Sanchayita Lahkar

The High Court at Calcutta (Intellectual Property Rights Division), Single Bench of Justice Ravi Krishan Kapur, set aside an earlier rejection of a patent application concerning a pharmaceutical compound and directed the Controller of Patents and Designs to reconsider the matter afresh. The court noted procedural lapses, non-consideration of vital technical data, and failure to apply settled legal principles while rejecting the patent application initially.

The appeal was filed against an order dated 12 April 2023 passed by the Deputy Controller of Patents & Designs, which rejected Patent Application No. 3939/KOLNP/2010 under Sections 2(1)(ja), 3(d), and 10(4) of the Patents Act, 1970. The patent application, filed by Takeda Pharmaceutical Co. Ltd. on 21 October 2010, claimed priority from PCT/US/2009/044918 dated 21 May 2009. The invention related to a novel class of protein kinase inhibitors, specifically targeting ALK (Anaplastic Lymphoma Kinase) while avoiding inhibition of Insulin Receptor (Ins-R).

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The compound claimed, Brigatinib, was designed for higher selectivity towards ALK to minimize side effects associated with non-selective kinase inhibition. The applicant had submitted data indicating Brigatinib's superior IC50 values for ALK versus Ins-R, pointing to increased therapeutic efficacy and reduced adverse effects. The compound’s selectivity was argued to be a crucial technical advancement.

During the patent prosecution, the claims were narrowed from a Markush structure to a single compound, Brigatinib. Despite this, the Deputy Controller rejected the application, holding that the compound lacked inventive steps and sufficient disclosure. The impugned order relied on multiple prior art references, including Zhao et al. and Schneider et al., concluding that the substitution of a sulfonyl group with a phosphoryl group was obvious.

The appellant argued that the order ignored significant technical evidence and post-hearing data submissions that demonstrated enhanced selectivity and therapeutic efficacy. Moreover, two pre-grant oppositions had been filed by Cancer Patients Aid Association and Ms. Mita Sheikh under various clauses including lack of novelty and inventive step.

The appellant contended that despite several affidavits and written submissions filed during the hearing process, the Deputy Controller failed to apply principles for assessing inventive step as established by precedents such as F. Hoffmann-La Roche Ltd. v. Cipla Ltd. and Avery Dennison Corporation v. Controller of Patents and Designs.

It was also contended that the findings of insufficiency under Section 10(4) were raised only later during prosecution and were not part of the original FER. The appellant submitted that the structure and process for Brigatinib had been disclosed adequately, and absence of clinical efficacy data at the time of filing should not vitiate the patent application.

Additionally, the appellant pointed out that Brigatinib had received US FDA approval and was registered in over 50 countries, supported by peer-reviewed journal publications and expert affidavits, all of which were not considered in the impugned order.

Justice Ravi Krishan Kapur recorded that "the impugned order has been passed without any application of mind and is based on mere assumptions and an incorrect understanding of the invention as well as the prior arts." The Court observed that "the respondent no.2 has failed to apply the settled principles for assessment of inventive steps and erred in appreciating the true scope of the invention."

Regarding inventive step, the Court quoted the decision in Avery Dennison Corporation v. Controller of Patents and Designs:

"In order to decide this issue, some of the fundamental principles for determining the existence of an inventive step and the lack of obviousness need to be stressed... This includes the 'obvious to try' approach, 'problem/solution' approach, 'could-would' approach, and the Teaching Suggestion Motivation (TSM) test."

It was stated that "mere structural similarity between compounds of the prior arts and the claimed invention does not make the entire invention obvious." The court further noted that even a single functional group change can significantly alter pharmacological properties and observed that "the difference of one functional group can drastically alter the properties of a compound."

On sufficiency of disclosure, the court held: "In a claim relating to a novel compound, the requirement of sufficiency of disclosure is satisfied if the structure of compound and the method for the preparation of said compound is disclosed, as it enables a person skilled in the art to perform the invention."

It was observed that "Section 10(4) of the Act does not require to demonstrate any kind of data or efficacy which is not part of the claim." The judgment recorded that the Deputy Controller had failed to apply this principle while evaluating the sufficiency of disclosure.

The court further recorded: "The respondent no. 2 had also ignored nor dealt with the data which would demonstrate the technical advancement and significant industrial acclaims attained by Brigatinib." It was also stated that "there were no reasons discussed in rejecting the subsequent experimental data. The non-consideration is not only in violation of the provisions of the Act but also contrary to the principles of natural justice."

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The Court set aside the impugned order dated 12 April 2023 and remanded the patent application for fresh consideration.

"For the above reasons, IPDTA 119 of 2023 stands allowed. The impugned order dated 12 April 2023 is set aside. The above application for patent is remanded to the respondents for consideration afresh after giving an adequate opportunity of hearing to all the parties and upon consideration all the materials on record and the experimental data. It is made clear that all points are left open to be adjudicated upon in accordance with law. The above exercise is to be completed within three months from the date of communication of this order."

Advocates Representing the Parties

For the Appellant: Swati Mittal, Advocate, Abhirup Chakraborty, Advocate, Varun Sharma, Advocate, Manisha Singh, Advocate, S. Singh, Advocate

For the Respondents: N. L. Singhania, Advocate, Sunil Kumar Singhania, Advocate

Case Title: Takeda Pharmaceutical Co Ltd vs Controller of Patents and Designs and Ors.

Case Number: IPDPTA/119/2023

Bench: Justice Ravi Krishan Kapur

[Read/Download order]