Section 3 of the Indian Patent Act discloses non patentable subject matters, which are not considered as invention as per Indian patent law. Section 3 (e) prohibits patenting of substances that are obtained just by mixing known ingredients or components, such substances comprising properties that is result of aggregation of such components. However, the Manual of Patent office Practice and Procedure holds that all the substances which are produced by mixing components or a process of producing such substances should satisfy the requirement of synergistic effect in order to be patentable.

The Guidelines for examination of patent applications in the field of Pharmaceuticals provides insight that “if the functional interaction between the features achieves a combined technical effect which is greater than the sum of the technical effects of the individual features, it indicates that such a composition is more than a mere aggregation of the features” and does not fall within the ambit of mere aggregation of features. In other words, the claimed invention exhibits synergistic effect.

Synergistic data plays a pivotal role in grant of patents

 Section 3 (e) objections are raised mostly in chemical and biotechnological fields. Generally such objections are raised when the invention relates to claims comprising more than one component. The burden lies on the Applicant to provide such data to overcome the objection. Many patent applications have been rightly rejected by the Indian Patent office due to failure to produce such data in support of the claimed subject matter.

 Alternatively, there have been instances where a grant of a patent application has been rejected objecting that the claimed invention fails to provide data for synergistic effect, although the description section of the patent application explicitly discloses such data. In this context, it worth mentioning a recent judgement passed by IPAB in favour of the Appellant (Willowood Chemicals Private Limited).The IPAB set aside the impugned order of the Respondent (Assistant Controller of Patents & Designs) against the Appellant and granted a patent to the Appellant stating that the complete specification discloses synergistic data. The Respondent made an erroneous decision ignoring the data provided in the complete specification and raised objection under (e), even though data for synergistic effect was disclosed.

Revocation of patent u/s 3(e)

Mere statement claiming the claimed invention shows synergistic effect would not suffice, the burden lies on the applicant to provide comparative analysis of data relating to individual and combined results. Lack of synergistic data in support of claimed invention may also lead to revocation of a granted patent. A patent granted to Troikaa Pharmaceuticals (IN231479) entitled “injectable preparations of Diclofenac and its pharmaceutically acceptable salts” was revoked u/s 3(e) and lack of inventive step. The patent office during the examination of the patent application failed to raise objection u/s 3(e) and granted a patent to Troikaa Pharmaceuticals. A post grant opposition was filed by “LINCOLN PHARMACEUTICALS LTD (opponent) against the granted patent. The opposition board later found that no data showing the synergistic effect was furnished by the Patentee. Excerpts from the order:

“Thus, from the above findings, it is clear that the composition of the impugned application under opposition does not must meet the above requirements that the composition is a not mere admixture and has the synergistic effect. Explicitly, the composition must noticeably show synergistic effect in respect of ‘reduction of pain’ as the same has claimed to address the said problem. However, there is no data provided in the specification which proving that there is a reduction in pain at the site of injection. In fact, not a single example provided in the composition which could prove there is reduction in pain while injecting. No clinical data of the claimed formulations is presented in the complete specification to show  less pain when increased therapeutic dose of 75mg in l ml is used over the prior art diclofenac injections.”

Conclusion:

Inclusion of section 3 (e) in the Patent regime is to prevent ever greening of patents. The Applicant should take due care while filing for patents that may attract section 3(e). It is advisable to include data pertaining to synergistic effect in the patent application at the time of filing the application. Such data may also be submitted during the prosecution stage in the form of affidavit.

On the other hand, the Patent office should also take utmost care, while examining such applications as any erroneous decision or negligence during the examination of the patent application may have a negative impact on the Applicant. The Applicant may have to incur unwanted expenses (example – litigation), which could have been averted, if the patent applications were examined scrupulously. Previously, the Applicant had an option to appeal to the IPAB against the order passed by the Indian Patent Office. However, after the dissolution of the IPAB recently, Applicant now has to file an appeal in the High Court against any decision which conflicts the Applicant’s interest. As a result, the High Courts will be overloaded with the increase in number of cases. Time factor i.e. the prolonged litigation process that provides limited period of monopoly for patents and high expense involved in the litigation may demotivate the Applicant to file for Patent in India, which may indirectly hamper the patent filings in India.

Please feel free check our services page to find out if we can cater to your requirements. You can also contact us to explore the option of working together. 

Best regards – Team InvnTree   

This work is licensed under a Creative Commons Attribution-Non Commercial 3.0 Unported License