Merck’s Injectable Keytruda Faces Legal Challenge from Halozyme Therapeutics

Merck’s plans to expand the reach of its blockbuster cancer drug Keytruda with a new subcutaneous (injectable) formulation are encountering a significant obstacle. Halozyme Therapeutics has accused Merck of infringing on its patents related to the hyaluronidase enzyme, which is critical for drug delivery. This dispute could jeopardize Merck’s strategy to maintain Keytruda’s market dominance as the patents for its intravenous (IV) version approach expiration.

Legal Battle Over Hyaluronidase Enzyme Patents

Halozyme claims that Merck’s new injectable version of Keytruda infringes its patented technology for hyaluronidase enzymes, which are used to facilitate the delivery of drugs through subcutaneous injections. This challenge threatens Merck’s efforts to transition Keytruda into an injectable format, potentially extending its market life after the expiration of its IV patents. In response, Merck has vehemently disputed the validity of Halozyme’s patents, signaling an impending and high-stakes legal showdown that could significantly impact the future of its cancer treatment.

Merck stated, “We strongly believe that any Halozyme patents attempting to cover this variant are invalid,” and confirmed it has already filed petitions with the U.S. Patent Office to challenge the patents’ legitimacy. Meanwhile, Merck continues clinical trials for the injectable version of Keytruda and anticipates its launch by early 2026.

The injectable form of Keytruda has shown promising results in clinical trials, with researchers finding it to be as effective as the traditional IV version, which generated $29.5 billion in sales in 2024. To bring the injectable version to market, Merck has partnered with South Korea-based biopharmaceutical company Alteogen, which has developed a variant of the hyaluronidase enzyme that enables large-volume subcutaneous administration.

Halozyme’s Role and Broader Industry Implications

Halozyme, which competes with Alteogen, also develops hyaluronidase enzyme-based drug delivery systems for injectable treatments. The company’s technology is already used in products from major pharmaceutical players like Roche, Johnson & Johnson, and Pfizer. While Halozyme prefers to establish licensing agreements for its intellectual property, it has not publicly commented on the potential for litigation with Merck.

The ongoing legal battle could have broader implications for the pharmaceutical industry’s use of hyaluronidase enzymes in drug delivery. If Merck is forced to halt its use of Halozyme’s technology, it could reshape the landscape of injectable treatments for a variety of drugs, not just Keytruda.

FDA Review for Keytruda’s New Indication

In addition to the ongoing patent dispute, Merck announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for Keytruda, seeking approval for its use as a neoadjuvant treatment for patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The application is supported by Phase 3 KEYNOTE-689 trial data, which showed significant improvements in event-free survival (EFS) and major pathological response (mPR) compared to standard adjuvant therapy alone.

The FDA has set a target action date of June 23, 2025, for this application, under the Prescription Drug User Fee Act (PDUFA). The review also falls under the FDA’s Project Orbis, which facilitates simultaneous reviews of oncology drugs across multiple countries, including Israel, Canada, Australia, and others.

Merck’s Expanding Keytruda Portfolio

Merck is also seeking to expand the use of Keytruda under Project Orbis, with a focus on reducing recurrence and disease progression in earlier stages of LA-HNSCC. Dr. Marjorie Green, Merck’s head of oncology clinical development, emphasized the need for new treatment options for LA-HNSCC, given that current standards have not changed for over 20 years. “We look forward to working with the FDA to potentially bring Keytruda to these patients as soon as possible,” said Green.

Keytruda is already approved for use in metastatic and unresectable recurrent HNSCC in combination with other therapies, and Merck hopes the new indication will provide additional treatment options for patients with earlier-stage disease.

The Competitive Landscape

This legal dispute underscores the competitive environment surrounding hyaluronidase enzyme-based drug delivery technologies. While Merck has teamed up with Alteogen for its injectable Keytruda, Halozyme’s technology is used by other major pharmaceutical companies, and the outcome of the dispute could have far-reaching effects on the future of injectable drug delivery systems.

As Merck fights to extend the market life of Keytruda, the legal and regulatory developments will play a crucial role in determining the drug’s trajectory in the years to come.

Teva Appeals Patent Ruling, despite Low Chances of Review

Teva Pharmaceutical Industries Ltd. is pushing for the U.S. Supreme Court to review its ongoing patent dispute over asthma inhaler patents, after the U.S. Court of Appeals for the Federal Circuit denied the company’s request to reconsider a decision ordering Teva to delist five patents related to its ProAir HFA asthma inhaler from the FDA’s Orange Book.

On March 4, Teva informed the Federal Circuit that it will seek Supreme Court intervention. That same day, the Federal Circuit affirmed its earlier ruling, which mandated Teva to remove the patents because they do not cover the active ingredient, albuterol sulfate, used in the inhaler. The court also denied Teva’s motion to delay enforcement of this decision while it seeks high court review. Without a stay, Teva argues it will lose significant statutory rights that protect its patents.

The issue stems from the FDA’s Orange Book, which lists patents tied to FDA-approved drugs. If a patent is listed, drugmakers can block generic competition for 30 months if a patent infringement suit is filed. The Federal Trade Commission (FTC) has raised concerns that some drugmakers improperly list patents that do not directly relate to the drug, such as device patents. Teva’s delisting of its patents could potentially set a precedent, leading to further challenges on similar drug-device patents.

Teva described its motion as “highly time-sensitive” because it must submit a request to the FDA by March 17 to delist the patents, with Teva arguing that any permanent delisting would result in irreparable harm, even if the patents are later reinstated.

Legal Experts Weigh In

Mark Lemley, a professor at Stanford University, stated that Teva’s case is unlikely to succeed at the Supreme Court, as it aligns with prior legal precedents and does not present a circuit split. “There is no clear legal error, and the decision seems correct,” Lemley said. He added, however, that Teva stands to make significant financial gains if it can delay the enforcement for several months.

Industry groups have been vocal on both sides of the dispute. Teva’s appeal has garnered support from major pharmaceutical companies like Sanofi and AstraZeneca, who argue that the ruling could help clarify standards for listing patents in the Orange Book. Additionally, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) filed briefs calling for a rehearing or revised opinion focused on device-related patents.

On the other side, Amneal Pharmaceuticals and supporters, including medical and law professors, argue that the ruling benefits patients by preventing improperly listed patents from blocking generic drug competition. “This ruling can help reduce barriers to generic entry and, ultimately, lower drug prices,” said William B. Feldman, a physician at Harvard Medical School.

Broader Implications for Drug-Device Patents

The case touches on broader issues within the generic-drug approval process, particularly around the listing of drug-device patents in the Orange Book. Legal experts say that while the Teva case is narrowly focused, it could have significant implications for how drug-device patents are treated in the future.

Robin Feldman, a professor at the University of California College of the Law, San Francisco, described the case as part of a “chessboard of moves” that drug companies use to protect their market share. If the Supreme Court takes the case, it could provide clarity on whether and how drug-device patents should be listed in the Orange Book.

Kevin Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff LLP, suggested that the case is more about statutory interpretation than broader legal principles, and he expects that drugmakers will continue to find ways to list patents that meet the necessary criteria.

Future Outlook

Even if the Supreme Court declines to hear the case, the ruling could still prompt changes in how patents are listed in the Orange Book. For example, Teva or other drugmakers could seek to amend their patents to cover methods of treatment rather than just devices. If granted, these patents could then be re-listed in the Orange Book.

Legal analysts also predict that other companies could join the Supreme Court battle, especially if they are concerned about the potential for broader challenges to their drug-device patents. The outcome of this case could set a significant precedent for how the industry handles the listing of device-related patents in the future.

The case is Teva Branded Pharm. Products R&D Inc. v. Amneal Pharms. of NY LLC, Fed. Cir., No. 24-1936.

Patent for New Technology ‘Polymer Based Pulley-Driven Centrifugal Pump’

Dr. A Ramarao, the Additional Project Coordinator for Samagra Shiksha, has been granted a Patent for 20-years by the Government of India for his groundbreaking innovation of the ‘Polymer Pulley-Driven Centrifugal Pump’. This patent was granted on March 4, 2025, and represents a major technological advancement in the field of mechanical engineering and in field of design of pump. The innovation is expected to revolutionize water pumping systems, offering a more sustainable and cost-effective solution for various applications in both rural and urban areas.

The Polymer Pulley-Driven Centrifugal Pump is a novel approach to pump design, incorporating polymer-based pulleys, which are lightweight, durable, and resistant to corrosion. In comparison of traditional metal pulleys, polymer materials offer distinct advantages, including reduced weight, lower maintenance requirements, and greater cost-effectiveness.

The Patent Details
The patent, awarded against the Application Number 202141035280, covers the unique design and operational features of the centrifugal pump system with polymer pulley. This invention is designed to be particularly effective in water pumping, where the need for a reliable, energy-efficient, and cost-effective pumping solution is paramount.

Key Features of the Polymer Pulley-Driven Centrifugal Pump:
Polymer-based Pulley
Corrosion Resistance
Cost-Effective Design
Energy Efficiency
Durability and Low Maintenance

Impact on Rural and Urban Water Systems
This patented Polymer Pulley-Driven Centrifugal Pump will address several challenges faced by rural and urban water systems in India. In rural areas, where access to reliable water sources is a significant concern, this invention will offer an affordable, low-maintenance solution for irrigation, drinking water supply, and sanitation. The lightweight nature of the pump also makes it easy to transport and install, particularly in remote locations.

For urban areas, the pump can be used in municipal water supply systems, wastewater treatment plants, and industrial applications where reliable and cost-effective pumping solutions are in high demand. Additionally, the polymer-based design makes the pump ideal for systems operating in areas where water quality may be an issue, as the corrosion resistance of the material ensures longevity even in challenging conditions.

A Significant Achievement for Samagra Shiksha
The grant of this patent is a significant achievement not only for Dr. Ramarao but also for Samagra Shiksha, a program aimed at improving the quality of education and infrastructure in India. The initiative focuses on integrating innovation with practical solutions that can benefit society, especially in the fields of education, technology, and sustainability.

Dr. Ramarao’s research and innovation are an excellent example of how scientific advancements can be applied to solve real-world problems, particularly in areas related to public infrastructure with low cost and high efficiency. Samagra Shiksha’s commitment to fostering research-driven solutions aligns with the broader goals of India’s national development, and the success of this patent is a testament to the program’s effectiveness.

The patent opens the door for further research and development in polymer-based pully systems. Dr. Ramarao and his team are already exploring ways to scale up the technology and bring it to market. In the coming months, collaborations with local manufacturers and industry players are expected to help commercialize the innovation, making it accessible to a broader audience.

As India continues to focus on water conservation and management, innovations like this pump can play a critical role in improving the efficiency of water use, reducing energy consumption, and ensuring a sustainable supply of water for both agricultural and industrial purposes.

Dr. A Ramarao’s award of a 20-year patent for the Polymer Pulley-Driven Centrifugal Pump marks a significant milestone in the field of sustainable engineering and water management technology. His dedication to developing cost-effective, energy-efficient, and durable systems has the potential to transform water pumping solutions across India, benefiting both rural and urban populations. This achievement underscores the importance of innovation in tackling some of India’s most pressing challenges and highlights the role of institutions like Samagra Shiksha in supporting research that can bring about meaningful change.

Madras High Court ruled in favor of Pfizer’s patent rights

In a recent global patent disputes, the Madras High Court has pronounced a ruling concerning the ongoing patent dispute in the United States involving Pfizer’s drug, VYNDAMAX (also known as TAFAMIDIS), which is used to treat a rare heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM).

The case is in focus due to the high stakes involved, as Pfizer holds a patent for VYNDAMAX, which is a formulation of TAFAMIDIS, a drug that stabilizes transthyretin (TTR) protein in the heart, which reduces the life-threatening effects of ATTR-CM. Pfizer’s patent rights on the drug have been contested in several jurisdictions, but this ruling in the Madras High Court is particularly noteworthy, as it reflects the broader international implications of the ongoing patent conflict.

In its order, the Madras High Court emphasized the importance of protecting intellectual property, especially for life-saving drugs like VYNDAMAX in pharma sector. The court ruled that Pfizer’s patent for TAFAMIDIS must be upheld in India, despite challenges from generic manufacturers. This ruling reinforces Pfizer’s exclusive rights over the formulation, production or distribution of VYNDAMAX in the Indian market.

The Madras High Court’s decision is groundbreaking for the global pharmaceutical industry, particularly in the realm of patent enforcement. The ongoing patent dispute in the other countries like United States has sparked heated debates over access to affordable medicines versus protecting the intellectual property rights of pharmaceutical companies. VYNDAMAX is considered a breakthrough in the treatment of a condition that severely impacts the heart, and its exclusivity remains a point of contention in markets where generic alternatives are being sought.

Pfizer has expressed its satisfaction with the ruling, stating that it affirms the company’s commitment to innovation and patient care. The company further emphasized that the decision will help ensure that VYNDAMAX remains available to those who need it while protecting the intellectual property rights of pharmaceutical innovators.

Although, it is expected that this ruling will have limited direct effect on markets outside of India, but it does signify the growing importance of patent protection in the global pharmaceutical landscape. Stakeholders, including patients, healthcare providers, and competitors, are keenly awaiting further developments in this high-profile case.

As the patent battle continues across borders, it remains to be seen how other jurisdictions will respond to similar challenges regarding VYNDAMAX and whether further legal actions will alter the course of the ongoing dispute.

Halozyme Therapeutics Claims Merck’s cancer drug’s New Version Infringes Its Patent

Halozyme Therapeutics, a leading biotechnology company which is specialized in the development of innovative drug delivery systems, has raised serious infringement issue regarding the latest iteration of Merck’s blockbuster cancer treatment, Keytruda. A report published by the Wall Street Journal on Wednesday, March 5, 2025 says that Halozyme has formally accused Merck of infringing on its patents with the new version of the cancer immunotherapy drug.

Basically, the dispute moves around the use of Halozyme’s proprietary technology in drug delivery. Halozyme has developed a platform known as ENHANZE, which uses the enzyme hyaluronidase to facilitate the delivery of injectable biologic therapies. The technology helps in enhancing the absorption and distribution of drugs, enabling patients to receive their medications more efficiently with the help of fewer injections. The company has licensed this technology to multiple pharmaceutical partners, including Merck.

Keytruda, Merck’s most successful immuno-oncology drug, is used in the treatment of various cancers, including lung, melanoma, and head and neck cancers. The drug works by inhibiting the PD-1 protein, which prevents the immune system from attacking cancer cells. Keytruda has become one of the highest-grossing cancer drugs globally, generating billions of dollars in revenue for Merck.

Although Keytruda has been available in its original formulation for years, Merck has recently introduced a new version designed to improve its dosing and delivery system as per patient convenience and to reduce the frequency of treatment. This new formulation, which involves a subcutaneous (under-the-skin) injection rather than an intravenous infusion, is said to incorporate Halozyme’s ENHANZE technology.

The patent dispute has raised significant concerns in the biotech and pharmaceutical industries, especially given the high stakes involved. Keytruda’s success has made it one of the most critical cancer therapies in the world, and any disruption to its continued availability or distribution could have far-reaching effects for both Merck and its patients. On the other hand, Halozyme’s potential legal victory could lead to lucrative compensation or even the suspension of Merck’s new Keytruda formulation.

However, both Halozyme and Merck have yet to provide formal public comments on the matter and spokespeople for the companies declining to offer further details beyond confirming their awareness of the issue.

This case highlights the broader importance of intellectual property protection and the intense scrutiny surrounding the use of cutting-edge technologies in the rapidly evolving world of drug development. The outcome of this dispute will likely have long-term ramifications for both companies and the pharma industry at large.

PAU has secured a Patent for new Maize Dryer technology

The Punjab Agricultural University (PAU) has secured a Patent No. 507172 for its innovative Portable Maize Dryer, a development is a ground breaking step for post-harvest processing in maize cultivation. This technology will replace traditional drying methods particularly in rural areas by the efficient grain drying solutions.

Development and Design

On the request of Punjab Secretary of Agriculture, PAU’s Department of Processing and Food Engineering embarked on designing a portable and efficient maize dryer. The project was led by Dr. Mahesh Kumar and Dr. Satish Kumar, with the support of Engineers from NU Tech Dairy, Ambala, under a Memorandum of Understanding (MoU) with PAU.

Technical Features

Capacity and Efficiency: The dryer can handle 3 tons of maize per batch, effectively reducing the moisture content of freshly harvested maize from 25% to 14%, ensuring safe storage.

Operational Flexibility: This dryer can be operated using a 35 HP tractor Power Take-Off (PTO) or a 15 kW electric power source, which makes it adaptable to various farming setups.

Heating Mechanism: This dryer is equipped with a three-pass indirect heating diesel-fired furnace, the dryer consumes 3-4 liters of diesel per hour.

Advanced Control Systems: This dryer has modern features to control the process including a Variable Frequency Drive (VFD) system, waste heat recovery unit, automated temperature control ranging from 50°C to 90°C, and a flame-based optical sensor, ensuring precision heating and enhanced energy efficiency.

The granting of this patent has enhanced the PAU’s commitment to advancing agricultural technology and supporting farmers with practical solutions that enhance productivity and sustainability in crop management.

NIT Rourkela secure Patent in New Solar Technology

National Institute of Technology (NIT) Rourkela has secured a low-cost technology patent which is designed to optimize the energy output from solar panels. This groundbreaking technology is a revolution in the field of solar power generation by improving efficiency, reducing the effective costs, and increasing the overall viability of solar energy as a sustainable power source. The patented technology has the potential to accelerating the global transition to clean energy and contribute significantly to India’s renewable energy goals.


According to one of the researchers, Mr. Susovon Samanta, Associate Professor in Electrical Engineering at NIT Rourkela, solar panels generate electricity by converting sunlight into power, but their output fluctuates throughout the day due to changes in temperature and sunlight intensity. The technology developed is called Maximum Power Point Tracking (MPPT), which ensure the panels consistently generate maximum energy. According to this technology, the system is designed in such a manner that it will adjusts the voltage and current based on sunlight and temperature.


Impact of technology on Solar Energy and the Environment
The new patented technology developed by NIT Rourkela has the potential to significantly increase the efficiency of solar panels, which would have a groundbreaking effect on the solar energy sector.

1. Increased Energy Output
This technology will improve the efficiency of solar panels, which will lead to higher energy yields for the same amount of sunlight.

2. Affordable Solar Energy
This technology ensures that solar panels can be produced at a more affordable price point, which is crucial for scaling up solar energy production.

3. Faster Adoption of Solar Power
With this technology the efficiency will be improved and affordable, this accelerate the adoption of solar energy in both residential and commercial sectors.

4. Sustainability and Clean Energy Transition
This technology will enhance performance and will reduce costs, that encourage more businesses and governments to invest in solar energy, further pushing the global transition towards clean and sustainable energy sources.

Zen Technologies secure a new Patent in defense

Zen Technologies, an Indian defense technology sector company, has granted a significant patent for an innovative “Automated Hard Kill Firearm Mounting System.” The application for patent was filed by the company on October 15, 2022, will be protected by the patent up to October 15, 2042 as per Patent Act 1970, subject to renewal of Patent.

This patent technology aims to redefine military defense capabilities by enhancing the mounting systems for firearms and providing a more precise, automated mechanism for deploying hard kill systems in military applications. The groundbreaking technology marks a significant milestone in Zen Technologies’ pursuit of technological advancements in the defense and security sectors.

Understanding the Automated Hard Kill Firearm Mounting System
This “Automated Hard Kill Firearm Mounting System” developed by Zen Technologies is designed to automatically deploy and control firearms used in defense systems, mainly focusing on vehicles or stationary defense structures. However, this system can play a crucial role in modern military requirements in operations, specifically in countering threats such as incoming projectiles, explosives, or adversarial forces.
By automating the hard kill process, it will reduce the human intervention and maximizes the effectiveness of military hardware during high-stakes operations.

Hard Kill Technology
A “hard kill” defense system means a technology which is designed to physically destroy or neutralize a threat, such as an incoming missile or projectile. The automated firearm mounting system is particularly useful in integrating firearms with hard kill defense mechanisms, which can enhance their accuracy and rapid response during combat.

Key Features of the Automated Hard Kill Firearm Mounting System
1. Automation
This patent technology is designed to rapidly identify and engage threats with minimal human input. This automation is critical and key point for military operations, where speed is essential in dealing with fast-moving or high-priority threats. This technology will ensure that defensive firearms are positioned correctly and are ready to fire at a moment’s notice.

2. Enhanced Accuracy
This technology is engineered to provide enhanced accuracy by using precise sensors and targeting mechanisms. It will ensures that the firearm is mounted and positioned at the optimal angle and trajectory, increasing the likelihood of hitting the intended target during an engagement.

3. Versatility
Zen Technologies’ automated patented technology is easy adaptable and can be used with various types of firearms of defense. Due to it’s flexibility it can be suitable for a wide range of military applications, including armored vehicles, unmanned ground vehicles (UGVs), and stationary defense positions.

4. Real-time Threat Assessment and Response
The system uses advanced algorithms and real-time data analytics to assess threats in real-time by use of sensor and real time feedback system. Once a threat is identified, the system will automatically respond by aligning and firing the mounted firearm at the target.

5. Integration with Other Defense Systems
The automated mounting system is designed to integrate seamlessly with any defense technologies, including radar systems, visual recognition systems, and countermeasure systems due to it’s flexibility of combination.

Potential Applications and Impact
The patented technology hard kill firearm mounting system offers numerous advantages and potential applications in defense sector.

1. Defense Vehicles
2. Unmanned Ground Vehicles (UGVs)
3. Coastal and Border Defense
4. Integration with Drones
5. Civilian and Private Security

Zen Technologies’ Vision for the Future
Zen Technologies, known for its expertise in defense and training sectors, has long focused on developing cutting-edge technologies for modern warfare. This is the 3rd grant in calendar year 2025 and 13th grant in financial year 2024-25 for Zen technology.

Conclusion
This patent for the Automated Hard Kill Firearm Mounting System represents a major leap forward in defense technology for Zen Technologies. This granted technology promises to enhance the precision, speed, and efficiency of military defense systems, which provides greater protection against a wide range of threats. It has potential applications in vehicles, unmanned systems, border defense, and even private security, the patented technology has the ability to shape the future of warfare, advancing the integration of automation into military strategy.

First Solar sues JinkoSolar over Infringement of New Patent Technology

First Solar an US solar panel manufacturer, has initiated legal action against JinkoSolar (Chinese solar panel manufacturer), alleging infringement of its U.S. Patent No. 9,130,074, which pertains to tunnel oxide passivated contact (TOPCon) solar technology. This patent was obtained by First Solar in 2013 through its aquiring of TetraSun, Inc.

The lawsuit was filed in the U.S. District Court for the District of Delaware. First Solar claims that JinkoSolar’s use of TOPCon technology infringes upon its patent rights. In defense, a JinkoSolar spokesperson stated that the company is having proof that the claims lack merit and intends to vigorously defend itself against what it considers baseless allegations by First solar.

Currently, the legal action is part of a broader trend in the solar industry, where several major manufacturers are engaged in patent disputes over TOPCon technology. In October 2024, First Solar notified several large competitors, including JinkoSolar, of alleged infringements on its TOPCon patents.

The outcome of this lawsuit could have significant implications for the solar industry market and manufacturers , particularly concerning the development and commercialization of advanced solar technologies like TOPCon worldwide.

Amazon to pay $39M to Lifestyle for trademark infringement

The Delhi High Court in a recent order on February 26, 2025, ordered Amazon to pay $39 million (approximately ₹340 crore) in damages to Lifestyle Equities CV for infringing upon its ‘Beverly Hills Polo Club’ trademark.

Lifestyle Equities had filed a trademark infringement suit in 2020, alleging that Amazon Technologies and associated sellers of amazon used a deceptively similar mark on apparel and other products sold on Amazon’s platform. The court had previously issued an interim injunction in October 2020, restraining Amazon and others from using the infringing logo and directing Amazon Seller Services to remove the infringing products from its platform.

During the proceedings it is found that the Cloudtail India, a major seller on Amazon.in, acknowledged its involvement in the sale of the infringing products and proposed a settlement that would include damages. The court also awarded damages of ₹4,78,484 against Cloudtail, representing 20% of its revenue from infringing products. Amazon Seller Services was removed from the list of involved parties, as it agreed to remove any future listings of infringing products.

This ruling has the importance of trademark protection and the legal consequences of infringement of intellectual property, particularly in the e-commerce sector.