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.
USPTO
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.
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.
Heimdal Receives U.S. Patent for Innovative AI-Powered DNS Threat Detection
Heimdal, a leading European cybersecurity firm, has been awarded U.S. Patent No. 18333620 for a proprietary method that predicts the likelihood of a domain being malicious. The patented technology, titled “Apparatus and Method of Predicting Malicious Domains,” marks a significant step forward in Heimdal’s mission to redefine DNS security.
This invention forms the foundation of Predictive DNS™, Heimdal’s AI-driven system designed to detect and block harmful domains before they are weaponized in phishing, ransomware, or data theft campaigns. The technology uses a combination of machine learning, natural language processing (NLP), and computer vision — all powered by neural networks trained on millions of data points including domain names and DNS behavior.
“It ensures we can continue to protect our customers with industry-leading innovation.”
The patented method allows for earlier and more accurate threat detection, giving security teams a powerful tool to prevent cyberattacks before they occur. Integrated into the company’s broader Heimdal XDR platform, this development supports fully automated, risk-aware threat prevention strategies.
With DNS traffic involved in over 90% of malware and breach-related activity, Heimdal’s technology addresses one of the most exploited yet often overlooked areas of cybersecurity.
Key features of Heimdal’s Predictive DNS™ include:
High-precision threat detection, measured by strong F1 scores.
Real-time adaptability, with AI models that evolve based on new data.
Seamless platform integration, enhancing Heimdal’s extended detection and response (XDR) capabilities.
As global threats grow more sophisticated, Heimdal’s latest achievement positions it as a critical player in next-generation cybersecurity.
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.
USPTO Streamlines Patent Issuance Timeline with Faster Turnaround Starting May 13
In a move that promises to bring greater efficiency to the U.S. patent system, the United States Patent and Trademark Office (USPTO) has announced a major update to its patent issuance process.
This improvement marks a significant shift in the patenting landscape, providing faster legal recognition of inventions and reducing administrative lag for both individual inventors and companies awaiting protection for their intellectual property.
Transition to Digital Patent Grants Accelerates the Process
The accelerated timeline has been made possible in large part due to the USPTO’s adoption of electronic patent grants (eGrants). With the USPTO now fully transitioned to digital issuance, those time-consuming steps have been eliminated, allowing for quicker finalization of granted patents.
The agency has stated that, once all requirements are met and the Issue Fee is paid, inventors typically receive an Issue Notification within one to two weeks. Under the new process, the formal patent will be granted just two weeks after this notification, as opposed to the previous three-week standard.
Benefits for Inventors and Legal Professionals
This change not only shortens the waiting period for inventors eager to see their rights formally granted, but it also has strategic legal benefits. The reduced timeline cuts down the so-called “lame duck” period—a window of time during which inventors and their legal counsel are still required to submit any known prior art that might affect the patent’s validity. During this period, submissions of relevant information could cause delays in issuance.
By shortening this window, the USPTO effectively reduces the likelihood of last-minute delays caused by prior art disclosures, allowing for smoother and more predictable patent finalizations.
A Win for Innovation and IP Management
The streamlined process is being welcomed by the patent community as a step in the right direction. Faster issuance allows inventors to enforce their rights sooner, boosts the value of patent portfolios more quickly, and provides an advantage to companies working in fast-moving sectors such as technology, pharmaceuticals, and biotech.
“This is a smart move by the USPTO,” said a patent attorney at a Washington-based IP law firm. “In a time where speed to market can make or break an invention’s commercial potential, cutting down unnecessary administrative lag can be a game-changer.”
Looking Ahead
The USPTO has been steadily modernizing its systems to better serve inventors, including the roll-out of digital filing systems, the modernization of examiner tools, and now this reduction in issuance lag. These changes reflect the agency’s ongoing commitment to streamlining operations while maintaining high standards for patent examination and grant quality.
As of May 13, inventors who receive their issue notifications can expect to see their patents granted just two weeks later—giving them the legal recognition and rights they’ve earned, faster than ever before.
This improvement marks a significant shift in the patenting landscape, providing faster legal recognition of inventions and reducing administrative lag for both individual inventors and companies awaiting protection for their intellectual property.
Transition to Digital Patent Grants Accelerates the Process
The accelerated timeline has been made possible in large part due to the USPTO’s adoption of electronic patent grants (eGrants). With the USPTO now fully transitioned to digital issuance, those time-consuming steps have been eliminated, allowing for quicker finalization of granted patents.
The agency has stated that, once all requirements are met and the Issue Fee is paid, inventors typically receive an Issue Notification within one to two weeks. Under the new process, the formal patent will be granted just two weeks after this notification, as opposed to the previous three-week standard.
Benefits for Inventors and Legal Professionals
This change not only shortens the waiting period for inventors eager to see their rights formally granted, but it also has strategic legal benefits. The reduced timeline cuts down the so-called “lame duck” period—a window of time during which inventors and their legal counsel are still required to submit any known prior art that might affect the patent’s validity. During this period, submissions of relevant information could cause delays in issuance.
By shortening this window, the USPTO effectively reduces the likelihood of last-minute delays caused by prior art disclosures, allowing for smoother and more predictable patent finalizations.
A Win for Innovation and IP Management
The streamlined process is being welcomed by the patent community as a step in the right direction. Faster issuance allows inventors to enforce their rights sooner, boosts the value of patent portfolios more quickly, and provides an advantage to companies working in fast-moving sectors such as technology, pharmaceuticals, and biotech.
“This is a smart move by the USPTO,” said a patent attorney at a Washington-based IP law firm. “In a time where speed to market can make or break an invention’s commercial potential, cutting down unnecessary administrative lag can be a game-changer.”
Looking Ahead
The USPTO has been steadily modernizing its systems to better serve inventors, including the roll-out of digital filing systems, the modernization of examiner tools, and now this reduction in issuance lag. These changes reflect the agency’s ongoing commitment to streamlining operations while maintaining high standards for patent examination and grant quality.
As of May 13, inventors who receive their issue notifications can expect to see their patents granted just two weeks later—giving them the legal recognition and rights they’ve earned, faster than ever before.
Shares of Lupin and Zydus Life Slide After Losing US Patent Case to Astellas Pharma
Shares of Indian pharmaceutical giants Lupin and Zydus Lifesciences came under significant selling pressure on April 16, falling by 3% and 4.5% respectively. The decline followed a ruling by the U.S. District Court in Delaware in favor of Astellas Pharma, the original patent holder of Myrbetriq, a drug used to treat overactive bladder (OAB). The court determined that Lupin and Zydus had infringed upon Astellas’s patent rights, potentially paving the way for the withdrawal of their generic versions from the U.S. market.
Court Ruling Favors Astellas
The dispute centers around the ‘780 patent, which protects the formulation of Mirabegron, the active ingredient in Myrbetriq. Astellas Pharma filed a lawsuit claiming that the generic products manufactured by Lupin and Zydus violated this patent.
The judgment emphasized that the defendants failed to demonstrate that the patent was invalid on grounds such as lack of enablement, inadequate written description, or indefiniteness. With the court upholding the validity of the ‘780 patent, the generics produced by Lupin and Zydus are now under threat of being barred from sale in the U.S.
Financial Implications Loom
Market analysts have raised concerns over the financial impact this legal defeat could have on the Indian pharma companies. Myrbetriq was anticipated to contribute nearly $30 million in quarterly revenues to each company, according to some industry estimates. The ruling could not only impact future earnings but also result in penalties.
Vishal Manchanda, a pharmaceutical sector analyst at Systematix Group, told CNBC-TV18, “We expect a tangible hit to FY26 earnings for both Zydus Life and Lupin due to this development. Moreover, damages and potential penalties, if levied by the jury trial, could further strain their financials.”
The final determination of damages and any remaining disputes over infringement or validity will be taken up in a consolidated jury trial scheduled for 2026.
Companies Respond
In a post-market statement, Zydus Lifesciences acknowledged the verdict and said it is currently reviewing the court order and assessing its implications. “We are evaluating the potential impact of the said order on the operations of the Company and the legal remedies available with the Company,” the statement read.
Both Zydus and Lupin have filed a ‘Motion to Clarify’ in an effort to assert additional arguments regarding the patent’s validity, which the court will consider during the 2026 trial.
Background on Myrbetriq and the Patent Dispute
Myrbetriq, approved by the U.S. Food and Drug Administration in 2012, has been a high-value product in the OAB treatment category, with global sales reaching over a billion dollars annually in recent years. The drug works by relaxing the bladder muscle to increase storage capacity and reduce urinary urgency.
The ‘780 patent, central to the lawsuit, covers specific formulations and the method of administration of Mirabegron. Patent infringement in this context refers to manufacturing or selling a product that falls within the patent’s claim scope without authorization from the patent holder.
The ruling highlights the risks generic manufacturers face when attempting to enter markets dominated by patented medications. It also reaffirms the legal strength of patent protections in the U.S., particularly for high-value pharmaceutical products.
Market Reaction
Investors reacted swiftly to the news, with both Lupin and Zydus Life stocks falling sharply in trading. Analysts believe the market is pricing in not only the potential loss of revenue but also uncertainty around future legal proceedings and penalties.
The verdict serves as a cautionary tale for generics manufacturers and underscores the importance of thorough patent analysis before launching competing products in major markets like the United States.
As the legal battle progresses, the pharmaceutical sector will be closely watching the developments in the run-up to the 2026 trial, which will determine the extent of financial liability and the long-term market prospects for generic versions of Myrbetriq.
Court Ruling Favors Astellas
The dispute centers around the ‘780 patent, which protects the formulation of Mirabegron, the active ingredient in Myrbetriq. Astellas Pharma filed a lawsuit claiming that the generic products manufactured by Lupin and Zydus violated this patent.
The judgment emphasized that the defendants failed to demonstrate that the patent was invalid on grounds such as lack of enablement, inadequate written description, or indefiniteness. With the court upholding the validity of the ‘780 patent, the generics produced by Lupin and Zydus are now under threat of being barred from sale in the U.S.
Financial Implications Loom
Market analysts have raised concerns over the financial impact this legal defeat could have on the Indian pharma companies. Myrbetriq was anticipated to contribute nearly $30 million in quarterly revenues to each company, according to some industry estimates. The ruling could not only impact future earnings but also result in penalties.
Vishal Manchanda, a pharmaceutical sector analyst at Systematix Group, told CNBC-TV18, “We expect a tangible hit to FY26 earnings for both Zydus Life and Lupin due to this development. Moreover, damages and potential penalties, if levied by the jury trial, could further strain their financials.”
The final determination of damages and any remaining disputes over infringement or validity will be taken up in a consolidated jury trial scheduled for 2026.
Companies Respond
In a post-market statement, Zydus Lifesciences acknowledged the verdict and said it is currently reviewing the court order and assessing its implications. “We are evaluating the potential impact of the said order on the operations of the Company and the legal remedies available with the Company,” the statement read.
Both Zydus and Lupin have filed a ‘Motion to Clarify’ in an effort to assert additional arguments regarding the patent’s validity, which the court will consider during the 2026 trial.
Background on Myrbetriq and the Patent Dispute
Myrbetriq, approved by the U.S. Food and Drug Administration in 2012, has been a high-value product in the OAB treatment category, with global sales reaching over a billion dollars annually in recent years. The drug works by relaxing the bladder muscle to increase storage capacity and reduce urinary urgency.
The ‘780 patent, central to the lawsuit, covers specific formulations and the method of administration of Mirabegron. Patent infringement in this context refers to manufacturing or selling a product that falls within the patent’s claim scope without authorization from the patent holder.
The ruling highlights the risks generic manufacturers face when attempting to enter markets dominated by patented medications. It also reaffirms the legal strength of patent protections in the U.S., particularly for high-value pharmaceutical products.
Market Reaction
Investors reacted swiftly to the news, with both Lupin and Zydus Life stocks falling sharply in trading. Analysts believe the market is pricing in not only the potential loss of revenue but also uncertainty around future legal proceedings and penalties.
The verdict serves as a cautionary tale for generics manufacturers and underscores the importance of thorough patent analysis before launching competing products in major markets like the United States.
As the legal battle progresses, the pharmaceutical sector will be closely watching the developments in the run-up to the 2026 trial, which will determine the extent of financial liability and the long-term market prospects for generic versions of Myrbetriq.