Prabuddha Ganguli
CEO
Vision-Ipr

The Indian Patent Act is on the verge of another long awaited welcome track change to ensure enhanced protection of inventions by the scrapping of Section 5 of the IPA (1970). That will allow product patents related to substances resulting from chemical reactions, pharmaceuticals, agro-chemicals and foods.

But non-patentable inventions will be defined in Section 3 of the new Act. These changes will enable India to meet its TRIPS obligations.

The standard criteria for the patentability of inventions should be novelty (N), non-obviousness i.e., the invention must have an inventive step (INS) and it must have usefulness i.e., be capable of industrial application (U). India's key strengths are in "incremental inventions", especially in pharmaceuticals and foods through formulations etc.

Recent debates on whether only new chemical entities should be patentable or whether formulations should be considered as subject matter for patent, or even include diverse structural forms of molecules/solid state phases (polymorphs), are misplaced as the patentability of an invention should not be guided by subjectivity.

That should only be decided along with the three internationally accepted criteria (NINSU).

The new Act should also provide for transparent guidelines for the examination of patents with regard to software so that software patents do not get restricted only to embedded software.

Section 47 (3) makes provisions for the experimental use of a patented invention. However it states that the grant of a patent under the Act shall be subject to the condition that "any machine, apparatus or other article in respect of which the patent is granted, or any article made by the use of the process in respect of which a patent is granted, may be made or used, by any person, for the purpose merely of experiment or research including the imparting of instructions to pupils"

In this statement, the word "merely" should be deleted. That would allow anyone to use a patented invention for experimentation or research without restriction. However if they went commercial with a patented invention, the patentee would continue to have the right under Section 48 to enforce his right.

Therefore the removal of the word merely from Section 47(3) would not dilute the right of a patentee but would give the option to use patented inventions to encourage R&D, which is the key purpose of a patent system.

The draft Bill proposes a system of post-grant opposition. However the concern is that India is now moving to a new product patent regime and Indian patent examiners will need time to gain experience in examining product patents.

They are not familiar with the construction of product claims and therefore wrong claims may be granted patents while, simultaneously, legitimate claims may not be granted thanks to inexperience. Every wrong grant could entail major social loss.

Therefore we should continue with the pre-grant opposition system for, say, a period of three years till our patent examiners gain expertise. Till then the public must have the option to oppose a patent, accepted by the patent office before it proceeds to grant.

The proposed system in the draft Bill, of post-grant opposition with an option to submit documents to the controller by way of objections after the statutory 18 months of publication, is not appropriate.

India provided for a mailbox provision with effect from January 1, 1995, in Section 5(2) of IPA (1970), after its first amendment. India also provided for the option of EMR in Sections 24 a-e. All applications in the mailbox would be examined after India moves the product patent regime.

The new Act should lay clear guidelines w.r.t. the date from which any product patent will be effective, especially for mail-box applications since these were filed between January 1, 1995 and January 1, 2005 during which India did not grant product patents. Such clarity would aid courts to arrive at a calculation of damages, if any, in matters related to the infringement of patents.

The Indian Act should define the term "working of patents" as it is crucial in matters related to the issuance of compulsory licences. Sections 83/84 of the present Act is silent on any clear definition on "working of patents".

These changes would ensure India's compliance with TRIPS and also protect national interests in a balanced and equitable manner.