Delhi High Court Sets Aside Refusal Of Patent For Cancer Drug Combination, Orders Fresh Review

The Delhi High Court has set aside the refusal of a US company's patent application for a pharmaceutical combination used to treat proliferative diseases, including colorectal cancer.

Holding that the Deputy Controller's findings on inventive step and patentability under Sections 3(d) and 3(i) of the Patents Act could not be sustained, the court remanded the matter for fresh consideration.

Justice Tushar Rao Gedela rejected the objection under Section 3(i), observing, "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 appeal was filed by US-based Array BioPharma Inc. against the Deputy Controller of Patents' order refusing its patent application titled "Pharmaceutical Combination Comprising A B Raf Inhibitor An EGFR Inhibitor And Optionally A PI3K Alpha Inhibitor."

The application claimed priority from a 2012 US filing and sought protection for a pharmaceutical combination comprising a B-Raf inhibitor, an EGFR inhibitor and, optionally, a PI3K-alpha inhibitor.

The Deputy Controller had refused the application on the grounds of lack of inventive step under Section 2(1)(ja) and non-patentability under Sections 3(d) and 3(i) of the Patents Act.

While considering the objection on inventive step, the court examined each of the four prior art documents relied upon in the refusal order. It found that none of them disclosed the specific combination claimed in the 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 Inhibitor), Encorafenib, and Erlotinib/Cetuximab (EGFR inhibitor)," the court observed.

The court also found that while invoking Section 3(d), the Deputy Controller had failed to identify the "known compound" of which the claimed invention was allegedly a derivative.

On the objection under Section 3(i), the court held that Claim 1 was directed to a pharmaceutical combination and not a treatment process, protocol or dosing schedule. Since Section 3(i) bars only processes for treatment and not products or pharmaceutical combinations, the provision did not apply.

Setting aside the refusal order, the court remanded the application to the Deputy Controller for fresh consideration. It directed the Controller to dispose of the application within six months after granting the appellant an opportunity of hearing.

The court clarified that the Controller "shall decide the subject patent application on its own merits without being influenced by the observations made above."