“Judge Signals Sanctions Against Patent Attorney for Sharing Netflix’s Confidential Data with Litigation Funder”

A federal judge in Oakland has signaled his intent to impose sanctions on patent attorney Bill Ramey and his firm, Ramey LLP, for violating a protective order by sharing Netflix Inc.’s confidential information with a litigation funder. The case stems from a patent infringement lawsuit filed by Finnish inventor Lauri Valjakka against Netflix, in which Ramey represented Valjakka.

During a hearing the U.S. District Court indicated that attorneys’ fees would be an appropriate sanction, noting that they would likely be substantial. The dispute centers on Ramey’s disclosure of Netflix’s source code and financial information to AiPi LLC, a litigation funding company, without proper authorization. Netflix contends that these materials, described as the “crown jewels of its business,” were shared in violation of the court’s protective order, which restricts access to sensitive information to authorized individuals only.

At the hearing, Netflix’s attorney, Sarah Piepmeier of Perkins Coie, argued that AiPi had access to the confidential information before Netflix was aware of the funding arrangement. She expressed concern that AiPi’s possession of Netflix’s proprietary data could influence its decisions in future litigation or inspire new lawsuits. Ramey defended his actions, asserting that the protective order allowed him to share the information with “affiliates,” a category he believed included AiPi’s attorneys. He further claimed that no harm had occurred because AiPi’s lawyers assured him they hadn’t used the materials inappropriately.

Judge Tigar expressed skepticism about Ramey’s defense, stating that having individuals affiliated with a litigation funder review Netflix’s source code constituted a situation of harm. He also indicated that he would consider referring Ramey to the California State Bar or another disciplinary body for further review.

This development adds to a series of legal challenges faced by Ramey and his firm. Earlier this year, Judge Tigar denied Ramey’s application for pro hac vice admission in a separate case, CyboEnergy Inc. v. Netflix Inc., ruling that Ramey had been practicing law in California without a state bar license. Additionally, Ramey has faced scrutiny over his firm’s handling of multiple patent cases in California without proper licensure, leading to questions about his compliance with state ethical standards .

The case, Valjakka v. Netflix Inc., continues to unfold, with potential implications for the intersection of patent law, litigation funding, and the protection of confidential business information.

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.

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.

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.

Flux Power Holdings Secures Patent for Groundbreaking AI-Powered Battery Cycle Life Maximization Algorithm

Flux Power Holdings, Inc. (NASDAQ: FLUX), a pioneering developer of advanced lithium-ion energy storage solutions, today announced that it has been granted a patent for its innovative Intelligent Battery Cycle Life Maximization Algorithm. This proprietary AI-driven technology is designed to optimize the performance and longevity of its battery systems by leveraging machine learning to adapt to real-world usage. With this breakthrough, Flux Power is positioning itself as a leader not only in energy storage but also in the development of software-driven electrification solutions for commercial and industrial sectors.

A Leap Forward in Battery Management
Flux Power’s latest patent reflects a major step forward in the evolution of battery management technologies. The Intelligent Battery Cycle Life Maximization Algorithm uses machine learning to continuously monitor and adjust the charging behavior of lithium-ion battery packs based on real-time usage data. By dynamically optimizing the maximum charge value for each battery pack depending on its actual field usage, the algorithm extends the cycle life of the batteries, improving both efficiency and operational performance.

Paulus Geantil, Chief Technology Officer (CTO) of Flux Power, explained the significance of the development:
“This algorithm uses real-time machine learning to tune battery cycling behavior based on actual usage patterns in the field, significantly extending system life and efficiency,” he said. “We’ve moved beyond conventional battery management systems. This algorithm not only optimizes the performance of each battery pack but learns and evolves with its application over time to deliver superior and sustainable performance.”

The new algorithm is a pivotal component of Flux Power’s broader strategy to evolve from being a battery manufacturer to a technology-driven energy solutions provider. This move aligns with the company’s goal of building smart, connected, and autonomous energy ecosystems that extend far beyond the simple manufacture of energy storage hardware.

Shaping the Future of Energy with AI
As the demand for sustainable and efficient energy solutions grows, Flux Power is looking to meet this demand by incorporating artificial intelligence (AI) and machine learning into its core products. The company’s CEO, Krishna Vanka, highlighted the shift towards AI-driven solutions, emphasizing the added value customers will gain from the new technology:

As the electrification of commercial and industrial equipment continues to accelerate, Flux Power is well-poised to capitalize on the shift towards battery-powered solutions that provide longer life cycles, improved operational efficiency, and reduced environmental impact. With the addition of this cutting-edge AI technology, Flux Power is positioning itself as a key player in the energy transformation landscape.

About Flux Power Holdings, Inc.
Flux Power Holdings, Inc. These sectors include material handling, airport ground support equipment (GSE), and stationary energy storage. Flux Power’s products provide a high-performance, environmentally friendly, and cost-effective alternative to traditional energy solutions, such as lead-acid and propane-based systems. By focusing on battery management systems (BMS), telemetry, and AI-driven innovations, Flux Power continues to expand its footprint in the energy storage industry.

Forward-Looking Statements
This release contains forward-looking statements that involve estimates, assumptions, risks, and other uncertainties, which may cause actual results to differ materially from those anticipated. These statements are not guarantees of future results, and actual results could vary based on a range of factors including market conditions, customer acceptance, product development, and other business risks. Investors are encouraged to review the risk factors outlined in Flux Power’s filings with the Securities and Exchange Commission (SEC) for further details.

U.S. Court of Appeals for the Federal Circuit Invalidates Patents Over Functional Claim Language in “Payment Handler” Case: Implications for AI Patents

In a precedential decision issued by the U.S. Court of Appeals for the Federal Circuit in February 2025, the court affirmed a district court ruling that the term “payment handler” in a patent claim was a “nonce” term—a placeholder for functional language. This ruling invoked 35 U.S.C. § 112, sixth paragraph, governing means-plus-function claiming, leading to the invalidation of the associated patents. The decision raises crucial questions about the drafting of patent claims in industries like artificial intelligence (AI), where functional language is often used to describe complex systems.

The Case: Payment Handler as Functional Language
The case, involving a dispute over software patents related to payment processing technologies, centered on the term “payment handler.” The court examined whether this term invoked means-plus-function claiming under § 112 ¶6, which applies when a claim term is expressed in purely functional terms, without reciting sufficient structural detail. Under this provision, if a claim lacks structural detail, it is considered indefinite unless the specification provides enough supporting structure or an algorithm corresponding to the claimed function.

The Federal Circuit began by discussing whether the term “payment handler” overcame the presumption against invoking means-plus-function claiming. The court ruled that the term indeed lacked sufficient structural specificity, as it only described the function of handling payments without specifying how this was achieved. The court likened the term “payment handler” to “module”, which has previously been considered a nonce term in patent law, representing a vague description of a software or hardware component that performs a specified function.

Why “Payment Handler” Was Deemed Indefinite
The court rejected several arguments put forth by the patent holder. For one, the plaintiff argued that terms like “operable to,” “configured to,” and “that” used in the claim language conferred sufficient structure to avoid means-plus-function treatment. The Federal Circuit noted that while these terms are often used in structural contexts, they do not automatically prevent means-plus-function claiming. Citing the case Rain Computing, Inc. v. Samsung Electronics America, the court pointed out that the applicability of § 112 ¶6 depends on the specific context and nature of the claims.

The court also addressed the argument that the “payment handler” terms were part of a recognized class of software structures like “code” or “applications,” which the court in Dyfan, LLC v. Target Corp. found to be sufficiently structural. However, the Federal Circuit emphasized that, unlike “code” or “application,” the term “payment handler” had no established meaning within the software development community. The patent holder had failed to provide expert testimony or concrete examples showing how the term conveyed structure.

Additionally, the court rejected the argument that the surrounding claim language—such as defining inputs, outputs, and operation of the payment handler—provided enough detail to make the term structural. The claim did not explain how the payment handler functioned, nor did it outline the specific “rules” or algorithm that would govern its operation. The Federal Circuit noted that the specification of the patent simply repeated the claim language without offering any substantial details about the underlying structure of the payment handler.

In essence, the court concluded that the term “payment handler” was functionally indefinite and did not include the necessary structural disclosure to satisfy § 112 ¶6. As a result, the court invalidated the patent claims that relied on this vague term.

Implications for AI Patent Applications
Although this decision did not directly address artificial intelligence (AI), it offers significant insights for AI-related patent drafting, where functional terms are often used to describe complex technologies. AI inventions, particularly those involving machine learning models, neural networks, and other advanced algorithms, may face similar challenges when their claims rely heavily on functional descriptions.

In AI patents, terms like “classifier,” “predictive model,” or “neural network” are often used to describe the operations of a system without fully detailing the underlying algorithm or architecture. While these terms may be widely accepted in the field, patent drafters must be cautious when they lack sufficient structural disclosure in the specification.

Provide Detailed Structural Descriptions: Instead of relying on broad, functional terms like “classifier” or “model,” drafters should disclose as much structural detail as possible, including algorithms and specific AI techniques used. For example, terms like “feed-forward neural network,” “convolutional neural network,” or “generative pre-trained transformer” provide concrete examples of structures and algorithms that could support the claims and avoid indefiniteness challenges.

Avoid Ambiguous Terminology: Terms like “handler” or “module,” which are commonly used as placeholders for functional components, should be avoided or supplemented with detailed explanations of their structure and operation. If a term like “payment handler” is essential, ensure the patent specification includes an in-depth description of the specific software or hardware involved and how it performs its function.

Use Recognized AI Terms for Structure: Where possible, use terms that are already well understood to connote structure in the AI field. For instance, the term “model” could be more structural in the AI context than terms like “classifier,” especially when it is described with reference to specific AI architectures and algorithms.

Include Dependent Claims for Clarity: Dependent claims can be used to provide more specific details on the structure of AI systems, such as the type of neural network or the algorithm being used.
Don’t Rely Solely on Claim Language: As the court emphasized, merely parroting the claim language in the specification is not enough. It’s crucial to explain the structural components in detail, particularly for AI inventions that involve complex algorithms and system architectures.

Conclusion: The Need for Clarity in AI Patents
The Federal Circuit’s decision underscores the importance of clarity and specificity in patent claims, particularly in fields like software and AI, where functional terms are commonly used. Patent applicants must ensure that functional language is supported by concrete structural details to avoid claims being deemed indefinite under § 112 ¶6. By providing comprehensive descriptions of the structure and algorithms underlying their inventions, AI patent drafters can strengthen their patent applications and reduce the risk of invalidation due to indefiniteness.

As AI technologies continue to evolve, patent law will need to adapt, and the case serves as a timely reminder that functional claims must be backed by sufficient structure to withstand legal scrutiny.

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.

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.

India’s Evolving Intellectual Property Landscape: A Key Turning Point for Pharma Industry

“The needle has moved,” declares Anil Matai, Director General of the Organization of Pharmaceutical Producers of India (OPPI), in a recent podcast interview with Scrip. The statement refers to the substantial changes in India’s intellectual property rights (IPR) regime, which witnessed some critical amendments in the past year. As the representative body for foreign pharmaceutical companies in India, OPPI plays a crucial role in shaping the country’s IPR and regulatory environment, which continues to evolve as the industry adapts to both domestic and global pressures.

Matai’s remarks signal that India’s pharmaceutical sector is undergoing a transformation, particularly in areas such as patent regulations, data protection, and the ongoing debates surrounding Section 3(d) of the Indian Patent Act.

Key Amendments and the State of Play
India’s intellectual property landscape has been in flux, with several key amendments to the patent law being introduced last year.
However, one of the most controversial aspects of India’s patent system remains Section 3(d) of the Indian Patents Act. Section 3(d) prevents the patenting of new forms of known substances unless they result in significantly enhanced efficacy.

The ruling emphasized the need for innovation beyond mere incremental changes, a stance that was seen as a win for public health over the interests of global pharmaceutical companies. However, for foreign firms like those represented by OPPI, Section 3(d) remains a longstanding sticking point. Matai pointed out that while India’s patent system has evolved, challenges such as these continue to make it difficult for global innovators to protect their products in the country.

Data Protection: A Global Imperative
Another critical issue discussed by Matai is the need for Regulatory Data Protection (RDP), which he describes as a “no-brainer.” RDP refers to the protection of clinical trial data submitted to regulatory authorities in the drug approval process, ensuring that competitors cannot rely on this data to gain approval for their own versions of a drug without conducting their own trials. Matai cites China’s rapid advancement in the biologics space as an example, noting that China has already made significant strides in protecting RDP and attracting global pharmaceutical investment.

China’s National Medical Products Administration (NMPA) recently introduced guidelines that outline specific periods of data exclusivity for different categories of drugs. These guidelines are part of the broader regulatory framework that has seen China move ahead of India in the biologics sector.

The issue of data exclusivity (DE) has been contentious in India for years. Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, India, like other member states, is required to protect undisclosed data necessary for regulatory approval of new chemical entities. However, India has not yet provided for data exclusivity in its laws. While the generics industry and public health advocates argue that this is a matter of confidentiality and not exclusivity, foreign firms see data exclusivity as crucial for fostering innovation and protecting intellectual property.

Matai emphasized that India’s reluctance to adopt data exclusivity is a hindrance to attracting foreign investment in the pharmaceutical sector. “Without adequate data protection, global pharmaceutical companies may look elsewhere for growth opportunities,” he warned, citing how China has leveraged RDP to become a hub for life sciences research and development.

US-India Trade Relations and the Road Ahead
The issue of intellectual property rights is not only a domestic matter but also an international one, particularly in the context of India’s trade relationships. India remains on the Priority Watch List in the United States Trade Representative’s (USTR) Special 301 Report, which highlights countries that are seen as not providing adequate protection for intellectual property rights. India shares this distinction with China, reflecting ongoing concerns about patent protection, data exclusivity, and the safeguarding of undisclosed data.

The U.S. has long pushed for stronger IP protection in India, with senior figures such as Eli Lilly’s CEO, David Ricks, calling for the country to rethink its stance on IPR and become a leader in life sciences. According to Ricks and other pharmaceutical leaders, India’s regulatory framework must evolve to align with global standards to attract the level of investment needed for the country to become a competitive player in the pharmaceutical industry.

Both India and the U.S. are now working toward the first tranche of a multi-sector Bilateral Trade Agreement (BTA), which is expected to be finalized by the fall of 2025. It remains to be seen whether intellectual property issues, including those surrounding patent eligibility and data exclusivity, will be part of the negotiations. If they are, the outcome could have a profound impact on the future of the pharmaceutical industry in India.

The Path Forward

India’s evolving IPR landscape presents both challenges and opportunities. While the changes in the regulatory environment signal progress, much remains to be done to balance the needs of public health with those of global pharmaceutical companies. As foreign firms continue to call for stronger IP protections, India faces the delicate task of crafting a system that promotes innovation without undermining access to affordable medicines.

Anil Matai’s comments reflect the tensions at play in this balancing act. As India moves toward a more integrated role in the global pharmaceutical market, the next few years will be pivotal in shaping the future of the country’s intellectual property and regulatory framework. Whether India can find the right balance between fostering innovation, attracting investment, and maintaining access to essential medicines will be key to its future as a global leader in the life sciences sector.

In the meantime, the global pharmaceutical community will be watching closely, as India’s regulatory evolution continues to unfold.

Heimdal Receives U.S. Patent for Innovative AI-Powered DNS Threat Detection

Heimdal, a leading European cybersecurity firm, has been awarded U.S. Patent No. 18333620 for a proprietary method that predicts the likelihood of a domain being malicious. The patented technology, titled “Apparatus and Method of Predicting Malicious Domains,” marks a significant step forward in Heimdal’s mission to redefine DNS security.

This invention forms the foundation of Predictive DNS™, Heimdal’s AI-driven system designed to detect and block harmful domains before they are weaponized in phishing, ransomware, or data theft campaigns. The technology uses a combination of machine learning, natural language processing (NLP), and computer vision — all powered by neural networks trained on millions of data points including domain names and DNS behavior.

“It ensures we can continue to protect our customers with industry-leading innovation.”

The patented method allows for earlier and more accurate threat detection, giving security teams a powerful tool to prevent cyberattacks before they occur. Integrated into the company’s broader Heimdal XDR platform, this development supports fully automated, risk-aware threat prevention strategies.

With DNS traffic involved in over 90% of malware and breach-related activity, Heimdal’s technology addresses one of the most exploited yet often overlooked areas of cybersecurity.

Key features of Heimdal’s Predictive DNS™ include:

High-precision threat detection, measured by strong F1 scores.

Real-time adaptability, with AI models that evolve based on new data.

Seamless platform integration, enhancing Heimdal’s extended detection and response (XDR) capabilities.

As global threats grow more sophisticated, Heimdal’s latest achievement positions it as a critical player in next-generation cybersecurity.