Statement by India on Agenda Item 6 (i) Opposition system under the Quality of patents, delivered by Dr. S. P. Subramaniyan, Assistant Controller of Patents during the 22nd meeting of Standing Committee on the Law of Patents

Madam Chair,

Patent monopoly is granted to encourage the inventor with larger public interest. The private right should not affect the public right. To meet the international obligation India amended Section 25 of the Act by introducing Pre-grant and Post-grant Opposition. Mere filing of patent application will not suffice to grant a patent, but should meet certain patentability criteria. Check and balances are provided in the Indian Patents Act to ensure the quality of patent as opposition (pre-grant & post grant) and revocation system.

In the pre-grant system, any person (person includes the Government) can file opposition, in writing along with evidence, if any, to the Controller against the grant of a patent after publication till grant of a patent. The longer period provided to public is to ensure the quality of the patent and preventing frivolous inventions. There are several grounds for opposing the grant of patent in the pre-grant stage such as wrongfully obtaining, prior publication, prior claiming, prior public knowledge, obviousness, not an invention under the Act or the invention not patentable under the Act, Insufficiency of disclosure, failure to disclose information or furnishing false information relating to foreign filing, convention application not filed within the prescribed time, incorrect mention of source/geographical origin of biological material, invention anticipated with regard to traditional knowledge. The controller notifies the details of the opposition to the applicant to submit his reply within three months time and then provides opportunity to both the parties.

It is India's experience, when product patent regime started from 2005, introduction of pre-grant opposition paved way to prevent frivolous product patents. The classical example is refusal of anti-cancer drug imatinib mesylate ’Gleevec’ in the pre-grant stage. But it is granted over 45 countries. The invention related to the modified form of known molecule which is disclosed in the earlier application. The patent application was opposed by pharma companies and NGO’s working for the people with cancer. The patent office refused the case after giving opportunities to all the parties. The Intellectual Property Appellate Board (IPAB) and the Hon’ble Supreme Court of India upheld the decision of the Controller.

In the post grant opposition, any person interested can submit notice of opposition before the expiry of a period of one year from the date of publication of grant of the patent. According to Section 2(1)(t) of the Act, "person interested" includes a person engaged in, or in promoting, research in the same field as that to which the invention relates. In response to the notice of opposition, the patentee submits reply statement and evidence to the opponent and controller for which the opponent shall submit reply evidence submitted to controller. Opposition board comprising three members constituted by the controller shall examine and submits recommendations. The controller offer opportunities to all the parties and decide case on merit.

During the prosecution of the post-grant opposition, many pharma  companies opposed the locus standi of the NGO working for the people living with diseases such as cancer and HIV, etc., for opposing the patent, because the provision allows only person working, doing research field. But the controller allowed NGOs in the post grant opposition by interpreting the open end phrase “person including” and referring the Hon’ble High Court of Delhi in AIR 1983 DELHI 496, the court held "In our opinion, a 'person interested' within the meaning of section 64 must be a person who has a direct, present and tangible commercial interest or public interest which is injured or affected by the continuance of the patent on the register."

IPAB for the same case upheld decision of the Controller and said:

"The continuance of an unworthy patent on the Register is not only against the interest of other persons carrying on the same business but also against the public interest.  For the protection of valid patents, we have no doubt to prevent the busybodies and unnecessary interferences.  But, it is as much against the public interest to allow unworthy patents to be on the Register, as it is to prevent third parties having no interest from attacking a deserving patent.  While liberally construing the words ‘person interested’, we could balance the cause of justice by awarding exemplary costs against an opponent who really has no interest in the grant of patent.  The interest should not be a fanciful interest."

There are many trivial inventions refused in India in the post grant stage. We strongly feel that the robust opposition system would not only improve the quality of patent but also the public health as well.

Thus this delegation feels a further study on pre-grant, post-grant oppositions and revocation of Patent in greater details to improve the quality of patent and for further discussion.

Thank you, Madam Chair.

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