The advent of 3D bioprinting has revolutionized regenerative medicine, offering unprecedented possibilities in tissue engineering, organ fabrication, and personalized healthcare. However, as this innovative field progresses, it encounters significant hurdles in securing patent protection, owing to intricate legal frameworks and ethical considerations.
The Promise of 3D Bioprinting
This technology holds immense potential for addressing organ shortages, enabling drug testing on human-like tissues, and advancing personalized medicine.
Patentability: A Complex Landscape
Securing patents for bioprinting innovations is fraught with challenges, primarily due to the intersection of biotechnology and intellectual property laws. In India, for instance, while the Indian Patents Act permits the patenting of bioprinting processes and bioinks, it imposes restrictions on products that closely resemble natural biological materials. Sections 3(b) and 3(j) of the Act exclude inventions that are contrary to public order or morality and those related to plants and animals, respectively. Consequently, bioprinted tissues or organs that are deemed too similar to natural counterparts may be considered non-patentable.
Similarly, in the United States, the patent eligibility of bioprinted products is influenced by precedents that preclude the patenting of natural phenomena. The “product of nature” doctrine, reinforced by cases like Association for Molecular Pathology v. Myriad Genetics, stipulates that naturally occurring substances, even if isolated, are not patentable. Therefore, bioprinted tissues must exhibit characteristics markedly different from their natural counterparts to qualify for patent protection.
Ethical and Legal Considerations
Beyond legal statutes, ethical concerns significantly impact the patentability of bioprinting innovations. The use of human embryonic stem cells (ESCs) in bioinks raises moral questions, leading to potential objections under provisions that prohibit inventions contrary to public morality. To navigate this, researchers are increasingly turning to induced pluripotent stem cells (iPSCs), which do not involve the destruction of embryos and are thus more ethically acceptable.
Moreover, the ownership of digital models derived from a patient’s biological data introduces complexities in intellectual property rights. Determining whether the patient, healthcare provider, or bioprinting company holds rights over these models is an ongoing debate, necessitating clear guidelines to protect individual privacy while fostering innovation.
Navigating the Path Forward
To surmount these challenges, stakeholders in the bioprinting domain must adopt strategic approaches:
Innovative Claim Drafting: Emphasizing the artificial aspects and technical advancements of bioprinted products can help distinguish them from natural entities, enhancing patent eligibility.
Ethical Compliance: Utilizing ethically sourced materials and transparent methodologies can mitigate moral objections, facilitating smoother patent approval processes.
Collaborative Frameworks: Establishing clear agreements on data ownership and usage rights can preempt legal disputes and promote collaborative research.
As 3D bioprinting continues to evolve, addressing the intertwined legal and ethical issues is paramount to unlocking its full potential. By proactively engaging with these challenges, the scientific community can pave the way for groundbreaking advancements that are both innovative and responsibly governed.
Gayatri
Delaware Court Upholds Acadia’s Patent Rights, Secures Protection for Nuplazid Formulation
In a significant legal victory for Acadia Pharmaceuticals Inc., a Delaware district court has ruled in favor of the company’s arguments concerning patent infringement and validity, providing crucial protection for its flagship product, Nuplazid. The ruling reinforces Acadia’s intellectual property rights and ensures continued exclusivity for the formulation of the drug, which is widely used in the treatment of Parkinson’s disease-related psychosis.
The decision, issued earlier this week by the U.S. District Court for the District of Delaware, concluded that Acadia’s patent covering the specific formulation of Nuplazid is both valid and enforceable, and that a proposed generic version would infringe on this patent. The case centered around challenges brought by a generic drug manufacturer seeking to introduce a competing product ahead of patent expiration.
Chief Executive Officer Catherine Owen Adams welcomed the ruling, stating, “This decision is a critical validation of our intellectual property strategy and our commitment to protecting innovations that bring value to patients. Patent protection for Nuplazid’s formulation is essential to ensuring we can continue investing in research and development to address unmet medical needs.”
Nuplazid, approved by the U.S. Food and Drug Administration in 2016, is known for Its unique formulation has been central to its clinical effectiveness and commercial success, making the preservation of its patent rights a top priority for Acadia.
The court’s ruling effectively blocks the launch of a generic version until the expiration of Acadia’s patent, currently set for 2030. Legal analysts noted that the decision could have broader implications for similar cases involving branded pharmaceuticals defending their market exclusivity against generic challengers.
Investors responded positively to the news, with Acadia’s shares rising in after-hours trading. The company reaffirmed its financial guidance for the year, citing confidence in the continued revenue stream from Nuplazid.
This ruling is expected to bolster confidence among stakeholders and reinforces the legal protections afforded to novel pharmaceutical formulations under U.S. patent law.
Innovative Food-Truck Design Patented by MDU’s Student Entrepreneurs and Faculty
In a significant achievement for innovation and entrepreneurship in academia, a group of student-entrepreneurs and faculty members from Maharshi Dayanand University (MDU), Rohtak, have been granted a patent for their novel food-truck design. The intellectual property, which blends utility with cutting-edge design features, is the brainchild of Prof. Ashish Dahiya and Sahil Saran, along with contributions from other student innovators.
According to an official statement released by the university administration today, the patented food-truck design represents a leap forward in mobile food service solutions. The design emphasizes space optimization, enhanced hygiene standards, energy efficiency, and modular functionality—key considerations for food entrepreneurs operating in urban and semi-urban environments.
“This is a proud moment for MDU. The achievement reflects the university’s focus on fostering innovation, applied research, and entrepreneurship among its students and faculty,” said a university spokesperson. “The patented design is a result of months of collaborative effort, practical experimentation, and ideation led by Prof. Dahiya and his team.”
The food truck integrates a smart layout that allows for multiple cooking stations, built-in waste management solutions, solar-powered electrical systems, and adjustable service counters. It has been engineered to cater to diverse culinary needs while ensuring compliance with safety and sanitation regulations.
Prof. Ashish Dahiya, who mentors the student entrepreneurs at MDU’s Centre for Innovation, Incubation and Entrepreneurship (CIIE), expressed gratitude for the support extended by the university administration. “This patent not only validates our design’s uniqueness and functionality but also sets a precedent for student-led innovation at MDU. We hope it inspires others to pursue real-world problem solving through interdisciplinary collaboration.”
Sahil Saran, one of the lead student inventors, highlighted the practical experiences that fueled their innovation. “We wanted to create a food truck that wasn’t just mobile but truly entrepreneurial—something that could serve as a sustainable business model for small vendors and young chefs looking to start up with minimal investment.”
The university has confirmed that efforts are underway to bring the patented design into commercial production. With potential interest from both private investors and government-supported start-up schemes, the food-truck project could soon become a real-world success story of campus innovation.
This patent adds to a growing list of intellectual property and start-up initiatives emerging from MDU in recent years, reaffirming the university’s rising stature as a hub for innovation and applied research in North India.
MU Ionic Solutions and CATL Forge Patent Licensing Agreement to Advance Lithium-Ion Battery Technologies
MU Ionic Solutions Corporation (MUIS), a subsidiary of Mitsubishi Chemical Corporation and UBE Corporation, has entered into a significant patent licensing agreement with Contemporary Amperex Technology Co., Limited (CATL), a global leader in energy storage and electric vehicle battery technologies. The agreement grants CATL access to MUIS’s patented lithium-ion battery (LIB) technologies, particularly in the field of electrolyte innovations.
Enhancing Battery Performance Through Collaboration
MUIS, established in 2020, focuses on the research, production, and global distribution of advanced electrolytes for lithium-ion batteries. Electrolytes are essential components that influence battery safety, performance, and lifespan. MUIS’s proprietary technology is designed to reduce side reactions within the battery, thereby improving power efficiency, extending battery life, and enhancing thermal stability.
By licensing these innovations, CATL aims to integrate MUIS’s cutting-edge electrolyte solutions into its battery systems, allowing for improvements in battery reliability, safety, and performance—particularly important for electric vehicles and renewable energy storage.
Supporting the Growing EV Market
The partnership arrives amid rapid growth in the global electric vehicle (EV) industry, where demand for high-performance, durable, and safe lithium-ion batteries continues to soar. Industry forecasts estimate a nearly 30% annual growth rate for automotive LIBs, driven by the worldwide push toward cleaner energy solutions and carbon neutrality.
Through this agreement, CATL is expected to leverage MUIS’s technologies to enhance its competitive edge in EV battery manufacturing. Meanwhile, MUIS benefits from expanded reach and validation of its proprietary electrolyte solutions in large-scale, real-world applications.
Toward a Sustainable Future
While the financial and technical details of the licensing deal remain confidential, the collaboration marks a strategic milestone for both companies. It exemplifies the power of cross-border partnerships in accelerating technological innovation and meeting the increasing global demand for sustainable energy solutions.
With MUIS’s expertise in electrolyte chemistry and CATL’s leadership in battery manufacturing, the two companies are well-positioned to contribute to the next generation of safer, more efficient lithium-ion batteries—supporting the global transition to electric mobility and renewable energy.
Apple Explores Gesture Recognition with Antenna-Based Object Detection in New Patent Application
The United States Patent and Trademark Office (USPTO) published a new patent application from Apple Inc. that unveils a potential leap in gesture recognition and object interaction technology for future electronic devices. The patent, titled “Electronic Devices with Antennas and VSWR Sensors for Object Detection,” outlines a system that utilizes wireless circuitry, multiple antennas, and Voltage Standing Wave Ratio (VSWR) sensors to detect the position and movement of external objects such as a user’s finger or an Apple Pencil.
The technology, according to the patent documentation, could enable Apple devices to sense the angular location and distance of objects in their vicinity, paving the way for advanced gesture control, adaptive signal direction, and more responsive device interactions — all without requiring traditional cameras or touchscreens.
The Role of VSWR Sensors in Object Detection
VSWR is a measurement typically used in antenna systems to determine impedance mismatches. In Apple’s proposed design, however, VSWR readings are repurposed for spatial sensing. The system measures how signals reflect off nearby objects, with changes in the reflected wave patterns offering clues about the object’s distance and angle relative to the device’s antennas.
By deploying multiple antennas at strategic locations on a device, each equipped with VSWR sensors, the device’s onboard processors can triangulate the position of external elements. For instance, if a user’s finger approaches the side of a tablet or an Apple Pencil hovers above a display, the system can detect this and respond appropriately.
Enhanced Communication and Gesture Recognition
One of the key innovations described in the patent is the device’s ability to adapt its wireless communication dynamically based on the location of nearby objects. If a user’s hand is found to be obstructing the optimal path for signal transmission, the device can automatically adjust beamforming directions or signal power to maintain performance.
More notably, the system opens new possibilities for gesture-based controls. Without relying on cameras or external sensors, a device could recognize finger movements or stylus gestures in the air, offering new ways to navigate interfaces, trigger shortcuts, or interact with content.
Apple suggests that this technology could be integrated into a range of future products, including smartphones, tablets, wearables, and even smart glasses or other head-mounted displays.
Potential Use Cases
The application hints at a number of forward-looking applications for the technology, including:
- Air-based gestures: Users could control volume, scroll through documents, or launch applications with mid-air swipes or circular motions near the device.
- Smart Pencil tracking: Apple Pencil movements could be detected even when not in contact with a screen, improving handwriting and drawing precision or enabling 3D input.
- Adaptive signal optimization: Devices could identify hand positions during use and redirect antennas for better network or accessory connections.
Future Implications
This patent aligns with Apple’s growing interest in spatial computing and non-contact interaction technologies. With products like the Vision Pro and advancements in LiDAR and ultra-wideband (UWB) sensors, Apple continues to push the envelope in how users interact with digital content and hardware.
While not all patents lead directly to commercial products, this filing reinforces Apple’s direction toward intuitive, touch-free user interfaces. It could ultimately influence the next generation of iPads, iPhones, and wearables, further blurring the line between the physical and digital worlds.
As with many of Apple’s patent applications, the timing and implementation of this technology remain uncertain. However, its publication offers a clear glimpse into the company’s ambitions for smarter, more context-aware devices that respond seamlessly to their users’ presence and intent.
Exclusive: Google Dominates AI Patent Applications, Cementing Its Leadership in the Field
In a sweeping assertion of technological supremacy, Google has emerged as the frontrunner in artificial intelligence (AI) innovation, filing more AI-related patents than any other company globally. This development underscores the tech giant’s aggressive strategy to dominate the rapidly evolving AI sector, with implications that stretch across industries, from healthcare and finance to autonomous vehicles and language processing.
A Surge in AI Patent Filings
According to data obtained from the United States Patent and Trademark Office (USPTO) and international intellectual property databases, Google filed over 6,500 AI-related patents in 2024 alone, marking a 20% increase from the previous year. This figure places Google ahead of other major contenders such as IBM, Microsoft, and Samsung, who have also heavily invested in AI research and development.
Industry analysts attribute this surge to Google’s ongoing integration of AI into its core products—ranging from its search engine and Google Assistant to Google Cloud and the Android ecosystem. Google’s AI research subsidiary, DeepMind, has also significantly contributed to this patent dominance through cutting-edge work in reinforcement learning, generative AI, and neural networks.
Strategic Areas of Innovation
Google’s patent portfolio reveals its strategic focus on foundational AI models, including large language models (LLMs), computer vision, and machine learning infrastructure. A significant portion of these patents centers around techniques to optimize training efficiency, reduce energy consumption, and improve model alignment and interpretability—areas critical to the safe and scalable deployment of AI systems.
Particularly notable are patents involving Gemini, Google’s flagship AI model series designed to compete with OpenAI’s GPT line and Anthropic’s Claude. Gemini has been integrated into products like Google Workspace, Chrome, and Pixel devices, showcasing Google’s commitment to AI-first development across its ecosystem.
Global Implications and Competitive Edge
The acceleration in patent filings not only reflects Google’s technological edge but also serves as a strategic maneuver in the increasingly competitive global AI race. With nations like China, South Korea, and the European Union investing heavily in AI capabilities, intellectual property has become a key battleground.
“Patents are not just about legal protections—they’re about market positioning,” said Dr. Evelyn Ramos, an AI policy expert at Stanford University. “Google’s dominance in AI patents gives it leverage in licensing, partnerships, and even regulatory discussions.”
Concerns Over Monopoly and Regulation
While Google’s patent prowess is celebrated in the innovation arena, it has also raised concerns about monopolistic behavior. Critics argue that the tech giant’s expansive IP portfolio may stifle competition by creating barriers for smaller players and startups aiming to innovate in the same space.
In response to these concerns, Google has emphasized its commitment to open-source contributions and responsible AI development. The company has released several tools and models under open licenses, including TensorFlow and portions of the Gemma models, to foster collaboration and transparency in AI research.
Looking Ahead
As AI becomes the defining technology of the next decade, Google’s aggressive push for intellectual property leadership is poised to influence everything from global standards to everyday user experiences. With generative AI reshaping content creation, education, and decision-making processes, Google’s dominance in the patent landscape ensures that it will remain at the forefront of both innovation and debate.
In an era where data is the new oil and algorithms are the new engines, Google’s strategy underscores a broader truth: in the AI race, ownership of ideas may matter as much as their execution.
This article is based on proprietary data analysis and expert interviews.
Delhi High Court Summons ‘Nashville Fried Chicken’ Over KFC Trademark Dispute
The Delhi High Court has issued a summons to ‘Nashville Fried Chicken’, a local restaurant, in response to a trademark infringement lawsuit filed by the globally recognized fast-food chain, Kentucky Fried Chicken (KFC). The legal action stems from KFC’s claims that the eatery is imitating its brand identity and misleading customers.
KFC Alleges Brand Imitation
KFC, operated by Yum! Brands, alleges that ‘Nashville Fried Chicken’ unlawfully uses branding elements that closely resemble those of KFC. This includes similarities in the visual design, menu presentation, and particularly the acronym “NFC”, which KFC claims is a deliberate attempt to confuse customers and exploit the popularity of its brand.
The lawsuit also highlights the use of the word “Nashville” in the restaurant’s name — a term that features prominently in KFC’s own menu item, the “Nashville Hot Chicken.” KFC maintains that this choice of branding is likely to mislead consumers into believing there is an association between the two businesses.
Court Issues Summons
Justice Anish Dayal, presiding over the case, admitted the matter and ordered the defendant to respond to the allegations. The court recognized the potential for consumer deception due to the overlapping branding and has scheduled the matter for further hearing in the coming weeks.
The court acknowledged KFC’s longstanding presence in India and noted that the alleged similarities in branding may amount to “passing off” — a situation where one business misrepresents its goods or services as those of another.
KFC Seeks Injunction and Damages
In the lawsuit, KFC has asked the court to issue a permanent injunction preventing ‘Nashville Fried Chicken’ from using the contested name and related branding. The company is also pursuing financial compensation, citing harm to its reputation and brand equity.
According to KFC, its brand elements — including its signature red-and-white color scheme, the image of Colonel Sanders, and its widely known slogans — have earned significant recognition among Indian consumers over the years. The company argues that any imitation not only confuses the public but also weakens its distinct brand identity.
Implications of the Case
The outcome of this legal battle could have broader implications for the Indian food and hospitality industry, particularly concerning brand protection and intellectual property rights. Legal analysts suggest that the case could set a benchmark on how Indian courts view brand mimicry, especially when smaller entities adopt marketing elements similar to established international brands.
The next hearing is expected to take place in June, where both parties will present their detailed arguments before the court.
Maruti Suzuki e-Vitara Patented in India; Launch Scheduled for September 2025
Maruti Suzuki has officially patented its upcoming electric SUV, the e-Vitara, in India, marking a significant step towards its anticipated launch in September 2025. This move positions Maruti Suzuki to compete in the rapidly expanding electric vehicle (EV) market in India.
Design and Platform
The e-Vitara is built on the Heartect-e platform, a collaboration between Suzuki and Toyota. This platform integrates eAxles, combining the motor and inverter into a single unit, enhancing efficiency and performance. The SUV features a rugged design with elements like 3-point Matrix LED DRLs, rear lamps, 18-inch alloy wheels, and active air vents at the front to improve aerodynamics .
Battery Options and Range
Maruti Suzuki offers two battery pack options, the larger 61 kWh battery is expected to provide a range of over 500 km on a single charge, making it competitive in its segment .
Interior Features
Inside, the e-Vitara boasts a modern cabin with a 10.25-inch instrument cluster, ambient lighting, a floating center console, a wireless charging pad, and a panoramic glass roof. The SUV also offers a 10-way electrically adjustable driver’s seat and a 40:20:40 split rear seat configuration, enhancing comfort and practicality .
Safety and Technology
Safety features include seven airbags as standard across all variants, a 360-degree camera, and a suite of Advanced Driver Assistance Systems (ADAS). These features aim to provide a high level of safety for occupants .
Pricing and Launch Details
The e-Vitara is expected to be priced competitively, with the base 49 kWh variant starting around ₹20 lakh (ex-showroom). The 61 kWh variant could be priced at approximately ₹25 lakh, while the AllGrip-e AWD model may approach ₹30 lakh . Production is set to commence at Maruti’s Gujarat plant, with exports planned to over 100 countries, including Europe and Japan .
Competitors in the Indian Market
Upon launch, the Maruti Suzuki e-Vitara will compete against several established and upcoming electric SUVs in India, including:
Tata Curvv EV: Expected to be priced between ₹17.49 lakh and ₹22.24 lakh .
Mahindra BE 6: Priced at ₹18.90 lakh .
Hyundai Creta Electric: Expected to be priced between ₹17.99 lakh and ₹24.38 lakh .
MG ZS EV: Priced between ₹18.98 lakh and ₹26.64 lakh .
With its competitive pricing, advanced features, and robust performance, the Maruti Suzuki e-Vitara is poised to be a strong contender in the Indian electric SUV market.
Design and Platform
The e-Vitara is built on the Heartect-e platform, a collaboration between Suzuki and Toyota. This platform integrates eAxles, combining the motor and inverter into a single unit, enhancing efficiency and performance. The SUV features a rugged design with elements like 3-point Matrix LED DRLs, rear lamps, 18-inch alloy wheels, and active air vents at the front to improve aerodynamics .
Battery Options and Range
Maruti Suzuki offers two battery pack options, the larger 61 kWh battery is expected to provide a range of over 500 km on a single charge, making it competitive in its segment .
Interior Features
Inside, the e-Vitara boasts a modern cabin with a 10.25-inch instrument cluster, ambient lighting, a floating center console, a wireless charging pad, and a panoramic glass roof. The SUV also offers a 10-way electrically adjustable driver’s seat and a 40:20:40 split rear seat configuration, enhancing comfort and practicality .
Safety and Technology
Safety features include seven airbags as standard across all variants, a 360-degree camera, and a suite of Advanced Driver Assistance Systems (ADAS). These features aim to provide a high level of safety for occupants .
Pricing and Launch Details
The e-Vitara is expected to be priced competitively, with the base 49 kWh variant starting around ₹20 lakh (ex-showroom). The 61 kWh variant could be priced at approximately ₹25 lakh, while the AllGrip-e AWD model may approach ₹30 lakh . Production is set to commence at Maruti’s Gujarat plant, with exports planned to over 100 countries, including Europe and Japan .
Competitors in the Indian Market
Upon launch, the Maruti Suzuki e-Vitara will compete against several established and upcoming electric SUVs in India, including:
Tata Curvv EV: Expected to be priced between ₹17.49 lakh and ₹22.24 lakh .
Mahindra BE 6: Priced at ₹18.90 lakh .
Hyundai Creta Electric: Expected to be priced between ₹17.99 lakh and ₹24.38 lakh .
MG ZS EV: Priced between ₹18.98 lakh and ₹26.64 lakh .
With its competitive pricing, advanced features, and robust performance, the Maruti Suzuki e-Vitara is poised to be a strong contender in the Indian electric SUV market.
Delhi High Court Clarifies Patent Law Standards in Landmark Ruling on Section 3(d) of the Indian Patents Act, 1970
In a landmark judgment, the Delhi High Court has provided critical clarity on the interpretation and application of Section 3(d) of the Indian Patents Act, 1970, particularly in cases concerning pharmaceutical innovations. The decision, rendered in the matter of Ischemix LLC v. The Controller of Patents, emphasizes the standards of patentability and the admissibility of post-filing data in applications involving new forms of known substances.
Section 3(d): A Barrier to Evergreening
Section 3(d) of the Indian Patents Act is a unique provision designed to prevent the “evergreening” of patents—where pharmaceutical companies attempt to extend patent monopolies by making minor modifications to known substances. The provision stipulates that a new form of a known substance is patentable only if it results in a significant enhancement of efficacy. In the context of pharmaceutical inventions, the Supreme Court, in its 2013 ruling in Novartis AG v. Union of India, interpreted “efficacy” to mean “therapeutic efficacy.”
The Ischemix LLC Case: Background
Ischemix LLC filed an appeal against the rejection of its patent application (No. 9739/DELNP/2011) by the Indian Patent Office on the grounds of Section 3(d). The applicant argued that they had submitted robust data—spanning in-vitro, in-vivo, and clinical trial results—along with expert opinions to demonstrate the enhanced therapeutic efficacy of the compound.
The Patent Office, however, rejected the application, noting that while comparative data had been submitted after the oral hearing, the data was not clearly explained or sufficiently correlated to therapeutic enhancement as claimed in the specification.
High Court’s Ruling: Key Takeaways
1. Therapeutic Efficacy as the Benchmark
The Delhi High Court reaffirmed the principle established in Novartis AG v. Union of India—that efficacy in the context of pharmaceutical patents must be understood as therapeutic efficacy. Mere improvements in physicochemical properties like stability or solubility are insufficient unless they translate to demonstrable therapeutic benefits.
2. Comparative Data: A Necessary Requirement
Drawing from its earlier ruling in DS Biopharma Limited v. Controller of Patents, the Court stressed that applicants must furnish comparative efficacy data to demonstrate enhancement over known substances. Importantly, this data should be provided in the form of structured comparative tables and supported by appropriate scientific evidence.
3. Admissibility of Post-Filing Data
The Court recognized the inherent delay in generating empirical efficacy data, especially in the pharmaceutical sector where clinical trials are time-intensive. It ruled that while some indication of efficacy should be included at the time of filing, post-filing data may be considered if it corroborates the technical effects disclosed in the original specification. This position is consistent with the Calcutta High Court’s judgment in Oyster Point Pharma Inc. v. Controller of Patents, which acknowledged the prolonged timeline for drug development.
4. Timing and Explanation of Additional Data
The Court made it clear that post-filing data must be submitted well before the final hearing at the Patent Office and should be clearly explained. Submitting complex efficacy data during written submissions post-hearing without oral explanation could render it ineffective, as the Controller may struggle to appreciate the technical details.
5. Requirement for Correlation with Specification
Referring to AstraZeneca AB v. Intas Pharmaceuticals Ltd., the Court ruled that post-filing data should only confirm technical effects already hinted at or described in the specification. It cannot be used to introduce an entirely new technical effect.
Court’s Direction in Ischemix Case
Recognizing the importance of the data but noting the lack of explanation linking the data to therapeutic efficacy, the Court directed Ischemix LLC to submit an explanatory note correlating the submitted evidence to enhanced efficacy. Upon the Patent Office’s consent, the Court remanded the application for re-examination, thereby allowing a fair opportunity for reconsideration.
Broader Implications for Patent Law
This judgment offers significant guidance to pharmaceutical companies and patent practitioners navigating Section 3(d). It strikes a delicate balance between encouraging genuine innovation and preventing the misuse of the patent system to monopolize marginal improvements. The judgment also reinforces procedural discipline, requiring that critical data be timely, complete, and clearly presented.
Conclusion
The Delhi High Court’s decision in Ischemix LLC v. The Controller of Patents builds upon the jurisprudence laid down in Novartis and contributes to a growing body of case law interpreting Section 3(d). As patent litigation continues to evolve in India’s dynamic pharmaceutical sector, such decisions will serve as important references for determining the scope of patentable subject matter and the treatment of post-filing evidence.
Legal experts expect that the continued engagement of the judiciary with Section 3(d) will bring greater predictability and transparency to India’s patent system, particularly for drug-related inventions.
Section 3(d): A Barrier to Evergreening
Section 3(d) of the Indian Patents Act is a unique provision designed to prevent the “evergreening” of patents—where pharmaceutical companies attempt to extend patent monopolies by making minor modifications to known substances. The provision stipulates that a new form of a known substance is patentable only if it results in a significant enhancement of efficacy. In the context of pharmaceutical inventions, the Supreme Court, in its 2013 ruling in Novartis AG v. Union of India, interpreted “efficacy” to mean “therapeutic efficacy.”
The Ischemix LLC Case: Background
Ischemix LLC filed an appeal against the rejection of its patent application (No. 9739/DELNP/2011) by the Indian Patent Office on the grounds of Section 3(d). The applicant argued that they had submitted robust data—spanning in-vitro, in-vivo, and clinical trial results—along with expert opinions to demonstrate the enhanced therapeutic efficacy of the compound.
The Patent Office, however, rejected the application, noting that while comparative data had been submitted after the oral hearing, the data was not clearly explained or sufficiently correlated to therapeutic enhancement as claimed in the specification.
High Court’s Ruling: Key Takeaways
1. Therapeutic Efficacy as the Benchmark
The Delhi High Court reaffirmed the principle established in Novartis AG v. Union of India—that efficacy in the context of pharmaceutical patents must be understood as therapeutic efficacy. Mere improvements in physicochemical properties like stability or solubility are insufficient unless they translate to demonstrable therapeutic benefits.
2. Comparative Data: A Necessary Requirement
Drawing from its earlier ruling in DS Biopharma Limited v. Controller of Patents, the Court stressed that applicants must furnish comparative efficacy data to demonstrate enhancement over known substances. Importantly, this data should be provided in the form of structured comparative tables and supported by appropriate scientific evidence.
3. Admissibility of Post-Filing Data
The Court recognized the inherent delay in generating empirical efficacy data, especially in the pharmaceutical sector where clinical trials are time-intensive. It ruled that while some indication of efficacy should be included at the time of filing, post-filing data may be considered if it corroborates the technical effects disclosed in the original specification. This position is consistent with the Calcutta High Court’s judgment in Oyster Point Pharma Inc. v. Controller of Patents, which acknowledged the prolonged timeline for drug development.
4. Timing and Explanation of Additional Data
The Court made it clear that post-filing data must be submitted well before the final hearing at the Patent Office and should be clearly explained. Submitting complex efficacy data during written submissions post-hearing without oral explanation could render it ineffective, as the Controller may struggle to appreciate the technical details.
5. Requirement for Correlation with Specification
Referring to AstraZeneca AB v. Intas Pharmaceuticals Ltd., the Court ruled that post-filing data should only confirm technical effects already hinted at or described in the specification. It cannot be used to introduce an entirely new technical effect.
Court’s Direction in Ischemix Case
Recognizing the importance of the data but noting the lack of explanation linking the data to therapeutic efficacy, the Court directed Ischemix LLC to submit an explanatory note correlating the submitted evidence to enhanced efficacy. Upon the Patent Office’s consent, the Court remanded the application for re-examination, thereby allowing a fair opportunity for reconsideration.
Broader Implications for Patent Law
This judgment offers significant guidance to pharmaceutical companies and patent practitioners navigating Section 3(d). It strikes a delicate balance between encouraging genuine innovation and preventing the misuse of the patent system to monopolize marginal improvements. The judgment also reinforces procedural discipline, requiring that critical data be timely, complete, and clearly presented.
Conclusion
The Delhi High Court’s decision in Ischemix LLC v. The Controller of Patents builds upon the jurisprudence laid down in Novartis and contributes to a growing body of case law interpreting Section 3(d). As patent litigation continues to evolve in India’s dynamic pharmaceutical sector, such decisions will serve as important references for determining the scope of patentable subject matter and the treatment of post-filing evidence.
Legal experts expect that the continued engagement of the judiciary with Section 3(d) will bring greater predictability and transparency to India’s patent system, particularly for drug-related inventions.
India Breaks into Top Six Globally in 6G Patent Filings: MoS Telecom
India has achieved a significant milestone in the global race for next-generation wireless technology by ranking among the top six nations in 6G patent filings. This advancement underscores the country’s growing influence in shaping the future of telecommunications.
Strategic Push for 6G Leadership
Under the ‘Bharat 6G Vision,’ India aims to become a leader in the design, development, and deployment of 6G technology by 2030. The government is actively supporting this initiative through various programs, including funding research and development, establishing testbeds, and fostering collaborations between academia and industry. These efforts are expected to contribute to India’s goal of securing a 10% share of global 6G patents and one-sixth of contributions to global standards within the next three years .
Terahertz Frequency Bands: The Heart of 6G Innovation
6G technology is set to revolutionize wireless communication by operating in terahertz (THz) frequency bands, specifically between 95 GHz and 3 THz. This spectrum allows for data rates up to 1 terabit per second, marking a hundredfold increase over 5G speeds. Such capabilities will enable applications like immersive extended reality, digital twins, and seamless integration of terrestrial and non-terrestrial networks .
To facilitate research and development in these high-frequency bands, the Telecom Regulatory Authority of India (TRAI) has recommended setting up experimental authorizations for operations in the THz spectrum. This move is expected to position India as a global hub for 6G R&D .
Collaborative Efforts and Future Outlook
India’s ascent in 6G patent filings is attributed to a combination of government initiatives, private sector investments, and academic collaborations. Telecom giants like Reliance Jio, Bharti Airtel, and Tata Communications are investing heavily in 6G research, establishing research centers, and forming international partnerships to drive innovation .
Looking ahead, India is set to host the World Telecommunications Standardisation Assembly (WTSA) in Delhi from October 14 to 24, 2024.
Conclusion
India’s entry into the top six nations for 6G patent filings signifies a strategic leap towards becoming a global leader in next-generation wireless technology. With continued investment in research, infrastructure, and international collaboration, India is poised to play a pivotal role in defining the future of telecommunications.
Strategic Push for 6G Leadership
Under the ‘Bharat 6G Vision,’ India aims to become a leader in the design, development, and deployment of 6G technology by 2030. The government is actively supporting this initiative through various programs, including funding research and development, establishing testbeds, and fostering collaborations between academia and industry. These efforts are expected to contribute to India’s goal of securing a 10% share of global 6G patents and one-sixth of contributions to global standards within the next three years .
Terahertz Frequency Bands: The Heart of 6G Innovation
6G technology is set to revolutionize wireless communication by operating in terahertz (THz) frequency bands, specifically between 95 GHz and 3 THz. This spectrum allows for data rates up to 1 terabit per second, marking a hundredfold increase over 5G speeds. Such capabilities will enable applications like immersive extended reality, digital twins, and seamless integration of terrestrial and non-terrestrial networks .
To facilitate research and development in these high-frequency bands, the Telecom Regulatory Authority of India (TRAI) has recommended setting up experimental authorizations for operations in the THz spectrum. This move is expected to position India as a global hub for 6G R&D .
Collaborative Efforts and Future Outlook
India’s ascent in 6G patent filings is attributed to a combination of government initiatives, private sector investments, and academic collaborations. Telecom giants like Reliance Jio, Bharti Airtel, and Tata Communications are investing heavily in 6G research, establishing research centers, and forming international partnerships to drive innovation .
Looking ahead, India is set to host the World Telecommunications Standardisation Assembly (WTSA) in Delhi from October 14 to 24, 2024.
Conclusion
India’s entry into the top six nations for 6G patent filings signifies a strategic leap towards becoming a global leader in next-generation wireless technology. With continued investment in research, infrastructure, and international collaboration, India is poised to play a pivotal role in defining the future of telecommunications.