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.
drug
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.
High Courts Should Not Intervene in SARFAESI Proceedings Unless Actions Are Clearly Illegal or Mala Fide: Allahabad High Court
In a recent judgment, the Allahabad High Court emphasized that judicial intervention in matters governed by the Securitisation and Reconstruction of Financial Assets and Enforcement of Security Interest (SARFAESI) Act, 2002, should be limited to instances where banks have acted either unlawfully or with mala fide intent.
The division bench, comprising Justice Shekhar B. Saraf and Justice Dr. Yogendra Kumar Srivastava, cited the Supreme Court’s ruling in United Bank of India vs. Satyawati Tondon & Others to support its stance. The bench noted, “Interference by this Court in SARFAESI-related issues is not warranted unless a clear case of illegality or bad faith is established on the part of the bank authorities.”
This section empowers financial institutions to recover dues by enforcing security interests if a borrower fails to repay within 60 days after receiving a demand notice under Section 13(2).
The petitioner argued that the bank did not respond to their objection filed under Section 13(3A) before initiating recovery action under Section 13(4). However, upon reviewing the documents submitted, the court found that the bank had issued an order addressing the objection and attempted to serve it via post. Though delivery to two of the petitioners was unsuccessful due to the premises being locked, the court acknowledged that proper service to one petitioner may not have occurred. Despite this, the petitioners had received the Section 13(4) notice and had subsequently challenged it before the Debts Recovery Tribunal (DRT).
The High Court pointed out that the petitioners initially failed to inform the court that they had already approached the DRT. This fact only came to light through a supplementary affidavit filed later. The court observed that since the petitioners had already sought remedy before the DRT, pursuing the same grievance through a writ petition constituted a case of attempting to “sail in two boats.”
“The existence of an order under Section 13(3A), the efforts made to deliver it, and the petitioners’ acknowledgment of the Section 13(4) notice suggest that they had the opportunity to raise their concerns before the appropriate forum. Having done so, they cannot now bypass that process by invoking the writ jurisdiction of this Court,” the bench observed.
The court further highlighted that the petitioners had already raised the same objections regarding Section 13(3A) in their application before the DRT, rendering their writ plea redundant.
Reaffirming the precedent set by the Supreme Court in Satyawati Tondon, the High Court stressed that although the Constitution allows for writ petitions even where alternate remedies exist, such discretion should be exercised sparingly when an effective statutory mechanism is available.
With no evidence of mala fide conduct by the bank and considering that the asset sale had already occurred, the court found no reason to intervene. Consequently, the writ petition was dismissed.
The division bench, comprising Justice Shekhar B. Saraf and Justice Dr. Yogendra Kumar Srivastava, cited the Supreme Court’s ruling in United Bank of India vs. Satyawati Tondon & Others to support its stance. The bench noted, “Interference by this Court in SARFAESI-related issues is not warranted unless a clear case of illegality or bad faith is established on the part of the bank authorities.”
This section empowers financial institutions to recover dues by enforcing security interests if a borrower fails to repay within 60 days after receiving a demand notice under Section 13(2).
The petitioner argued that the bank did not respond to their objection filed under Section 13(3A) before initiating recovery action under Section 13(4). However, upon reviewing the documents submitted, the court found that the bank had issued an order addressing the objection and attempted to serve it via post. Though delivery to two of the petitioners was unsuccessful due to the premises being locked, the court acknowledged that proper service to one petitioner may not have occurred. Despite this, the petitioners had received the Section 13(4) notice and had subsequently challenged it before the Debts Recovery Tribunal (DRT).
The High Court pointed out that the petitioners initially failed to inform the court that they had already approached the DRT. This fact only came to light through a supplementary affidavit filed later. The court observed that since the petitioners had already sought remedy before the DRT, pursuing the same grievance through a writ petition constituted a case of attempting to “sail in two boats.”
“The existence of an order under Section 13(3A), the efforts made to deliver it, and the petitioners’ acknowledgment of the Section 13(4) notice suggest that they had the opportunity to raise their concerns before the appropriate forum. Having done so, they cannot now bypass that process by invoking the writ jurisdiction of this Court,” the bench observed.
The court further highlighted that the petitioners had already raised the same objections regarding Section 13(3A) in their application before the DRT, rendering their writ plea redundant.
Reaffirming the precedent set by the Supreme Court in Satyawati Tondon, the High Court stressed that although the Constitution allows for writ petitions even where alternate remedies exist, such discretion should be exercised sparingly when an effective statutory mechanism is available.
With no evidence of mala fide conduct by the bank and considering that the asset sale had already occurred, the court found no reason to intervene. Consequently, the writ petition was dismissed.
India Sees 310% Rise in Patent Filings by Startups and MSMEs in Last Five Years
India has witnessed an extraordinary increase in patent filings by startups and micro, small, and medium enterprises (MSMEs), with data revealing a 310% growth over the past five years. This surge underscores the country’s growing focus on innovation, research, and intellectual property protection among emerging businesses.
According to recent government and industry data, this dramatic rise in patent activity reflects the effectiveness of initiatives aimed at nurturing a robust innovation ecosystem. Supportive policies, such as reduced filing fees, fast-track examination processes, and government-backed awareness programs, have played a critical role in encouraging smaller enterprises and startups to safeguard their inventions.
Experts believe that the increasing participation of startups and MSMEs in patenting not only signals a maturing entrepreneurial landscape but also positions India as a rising innovation hub on the global stage.
Government officials have noted that this trend aligns with the vision of making India self-reliant and technology-driven. The growing number of intellectual property filings by smaller players is also contributing to job creation, export potential, and overall economic growth.
The momentum is expected to continue as more early-stage ventures recognize the strategic value of protecting their intellectual property, particularly in sectors such as artificial intelligence, healthcare, clean energy, and digital technologies.
According to recent government and industry data, this dramatic rise in patent activity reflects the effectiveness of initiatives aimed at nurturing a robust innovation ecosystem. Supportive policies, such as reduced filing fees, fast-track examination processes, and government-backed awareness programs, have played a critical role in encouraging smaller enterprises and startups to safeguard their inventions.
Experts believe that the increasing participation of startups and MSMEs in patenting not only signals a maturing entrepreneurial landscape but also positions India as a rising innovation hub on the global stage.
Government officials have noted that this trend aligns with the vision of making India self-reliant and technology-driven. The growing number of intellectual property filings by smaller players is also contributing to job creation, export potential, and overall economic growth.
The momentum is expected to continue as more early-stage ventures recognize the strategic value of protecting their intellectual property, particularly in sectors such as artificial intelligence, healthcare, clean energy, and digital technologies.
SK bioscience Claims Final Victory in mRNA Patent Dispute Against Moderna
South Korea’s SK bioscience, the biopharmaceutical subsidiary of SK Group, announced on Wednesday that it has secured a decisive win in a patent dispute against U.S.-based biotechnology company Moderna, known globally for its development of mRNA COVID-19 vaccines.
The legal challenge, initiated in 2023, contested Moderna’s South Korean patent concerning the use and modification of nucleosides, nucleotides, and nucleic acids in mRNA technology. According to SK bioscience, the patent posed a significant barrier to domestic research and innovation by granting what it called “unjust priority rights.” This patent, reportedly the only one of its kind registered in South Korea related to mRNA production, was viewed as crucial to SK bioscience’s ongoing projects, including its experimental mRNA vaccine for Japanese encephalitis, GBP560.
The vaccine project is being conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), a global health organization supported by funding from philanthropist Bill Gates.
A spokesperson for the company highlighted that, if successful, its mRNA-based vaccines could be distributed in developing regions such as Africa, Southeast Asia, Latin America, and the Middle East—areas where Moderna has not yet secured intellectual property rights for its mRNA technology.
The ruling in SK bioscience’s favor came from the Intellectual Property Trial and Appeal Board last month, and with Moderna opting not to appeal within the designated timeframe, the decision stands as final. The company believes this outcome will accelerate its ambitions to become a key player in the mRNA vaccine space, which analysts project could surpass 84 trillion won (around $58.9 billion) in market value by 2033.
SK bioscience now aims to develop a robust mRNA platform that can be used to combat not just pandemics, but a broader array of infectious diseases worldwide.
The legal challenge, initiated in 2023, contested Moderna’s South Korean patent concerning the use and modification of nucleosides, nucleotides, and nucleic acids in mRNA technology. According to SK bioscience, the patent posed a significant barrier to domestic research and innovation by granting what it called “unjust priority rights.” This patent, reportedly the only one of its kind registered in South Korea related to mRNA production, was viewed as crucial to SK bioscience’s ongoing projects, including its experimental mRNA vaccine for Japanese encephalitis, GBP560.
The vaccine project is being conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), a global health organization supported by funding from philanthropist Bill Gates.
A spokesperson for the company highlighted that, if successful, its mRNA-based vaccines could be distributed in developing regions such as Africa, Southeast Asia, Latin America, and the Middle East—areas where Moderna has not yet secured intellectual property rights for its mRNA technology.
The ruling in SK bioscience’s favor came from the Intellectual Property Trial and Appeal Board last month, and with Moderna opting not to appeal within the designated timeframe, the decision stands as final. The company believes this outcome will accelerate its ambitions to become a key player in the mRNA vaccine space, which analysts project could surpass 84 trillion won (around $58.9 billion) in market value by 2033.
SK bioscience now aims to develop a robust mRNA platform that can be used to combat not just pandemics, but a broader array of infectious diseases worldwide.
ToolGen Initiates UK Patent Lawsuit Against Vertex Over Groundbreaking Gene Therapy CASGEVY
ToolGen, Inc. (KOSDAQ: 199800), a biotechnology firm at the forefront of genome editing innovations, has filed a patent infringement lawsuit in the United Kingdom against Vertex Pharmaceuticals and its key manufacturing partners, Lonza and RoslinCT. The legal action centers on Vertex’s approved CRISPR-based gene therapy, CASGEVY, which ToolGen alleges utilizes its proprietary technology without proper authorization.
ToolGen claims the development and commercialization of CASGEVY infringe upon its intellectual property related to the use of CRISPR RNP (ribonucleoprotein complex) technology. The South Korea-based company holds global patents, including those granted in Europe, for its CRISPR RNP methodology. This advanced technique enables the direct delivery of the Cas9 protein into target cells in its active protein form—bypassing the use of DNA or mRNA vectors. Such an approach not only reduces the risk of genomic integration and cellular toxicity but also offers enhanced precision and safety, making it a preferred platform in human therapeutics, as well as agricultural and animal biotechnology.
CASGEVY made history as the first gene editing therapy to be approved for clinical use, beginning with authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023, and subsequently by the European Commission in February 2024.
In December 2023, Vertex signed a licensing deal with Editas Medicine to access CRISPR-related technology. However, ToolGen asserts that this agreement does not cover critical components of the CRISPR RNP delivery system, which it pioneered and for which it holds enforceable patents.
“CASGEVY is a remarkable achievement, but it rests on a technological foundation developed by ToolGen. We believe Vertex’s therapy makes essential use of our CRISPR RNP and Cas9 technologies, and it is only fair that ToolGen be properly compensated through an appropriate licensing arrangement.”
Dr. Ryu clarified that the company’s legal move is not intended to hinder patient access to the life-changing treatment.
“This action is not about limiting access to CASGEVY in any way,” he said. “Our goal is to ensure that ToolGen’s contributions are justly recognized and rewarded.”
The lawsuit is expected to draw attention from across the biotech sector, as it highlights ongoing disputes in the fast-evolving field of genome editing, where overlapping patents and complex licensing agreements remain a point of contention.
As the legal process unfolds, industry observers will be watching closely, not only for the outcome of the case but also for its potential implications on future licensing practices and collaborations in CRISPR therapeutics worldwide.
ToolGen claims the development and commercialization of CASGEVY infringe upon its intellectual property related to the use of CRISPR RNP (ribonucleoprotein complex) technology. The South Korea-based company holds global patents, including those granted in Europe, for its CRISPR RNP methodology. This advanced technique enables the direct delivery of the Cas9 protein into target cells in its active protein form—bypassing the use of DNA or mRNA vectors. Such an approach not only reduces the risk of genomic integration and cellular toxicity but also offers enhanced precision and safety, making it a preferred platform in human therapeutics, as well as agricultural and animal biotechnology.
CASGEVY made history as the first gene editing therapy to be approved for clinical use, beginning with authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023, and subsequently by the European Commission in February 2024.
In December 2023, Vertex signed a licensing deal with Editas Medicine to access CRISPR-related technology. However, ToolGen asserts that this agreement does not cover critical components of the CRISPR RNP delivery system, which it pioneered and for which it holds enforceable patents.
“CASGEVY is a remarkable achievement, but it rests on a technological foundation developed by ToolGen. We believe Vertex’s therapy makes essential use of our CRISPR RNP and Cas9 technologies, and it is only fair that ToolGen be properly compensated through an appropriate licensing arrangement.”
Dr. Ryu clarified that the company’s legal move is not intended to hinder patient access to the life-changing treatment.
“This action is not about limiting access to CASGEVY in any way,” he said. “Our goal is to ensure that ToolGen’s contributions are justly recognized and rewarded.”
The lawsuit is expected to draw attention from across the biotech sector, as it highlights ongoing disputes in the fast-evolving field of genome editing, where overlapping patents and complex licensing agreements remain a point of contention.
As the legal process unfolds, industry observers will be watching closely, not only for the outcome of the case but also for its potential implications on future licensing practices and collaborations in CRISPR therapeutics worldwide.
USPTO Suspends Expedited Examination for Design Applications Amid Fraud Concerns and Case Backlog
In a decisive move aimed at improving efficiency and safeguarding the integrity of the U.S. intellectual property system, the United States Patent and Trademark Office (USPTO) has announced the suspension of expedited examination for design patent applications, effective April 17, 2025. The policy change was officially detailed in a notice published in the USPTO’s Official Gazette on April 14.
The decision comes in response to a 560% surge in requests for expedited design application reviews—a trend the USPTO attributes in large part to a rise in fraudulent filings. This suspension is part of a broader strategy to reduce the growing inventory of unexamined design applications, curb misuse of the system, and ensure accurate and fair processing for legitimate applicants.
Key Reasons Behind the Suspension
According to the USPTO, the unexpected spike in expedited examination requests has placed significant pressure on examiners and contributed to increased backlogs in the design application pipeline. Much of this rise, the agency notes, is linked to fraudulent filings, which not only distort processing timelines but also pose risks to the integrity of the U.S. intellectual property system.
The USPTO also cites a rise in erroneous micro entity certifications—false claims to fee discounts intended for small applicants—as a factor in its decision. These certifications have become a growing concern in recent years, complicating the patent review process and necessitating additional scrutiny.
What the Suspension Means for Applicants
Starting April 17, 2025, the USPTO will no longer grant requests for expedited examination of design applications, including any renewed or pending requests submitted on or after that date. In line with this change:
Associated fees will be refunded in full for requests made after the effective date.
The USPTO will continue to examine design applications under its standard timeline, as it works to reduce overall pendency and inventory.
Impact on the Design Patent Community
The suspension will have a notable impact on companies and individuals relying on faster design patent protection for products with short market cycles, particularly in sectors like fashion, consumer electronics, and packaging design. However, the USPTO maintains that ensuring quality and transparency in the application process outweighs the short-term disruption caused by the policy shift.
Industry analysts suggest that while the suspension may create delays for some innovators, the move is likely to improve the reliability and credibility of granted design patents in the long run, which is critical for both domestic and international enforcement.
Broader Reform Efforts
This policy change is one component of the USPTO’s wider agenda to combat abuse and strengthen the integrity of the IP system. The office has been ramping up enforcement against fraudulent filings, improving data analytics to detect suspicious activity, and refining procedures for certifying applicant eligibility for reduced fees.
The USPTO also continues to explore new technologies and staffing solutions to address examination delays and ensure legitimate applications are processed efficiently.
New Guide Offers Strategic Insights to Strengthen Drug Patent Applications for Pharma Innovators
In a move designed to bridge the gap between pharmaceutical research and market success, a newly released guide is offering strategic advice to drug developers on how to craft more effective patent applications. Published on the widely respected platform DrugPatentWatch, the guide is titled “Drafting Effective Drug Patent Applications: Turning Science into Market Power” and is aimed at pharmaceutical companies, research institutions, and individual innovators seeking to protect and capitalize on their scientific breakthroughs.
Accessible via DrugPatentWatch’s blog, the guide draws from hands-on experience in supporting drug developers through the complexities of patent law and the commercial pharmaceutical landscape.
Why a Strong Patent Application Matters
In today’s competitive pharmaceutical sector, patents are among the most critical assets that determine a drug’s commercial viability. The guide emphasizes that a poorly drafted patent—regardless of the novelty of the underlying science—can leave a drug vulnerable to challenges or fail to provide adequate market exclusivity.
The document outlines that successful drug patents must not only be scientifically robust but also strategically written to withstand scrutiny from regulators and potential competitors. This involves anticipating legal hurdles, clearly defining claims, and demonstrating how the invention contributes to solving a real-world medical need.
Turning Research Into Revenue
A key theme of the guide is the recognition that cutting-edge research does not always equate to market success. Despite advances in biotechnology and pharmaceutical sciences, many innovations fail to reach their commercial potential due to weak or incomplete intellectual property protection.
To address this, the guide outlines methods for:
Aligning scientific advancements with patent requirements
Crafting claims that cover current and future formulations or uses
Navigating jurisdictional differences in patent standards
Ensuring that the application supports potential lifecycle management strategies
By offering this structured framework, the guide seeks to empower researchers and IP professionals to build comprehensive patent portfolios that enhance a drug’s appeal to investors and increase its resilience in the face of generic competition.
Target Audience and Industry Relevance
The guide is designed for a wide audience in the life sciences sector, including:
Pharmaceutical companies seeking to secure longer market exclusivity
Academic researchers and biotech startups transitioning from bench to business
Patent attorneys and legal teams involved in drug innovation strategy
Technology transfer offices managing intellectual property portfolios for universities and public research institutes
With regulatory and patent landscapes evolving rapidly, particularly in areas like biologics, personalized medicine, and drug-device combinations, the release of this guide is both timely and relevant.
Industry Commentary
Experts note that as drug development becomes more expensive and more globalized, robust IP protection is central to attracting investment and partnerships. “You can have the most innovative compound in the world, but without a strong patent, you risk losing the commercial advantage,” said one industry insider familiar with patent litigation.
The guide reinforces the idea that IP strategy should not be an afterthought but an integral part of the drug development process from the earliest stages.
A Proactive Tool for the Innovation Economy
By offering a roadmap for turning laboratory breakthroughs into protected, marketable products, “Drafting Effective Drug Patent Applications” is expected to serve as a valuable resource for pharmaceutical innovators who want to strengthen their market position while ensuring that vital therapies make it to patients with the necessary legal safeguards in place.
As the pressure mounts for pharmaceutical companies to innovate faster and more effectively, this guide could be a game-changer for R&D-driven firms looking to extract maximum value from their scientific achievements.
Accessible via DrugPatentWatch’s blog, the guide draws from hands-on experience in supporting drug developers through the complexities of patent law and the commercial pharmaceutical landscape.
Why a Strong Patent Application Matters
In today’s competitive pharmaceutical sector, patents are among the most critical assets that determine a drug’s commercial viability. The guide emphasizes that a poorly drafted patent—regardless of the novelty of the underlying science—can leave a drug vulnerable to challenges or fail to provide adequate market exclusivity.
The document outlines that successful drug patents must not only be scientifically robust but also strategically written to withstand scrutiny from regulators and potential competitors. This involves anticipating legal hurdles, clearly defining claims, and demonstrating how the invention contributes to solving a real-world medical need.
Turning Research Into Revenue
A key theme of the guide is the recognition that cutting-edge research does not always equate to market success. Despite advances in biotechnology and pharmaceutical sciences, many innovations fail to reach their commercial potential due to weak or incomplete intellectual property protection.
To address this, the guide outlines methods for:
Aligning scientific advancements with patent requirements
Crafting claims that cover current and future formulations or uses
Navigating jurisdictional differences in patent standards
Ensuring that the application supports potential lifecycle management strategies
By offering this structured framework, the guide seeks to empower researchers and IP professionals to build comprehensive patent portfolios that enhance a drug’s appeal to investors and increase its resilience in the face of generic competition.
Target Audience and Industry Relevance
The guide is designed for a wide audience in the life sciences sector, including:
Pharmaceutical companies seeking to secure longer market exclusivity
Academic researchers and biotech startups transitioning from bench to business
Patent attorneys and legal teams involved in drug innovation strategy
Technology transfer offices managing intellectual property portfolios for universities and public research institutes
With regulatory and patent landscapes evolving rapidly, particularly in areas like biologics, personalized medicine, and drug-device combinations, the release of this guide is both timely and relevant.
Industry Commentary
Experts note that as drug development becomes more expensive and more globalized, robust IP protection is central to attracting investment and partnerships. “You can have the most innovative compound in the world, but without a strong patent, you risk losing the commercial advantage,” said one industry insider familiar with patent litigation.
The guide reinforces the idea that IP strategy should not be an afterthought but an integral part of the drug development process from the earliest stages.
A Proactive Tool for the Innovation Economy
By offering a roadmap for turning laboratory breakthroughs into protected, marketable products, “Drafting Effective Drug Patent Applications” is expected to serve as a valuable resource for pharmaceutical innovators who want to strengthen their market position while ensuring that vital therapies make it to patients with the necessary legal safeguards in place.
As the pressure mounts for pharmaceutical companies to innovate faster and more effectively, this guide could be a game-changer for R&D-driven firms looking to extract maximum value from their scientific achievements.