In a significant ruling that underscores the importance of transparency, reasoned decision-making, and procedural fairness in patent examination, the Calcutta High Court has set aside a refusal order issued by the Patent Office in the case of Takeda Pharmaceutical Co. Ltd. v. Controller of Patents and Designs & Ors. The Court found that the Patent Office’s failure to consider crucial post-filing data demonstrating technical advancement violated the principles of natural justice and remanded the matter for fresh consideration.
Facts of the Case
Takeda Pharmaceutical Co. Ltd. (“Takeda”) filed a patent application in 2010 for a novel class of protein kinase inhibitors intended for treating cancers associated with abnormal kinase activity. The application specifically claimed Brigatinib, a compound designed to selectively inhibit Anaplastic Lymphoma Kinase (ALK) over closely related kinases, including the insulin receptor (Ins-R). This selective inhibition was critical to Brigatinib’s therapeutic efficacy, as it reduced side effects that typically arise from off-target binding to Ins-R.
During the course of prosecution, Takeda submitted experimental data demonstrating Brigatinib’s enhanced selectivity for ALK, as evidenced by reduced IC50 values (the concentration needed to inhibit 50% of kinase activity). Additionally, Takeda provided expert affidavits, comparative data with other marketed drugs, and evidence of industrial acclaim to substantiate the compound’s technical advancement and superior efficacy.
Refusal Order by the Controller
Despite the supporting data, the Controller of Patents rejected Takeda’s application on three grounds:
Lack of Inventive Step under Section 2(1)(ja)
Non-patentability under Section 3(d) of the Patents Act, which prevents the patenting of mere derivatives of known substances unless they show significant improvement in therapeutic efficacy
Insufficiency of Disclosure under Section 10(4), alleging that Takeda had not adequately described the invention.
Furthermore, the Controller contended that the application lacked any evidence of technical advancement or enhanced efficacy at the time of filing the specification.
Arguments by Takeda
They argued that the Controller had disregarded supplementary data and expert affidavits that demonstrated Brigatinib’s superior selectivity and efficacy. Takeda claimed that the inventive step analysis was flawed, arguing that the Controller had used hindsight to select prior art compounds and had wrongly assumed that a minor structural modification (the sulfonyl-phosphoryl substitution) would not have a significant effect on the compound’s performance.
Takeda further pointed out that the Controller had failed to consider the post-filing data submitted during prosecution, which demonstrated Brigatinib’s enhanced selectivity for ALK over Ins-R, reducing off-target effects and improving the drug’s therapeutic profile. According to Takeda, the hasty rejection failed to account for the complexity and novelty of their invention.
Court’s Findings
The Calcutta High Court sided with Takeda, finding that the Controller’s refusal was unreasoned and erroneous. In its judgment, the Court emphasized that the inventive step must be assessed in the context of the entire invention, and prior art should not be merely compared to isolated features of the invention. The Court specifically noted that the mere presence of structurally similar elements in the prior art does not make an invention obvious. The invention must be evaluated as a whole, considering its technical merits and novel contributions.
The Court also found that the Controller had misinterpreted the concept of bioisosterism and failed to consider that Brigatinib’s modification—substituting a sulfonyl group with a phosphoryl group—was not obvious in the context of the prior art. It emphasized that there was no teaching in the prior art to modify the structure of TAE684 in the way required to produce Brigatinib, particularly with regard to selective inhibition between ALK and Ins-R.
Regarding the issue of technical advancement, the Court pointed out that Takeda had submitted critical data, including experimental results showing Brigatinib’s superior selectivity for ALK and reduced off-target effects. The Court noted that the Controller had improperly disregarded this data, which was directly relevant to proving therapeutic efficacy.
Key Legal Principles: Procedural Fairness and Transparency
The Court ruled that the Controller had violated the principles of natural justice by failing to adequately consider all material facts and evidence submitted by Takeda, including post-filing data. The Court emphasized that under Indian patent law, post-filing data demonstrating technical advancement is not prohibited and must be duly considered by the examining authorities.
Furthermore, the Court held that the refusal was not supported by adequate reasoning and that the Controller’s decision-making process lacked clarity and fairness. The judgment highlighted the need for a reasoned order, one that addresses all relevant factors and provides a comprehensive explanation of why certain evidence is accepted or rejected.
Conclusion
By setting aside the refusal order, the Court has provided a clear directive to the Patent Office to re-evaluate the application in light of all available evidence, including post-filing data, and to ensure that all parties are given an adequate opportunity to be heard.
The Court has also remanded the case to the Patent Office for fresh consideration, with a mandate to complete the process within three months from the date of communication of the order. This ruling not only benefits Takeda but also reinforces the importance of ensuring fairness and accountability in the patent grant process, particularly in high-stakes pharmaceutical and biotechnology patents.
Impact on Patent Law in India
This judgment is expected to have far-reaching implications for patent law practice in India, especially in complex patent cases involving pharmaceutical and biotechnology inventions. It reinforces the need for patent examiners to engage thoroughly with the evidence presented, ensuring that decisions are based on substantive and comprehensive analyses rather than superficial assessments. This decision could also encourage more transparency in the examination process, ultimately fostering an environment that supports innovation and fair competition in the Indian patent ecosystem.