In a landmark decision, the Court of Justice of the European Union (CJEU) has clarified jurisdictional issues surrounding cross-border patent infringement disputes, opening the door for broader European legal recourse in national courts. The case, BSH Hausgeräte vs Electrolux (C-339/22), addresses critical questions related to the Brussels I bis Regulation, which governs jurisdiction in civil and commercial matters across EU Member States. This ruling is expected to have significant implications for patent litigation across Europe, particularly concerning the jurisdiction of national courts in cases involving patents granted in different EU states.
Key Points of the CJEU Ruling
The CJEU’s ruling provides several important clarifications:
Jurisdiction for Infringement Actions: A court in an EU Member State where the defendant is domiciled has jurisdiction to hear an infringement action related to a patent granted in another EU Member State, regardless of whether the defendant raises an invalidity defense.
Jurisdiction for Invalidity Defenses in Non-EU Patents: Courts in the EU Member State where the defendant is domiciled may also assess the validity of patents granted outside the EU (such as in non-EU countries) in cases involving patent infringement claims that include those patents.
Cross-Border Injunctions: The decision confirms the availability of cross-border injunctions in cases before both national courts and the new Unified Patent Court (UPC), providing broader options for patent holders seeking to enforce their rights across Europe.
Legal Background: The Brussels I bis Regulation
The CJEU’s decision centers on the interpretation of Articles 4(1) and 24(4) of the Brussels I bis Regulation, which governs jurisdiction in civil and commercial matters within the EU.
Article 4(1) establishes general jurisdiction for cases involving defendants domiciled in an EU Member State. In the context of patent infringement, this means that the court in the EU Member State where the defendant is domiciled can hear infringement actions, even if the patent in question was granted in another Member State.
Article 24(4) provides an exception to the general jurisdiction principle, specifying that disputes regarding the registration or validity of patents must be heard by the court of the Member State where the patent was granted. This exclusive jurisdiction applies regardless of whether the validity issue is raised by way of an action or a defense.
In GAT v LuK (C-4/03), the CJEU had previously ruled that when a court in the defendant’s domicile state hears an infringement case and the defendant raises an invalidity defense, that court does not have jurisdiction to rule on the validity of the patent. Instead, the court must refer the validity issue to the jurisdiction of the Member State where the patent was granted. This ruling set the precedent that national courts could not simultaneously handle both infringement and validity claims.
The CJEU’s Latest Decision: Jurisdiction for Infringement and Invalidity
The CJEU’s recent ruling provides clarity on the scope of Article 24(4) in the context of cross-border patent disputes. The court determined that the exclusive jurisdiction under Article 24(4) applies only to the validity of patents. This means that a court in the Member State of the defendant’s domicile can still hear an infringement case, even if the defendant challenges the patent’s validity.
This interpretation narrows the scope of Article 24(4) and helps avoid situations where a defendant’s defense could undermine the court’s jurisdiction over infringement claims. The CJEU’s reasoning is based on the goal of legal certainty, emphasizing that allowing the defendant’s choice of defense (i.e., invalidity) to determine jurisdiction over the entire dispute would lead to uncertainties in jurisdiction and impede the efficient resolution of cases.
Moreover, the CJEU ruled that infringement proceedings can continue in the court of the defendant’s domicile pending the outcome of any validity challenges in another Member State. This allows courts to stay proceedings while awaiting decisions from other jurisdictions where the validity of the patent is being contested.
Implications for Cross-Border Patent Litigation
This ruling has significant practical implications for patent litigation in Europe:
Cross-Border Injunctions and Litigation: The decision affirms that patent holders can seek cross-border injunctions not only through the UPC but also in national courts. This will make it easier for patent holders to enforce their rights across multiple jurisdictions, increasing the effectiveness of enforcement strategies.
Potential for Anti-Suit Injunctions: The ruling may increase the likelihood of parties seeking anti-suit injunctions in non-EU jurisdictions (such as the UK or the US), particularly in cases where the same patent is subject to litigation in both the EU and outside the EU. This is especially relevant in cases where a court in one jurisdiction has already heard a dispute regarding a patent granted in a non-EU state, and a party seeks to prevent further litigation in another jurisdiction.
UPC Alignment: The CJEU’s decision aligns with the UPC’s decision in Fujifilm v Kodak (UPC_CFI_355/2023), where the court ruled it had jurisdiction over infringement cases concerning UK parts of European patents. This reinforces the consistency of the UPC’s jurisdictional principles and its authority over cross-border patent disputes in Europe.
Jurisdiction Over Third-Party Patents: The decision also addresses jurisdictional issues involving patents granted in non-EU states. The CJEU ruled that while Article 24(4) does not apply to third-party patents (e.g., patents granted in the UK or the US), an EU court may still have jurisdiction to rule on the validity of such patents in certain circumstances. However, such decisions would only have inter partes effect, meaning they would not affect the validity of the patent in the non-EU jurisdiction.
Conclusion
The CJEU’s ruling in BSH Hausgeräte v Electrolux (C-339/22) represents a crucial development in European patent law, expanding the jurisdictional reach of EU courts in cross-border patent infringement disputes. It provides clarity on the interplay between national and UPC courts, allowing for more streamlined enforcement of patent rights across multiple jurisdictions. With this decision, patent holders now have enhanced options for securing cross-border injunctions and pursuing infringement actions in EU courts, while also navigating the complexities of invalidity defenses. The ruling paves the way for a more flexible and efficient patent litigation landscape in Europe.
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Apple Wins Legal Battle Over Heart-Rate Monitoring Patent
At the end of 2023 and the beginning of 2024, Apple faced a significant setback as a patent dispute with Masimo temporarily blocked the sale of its Apple Watch Series 9 and flagship Apple Watch Ultra 2 in U.S. stores. The dispute centered around the use of Masimo’s blood oxygen sensor technology in the wearables, which led to a ruling that forced Apple to temporarily remove certain functionality from its watches to comply with the court’s decision. However, Apple managed to get its products back on the market after modifying the functionality in question.
As if this legal battle wasn’t enough, Apple faced another looming challenge: a multi-year patent infringement case with AliveCor, a company that accused Apple of violating patents related to heart-rate monitoring technology in its Apple Watch models. This new legal fight had the potential to disrupt Apple’s popular wearable line, especially since the Apple Watch is a key player in the smartwatch and health-monitoring markets.
However, this week, Apple received good news. The U.S. Court of Appeals for the Federal Circuit upheld the previous ruling of the Patent Trial and Appeal Board (PTAB), which had concluded that all three of AliveCor’s patents were unpatentable. The court’s decision to back PTAB’s ruling marks a major victory for Apple, as it effectively puts an end to the legal battle over heart-rate monitoring technology and clears the way for the company to continue selling its wearables without further risk of patent disputes on this front.
The AliveCor Patent Dispute: A Multi-Year Legal Battle
The legal dispute between Apple and AliveCor began several years ago when AliveCor, a startup known for its heart-rate monitoring devices, accused Apple of infringing on its patents related to ECG (electrocardiogram) functionality and heart-rate monitoring on the Apple Watch. AliveCor alleged that Apple used its patented technology to enable heart-rate and ECG monitoring in the Apple Watch Series 4 and later models without permission.
In 2021, AliveCor filed a complaint with the U.S. International Trade Commission (ITC), seeking an import ban on the affected Apple Watch models. However, Apple pushed back, claiming that the patents were either invalid or already expired. As the case progressed, AliveCor also filed lawsuits in various jurisdictions, asserting that Apple’s wearable devices were infringing its intellectual property.
AliveCor’s claims hinged on its patents, which it argued covered the ability to use sensors in a wearable device to monitor heart rate and perform ECG tests. This functionality had become a major selling point for Apple Watches, especially as the company marketed its devices as essential tools for tracking health data.
Court’s Ruling: Patent Invalidity
In a significant turn of events, the Patent Trial and Appeal Board (PTAB) sided with Apple, ruling that AliveCor’s patents were unpatentable. The PTAB determined that the technology described in AliveCor’s patents was either obvious in light of prior innovations or too broad to be enforceable. This ruling effectively nullified AliveCor’s claims, and the decision was subsequently upheld by the U.S. Court of Appeals for the Federal Circuit this week.
When courts conclude that patents are unpatentable, it typically means the patents either lack novelty, are too general, or are not sufficiently distinct from prior art. In the case of AliveCor’s patents, the ruling indicated that the technology they covered was not new or sufficiently groundbreaking to warrant exclusive protection, thereby freeing Apple from any further legal threat on this front.
Implications for Apple and the Wearables Market
With the legal challenge from AliveCor resolved in Apple’s favor, the company can now breathe easier knowing that its heart-rate monitoring functionality is no longer under threat. This is especially crucial for Apple, given the growing importance of health features in its wearables, which have become a major part of its strategy to dominate the smartwatch market.
Apple has been aggressively expanding the health capabilities of its devices, with features like ECG, heart rate monitoring, blood oxygen tracking, and even fall detection. These features are key selling points for the Apple Watch, and resolving this patent dispute clears the way for continued innovation in these areas.
This victory comes at a time when Apple is facing increasing competition in the wearables market, with companies like Samsung, Garmin, and Fitbit offering competing devices. Ensuring that its core health-monitoring features remain unchallenged by patent litigation gives Apple a significant advantage in maintaining its leadership in the sector.
Looking Ahead
While the AliveCor dispute has now been settled, Apple is no stranger to patent challenges. The company has faced, and likely will continue to face, legal battles over its intellectual property as its product lineup expands and new technologies emerge. In fact, the Masimo dispute over blood oxygen monitoring functionality highlighted the ongoing risks Apple faces as it integrates advanced health features into its wearables.
However, the resolution of the AliveCor case signals that Apple remains committed to defending its technologies against patent challenges, whether through legal means or by negotiating licensing agreements with other companies. With the court ruling now firmly in its favor, Apple can move forward with its wearables strategy, undeterred by the threat of legal action from AliveCor or other competitors in the space.
For now, it seems Apple’s wearables are no longer at risk of being pulled from the market, and consumers can continue to rely on the Apple Watch as a leading device for health and fitness tracking, free from the threat of patent litigation — at least for the time being.
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.
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.
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.
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.