The Hindu Business Line : Indian patent law — Needed, proper definition of `inventive step'

It is indeed possible for the Patent Office to prevent "ever-greening" and patenting of worthless inventions by properly defining and interpreting the term "inventive step".

After India acceded to the World Trade Organisation, and thereby to the TRIPs (Agreement on Trade Related Intellectual Property Rights), in 1995, it was obliged to grant patents for pharmaceutical products from January 1, 2005.

India had, therefore, to amend, in 2005, the Patents Act, 1970 to provide patent protection for substances capable of being used as pharmaceutical products or drugs.

While amending its law, India limited the patentability of pharmaceutical substances to new chemical entities. Section 3(d) of the Patents Act, 1970 explains that the new form of a known substance is not different from the known substance and is, therefore, not an invention, unless there is a significant increase in efficacy.

The said Section lists various derivatives that cannot be treated as an `invention' within the definition of the term under Section 2(1)(j) of the Act. This added requirement of the `inventive step' for pharmaceutical substances is intended to prevent "ever-greening".

But, interestingly, the Act does not define the phrase `significant increase in efficacy'.

It may even be possible to define `efficacy' objectively, but `significant increase in efficacy' is something that can be judged only on a case-by-case basis, which may give rise to arbitrariness on the part of the Examiner.

Novartis case

Recently, in a pre-grant representation, the Patent Office rejected, on various grounds, an application for a patent filed by Novartis for a pharmaceutical substance that is a beta-crystalline form of imatinib mesylate, which is sold worldwide under the brand name Gleevac/Glivec.

One of the established grounds of opposition was that the beta-crystalline form of imatinib mesylate is the salt of a known substance without an increase in efficacy and, therefore, not an invention under Section 3(d).

As expected, Novartis took the Government of India and the Patent Office to court for rejecting its application under Section 3(d) of the Act (even if Novartis proves the unconstitutionality of Section 3(d), it will still not be granted a patent as at least five other grounds have been established).

In a writ petition filed before the Madras High Court, Novartis claimed that India, being a signatory to the TRIPs Agreement, has failed to meet its obligations under TRIPs by having Section 3(d) in the Act, which it feels is not authorised by the TRIPs agreement.

It has requested the Court to declare Section 3(d) null and void as going against the spirit of a binding international treaty.

Indian courts have intervened in the past in the implementation of international treaties whenever national or municipal laws affect human rights and other fundamental rights; the court's decision in a matter involving private profit is awited keenly.

Also, the duty enshrined in Article 21 of the Constitution overrides every other obligation of the state including those under international treaties to which it is a party.

Unlike other countries, the Indian patent law has not evolved through judicial interpretations; it has been mostly Patent Office interpretation of the Act.

The Patent Office's Manual of Patent Practice and Procedure interestingly cites, at many places, foreign case laws, including that of the US Court of Appeal of the Federal Circuit, the US Supreme Court and the EPO Board of Appeal, to make a point. Therefore, this case, being followed with much interest, is expected to throw light on certain key concepts of Indian patent law.

Does India need Section 3 (d)?

Why should someone who strongly feels that the subject matter of the invention has no efficacy oppose a patent on the ground that it has no efficacy? There is logically no public interest in preventing `ever-greening' of non-efficacious salts.

In any case, it is impossible for the Patent Office to ascertain `efficacy' from the patent specification. The Examiner may have to study a huge volume of clinical trial data and make comparative studies to acknowledge `efficacy', which is outside the competence of the Examiner and scope of the sufficiency requirements of the specification under Section 10(4).

Section 3(d) may not be required at all if the `inventive step' is properly defined. Section 2(1)(j) of the Act defines `invention' as a new product or process involving an inventive step and capable of industrial application.

As it stands, Section 2(1)(ja) defines `inventive step' as a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance, or both, in addition to being not obvious to a person skilled in the art.

Different Definitions

Every country has its own interpretation of `inventive step'. The European Patent Office uses a problem-solution approach, where the invention should make a technical contribution to the state of the art while in the US an invention is non-obvious (has an inventive step), if, after considering the state of the art, the invention is not obvious to a person having ordinary skill in the art, irrespective of whether the non-obviousness is technical or not.

The present definition of `inventive step' allows an applicant to prove inventive step by showing the economic significance of his/her invention. Even in the US, which has the most liberal patent regime, economic significance is one of the secondary criteria to prove inventive step or non-obviousness.

It cannot be used to show prima facie non-obviousness. It remains to be seen how the Indian Patent Office judges economic significance of an invention without having recourse to secondary evidence that need not be part of a specification.

It is indeed highly possible for the Patent Office to prevent "ever-greening" and patenting of worthless inventions by properly defining and interpreting the term "inventive step".

The TRIPs Agreement requires that patents should be available for inventions that are new, involve an inventive step and are industrially applicable. It does not define any of these fundamental requirements. The member-countries are allowed to define and interpret each of these terms in their own way, provided, there is no discrimination as to the place of invention and field of technology. For instance, the conditions for anticipation (novelty) in Europe or India are different from those in the US.

By including the phrase `technical advance' (not defined by the Act), India clearly wanted to have a European interpretation of the term `inventive step', but the possibility of showing prima facie economic significance has taken away that advantage.

(The author is Senior Manager — Patents — with Scope e-Knowledge Centre, Chennai. The views are personal and not those of the company he represents or advises.)

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