Delhi High Court Sets Aside Refusal of Array BioPharma's Cancer Drug Combination Patent, Orders Fresh Review
Key Insights
The Delhi High Court overturned the Patent Office's rejection of Array BioPharma's patent application for a pharmaceutical combination targeting colorectal cancer (search) and other proliferative diseases.
The court ruled that the Deputy Controller's findings on lack of inventive step and non-patentability under Sections 3(d) and 3(i) of the Patents Act could not be sustained.
The court clarified that Section 3(i) bars only processes for treatment, not pharmaceutical combinations or products, and that none of the cited prior art disclosed the specific B-Raf (search)/EGFR (search)/PI3K-alpha (search) inhibitor combination.
The Delhi High Court has set aside the Patent Office's refusal of Array BioPharma Inc.'s patent application for a novel pharmaceutical combination designed to treat proliferative diseases, including colorectal cancer (search), and has remanded the matter for fresh consideration.
Justice Tushar Rao Gedela, in a detailed ruling, held that the Deputy Controller of Patents' findings on lack of inventive step and non-patentability under Sections 3(d) and 3(i) of the Patents Act could not be sustained, paving the way for a re-examination of the application.
The Invention at Issue
The patent application, titled "Pharmaceutical Combination Comprising A B Raf Inhibitor An EGFR (search) Inhibitor And Optionally A PI3K Alpha Inhibitor," claims priority from a 2012 US filing. The claimed invention covers a pharmaceutical combination comprising a B-Raf (search) inhibitor, an EGFR inhibitor, and optionally, a PI3K-alpha (search) inhibitor — a multi-targeted approach aimed at treating proliferative diseases such as colorectal cancer (search).
The Deputy Controller had refused the application on three grounds: lack of inventive step under Section 2(1)(ja), and non-patentability under Sections 3(d) and 3(i) of the Patents Act.
Court's Analysis on Inventive Step
In examining the inventive step objection, the court carefully reviewed each of the four prior art documents (D1 through D4) cited in the refusal order. The court found that none of these documents disclosed the specific combination claimed in Array BioPharma's application.
"Thus it can be safely inferred that none of the cited prior art D1 to D4 specify the combination of compound A (B-Raf (search) Inhibitor), Encorafenib, and Erlotinib/Cetuximab (EGFR (search) inhibitor)," the court observed.
The court further noted that the Deputy Controller, while invoking Section 3(d), had failed to identify the "known compound" of which the claimed invention was allegedly a derivative — a fundamental requirement for applying this provision.
Clarification on Section 3(i)
On the objection under Section 3(i), which bars patents on "any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings," the court provided important clarity. Justice Gedela observed that Claim 1 of the subject application is directed to a pharmaceutical combination and is "not framed as a process/ a protocol/ a dosing schedule, or a treatment regimen."
"It is clear that claim 1 of the subject application is not framed as a process/ a protocol/ a dosing schedule, or a treatment regimen. Therefore, the subject matter of the present invention is excluded by Section 3(i) of the Act as the said provision bars a process, not a product and a combination," the court ruled.
Directions on Remand
Setting aside the refusal order, the court directed the Deputy Controller to dispose of the application afresh within six months, after granting the appellant an opportunity of hearing. This remand ensures that Array BioPharma's application will receive a de novo evaluation consistent with the court's findings on the scope of Sections 3(d) and 3(i).
The ruling reinforces the distinction between patent claims directed to pharmaceutical products and combinations versus those directed to methods of treatment, providing important guidance for pharmaceutical patent prosecution in India.