Court directs Deputy Controller of Patents to reassess the pharmaceutical combination patent for inventive step and non-patentability concerns.
In a significant judgment, the Delhi High Court has remanded a patent application filed by Array Biopharma Inc., concerning a pharmaceutical combination comprising a B-Raf inhibitor, an EGFR inhibitor, and optionally a PI3K-α inhibitor, back to the Deputy Controller of Patents and Designs for fresh consideration. The decision was rendered by Justice Tushar Rao Gedela, emphasizing the need for a de novo evaluation due to inadequacies in the initial assessment by the Controller.
The patent application, initially refused on grounds of lacking inventive step and non-patentability under Sections 2(1)(ja), 3(d), and 3(i) of the Patents Act, 1970, is directed towards a therapeutic combination aimed at treating proliferative diseases. The High Court found deficiencies in the Controller’s reasoning, particularly in identifying prior art and articulating the technical problem solved by the claimed invention.
Justice Gedela noted that the combination of specific compounds claimed by Array Biopharma was not evidently disclosed in the cited prior arts. The Court also highlighted that the Controller's analysis failed to consider the clinical trial data demonstrating unexpected therapeutic benefits, which could indicate a technical advancement, a key element in patentability.
Furthermore, the judgment clarified that the claimed invention, a product and not a process, does not fall under the exclusion criteria of Section 3(i), which pertains to methods of treatment. The Court referenced previous judgments to substantiate that the claims should be assessed as a whole and not fragmented to classify them erroneously as methods of treatment.
The appellant, represented by Ms. Archana Shankar, argued that the combination of independent active pharmaceutical agents does not constitute derivatives of known substances, thus falling outside the scope of Section 3(d) of the Act. The Court agreed, citing the need for a clearer identification of "known compounds" in the prior art.
The Deputy Controller of Patents and Designs has been instructed to reassess the application within six months, providing a fair opportunity for the appellant to present its case. This ruling sets a precedent for thorough and reasoned evaluations in patent applications, ensuring innovation is appropriately recognized and protected within the framework of Indian patent law.
Bottom line:-
Patent Law - Pharmaceutical combination comprising specific inhibitors - Evaluation of inventive step and non-patentability under Sections 2(1)(ja), 3(d), and 3(i) of the Patents Act, 1970 - Remanded for reconsideration due to lack of specific identification and reasoning in objections.
Statutory provision(s):
Sections 2(1)(ja), 3(d), 3(i), 10(5), 10(4)(c) of the Patents Act, 1970
