Section 3(i) of the Patents Act is short, and for pharmaceutical applicants it is one of the most expensive sentences in Indian law. It excludes from patentability any process for the medicinal, curative or prophylactic treatment of human beings. Products are patentable. Treating people with them is not.

The line sounds clean until you try to draft across it.

Combination therapies are the awkward case. What is inventive about a combination is frequently not the molecules — those are known, often long known — but the fact that giving them together produces an effect neither produces alone. To claim that meaningfully, the specification has to say something about how they are given. Together. Separately. In sequence. And the moment the claim says so, an examiner can read it as describing a course of treatment.

Array BioPharma ran into exactly this, and the Delhi High Court has now told the Patent Office it read the claim wrong.

What Was Refused

The application was titled "Pharmaceutical Combination Comprising A B Raf Inhibitor, An EGFR Inhibitor And Optionally A PI3K Alpha Inhibitor" — a targeted oncology combination, of the sort that has driven a great deal of cancer drug development over the past fifteen years.

The Controller refused it. Three grounds: section 3(d), section 3(i), and want of inventive step. Array appealed under section 117A.

The section 3(i) finding is the one that matters most widely, because of how the Controller reached it. The claim referred to the components being administered simultaneously, separately or sequentially. That reference — the Controller reasoned — made the claim a method of treatment, and section 3(i) shut the door.

The Distinction the Court Drew

The Court's answer was that describing administration is not the same as claiming it.

A claim to a pharmaceutical combination remains a claim to a product. Language explaining that the components may be given at the same time, or apart, or one after another, defines the combination — it tells you what the claimed thing is and how its elements relate. It does not convert the claim into a monopoly over the act of treating a patient.

The test, in other words, is what the claim asks to own. A product claim that describes an administration regimen still asks to own the product. A method claim asks to own the doing. Section 3(i) bites on the second, and the Controller had applied it to the first.

It sounds like a fine distinction. It is not: the difference is between a granted patent and a refused application.

Remand, Not Grant

Array did not walk out with a patent. The matter went back to the Controller for de novo consideration, with a direction to dispose of the application within six months.

That is worth sitting with, because the pattern recurs across the Delhi High Court's patent appeal docket. The Court is not, in these appeals, substituting its own view on patentability. It is examining whether the Controller applied the right test and gave reasons capable of supporting the conclusion — and where the answer is no, sending the application back to be decided properly.

The applicant's gain is procedural. A refusal is set aside; the examination happens again, on the correct legal footing. But the substantive questions of inventive step and section 3(d) survive the remand and have to be met on their merits.

Six months of the Controller's time, plus the years already spent on the appeal, is the price of an examination that should have been correct the first time.

Why This Reaches Beyond Oncology

Every applicant filing a combination — pharmaceutical, agrochemical, nutraceutical, veterinary — faces the same drafting problem. The inventive contribution lives in the relationship between the components, and the relationship is hard to describe without saying something about administration or use.

Two working conclusions follow.

The first is that administration language, properly framed, is defensible. It has now been held not to convert a product claim into a method claim, and an applicant meeting a section 3(i) objection on that basis has authority to point to. The objection is answerable rather than fatal, and it should be answered at the examination stage rather than conceded through amendment.

The second is subtler and cuts the other way. A claim that survives section 3(i) still has to survive section 3(d) and the inventive step enquiry, and combinations are vulnerable on both. Winning the characterisation argument gets the claim past a threshold objection. It does not answer whether the combination shows enhanced efficacy, or whether a person skilled in the art would have arrived at it anyway.

The Takeaway

For anyone prosecuting combination claims in India, the practical shift is that a section 3(i) objection founded solely on the presence of administration language is now considerably weaker than it was. That objection has been a routine feature of examination reports, and it has driven applicants into amendments that narrowed claims unnecessarily.

The wider point concerns how these objections get handled. An adverse finding on section 3(i) is not the end of the application, but the route past it — section 117A appeal, then remand, then fresh examination — takes years and returns the applicant to where the examination should have started. Meeting the objection properly in the reply to the examination report, with the characterisation argument made squarely and on the record, is faster than establishing the same proposition on appeal.

The Court has clarified what the provision means. Whether that clarity reaches the examination stage, or only the appellate one, is the question that determines what it is actually worth to applicants.