ToolGen Initiates UK Patent Lawsuit Against Vertex Over Groundbreaking Gene Therapy CASGEVY

ToolGen, Inc. (KOSDAQ: 199800), a biotechnology firm at the forefront of genome editing innovations, has filed a patent infringement lawsuit in the United Kingdom against Vertex Pharmaceuticals and its key manufacturing partners, Lonza and RoslinCT. The legal action centers on Vertex’s approved CRISPR-based gene therapy, CASGEVY, which ToolGen alleges utilizes its proprietary technology without proper authorization.

ToolGen claims the development and commercialization of CASGEVY infringe upon its intellectual property related to the use of CRISPR RNP (ribonucleoprotein complex) technology. The South Korea-based company holds global patents, including those granted in Europe, for its CRISPR RNP methodology. This advanced technique enables the direct delivery of the Cas9 protein into target cells in its active protein form—bypassing the use of DNA or mRNA vectors. Such an approach not only reduces the risk of genomic integration and cellular toxicity but also offers enhanced precision and safety, making it a preferred platform in human therapeutics, as well as agricultural and animal biotechnology.

CASGEVY made history as the first gene editing therapy to be approved for clinical use, beginning with authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023, and subsequently by the European Commission in February 2024.
In December 2023, Vertex signed a licensing deal with Editas Medicine to access CRISPR-related technology. However, ToolGen asserts that this agreement does not cover critical components of the CRISPR RNP delivery system, which it pioneered and for which it holds enforceable patents.

“CASGEVY is a remarkable achievement, but it rests on a technological foundation developed by ToolGen. We believe Vertex’s therapy makes essential use of our CRISPR RNP and Cas9 technologies, and it is only fair that ToolGen be properly compensated through an appropriate licensing arrangement.”

Dr. Ryu clarified that the company’s legal move is not intended to hinder patient access to the life-changing treatment.

“This action is not about limiting access to CASGEVY in any way,” he said. “Our goal is to ensure that ToolGen’s contributions are justly recognized and rewarded.”

The lawsuit is expected to draw attention from across the biotech sector, as it highlights ongoing disputes in the fast-evolving field of genome editing, where overlapping patents and complex licensing agreements remain a point of contention.

As the legal process unfolds, industry observers will be watching closely, not only for the outcome of the case but also for its potential implications on future licensing practices and collaborations in CRISPR therapeutics worldwide.

USPTO Suspends Expedited Examination for Design Applications Amid Fraud Concerns and Case Backlog

In a decisive move aimed at improving efficiency and safeguarding the integrity of the U.S. intellectual property system, the United States Patent and Trademark Office (USPTO) has announced the suspension of expedited examination for design patent applications, effective April 17, 2025. The policy change was officially detailed in a notice published in the USPTO’s Official Gazette on April 14.

The decision comes in response to a 560% surge in requests for expedited design application reviews—a trend the USPTO attributes in large part to a rise in fraudulent filings. This suspension is part of a broader strategy to reduce the growing inventory of unexamined design applications, curb misuse of the system, and ensure accurate and fair processing for legitimate applicants.

Key Reasons Behind the Suspension
According to the USPTO, the unexpected spike in expedited examination requests has placed significant pressure on examiners and contributed to increased backlogs in the design application pipeline. Much of this rise, the agency notes, is linked to fraudulent filings, which not only distort processing timelines but also pose risks to the integrity of the U.S. intellectual property system.

The USPTO also cites a rise in erroneous micro entity certifications—false claims to fee discounts intended for small applicants—as a factor in its decision. These certifications have become a growing concern in recent years, complicating the patent review process and necessitating additional scrutiny.

What the Suspension Means for Applicants
Starting April 17, 2025, the USPTO will no longer grant requests for expedited examination of design applications, including any renewed or pending requests submitted on or after that date. In line with this change:

Associated fees will be refunded in full for requests made after the effective date.

The USPTO will continue to examine design applications under its standard timeline, as it works to reduce overall pendency and inventory.

Impact on the Design Patent Community
The suspension will have a notable impact on companies and individuals relying on faster design patent protection for products with short market cycles, particularly in sectors like fashion, consumer electronics, and packaging design. However, the USPTO maintains that ensuring quality and transparency in the application process outweighs the short-term disruption caused by the policy shift.

Industry analysts suggest that while the suspension may create delays for some innovators, the move is likely to improve the reliability and credibility of granted design patents in the long run, which is critical for both domestic and international enforcement.

Broader Reform Efforts
This policy change is one component of the USPTO’s wider agenda to combat abuse and strengthen the integrity of the IP system. The office has been ramping up enforcement against fraudulent filings, improving data analytics to detect suspicious activity, and refining procedures for certifying applicant eligibility for reduced fees.

The USPTO also continues to explore new technologies and staffing solutions to address examination delays and ensure legitimate applications are processed efficiently.

New Guide Offers Strategic Insights to Strengthen Drug Patent Applications for Pharma Innovators

In a move designed to bridge the gap between pharmaceutical research and market success, a newly released guide is offering strategic advice to drug developers on how to craft more effective patent applications. Published on the widely respected platform DrugPatentWatch, the guide is titled “Drafting Effective Drug Patent Applications: Turning Science into Market Power” and is aimed at pharmaceutical companies, research institutions, and individual innovators seeking to protect and capitalize on their scientific breakthroughs.

Accessible via DrugPatentWatch’s blog, the guide draws from hands-on experience in supporting drug developers through the complexities of patent law and the commercial pharmaceutical landscape.

Why a Strong Patent Application Matters
In today’s competitive pharmaceutical sector, patents are among the most critical assets that determine a drug’s commercial viability. The guide emphasizes that a poorly drafted patent—regardless of the novelty of the underlying science—can leave a drug vulnerable to challenges or fail to provide adequate market exclusivity.

The document outlines that successful drug patents must not only be scientifically robust but also strategically written to withstand scrutiny from regulators and potential competitors. This involves anticipating legal hurdles, clearly defining claims, and demonstrating how the invention contributes to solving a real-world medical need.

Turning Research Into Revenue
A key theme of the guide is the recognition that cutting-edge research does not always equate to market success. Despite advances in biotechnology and pharmaceutical sciences, many innovations fail to reach their commercial potential due to weak or incomplete intellectual property protection.

To address this, the guide outlines methods for:

Aligning scientific advancements with patent requirements

Crafting claims that cover current and future formulations or uses

Navigating jurisdictional differences in patent standards

Ensuring that the application supports potential lifecycle management strategies

By offering this structured framework, the guide seeks to empower researchers and IP professionals to build comprehensive patent portfolios that enhance a drug’s appeal to investors and increase its resilience in the face of generic competition.

Target Audience and Industry Relevance
The guide is designed for a wide audience in the life sciences sector, including:

Pharmaceutical companies seeking to secure longer market exclusivity

Academic researchers and biotech startups transitioning from bench to business

Patent attorneys and legal teams involved in drug innovation strategy

Technology transfer offices managing intellectual property portfolios for universities and public research institutes

With regulatory and patent landscapes evolving rapidly, particularly in areas like biologics, personalized medicine, and drug-device combinations, the release of this guide is both timely and relevant.

Industry Commentary
Experts note that as drug development becomes more expensive and more globalized, robust IP protection is central to attracting investment and partnerships. “You can have the most innovative compound in the world, but without a strong patent, you risk losing the commercial advantage,” said one industry insider familiar with patent litigation.

The guide reinforces the idea that IP strategy should not be an afterthought but an integral part of the drug development process from the earliest stages.

A Proactive Tool for the Innovation Economy
By offering a roadmap for turning laboratory breakthroughs into protected, marketable products, “Drafting Effective Drug Patent Applications” is expected to serve as a valuable resource for pharmaceutical innovators who want to strengthen their market position while ensuring that vital therapies make it to patients with the necessary legal safeguards in place.

As the pressure mounts for pharmaceutical companies to innovate faster and more effectively, this guide could be a game-changer for R&D-driven firms looking to extract maximum value from their scientific achievements.

Delhi High Court Denies Roche Injunction Against Natco, Puts Public Health Over Patent in Rare Disease Drug Case

The case, centered on Roche’s high-priced drug risdiplam used to treat Spinal Muscular Atrophy (SMA), brought public health and drug affordability to the forefront of the legal discourse.

Justice Mini Pushkarna, delivering the verdict on March 24, underscored the primacy of public health in patent litigation involving critical medications. “Public health is not something that should be dealt with lightly,” she wrote, adding that when a drug is the only available treatment for a rare disease in India, its affordable availability to the public becomes a “material factor” in deciding whether to grant an injunction. Notably, she emphasized that while pharmaceutical companies can be compensated monetarily, the public “has no such right to compensate itself.”

Roche vs Natco: The Core Dispute
Roche had filed a patent infringement suit seeking to block Natco from manufacturing a generic version of risdiplam, marketed by Roche as Evrysdi. The oral medication is the only approved treatment for SMA in India, a rare and progressive genetic disorder that impairs motor function and eventually leads to loss of movement and breathing capability.

Roche argued that Natco’s generic infringed on its Indian species patent, valid until 2035. Natco, however, challenged the legitimacy of the patent, citing an earlier genus patent filed internationally, claiming Roche was attempting to extend its monopoly illegitimately.

The Affordability Crisis
One of the case’s most compelling elements was the stark reality of Evrysdi’s cost. For an SMA patient weighing over 20 kg, that equates to ₹1.8 crore annually—a prohibitive amount for most Indian families.

Seba P. A., an SMA patient, and Purva Mittal, who is awaiting treatment at Lok Nayak Jai Prakash Hospital in Delhi, both intervened in the suit, highlighting the devastating impact of the drug’s unaffordability.

Roche’s Limited Patient Assistance Programme Rejected
Roche, like many multinational pharmaceutical firms, proposed offering risdiplam at a subsidized rate under a Patient Assistance Programme (PAP). But the court found this insufficient. The judge noted that the programme was too limited in scope, benefiting only a select group of patients, and would still exclude a significant number of SMA sufferers.

Furthermore, Roche’s plan to work with the National Rare Diseases Committee was seen as impractical, given limited funding under the National Policy for Rare Diseases (NPRD). The court referenced a 2024 government release stating that while up to ₹50 lakh is allocated per patient, only 1,118 patients had received support for any rare disease, despite 63 such diseases being recognized.

Court Favors Balance of Convenience
In assessing whether to grant the injunction, the court applied the principle of balance of convenience—weighing which party would suffer more harm from the interim decision. Justice Pushkarna concluded that Natco stood on stronger ground, especially since damages could compensate Roche if it ultimately prevailed, whereas denying access to a life-saving drug could not be reversed for patients.

The judge also drew parallels to a prior case in 2008, where Roche had sought to block Cipla’s generic version of the cancer drug erlotinib (marketed as Tarceva). That case also emphasized affordability, with the court refusing an injunction because Cipla’s generic cost ₹48,000 per month, while Roche’s version was priced at ₹1.4 lakh.

A Global Legal Battle
While Natco has prevailed in India for now, the battle over risdiplam continues elsewhere. In the United States, Roche is pursuing legal action against Natco and other generic makers who have filed Abbreviated New Drug Applications (ANDAs) with the FDA. Despite SMA being a rare condition, Evrysdi’s U.S. sales hit $1.8 billion in 2024, bolstered by its oral formulation, which provides a less invasive option compared to competitor drugs that require spinal injections.

Patent Complexity: Genus vs. Species
At the heart of the legal challenge is the distinction between genus and species patents. Roche holds a species patent for risdiplam in India, valid until 2035, while the earlier genus patent—covering a broader class of compounds—expires in 2033. Natco argues that risdiplam was already disclosed in the genus patent and that Roche is attempting to unfairly extend patent protection through strategic filings. Similar allegations of patent misuse have emerged against Roche in other international jurisdictions.

A Turning Point for Access and IP Law?
Justice Pushkarna’s ruling is being hailed as a significant judicial stance on the issue of drug affordability, especially in the context of rare diseases. While Indian courts have occasionally refused to grant injunctions against generic firms in the past, few have spoken as plainly about the right to health and the public’s interest in affordable medicine.

The case is far from over—trial proceedings will continue to decide the validity of Roche’s patent. However, the court has made it clear: innovation must not come at the cost of accessibility.

As the world grapples with balancing intellectual property rights and public health imperatives, this decision may serve as a legal and moral benchmark—especially for lower-income countries navigating similar dilemmas.

Biodegradable Plastics Enter the Mainstream as Global Patent Race Heats Up, Says Questel Report

With plastic pollution reaching critical levels, a growing number of innovators and companies are racing to develop sustainable alternatives. A new patent landscape analysis from Questel, led by chemistry specialist and business intelligence consultant Donia Ben Zakour, offers a comprehensive look into the evolving world of biodegradable plastics—and the findings suggest a wave of green innovation is gaining serious momentum.

A Growing Crisis Demands a Sustainable Response
Conventional plastics have become synonymous with environmental harm. Every year, an estimated 12.7 million tonnes of plastic waste enter the oceans. Meanwhile, only 9% of all plastic ever produced has been recycled. As global concern deepens, the spotlight is turning to biodegradable plastics as a promising solution.

What Are Biodegradable Plastics—and Why Do They Matter?
Biodegradable plastics are engineered to degrade through microbial activity, breaking down into natural substances such as carbon dioxide, water, and biomass within a defined timeframe. These materials, which include polylactic acid (PLA), polyhydroxyalkanoates (PHA), and starch-based compounds, are particularly suited for single-use applications like packaging.

Their chemical structures and environmental degradability make them a vital alternative in sectors looking to cut their plastic footprint.

The Patent Landscape: Questel’s Key Findings
Questel’s in-depth analysis examines more than 9,000 patent families related to biodegradable plastics filed over the past two decades (excluding Chinese non-extended patents). It provides valuable insights into trends in innovation, market leaders, and regional activity.

📈 Patent Filing Trends (2005–2023)
2005–2018: Patent activity was relatively steady, with 200–300 new filings annually. However, many early patents are now considered “dead” due to abandonment or expiration.

2015–2023: A dramatic surge in activity, particularly from 2018 onward, saw annual filings exceed 1,000 by 2021. The growing number of “pending” applications reflects a vibrant pipeline of new technologies.

Filings from 2024 and 2025 appear lower but are likely underreported due to the standard 18-month delay between filing and publication.

🌍 Geographical Hotspots
Patent data shows that innovation is concentrated in Japan, South Korea, and the United States. These regions account for the majority of first-priority filings:

Japan was an early leader but saw a lull before a recent rebound.

South Korea took the lead after 2018, driven by aggressive R&D from major firms.

India is emerging as a noteworthy player, while Europe maintains consistent, though fragmented, contributions.

🏢 Leading Innovators in the Space
Top contributors include:

LG Chem – developing bio-based polymers for industrial and packaging use.

Hyundai Motor – incorporating biodegradable materials into vehicle interiors.

CJ CheilJedang – advancing PHA-based biodegradable plastic technologies for a wide range of applications.

⚙️ Key Technologies and Manufacturing Processes
Dominant areas of innovation include:

Core materials: PLA, PHA, starch-based bioplastics, biodegradable polyesters.

Processing methods: Injection molding, extrusion, and polymer blending.

Real-World Adoption and the Push for Sustainability
Biodegradable plastics are increasingly making the leap from labs to commercial shelves. Global brands are actively seeking replacements for conventional plastics in packaging, while automotive and electronics industries are integrating biodegradable materials into their design and production processes.

Zakour emphasizes that this movement reflects more than just a trend—it’s a systemic shift in how innovation meets sustainability. “We’re witnessing a convergence of environmental responsibility, regulatory pressure, and consumer demand,” she explains. “Biodegradable plastics are now seen not just as an alternative, but as a necessity for sustainable growth.”

Looking Ahead
Despite economic uncertainties and regulatory complexity, Questel’s report points to a dynamic and competitive innovation landscape. With global filings surging and real-world applications expanding, biodegradable plastics are rapidly becoming a key pillar of environmental strategy for forward-thinking companies.

The global patent race is far from over—but one thing is clear: the future of plastic is biodegradable.

China Sees Sharp Decline in Invention Patent Grants in Q1 2025, Reflecting Shift Toward Patent Quality Over Quantity

China’s National Intellectual Property Administration (CNIPA) released new statistics on April 15, 2025, revealing a significant decline in invention patent grants during the first quarter of the year. According to the official data, the number of invention patents granted between January and March 2025 dropped by 20.99% year-on-year, amounting to a reduction of 52,870 patents, with a total of 199,012 invention patents granted during the period.

The downward trend was not isolated to invention patents alone. Utility model grants, another category of intellectual property protection frequently used in China, also saw a marginal decline of 2.33%, decreasing by 11,032 grants compared to the first quarter of 2024, bringing the total to 408,419 utility model grants.

However, in contrast to the broader decline, design patent grants recorded a notable increase. The CNIPA reported a 10.11% year-on-year growth, with 161,058 design patents granted in Q1 2025—an increase of 14,788 grants compared to the same period last year.

Trademark Registrations Also Down
The downturn extended into trademark registrations. From January to March 2025, the number of new trademarks registered in China fell by 193,996, reflecting a 14.97% decline compared to the first quarter of 2024. This slump may reflect broader economic uncertainties or shifts in business activity.

Factors Behind the Decline
While CNIPA has not issued an official explanation for the steep decline in invention patent grants, several contributing factors appear to be at play—chief among them, China’s evolving strategy around intellectual property quality and enforcement.

End of Patent Subsidies: Government subsidies for patent grants, once a major driver behind China’s patent filing boom, have officially ended in 2025. This move was aimed at reducing low-quality and opportunistic filings.

Crackdown on “Abnormal” Applications: Chinese authorities have continued to intensify scrutiny on fraudulent or low-value patent applications. This regulatory push has likely discouraged mass filing practices that previously inflated patent figures.

Shift Toward High-Value Patents: China has reoriented its IP strategy from emphasizing sheer volume to focusing on the number of high-value patents per 10,000 people, moving away from raw patent filing counts as the primary performance metric.

In addition, the broader slowdown in China’s economy may be influencing innovation output and intellectual property activity. However, due to the nature of patent processing timelines, such effects may manifest with a delay, making patent grants a lagging indicator of underlying economic trends.

Long-Term Outlook Remains Ambitious
Despite the recent decline, CNIPA’s 2025 budget signals continued confidence in long-term innovation momentum. The agency expects to receive over 5 million patent applications this year and plans to examine more than 2 million invention patent applications. These targets reflect China’s sustained investment in intellectual property infrastructure and commitment to fostering innovation at scale.

The full dataset, published in Chinese under the title “2025年3月国家知识产权局审查注册登记统计月报(外部版)”, offers a detailed monthly breakdown of IP activity and can be accessed through CNIPA’s official platform.

As China continues to prioritize patent quality and reform its intellectual property system, the first quarter data may represent more than just a temporary dip—it could signal a lasting transformation in how innovation is measured and rewarded in the world’s second-largest economy.

USPTO Streamlines Patent Issuance Timeline with Faster Turnaround Starting May 13

In a move that promises to bring greater efficiency to the U.S. patent system, the United States Patent and Trademark Office (USPTO) has announced a major update to its patent issuance process.
This improvement marks a significant shift in the patenting landscape, providing faster legal recognition of inventions and reducing administrative lag for both individual inventors and companies awaiting protection for their intellectual property.

Transition to Digital Patent Grants Accelerates the Process
The accelerated timeline has been made possible in large part due to the USPTO’s adoption of electronic patent grants (eGrants). With the USPTO now fully transitioned to digital issuance, those time-consuming steps have been eliminated, allowing for quicker finalization of granted patents.

The agency has stated that, once all requirements are met and the Issue Fee is paid, inventors typically receive an Issue Notification within one to two weeks. Under the new process, the formal patent will be granted just two weeks after this notification, as opposed to the previous three-week standard.

Benefits for Inventors and Legal Professionals
This change not only shortens the waiting period for inventors eager to see their rights formally granted, but it also has strategic legal benefits. The reduced timeline cuts down the so-called “lame duck” period—a window of time during which inventors and their legal counsel are still required to submit any known prior art that might affect the patent’s validity. During this period, submissions of relevant information could cause delays in issuance.

By shortening this window, the USPTO effectively reduces the likelihood of last-minute delays caused by prior art disclosures, allowing for smoother and more predictable patent finalizations.

A Win for Innovation and IP Management
The streamlined process is being welcomed by the patent community as a step in the right direction. Faster issuance allows inventors to enforce their rights sooner, boosts the value of patent portfolios more quickly, and provides an advantage to companies working in fast-moving sectors such as technology, pharmaceuticals, and biotech.

“This is a smart move by the USPTO,” said a patent attorney at a Washington-based IP law firm. “In a time where speed to market can make or break an invention’s commercial potential, cutting down unnecessary administrative lag can be a game-changer.”

Looking Ahead
The USPTO has been steadily modernizing its systems to better serve inventors, including the roll-out of digital filing systems, the modernization of examiner tools, and now this reduction in issuance lag. These changes reflect the agency’s ongoing commitment to streamlining operations while maintaining high standards for patent examination and grant quality.

As of May 13, inventors who receive their issue notifications can expect to see their patents granted just two weeks later—giving them the legal recognition and rights they’ve earned, faster than ever before.

Astellas Pharma Prevails in German Patent Dispute Over Prostate Cancer Drug Xtandi

Astellas Pharma, alongside the Regents of the University of California, has secured a major legal victory in Germany as the Federal Patent Court rejected a nullity suit challenging one of its key intellectual property rights protecting the blockbuster prostate cancer treatment Xtandi. The decision strengthens Astellas’ position as it continues to defend its IP portfolio for the drug across multiple jurisdictions.

The patent at the center of the dispute is European Patent EP 1 893 196, which protects the active pharmaceutical ingredient enzalutamide, the core compound in Xtandi. In Germany, the Supplementary Protection Certificate (SPC 12 2013 000 155.0) linked to EP 196 extends market exclusivity until June 25, 2028, beyond the patent’s official expiry in May 2026.

A Coordinated Challenge by Generics
The challenge was led by Hexal, a subsidiary of Sandoz, with Accord Healthcare, Synthon, and Stada joining the suit in a bid to invalidate the patent and gain earlier access to the market for generic enzalutamide formulations. However, in the recently concluded German case (3 Ni 20/23), the court sided with the patent holders.

Astellas, the exclusive sub-licensee of the patent rights for enzalutamide, participated in the proceedings as an intervenor, backing the University of California, which holds the original rights. The court found no grounds to invalidate the patent, thus preserving Astellas’ market exclusivity in Germany.

Wider Legal Landscape in the UK and Netherlands
The German case is part of a broader litigation strategy by generic manufacturers to challenge enzalutamide-related patents across Europe.

In October 2024, the UK High Court upheld both the British portion of EP 196 and the associated SPC in full. However, the ruling is currently under appeal.

In the Netherlands, the District Court of The Hague is expected to deliver its decision on EP 196 soon. Earlier this year, the same court upheld a related patent—EP 3 725 778, which protects enzalutamide’s formulation—marking another win for Astellas and its partners.

Legal Teams Behind the Battle
The high-profile nature of the case brought out some of Europe’s most experienced IP law firms specializing in life sciences:

Hexal was represented by patent specialists from df-mp Dörries Frank-Molnia & Pohlmann, a Munich-based firm with a strong track record in pharmaceutical patent disputes. Lead partner Elisabeth Greiner, supported by Holger Schimmel and Tom Schwarzer, led the challenge.

Accord Healthcare received support from patent attorneys Christian Hollatz and Veronika Müller at Ter Meer Steinmeister, and litigator Daniel Hoppe from the newly formed boutique Bonabry. Hoppe was joined by colleagues Konstantin Schallmoser and Sarah Salaschek, representing Synthon.

Stada’s case was handled by Alexander Wittkopp of Hamm & Wittkopp, another firm deeply entrenched in generic pharmaceutical patent litigation.

On the defence side, the Regents of the University of California and Astellas relied on the well-regarded Hoffmann Eitle team, led by Peter Klusmann and Dirk Schüßler-Langeheine, with assistance from Jan Zillies and Melanie Schain.

In UK proceedings, Kirkland & Ellis represented Astellas and the University, while the claimants were advised by Pinsent Masons.

In the Dutch litigation, Brinkhof is handling representation for the generics challengers, while Hoyng ROKH Monegier is acting for Astellas.

A Strategic Asset in Astellas’ Oncology Portfolio
Xtandi (enzalutamide) is a cornerstone of Astellas’ oncology franchise and one of the most commercially successful treatments for advanced prostate cancer, with global sales running into billions of dollars. Despite being indicated for a rare form of advanced cancer, the drug has seen significant market growth, especially in oral formulations that offer ease of use over competing treatments requiring injection.

The ongoing court battles underscore the value of enzalutamide’s exclusivity, and the resilience of Astellas’ legal defense so far suggests a robust IP strategy.

What Comes Next?
As litigation continues in the UK and Netherlands, and likely other markets, Astellas will aim to maintain its competitive edge through the strength of its patent portfolio. The latest German ruling will likely bolster its position in future proceedings, serving as a precedent that supports the validity and enforceability of EP 196 and its SPC.

For generic manufacturers, the fight isn’t over—but their path to market is now more complex, as courts increasingly affirm Astellas’ rights to protect a therapy that has reshaped treatment protocols for prostate cancer patients worldwide.

Shares of Lupin and Zydus Life Slide After Losing US Patent Case to Astellas Pharma

Shares of Indian pharmaceutical giants Lupin and Zydus Lifesciences came under significant selling pressure on April 16, falling by 3% and 4.5% respectively. The decline followed a ruling by the U.S. District Court in Delaware in favor of Astellas Pharma, the original patent holder of Myrbetriq, a drug used to treat overactive bladder (OAB). The court determined that Lupin and Zydus had infringed upon Astellas’s patent rights, potentially paving the way for the withdrawal of their generic versions from the U.S. market.

Court Ruling Favors Astellas
The dispute centers around the ‘780 patent, which protects the formulation of Mirabegron, the active ingredient in Myrbetriq. Astellas Pharma filed a lawsuit claiming that the generic products manufactured by Lupin and Zydus violated this patent.

The judgment emphasized that the defendants failed to demonstrate that the patent was invalid on grounds such as lack of enablement, inadequate written description, or indefiniteness. With the court upholding the validity of the ‘780 patent, the generics produced by Lupin and Zydus are now under threat of being barred from sale in the U.S.

Financial Implications Loom
Market analysts have raised concerns over the financial impact this legal defeat could have on the Indian pharma companies. Myrbetriq was anticipated to contribute nearly $30 million in quarterly revenues to each company, according to some industry estimates. The ruling could not only impact future earnings but also result in penalties.

Vishal Manchanda, a pharmaceutical sector analyst at Systematix Group, told CNBC-TV18, “We expect a tangible hit to FY26 earnings for both Zydus Life and Lupin due to this development. Moreover, damages and potential penalties, if levied by the jury trial, could further strain their financials.”

The final determination of damages and any remaining disputes over infringement or validity will be taken up in a consolidated jury trial scheduled for 2026.

Companies Respond
In a post-market statement, Zydus Lifesciences acknowledged the verdict and said it is currently reviewing the court order and assessing its implications. “We are evaluating the potential impact of the said order on the operations of the Company and the legal remedies available with the Company,” the statement read.

Both Zydus and Lupin have filed a ‘Motion to Clarify’ in an effort to assert additional arguments regarding the patent’s validity, which the court will consider during the 2026 trial.

Background on Myrbetriq and the Patent Dispute
Myrbetriq, approved by the U.S. Food and Drug Administration in 2012, has been a high-value product in the OAB treatment category, with global sales reaching over a billion dollars annually in recent years. The drug works by relaxing the bladder muscle to increase storage capacity and reduce urinary urgency.

The ‘780 patent, central to the lawsuit, covers specific formulations and the method of administration of Mirabegron. Patent infringement in this context refers to manufacturing or selling a product that falls within the patent’s claim scope without authorization from the patent holder.

The ruling highlights the risks generic manufacturers face when attempting to enter markets dominated by patented medications. It also reaffirms the legal strength of patent protections in the U.S., particularly for high-value pharmaceutical products.

Market Reaction
Investors reacted swiftly to the news, with both Lupin and Zydus Life stocks falling sharply in trading. Analysts believe the market is pricing in not only the potential loss of revenue but also uncertainty around future legal proceedings and penalties.

The verdict serves as a cautionary tale for generics manufacturers and underscores the importance of thorough patent analysis before launching competing products in major markets like the United States.

As the legal battle progresses, the pharmaceutical sector will be closely watching the developments in the run-up to the 2026 trial, which will determine the extent of financial liability and the long-term market prospects for generic versions of Myrbetriq.

LPU Tops India in Innovation with Record 1,418 Patent Filings in 2023–24: Government Report

​Lovely Professional University (LPU) has once again demonstrated its leadership in innovation by filing a total of 1,418 patent applications during the 2023-2024 academic year. This achievement is detailed in the Government of India’s Annual Report of Intellectual Property India for the 2023-2024 period. Notably, this figure surpasses the combined total of 1106 patent applications filed by all Indian Institutes of Technology (IITs) during the same timeframe. ​

Dr. Ashok Kumar Mittal, Member of Rajya Sabha and Founder Chancellor of LPU, expressed pride in the university’s research community, stating that their relentless dedication has significantly contributed to India’s global innovation standing. He emphasized that such accomplishments play a pivotal role in enhancing India’s position as a leading innovative economy worldwide. ​

Beyond patent filings, LPU’s research credentials are further bolstered by over 22,000 publications, 129,000 Scopus citations, and an H-Index of 118. The university also boasts more than 1,800 granted Intellectual Property Rights (IPRs), 9,450+ funded projects, and over 550 global collaborations. Notably, many LPU faculty members are recognized among the top 2% of scientists worldwide by Stanford University. ​

The Division of Research and Development (DRD) at LPU plays a pivotal role in fostering interdisciplinary research across STEM, Humanities, and Management disciplines. The university’s state-of-the-art laboratories and collaborative culture provide a robust ecosystem for innovation, addressing both societal challenges and global technological needs. ​

LPU’s exceptional performance in patent filings not only highlights its leadership in innovation but also significantly contributes to India’s standing as a top innovative economy globally.