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.
infringement
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.
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.
Dorsey and Musk Call to ‘Delete All IP Law’ Sparks Backlash Amid AI Copyright Battles
In a cryptic yet explosive post on X, Twitter co-founder Jack Dorsey called for the wholesale abolition of intellectual property law, declaring simply: “delete all IP law.” The message, posted without explanation or context, quickly drew a wave of attention — and an immediate show of support from Elon Musk, who replied in agreement.
While both tech billionaires are known for their provocative online personas, this statement has ignited a serious debate about the future of intellectual property (IP) in the digital age — particularly as artificial intelligence continues to test the boundaries of content ownership, authorship, and creative rights.
What Exactly Do They Want to Delete?
Dorsey’s call raises more questions than it answers. “All IP law” could encompass a broad swath of legal protections, including:
Patent law, which protects inventions and technological processes
Copyright law, which guards original works of authorship
Trademark law, which ensures brand and consumer recognition
Rights of publicity, which allow individuals to control the use of their name, image, and likeness
The ambiguity of Dorsey’s post leaves it unclear whether he is advocating for the dismantling of all of these systems or speaking more narrowly. What is clear is that both Dorsey and Musk have long been critical of formal IP protections.
Musk, in particular, has famously stated that “patents are for the weak,” suggesting that true innovation doesn’t rely on legal shields. Yet, critics argue that such a stance reflects a privileged position — one made possible by enormous capital, market dominance, and access to elite legal teams.
IP as a Shield for the Powerless
While tech titans may view IP law as an inconvenience, others see it as a vital safeguard — especially for independent creators, startups, and inventors. Intellectual property laws serve as a means of leveling the playing field, providing smaller players a tool to protect their work and negotiate with larger, more powerful entities.
“This idea that IP protections are unnecessary ignores the reality of how innovation happens outside of billion-dollar companies,” said one Washington-based legal scholar. “The rule of law, including IP rights, is often the only recourse small creators have to protect their contributions.”
USPTO Pushes Back
In response to Dorsey and Musk’s remarks, Coke Morgan Stewart, the Acting Director of the U.S. Patent and Trademark Office (USPTO), issued a rebuttal defending the IP system. Citing examples ranging from President Biden and Vice President Harris, to J.D. Vance’s “Hillbilly Elegy” and Donald Trump’s trademarks, Stewart argued that IP laws underpin creativity, entrepreneurship, and economic opportunity.
She also referenced the popular show Shark Tank, where patent and trademark protections are often pivotal to whether an entrepreneur secures funding. “IP rights are not abstract legal constructs,” Stewart emphasized. “They are practical tools that empower innovation, protect integrity in the marketplace, and help turn ideas into viable businesses.”
Silicon Valley’s Complicated Relationship with IP
Silicon Valley has long walked a tightrope when it comes to intellectual property. Many of its biggest success stories — from Google’s search engine, which indexes others’ work, to social media platforms like X and Instagram that depend entirely on user-generated content — have been built on models that leverage the creativity of the masses.
Meanwhile, the rise of artificial intelligence has introduced a new layer of complexity. Modern AI systems are trained on massive datasets, often scraped from publicly available — but still copyrighted — sources. This has triggered a wave of lawsuits from authors, artists, and rights holders who argue their works have been co-opted without permission or compensation.
That includes legal action against companies like OpenAI (which Musk co-founded), as well as lawsuits against image and video generators. Both Musk and Dorsey are reportedly developing or investing in their own AI ventures, making their recent anti-IP remarks appear less like philosophical positions and more like preemptive strikes against legal obstacles.
The Bigger Picture: Control vs. Creativity
For critics, the timing of Dorsey’s and Musk’s statements is telling. As the legal landscape tightens around AI training data and content use, the call to abolish IP law seems less about freeing innovation and more about escaping accountability. Yet, for the creative community — from musicians and writers to small software developers — IP remains one of the few tools available to ensure fair treatment in a tech-dominated economy.
“The strongest don’t need the law,” one commentator noted. “But the rest of us do.”
While both tech billionaires are known for their provocative online personas, this statement has ignited a serious debate about the future of intellectual property (IP) in the digital age — particularly as artificial intelligence continues to test the boundaries of content ownership, authorship, and creative rights.
What Exactly Do They Want to Delete?
Dorsey’s call raises more questions than it answers. “All IP law” could encompass a broad swath of legal protections, including:
Patent law, which protects inventions and technological processes
Copyright law, which guards original works of authorship
Trademark law, which ensures brand and consumer recognition
Rights of publicity, which allow individuals to control the use of their name, image, and likeness
The ambiguity of Dorsey’s post leaves it unclear whether he is advocating for the dismantling of all of these systems or speaking more narrowly. What is clear is that both Dorsey and Musk have long been critical of formal IP protections.
Musk, in particular, has famously stated that “patents are for the weak,” suggesting that true innovation doesn’t rely on legal shields. Yet, critics argue that such a stance reflects a privileged position — one made possible by enormous capital, market dominance, and access to elite legal teams.
IP as a Shield for the Powerless
While tech titans may view IP law as an inconvenience, others see it as a vital safeguard — especially for independent creators, startups, and inventors. Intellectual property laws serve as a means of leveling the playing field, providing smaller players a tool to protect their work and negotiate with larger, more powerful entities.
“This idea that IP protections are unnecessary ignores the reality of how innovation happens outside of billion-dollar companies,” said one Washington-based legal scholar. “The rule of law, including IP rights, is often the only recourse small creators have to protect their contributions.”
USPTO Pushes Back
In response to Dorsey and Musk’s remarks, Coke Morgan Stewart, the Acting Director of the U.S. Patent and Trademark Office (USPTO), issued a rebuttal defending the IP system. Citing examples ranging from President Biden and Vice President Harris, to J.D. Vance’s “Hillbilly Elegy” and Donald Trump’s trademarks, Stewart argued that IP laws underpin creativity, entrepreneurship, and economic opportunity.
She also referenced the popular show Shark Tank, where patent and trademark protections are often pivotal to whether an entrepreneur secures funding. “IP rights are not abstract legal constructs,” Stewart emphasized. “They are practical tools that empower innovation, protect integrity in the marketplace, and help turn ideas into viable businesses.”
Silicon Valley’s Complicated Relationship with IP
Silicon Valley has long walked a tightrope when it comes to intellectual property. Many of its biggest success stories — from Google’s search engine, which indexes others’ work, to social media platforms like X and Instagram that depend entirely on user-generated content — have been built on models that leverage the creativity of the masses.
Meanwhile, the rise of artificial intelligence has introduced a new layer of complexity. Modern AI systems are trained on massive datasets, often scraped from publicly available — but still copyrighted — sources. This has triggered a wave of lawsuits from authors, artists, and rights holders who argue their works have been co-opted without permission or compensation.
That includes legal action against companies like OpenAI (which Musk co-founded), as well as lawsuits against image and video generators. Both Musk and Dorsey are reportedly developing or investing in their own AI ventures, making their recent anti-IP remarks appear less like philosophical positions and more like preemptive strikes against legal obstacles.
The Bigger Picture: Control vs. Creativity
For critics, the timing of Dorsey’s and Musk’s statements is telling. As the legal landscape tightens around AI training data and content use, the call to abolish IP law seems less about freeing innovation and more about escaping accountability. Yet, for the creative community — from musicians and writers to small software developers — IP remains one of the few tools available to ensure fair treatment in a tech-dominated economy.
“The strongest don’t need the law,” one commentator noted. “But the rest of us do.”
Battery X Advances EV Sustainability with New Patents, NRC Validation, and Next-Gen Prototype Development
Battery X Metals Inc. has announced a major leap forward in battery rebalancing technology through its fully owned subsidiary, Battery X Rebalancing Technologies Inc. The company is pushing boundaries in battery diagnostics and lifespan extension, reinforcing its role in the evolving energy transition space.
New Patent Filings for Battery Optimization
Battery X Rebalancing Technologies has filed two provisional patent applications with the United States Patent and Trademark Office (USPTO). The applications cover proprietary software and hardware systems developed to identify, rebalance, and extend the lifespan of lithium-ion and electric vehicle (EV) batteries. These innovations are the result of extensive research and years of development aimed at improving battery performance and sustainability.
Independent Validation by NRC
In a significant endorsement, the National Research Council of Canada (NRC) has independently verified the effectiveness of Battery X’s core rebalancing technology. Test results revealed the system’s ability to recover nearly all capacity lost due to cell imbalances—an issue that commonly affects battery efficiency over time. The validation confirms not only the effectiveness of the technology but also its safety and reliability in real-world applications.
Next-Generation Prototype Nearing Completion
Development is underway on Prototype 2.0, the next iteration of Battery X’s rebalancing unit. This version will include refined hardware, enhanced diagnostic tools, and improved connectivity features. The company anticipates finalizing the prototype by the end of April 2025, signaling a move toward potential commercialization and broader industry adoption.
Rebranding Reflects Unified Vision
Alongside these technical milestones, the company has rebranded its subsidiary from Li-ion Renewable Technologies Inc. to Battery X Rebalancing Technologies Inc. The rebrand follows the full acquisition of the subsidiary and reflects a strategic alignment with Battery X Metals’ overarching goals in battery innovation and resource optimization.
Driving the Energy Transition
Battery X Rebalancing Technologies continues to develop solutions that support battery longevity, reduce electronic waste, and advance the electric vehicle ecosystem. The company is positioned at the intersection of resource exploration and clean tech innovation, committed to enabling a more sustainable, efficient energy future.
About Battery X Metals Inc.
Battery X Metals is a Canadian company focused on energy transition initiatives, combining resource exploration with cutting-edge battery technology development to support the growing demand for sustainable energy solutions.
New Patent Filings for Battery Optimization
Battery X Rebalancing Technologies has filed two provisional patent applications with the United States Patent and Trademark Office (USPTO). The applications cover proprietary software and hardware systems developed to identify, rebalance, and extend the lifespan of lithium-ion and electric vehicle (EV) batteries. These innovations are the result of extensive research and years of development aimed at improving battery performance and sustainability.
Independent Validation by NRC
In a significant endorsement, the National Research Council of Canada (NRC) has independently verified the effectiveness of Battery X’s core rebalancing technology. Test results revealed the system’s ability to recover nearly all capacity lost due to cell imbalances—an issue that commonly affects battery efficiency over time. The validation confirms not only the effectiveness of the technology but also its safety and reliability in real-world applications.
Next-Generation Prototype Nearing Completion
Development is underway on Prototype 2.0, the next iteration of Battery X’s rebalancing unit. This version will include refined hardware, enhanced diagnostic tools, and improved connectivity features. The company anticipates finalizing the prototype by the end of April 2025, signaling a move toward potential commercialization and broader industry adoption.
Rebranding Reflects Unified Vision
Alongside these technical milestones, the company has rebranded its subsidiary from Li-ion Renewable Technologies Inc. to Battery X Rebalancing Technologies Inc. The rebrand follows the full acquisition of the subsidiary and reflects a strategic alignment with Battery X Metals’ overarching goals in battery innovation and resource optimization.
Driving the Energy Transition
Battery X Rebalancing Technologies continues to develop solutions that support battery longevity, reduce electronic waste, and advance the electric vehicle ecosystem. The company is positioned at the intersection of resource exploration and clean tech innovation, committed to enabling a more sustainable, efficient energy future.
About Battery X Metals Inc.
Battery X Metals is a Canadian company focused on energy transition initiatives, combining resource exploration with cutting-edge battery technology development to support the growing demand for sustainable energy solutions.
💡 Why VCs Are Betting Big on Patent-Led Startups in India
In India’s ever-evolving startup landscape, one thing is becoming crystal clear: ideas alone aren’t enough. Investors are now looking for proof of real innovation, and the clearest sign of that? Intellectual Property (IP) — especially patents.
Gone are the days when startups could raise millions based on flashy pitches or vague promises of AI-powered disruption. In 2025, IP is the new currency, and deep-tech startups are leading the charge.
🚀 The Numbers Tell the Story
According to Tracxn, Indian startups focused on deep technology and backed by solid IP portfolios raised a whopping $994 million across 284 deals in 2024. And the momentum is only building — 47 IP-led startups have already attracted $220.5 million this year alone.
Names like Infinite Uptime, Bellatrix Aerospace, SpotDraft, and Attentive AI are drawing serious investor interest — and for good reason.
🛡️ Why Patents Matter More Than Ever
Venture capitalists are becoming increasingly cautious, especially in sectors like AI, where hype often outpaces substance. “We’re looking for proof of technical depth,” says Manu Iyer, Co-founder at Bluehill.vc.
Patents create barriers to entry, signal technical competence, and offer strategic advantages in global markets. They also act as safety nets — providing potential licensing revenues or sale value even if a startup needs to pivot.
🧠 The IP-Driven Startups Drawing Big Checks
Startups with a solid patent strategy are standing out. Think:
Ather Energy – innovating in EV and battery tech
Agnikul & Skyroot – pushing boundaries in space tech
Log9 Materials & Lohum – leading battery and recycling innovation
IdeaForge – soaring with drone technology
Niramai – reimagining health diagnostics with AI
These startups are backed by heavyweights like pi Ventures, Axilor, Temasek, GIC, Tiger Global, and InnoVen Capital — all of whom are putting their faith (and funds) into IP-backed innovation.
🔧 Real Innovation Over Assembly
Take Raptee. HV, a Chennai-based electric motorcycle startup. Unlike many others in the space, Raptee designs everything in-house — including its high-voltage powertrain. The company has filed 156 patents around its tech.
“We’re not just assembling off-the-shelf components,” says Co-founder and CEO Dinesh Arjun. “Our IP is what sets us apart — it proves we’re solving real problems with original engineering.”
🌍 Beyond India: IP Opens Global Doors
Beyond just securing funding, IP helps startups scale globally. It opens up new revenue streams through licensing, enables strategic partnerships, and most importantly, acts as a shield against legal battles or copycat competitors.
As Bhaskar Majumdar, Managing Partner at Unicorn India Ventures, puts it: “Startups with strong technical foundations and proprietary IP stand out in today’s noisy innovation landscape.”
📈 The Bottom Line
India’s startup ecosystem is maturing, and with it, VC expectations are evolving. The message is clear: deeptech, defensibility, and differentiation matter more than ever. In this new era, patents aren’t just paperwork — they’re power.
So, if you’re building the next big thing, don’t just chase the buzz. Build real tech. File those patents. And let your innovation speak for itself.
Navigating the Complexities of Biotech Patent Law: A Look at REGENXBIO v. Sarepta Therapeutics
The rapidly evolving field of biotech patent law continues to present significant challenges, particularly when it comes to innovations involving recombinant nucleic acids and biological sequences. A recent ruling in REGENXBIO v. Sarepta Therapeutics by the US District Court for the District of Delaware has brought to light critical issues regarding patent eligibility for biotechnological inventions. Judge Richard Andrews ruled that the mere act of combining natural AAV (adeno-associated virus) sequences with heterologous (non-AAV) sequences in a cultured host cell—without further modifications—does not satisfy the requirements for patent eligibility under 35 U.S.C. § 101.
This decision has stirred discussions within the biotech community, as it reflects an ongoing trend of courts scrutinizing the extent of modifications required to make genetic and biological innovations eligible for patent protection. The ruling suggests that simply combining existing natural biological sequences may not meet the necessary standards for patent eligibility unless the innovation includes further modifications that can be considered novel or non-obvious.
What Does the Court’s Ruling Mean for the Biotech Industry?
The REGENXBIO v. Sarepta Therapeutics case builds on the precedent set by Funk Brothers Seed Co. v. Kalo Inoculant Co., where the U.S. Supreme Court ruled that naturally occurring substances could not be patented unless they had been modified in a way that created new and non-obvious properties. In this case, the court applied the same logic, finding that simply combining natural sequences from AAV with other biological materials does not meet the standards of patentability under 35 U.S.C. § 101, which requires inventions to be novel, non-obvious, and useful.
This decision has significant implications for gene therapy innovations and other biotech patent strategies. It raises important questions about the scope of patent protection available for new biotechnologies, especially in cases where the innovation involves natural biological elements. For biotech companies and researchers, this ruling emphasizes the importance of demonstrating how their innovations go beyond simple combinations of natural materials and truly push the boundaries of scientific knowledge and utility.
Join the Discussion: Biotech Patent Eligibility and Innovation
To further explore the impact of this ruling and the broader challenges within the realm of biotech patent law, a key discussion will be held on Tuesday, April 15. WilmerHale Partner Omar Khan will be joined by Christen DiPetrillo, Head of Intellectual Property, and Kevin Marks, Chief Legal Officer at the Parker Institute for Cancer Immunotherapy, at Biocom California’s joint meeting of the IP and Cellular Gene Therapy Committees.
During this session, the panel will explore:
The historical context of biotech patent eligibility.
The implications of the ruling for gene therapy innovations and biotech patent strategies moving forward.
This discussion will offer valuable insights into the complexities of patenting biotechnological innovations and the legal hurdles that companies face when seeking patent protection for cutting-edge research in genetic therapies and biologics.
Conclusion
As the biotech industry continues to push the boundaries of science, navigating the complexities of patent law becomes increasingly critical. The REGENXBIO v. Sarepta Therapeutics decision highlights the challenges companies face when attempting to secure patent protection for genetic and biological innovations. As more companies and researchers grapple with patent eligibility, understanding the intricacies of patent law and its evolving landscape will be essential to fostering continued innovation and growth in the biotech sector.
For those looking to stay at the forefront of these developments, attending the upcoming discussion on biotech patent eligibility is an excellent opportunity to deepen your understanding of the legal challenges and strategies shaping the future of gene therapy and biotechnology.
Landmark Delhi High Court Ruling Prioritizes Access to Life-Saving Drugs Over Patent Protection
In a powerful judgment that resonates with the ongoing global debate on healthcare access versus intellectual property rights, Justice Mini Pushkarna of the Delhi High Court has delivered a standout ruling that places public health and patient affordability at the heart of India’s patent law jurisprudence.
On March 24, 2025, the Court dismissed a patent infringement suit filed by Swiss pharmaceutical giant Hoffman-La Roche against Hyderabad-based Natco Pharma, in a case involving the prohibitively expensive spinal muscular atrophy (SMA) drug, risdiplam, marketed internationally as Evrysdi.
💊 The High Stakes: Life-Saving Medicine or Legal Monopoly?
Spinal muscular atrophy is a rare genetic disorder that progressively weakens muscles used for breathing, walking, and other vital functions. Risdiplam is the only approved oral treatment available in India for SMA, and its cost places it far out of reach for most patients. One bottle reportedly costs ₹6 lakh, with a typical patient requiring 30 bottles a year—a staggering ₹1.8 crore annually.
Natco Pharma has developed a generic version of risdiplam, challenging Roche’s patent rights. Roche, in response, approached the court to halt the sale of Natco’s version, claiming patent infringement and requesting an interim injunction.
⚖️ Justice Pushkarna’s Clear Stand: People First
In a firm and clear ruling, Justice Pushkarna refused the injunction, emphasizing that public health cannot be treated lightly. She wrote:
She also highlighted a critical point in patent law: while pharma companies can be compensated later through damages, there is no mechanism to compensate the public for a lack of access to essential medicine.
This case stands out because the voice of patients was directly heard in court. Two SMA patients intervened to share their lived experiences—stating unequivocally that they could not afford Roche’s drug and had no alternative treatment available.
💸 Big Pharma’s “Patient Assistance” Argument Falls Flat
Roche attempted to soften the blow by pointing to its Patient Assistance Programme (PAP)—an initiative that offers discounted medication to a limited number of patients. But the court saw through the strategy.
Justice Pushkarna called the program “far too limited” and noted that even the proposed reduced prices (revealed in a sealed cover) were insufficient to address widespread affordability. Only a fraction of patients could potentially benefit, leaving many out in the cold.
She also acknowledged budgetary limitations of the National Policy for Rare Diseases (NPRD)—a government scheme that provides up to ₹50 lakh per patient but has only been able to support 1,118 patients, despite India recognizing 63 rare diseases.
🔄 Global Implications & Legal Loopholes
Interestingly, this is not the only battleground for Roche and Natco. In the U.S., Natco is seeking approval to launch its generic risdiplam through an Abbreviated New Drug Application (ANDA), and is currently facing another infringement suit there. Despite being a rare disease drug, Evrysdi clocked $1.8 billion in U.S. sales in 2024, a growth of 18%, thanks to its user-friendly oral format.
Back in India, the patent debate hinges on Roche’s attempt to claim protection under a “species patent”, even though a broader “genus patent” had been filed earlier internationally. Natco argues that Roche is trying to extend its monopoly by segmenting patents, which is not allowed under Indian law if the new invention was already disclosed.
🧠 A Legal Shift in Priorities
The ruling isn’t just about one drug or one company. It signals a broader shift in judicial thinking, where courts are weighing public health more heavily in patent disputes, especially for essential or life-saving medicines.
This isn’t the first time Indian courts have leaned this way. In a 2008 case, Roche sought an injunction against Cipla over its cancer drug erlotinib (Tarceva). The court refused, noting that Cipla’s version was significantly cheaper, and the balance of convenience lay with affordable treatment.
🧬 What This Means for Patients and Policy
This case is likely to become a benchmark in how rare disease drugs are treated in Indian courts, especially when affordability is at stake. It also brings renewed focus on the inadequacy of current government schemes to support patients with ultra-expensive therapies.
For pharmaceutical companies, it’s a wake-up call: patent rights do not guarantee exclusivity if access is denied to the vast majority.
For patients, it is a glimmer of hope—an acknowledgment that their right to live cannot be outweighed by corporate profits.
📝 Final Thoughts
In Justice Pushkarna’s words, “There exists no right for the public to lessen or compensate itself.” This ruling flips the script, putting people before patents, and serves as a reminder that innovation must go hand in hand with access.
India has long been seen as the pharmacy of the developing world, and rulings like this ensure that mantle remains intact.
Could Intellectual Property Retaliation Be the Game-Changer in Trade Wars?
In response to President Donald Trump’s tariff policies, many countries are considering retaliation, primarily through higher tariffs and import restrictions. While these measures may impact the U.S. economy, they also pose risks for the countries imposing them. The goal is to make the pain felt in the U.S. greater than the consequences suffered by the retaliating nation. While this strategy may hold true in many cases, countries like the European Union (EU), Canada, and other trading partners could take a more direct and potentially more damaging approach—targeting the United States’ intellectual property (IP) rights.
Intellectual property, particularly patents and copyrights, has long been a cornerstone of U.S. economic dominance. In 2024, the United States received nearly $150 billion in royalties and licensing fees alone, which makes up over 5% of total after-tax corporate profits. But these fees represent only the direct payments for IP use; they don’t account for embedded costs in products like software and technology, which are often used globally in consumer goods.
One possible retaliatory strategy involves countries announcing that they will no longer respect U.S. patents and copyrights for as long as Donald Trump continues his tariff policies. This kind of action would target U.S. companies that rely on their intellectual property rights for profit, such as tech giants like Microsoft and pharmaceutical companies like Pfizer and Merck.
The concept of not honoring foreign patents is not without precedent. During World War I, the U.S. invoked the Trading with the Enemy Act to allow the compulsory licensing of patents held by German companies. This measure allowed U.S. businesses to use these patents without permission, as long as they paid a minimal licensing fee set by the U.S. government. Countries like Canada, the EU, and others could implement a similar policy to challenge the United States’ trade practices.
The potential benefits of this type of retaliation are twofold. First, it would allow consumers in the retaliating countries to access cheaper products—such as generic drugs, which could drastically reduce the cost of life-saving medications like those used in cancer and heart disease treatments. Second, it would lower the cost of everyday goods like computers, by bypassing the licensing fees for software from companies like Microsoft.
For consumers, this could mean cheaper access to essential products and technologies, making it a win-win situation. Imagine having access to affordable generics of expensive drugs or the latest software without the added cost of licensing fees. This approach would directly benefit the people in those countries, and it would provide a powerful counterweight to the economic challenges posed by Trump’s tariffs.
Such an approach would also hit U.S. corporations where it hurts—potentially changing the landscape of global trade in ways that tariffs alone may not. If other nations got accustomed to accessing cheap drugs, software, and entertainment content, it could shift global perceptions of U.S. intellectual property practices. This shift could permanently disrupt the revenue models of many major U.S. companies that rely on high licensing fees and patent monopolies. For instance, without the constraints of patent monopolies, Americans themselves could spend far less on prescription drugs—possibly saving around $550 billion annually.
Intellectual property, particularly patents and copyrights, has long been a cornerstone of U.S. economic dominance. In 2024, the United States received nearly $150 billion in royalties and licensing fees alone, which makes up over 5% of total after-tax corporate profits. But these fees represent only the direct payments for IP use; they don’t account for embedded costs in products like software and technology, which are often used globally in consumer goods.
One possible retaliatory strategy involves countries announcing that they will no longer respect U.S. patents and copyrights for as long as Donald Trump continues his tariff policies. This kind of action would target U.S. companies that rely on their intellectual property rights for profit, such as tech giants like Microsoft and pharmaceutical companies like Pfizer and Merck.
The concept of not honoring foreign patents is not without precedent. During World War I, the U.S. invoked the Trading with the Enemy Act to allow the compulsory licensing of patents held by German companies. This measure allowed U.S. businesses to use these patents without permission, as long as they paid a minimal licensing fee set by the U.S. government. Countries like Canada, the EU, and others could implement a similar policy to challenge the United States’ trade practices.
The potential benefits of this type of retaliation are twofold. First, it would allow consumers in the retaliating countries to access cheaper products—such as generic drugs, which could drastically reduce the cost of life-saving medications like those used in cancer and heart disease treatments. Second, it would lower the cost of everyday goods like computers, by bypassing the licensing fees for software from companies like Microsoft.
For consumers, this could mean cheaper access to essential products and technologies, making it a win-win situation. Imagine having access to affordable generics of expensive drugs or the latest software without the added cost of licensing fees. This approach would directly benefit the people in those countries, and it would provide a powerful counterweight to the economic challenges posed by Trump’s tariffs.
Such an approach would also hit U.S. corporations where it hurts—potentially changing the landscape of global trade in ways that tariffs alone may not. If other nations got accustomed to accessing cheap drugs, software, and entertainment content, it could shift global perceptions of U.S. intellectual property practices. This shift could permanently disrupt the revenue models of many major U.S. companies that rely on high licensing fees and patent monopolies. For instance, without the constraints of patent monopolies, Americans themselves could spend far less on prescription drugs—possibly saving around $550 billion annually.
Ericsson and Lenovo Settle Patent Licensing Dispute, Arbitration to Resolve Remaining Issues
Ericsson and Lenovo have reached a settlement to partially resolve their ongoing patent licensing dispute, stemming from a multi-year, global patent cross-license agreement between the two companies.
Under the terms of the settlement, all current lawsuits and administrative proceedings initiated by both parties across multiple jurisdictions, including those before the United States International Trade Commission (USITC), will be withdrawn, effectively ending all ongoing patent-related legal proceedings.
Financial impacts from the partial settlement are expected to be recognized starting in Q2 2025. However, the two companies have agreed to pursue arbitration to fully and finally resolve the remaining issues related to their patent licensing dispute.
Ericsson, a leading player in mobile technology and a key contributor to 3GPP and global mobile standards, holds a robust patent portfolio of over 60,000 granted patents, further bolstered by its leadership in 5G technology. The company continues to invest heavily in research and development, with annual expenditures exceeding SEK 50 billion. Ericsson is optimistic about increasing its intellectual property revenues, particularly through new 5G agreements and expansion into other licensing areas in the long term.
The settlement between Ericsson and Lenovo marks a significant step in resolving the patent dispute, providing both companies the opportunity to focus on their business activities moving forward while continuing to engage in discussions through arbitration to address remaining licensing matters.
Under the terms of the settlement, all current lawsuits and administrative proceedings initiated by both parties across multiple jurisdictions, including those before the United States International Trade Commission (USITC), will be withdrawn, effectively ending all ongoing patent-related legal proceedings.
Financial impacts from the partial settlement are expected to be recognized starting in Q2 2025. However, the two companies have agreed to pursue arbitration to fully and finally resolve the remaining issues related to their patent licensing dispute.
Ericsson, a leading player in mobile technology and a key contributor to 3GPP and global mobile standards, holds a robust patent portfolio of over 60,000 granted patents, further bolstered by its leadership in 5G technology. The company continues to invest heavily in research and development, with annual expenditures exceeding SEK 50 billion. Ericsson is optimistic about increasing its intellectual property revenues, particularly through new 5G agreements and expansion into other licensing areas in the long term.
The settlement between Ericsson and Lenovo marks a significant step in resolving the patent dispute, providing both companies the opportunity to focus on their business activities moving forward while continuing to engage in discussions through arbitration to address remaining licensing matters.
GSK Resolves Patent Lawsuit Against Pfizer Over RSV Vaccines
Pharmaceutical giants GSK and Pfizer have reached a settlement to resolve a long-running patent dispute related to respiratory syncytial virus (RSV) vaccines. The legal battle, which revolved around patent infringement claims, has now been brought to a close through an agreement between the two companies.
The lawsuit centered on allegations that Pfizer’s RSV vaccine infringed on patents held by GSK, specifically related to the technology behind the development and production of vaccines targeting the virus. RSV, a major cause of respiratory illness, has long been a focus of vaccine research, especially as both companies have worked to bring their respective RSV vaccines to market.
In a joint statement, both companies confirmed that the settlement would allow them to avoid further litigation and continue their efforts in addressing the global health threat posed by RSV. The terms of the settlement were not disclosed, but both GSK and Pfizer emphasized that the agreement would not affect their ongoing work on RSV vaccines, nor would it impact the availability of these vaccines for public health use.
The resolution of the patent dispute comes at a crucial time as RSV continues to strain healthcare systems worldwide, particularly among vulnerable populations like infants, elderly adults, and individuals with underlying health conditions. Both GSK and Pfizer are major players in the global vaccine market, with their respective RSV vaccines being part of a growing effort to combat the virus.
This settlement marks the end of a significant chapter in the intellectual property conflicts between the two pharmaceutical leaders, allowing both to focus on advancing their respective vaccine candidates in the fight against RSV
The lawsuit centered on allegations that Pfizer’s RSV vaccine infringed on patents held by GSK, specifically related to the technology behind the development and production of vaccines targeting the virus. RSV, a major cause of respiratory illness, has long been a focus of vaccine research, especially as both companies have worked to bring their respective RSV vaccines to market.
In a joint statement, both companies confirmed that the settlement would allow them to avoid further litigation and continue their efforts in addressing the global health threat posed by RSV. The terms of the settlement were not disclosed, but both GSK and Pfizer emphasized that the agreement would not affect their ongoing work on RSV vaccines, nor would it impact the availability of these vaccines for public health use.
The resolution of the patent dispute comes at a crucial time as RSV continues to strain healthcare systems worldwide, particularly among vulnerable populations like infants, elderly adults, and individuals with underlying health conditions. Both GSK and Pfizer are major players in the global vaccine market, with their respective RSV vaccines being part of a growing effort to combat the virus.
This settlement marks the end of a significant chapter in the intellectual property conflicts between the two pharmaceutical leaders, allowing both to focus on advancing their respective vaccine candidates in the fight against RSV