This IP newsletter covers categories of updates relating to Legal Updates, Industry Spotlight, Case Studies and Precedents, Practical Insights for IP Professionals, Upcoming Events and Webinars, and Spotlight on Innovation.
Intellectual Property (IP) Rights Updates
1. UPC and EPO diverge on inventive step: lessons from Amgen's PCSK9 patent battle
The dispute between Amgen and Sanofi over European patent EP 3 666 797 has brought to light a significant divergence between the Unified Patent Court and the European Patent Office on the issue of inventive step. The UPC, in a decision delivered in July 2024, revoked Amgen's patent on the grounds that the development of PCSK9-inhibiting antibodies would have been an obvious step based on prior knowledge. It held that a skilled person would logically pursue the development of such antibodies using routine methods, given the existing identification of PCSK9 as a valid therapeutic target for lowering LDL cholesterol. This ruling came as part of a revocation action initiated by Sanofi on the very day the UPC began its operations.
In contrast, the EPO upheld the same patent during post-grant opposition proceedings. While it acknowledged that the prior art could motivate further antibody development, it concluded that the claimed therapeutic effect was not obvious due to a lack of direct supporting evidence and the inherent unpredictability of biological systems. The EPO emphasized that the prior art did not provide a reasonable expectation of success in achieving therapeutic efficacy, and it criticized the UPC's failure to give due weight to this aspect. The divergent outcomes have heightened uncertainty for patent holders in the life sciences sector and may influence their decisions regarding whether to opt in to the UPC framework or pursue national enforcement routes.
DLL Analysis - The case highlights an emerging fragmentation in the European patent system that could significantly affect patenting strategies in biotechnology and pharmaceuticals. With the UPC applying a more development-focused standard and the EPO maintaining a threshold grounded in therapeutic unpredictability, life sciences innovators must navigate a complex and potentially conflicting landscape. Success will depend not only on scientific innovation but also on the ability to craft robust patent claims that can withstand scrutiny under both frameworks. Companies that invest in strategic IP positioning and gather strong preclinical evidence will be better equipped to secure and defend valuable patents as this dual-track system evolves.
2. Therapeutic efficacy is a must for a novel intermediate compound to overcome Section 3(d) objection
In a recent decision by the Delhi High Court in the case of Zeria Pharmaceutical Co. Ltd. v. The Controller of Patents, the court upheld the rejection of a divisional patent application for a novel intermediate compound. The patent application was filed by a Japanese corporation and had been refused by the Indian Patent Office on grounds of lack of inventive step and non-patentability under Section 3(d) of the Patents Act. The appellant argued that the cited prior art documents did not render the invention obvious and that the claimed compound demonstrated improved reaction conditions. However, the court found that the structural modification from ethoxy to methoxy was a routine variation and did not satisfy the inventive step requirement under Section 2(1)(ja).
The court also held that the claimed intermediate compound failed to meet the threshold of enhanced therapeutic efficacy as required under Section 3(d), referencing the Supreme Court's interpretation in Novartis v. Union of India. The appellant's argument that therapeutic efficacy was not demonstrable due to the compound being an intermediate was not accepted. The court emphasized that even intermediates must demonstrate such efficacy to overcome the bar under Section 3(d), and mere process improvements such as better yield or fewer impurities do not meet this standard. Accordingly, the appeal was dismissed on 27 May 2025.
DLL Analysis- This case underscores the strict interpretation of Section 3(d) by Indian courts and its application even to pharmaceutical intermediates. For industry stakeholders, it reinforces the importance of demonstrating therapeutic efficacy rather than relying solely on improvements in synthesis or purity. The decision highlights that minor chemical modifications or better process metrics will not substitute for the required inventive contribution when seeking protection for derivatives of known compounds. Going forward, applicants must prepare robust technical evidence and avoid assuming that intermediates will be exempt from the rigorous standards set by Indian patent law.
3. Discontinuation of the Accelerated Examination program for utility applications
Effective July 10, 2025, the USPTO is discontinuing the Accelerated Examination (AE) program for utility patent applications due to its low usage and high administrative burden, particularly in light of the more efficient and popular Track One (prioritized examination) program. AE required additional procedural steps like pre-examination searches and support documents, whereas Track One streamlines expedited processing through a fee-based system with discounts for small and micro entities. The rule change aims to reallocate resources to reduce overall examination pendency and first-action delays. Additionally, the USPTO amended 37 CFR 1.102 to remove outdated AE provisions and clarify that petitions to make special without a fee apply only in cases involving an inventor's age or health, aligning terminology with the post-AIA distinction between "inventor" and "applicant."
DLL Analysis- This move reflects a shift toward reducing administrative burden and focusing resources on clearing examination backlogs. Applicants seeking faster prosecution must now rely on Track One, which offers expedited review without the complex procedural requirements of AE. The update also clarifies that only an inventor's age or health—not the applicant's—qualifies for a fee-free petition to make special, ensuring consistency with post-AIA definitions.
4. Federal Circuit vacates $300M Apple Verdict in Optis SEP war
The U.S. Court of Appeals for the Federal Circuit has vacated a $300 million patent infringement judgment against Apple, sending its long-running legal battle with Optis Cellular Technology back for a completely new trial. The dispute centres on five of Optis's patents that are essential to the LTE cellular standard. The court's precedential decision hinged on a critical procedural flaw in the trial process: the use of a single verdict question that asked the jury if Apple had infringed "ANY" of the five asserted patents. The Federal Circuit ruled this violated Apple's Seventh Amendment right to a unanimous jury verdict on each distinct legal claim, as each patent constitutes a separate cause of action. This flawed verdict form made it possible for the jury to find Apple liable without unanimously agreeing on which specific patent or patents were actually infringed.
Beyond the procedural error, the court made several other key rulings that weaken Optis's position for the new trial. It reversed the lower court on two patents, finding one was directed to an unpatentable "abstract idea" (a mathematical formula), and another was subject to a stricter "means-plus-function" analysis, putting both at high risk of being invalidated. Furthermore, the court held that the district court abused its discretion by admitting evidence of the massive Apple-Qualcomm settlement agreement, ruling its minimal relevance was substantially outweighed by the danger of unfairly prejudicing the jury. The decision creates significant uncertainty in the global SEP landscape, as a UK court recently ordered Apple to pay Optis approximately $502 million for a global license, a ruling that was partly predicated on the now-overturned U.S. verdicts.
DLL Analysis - This ruling represents a major strategic reset for complex patent litigation in the U.S. It effectively dismantles the plaintiff strategy of presenting a "portfolio" of patents as a single infringement narrative, forcing a more granular and costly patent-by-patent proof at trial. This procedural shift gives defendants significant leverage to "divide and conquer" by focusing on the weakest patents in a portfolio to reduce potential damages. The decision also signals continued judicial scrutiny of algorithm and software-based patents, posing a systemic threat to many SEPs that underpin modern telecommunications. Finally, the case highlights a growing divergence between U.S. and UK courts on handling global FRAND disputes, with the U.S. system enabling wars of procedural attrition while UK courts move more pragmatically to set global commercial rates, a split that will likely fuel more strategic forum shopping in the future.
5. OpenAI's Trademark Clash: IYO sues over 'io' name, raising bigger questions
IYO, a company that is suing OpenAI for trademark infringement, was chastised by OpenAI CEO Sam Altman. IYO asserts that "io," OpenAI's recent acquisition, is too similar to their moniker and would mislead consumers. Jason Rugolo, the CEO of IYO, had made several attempts to persuade OpenAI to purchase or invest in his business prior to filing the lawsuit.
Altman said it's inappropriate to sue when investment conversations don't work out and called the case "silly." The court permitted the case to proceed and mandated that OpenAI temporarily cease using the "io" name. As a result, OpenAI removed the announcement about the project from their website. In October, a hearing is scheduled.
DLL Analysis- A well-known illustration of how intellectual property conflicts may be both a tactical business decision and a legal requirement is the IYO v. OpenAI case. If IYO's trademark claim is successful, this action may postpone or even halt OpenAI's hardware push. However, IYO's legal approach may serve as a caution to bigger businesses to think carefully about their branding initiatives and acquisitions in order to steer clear of expensive and reputation-damaging legal disputes.
6. Getty Images vs. Stability AI: Key legal battle could shape AI and Intellectual Property laws
During a UK court battle, Getty Images chose to withdraw its copyright charges against Stability AI, an AI startup. This occurred right before the conclusion of the arguments. Getty filed a lawsuit against Stability, claiming that its artificial intelligence product, Stable Diffusion, had breached copyright rules by using Getty's photographs without authorization.
At first, Getty accused Stability of violating databases, trademarks, and copyright. But following expert testimony, Getty decided to limit its attention to allegations of secondary copyright concerns and trademark infringement. According to Getty, Stability trained its AI on its watermarked photographs, and some of those watermarks even showed up in images that the AI produced.
However, Stability argues that since the AI was trained on Amazon's systems in the United States, outside of the United Kingdom, UK regulations shouldn't be applicable.
Both businesses are still awaiting the court's final verdict after Stability applauded Getty's move to withdraw the copyright claim.
DLL Analysis - The case between Getty Images and Stability AI is crucial for both the creative and tech industries. Getty dropping its copyright claims shows it may not have a strong case, focusing instead on trademark issues like watermarks. Stability AI argues the case doesn't belong in the UK, as its AI was trained elsewhere.
The outcome could set important rules for how AI companies use public content to train models, impacting future legal battles and the relationship between AI and intellectual property laws.
Case Laws
1. RSPL Health Pvt. Ltd vs Sun Pharma Laboratories Limited & Anr on 12 June 2025
In the case of RSPL Health Pvt. Ltd. v. Sun Pharma Laboratories Ltd. & Anr., the Delhi High Court dismissed an appeal challenging a Commercial Court's refusal to grant an interim injunction against the use of the mark "PRUEASE" by Sun Pharma. RSPL, owner of the registered mark "PRO-EASE" for sanitary products, alleged that Sun Pharma's mark was deceptively similar and caused confusion. However, the Court found that the two sets of goods—sanitary napkins and pharmaceutical medicines for constipation—are entirely distinct in nature, trade channels, and consumer base. It concluded that there was no likelihood of confusion under Section 29 of the Trade Marks Act. The appellant's claim that the mark should be protected for future expansion into pharmaceuticals was dismissed as speculative.
The Court further observed that Sun Pharma had prima facie demonstrated continuous use of the impugned mark since 2017 and had coined the name "PRUEASE" in reference to the drug's active ingredient, prucalopride. The Court held that mere registration of a trademark in Class 5 did not confer monopoly over all goods within that class if the goods were unrelated. It also found that RSPL had failed to meet the conditions for interim relief, including the establishment of a strong prima facie case, balance of convenience, and irreparable harm. The decision emphasized that trademark protection is not absolute across dissimilar goods even within the same class.
DLL Analysis- This judgment reinforces the principle that trademark rights do not automatically extend to dissimilar products within the same classification. For brand owners, especially those in consumer goods and pharmaceuticals, it affirms the need to provide clear evidence of actual use and consumer association when seeking injunctions. Courts continue to prioritize market realities, such as product nature and distribution channels, over mere registration status. The decision also reflects judicial caution in granting discretionary relief, particularly where the applicant has failed to disclose relevant facts or substantiate potential confusion. As trademark portfolios become more diversified, businesses must adopt tailored brand strategies and avoid overreliance on broad class coverage to enforce exclusivity.
2. Hybrid Pharma LLC v. Matthew Knispel, et al, No. 24-13095 (11th Cir. 2025)
In the case of Hybrid Pharma LLC v. Matthew Knispel and Others, the United States Court of Appeals for the Eleventh Circuit affirmed the district court's grant of summary judgment, dismissing Hybrid Pharma's claim under 42 U.S.C. § 1983. Hybrid alleged that Florida Department of Health (FDOH) officials selectively enforced pharmaceutical regulations against it, violating the Equal Protection Clause through a "class-of-one" theory. Hybrid contended it was treated differently from two comparators, Olympia Pharmacy (OPS) and KRS Global Biotechnology (KRS), despite operating under the same regulatory framework. However, the court found that Hybrid failed to provide sufficient evidence that these comparators were similarly situated in all relevant respects, as required under settled precedent.
The court emphasized that superficial similarities such as licensing and regulatory jurisdiction were insufficient without evidence of equivalent violations and circumstances. Hybrid could not demonstrate that OPS or KRS committed the same infractions without receiving similar sanctions. It relied largely on the volume of inspections and perceived enforcement disparities, without showing that OPS or KRS had the same deficiencies. The court noted that Hybrid's interpretation of "similarly situated" was too broad and that differences in regulatory outcomes were justifiable based on the factual distinctions in violations. The appeal was dismissed, affirming the finding that Hybrid had not established a valid equal protection claim.
DLL Analysis- This decision highlights the stringent standard courts apply when evaluating equal protection claims under a class-of-one theory, particularly in complex regulatory environments. The Eleventh Circuit reaffirmed that entities must be "prima facie identical in all relevant respects" for a comparison to succeed. For businesses operating in heavily regulated sectors like pharmaceuticals, the case underscores the evidentiary burden of demonstrating unequal treatment. Merely showing differences in regulatory scrutiny or outcomes is not enough; a claimant must offer concrete proof of materially similar conduct and circumstances. Regulatory discretion, when exercised based on factual differences, does not constitute unconstitutional discrimination. The ruling serves as a cautionary reminder that procedural fairness claims must be tightly anchored in factual parity, not general industry similarities.
3. DIVX, LLC vs Unified Patents, LLC
The U.S. Court of Appeals for the Federal Circuit has affirmed a Patent Trial and Appeal Board (PTAB) decision that invalidated key claims of a DivX patent for adaptive bitrate streaming technology. The patent described a media playback device that uses two distinct streaming methods: one for an initial startup period that does not consider the device's buffer state, and a second, different method that activates after a minimum buffer level is met, which does take the buffer into account. The PTAB had found the invention obvious by combining two prior art references, known as Biderman and Gigliotti.
In its June 24, 2025, nonprecedential opinion, the Federal Circuit rejected DivX's primary argument that a skilled artisan would not have combined the references in the claimed manner because it would leave a "flawed methodology" in place during the startup period. The court held that a proposed combination of prior art does not need to be the "best option, only that it be a suitable option" for a skilled person to try. The court also dismantled DivX's second argument that the prior art did not teach the use of two different streaming methods, finding that the Gigliotti reference by itself disclosed a two-stage process: an initial stream at a first bitrate to fill a buffer, followed by a transition to a different adaptive bitrate scheme.
DLL Analysis - This ruling reinforces the formidable challenge of overcoming an obviousness rejection in crowded and incremental technology fields like media streaming. It underscores the principle that patentees cannot defeat an obviousness claim merely by arguing that a proposed combination of prior art is suboptimal; if the combination is a "suitable option" that a skilled person would have been motivated to try to solve a known problem, it can be sufficient to render an invention obvious. The decision also serves as a crucial reminder of the depth to which prior art is analysed. The court's ability to find a two-stage process within a single prior art reference proved fatal to the patentee's appeal, highlighting that a challenger's success can hinge on a granular reading of individual references, not just their combination. For technology companies, this case illustrates the effectiveness of the inter partes review (IPR) process as a tool for invalidating patents and the high bar required to overturn a well-reasoned PTAB decision on appeal.
4. Cabo Concepts Limited and The Licence World Limited V. Mga Entertainment (Uk) Limited and Mga Entertainment, Inc
At the core of this dispute was the tension between legitimate IPR enforcement and anti-competitive misuse of those rights. MGA Entertainment, known for its wildly successful LOL Surprise! toys, allegedly threatened retailers with patent infringement claims if they stocked Worldeez, a rival collectible toy launched by Cabo Concepts. Cabo argued that these threats were unjustified and constituted an abuse of patent rights under Section 70 of the UK Patents Act 1977 and a broader abuse of dominance under UK and EU competition law.
Cabo claimed the threats violated Section 70, which prohibits making unjustified threats of patent infringement. However, the court found that Cabo could not sufficiently prove the threats were legally baseless, or that they alone caused the commercial failure. The case also highlighted how IPR holders must be cautious in asserting their rights, especially where their market power might raise competition concerns.
DLL Analysis- The case serves as an important example of the fine line between protecting innovation through IPR and misusing the rights to stifle emerging competitors. It reinforces the principle that IPR must be exercised responsibly, especially by market leaders, or it risks scrutiny under competition law. For IPR professionals, it also underscores the importance of documenting infringement concerns clearly and avoiding informal threats that may be seen as coercive or commercially damaging.
5. National Interest Overrides Trademark Fame: HC Denies TikTok Well-Known Status
The Bombay High Court maintained the decision to exclude "TikTok" from the list of well-known trademarks in India in the matter of TikTok Ltd. v. Registrar, Trade Marks. TikTok had contested the Registrar's ruling, claiming that it was based on press releases and news articles regarding the TikTok suspension and that it had incorrectly used Section 9 of the Trade Marks Act rather than Section 11. The Court determined that the Registrar's judgment was proper despite acknowledging this error.
The Court's primary justification was India's statewide ban on TikTok, which was put in place because to worries about public order, data privacy, and national security. The Court believed that TikTok did not fit the requirements to be acknowledged as a well-known brand in India because of the continued restriction.
DLL Analysis - This ruling demonstrates that a trademark may not have special protection in India, even if it is well-known throughout the world, if it is associated with matters that impact public safety or interest. Being "well-known" involves more than just being famous; it also entails having a spotless record in the eyes of the government and the law. The ruling also demonstrates that the Trade Marks Office can consider national concerns in addition to standard trademark considerations when making decisions.
6. Royalty for exclusive trademark license not taxable as service: CESTAT
The dispute was on whether the service fee was demanded correctly from Bajaj Resources Private Limited (East Bajaj Consumer Care Limited), which is in relation to the Royalty received under 1.a trademark -license system with a complete Eid subsidiary Bajaj Corp Limited. March 12, 2008, the dated original agreement granted a non-exclusive trademark license for 10 years within Andhra Pradesh. It was later changed by a national agreement on February 24, 2010, which extended the term to 99 years and made the license unique globally. The department considered Royalty received under this Agreement as an idea of a taxable service under "Intangible Real Estate Service" and required service fees. However, Bajaj argued that the transaction formed "the employed cell" in accordance with Article 366 (29a) of the Constitution and therefore excluded the purpose of service fee in accordance with § 65b (44) in the Financial Act, 1994. The tribunal agreed with Nudge, as universally universal, which meets special, long -terms. 2.The amount of transfer of the right to use the goods - that is, an understandable sale - not a service. As a result, the demand for service fees was placed on one side.
On the other hand, the Board of Bajaj's reimbursement requirement for previous service fees in 2013-14. Although the payment was carried out without a legal basis, the Board found that Bajaj had passed his subsidiary his tax burden and provided no evidence to resume unfair enrastery estimate. According to the Supreme Court's decisions in Mafatlal Industries and ITC Limited, reimbursement is impenetrable under such circumstances. Thus, rejection of the reimbursement requirement was maintained.
DLL Analysis- The ruling clarifies that long-term exclusive IP licenses may be treated as Deemed Sales, and thus not subject to service tax.
Practical Insights for IP Professionals
- AI-driven patent analytics is transforming how intellectual property teams manage and evaluate patent portfolios. These advanced tools use machine learning algorithms and natural language processing to analyze large volumes of patent data, including claims, specifications, prior art citations, and litigation history. By doing so, they help identify patterns and insights that would be difficult to detect manually. For example, AI systems can assess claim breadth across jurisdictions, flag overlapping technologies, and uncover hidden prior art that may impact validity. This enables IP professionals to make faster and more informed decisions during prosecution, opposition, or due diligence processes.
- In strategic planning, these analytics platforms are increasingly being used to forecast litigation risks, identify weak patents, and focus enforcement efforts on the most defensible assets. AI tools can rank patents by strength, value, or enforceability, guiding investment in renewals, divisional filings, or monetization. During M&A or licensing negotiations, AI-backed portfolio audits offer a clearer view of risk and opportunity. While AI cannot replace legal judgment, it is becoming indispensable in enhancing efficiency, reducing oversight, and sharpening the competitive edge of IP strategies.
Spotlight on Innovation
1. Live mycelium materials represent a cutting-edge innovation at the intersection of biology, materials science, and environmental engineering. By integrating living fungal networks with synthetic or biodegradable scaffolds, researchers have developed materials that are not only lightweight and sustainable but also possess self-healing capabilities. These materials can grow, adapt to environmental stress, and regenerate after damage, making them ideal for use in eco-conscious construction, packaging, wearable technologies, and environmental remediation. Their unique ability to merge organic life with structural function creates new frontiers for technological advancement.
From an intellectual property perspective, live mycelium materials raise complex and novel considerations. Inventors are now seeking protection not only for the composite structures but also for the methods of cultivation, functional integration, and adaptive response mechanisms. As the applications of these living materials expand from bio design and circular architecture to pollutant-absorbing systems. The IP professionals must consider strategies that encompass utility patents, trade secrets for growth protocols, and potentially new frameworks for protecting living-engineered systems. This innovation opens up a fresh category of biomaterial technologies where IP protection plays a crucial role in driving adoption and investment.
2. Unified Digital Platforms for Aerospace Engineering: Leading aerospace firms like Avio are moving beyond discrete software tools to adopt comprehensive digital ecosystems, such as Dassault Systèmes' 3DEXPERIENCE platform, to manage the entire lifecycle of complex space programs. Announced in June 2025, this strategy creates a single, data-driven virtual environment that unifies every stage from initial design ("Winning Concept") to manufacturing ("Build to Operate"), enabling seamless, real-time collaboration across the entire value chain of engineers, partners, and suppliers. This strategic re-platforming opens new IP opportunities not just for the final product, but for the proprietary integrated workflows, data management methods, and automated processes developed on the platform, which provide a significant competitive advantage in quality, cost, and innovation speed.
Contributors to the newsletter-
Abhimanyu Singh (Associate Vice President - Electronics and
Engineering) Manoj Singh Kathayat (Patent Engineer)
Rinky Rani (Senior Patent Engineer)
Sakshi Shikha (Associate)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
