INTRODUCTION
Assessment of Patentability of combination/ composition patents at the Indian Patent Office (IPO) is highly dependent on section 3(e) of the Patents Act, 1970 (hereinafter the Act). A common strategy adopted by applicants of pharmaceutical inventions has been to draft a formulation/composition/ combination claim to move the application away from the scrutiny of section 3(d). In case of a formulation/composition/combination claim when the overall effect of the combination claim produces an unpredictable change from the individual derivatives' functions, the result is termed "synergistic." Synergism then is the combining of known derivatives to produce unique result.
Section 3(e) precludes patenting of "a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance". The following article is an analysis of IPO's interpretation of synergism in light of Section 3(e) of the Act.
SYNERGY AND NON-OBVIOUSNESS
As per the Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (October 2014), synergy means a surprising effect/ outcome of the combinations, prior art prejudice etc. which usually demonstrates the non-obvious nature of the invention. Synergy refers to therapeutic activity in case of chemical composition claims, for example, composition of compound "A" in claimed range with pharmaceutically acceptable excipients in claimed range provides therapeutic activity.
As per the manual of Patent office Practice and Procedure (Version 3.0, 01 March 2019), "Synergistic effect should be clearly brought out in the description as per Section 3(e) by way of comparison at the time of filing of the Application itself. The subsequent submissions regarding synergism can be accepted in a reply to the office action as a further support of synergy". Therefore, post-filing experimental data should be within the scope of the originally-filed specification. IPO accepts post filing of experimental data. However, when there is no mention of said synergy in the specification but it is relied upon in securing a Patent, then the originally filed claims should possess everything that covers 'the synergistic effect' and it must be described in the specification. There are a few instances where even though no data regarding therapeutic efficacy or synergism was produced nevertheless patents were granted by IPO. In some cases, the decision granting the patent refers to the IPAB decision in Ajantha Pharma Ltd v. Allergan Inc1, which finds mention in the 2014 pharmaceutical guidelines.
The relevant extract from the order is as follows:
"The combination mentioned in the Explanation can only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy."
PATENTS THAT WERE GRANTED WITHOUT SYNERGY DATA IN THE CONTROLLER'S ORDER
- In 255959, objection under section 3(d) was found not relevant and section 3(e) grounds were not sustainable owing to synergy of delivery However, the order doesn't provide any reasons or data used to overcome the objections.
- In 268726, objections under section 3(e) were waived as the applicant had shown different unexpected results in the reply to FER. In 271316, Section 3(e) objection was raised not under Section 15 but only in FER. The applicant showed improved effects.
- In 271352, it was shown that efficacy was better as a combination compared to individual ones.
- In 272359 which is composition claim, synergism was explained to overcome section 3(e) without any data to justify. Applicant argued against section 3(d) here, suggesting this is a combination of known active ingredient and an unknown
- In 273120, Composition claim, applicant mentions that having 3 active agents will have a broader efficacy. The applicant amended the claims to overcome sections 3(e) and 3(d). No data was reproduced in the order of the
PATENTS THAT WERE GRANTED WITH SYNERGY DATA IN THE CONTROLLER'S ORDER
- In 262783, for objection regarding section 3(e) the composition of the present invention was submitted as superior composition by the applicant by producing comparison data, however, efficacy was not demonstrated by proper comparison.
- In 262988, section 3(e) objection was overcome by the data submitted that demonstrated the composition claimed shows superior stability and provides a formulation which is suitable for administration of voriconazole for the first time.
- In 264718, data was submitted to show that the claimed composition is efficacious, effective, and synergistic.
- In 266487, the applicant showed that the present invention is a novel and inventive composition and supplemented it with the pharmacokinetic profile to show the improved treatment by the instant composition, thereby satisfying the requirements of sections 3(d) & 3(e).
- In 268062, the specification shows the synergistic effect of the composition of the present invention. The objection for section 3(e) is also waived in view of the submission for inventive steps and novelty and the affidavit submitted by the
- In 268331, the Controller concluded that the formulation of present invention is not a mere admixture but shown synergism /surprising
- In 27116, claims that were amended after a hearing to overcome section 3(e) showed improved technical effect showing structured vesicular arrangement in the data submitted as
- Further in the granted patent numbers 273641, 274779 and 275630 synergistic effect data such as pharmacokinetic data in the specification was provided to overcome section 3(e) objection.
CONCLUSION
From the decisions above, it can be inferred that there exists differing standards and inconsistencies in granting or rejecting patents in case of pharmaceutical patents. Such inconsistencies may prove detrimental in providing access to drugs for different diseases.
Footnote
1 Ajantha Pharma Ltd v. Allergan Inc, IPAB, ORA/21/2011/PT/KOL of Order no. 173 of 2013.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.