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.
pharma
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.
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.
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.
💡 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.
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.
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.
CERo Therapeutics Expands Patent Portfolio with Two Key Approvals for Cancer-Fighting T Cell Therapy
In a significant step forward for next-generation immunotherapy, CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced the allowance of two patent applications by the U.S. Patent and Trademark Office (USPTO). These approvals further strengthen the company’s intellectual property portfolio and advance its mission to revolutionize cancer treatment through engineered T cell technology.
🧬 What the New Patents Cover
The first allowance, Patent Application No. 17/040,472, titled “Cellular Immunotherapy Compositions and Uses Thereof,” provides coverage for both the composition and methods of use for CERo’s lead therapeutic candidate, CER-1236.
This patent secures protection for a combination of phosphatidylserine-targeting CD4+ CER-T cells alongside either CD8+ CAR-T cells or CD8+ recombinant TCR-T cells — a potentially powerful duo in the fight against cancer. The application was allowed on March 13, 2025, and is expected to formally issue as a U.S. patent pending final administrative steps.
The second allowance, Patent Application No. 17/040,317, focuses on the design elements of CER-1236.
Together, these new additions bring CERo’s total IP protection to 17 issued and allowed patents globally, covering 9 patent families and ensuring exclusivity through at least 2039 in the U.S.
🚀 Why This Matters
According to Chris Ehrlich, CEO of CERo Therapeutics:
This announcement comes on the heels of two major developments for CERo — the opening of its first clinical trial site for a Phase 1 trial in Acute Myeloid Leukemia (AML) and the FDA’s clearance of an Investigational New Drug (IND) application to begin human trials targeting ovarian and non-small cell lung cancers.
🧪 What Sets CERo Apart
CERo’s platform centers on what it calls Chimeric Engulfment Receptor T cells (CER-T) — a unique blend of adaptive and innate immune functionalities. Unlike traditional CAR-T cells, which rely on antigen recognition and activation, CER-T cells incorporate engulfment pathways that allow them to phagocytose and destroy cancer cells — mimicking a mechanism usually seen in innate immune cells.
This hybrid design could position CER-Ts as a more versatile alternative, with the potential to treat both blood cancers and solid tumors, a key limitation in current CAR-T therapies.
🧭 Looking Ahead
CERo is preparing to initiate clinical trials for CER-1236 in hematologic malignancies in 2025, and with its fortified patent portfolio, the company is well-positioned to push its immunotherapy pipeline forward — both scientifically and commercially.
The additional patent protections will not only support ongoing R&D and commercialization efforts but also provide a competitive moat in an increasingly crowded cell therapy space.
Conclusion:
As CERo advances toward clinical trials, these patent approvals reflect growing validation for its novel T cell engineering approach. With a focus on real innovation and strong IP protection, CERo Therapeutics continues to stake its claim as a leader in the evolving world of cellular immunotherapy.
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.
Patents: A Hidden Cost Trap for Startups – How to Navigate Without Overspending
For many startups, patents seem like a necessary but one-time expense. However, the reality is far more complicated. Filing a patent might appear straightforward, but the costs involved are anything but. From legal fees and government charges to international filings and ongoing maintenance costs, the true expense of a U.S. patent can easily exceed $50,000 over its lifetime.
This hefty price tag raises questions for founders: Is patenting worth it? I’ve seen firsthand how many entrepreneurs hesitate to move forward with patent filings, uncertain whether the return on investment justifies the expenditure. However, skipping patents altogether can present even more dire consequences for your business:
A competitor could beat you to the patent office, locking you out of your own market.
Investors may lose interest if they don’t see a clear intellectual property (IP) strategy.
A legal battle might emerge just as your business gains momentum, forcing you into costly litigation.
So, the question isn’t whether you should patent, but rather how you can do so without draining your resources.
Strategies for Smart Patent Filing on a Budget
The key to navigating the patent process effectively is knowing where to focus your budget. Fortunately, it’s easier than you think. Here are some proven strategies to help you patent without overspending.
1. Identify High-Value Innovations for Patent Protection
Startups often make two costly mistakes when it comes to patents: over-patenting or under-patenting. Both can harm your business.
Under-patenting happens when startups fail to document and protect innovations, allowing valuable ideas to slip through the cracks. Without a structured process like Invention Disclosure Forms (IDFs), innovations may not be patented in time, especially when funds are limited.
Over-patenting involves filing patents for ideas that don’t significantly strengthen your market position. It’s akin to betting on every horse instead of choosing the one with the best odds of winning. Instead, focus on innovations that have the potential to generate revenue or block competitors.
To avoid these pitfalls, use a structured patentability assessment. This process, which involves input from R&D, legal teams, and business leaders, evaluates the patent’s business value, the likelihood of patenting success, and the associated costs. Only the most valuable ideas should move forward.
As a rule of thumb: If losing an idea wouldn’t hurt your business, don’t patent it.
2. Plan Your IP Budget Wisely
Filing a patent without a clear budget is risky and irresponsible. Many startups rush into patent applications, only to run out of funds midway through the process, leaving their filings incomplete or allowing issued patents to expire.
Patent costs accumulate in phases—drafting fees, prosecution costs, government fees, and maintenance costs after the patent is granted. The total cost can soar, especially when foreign patents are involved. If you only budget for the initial filing, you may be forced to abandon a patent midway as costs balloon.
To prevent this, set a comprehensive patent budget before you file. Ensure you account for all phases of the patenting process, from drafting through maintenance. It’s also crucial to discuss fixed-fee structures or end-to-end budgets with your attorney to avoid any surprise costs. Once the patent is in progress, use cost estimation tools to track your ongoing expenses.
A well-planned budget ensures that your patents work for you, not against you.
3. Use Smart Filing Strategies to Cut Costs
Cutting corners on patent filings can be tempting, but it often leads to rejections, poor strategy, or patents that are ineffective when needed most. Here are some smarter ways to save:
Provisional Patents: Start with a provisional patent. For as little as $140 in USPTO fees (with lower legal fees as well), a provisional patent locks in your filing date and gives you 12 months to refine your invention before committing to a full application.
Government Fee Discounts: If you qualify as a small or micro-entity, you can save 50-75% on USPTO fees. Many startups overlook this, leaving money on the table.
Foreign Filings: Avoid rushing into international filings unless you’re committed to those markets. Foreign patent costs can range from $5,000-$10,000 per country initially, with total costs reaching $25,000-$75,000. Start with U.S. filings, then use the PCT (Patent Cooperation Treaty) system to delay foreign decisions for up to 30 months, giving you more time to assess demand.
Avoid Excessive Prosecution: Don’t waste money on tough examination areas. Use predictor tools to steer clear of technologies where patenting is challenging. You can also analyze examiner statistics and request interviews to improve your chances of success. If your application is unlikely to succeed, consider abandoning it early to avoid sinking more money into a lost cause.
4. Prune Low-Value Patents to Cut Unnecessary Fees
Many startups waste up to 20% of their patent budget on patents that no longer serve their business needs. If a patent is no longer protecting a key technology or providing a competitive edge, there’s no reason to keep paying for it.
Review your patent portfolio annually and study does this patent still align with my business strategy? If not, consider dropping it, selling it, or licensing it to recover costs. If your business has exited a market, stop paying for patents in that market.
5. Use Data, Not Guesswork
Smart patenting isn’t about making intuitive decisions—it’s about using data to guide your moves. The right tools can assess the likelihood of approval, predict overall patenting costs, and reveal cost-saving opportunities. This data-driven approach helps you determine which patents are worth pursuing and maintaining.
Successful innovation managers don’t file patents blindly; they track, analyze, and adjust based on data. If you want to win, adopt the same strategy.
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.