Catheter Precision, Inc. (NYSE American: VTAK), a leading U.S.-based developer of advanced medical devices in the cardiac electrophysiology field, has received a significant boost to its intellectual property portfolio. The company announced today that the United States Patent and Trademark Office has issued a notice of allowance for its first U.S. patent for LockeT, a specialized surgical closure device designed for orthoscopic entry wounds. The patent application was originally filed in December 2022.
LockeT, a Class 1 device registered with the U.S. Food and Drug Administration (FDA), is a suture retention product aimed at facilitating wound closure following percutaneous venous procedures. This latest patent strengthens Catheter Precision’s competitive position in the U.S. market and builds upon its growing foundation of international intellectual property protections.
“This first U.S. patent for LockeT complements our portfolio of international patents already granted in China, Europe, and the United Kingdom,” said David Jenkins, Chief Executive Officer of Catheter Precision. “Securing IP protection in the U.S. is particularly meaningful as we continue discussions for product distribution in key global markets, including China and Europe.”
The company is also anticipating regulatory clearance in the form of a CE mark within the current quarter, which would authorize LockeT’s commercial use across European markets. According to Jenkins, this approval is expected to open new revenue opportunities and accelerate market entry efforts abroad.
“We’re encouraged by the reception LockeT has received since its limited rollout in the U.S. late last year,” Jenkins added. “Healthcare systems globally are increasingly looking for devices that can improve clinical outcomes while also reducing overall procedural costs. LockeT is well-positioned to meet these dual objectives.”
LockeT represents a key addition to the company’s product lineup, especially as hospitals and surgical centers seek more effective wound management solutions that minimize complications and enhance recovery.
About Catheter Precision
Based in the United States, Catheter Precision, Inc. is a medical technology company dedicated to improving the treatment of cardiac arrhythmias. The company collaborates closely with clinicians to design and deliver innovative electrophysiology devices that raise the standard of care in cardiac procedures.
Forward-Looking Information
This news article contains statements that may be considered forward-looking under the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties, including those related to product approvals, market adoption, and commercial success. Actual results may differ materially due to various factors, including those detailed in the company’s filings with the Securities and Exchange Commission (SEC).
pharma
Conduit Pharmaceuticals Receives Additional Patent Approval for Lead Autoimmune Disease Asset
Conduit Pharmaceuticals Inc. (NASDAQ: CDT), a biopharmaceutical company focused on developing treatments for autoimmune and inflammatory diseases, announced today that it has received further patent approval for its lead therapeutic asset targeting autoimmune conditions. The newly granted patent strengthens the company’s intellectual property portfolio and provides added protection for its innovative approach to treating autoimmune diseases such as sarcoidosis and lupus.
The patent, issued by the United States Patent and Trademark Office (USPTO), covers key methods of use and compositions relating to Conduit’s investigational drug, which is designed to modulate the immune response in patients with chronic autoimmune disorders. According to company officials, the approval not only broadens the existing patent family but also enhances the commercial potential of the lead compound as it advances through clinical development.
“This new patent grant is a major milestone for Conduit Pharmaceuticals, as it secures crucial proprietary rights over our lead autoimmune asset,” said Dr. David Tapolczay, Chief Executive Officer of Conduit Pharmaceuticals. “Our mission is to bring safe and effective treatments to patients suffering from complex autoimmune conditions, and this patent approval is a significant step forward in protecting the innovation that underpins our approach.”
The company’s lead asset, originally acquired from a major pharmaceutical partner, has demonstrated promising results in preclinical and early clinical studies. The drug works by selectively targeting pathways involved in the overactive immune response characteristic of autoimmune diseases, while minimizing systemic immunosuppression.
Conduit Pharmaceuticals has emphasized its strategy of revitalizing underutilized assets from larger pharmaceutical companies and accelerating them through late-stage development. The expanded patent protection ensures a longer runway for exclusivity, which could facilitate future licensing agreements or commercial partnerships.
Industry analysts view the patent approval as a positive development that enhances Conduit’s valuation and strengthens its position in the competitive autoimmune drug market, projected to surpass $150 billion globally by 2030.
The company plans to continue progressing its lead candidate through clinical trials, with additional updates expected later this year regarding regulatory filings and potential Phase 2 study initiations.
For more information, visit www.conduitpharma.com.
WHO and Medicines Patent Pool Support Nigerian Innovation in Health Diagnostic
In a landmark step towards strengthening healthcare innovation in Africa, the World Health Organization (WHO) and the Medicines Patent Pool (MPP) have announced strategic support for Nigerian-led advancements in health diagnostics. This collaboration is aimed at fostering local innovation, improving access to affordable diagnostic tools, and enhancing the country’s capacity to respond to pressing public health challenges.
The initiative comes under WHO’s Global Initiative on Digital Health and the MPP’s commitment to equitable access to medical innovations. Nigeria has been identified as a critical partner due to its growing innovation ecosystem and urgent need for scalable, cost-effective diagnostic solutions for diseases such as malaria, tuberculosis, hepatitis, and HIV/AIDS.
Speaking at a press briefing in Abuja, WHO Nigeria Country Representative, Dr. Walter Kazadi Mulombo, emphasized the importance of locally developed technologies in transforming health outcomes. “Nigeria has demonstrated significant potential in biomedical innovation,” he stated. “By supporting homegrown diagnostic solutions, we aim to empower Nigerian researchers and entrepreneurs to develop tools that are not only technologically sound but also contextually appropriate for local health challenges.”
The partnership will provide technical assistance, funding opportunities, and pathways to intellectual property management through the MPP. Nigerian innovators will gain access to international patent licensing frameworks, regulatory support, and opportunities for technology transfer. This is expected to facilitate the development, manufacturing, and distribution of diagnostics that meet global standards while remaining affordable for local healthcare systems.
“Affordable diagnostics are a cornerstone of universal health coverage,” he said. “Through this collaboration, we aim to bridge the gap between innovation and access, ensuring that promising technologies from Nigeria can benefit both the country and the wider global South.”
Among the early beneficiaries of the initiative is a Lagos-based biotech startup that has developed a rapid point-of-care diagnostic test for tuberculosis, which uses AI-powered image recognition. Another group from Ahmadu Bello University is working on a low-cost paper-based testing kit for hepatitis B and C, tailored for use in rural and underserved communities.
Health experts have welcomed the announcement, noting that empowering local solutions can reduce dependency on imported diagnostics and improve response times during outbreaks. Dr. Amina Balogun, a public health analyst, noted: “This kind of support is crucial for building a self-reliant health system. It’s not just about the tools, but about building confidence and capacity in our institutions and scientists.”
As part of the next phase, WHO and MPP plan to host a regional innovation forum in Nigeria later this year to showcase emerging diagnostic technologies and connect local developers with global health agencies and funders.
This partnership marks a significant step in aligning Nigeria’s innovation capacity with global health goals and demonstrates how strategic international collaboration can empower local solutions to meet both national and international health needs.
AI Tools Accelerate Insights in CAR T-Cell Therapy Research for Multiple Myeloma
A research team focused on advancing chimeric antigen receptor (CAR) T-cell therapies has harnessed artificial intelligence tools to streamline data analysis and extract key insights in the field. Their work was highlighted as part of the late-breaking research presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois.
The investigators explored the evolving landscape of CAR T-cell treatments for multiple myeloma (MM) by leveraging two AI-powered platforms: BiblioEngine, developed by 23Strands, and Cool.AF from Neural Hinge. These tools were used to mine publicly accessible clinical literature, with a focus on manufacturing methods, clinical trial structures, and therapeutic outcomes. The team also conducted a comprehensive review of related patent filings across jurisdictions including the United States, European Union, and India.
By utilizing AI-driven analytics, the researchers efficiently processed large volumes of data and identified emerging trends in how CAR T-cell therapies are developed and applied in real-world clinical settings. The tools enabled detailed comparisons between datasets, shedding light on factors influencing successful patent applications and highlighting the structure of collaborative networks among researchers in the field.
The analysis not only revealed current gaps in MM treatment strategies but also pointed to opportunities for future innovation and patent development. These findings are expected to guide more strategic clinical trial design and support intellectual property planning that avoids overlap with existing patents.
Moreover, the team’s work identified opportunities to foster new research partnerships by mapping the relationships among authors in the field, potentially expanding the collaborative network and accelerating progress in CAR T-cell therapy innovation.
The investigators explored the evolving landscape of CAR T-cell treatments for multiple myeloma (MM) by leveraging two AI-powered platforms: BiblioEngine, developed by 23Strands, and Cool.AF from Neural Hinge. These tools were used to mine publicly accessible clinical literature, with a focus on manufacturing methods, clinical trial structures, and therapeutic outcomes. The team also conducted a comprehensive review of related patent filings across jurisdictions including the United States, European Union, and India.
By utilizing AI-driven analytics, the researchers efficiently processed large volumes of data and identified emerging trends in how CAR T-cell therapies are developed and applied in real-world clinical settings. The tools enabled detailed comparisons between datasets, shedding light on factors influencing successful patent applications and highlighting the structure of collaborative networks among researchers in the field.
The analysis not only revealed current gaps in MM treatment strategies but also pointed to opportunities for future innovation and patent development. These findings are expected to guide more strategic clinical trial design and support intellectual property planning that avoids overlap with existing patents.
Moreover, the team’s work identified opportunities to foster new research partnerships by mapping the relationships among authors in the field, potentially expanding the collaborative network and accelerating progress in CAR T-cell therapy innovation.
Heron Therapeutics Reaches Patent Settlement with Mylan Over Cancer-Related Drugs
Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biopharmaceutical firm valued at approximately $324 million, has resolved ongoing patent litigation with Mylan Pharmaceuticals, Inc., a Viatris Inc. subsidiary.
Under the terms of the agreement, Heron has granted Mylan the right to begin selling generic alternatives to both drugs starting June 1, 2032. This resolution ends two separate legal proceedings filed in the U.S. District Court for the District of Delaware, which were initiated in September 2023 and January 2024 after Mylan sought FDA approval for generics ahead of the drugs’ patent expirations in 2035. As part of the agreement, both companies will ask the court to dismiss the lawsuits.
CINVANTI® and APONVIE® are formulations of the active ingredient aprepitant, used to prevent chemotherapy-induced nausea and vomiting. The deal allows for the possibility of an earlier launch of Mylan’s generics under standard conditions, although the formal market entry date remains set for 2032.
Heron, known for its focus on acute care and oncology-related treatments, continues to show signs of financial health and strategic growth. InvestingPro data shows a solid current ratio of 2.29, indicating strong short-term liquidity. The company has also reported a 13.57% increase in revenue over the last 12 months.
The patent settlement comes on the heels of a strong fourth quarter for Heron. The company reported adjusted earnings of $0.02 per share, outperforming analysts’ expectations of a $0.03 loss. Quarterly revenue reached $40.78 million—above the $37.3 million forecast—and reflected a 19.1% increase year-over-year. A significant contributor was ZYNRELEF, Heron’s pain management therapy, which brought in $8.5 million in Q4, up nearly 49% from the same period last year.
For the full year 2024, Heron posted total revenue of $144.2 million, a 13.6% increase compared to 2023. Looking ahead, the company projects 2025 revenues between $153 million and $163 million, in line with analyst expectations. Additionally, Heron estimates adjusted EBITDA between $0 and $8 million for the year.
In December 2024, the company expanded the label indications for ZYNRELEF and introduced a new vial access needle, further enhancing its product offerings. Heron closed the year with $59.3 million in cash and short-term investments, reinforcing its financial stability as it continues to grow its commercial footprint.
Under the terms of the agreement, Heron has granted Mylan the right to begin selling generic alternatives to both drugs starting June 1, 2032. This resolution ends two separate legal proceedings filed in the U.S. District Court for the District of Delaware, which were initiated in September 2023 and January 2024 after Mylan sought FDA approval for generics ahead of the drugs’ patent expirations in 2035. As part of the agreement, both companies will ask the court to dismiss the lawsuits.
CINVANTI® and APONVIE® are formulations of the active ingredient aprepitant, used to prevent chemotherapy-induced nausea and vomiting. The deal allows for the possibility of an earlier launch of Mylan’s generics under standard conditions, although the formal market entry date remains set for 2032.
Heron, known for its focus on acute care and oncology-related treatments, continues to show signs of financial health and strategic growth. InvestingPro data shows a solid current ratio of 2.29, indicating strong short-term liquidity. The company has also reported a 13.57% increase in revenue over the last 12 months.
The patent settlement comes on the heels of a strong fourth quarter for Heron. The company reported adjusted earnings of $0.02 per share, outperforming analysts’ expectations of a $0.03 loss. Quarterly revenue reached $40.78 million—above the $37.3 million forecast—and reflected a 19.1% increase year-over-year. A significant contributor was ZYNRELEF, Heron’s pain management therapy, which brought in $8.5 million in Q4, up nearly 49% from the same period last year.
For the full year 2024, Heron posted total revenue of $144.2 million, a 13.6% increase compared to 2023. Looking ahead, the company projects 2025 revenues between $153 million and $163 million, in line with analyst expectations. Additionally, Heron estimates adjusted EBITDA between $0 and $8 million for the year.
In December 2024, the company expanded the label indications for ZYNRELEF and introduced a new vial access needle, further enhancing its product offerings. Heron closed the year with $59.3 million in cash and short-term investments, reinforcing its financial stability as it continues to grow its commercial footprint.
Cybin Secures New U.S. Patent, Expands Clinical Trials for Depression and Anxiety Treatments
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.
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.
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.
Calcutta High Court Upholds Transparency and Fairness in Patent Examination: Takeda Pharmaceutical Co. Ltd. v. Controller of Patents
In a significant ruling that underscores the importance of transparency, reasoned decision-making, and procedural fairness in patent examination, the Calcutta High Court has set aside a refusal order issued by the Patent Office in the case of Takeda Pharmaceutical Co. Ltd. v. Controller of Patents and Designs & Ors. The Court found that the Patent Office’s failure to consider crucial post-filing data demonstrating technical advancement violated the principles of natural justice and remanded the matter for fresh consideration.
Facts of the Case
Takeda Pharmaceutical Co. Ltd. (“Takeda”) filed a patent application in 2010 for a novel class of protein kinase inhibitors intended for treating cancers associated with abnormal kinase activity. The application specifically claimed Brigatinib, a compound designed to selectively inhibit Anaplastic Lymphoma Kinase (ALK) over closely related kinases, including the insulin receptor (Ins-R). This selective inhibition was critical to Brigatinib’s therapeutic efficacy, as it reduced side effects that typically arise from off-target binding to Ins-R.
During the course of prosecution, Takeda submitted experimental data demonstrating Brigatinib’s enhanced selectivity for ALK, as evidenced by reduced IC50 values (the concentration needed to inhibit 50% of kinase activity). Additionally, Takeda provided expert affidavits, comparative data with other marketed drugs, and evidence of industrial acclaim to substantiate the compound’s technical advancement and superior efficacy.
Refusal Order by the Controller
Despite the supporting data, the Controller of Patents rejected Takeda’s application on three grounds:
Lack of Inventive Step under Section 2(1)(ja)
Non-patentability under Section 3(d) of the Patents Act, which prevents the patenting of mere derivatives of known substances unless they show significant improvement in therapeutic efficacy
Insufficiency of Disclosure under Section 10(4), alleging that Takeda had not adequately described the invention.
Furthermore, the Controller contended that the application lacked any evidence of technical advancement or enhanced efficacy at the time of filing the specification.
Arguments by Takeda
They argued that the Controller had disregarded supplementary data and expert affidavits that demonstrated Brigatinib’s superior selectivity and efficacy. Takeda claimed that the inventive step analysis was flawed, arguing that the Controller had used hindsight to select prior art compounds and had wrongly assumed that a minor structural modification (the sulfonyl-phosphoryl substitution) would not have a significant effect on the compound’s performance.
Takeda further pointed out that the Controller had failed to consider the post-filing data submitted during prosecution, which demonstrated Brigatinib’s enhanced selectivity for ALK over Ins-R, reducing off-target effects and improving the drug’s therapeutic profile. According to Takeda, the hasty rejection failed to account for the complexity and novelty of their invention.
Court’s Findings
The Calcutta High Court sided with Takeda, finding that the Controller’s refusal was unreasoned and erroneous. In its judgment, the Court emphasized that the inventive step must be assessed in the context of the entire invention, and prior art should not be merely compared to isolated features of the invention. The Court specifically noted that the mere presence of structurally similar elements in the prior art does not make an invention obvious. The invention must be evaluated as a whole, considering its technical merits and novel contributions.
The Court also found that the Controller had misinterpreted the concept of bioisosterism and failed to consider that Brigatinib’s modification—substituting a sulfonyl group with a phosphoryl group—was not obvious in the context of the prior art. It emphasized that there was no teaching in the prior art to modify the structure of TAE684 in the way required to produce Brigatinib, particularly with regard to selective inhibition between ALK and Ins-R.
Regarding the issue of technical advancement, the Court pointed out that Takeda had submitted critical data, including experimental results showing Brigatinib’s superior selectivity for ALK and reduced off-target effects. The Court noted that the Controller had improperly disregarded this data, which was directly relevant to proving therapeutic efficacy.
Key Legal Principles: Procedural Fairness and Transparency
The Court ruled that the Controller had violated the principles of natural justice by failing to adequately consider all material facts and evidence submitted by Takeda, including post-filing data. The Court emphasized that under Indian patent law, post-filing data demonstrating technical advancement is not prohibited and must be duly considered by the examining authorities.
Furthermore, the Court held that the refusal was not supported by adequate reasoning and that the Controller’s decision-making process lacked clarity and fairness. The judgment highlighted the need for a reasoned order, one that addresses all relevant factors and provides a comprehensive explanation of why certain evidence is accepted or rejected.
Conclusion
By setting aside the refusal order, the Court has provided a clear directive to the Patent Office to re-evaluate the application in light of all available evidence, including post-filing data, and to ensure that all parties are given an adequate opportunity to be heard.
The Court has also remanded the case to the Patent Office for fresh consideration, with a mandate to complete the process within three months from the date of communication of the order. This ruling not only benefits Takeda but also reinforces the importance of ensuring fairness and accountability in the patent grant process, particularly in high-stakes pharmaceutical and biotechnology patents.
Impact on Patent Law in India
This judgment is expected to have far-reaching implications for patent law practice in India, especially in complex patent cases involving pharmaceutical and biotechnology inventions. It reinforces the need for patent examiners to engage thoroughly with the evidence presented, ensuring that decisions are based on substantive and comprehensive analyses rather than superficial assessments. This decision could also encourage more transparency in the examination process, ultimately fostering an environment that supports innovation and fair competition in the Indian patent ecosystem.
Facts of the Case
Takeda Pharmaceutical Co. Ltd. (“Takeda”) filed a patent application in 2010 for a novel class of protein kinase inhibitors intended for treating cancers associated with abnormal kinase activity. The application specifically claimed Brigatinib, a compound designed to selectively inhibit Anaplastic Lymphoma Kinase (ALK) over closely related kinases, including the insulin receptor (Ins-R). This selective inhibition was critical to Brigatinib’s therapeutic efficacy, as it reduced side effects that typically arise from off-target binding to Ins-R.
During the course of prosecution, Takeda submitted experimental data demonstrating Brigatinib’s enhanced selectivity for ALK, as evidenced by reduced IC50 values (the concentration needed to inhibit 50% of kinase activity). Additionally, Takeda provided expert affidavits, comparative data with other marketed drugs, and evidence of industrial acclaim to substantiate the compound’s technical advancement and superior efficacy.
Refusal Order by the Controller
Despite the supporting data, the Controller of Patents rejected Takeda’s application on three grounds:
Lack of Inventive Step under Section 2(1)(ja)
Non-patentability under Section 3(d) of the Patents Act, which prevents the patenting of mere derivatives of known substances unless they show significant improvement in therapeutic efficacy
Insufficiency of Disclosure under Section 10(4), alleging that Takeda had not adequately described the invention.
Furthermore, the Controller contended that the application lacked any evidence of technical advancement or enhanced efficacy at the time of filing the specification.
Arguments by Takeda
They argued that the Controller had disregarded supplementary data and expert affidavits that demonstrated Brigatinib’s superior selectivity and efficacy. Takeda claimed that the inventive step analysis was flawed, arguing that the Controller had used hindsight to select prior art compounds and had wrongly assumed that a minor structural modification (the sulfonyl-phosphoryl substitution) would not have a significant effect on the compound’s performance.
Takeda further pointed out that the Controller had failed to consider the post-filing data submitted during prosecution, which demonstrated Brigatinib’s enhanced selectivity for ALK over Ins-R, reducing off-target effects and improving the drug’s therapeutic profile. According to Takeda, the hasty rejection failed to account for the complexity and novelty of their invention.
Court’s Findings
The Calcutta High Court sided with Takeda, finding that the Controller’s refusal was unreasoned and erroneous. In its judgment, the Court emphasized that the inventive step must be assessed in the context of the entire invention, and prior art should not be merely compared to isolated features of the invention. The Court specifically noted that the mere presence of structurally similar elements in the prior art does not make an invention obvious. The invention must be evaluated as a whole, considering its technical merits and novel contributions.
The Court also found that the Controller had misinterpreted the concept of bioisosterism and failed to consider that Brigatinib’s modification—substituting a sulfonyl group with a phosphoryl group—was not obvious in the context of the prior art. It emphasized that there was no teaching in the prior art to modify the structure of TAE684 in the way required to produce Brigatinib, particularly with regard to selective inhibition between ALK and Ins-R.
Regarding the issue of technical advancement, the Court pointed out that Takeda had submitted critical data, including experimental results showing Brigatinib’s superior selectivity for ALK and reduced off-target effects. The Court noted that the Controller had improperly disregarded this data, which was directly relevant to proving therapeutic efficacy.
Key Legal Principles: Procedural Fairness and Transparency
The Court ruled that the Controller had violated the principles of natural justice by failing to adequately consider all material facts and evidence submitted by Takeda, including post-filing data. The Court emphasized that under Indian patent law, post-filing data demonstrating technical advancement is not prohibited and must be duly considered by the examining authorities.
Furthermore, the Court held that the refusal was not supported by adequate reasoning and that the Controller’s decision-making process lacked clarity and fairness. The judgment highlighted the need for a reasoned order, one that addresses all relevant factors and provides a comprehensive explanation of why certain evidence is accepted or rejected.
Conclusion
By setting aside the refusal order, the Court has provided a clear directive to the Patent Office to re-evaluate the application in light of all available evidence, including post-filing data, and to ensure that all parties are given an adequate opportunity to be heard.
The Court has also remanded the case to the Patent Office for fresh consideration, with a mandate to complete the process within three months from the date of communication of the order. This ruling not only benefits Takeda but also reinforces the importance of ensuring fairness and accountability in the patent grant process, particularly in high-stakes pharmaceutical and biotechnology patents.
Impact on Patent Law in India
This judgment is expected to have far-reaching implications for patent law practice in India, especially in complex patent cases involving pharmaceutical and biotechnology inventions. It reinforces the need for patent examiners to engage thoroughly with the evidence presented, ensuring that decisions are based on substantive and comprehensive analyses rather than superficial assessments. This decision could also encourage more transparency in the examination process, ultimately fostering an environment that supports innovation and fair competition in the Indian patent ecosystem.
Patent Applicants Face Tighter Deadlines: What the New USPTO Rule Means for Continuation and Divisional Applications
Starting May 13, 2025, patent applicants will experience a significant change in the timeline for filing continuation and divisional applications with the U.S. Patent and Trademark Office (USPTO). Under the new rule, the window between paying the issue fee and a patent officially issuing will shrink dramatically—from about three weeks to just one week.
For those familiar with the process, this may feel like a significant shift. Previously, applicants had a comfortable amount of time to make key decisions regarding the filing of continuation or divisional applications after paying the issue fee. This period, although not extensive, offered ample opportunity to consider further filings and get the necessary paperwork in order. Now, with the new timeline, applicants will have to act quickly or risk missing the opportunity to file these crucial applications before the parent patent officially issues.
A Major Change for Continuation and Divisional Filings
For those in the patent world, continuation and divisional applications are powerful tools used to refine, expand, or protect different aspects of an invention disclosed in the original patent application. These tools allow applicants to pursue additional claims or protect additional inventions within the same family of patents.
This might happen if an applicant wants broader protection or if new claims emerge that were not included in the original application. A continuation application essentially gives the applicant another opportunity to further develop the patent without starting the process from scratch.
Divisionals, on the other hand, are filed when the USPTO requests the applicant to divide the original application into separate filings because the application covers more than one invention. This is typically seen in cases where the original application is too broad or contains more than one distinct invention.
The critical detail here is that both continuation and divisional applications must be filed before the parent patent is granted. Once the patent issues, the opportunity to file such applications is largely closed, and reopening prosecution after issuance can be costly and difficult.
The New Deadline: A Week to Act
Historically, applicants had about three weeks, sometimes longer, to file continuation or divisional applications after paying the issue fee. This gave them time to review their options, consult with colleagues or patent attorneys, and finalize their strategy before the patent officially issued.
However, with the new rule coming into effect on May 13, 2025, applicants will have only one week between paying the issue fee and the patent issuing. This means the timeline for making decisions has been drastically compressed. The issue fee, which is typically paid after receiving a Notice of Allowance from the USPTO, serves as an indication that the patent is about to be granted. With the tighter timeline, applicants must be ready to act quickly to file continuation or divisional applications—or risk missing the opportunity altogether.
For patent professionals who file these types of applications regularly, this change represents a considerable shift in workflow. The new rule is likely to require better planning, quicker decision-making, and perhaps even a shift in internal procedures to ensure applications are filed on time.
Best Practices for Navigating the Change
While the new rule presents challenges, there are several best practices that applicants can adopt to ensure they stay ahead of the game:
File Before Paying the Issue Fee
This gives ample time to review the strategy and decide on any additional filings. Filing before paying the issue fee ensures that applicants can secure their desired protection without the stress of a shortened timeline.
Incorporate Continuation and Divisional Discussions into the Review Process
Patent applicants should include discussions of continuation and divisional strategies as part of their regular Notice of Allowance review. This can involve consulting with patent attorneys, revisiting claims, and carefully evaluating whether additional applications are necessary.
Set Internal Deadlines
This gives teams time to deliberate and take a more measured approach to filings, without the added pressure of an approaching deadline.
Treat the Issue Fee as a Warning Signal
The issue fee payment should be viewed as a signal to take immediate action, not as a last-minute task. Instead of waiting until the last moment, applicants should be proactive and take time to file any necessary applications well ahead of the fee payment deadline. Procrastination can lead to missed opportunities.
Why the Change Matters
The USPTO’s decision to tighten this filing window is likely a response to the growing complexity of the patent process and the increasing speed at which innovation is occurring.
For applicants, however, this presents a new set of challenges. The need for quick decision-making and a more nimble approach to patent strategy has never been more important. Companies will need to ensure their patent portfolios are managed with greater efficiency and foresight. In particular, patent attorneys and in-house counsel will need to be highly organized to ensure that crucial filings are made within the shortened timeline.
The Bottom Line: Speed and Preparation Are Key
The new rule that takes effect on May 13, 2025, is a significant change that will impact the way patent applicants file continuation and divisional applications. With only one week between paying the issue fee and the patent issuing, applicants must be prepared to act quickly to protect additional claims or inventions.
The smartest strategy is to file continuation and divisional applications before paying the issue fee, giving applicants more time to review and finalize their filing strategy. By setting internal deadlines, planning ahead, and treating the issue fee payment as a cue to take immediate action, patent applicants can ensure they are not caught off guard by the new, shorter timeline.
In the world of patent law, timing is everything—and starting May 2025, those who act early will be best positioned to navigate the new filing requirements.
For those familiar with the process, this may feel like a significant shift. Previously, applicants had a comfortable amount of time to make key decisions regarding the filing of continuation or divisional applications after paying the issue fee. This period, although not extensive, offered ample opportunity to consider further filings and get the necessary paperwork in order. Now, with the new timeline, applicants will have to act quickly or risk missing the opportunity to file these crucial applications before the parent patent officially issues.
A Major Change for Continuation and Divisional Filings
For those in the patent world, continuation and divisional applications are powerful tools used to refine, expand, or protect different aspects of an invention disclosed in the original patent application. These tools allow applicants to pursue additional claims or protect additional inventions within the same family of patents.
This might happen if an applicant wants broader protection or if new claims emerge that were not included in the original application. A continuation application essentially gives the applicant another opportunity to further develop the patent without starting the process from scratch.
Divisionals, on the other hand, are filed when the USPTO requests the applicant to divide the original application into separate filings because the application covers more than one invention. This is typically seen in cases where the original application is too broad or contains more than one distinct invention.
The critical detail here is that both continuation and divisional applications must be filed before the parent patent is granted. Once the patent issues, the opportunity to file such applications is largely closed, and reopening prosecution after issuance can be costly and difficult.
The New Deadline: A Week to Act
Historically, applicants had about three weeks, sometimes longer, to file continuation or divisional applications after paying the issue fee. This gave them time to review their options, consult with colleagues or patent attorneys, and finalize their strategy before the patent officially issued.
However, with the new rule coming into effect on May 13, 2025, applicants will have only one week between paying the issue fee and the patent issuing. This means the timeline for making decisions has been drastically compressed. The issue fee, which is typically paid after receiving a Notice of Allowance from the USPTO, serves as an indication that the patent is about to be granted. With the tighter timeline, applicants must be ready to act quickly to file continuation or divisional applications—or risk missing the opportunity altogether.
For patent professionals who file these types of applications regularly, this change represents a considerable shift in workflow. The new rule is likely to require better planning, quicker decision-making, and perhaps even a shift in internal procedures to ensure applications are filed on time.
Best Practices for Navigating the Change
While the new rule presents challenges, there are several best practices that applicants can adopt to ensure they stay ahead of the game:
File Before Paying the Issue Fee
This gives ample time to review the strategy and decide on any additional filings. Filing before paying the issue fee ensures that applicants can secure their desired protection without the stress of a shortened timeline.
Incorporate Continuation and Divisional Discussions into the Review Process
Patent applicants should include discussions of continuation and divisional strategies as part of their regular Notice of Allowance review. This can involve consulting with patent attorneys, revisiting claims, and carefully evaluating whether additional applications are necessary.
Set Internal Deadlines
This gives teams time to deliberate and take a more measured approach to filings, without the added pressure of an approaching deadline.
Treat the Issue Fee as a Warning Signal
The issue fee payment should be viewed as a signal to take immediate action, not as a last-minute task. Instead of waiting until the last moment, applicants should be proactive and take time to file any necessary applications well ahead of the fee payment deadline. Procrastination can lead to missed opportunities.
Why the Change Matters
The USPTO’s decision to tighten this filing window is likely a response to the growing complexity of the patent process and the increasing speed at which innovation is occurring.
For applicants, however, this presents a new set of challenges. The need for quick decision-making and a more nimble approach to patent strategy has never been more important. Companies will need to ensure their patent portfolios are managed with greater efficiency and foresight. In particular, patent attorneys and in-house counsel will need to be highly organized to ensure that crucial filings are made within the shortened timeline.
The Bottom Line: Speed and Preparation Are Key
The new rule that takes effect on May 13, 2025, is a significant change that will impact the way patent applicants file continuation and divisional applications. With only one week between paying the issue fee and the patent issuing, applicants must be prepared to act quickly to protect additional claims or inventions.
The smartest strategy is to file continuation and divisional applications before paying the issue fee, giving applicants more time to review and finalize their filing strategy. By setting internal deadlines, planning ahead, and treating the issue fee payment as a cue to take immediate action, patent applicants can ensure they are not caught off guard by the new, shorter timeline.
In the world of patent law, timing is everything—and starting May 2025, those who act early will be best positioned to navigate the new filing requirements.
India’s Evolving Intellectual Property Landscape: A Key Turning Point for Pharma Industry
“The needle has moved,” declares Anil Matai, Director General of the Organization of Pharmaceutical Producers of India (OPPI), in a recent podcast interview with Scrip. The statement refers to the substantial changes in India’s intellectual property rights (IPR) regime, which witnessed some critical amendments in the past year. As the representative body for foreign pharmaceutical companies in India, OPPI plays a crucial role in shaping the country’s IPR and regulatory environment, which continues to evolve as the industry adapts to both domestic and global pressures.
Matai’s remarks signal that India’s pharmaceutical sector is undergoing a transformation, particularly in areas such as patent regulations, data protection, and the ongoing debates surrounding Section 3(d) of the Indian Patent Act.
Key Amendments and the State of Play
India’s intellectual property landscape has been in flux, with several key amendments to the patent law being introduced last year.
However, one of the most controversial aspects of India’s patent system remains Section 3(d) of the Indian Patents Act. Section 3(d) prevents the patenting of new forms of known substances unless they result in significantly enhanced efficacy.
The ruling emphasized the need for innovation beyond mere incremental changes, a stance that was seen as a win for public health over the interests of global pharmaceutical companies. However, for foreign firms like those represented by OPPI, Section 3(d) remains a longstanding sticking point. Matai pointed out that while India’s patent system has evolved, challenges such as these continue to make it difficult for global innovators to protect their products in the country.
Data Protection: A Global Imperative
Another critical issue discussed by Matai is the need for Regulatory Data Protection (RDP), which he describes as a “no-brainer.” RDP refers to the protection of clinical trial data submitted to regulatory authorities in the drug approval process, ensuring that competitors cannot rely on this data to gain approval for their own versions of a drug without conducting their own trials. Matai cites China’s rapid advancement in the biologics space as an example, noting that China has already made significant strides in protecting RDP and attracting global pharmaceutical investment.
China’s National Medical Products Administration (NMPA) recently introduced guidelines that outline specific periods of data exclusivity for different categories of drugs. These guidelines are part of the broader regulatory framework that has seen China move ahead of India in the biologics sector.
The issue of data exclusivity (DE) has been contentious in India for years. Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, India, like other member states, is required to protect undisclosed data necessary for regulatory approval of new chemical entities. However, India has not yet provided for data exclusivity in its laws. While the generics industry and public health advocates argue that this is a matter of confidentiality and not exclusivity, foreign firms see data exclusivity as crucial for fostering innovation and protecting intellectual property.
Matai emphasized that India’s reluctance to adopt data exclusivity is a hindrance to attracting foreign investment in the pharmaceutical sector. “Without adequate data protection, global pharmaceutical companies may look elsewhere for growth opportunities,” he warned, citing how China has leveraged RDP to become a hub for life sciences research and development.
US-India Trade Relations and the Road Ahead
The issue of intellectual property rights is not only a domestic matter but also an international one, particularly in the context of India’s trade relationships. India remains on the Priority Watch List in the United States Trade Representative’s (USTR) Special 301 Report, which highlights countries that are seen as not providing adequate protection for intellectual property rights. India shares this distinction with China, reflecting ongoing concerns about patent protection, data exclusivity, and the safeguarding of undisclosed data.
The U.S. has long pushed for stronger IP protection in India, with senior figures such as Eli Lilly’s CEO, David Ricks, calling for the country to rethink its stance on IPR and become a leader in life sciences. According to Ricks and other pharmaceutical leaders, India’s regulatory framework must evolve to align with global standards to attract the level of investment needed for the country to become a competitive player in the pharmaceutical industry.
Both India and the U.S. are now working toward the first tranche of a multi-sector Bilateral Trade Agreement (BTA), which is expected to be finalized by the fall of 2025. It remains to be seen whether intellectual property issues, including those surrounding patent eligibility and data exclusivity, will be part of the negotiations. If they are, the outcome could have a profound impact on the future of the pharmaceutical industry in India.
The Path Forward
India’s evolving IPR landscape presents both challenges and opportunities. While the changes in the regulatory environment signal progress, much remains to be done to balance the needs of public health with those of global pharmaceutical companies. As foreign firms continue to call for stronger IP protections, India faces the delicate task of crafting a system that promotes innovation without undermining access to affordable medicines.
Anil Matai’s comments reflect the tensions at play in this balancing act. As India moves toward a more integrated role in the global pharmaceutical market, the next few years will be pivotal in shaping the future of the country’s intellectual property and regulatory framework. Whether India can find the right balance between fostering innovation, attracting investment, and maintaining access to essential medicines will be key to its future as a global leader in the life sciences sector.
In the meantime, the global pharmaceutical community will be watching closely, as India’s regulatory evolution continues to unfold.