the added value customers will gain from the new technology:
As the electrification of commercial and industrial equipment continues to accelerate, Flux Power is well-poised to capitalize on the shift towards battery-powered solutions that provide longer life cycles, improved operational efficiency, and reduced environmental impact. With the addition of this cutting-edge AI technology, Flux Power is positioning itself as a key player in the energy transformation landscape.
About Flux Power Holdings, Inc.
Flux Power Holdings, Inc. These sectors include material handling, airport ground support equipment (GSE), and stationary energy storage. Flux Power’s products provide a high-performance, environmentally friendly, and cost-effective alternative to traditional energy solutions, such as lead-acid and propane-based systems. By focusing on battery management systems (BMS), telemetry, and AI-driven innovations, Flux Power continues to expand its footprint in the energy storage industry.
Forward-Looking Statements
This release contains forward-looking statements that involve estimates, assumptions, risks, and other uncertainties, which may cause actual results to differ materially from those anticipated. These statements are not guarantees of future results, and actual results could vary based on a range of factors including market conditions, customer acceptance, product development, and other business risks. Investors are encouraged to review the risk factors outlined in Flux Power’s filings with the Securities and Exchange Commission (SEC) for further details.
A Leap Forward in Battery Management
Flux Power’s latest patent reflects a major step forward in the evolution of battery management technologies. The Intelligent Battery Cycle Life Maximization Algorithm uses machine learning to continuously monitor and adjust the charging behavior of lithium-ion battery packs based on real-time usage data. By dynamically optimizing the maximum charge value for each battery pack depending on its actual field usage, the algorithm extends the cycle life of the batteries, improving both efficiency and operational performance.
Paulus Geantil, Chief Technology Officer (CTO) of Flux Power, explained the significance of the development:
“This algorithm uses real-time machine learning to tune battery cycling behavior based on actual usage patterns in the field, significantly extending system life and efficiency,” he said. “We’ve moved beyond conventional battery management systems. This algorithm not only optimizes the performance of each battery pack but learns and evolves with its application over time to deliver superior and sustainable performance.”
The new algorithm is a pivotal component of Flux Power’s broader strategy to evolve from being a battery manufacturer to a technology-driven energy solutions provider. This move aligns with the company’s goal of building smart, connected, and autonomous energy ecosystems that extend far beyond the simple manufacture of energy storage hardware.
Shaping the Future of Energy with AI
As the demand for sustainable and efficient energy solutions grows, Flux Power is looking to meet this demand by incorporating artificial intelligence (AI) and machine learning into its core products. The company’s CEO, Krishna Vanka, highlighted the shift towards AI-driven solutions, emphasizing the added value customers will gain from the new technology:
As the electrification of commercial and industrial equipment continues to accelerate, Flux Power is well-poised to capitalize on the shift towards battery-powered solutions that provide longer life cycles, improved operational efficiency, and reduced environmental impact. With the addition of this cutting-edge AI technology, Flux Power is positioning itself as a key player in the energy transformation landscape.
About Flux Power Holdings, Inc.
Flux Power Holdings, Inc. These sectors include material handling, airport ground support equipment (GSE), and stationary energy storage. Flux Power’s products provide a high-performance, environmentally friendly, and cost-effective alternative to traditional energy solutions, such as lead-acid and propane-based systems. By focusing on battery management systems (BMS), telemetry, and AI-driven innovations, Flux Power continues to expand its footprint in the energy storage industry.
Forward-Looking Statements
This release contains forward-looking statements that involve estimates, assumptions, risks, and other uncertainties, which may cause actual results to differ materially from those anticipated. These statements are not guarantees of future results, and actual results could vary based on a range of factors including market conditions, customer acceptance, product development, and other business risks. Investors are encouraged to review the risk factors outlined in Flux Power’s filings with the Securities and Exchange Commission (SEC) for further details.
U.S. Court of Appeals for the Federal Circuit Invalidates Patents Over Functional Claim Language in “Payment Handler” Case: Implications for AI Patents
In a precedential decision issued by the U.S. Court of Appeals for the Federal Circuit in February 2025, the court affirmed a district court ruling that the term “payment handler” in a patent claim was a “nonce” term—a placeholder for functional language. This ruling invoked 35 U.S.C. § 112, sixth paragraph, governing means-plus-function claiming, leading to the invalidation of the associated patents. The decision raises crucial questions about the drafting of patent claims in industries like artificial intelligence (AI), where functional language is often used to describe complex systems.
The Case: Payment Handler as Functional Language
The case, involving a dispute over software patents related to payment processing technologies, centered on the term “payment handler.” The court examined whether this term invoked means-plus-function claiming under § 112 ¶6, which applies when a claim term is expressed in purely functional terms, without reciting sufficient structural detail. Under this provision, if a claim lacks structural detail, it is considered indefinite unless the specification provides enough supporting structure or an algorithm corresponding to the claimed function.
The Federal Circuit began by discussing whether the term “payment handler” overcame the presumption against invoking means-plus-function claiming. The court ruled that the term indeed lacked sufficient structural specificity, as it only described the function of handling payments without specifying how this was achieved. The court likened the term “payment handler” to “module”, which has previously been considered a nonce term in patent law, representing a vague description of a software or hardware component that performs a specified function.
Why “Payment Handler” Was Deemed Indefinite
The court rejected several arguments put forth by the patent holder. For one, the plaintiff argued that terms like “operable to,” “configured to,” and “that” used in the claim language conferred sufficient structure to avoid means-plus-function treatment. The Federal Circuit noted that while these terms are often used in structural contexts, they do not automatically prevent means-plus-function claiming. Citing the case Rain Computing, Inc. v. Samsung Electronics America, the court pointed out that the applicability of § 112 ¶6 depends on the specific context and nature of the claims.
The court also addressed the argument that the “payment handler” terms were part of a recognized class of software structures like “code” or “applications,” which the court in Dyfan, LLC v. Target Corp. found to be sufficiently structural. However, the Federal Circuit emphasized that, unlike “code” or “application,” the term “payment handler” had no established meaning within the software development community. The patent holder had failed to provide expert testimony or concrete examples showing how the term conveyed structure.
Additionally, the court rejected the argument that the surrounding claim language—such as defining inputs, outputs, and operation of the payment handler—provided enough detail to make the term structural. The claim did not explain how the payment handler functioned, nor did it outline the specific “rules” or algorithm that would govern its operation. The Federal Circuit noted that the specification of the patent simply repeated the claim language without offering any substantial details about the underlying structure of the payment handler.
In essence, the court concluded that the term “payment handler” was functionally indefinite and did not include the necessary structural disclosure to satisfy § 112 ¶6. As a result, the court invalidated the patent claims that relied on this vague term.
Implications for AI Patent Applications
Although this decision did not directly address artificial intelligence (AI), it offers significant insights for AI-related patent drafting, where functional terms are often used to describe complex technologies. AI inventions, particularly those involving machine learning models, neural networks, and other advanced algorithms, may face similar challenges when their claims rely heavily on functional descriptions.
In AI patents, terms like “classifier,” “predictive model,” or “neural network” are often used to describe the operations of a system without fully detailing the underlying algorithm or architecture. While these terms may be widely accepted in the field, patent drafters must be cautious when they lack sufficient structural disclosure in the specification.
Provide Detailed Structural Descriptions: Instead of relying on broad, functional terms like “classifier” or “model,” drafters should disclose as much structural detail as possible, including algorithms and specific AI techniques used. For example, terms like “feed-forward neural network,” “convolutional neural network,” or “generative pre-trained transformer” provide concrete examples of structures and algorithms that could support the claims and avoid indefiniteness challenges.
Avoid Ambiguous Terminology: Terms like “handler” or “module,” which are commonly used as placeholders for functional components, should be avoided or supplemented with detailed explanations of their structure and operation. If a term like “payment handler” is essential, ensure the patent specification includes an in-depth description of the specific software or hardware involved and how it performs its function.
Use Recognized AI Terms for Structure: Where possible, use terms that are already well understood to connote structure in the AI field. For instance, the term “model” could be more structural in the AI context than terms like “classifier,” especially when it is described with reference to specific AI architectures and algorithms.
Include Dependent Claims for Clarity: Dependent claims can be used to provide more specific details on the structure of AI systems, such as the type of neural network or the algorithm being used.
Don’t Rely Solely on Claim Language: As the court emphasized, merely parroting the claim language in the specification is not enough. It’s crucial to explain the structural components in detail, particularly for AI inventions that involve complex algorithms and system architectures.
Conclusion: The Need for Clarity in AI Patents
The Federal Circuit’s decision underscores the importance of clarity and specificity in patent claims, particularly in fields like software and AI, where functional terms are commonly used. Patent applicants must ensure that functional language is supported by concrete structural details to avoid claims being deemed indefinite under § 112 ¶6. By providing comprehensive descriptions of the structure and algorithms underlying their inventions, AI patent drafters can strengthen their patent applications and reduce the risk of invalidation due to indefiniteness.
As AI technologies continue to evolve, patent law will need to adapt, and the case serves as a timely reminder that functional claims must be backed by sufficient structure to withstand legal scrutiny.
The Case: Payment Handler as Functional Language
The case, involving a dispute over software patents related to payment processing technologies, centered on the term “payment handler.” The court examined whether this term invoked means-plus-function claiming under § 112 ¶6, which applies when a claim term is expressed in purely functional terms, without reciting sufficient structural detail. Under this provision, if a claim lacks structural detail, it is considered indefinite unless the specification provides enough supporting structure or an algorithm corresponding to the claimed function.
The Federal Circuit began by discussing whether the term “payment handler” overcame the presumption against invoking means-plus-function claiming. The court ruled that the term indeed lacked sufficient structural specificity, as it only described the function of handling payments without specifying how this was achieved. The court likened the term “payment handler” to “module”, which has previously been considered a nonce term in patent law, representing a vague description of a software or hardware component that performs a specified function.
Why “Payment Handler” Was Deemed Indefinite
The court rejected several arguments put forth by the patent holder. For one, the plaintiff argued that terms like “operable to,” “configured to,” and “that” used in the claim language conferred sufficient structure to avoid means-plus-function treatment. The Federal Circuit noted that while these terms are often used in structural contexts, they do not automatically prevent means-plus-function claiming. Citing the case Rain Computing, Inc. v. Samsung Electronics America, the court pointed out that the applicability of § 112 ¶6 depends on the specific context and nature of the claims.
The court also addressed the argument that the “payment handler” terms were part of a recognized class of software structures like “code” or “applications,” which the court in Dyfan, LLC v. Target Corp. found to be sufficiently structural. However, the Federal Circuit emphasized that, unlike “code” or “application,” the term “payment handler” had no established meaning within the software development community. The patent holder had failed to provide expert testimony or concrete examples showing how the term conveyed structure.
Additionally, the court rejected the argument that the surrounding claim language—such as defining inputs, outputs, and operation of the payment handler—provided enough detail to make the term structural. The claim did not explain how the payment handler functioned, nor did it outline the specific “rules” or algorithm that would govern its operation. The Federal Circuit noted that the specification of the patent simply repeated the claim language without offering any substantial details about the underlying structure of the payment handler.
In essence, the court concluded that the term “payment handler” was functionally indefinite and did not include the necessary structural disclosure to satisfy § 112 ¶6. As a result, the court invalidated the patent claims that relied on this vague term.
Implications for AI Patent Applications
Although this decision did not directly address artificial intelligence (AI), it offers significant insights for AI-related patent drafting, where functional terms are often used to describe complex technologies. AI inventions, particularly those involving machine learning models, neural networks, and other advanced algorithms, may face similar challenges when their claims rely heavily on functional descriptions.
In AI patents, terms like “classifier,” “predictive model,” or “neural network” are often used to describe the operations of a system without fully detailing the underlying algorithm or architecture. While these terms may be widely accepted in the field, patent drafters must be cautious when they lack sufficient structural disclosure in the specification.
Provide Detailed Structural Descriptions: Instead of relying on broad, functional terms like “classifier” or “model,” drafters should disclose as much structural detail as possible, including algorithms and specific AI techniques used. For example, terms like “feed-forward neural network,” “convolutional neural network,” or “generative pre-trained transformer” provide concrete examples of structures and algorithms that could support the claims and avoid indefiniteness challenges.
Avoid Ambiguous Terminology: Terms like “handler” or “module,” which are commonly used as placeholders for functional components, should be avoided or supplemented with detailed explanations of their structure and operation. If a term like “payment handler” is essential, ensure the patent specification includes an in-depth description of the specific software or hardware involved and how it performs its function.
Use Recognized AI Terms for Structure: Where possible, use terms that are already well understood to connote structure in the AI field. For instance, the term “model” could be more structural in the AI context than terms like “classifier,” especially when it is described with reference to specific AI architectures and algorithms.
Include Dependent Claims for Clarity: Dependent claims can be used to provide more specific details on the structure of AI systems, such as the type of neural network or the algorithm being used.
Don’t Rely Solely on Claim Language: As the court emphasized, merely parroting the claim language in the specification is not enough. It’s crucial to explain the structural components in detail, particularly for AI inventions that involve complex algorithms and system architectures.
Conclusion: The Need for Clarity in AI Patents
The Federal Circuit’s decision underscores the importance of clarity and specificity in patent claims, particularly in fields like software and AI, where functional terms are commonly used. Patent applicants must ensure that functional language is supported by concrete structural details to avoid claims being deemed indefinite under § 112 ¶6. By providing comprehensive descriptions of the structure and algorithms underlying their inventions, AI patent drafters can strengthen their patent applications and reduce the risk of invalidation due to indefiniteness.
As AI technologies continue to evolve, patent law will need to adapt, and the case serves as a timely reminder that functional claims must be backed by sufficient structure to withstand legal scrutiny.
Akums Drugs & Pharmaceuticals Secures Patent for Extended-Release Doxylamine and Pyridoxine Formulation for Nausea and Vomiting in Pregnancy
In a significant breakthrough for maternal healthcare, Akums Drugs & Pharmaceuticals has been granted a patent for its extended-release combination formulation of Doxylamine and Pyridoxine, developed to manage nausea and vomiting in pregnancy (NVP). The formulation, which utilizes Akums’ proprietary “tablet-in-tablet” technology, has recently received approval from the Drug Controller General of India (DCGI).
Addressing a Widespread Issue in Pregnancy Care
NVP can severely impact a woman’s nutrition, daily activities, and overall well-being, creating a need for effective treatments that address both the short-term and long-term needs of expectant mothers.
Akums’ innovative formulation provides an effective solution to this problem by combining the benefits of immediate and extended drug release in a single tablet. This novel combination is designed to offer prolonged symptom relief and reduce the frequency of dosing, improving patient adherence to the treatment regimen.
Dual-Action Mechanism for Improved Convenience
The tablet-in-tablet technology developed by Akums is a significant advancement in drug delivery. The formulation consists of two layers: an outer layer that provides a rapid onset of action to quickly alleviate the symptoms of nausea, and an inner core that ensures a longer therapeutic effect. This dual-action mechanism aims to enhance the convenience of treatment by reducing the need for frequent dosing and improving overall symptom management.
The company believes that this formulation will offer better symptom control for expectant mothers, allowing them to manage NVP more effectively and comfortably throughout their pregnancy.
Key Approvals and Regulatory Considerations
The DCGI approval marks a pivotal moment in Akums’ journey to provide a solution for a widespread condition that affects many pregnant women. The formulation has already undergone a bioequivalence study, and while the specific number of subjects in the study remains confidential due to regulatory norms, Akums confirmed that the data submitted was sufficient for obtaining the DCGI’s approval.
The company emphasizes that the approval of this extended-release formulation provides a new treatment option for expectant mothers, addressing a significant gap in pregnancy care by offering long-lasting control of nausea and vomiting. Akums has designed the formulation with a focus on safety, efficacy, and patient adherence, ensuring that it can be a trusted part of pregnancy care routines.
The launch of this new formulation underscores Akums’ commitment to innovative drug delivery technologies and their ongoing efforts to address significant unmet needs in the pharmaceutical market. The company is known for its robust contract development and manufacturing organization (CDMO) services, and this latest development adds to its growing portfolio of drug delivery innovations.
Akums’ Expansive Operations and Product Portfolio
Akums operates with a large-scale infrastructure that includes 12 manufacturing units, four R&D centers, and over 16,000 employees. The company reports having successfully commercialized over 4,100 formulations and has more than 220 products under development across various therapeutic categories.
The approval of the Doxylamine and Pyridoxine combination formulation is part of Akums’ broader strategic initiative to enhance its presence in both domestic and export pharmaceutical markets. The company’s growing product pipeline spans a wide range of dosage forms and therapeutic areas, reflecting its ability to innovate in diverse segments of the pharmaceutical industry.
A Key Step in Pregnancy Care
This development is a step forward in addressing the challenges faced by pregnant women suffering from NVP. By offering an extended-release formulation, Akums has created a treatment that not only provides effective symptom control but also improves the convenience and adherence to medication, which is often a challenge for expectant mothers managing NVP.
The formulation is poised to meet the growing demand for more accessible and effective healthcare options for pregnant women. Akums’ focus on patient-centric innovation positions the company as a key player in improving maternal health outcomes, particularly in regions where access to modern treatments remains a challenge.
Looking Ahead
With the DCGI’s approval, Akums is now poised to roll out this extended-release Doxylamine and Pyridoxine formulation to a wide market, benefiting pregnant women across India and potentially beyond. As the company continues to expand its research and development efforts, it is likely to remain at the forefront of pharmaceutical innovation, developing new treatments that meet the evolving needs of patients in both domestic and international markets.
In summary, Akums’ patented formulation for nausea and vomiting in pregnancy represents a significant achievement in the realm of maternal health. By leveraging its proprietary drug delivery technology and addressing a critical gap in pregnancy care, Akums is setting new standards for how pharmaceutical companies can innovate to improve the quality of life for expectant mothers.
Addressing a Widespread Issue in Pregnancy Care
NVP can severely impact a woman’s nutrition, daily activities, and overall well-being, creating a need for effective treatments that address both the short-term and long-term needs of expectant mothers.
Akums’ innovative formulation provides an effective solution to this problem by combining the benefits of immediate and extended drug release in a single tablet. This novel combination is designed to offer prolonged symptom relief and reduce the frequency of dosing, improving patient adherence to the treatment regimen.
Dual-Action Mechanism for Improved Convenience
The tablet-in-tablet technology developed by Akums is a significant advancement in drug delivery. The formulation consists of two layers: an outer layer that provides a rapid onset of action to quickly alleviate the symptoms of nausea, and an inner core that ensures a longer therapeutic effect. This dual-action mechanism aims to enhance the convenience of treatment by reducing the need for frequent dosing and improving overall symptom management.
The company believes that this formulation will offer better symptom control for expectant mothers, allowing them to manage NVP more effectively and comfortably throughout their pregnancy.
Key Approvals and Regulatory Considerations
The DCGI approval marks a pivotal moment in Akums’ journey to provide a solution for a widespread condition that affects many pregnant women. The formulation has already undergone a bioequivalence study, and while the specific number of subjects in the study remains confidential due to regulatory norms, Akums confirmed that the data submitted was sufficient for obtaining the DCGI’s approval.
The company emphasizes that the approval of this extended-release formulation provides a new treatment option for expectant mothers, addressing a significant gap in pregnancy care by offering long-lasting control of nausea and vomiting. Akums has designed the formulation with a focus on safety, efficacy, and patient adherence, ensuring that it can be a trusted part of pregnancy care routines.
The launch of this new formulation underscores Akums’ commitment to innovative drug delivery technologies and their ongoing efforts to address significant unmet needs in the pharmaceutical market. The company is known for its robust contract development and manufacturing organization (CDMO) services, and this latest development adds to its growing portfolio of drug delivery innovations.
Akums’ Expansive Operations and Product Portfolio
Akums operates with a large-scale infrastructure that includes 12 manufacturing units, four R&D centers, and over 16,000 employees. The company reports having successfully commercialized over 4,100 formulations and has more than 220 products under development across various therapeutic categories.
The approval of the Doxylamine and Pyridoxine combination formulation is part of Akums’ broader strategic initiative to enhance its presence in both domestic and export pharmaceutical markets. The company’s growing product pipeline spans a wide range of dosage forms and therapeutic areas, reflecting its ability to innovate in diverse segments of the pharmaceutical industry.
A Key Step in Pregnancy Care
This development is a step forward in addressing the challenges faced by pregnant women suffering from NVP. By offering an extended-release formulation, Akums has created a treatment that not only provides effective symptom control but also improves the convenience and adherence to medication, which is often a challenge for expectant mothers managing NVP.
The formulation is poised to meet the growing demand for more accessible and effective healthcare options for pregnant women. Akums’ focus on patient-centric innovation positions the company as a key player in improving maternal health outcomes, particularly in regions where access to modern treatments remains a challenge.
Looking Ahead
With the DCGI’s approval, Akums is now poised to roll out this extended-release Doxylamine and Pyridoxine formulation to a wide market, benefiting pregnant women across India and potentially beyond. As the company continues to expand its research and development efforts, it is likely to remain at the forefront of pharmaceutical innovation, developing new treatments that meet the evolving needs of patients in both domestic and international markets.
In summary, Akums’ patented formulation for nausea and vomiting in pregnancy represents a significant achievement in the realm of maternal health. By leveraging its proprietary drug delivery technology and addressing a critical gap in pregnancy care, Akums is setting new standards for how pharmaceutical companies can innovate to improve the quality of life for expectant mothers.
Philips Wins Landmark Patent Case in India, Strengthening Enforcement of Standard Essential Patents (SEPs)
In a significant ruling delivered in February 2025, the Delhi High Court reinforced the enforcement of Standard Essential Patents (SEPs) in India, delivering a victory to Philips Koninklijke Philips N.V. (Philips) in its long-standing legal battle against three Indian digital versatile disc (DVD) manufacturers. The case, titled Koninklijke Philips Electronics N.V. v Maj (Retd) Sukesh Behl & Anr, centered around Philips’ patented Eight-to-Fourteen Modulation Plus (EFM+) technology, an innovation crucial to the production of DVDs with minimal error rates and maximum storage capacity.
The case, which dates back to 2012, saw Philips accuse the defendants—Pearl Engineering Company, Powercube Infotech, and Siddharth Optical Disc Private Ltd—of using its EFM+ technology in their DVD production processes without obtaining a proper license. The technology, part of the DVD standard, plays a pivotal role in ensuring compatibility across devices by encoding data in a way that maximizes storage while minimizing data corruption. Philips sought a permanent injunction to halt further infringement and sought compensatory damages for the losses caused by the defendants’ actions.
The Legal Battle: Defendants’ Claims and Philips’ Counterarguments
The defendants countered the accusations of patent infringement, arguing that their DVD production methods did not use the patented EFM+ technology.
Non-compliance with Section 8: They argued that Philips had failed to disclose necessary information regarding foreign filings of the patent.
False Suggestions: The defendants claimed that the patent was granted due to false representations or suggestions made during the filing process.
Patent Eligibility: They contested the patent’s eligibility, claiming that it covered a method of performing mental acts (Section 3(m)) or a computer program per se (Section 3(k)), both of which are excluded from patentability under the Act.
Lack of Novelty and Inventive Step: The defendants further contended that the technology lacked novelty and inventive step, referencing a prior patent owned by Sony.
Insufficient Description: They also argued that the patent lacked a clear and sufficient description to allow replication by a skilled person in the field.
It asserted that any omission in the disclosure of foreign filings was unintentional and based on the available data within their records. Regarding the patent’s subject matter, Philips argued that the EFM+ technology involved a technical process that required hardware components, such as circuits and buses, and could not be performed mentally or abstractly. Therefore, it should not be classified under the excluded categories of Section 3(m) or Section 3(k).
The company further defended its technology, emphasizing that the EFM+ system was a novel invention in the field of digital storage, contributing to substantial technical advancements. Philips argued that the invention was not a mere software-based process but incorporated hardware elements that led to significant improvements in DVD manufacturing and storage capacity.
The Court’s Ruling: Affirming the SEP and Infringement
The Delhi High Court, in its judgment, sided with Philips, affirming the patent’s status as a Standard Essential Patent (SEP). It ruled that the defendants had indeed infringed upon Philips’ patent by utilizing the patented EFM+ technology in their DVD production without obtaining the necessary license.
The Court took a meticulous approach to the issue of FRAND (Fair, Reasonable, and Non-Discriminatory) licensing, emphasizing the global significance of SEPs in ensuring consistent and interoperable standards across industries. Despite the patent having expired during the course of the litigation, the Court highlighted that the defendants’ continued use of the patented technology without engaging in fair licensing negotiations violated the obligations under FRAND terms. As a result, the Court ruled in favor of awarding damages to Philips, emphasizing that the infringement had caused significant harm to the company.
Award of Damages: A Detailed Breakdown
The Court awarded Philips significant damages based on the established FRAND royalty rate for the patented technology. Philips had set a standard royalty rate of $0.03 per DVD. The defendants, however, had failed to disclose their actual sales figures, forcing the Court to estimate the number of DVDs that were manufactured using the EFM+ technology. The estimated sales figures for the defendants were as follows:
Pearl Engineering: Approximately 250 million DVDs.
Siddharth Optical: Around 65 million DVDs.
Powercube Infotech: Close to 499.3 million DVDs.
Using these estimates, the Court calculated the damages and converted the total sum into Indian Rupees at the current exchange rate of INR 83 per USD. The Court also took into account the time value of money during the prolonged litigation period, awarding interest at 12% per annum from the date the lawsuit was filed until the date of actual payment.
Furthermore, aggravated damages were imposed on the defendants due to their willful infringement and deliberate nondisclosure of sales records. This penalty was designed to reflect the defendants’ procedural misconduct and failure to comply with the legal requirements.
Breakdown of Financial Penalties
Pearl Engineering: Ordered to pay INR 6.22 crores (approx. USD 8,70,000) in royalty damages, plus INR 1 crore in aggravated damages, with interest accruing at 12% per annum from July 24, 2012 to February 25, 2025.
Siddharth Optical: Liable for approximately INR 1.61 crore in royalty damages and INR 1 crore in aggravated damages (approx. USD 3,14,458), with interest from May 28, 2012 to February 25, 2025.
Powercube Infotech: Faced the largest financial penalty, totaling INR 12.43 crore in royalty damages, plus INR 1 crore in aggravated damages (approx. USD 1,61,807), with interest from September 4, 2012 to February 20, 2025.
In addition to the damages, the Court mandated that the defendants cover the full costs of the litigation, citing the delay tactics used by the defendants that led to the prolonged legal proceedings.
A Landmark Judgment for SEP Enforcement
This ruling marks a critical milestone for the enforcement of Standard Essential Patents in India. It not only underscores the importance of adhering to FRAND terms but also sets a precedent for how similar cases might be handled in the future. The judgment highlights India’s increasing commitment to respecting and enforcing international patent licensing standards, especially in the realm of technology that has global implications for industry standards.
The case also demonstrates the growing importance of intellectual property rights (IPR) in India’s expanding technological and digital landscape. As the country continues to be an emerging hub for innovation and manufacturing, decisions like this reinforce the need for robust protections for innovators and patent holders.
In conclusion, this case reinforces the legal protections for SEPs in India, signaling to global markets that India is serious about enforcing patent rights and ensuring fair, non-discriminatory licensing in critical industries like electronics and telecommunications.
The case, which dates back to 2012, saw Philips accuse the defendants—Pearl Engineering Company, Powercube Infotech, and Siddharth Optical Disc Private Ltd—of using its EFM+ technology in their DVD production processes without obtaining a proper license. The technology, part of the DVD standard, plays a pivotal role in ensuring compatibility across devices by encoding data in a way that maximizes storage while minimizing data corruption. Philips sought a permanent injunction to halt further infringement and sought compensatory damages for the losses caused by the defendants’ actions.
The Legal Battle: Defendants’ Claims and Philips’ Counterarguments
The defendants countered the accusations of patent infringement, arguing that their DVD production methods did not use the patented EFM+ technology.
Non-compliance with Section 8: They argued that Philips had failed to disclose necessary information regarding foreign filings of the patent.
False Suggestions: The defendants claimed that the patent was granted due to false representations or suggestions made during the filing process.
Patent Eligibility: They contested the patent’s eligibility, claiming that it covered a method of performing mental acts (Section 3(m)) or a computer program per se (Section 3(k)), both of which are excluded from patentability under the Act.
Lack of Novelty and Inventive Step: The defendants further contended that the technology lacked novelty and inventive step, referencing a prior patent owned by Sony.
Insufficient Description: They also argued that the patent lacked a clear and sufficient description to allow replication by a skilled person in the field.
It asserted that any omission in the disclosure of foreign filings was unintentional and based on the available data within their records. Regarding the patent’s subject matter, Philips argued that the EFM+ technology involved a technical process that required hardware components, such as circuits and buses, and could not be performed mentally or abstractly. Therefore, it should not be classified under the excluded categories of Section 3(m) or Section 3(k).
The company further defended its technology, emphasizing that the EFM+ system was a novel invention in the field of digital storage, contributing to substantial technical advancements. Philips argued that the invention was not a mere software-based process but incorporated hardware elements that led to significant improvements in DVD manufacturing and storage capacity.
The Court’s Ruling: Affirming the SEP and Infringement
The Delhi High Court, in its judgment, sided with Philips, affirming the patent’s status as a Standard Essential Patent (SEP). It ruled that the defendants had indeed infringed upon Philips’ patent by utilizing the patented EFM+ technology in their DVD production without obtaining the necessary license.
The Court took a meticulous approach to the issue of FRAND (Fair, Reasonable, and Non-Discriminatory) licensing, emphasizing the global significance of SEPs in ensuring consistent and interoperable standards across industries. Despite the patent having expired during the course of the litigation, the Court highlighted that the defendants’ continued use of the patented technology without engaging in fair licensing negotiations violated the obligations under FRAND terms. As a result, the Court ruled in favor of awarding damages to Philips, emphasizing that the infringement had caused significant harm to the company.
Award of Damages: A Detailed Breakdown
The Court awarded Philips significant damages based on the established FRAND royalty rate for the patented technology. Philips had set a standard royalty rate of $0.03 per DVD. The defendants, however, had failed to disclose their actual sales figures, forcing the Court to estimate the number of DVDs that were manufactured using the EFM+ technology. The estimated sales figures for the defendants were as follows:
Pearl Engineering: Approximately 250 million DVDs.
Siddharth Optical: Around 65 million DVDs.
Powercube Infotech: Close to 499.3 million DVDs.
Using these estimates, the Court calculated the damages and converted the total sum into Indian Rupees at the current exchange rate of INR 83 per USD. The Court also took into account the time value of money during the prolonged litigation period, awarding interest at 12% per annum from the date the lawsuit was filed until the date of actual payment.
Furthermore, aggravated damages were imposed on the defendants due to their willful infringement and deliberate nondisclosure of sales records. This penalty was designed to reflect the defendants’ procedural misconduct and failure to comply with the legal requirements.
Breakdown of Financial Penalties
Pearl Engineering: Ordered to pay INR 6.22 crores (approx. USD 8,70,000) in royalty damages, plus INR 1 crore in aggravated damages, with interest accruing at 12% per annum from July 24, 2012 to February 25, 2025.
Siddharth Optical: Liable for approximately INR 1.61 crore in royalty damages and INR 1 crore in aggravated damages (approx. USD 3,14,458), with interest from May 28, 2012 to February 25, 2025.
Powercube Infotech: Faced the largest financial penalty, totaling INR 12.43 crore in royalty damages, plus INR 1 crore in aggravated damages (approx. USD 1,61,807), with interest from September 4, 2012 to February 20, 2025.
In addition to the damages, the Court mandated that the defendants cover the full costs of the litigation, citing the delay tactics used by the defendants that led to the prolonged legal proceedings.
A Landmark Judgment for SEP Enforcement
This ruling marks a critical milestone for the enforcement of Standard Essential Patents in India. It not only underscores the importance of adhering to FRAND terms but also sets a precedent for how similar cases might be handled in the future. The judgment highlights India’s increasing commitment to respecting and enforcing international patent licensing standards, especially in the realm of technology that has global implications for industry standards.
The case also demonstrates the growing importance of intellectual property rights (IPR) in India’s expanding technological and digital landscape. As the country continues to be an emerging hub for innovation and manufacturing, decisions like this reinforce the need for robust protections for innovators and patent holders.
In conclusion, this case reinforces the legal protections for SEPs in India, signaling to global markets that India is serious about enforcing patent rights and ensuring fair, non-discriminatory licensing in critical industries like electronics and telecommunications.
Calcutta High Court Upholds Transparency and Fairness in Patent Examination: Takeda Pharmaceutical Co. Ltd. v. Controller of Patents
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.
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.
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.
India’s Evolving Intellectual Property Landscape: A Key Turning Point for Pharma Industry
“The needle has moved,” declares Anil Matai, Director General of the Organization of Pharmaceutical Producers of India (OPPI), in a recent podcast interview with Scrip. The statement refers to the substantial changes in India’s intellectual property rights (IPR) regime, which witnessed some critical amendments in the past year. As the representative body for foreign pharmaceutical companies in India, OPPI plays a crucial role in shaping the country’s IPR and regulatory environment, which continues to evolve as the industry adapts to both domestic and global pressures.
Matai’s remarks signal that India’s pharmaceutical sector is undergoing a transformation, particularly in areas such as patent regulations, data protection, and the ongoing debates surrounding Section 3(d) of the Indian Patent Act.
Key Amendments and the State of Play
India’s intellectual property landscape has been in flux, with several key amendments to the patent law being introduced last year.
However, one of the most controversial aspects of India’s patent system remains Section 3(d) of the Indian Patents Act. Section 3(d) prevents the patenting of new forms of known substances unless they result in significantly enhanced efficacy.
The ruling emphasized the need for innovation beyond mere incremental changes, a stance that was seen as a win for public health over the interests of global pharmaceutical companies. However, for foreign firms like those represented by OPPI, Section 3(d) remains a longstanding sticking point. Matai pointed out that while India’s patent system has evolved, challenges such as these continue to make it difficult for global innovators to protect their products in the country.
Data Protection: A Global Imperative
Another critical issue discussed by Matai is the need for Regulatory Data Protection (RDP), which he describes as a “no-brainer.” RDP refers to the protection of clinical trial data submitted to regulatory authorities in the drug approval process, ensuring that competitors cannot rely on this data to gain approval for their own versions of a drug without conducting their own trials. Matai cites China’s rapid advancement in the biologics space as an example, noting that China has already made significant strides in protecting RDP and attracting global pharmaceutical investment.
China’s National Medical Products Administration (NMPA) recently introduced guidelines that outline specific periods of data exclusivity for different categories of drugs. These guidelines are part of the broader regulatory framework that has seen China move ahead of India in the biologics sector.
The issue of data exclusivity (DE) has been contentious in India for years. Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, India, like other member states, is required to protect undisclosed data necessary for regulatory approval of new chemical entities. However, India has not yet provided for data exclusivity in its laws. While the generics industry and public health advocates argue that this is a matter of confidentiality and not exclusivity, foreign firms see data exclusivity as crucial for fostering innovation and protecting intellectual property.
Matai emphasized that India’s reluctance to adopt data exclusivity is a hindrance to attracting foreign investment in the pharmaceutical sector. “Without adequate data protection, global pharmaceutical companies may look elsewhere for growth opportunities,” he warned, citing how China has leveraged RDP to become a hub for life sciences research and development.
US-India Trade Relations and the Road Ahead
The issue of intellectual property rights is not only a domestic matter but also an international one, particularly in the context of India’s trade relationships. India remains on the Priority Watch List in the United States Trade Representative’s (USTR) Special 301 Report, which highlights countries that are seen as not providing adequate protection for intellectual property rights. India shares this distinction with China, reflecting ongoing concerns about patent protection, data exclusivity, and the safeguarding of undisclosed data.
The U.S. has long pushed for stronger IP protection in India, with senior figures such as Eli Lilly’s CEO, David Ricks, calling for the country to rethink its stance on IPR and become a leader in life sciences. According to Ricks and other pharmaceutical leaders, India’s regulatory framework must evolve to align with global standards to attract the level of investment needed for the country to become a competitive player in the pharmaceutical industry.
Both India and the U.S. are now working toward the first tranche of a multi-sector Bilateral Trade Agreement (BTA), which is expected to be finalized by the fall of 2025. It remains to be seen whether intellectual property issues, including those surrounding patent eligibility and data exclusivity, will be part of the negotiations. If they are, the outcome could have a profound impact on the future of the pharmaceutical industry in India.
The Path Forward
India’s evolving IPR landscape presents both challenges and opportunities. While the changes in the regulatory environment signal progress, much remains to be done to balance the needs of public health with those of global pharmaceutical companies. As foreign firms continue to call for stronger IP protections, India faces the delicate task of crafting a system that promotes innovation without undermining access to affordable medicines.
Anil Matai’s comments reflect the tensions at play in this balancing act. As India moves toward a more integrated role in the global pharmaceutical market, the next few years will be pivotal in shaping the future of the country’s intellectual property and regulatory framework. Whether India can find the right balance between fostering innovation, attracting investment, and maintaining access to essential medicines will be key to its future as a global leader in the life sciences sector.
In the meantime, the global pharmaceutical community will be watching closely, as India’s regulatory evolution continues to unfold.
Indian Patent Granted for Cutting-Edge Drought Monitoring System Using AI, IoT, and Geospatial Technology
In a significant step forward for drought preparedness and management, the Indian Patent Office has granted a patent for an advanced system that utilizes AI, Internet of Things (IoT), and geospatial technologies to monitor and assess drought conditions in real time.
Designed to address the pressing need for accurate and timely drought data—particularly in vulnerable regions like Marathwada, which frequently faces water shortages—the system offers a modern alternative to outdated assessment methods.
“Conventional techniques such as Annewari and Paisewari, while historically relevant, are not equipped to deliver the precision and speed required for effective drought response today,” said Prof. Kale. “These methods often delay estimates until months after crop damage has occurred—December for Kharif and March for Rabi—hampering timely relief efforts.”
The patented technology was the result of collaborative research led by Gaikwad with critical contributions from Dr. Amol Vibhute, Dr. Rajesh Dhumal, and Dr. Rupali Surase. Their innovation integrates satellite-based remote sensing, mobile-based field data collection, and IoT-enabled sensor networks to deliver highly accurate and localized drought assessments.
A pilot implementation of the system was carried out in the Vaijapur tehsil of Chhatrapati Sambhajinagar district, a region known for recurrent droughts. According to Gaikwad, the new system demonstrated strong potential to transform the way droughts are tracked and responded to.
“This solution provides real-time, location-specific insights that can help authorities and farmers take timely preventive measures, ultimately minimizing the agricultural and socio-economic impact of droughts,” Gaikwad explained.
Prof. Kale added that the system is not only scalable but also adaptable for use in other drought-prone areas across India. The team believes that this technology could play a vital role in strengthening the country’s resilience to climate-induced challenges in agriculture.
Designed to address the pressing need for accurate and timely drought data—particularly in vulnerable regions like Marathwada, which frequently faces water shortages—the system offers a modern alternative to outdated assessment methods.
“Conventional techniques such as Annewari and Paisewari, while historically relevant, are not equipped to deliver the precision and speed required for effective drought response today,” said Prof. Kale. “These methods often delay estimates until months after crop damage has occurred—December for Kharif and March for Rabi—hampering timely relief efforts.”
The patented technology was the result of collaborative research led by Gaikwad with critical contributions from Dr. Amol Vibhute, Dr. Rajesh Dhumal, and Dr. Rupali Surase. Their innovation integrates satellite-based remote sensing, mobile-based field data collection, and IoT-enabled sensor networks to deliver highly accurate and localized drought assessments.
A pilot implementation of the system was carried out in the Vaijapur tehsil of Chhatrapati Sambhajinagar district, a region known for recurrent droughts. According to Gaikwad, the new system demonstrated strong potential to transform the way droughts are tracked and responded to.
“This solution provides real-time, location-specific insights that can help authorities and farmers take timely preventive measures, ultimately minimizing the agricultural and socio-economic impact of droughts,” Gaikwad explained.
Prof. Kale added that the system is not only scalable but also adaptable for use in other drought-prone areas across India. The team believes that this technology could play a vital role in strengthening the country’s resilience to climate-induced challenges in agriculture.