Array Biopharma Inc v. Deputy Controller of Patents and Designs

Relevant Acts and provisions

Patents Act, 1970

Section 10(4)Section 2(1)(ja)Section 3(d)Section 3(i)

Provisions considered: Sections 2(1)(ja), 3(d), 3(i) and 10(4) of the Patents Act, 1970 (as amended).

Brief facts

The Appellant applied for a patent for a pharmaceutical combination consisting of (a) Encorafenib (a B-Raf inhibitor), (b) Cetuximab or Erlotinib (EGFR inhibitors), and optionally (c) Alpelisib (a PI3K-alpha inhibitor). Data from Phase Ib and Phase II clinical trials was provided showing that the combination was significantly better at stopping tumour growth than the drugs used alone. The Controller rejected the application on three grounds: that it was a non-patentable method of treatment under Section 3(i); that it was a mere derivative of known substances under Section 3(d); and that it was obvious over four earlier patents (D1 to D4).

Issues before the Court

1. Is the claimed combination a known process or a derivative excluded under Section 3(d)?
2. Does the claim for a pharmaceutical combination amount to a prohibited method of treatment under Section 3(i)?
3. Does the invention involve an inventive step considering the prior art documents D1 to D4?

Court's findings

The Court observed that Section 3(i) rejections must focus on the pith and marrow of the claim; if the invention is a physical combination of drugs it is a patentable product, and the Controller cannot reject a product merely because the instructions explain the dosing schedule. The application did not claim a process, protocol, dosing schedule or treatment regimen, and Section 3(i) bars only a process, not a product or combination.

On obviousness, the Court noted the prior art D1 to D4 was insufficient: while D1 mentioned certain inhibitors, it did not specify the exact PI3K-alpha inhibitor used in the Appellant's invention. To reject a patent as obvious the Patent Office must show that the exact combination of the specific chemicals was already suggested, rather than just general classes of drugs.

The Court emphasised technical advancement, observing that clinical trial data showing a reduction in tumour progression is strong evidence of an inventive step that the Patent Office is legally required to consider.

On Section 3(d), the Court observed that the provision is inapplicable to combinations of two separate active drugs, as such combinations cannot be treated as derivatives of each other; and that where the Controller fails to identify a specific known substance in the cited prior art and the objection under Section 2(1)(ja) is unsustainable, a rejection under Section 3(d) cannot be legally sustained.

Decision

The Delhi High Court remanded the patent application back to the Controller for de novo consideration.

Keywords

Inventive Step Method of Treatment Pharmaceutical Combination Prior Art Section 3(d) Section 3(i) Synergistic Interaction