Patent Appeal Highlights Procedural Fairness and Inventive Step Evaluation

Case: Stromag Gmbh vs The Controller General Of Patents on 4 September 2025 (Calcutta High Court)

The Patents Act, 1970 (as amended): Section 2(1)(ja), Section 3(f), Section 10

In a recent appeal concerning patent law and procedural fairness, the Appellant contested the rejection of its patent application for a hydraulically actuatable disk brake. The Indian Patent Office had dismissed the application solely on the ground that the claimed invention was an obvious aggregation of elements from seven prior art documents, thereby lacking an inventive step under Section 2(1)(ja) of the Patents Act, 1970. The Appellant, however, raised serious concerns regarding the decision-making process, asserting that the Controller’s order not only failed to engage in a reasoned analysis of the inventive concept but also violated principles of natural justice by providing no substantive justification for the rejection. The case brings to the forefront critical issues surrounding the assessment of inventive step and the duty to provide a reasoned, transparent decision in patent proceedings.

 Appellant’s Argument:

The Appellant contended that the Controller’s order merely summarized the seven prior art documents without explaining how these references rendered the claimed invention obvious. The Appellant emphasized that all elements of the claimed invention, including configuration and functionality, were independently inventive and could not be dismissed as an arbitrary combination of prior art. The Appellant also submitted amended claims and detailed written arguments to demonstrate the inventive step and differentiate the invention from prior art.

 Respondent’s Argument:

The Respondent submitted that the application was liable for rejection and that the impugned order addressed the objections raised in the First Examination Report (FER). It was argued that the invention could be derived by combining the cited prior arts and that the Appellant’s claims lacked inventive merit.

Court Analysis and Findings:

The Court observed that a quasi-judicial order must “speak for itself” through reasoned analysis and cannot rely on mere summaries or mechanical conclusions. The impugned order failed to explain how the cited prior art rendered the invention obvious, thereby violating fundamental principles of natural justice. The Court referred to several precedents, including Kranti Associates v. Masood Ahmed Khan and UPSC v. Bibhu Prasad Sarangi, emphasizing that reasons form the “soul of a judicial decision” and that mere citation of prior art without analysis is insufficient.

Further, the Court noted that the inventive step must be assessed as a whole, and the Controller cannot arbitrarily mosaic prior art references to reject the application. The Court also highlighted that each element of the claimed invention, including its specific configuration and functionality, must be independently evaluated for inventive merit.

Conclusion:
The Court set aside the impugned order and remanded the matter to a different Hearing Officer for fresh consideration. The Hearing Officer is directed to adjudicate the application afresh within four months, applying the law and considering all submissions of the Appellant.

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Patent Showdown: Saint-Gobain Loses Appeal on Coated Glass Patent

Case: Saint Gobain Glass France vs Assistant Controller Of Patents And Designs & Anr. on 11 September 2025 (Delhi High Court)

The Patents Act, 1970 (as amended): Section 2(1)(j), 2(1)(ja), 3(d), 10, 25, 59; Section 117A (Appeal)

Case Background

Saint-Gobain Glass France filed an appeal challenging the Assistant Controller of Patents’ refusal of its Indian patent application (No. 201717045317) titled “Material comprising a stack of thin layers.” The invention concerned a coated glass substrate featuring a silver-based functional layer, flanked by dielectric coatings and nickel/chromium blocking layers, which was designed to deliver high external reflectivity combined with a distinctive glossy silver finish. The Controller had rejected the application on the ground that the claimed results could be achieved through routine optimization of existing prior art, thus lacking the requisite inventive step. The appeal raised important questions about the boundaries between inventive innovation and routine development in patent law.

Plaintiff’s Argument (Saint-Gobain)

The Plaintiff contended that the invention represented a technical advancement over prior art by:

• Achieving neutral colours in transmission,
• Delivering high external reflection (>30%), and
• Providing a glossy silver appearance.

Counsel argued that the Controller had erred in mosaicing prior art and applying hindsight. Experimental data and an expert affidavit were submitted to demonstrate novelty and inventive step. The Plaintiff also noted that corresponding foreign patents, including EPO grants, had been approved, suggesting that the Indian Patent Office should recognize the invention similarly.

Defendant’s Argument (Patent Office & Opponent)

The Defendant countered that the claims were obvious combinations of existing technologies, including dielectric coatings, silver layers, and blocking layers. Comparative data failed to establish any significant technical advancement, and some prior art, including Saint-Gobain’s own earlier filings, already disclosed similar outcomes. The Defendant further argued that foreign patent grants were irrelevant under Indian law and that the application amounted to “evergreening” through minor thickness optimisations.

Court’s Analysis

The Court applied the five-step test from F. Hoffmann-La Roche v. Cipla and the three-step test from Novartis v. Union of India. It found that Saint-Gobain’s claimed improvements were routine workshop modifications rather than genuine inventions. Comparative data were inconsistent, and the expert affidavit lacked essential parameters such as solar factor and energy reflection, undermining its credibility. Prior art documents (WO2014/177798, WO2011062574A1, IN 3022/KOLNP/2010, IN 3417/KOLNP/2010) already disclosed the same stack structure and properties, leaving no unexpected technical effect. The Court also noted that foreign patent grants carried no persuasive value in India.

Conclusion
The Delhi High Court upheld the Controller’s refusal. It ruled that Saint-Gobain’s application lacked inventive step under Section 2(1)(ja), as the differences over prior art were mere routine optimisations and did not constitute a technical advance. The appeal was dismissed.

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The Clock’s Ticking: How Novartis Lost Its Cross-Examination Bid in Patent Opposition

Case: Novartis Ag vs Controller Of Patents And Designs & Anr on 16 September, 2025

The Patents Act, 1970 (as amended): Section 3(d), Section 79, Rule 60, Rule 128

Background

Novartis’s Indian patent application (IN 4412/DELNP/2007), covering the cardiovascular drug Entresto (Valsartan/Sacubitril), was granted in December 2022 after surviving a decade-long pre-grant opposition battle. Following the grant, several generic manufacturers, including IPCA Laboratories, Micro Labs, and the Indian Pharmaceutical Alliance, filed post-grant oppositions alleging lack of inventive step and violation of Section 3(d) of the Patents Act.

In July 2024, the opponents submitted expert affidavits, which Novartis challenged procedurally. While the Controller admitted the opponents’ evidence, Novartis was initially denied the opportunity to file rebuttal evidence. This prompted a successful writ before the Delhi High Court, which restored Novartis’s right to respond and mandated a strict timeline.

Novartis submitted its rebuttal in June 2025. A fresh Opposition Board recommended revocation in July. Just before the hearing, Novartis filed a Rule 128 petition seeking cross-examination of the opponents’ experts, which the Controller declined to entertain due to timing. After Novartis failed to appear at the final hearing, the Controller proceeded ex parte. Novartis then filed a second writ petition, alleging denial of natural justice.

Novartis’s Arguments

• Asserted a statutory right to cross-examination under Section 79 of the Patents Act.
• Cited the Onyx Therapeutics decision, arguing that denying cross-examination violated principles of natural justice.
• Claimed the delay in seeking cross-examination (a year after receiving opponent evidence) was justified, as it arose only after consulting its own experts and filing rebuttal evidence.
• Proposed an expedited cross-examination process, claiming it would not prejudice opponents or delay proceedings materially.

Opponents’ Counterarguments

• Argued the petition was a tactical move aimed at delaying the inevitable revocation until the patent’s expiry in November 2026.
• Highlighted that Novartis had multiple opportunities to seek cross-examination but failed to do so until the eleventh hour.
• Distinguished the Onyx ruling, noting that the patentee in that case requested cross-examination at the earliest opportunity, unlike Novartis.
• Opposed reopening proceedings post-recommendation by the Opposition Board, citing disruption and procedural unfairness.

Court’s Analysis

• The Court distinguished the present case from Onyx Therapeutics, emphasizing that Novartis never sought cross-examination until more than a year after receiving evidence—despite actively litigating other procedural aspects.
• Cross-examination is not an absolute right; it must be invoked promptly and not as an afterthought. Filing rebuttal evidence without seeking cross-examination signified a conscious election of procedural strategy.
• The Court found no violation of natural justice, as Novartis had been granted a full opportunity to counter the opponent’s case through rebuttal evidence.
• Allowing cross-examination after the Opposition Board’s second recommendation would invalidate the Court’s previous timelines and derail the statutory goal of expeditious disposal.
• Strong language was used, with the Court calling the petition an “abuse of process” and dismissing claims of prejudice or unfairness. Novartis’s failure to attend the hearing further undermined its case.

Conclusion

• The Delhi High Court dismissed Novartis’s writ petition, upholding the Controller’s refusal to permit cross-examination and his final hearing process. It held that:
• The right to cross-examine is not absolute and must be exercised at the appropriate stage.
• Strategic silence or delay can amount to waiver of procedural rights.
• Courts will not reward dilatory tactics, especially in proceedings bound by judicially imposed timelines.
• The principle of natural justice must not be weaponized to obstruct timely adjudication.

Key Takeaways:

• Timing is crucial: Rights not timely exercised may be deemed waived.
• Section 79 does not guarantee cross-examination—Controller discretion is key.
• Judicial scrutiny of litigation conduct is intensifying in patent cases.
• This case reinforces that expeditious opposition proceedings are paramount and must not be derailed by tactical manoeuvres.

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Strengthening Patent Protection for AYUSH: New Examination Guidelines Released

On the occasion of National Ayurveda Day (September 23, 2025), the Office of the Controller General of Patents, Designs, and Trade Marks (CGPDTM) issued the Guidelines for the Examination of AYUSH-Related Inventions, marking a pivotal shift in the treatment of intellectual property rights in the traditional medicine sector.

The guidelines aim to provide greater clarity for applicants working in diverse areas of the AYUSH systems, such as patent claims relating to herbal formulations for diabetes, automated devices for Panchakarma therapy, homoeopathic compositions for immune modulation, or yoga-based diagnostic wearables. By aligning examination standards with the Patents Act, 1970, the Patents Rules, 2003, and the Biological Diversity Act, 2002, the CGPDTM seeks to bridge traditional knowledge systems with modern IP frameworks.

This move is expected to aid research institutions, start-ups in the wellness sector, pharmaceutical companies, and device innovators in understanding what qualifies as patentable subject matter,  particularly in areas where innovation intersects with long-standing traditional practices.

Key Takeaways for Applicants and Stakeholders

Applicable Legal Provisions

• Section 3 of the Patents Act remains central in evaluating AYUSH-related claims. Notably, the following are excluded from patentability:
• Discoveries of natural substances
• Mere admixtures without demonstrated synergy
• Traditional knowledge and formulations
• Known device combinations lacking novelty
• Therapeutic and diagnostic methods
• Biological Diversity Act, 2002:
• Section 6 mandates prior approval from the National Biodiversity Authority (NBA) when biological resources are involved.
• Non-compliance with disclosure requirements (source and geographical origin) can lead to refusal, pre-grant/post-grant opposition, or revocation under the Patents Act.

Filing and Examination Process

• Eligible applicants include inventors, their assignees, and legal representatives.
• Applications may be filed online or through physical offices in Delhi, Mumbai, Chennai, or Kolkata.

During examination, patent claims are assessed for:

• Novelty
• Inventive Step
• Industrial Applicability

Prior Art, including from TKDL and other authoritative databases (e.g., AYUSH Research Portal, e-Charak, Medicinal Plants Database).

“Substantive Guidelines for Patentability” to assist both applicants and examiners, the CGPDTM has outlined key principles with practical illustrations. These include:

• Plant Extracts and Isolates: Known extracts are not patentable unless the process yields improved results (e.g., higher purity or yield).
• Ingredient Combinations: Combinations of known ingredients used traditionally for the same indication are presumed obvious unless:
• A novel ratio is claimed, or a synergistic effect is demonstrated with experimental data.
• New Use of Known Ingredients: Repurposing known substances in new combinations for the same ailment lacks inventiveness unless an unexpected result is established.
• Optimization of Dosages or Ranges: Adjusting known quantities is typically not patentable unless such modification leads to a technical advantage.
• Use of Individual Components from Known Formulations: Isolating a known ingredient from a traditional formulation does not suffice unless novel effects are substantiated.
• Devices and Instruments for AYUSH Procedures: Devices used in traditional treatments may be patentable if they incorporate technical advancements or automation (e.g., a sensor-based Vamana Karma device).

Synergy and Section 3(e): Patent claims involving multiple known ingredients must provide experimental proof of synergism. The effect must exceed the sum of individual contributions to qualify for patent protection. Mere additive benefits are insufficient.

Practical Guidance for Applicants: To enhance the chances of securing patent protection for AYUSH-related innovations, the following is recommended:

• Conducting prior art searches using the TKDL and other sector-specific databases.
• Avoiding broad or traditional claims that are likely to be rejected under Section 3.
• Focusing on novel processes, dosage innovations, or formulations with clear, non-obvious benefits.
• Generating robust experimental data to support claims of synergy or unexpected effects.
• Ensuring compliance with NBA approvals and full disclosure of biological material sources and origins.

Why This Matters?

The release of these guidelines is a welcome move for innovators, start-ups, academic institutions, and companies in the AYUSH domain. It helps demystify the patent examination process for this sector and supports the ethical commercialization of India’s traditional knowledge systems while preventing misappropriation.

This framework also brings India’s IP practices more in line with global expectations around biocultural knowledge protection and evidence-based innovation.

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Delhi High Court Dismisses Ultrahuman’s Patent Infringement Suit Against Oura Ring

Case: Ultrahuman Healthcare Pvt Ltd vs Oura Health Oy & Anr on 1 September 2025 (Delhi High Court)

The Patents Act: Sections 2(l);

Commercial Courts Act, 2015: Section 12A;

CPC: Sections 151, Order VI Rule 15A, Order XI Rule 1(1)

In the present matter, the Plaintiff, Ultrahuman, an Indian startup, filed a patent infringement suit against Oura Health Oy and its U.S.-based subsidiary, Oura ring Inc. (collectively, the “Defendants”). The Plaintiff alleged that the Defendants infringed Indian Patent No. IN 549915, which was granted on 10.09.2024, covering an electronic ring equipped with sensors for monitoring health and fitness parameters. The alleged infringement arose from the sale of the Oura Ring 4 product in India. Accordingly, the Plaintiff sought a permanent injunction restraining the Defendants from infringing the said patent.

Plaintiff’s Allegation:

The Plaintiff contended that the Defendants’ sale of the Oura Ring 4 in India constituted an act of patent infringement and sought to enforce its rights under the Indian patent regime. It was asserted that the Defendants had launched the product in the United States in October 2024 and had subsequently introduced it into the Indian market through various e-commerce platforms.

Defendants’ Submission:

The Defendants submitted that the Plaintiff had wilfully suppressed material orders issued by the United States International Trade Commission (“ITC”) in Investigation No. 337-TA-1398. The orders dated 18.04.2025 (preliminary exclusion) and 21.08.2025 (final ruling) found that the Plaintiff’s products infringed the Defendants’ US patents (US 11,868,178 B2 and US 2020/0089272 A1). The Defendants contended that these orders were directly relevant to the dispute in India and that the Plaintiff’s failure to disclose them constituted a material non-disclosure.

Court Analysis and Findings:

The Court observed that a commercial suit requires full disclosure of all material facts. The Plaintiff’s omission of the ITC orders deprived the Court of relevant information regarding the competing claims of the parties. The Court noted that the orders were “germane” to the dispute, as they addressed the same technology and involved the same parties.

The Court further noted that the Plaintiff exhibited no contrition for the non-filing of the ITC orders and that this failure was deliberate. It emphasized that wilful suppression of material facts under the pretext of subjective relevance is unacceptable in commercial litigation. References were made to settled precedents highlighting the importance of disclosure, including S.P. Chengalvaraya Naidu v. Jagannath and related judgments.

Conclusion:
The Court dismissed the Plaintiff’s suit at the threshold for non-disclosure of material ITC orders. However, the Court granted the Plaintiff liberty to file a fresh suit after making full disclosure of the suppressed orders and any other relevant information, including an explanation of why the findings in the ITC orders do not affect the claims in the new proceedings. Pending applications, if any, were disposed of.

Observations:
The judgment reinforces the principle that non-disclosure of material foreign proceedings, especially those involving the same parties and technology, may result in dismissal of a suit irrespective of its substantive merits. The Court emphasized that procedural compliance and transparency are integral to the administration of justice in patent litigation.

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Pharmacyclics LLC v. Deputy Controller of Patents & Designs: Calcutta High Court Allows Divisional Patent Application

Case: Pharmacyclics Llc vs Deputy Controller Of Patents & Designs on 2 September 2025 (Calcutta High Court)

The Patents Act, 1970 (as amended): Section 16

Overview:
This case concerns an appeal filed by Pharmacyclics LLC against the refusal of its divisional patent application (201838043708) derived from the parent application 3985/KOLNP/2012. The parent application related to a compound for treating relapsed or refractory non-Hodgkin’s lymphoma, while the divisional application sought protection for a combination therapy involving Ibrutinib and anti-CD20 antibodies (Rituximab/Ofatumumab). The Deputy Controller of Patents had refused the divisional application, asserting that the amendments made in the divisional claims constituted a voluntary change and were not adequately justified.

Appellant’s Submission:

Pharmacyclics argued that the divisional application was fully supported by the parent specification and involved a combination of two active ingredients, Ibrutinib and an anti-CD20 antibody, demonstrating unexpected technical synergy. The appellant highlighted that no objections regarding the maintainability or claim amendments were raised in the First Examination Report (FER), which had acknowledged that the divisional claims were supported by the parent application.

Respondent’s Position:

The Deputy Controller maintained that the divisional application represented a voluntary amendment beyond the scope of the parent application and that reasons for the amendments should have been provided. The refusal relied on the distinction between the originally filed parent claims and the claims presented in the divisional application.

Court Analysis:

The Calcutta High Court examined Section 16 of the Patents Act, 1970, which governs divisional applications. The Court emphasized that a divisional application must be supported by the complete specification of the parent application and should not include matter beyond what is disclosed in the parent specification. The Court clarified that there is no requirement for the claims of a divisional application to strictly mirror the claims of the parent application; it is sufficient if they are supported by the disclosure in the parent specification.

Observation & Findings:

The Court noted that the parent application disclosed a plurality of inventions, including both the compound and its possible combinations. The divisional application claimed a combination of two active ingredients, which were disclosed in the parent specification. No voluntary amendment had been filed in the divisional application itself, and the FER had recognized the divisional application’s maintainability.

Ruling:
Relying on precedents including Syngenta, Gensquare LLC, and Victaulic Company, the Court set aside the refusal order dated March 5, 2024. It directed that the divisional application be reconsidered afresh by another officer, with an opportunity for a hearing provided to the applicant.

Conclusion:

It is clear from the analysis & ruling that divisional applications play a crucial role in protecting distinct inventions disclosed in a parent specification while ensuring compliance with patent law. Such applications are permissible as long as their claims are supported by the parent specification, even if they differ from the original claims of the parent application. Amendments made in the parent application, provided they are not objected to by the Patent Office, can serve as a valid basis for subsequent divisional claims. Furthermore, once the Patent Office recognizes the maintainability of a divisional application in the First Examination Report (FER), the examination of the divisional application should proceed independently of the parent application, without being influenced by the outcome of the parent application.

This ruling reinforces the principle that divisional applications can protect distinct inventions disclosed in a parent specification, supporting innovation while providing clarity on claim support under Section 16 of the Patents Act, 1970.