By Shivani Bisht

 

Introduction

Pre-grant opposition is regarded as a key safeguard against over-reaching monopolies, particularly for pharmaceutical patents. To give this sufficient teeth, Section 25(1) of the Patents Act of India, expressly entitles ‘any person’ to file it before the Controller of Patents. However, in a matter concerning Pfizer’s patent for a major drug, the Hon’ble Bombay High Court in the year 2020 passed an order indicating (rather qualifying) the need to establish bonafide of a pre-grant opponent vis-à-vis the personal knowledge and educational background possessed to oppose a patent.

Background of the Case

The Petitioner Mr. Dhaval Diyora, a public-spirited individual, filed a pre-grant opposition against one patent application by Pfizer Inc. for the generic drug Tofa on 18.08.2020. Pertinently, the said patent application was already rejected by the Controller of Patents three times earlier and the applicant thereto filed an appeal against the same at Intellectual Property Appellate Board (IPAB). IPAB passed an order dated 21.08.2020 allowing the appeal and furthering the patent for grant while disregarding the pre-grant opposition filed by the Petitioner. A pretext was also taken that the opponent is a Front-man/ Straw-man to oppose the mentioning when the pending pre-grant opposition was brought to the IPAB’s attention.

Being aggrieved on account of the patent furthered for a grant without having heard his pre-grant opposition, the petitioner preferred said Writ Petition against the IPAB order at the Hon’ble High Court of Bombay. The court while reviewing other matters of technical nature, invested itself in inquiring into the educational and professional background as a factor for filing bonafide pre-grant opposition and went on to pass an order (dated 05 Nov 2020) dismissing the writ petition with the cost of INR 25,000/-, raising several questions that this article puts forth.

The Decision 

In Para 35 of the order; which deals with the conduct of the petitioner vis-à-vis the requirement of the educational background of the Petitioner in the pharmaceutical domain to file pre-grant opposition, it is stated that:

“The Petitioner has raised detailed grounds stating various scientific facts. The obvious question is how the Petitioner has intricate knowledge of pharmaceutical compounds when he is a businessman engaged in diamond business. We have not been informed about the educational background of the Petitioner. The Petitioner has made no statements on oath. It is argued that the Petitioner has employed a team of researchers. Particulars of these researchers and who pays the team are not given. Credential of the researchers are not informed.

This propels a conscientious scrutiny on the provision of section 25(1) of the Patents Act, which expressly and literally writes that “any person” can file a pre-grant opposition while the post-grant opposition can only be filed by “person interested”. While the legislature defines the term “person interested” under section 2(t) of the Act, as “person interested” includes a person engaged in, or in promoting, research in the same field as that to which the invention relates;” no definition for “any person” is included.

Should that not imply that any person shall mean any person, entity, partnership firm, private limited company so on and so forth?

When there is no pre-qualification as to “any person”, it is hard to surmise that the legislative intent is to mean that ‘any person’ must be a person with skills or background in the field of invention sought to be opposed, particularly when patents in any field – let alone life sciences and software – can have far-reaching impact on society at large.

In fact, Para 20 of the order which notes the Respondent’s pleading with respect to the scope of “any person” itself illustrates:

The Patents (Amendment) Act, 2005, amended S. 25(1) to permit Any Person to oppose the grant of a patent where an application for a patent has been published, but a patent has not been granted. Earlier this right was restricted to the person interested. By enlarging the locus standi under S. 25(1), the legislature intends to bring transparency in the proceedings before the Controller. Patents confer a monopoly of use. Some monopolies could be detrimental to welfare measures for the masses. The widened locus standi now permits any person, which can include researchers, nongovernmental organisation, to oppose a patent application by submitting information to the Controller in the interest of the society.”

In what may seem like a contradiction of approach and words, the Hon’ble Court appears to have taken a rather narrow interpretation of the widened locus standi, and disregarded the applicability of the judgment laid down in Indian Network for People living with HIV /AIDS and Ors. vs. Union of India (UOI) & Ors. The case, which endorsed the oppositions by parties clearly without a professional or academic background in the pharma sector, was deemed not applicable to the instant case as the petitioner here was merely an individual and ‘not a registered society providing support to people living with HIV positive’.

When the Petitioner contended that he is a public-spirited person and employed a team of researchers for technical expertise, the Honourable Court went a step further and concerned itself examining ‘particulars of these researchers and who pays the team’.

Would this mean an individual who has filed a pre-grant opposition (‘PGO’) will now have to first prove he is not a benami/Frontman in addition to other grounds to further his pre-grant opposition and even detail out his procedure and a team of research? If so, how will a person even prove that he’s not Benami? Would it then require a new set of yardsticks on what background checks must be met to qualify as such? A question can be raised whether merely having a technical background in the same domain can be the test to assess a benami person? Would an actual front man having a technical background not be considered benami?

Quite possibly so, if the Controller or the Applicant chooses to derive that straw from this order, and decide to call the opponent a straw-man; even though several courts have pronounced that the burden of proof regarding Benami lies on the alleger.

Another important aspect here that knocks a legal head is that while there is no pre-qualification for a person to become an inventor in order to file a Patent application; how logical is it to construe that relevant educational/ professional background is required to file pre-grant opposition? In absence of which opponent would be at the risk of being labelled as a Benami Crusader. Going by that logic, substantial numbers of pre-grant oppositions would become Benami irrespective of how valid the grounds are. Keeping the legislative intent of Section 25(1) in context, shouldn’t the test for a pre-grant opposition be on its merit concerning technical/ legal grounds instead of evaluating the opponent’s background and motive? What if the person’s opposition is strong on merits, bringing a clear and strong ground for refusal? Will that be denied only on the premise of an educational background of the person filing?

While one can appreciate that the order is directed with an intention to expedite the process of patent grant; this factor needs to be seen in the light of the very existence of pre-grant opposition itself. Despite the fact that pre-grant oppositions can slow down a patent grant, among a myriad other factor of delays; it has been in continuance and effectively used to prevent an undeserving patent from being granted, Novartis’ Glivec being among the most popular examples for the same. Isn’t it so because the balance of impact is deemed to be in favour of society, and isn’t that why the law empowers ‘any person’ of that society to file a pre-grant opposition, and shouldn’t any person mean ‘any person’?

In the instant case too, not even a single instance of delay caused by the Opponent has been given, whereas the Petitioner, through data, clearly tried to respectfully submit that his oppositions have led to the refusal of patent applications and also led to the abandonment of many patent applications by patent applicants. Could that be even possible if the oppositions didn’t have merit or strong grounds?

In the end, we can subsume all the questions raised hereinabove within a simple and final one – how well served is the legislative intent of ‘any person’ in the provisions of section 25(1) of the Patents Act, 1970, if the merits of opponent’s identity can take precedence over merits of the pre-grant opposition itself?

 

The author is an Assistant Professor at Graphic Era Hill University, Dehradun.

Image Source: Photo by mike_ramirez_mx on Pixabay