Department Related Parliamentary Standing Committee on Commerce  Report on ‘Review of the IPR Regime in India’

India must not compromise on the patentability criteria under Section 3(d) since India as a sovereign nation has the flexibility to stipulate limitations on grants of patents in consistence with its prevailing socio-economic conditions.

By Vijaykumar Shivpuje

Department Related Parliamentary Standing Committee on Commerce presented 161^st  Report on ‘Review of the IPR Regime in India’ recently. The report analysed overall scenario of IPR regime in India and its contribution in promoting innovation and entrepreneurship.  The Report examined the IPRs in pharmaceutical sector among others.

This article examines the impact of these recommendations on the pharmaceutical patenting, if accepted.

Recommendations related to patent prosecution at patent office

The Department to explore opportunities in establishing patent prosecution highway (PPH) with other nations as well which would be highly advantageous to India in expediting and processing of patent applications after impact assessment of the Japan PPH model. Covid-19 outbreak has led to rise in filing of innovations to grant them as patents in areas of vaccines, pharmaceuticals and medical devices.

India must not compromise on the patentability criteria under Section 3(d) since India as a sovereign nation has the flexibility to stipulate limitations on grants of patents in consistence with its prevailing socio-economic conditions. It also recommends that in order to avert any misinterpretation of the provision, the Department should examine the aspect on giving an expansive meaning to Section 3(d) for giving further clarity.

Necessary steps may be taken to expedite the process of examining/ granting patents.

Welcome steps in order to reduce the burden of the patent offices and should also provide better clarity for the pharma industry for patenting of the invention in multiple jurisdictions.

Clarity on section 3 [d] has been the demand by patent practitioners as well as the pharma industry since long as this would rationalize the patent grant process for pharmaceutical inventions in India.

Recommendations related Covid-19 pandemic

Compulsory License be considered in case of production of medicines and vaccines for treatment of Covid-19 since pandemic has led to a national health emergency. The Government should delve into prospect of temporarily wavering patents rights and issuing Compulsory Licensing to tackle the inadequacy in availability and accessibility of Covid-19 vaccines and drugs during an emergency like situation induced by the pandemic.

A long term policy rather than a short term solution during the pandemic after the discussion with key stakeholders would be highly appreciated. The impact of temporarily waving of the rights during the pandemic should not hinder the overall innovation in the domain due to lack of motivation to innovate.

Recommendations related to Herbal and ayurvedic research and its patenting

To review Section 3(p) of the Patents Act for including traditional knowledge under patents ensuring growth of an inclusive IPR regime in India.

Another welcome step to provide clarity for the purpose of herbal and ayurvedic research and its patenting would help the industries to focus on the research in the sector especially in the research and development.

The Government to address the structural issues in implementing a systematic mechanism of documentation and preservation of traditional knowledge in the country along with taking measures to strengthen TKDL as an effective database.

If this recommendation sees the day of the light, it may change the entire global landscape of the traditional knowledge and the further research on the same.

To undertake an intensive research on AYUSH medicines and drugs including herbal remedies that would lead to advancement in availability of innovative drugs and medicines for treatment of novel diseases.

Recommendations related to research and development promotion

Joint research with global pharma players on discoveries of new molecules and compositions should be undertaken by the Department.

To encourage research and development in the Pharmaceutical Sector, policies for attracting investments from both the public and private sector may be explored by providing incentives such as tax rebate, reducing processing time and through industry academia partnership.

(The author is Director, Patlex Business Solutions, Navi Mumbai. The article is for informational purposes only. Views expressed are personal and do not reflect the official position or policy of the Financial Express Online.)