Towards a Stronger Patent Ecosystem - KG Ananthakrishnan, Director-General, OPPI

Towards a Stronger Patent Ecosystem

KG Ananthakrishnan, Director-General, OPPI

?India’s economic liberalization revolutionised Indian industries as they began building capacities and capabilities to become globally competitive. Two decades later, we are witnessing yet another liberalization wherein inviting foreign investments and increasing exports – are the key focus areas. This is further strengthened with the ?journey to not only ‘Make in India’ but also to ‘Discover in India’. This has called for several sectors, most importantly the pharmaceutical sector, to rethink and revisit its long-term strategies and business models. Factors such as industry-academia collaboration, funding mechanisms, changing regulatory system and need for protection of intellectual property rights particularly, patents form a significant part of this recalibration.

Patent issues continue to be of particular concern for innovative industries and now, as India is committed to build a pharma research-ecosystem, it is imperative to understand and find effective and sustainable solutions for these challenges.

While the Patents Act 1970 grants patent rights, incentivizes innovators and thereby ensures continued research towards ensuring better access to newer therapies, we also need to bridge gaps if we are to innovate for a better and healthier future for all.

Specialized Problems Require Specialized Solutions

The intricacies of patents and intellectual property rights require transparent, predictable and secure processes to adequately address the ?challenges faced by the innovators. The following recommendations will pave way for building a stronger patent ecosystem, which encourages innovation and better therapies to address the unmet medical needs.

·??????Importance of patent period: Despite patent infringements or challenges, regulations must be such that ensure interim reliefs/reliefs to patentees till such time the patents are held to be invalid..

?·??????Streamline pre-grant opposition: Globally aligning with other countries on removing or revising provisions on pre-grant opposition from the Patents Act, 1970. Furthermore, the Patents Act 1970 must be amended to provide patent term restoration for the time lost due to filing pre-grant oppositions and cyclic filing of pre-grant oppositions on identical grounds must not be entertained. ??Further, to ensure transparency in the process, there should be clear criteria to restrict filing of pre-grant oppositions by “interested parties” only.

?·??????Data protection: The regulatory authorities must not disclose and rely on the innovators’ data to grant marketing approvals to third parties as the same amounts to unfair commercial use. Through Regulatory data protection (RDP), the proprietary pre-clinical and clinical data required to be generated by the innovators for establishing a drug’s safety and efficacy and submitted before the regulatory authorities is protected. RDP is critical to safeguard both patient data as well as wayward infringement.

?·??????Reduce litigation: The Sugam portal by CDSCO is a good initiative that must be utilized to its fullest potential. Establishment of a fair, transparent, equitable and effective Sugam portal where non-commercial information on manufacturing, marketing applications filed and pending before the central and the state regulators ?would help reduce business uncertainty, increase investor confidence, facilitate ease of doing business in India and increase patient safety.

?·??????Dedicated benches with technical experts: The highly technical nature of patent issues particularly, pharmaceutical patents, require a thorough understanding of biology, chemistry, and trade and commerce in addition to law. As the Intellectual Property Appellate Board has been dissolved, instituting specialized patent benches / courts in High Courts with experts would enable in effective dispute resolution.

Protecting the Innovation and the Innovator:

Sustaining the sector’s phenomenal growth requires a strong R&D ecosystem. This in turn relies on several important factors, specifically a transparent, robust and effective patent regime which will benefit both patients and innovators. It is imperative thus, that as a country that wishes to discover more internally, a structure that understands, accepts, protects, builds and nurtures the innovation and the innovative mind-set is provided. Industry-Govt.-Academia coming together to collaborate on this will eventually help the industry grow leaps and bounds.

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