STRATJURIS NEWSLETTER APR- 2025

Delhi High Court Ruling Strengthens Patent Enforcement: Philips Wins Long-Standing SEP Dispute Over DVD Technology, With Severe Damages for Infringers

Section 8 and Section 48

In a significant ruling about standard essential patents (SEP), the Delhi High Court passed a judgment on a long-standing dispute between Phillips and three defendants, including Pearl Industries, Siddharth Optical, and Power Cube Infotech, regarding an alleged infringement of Phillips’ patent related to DVD player technology. The Patent titled “Method of Converting Information Words to a Modulated Signal” covered EFM+ technology, which facilitates efficient data encoding by converting 8-bit information words into 16-bit code for improved transmission. The case was originally filed in 2012 and concluded after 13 years.

The defendants had contended that they outsourced the replication process from a third party, which does not lead to direct infringement. Defendants had also challenged the patent’s validity on multiple grounds, such as lack of novelty, exclusion under Sections 3(k) and 3(m) of the Patents Act, 1970 (as amended), and non-disclosure of foreign patent applications under Section 8. However, defendants’ arguments were deemed inconsistent, leading to undermining their defence.

Analysis:

The Court observed that Philips has established its patent rights, whereas the defendants failed to take the necessary licences. Further, the defendants failed to provide adequate information regarding the scale of their infringing activities, leading the court to rely on third-party data, which includes submissions from Moser Baer and records from the Registrar of Companies. The court also found that the defendants deliberately prolonged proceedings to avoid liability. The court determined that damages should be calculated based on the number of DVDs replicated by the defendants and the samples sold by them. Further, Philips also made diligent and repeated efforts to offer the defendants a licence under FRAND terms. However, the defendants, despite having been notified, neither secured a licence nor discontinued their replication activities, which made them appear as wilful infringers. Further, a 12% interest rate was imposed on the damages, addressing the financial loss suffered by Philips due to the prolonged litigation, and the court further imposed INR 1 Crore as punitive damages, citing the defendants’ deliberate withholding of material information and wilful infringement of Philips’ patent.

Conclusion:

The Court ruled in favour of Philips, supporting India’s stance on SEP enforcement while also addressing procedural lapses in the patent filing process. The decision given by the court acknowledged Philips’ failure to disclose foreign patent applications under section 8, but treated it as a clerical error. The Court rejected the defendants’ invalidity claims and ruled that any replicated DVD, regardless of who performs the protected process, falls under the patented claims, making the defendants liable for infringement. The ruling aligns with previous Indian judgments on SEP disputes and further strengthens the role of the judiciary in balancing patent rights with fair litigation practices.

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Patent Office Unveils Draft Guidelines for Examining Computer-Related Inventions (CRI) 2025: Key Updates

On March 25 2025, the Patent Office published the Draft Guidelines for the Examination of Computer-Related Inventions (CRI), 2025, inviting stakeholders and the public to submit comments and suggestions by April 15, 2025.

Note: The proposed CRI guidelines encompass inventions that utilize computers, computer networks, or other programmable apparatus and techniques, including those wherein one or more features are realized, either partially or wholly, through computer hardware or software.

Key Highlights:

• Terms/ Definitions:
• The scope of “Algorithm” and “per se” term is expanded.
• New definitions of terms “Hardware” and “Firmware” are added.
• A new Term “Secure System” (with its Definition) has been added.

 

• Legal Provisions and recent jurisprudence relating to CRIs:
• The Joint Parliament Committee’s views regarding the suffix “per se” to computer programme in section 3(k) while examining the Patents (Amendments) Bill, 2002, has been added.
• The “Recent Jurisprudence” related to CRI has been added.

 

• Examination Procedure Related to CRI Applications:
• The 7 steps of “Novelty” have been added.
• The recent case study is also added based on the 5-step analysis approach of “Inventive Step”.
• The scope of “Sufficiency of Disclosure” is elaborated.
• The scope of the terms “Claims directed as ‘Mathematical Method’, ‘Business Method’, ‘Algorithm’ & ‘Computer Programme per se’ is expanded.
• Examples have been added to illustrate the patentable/non-patentable CRI claims.

Provided below is a concise summary of the Draft (Amendment) of CRI guidelines:

Section	Terms	Amendments
Terms/ Definitions	Algorithm	The definition of the term “Algorithm” has been referred from the High court case.
	Per Se	The definition of the term “Per Se” has been referred from the High court case.
	Hardware	The new definition of the term “Hardware” is added from the dictionary.
	Firmware	The new definition of the term “Firmware” is added from the dictionary.
	Secure System	The term “Secure system” is newly introduced, which is defined in the Information Technology Act, 2000 (No. 21 of 2000).
Legal Provisions and recent jurisprudence relating to CRIs	The Joint Parliament Committee expressed the views regarding suffix “per se” to computer programme in section 3(k) while examining Patents (Amendments) Bill, 2002, which were added to the CRI guidelines.	The guidelines highlights the views of the Joint Parliament Committee (JPC) on the insertion of suffix “per se” in the then proposed new clause (k). The clause (k) has been proposed to clarify that the computer program may include certain other things, ancillary thereto or developed thereon. The intention of the JPC here was not to reject such computer programmes for grant of patent if they are inventions. However, the computer programmes as such are not intended to be granted patent.
	Recent Jurisprudence	The guidelines highlights/summarizes the findings/observations of different high courts in various cases pertaining to different “computer related inventions” emphasizing that – If the invention has a “technical effect and a technical enhancement” that is patentable.
Examination Procedure Related to CRI Applications	Novelty	The 7 steps of “Novelty” has been added.
	Inventive Step	“The recent case study is also added based on 5-step analysis approach for assessment of “Inventive Step”.
	Sufficiency of Disclosure	“The requirement for “sufficiency of disclosure” under the Act is established in Section 10 of the Act, under the section titled “Content of Specification”.
		The guidelines highlights the requirements of sufficiency of disclosure under the act by emphasizing that the disclosure of the CRI should not only specify “what” the invention is about but also “how” to perform the invention. The guidelines also prescribes incorporation of the best method followed to describe the invention fully and particularly in a great clear manner.
	Claims	“Mathematical Method”: The new case has been added to this section to clarify the aspect of mathematical method.
		“Business Method”: The new case has been added to this section to clarify the aspect of Business method
		“Algorithm”: The new case has been added to this section to clarify the aspect of Algorithm.
		“Computer Programme per se”: The new case has been added to this section to clarify the aspect of Computer Programme per se.   The term “Technical Effect/ Technical Contribution” is also added to state what is the technical effect.
Examples	Patentable Claims	Illustrative examples of both patentable CRI claims and non-patentable CRI claims have been added.

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Arcturus Therapeutics Inc v. Assistant Controller: Delhi High Court Sets Aside Patent Rejection Due to Procedural Delay

Section 117A, Rule 138

The present appeal was filed under Section 117A of the Patents Act, 1970, challenging the order dated 25^th July 2023, by which the Assistant Controller of Patents refused Indian Patent Application No. 201617019205, titled “Ionizable Cationic Lipid for RNA Delivery.” The patent application was a national phase entry in India under the Patent Cooperation Treaty (PCT), filed on 2^nd June 2016. A First Examination Report (FER) was issued on 15th February 2019. The appellant responded to the FER on 13^th August 2019. The first hearing was conducted on 29^th March 2022, followed by the filing of written submissions on 13^th May 2022. A second hearing was held on 2^nd May 2023. After this hearing, the appellant sought an extension under Rule 138 for submitting additional written submissions. The extension was granted until 17^th June 2023, but the appellant could only file the written submissions on 25^th July 2023, by which time the rejection order had already been issued.

The appellant argued that the rejection was based purely on procedural grounds without an evaluation of the merits of the invention – that the additional written submissions and comparative data were not filed within the prescribed period. The appellant contended that the delay occurred due to the time-consuming nature of conducting empirical studies to generate the required comparative data. The rejection order, however, did not analyse the technical merits of the invention, nor did it consider the responses previously submitted by the appellant, including the FER reply, prior written submissions, or oral arguments made during the hearings.

Analysis:

The Court observed that the rejection order failed to assess the substantive merits of the invention. It emphasized that patent rights are valuable intellectual property assets, and their rejection solely on procedural grounds could have serious consequences for the applicant. The Court held that procedural delays should not outweigh the necessity of a reasoned decision on the merits of a patent application. Even if the appellant failed to file the additional written submissions within the prescribed period, the Assistant Controller was obligated to issue a reasoned order addressing the merits of the case. The Court stressed that the principles of natural justice require that the claims of the appellant be examined on their substantive merits rather than being dismissed on a procedural technicality.

In conclusion, the Court emphasized the importance of a reasoned rejection order, which must clearly outline the statutory basis, prior art references, and the rationale for the decision, ensuring adherence to the principles of natural justice. Following multiple previous orders requiring the Controller to issue reasoned decisions, the Court set aside the impugned order and remanded the matter to the Assistant Controller of Patents for reconsideration on its merits – i.e., to be made based on the existing record, including the additional submissions filed by the appellant. The Court also directed that a fresh hearing notice be issued to the appellant and instructed that the matter be decided within three months.

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Milliken And Company v. Controller of Patents and Designs & Anr.: A Victory for Fair Consideration and Due Process

Section 117(A), Rule 28(7)

The Delhi High Court reviewed an appeal filed by Milliken and Company under Section 117(A) of the Patents Act, 1970, challenging the refusal of its Indian patent application no. 6093/DELNP/2013. The appellant sought to quash the impugned order dated 17^th February 2023, passed by the Assistant Controller of Patents and Designs, by arguing that the Assistant Controller failed to consider the expert testimony (statement) of Dr. Nathan A Mehl, which was filed along with the post-hearing written submissions. The appellant contended that this statement addressed objections related to inventive step and sufficiency of disclosure, and its non-consideration led to an inaccurate rejection.

The respondent, Controller of Patents and Designs, countered that the statement of Dr. Nathan A Mehl was filed years after the initial application and was not relevant to the inventive step objection. The respondent also argued that since Dr. Nathan A Mehl was an employee of the appellant, he could not be treated as an independent expert. Additionally, reliance was placed on a European Patent Office (EPO) decision, which had rejected the same statement in a related case.

Analysis:

The Court held that the appellant filed the statement of Dr. Nathan A Mehl within the prescribed time under Rule 28(7) of the Patent Rules, 2003, and its submission was not belated. The employment of Dr. Nathan A Mehl by the appellant did not automatically disqualify his statement from consideration, as the company’s involvement in chemical product development meant it was likely to employ technical experts. The Court also observed that patent decisions in other jurisdictions, including the EPO’s rejection of the statement, were not binding on the Indian Patent Office. The Assistant Controller, therefore, should have considered the statement independently before making a decision.

In conclusion, emphasizing the principles of natural justice and proper due process, the Delhi High Court remanded the case to the Assistant Controller for a fresh evaluation, instructing that Dr. Nathan A. Mehl’s statement be assessed on its merits. The appellant was granted a new hearing, and the Court directed the issuance of a reasoned order thereafter. The appeal was disposed of in these terms.

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Delhi HC Asks Natco Pharma to Halt Risdiplam Launch Amid Patent Dispute

In a significant development, a division bench of the Delhi High Court directed Natco Pharma to pause the launch of its drug Risdiplam until the next hearing, amid an ongoing patent dispute with Swiss pharmaceutical company F. Hoffmann-La Roche AG (Roche).

Roche had appealed against a single judge’s order passed on March 24, which had refused to stop Natco Pharma from producing a generic version of Risdiplam.

Risdiplam is an oral medication used to treat spinal muscular atrophy (SMA) in patients aged two months and older. SMA is a rare, progressive genetic disease that affects motor neurons in the spinal cord, leading to muscle weakness and atrophy.

Roche holds a registered patent for Risdiplam, the active ingredient in its commercial product, Evrysdi, which is marketed globally. Roche sought an injunction to prevent Natco Pharma from manufacturing a generic version of Risdiplam, claiming this would infringe upon its patent, set to expire in May 2035.

However, the single judge bench of Justice Mini Pushkarna had rejected Roche’s request on March 24, stating that the public interest outweighed the need for an injunction.

The verdict had significant implications for the treatment of SMA in India. With the approval for Natco Pharma to produce a generic version of Risdiplam, the annual treatment cost for SMA was expected to decrease drastically, from Rs 22 lakh – Rs 72 lakh, to just Rs 3,000 annually. This was seen as a major relief for patients in India.

Justice Mini Pushkarna emphasized the importance of public interest in such matters, stating, “A drug which is the only one available for treatment in India, for a rare disease, its availability to the public at large at very economical and competitive prices, is a material factor which a Court will consider at the time of dealing with an application for interim injunction.”

Following this, Roche appealed the decision, leading the division bench of the Delhi High Court to instruct Natco to maintain the status quo and delay the drug’s launch until the next hearing on April 2. This temporary pause allows the court to further examine the patent dispute and balance the interests of patent protection with the need for accessible treatment options for SMA patients in India, emphasizing the importance of ensuring both innovation incentives and equitable access to life-saving therapies.

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Is a claimed invention related to diagnosis but does not per se disclose pathology disqualified under Section 3(i) of the Indian Patents Act?

Section 3(i), Section 117A

In a recent judgment dated Feb 13, 2025, the Hon. High Court, while hearing an appeal under Section 117A of the Patents Act, 1970 (as amended), set aside an impugned order that the Assistant Controller of Patents had passed, citing denial of a reasonable opportunity for the appellant to establish that the claimed invention was not a diagnostic method under Section 3(i) of the Act.

Shimadzu Corporation, the appellant in this case, had filed a patent application for an invention titled ‘Surrogate Biomarker for Evaluating Intracerebral Amyloid β Peptide Accumulation and Method for Analysis Thereof’. The Assistant Controller rejected the application on the ground that the invention was disqualified under Section 3(i) as a diagnostic method.

The appellant contended that they were denied an opportunity to demonstrate that the claimed invention did not per se disclose pathology and, therefore, should not be disqualified under Section 3(i). They relied on a prior judgment of the same Court in Somalogic Operating Company INC. v. The Assistant Controller of Patents and Designs, CMA(PT)/25/2024, which clarified that ‘an invention qualifies as diagnostic only if it explicitly discloses pathology. If an invention merely relates to diagnosis, it would not fall under Section 3(i).’

The Hon. High Court considered these submissions and held that the appellant was deprived of the opportunity to present their case against the Section 3(i) rejection. It ruled that, similar to the Somalogic case, the appellant should be given a fair chance to establish that their invention did not fall under the exclusionary provision of Section 3(i). Consequently, the Court quashed the impugned order and remanded the matter for fresh consideration under the following terms:

1. To avoid the possibility of pre-determination, the re-evaluation shall be conducted by a different officer than the one who issued the impugned order.
2. The appellant shall be granted a reasonable opportunity, including a personal hearing, before a fresh order is issued.
3. The reconsideration process must be completed, and a new order issued within four months from the date of receipt of this judgment.
4. The Court clarified that it was not expressing any opinion on the merits of the patent application.

In response, the Ld. Controller, argued that the claimed invention relates to diagnosing diseases such as Alzheimer’s and explicitly discloses pathology, qualifying as a diagnostic method under Section 3(i). However, the Hon. High Court ruled that a fresh review was necessary to ensure due process and adherence to the principles of natural justice; thereby focusing on ensuring a fair and impartial reconsideration process in patent evaluation.

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Clarifying Patent Boundaries: The Delhi High Court’s Stance on Disclosure and Scope in Biotechnology Inventions

Sections 10(4), 10(5) & 3(c)

The Delhi High Court recently upheld the Controller’s decision to refuse the patent application IN201717005699 by The Regents of the University of California for a vaccine targeting livestock production systems. The application, filed on 17 February 2017, related to a recombinant Salmonella microorganism intended for use as a vaccine. The Controller had refused the application on two grounds: (1) the claims lacked sufficient disclosure under Sections 10(4) and 10(5) of the Patents Act, 1970, and (2) the claims amounted to the discovery of a living organism under Section 3(c) of the Patents Act, excluding them from patentability.

Legal Context:

• Section 3(c): Excludes from patentability the discovery of living organisms or substances occurring in nature.
• Section 10(4): Requires a complete specification to provide a full description of the invention and disclose the best method of performing it.
• Section 10(5): Mandates that patent claims must be clear, succinct, and based on the matter disclosed in the specification.

Court Analysis and Decision:

• Section 3(c) – Non-Patentability: The Court found that a comprehensive reading of both the claims and the detailed description in the complete specification revealed a broader interpretation. The Court pointed out that the patent application described not just deliberate genetic modifications, but also encompassed a variety of loss-of-function mutations in selected genes of Salmonella microorganisms. The specification further clarified that these mutations did not necessarily need to be artificially induced; it was enough for the gene’s native product to be functionally disrupted in any way.

This broader scope of mutation, which could include naturally occurring gene disruptions, significantly expanded the range of microorganisms covered by the application. The Court emphasized that such a broad scope posed a risk of including naturally mutated Salmonella microorganisms, which are excluded from patentability under Section 3(c) of the Patents Act. Section 3(c) specifically excludes from patentability the discovery of naturally occurring substances, and the Court stressed that it was imperative to ensure that the claims did not inadvertently cover such subject matter.

Thus, the Court underlined the necessity of clear, precise, and sufficient disclosure in the patent application. It was crucial for the applicant to properly define the scope of the invention to avoid including naturally occurring genetic mutations, which would render the claims invalid under the Act. In this case, the Court held that the applicant’s lack of clarity in defining the precise scope of the claimed invention, particularly the types of mutations covered, made the application non-compliant with patentability requirements.

• Sections 10(4) and 10(5) – Disclosure Deficiencies: The Court found that the specification did not adequately disclose the details required to enable a skilled person to perform the invention. The claims, which referred to several possible genetic mutations, lacked the necessary specificity and clarity. The Court emphasized that claims should not cover permutations of mutations without providing sufficient experimental or descriptive data. Additionally, it was noted that the specification should disclose the best method for performing the invention, which was not adequately supported by the information provided.
• Requirement for Material Deposit: The Court also ruled that, since the recombinant Salmonella microorganisms were not publicly available, they must be deposited with an international depository authority under the Budapest Treaty, further highlighting the importance of full transparency in patent filings.

The Delhi High Court’s decision underscores the importance of clear and precise disclosure in patent applications, particularly for biotechnological inventions. Despite similar applications being granted in the US and Europe, the Court upheld the refusal on the grounds of insufficient disclosure and non-patentability under Section 3(c). The ruling highlights the challenges patent applicants face when dealing with complex biotechnological claims and emphasizes the need for thorough documentation and precise claim definitions to meet the stringent requirements under Indian patent law.