Sankalp Rehabilitation Trust V Hoffman La Roche: A Case Revisited

Sankalp Rehabilitation Trust V Hoffman La Roche: A Case Revisited

(The Real Impact of Section 8[1] Requirement under the Indian Patents Act)

Dr. Mohaan R. Dewan

Section 8 of the Indian Patents Act mandates applicant(s) filing an application for a patent in India to furnish information pertaining to patent applications filed in ‘any country outside India’ for ‘the same or substantially the same invention’ filed in India. The provision is generally taken as an equivalent to the duty to disclose information material to patentability under 37 CFR § 1.56 of the United States Patent and Trademark Office (USPTO) rules. However, unlike in the US, where it’s a duty of candor and good faith towards the USPTO, in India the provision is statutory and it is mandatory for the applicant to fulfill on his own, from time to time, as well as when asked to be fulfilled by the Controller, without fail. 

Each of the two sub-sections of Section 8 creates specific obligations on the applicant(s). Section 8(1)(a) read with Rules 12(1) and 12(1A) of the Patents Rules, 2003, requires the applicant(s) to provide ‘a statement setting out detailed particulars of such application(s)’ in the prescribed ‘Form 3’ at the time of filing the application in India or subsequently within six months. Section 8(1)(b) read with Rule 12(2) of the Patents Rules further requires the applicant(s) to undertake to furnish information of ‘every other application,’ if any, filed elsewhere, subsequent to the filing of the statement under Section 8(1)(a) within six months of filing such new application. Section 8(2) read with Rule 12(3) of the Patents Rules requires the applicant(s) to ‘furnish details, as may be prescribed, relating to the processing of the application in a country outside India’ upon requisition by the Controller within six months of such a request. The obligations under Sections 8(1)(b) and 8(2) of the Patents Act are to be carried out till the disposal (grant or refusal) of the application for patent in India.

There is a lot of discussion and debate going on regarding the jurisprudence on section 8 in India developed over the past decade or so, which, according to a few critics, has witnessed a relative waning trend in its implementation starting from the Chemtura Corp vs Union of India[2] case to the Koninklijke Philips Vs Sukesh Behl[3] case.

There is no doubt about the fact that Section 8 is considered a “mandatory” requirement, because of the use of the word “shall” in both sections 8(1) and 8(2), failing which post-grant oppositions/ revocation proceedings under Section 25(2)/Section 64 of the Act, respectively, as the case may be attracted. However, in 2012 Roche Vs Cipla[4] decision, the Delhi High Court allowed for the exercise of discretion by the Court to decide whether the patent needs to be revoked or not with regards to Section 64(1)(m) of the Act, despite the violation of Section 8. The 2013 Delhi High Court decision in Koninklijke Philips, which many see as a further relaxation for the applicants and taking the requirement under section 8 closer to ‘inequitable conduct’ in the US, is however a decision on whether to allow a decree at an interim stage or not on the basis of an admission under Order XII Rule 6 of Civil Procedure Code, 1908 in relation to an alleged section 8 violation. The author believes that it would be a complete misunderstanding of the law taking it as a further relaxation in relation to section 8 under judicial precedence.

Nevertheless, the question that needs to be addressed at this stage is - has section 8 lost any teeth, say in terms of attacking validity of a “granted” patent under section 25(2) or section 64 of the Act?

To answer the question, one needs to take a few steps back and revisit Intellectual Property Appellate Board’s (IPAB[5], hereinafter referred to as the “Board”) decision in the year 2013 in Sankalp Rehabilitation Trust V Hoffman La Roche[6]. The decision truly maintains the letter and the spirit of section 8 provision while balancing the public interest side-by-side and therefore demands our due attention and deliberation.

The Case

During the time and probably a few months later of the much debated Roche Vs Cipla case, Hon’ble Smt. Justice Prabha Sridevan, then Chairman IPAB, gave this detailed order in a revocation application filed by Sankalp Rehabilitation Trust, the petitioner, for the revocation of Patent No. 221017 in the name of Hoffman La Roche, the patentee and the respondent in the instant matter, on various grounds including non-disclosure under Section 8 of the Patents Act, 1970. 

Facts

Hoffman La Roche, in the year 2008, got monopoly rights in India on its patent application IN/PCT/2000/130/KOL filed in 1999, titled, BICYCLIC HETEROAROMATIC COMPOUNDS, and the 221017 patent was issued by the Indian Patents Office.

Sankalp Rehabilitation Trust, the petitioner in the matter, filed for the revocation of the said patent 221017 at the IPAB on various grounds including that of violation of Section 8.

The petitioner’s case was that the respondent had failed to comply with the requirements under Section 8, while the respondent asserted that the requirements were met and provided details so furnished in Form 3.

Findings

This case gives some wonderful insights into Section 8 in terms of pleading and proving the case in a legal proceeding. The Board started with the basics, stating that the provision under Section 8 “is not intended to be a bonanza for all those who want an inconvenient patent removed” in the light of the Ayyangar Committee Report.

It discussed matters[7] where the revocation ground under S.64(1)(m) was clearly made out, for instance, when a respondent gave wrong particulars about a corresponding foreign application, and suppressed the IPER relating to another corresponding foreign application, which was not pursued and the IPER had rejected certain claims on the grounds of both novelty and inventive step.

It looked into the disclosure obligation as required by the USPTO and the doctrine of “inequitable conduct” followed in the U.S. in the Court of Appeals for the Federal Circuit’s decision in Therasense[8], where the majority ruled that the “materiality” required to establish inequitable conduct is a “but-for” materiality – that is, “if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.”

It went on to discuss the de minimis principle (as invoked by the respondent/patent owner) and the factors to be considered in applying them namely size and type of harm, cost of adjudication, purpose of violated legal obligation, effect on legal rights of third parties and intent of wrong doer. That Board observed that if the obligation under S.8 has been violated then the harm caused is the continuance of a patent which deserves to be removed.

The Board then finally came up with its findings with regard to the objective of the provision, that is, “to ensure disclosure”, and that it “will adopt that a construction which is to advance the object”. That Board looked at the Ayyangar Committee Report’s observations that “this section has been introduced to make sure that the person who is given an exclusive monopoly is candid and fair in his conduct and discloses all the official actions regarding patent filing outside India in respect of the same or substantially the same inventions” and therefore “we cannot adopt a construction which relieves the patentee of this duty”.

Regarding the duty of the Controller in handling such matters, the Board dismissed the pleadings taken by the patentee/respondent that the information pertaining to the foreign family applications is available online and that the Controller should have held contrary (to the holding of the Board that it is “the duty of the patentee to furnish the particulars under S. 8”). The Board reminded, “This is not the law”. The Board, in paragraph 46, laid stress upon the seriousness with which a patentee should take the provision under Section 8, as is apparent from the following lines:

This duty under Section 8 cannot be breached and if violated results in revocation. It deserves to be accorded due respect. What should be furnished by the Patentee shall be furnished by the Patentee. So the Controller shall bear this in mind while considering the ground under S.8 and examine whether the Appellant has fully complied with the S.8 Requirements.

In particular, regarding taking the law “as it is”, the Board in paragraph 47 mentioned:

We must remember that we are not the law makers. For good reasons S.8 is there in the Act. The Controllers cannot ignore it and condone the breach. The patentee cannot tell the Examiners, We are filing applications nineteen to the dozen, compliance is very difficult, and in any case there is the Super Kamadhenu the Internet which will give you what you want. We cannot wish S.8 a relieved farewell. Tough for Inventors, but they must comply with the requirements of S.8. When George Mallory was asked Why do you want to climb Mount Everest? he is supposed to have replied, Because it is there. To the question Why should we comply with S.8? The Answer is Because it is there.

Coming to proving a case of violation under section 8, the Board made it clear that the applicant making the revocation application must show that these [applications], including divisional, are the foreign applications that were not included in Form 3 and office actions/amendment details are not furnished with the patent office. The applicant must plead “how S.8 was violated and why that particular foreign filing ought to have been filed”. The applicant must plead “how it is the same or substantially the same invention”.

The Board made it amply clear that the patentees must comply with S.8(1) provision however inconvenient it is. The Board, however, rejected the Section 8 objection in the instant matter, because the petitioner had not made out the grounds of attack by stating the facts. The Board remarked that a bald statement will not suffice by merely reproducing the language of the section and that the facts have to be pleaded.

Conclusion:

Section 8 is and does remain a sacred provision under the Act and any violation of it, either unintentional, could be detrimental to the interest of the applicants, as is evident from the reading of the case. Being a decision of the IPAB, which is considered at par with various High Courts of the country, the decision is to be considered the law of the land.