USPTO

American Clean Energy Faces Growing Patent Pressure from Foreign Rivals

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The United States clean energy industry is feeling the heat from foreign patent competition, as global innovation accelerates in solar, wind, and battery technologies. A new report by OilPrice.com warns that foreign firms, particularly from China, are reshaping the intellectual property (IP) landscape and squeezing U.S. players out of key technology domains.

Growth Slows Across Renewable Sectors

U.S. clean energy capacity is projected to grow only 7 percent in 2025 — the weakest rate in over a decade. Wind power is expected to expand just 1.8 percent, its slowest growth since 2010. Analysts attribute this slowdown to a mix of policy delays, permitting hurdles, and competitive patent claims that make domestic expansion more complex.

Offshore wind projects have faced funding cuts and regulatory freezes, further eroding investor confidence in American renewables.

Foreign Patents Redefining Innovation Boundaries

The article highlights a surge in patent filings by non-U.S. firms. Chinese, European, and Canadian companies now dominate patent registries in core clean energy technologies such as solar cells, energy storage, and grid efficiency systems.

This trend complicates efforts by U.S. companies to secure exclusive rights or defend against infringement suits. Many of the latest clean energy innovations are born outside the United States, where U.S. patent examiners struggle to verify prior art or challenge overlapping claims.

Ongoing Legal Battles Intensify

Recent court cases illustrate the deepening patent conflict.

  • Tigo Energy and SMA Solar Technology reached a settlement over rapid shutdown systems for solar installations.
  • Maxeon Solar Technologies has sued Canadian Solar and other firms for allegedly infringing its TOPCon solar cell patents.

Such disputes underscore the rising legal costs and strategic risks facing American renewable energy manufacturers.

China’s Lead in Clean Energy Technology

China’s rapid clean energy growth adds pressure on U.S. companies. The country has not only scaled up solar and wind manufacturing but also unveiled the world’s first operational thorium reactor — a symbol of its advanced energy ambitions.

Chinese firms enjoy state subsidies, integrated supply chains, and broad patent portfolios that strengthen their global influence. Industry experts warn that this combination could limit U.S. access to critical technologies and components.

Patent System Under Strain

The U.S. Patent and Trademark Office (USPTO) faces increasing difficulty handling foreign-dominated innovation landscapes. Examiners often lack access to non-U.S. databases and prior art in languages like Chinese or Korean.

Legal experts suggest American firms must adapt by narrowing patent claims, improving defensive IP strategies, and pursuing international licensing or joint ventures.

Outlook: Balancing Innovation and Protection

As the U.S. races to meet its climate and energy goals, intellectual property strategy could become a key battleground. Strengthening domestic R&D, improving patent transparency, and streamlining approval processes are now critical to keeping pace with foreign competitors.

Analysts believe that without decisive action, the United States risks losing not only technological leadership but also control over the future of global clean energy.

Apple Explores Gesture Recognition with Antenna-Based Object Detection in New Patent Application

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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.

Nobel Prize Winners Convince Court to Revive CRISPR Patent Dispute

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In a significant legal development with profound implications for the future of genetic engineering, a U.S. federal appeals court has agreed to revisit a high-stakes patent battle over CRISPR-Cas9 gene-editing technology. This decision follows a petition spearheaded by Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier, who are seeking to reclaim intellectual property rights over one of the most groundbreaking discoveries in modern biology.

The CRISPR Breakthrough

CRISPR-Cas9, a revolutionary tool that enables precise editing of DNA, has transformed the field of genetics since its development in the early 2010s. The technology allows scientists to alter genes with unprecedented ease and accuracy, offering promise in treating genetic diseases, improving crops, and even combating climate change. In 2020, Doudna and Charpentier were awarded the Nobel Prize in Chemistry for their pioneering work on CRISPR.

A Complex Legal Landscape

The CRISPR patent battle has pitted the University of California, Berkeley—where Doudna conducted much of her research—against the Broad Institute of MIT and Harvard. In 2022, the U.S. Patent and Trademark Office (USPTO) ruled in favor of the Broad Institute, recognizing its claim over the use of CRISPR in eukaryotic cells, including human cells.

UC Berkeley had earlier filed for the foundational CRISPR patent, but the Broad Institute’s expedited filing and specific focus on eukaryotic applications earned it a separate, and so far, legally upheld claim. The dispute centers on whether the Broad’s innovations were obvious extensions of the original CRISPR work or merited independent patent protection.

The Revival of the Case

In a rare move, the U.S. Court of Appeals for the Federal Circuit has agreed to review the previous ruling, citing newly presented arguments and scientific evidence by the UC Berkeley team and their legal representatives. Doudna and her colleagues argue that the Broad Institute’s patents should be invalidated on the grounds that the underlying concept of CRISPR in eukaryotic cells was an “obvious” step from their foundational research.

“The decision to revisit the case acknowledges the evolving understanding of CRISPR’s development and the need to fairly assign credit for its invention,” said a UC Berkeley spokesperson.

Legal analysts believe that the court’s decision could reshape the landscape of biotechnology patents. “This is not just about who owns CRISPR,” said Lisa Morgan, a biotech patent attorney in Washington. “It’s about how intellectual property is awarded in rapidly advancing scientific fields.”

Scientific and Commercial Stakes

The implications of the patent dispute are enormous. CRISPR-based therapies are currently in clinical trials for conditions such as sickle cell anemia, cancer, and blindness. With billions of dollars in potential revenue at stake, the ownership of key CRISPR patents determines who can license the technology and at what cost.

The legal battle has also sparked concern within the scientific community over how intellectual property law intersects with collaborative research and open science. Many researchers argue that patent disputes could stifle innovation and slow the development of life-saving treatments.

What’s Next?

The appeals court is expected to hear oral arguments later this year, with a decision anticipated in early 2026. Until then, the scientific community, biotech firms, and investors will be closely watching the proceedings.

As the legal saga unfolds, the core of the dispute remains a fundamental question about innovation in science: Who truly owns a discovery when multiple researchers contribute to a single transformative breakthrough?

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

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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

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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

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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

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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

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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

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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

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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.