Seed Regulatory and IP Audit for leading seed company with global presence

Context 

“Conducted a seed regulatory and IP audit for a leading seed company having operations across several countries including India. The audit was conducted to create an inventory of existing IP assets, examine systems to maintain end-to-end traceability of biomaterials (within the purview of national biodiversity laws, seed regulations, and plant quarantine regulations) used in the client’s commercial material, and identify gaps in current practices followed within the organization from an IP standpoint. The client was keen on centralizing their IP asset management system, and conducting an IP audit as a first step towards fulfilling the objective of IP centralization.” 

The challenge for a seed company with operations in several countries is that, their product pipeline involves complexities in terms of cross-border movement of biomaterials (in the form of plant genetic materials such as seeds and tissues, germplasm of wild and elite breeding lines, and imported parental lines). While R&D activities may be undertaken centrally, crop breeding activities may take place in geographically conducive locations, whereas sales and marketing may be distributed globally. 

In consideration of the complexities of a seed business, freedom-to-operate determines the ability of a company to proceed with research, development, and commercial production of a new crop product or plant breeding technique, with minimal risk of infringing IP rights of third parties and ensure compliance with the laws-of-the-land. Sathguru helped the client to assess their current status, as well as risk mitigation strategy to ensure compliance with national and international laws and regulations including IP laws, seed acts, and biodiversity regulations. 

Scope 

1. Creating an inventory of existing IP assets owned by the company 
2. Assess usage status of existing and future IP assets 
3. Compliance with national/international seed regulations and trans-boundary movement 
4. Freedom-to-operate and mitigation strategies for compliance related issues 

Approach 

1. Shared pre-visit questionnaire with client for creating inventory of IP assets currently held 
2. Conducted in-country visits for stakeholder interactions to gain insights into state-of-the-current 
3. Thorough review of the company’s contractual obligations and evidences provided for audit 
4. Mapped country-specific entities observations with regulation requirements 
5. Developed an improvement matrix to assess each entity’s IP compliance status 

Recommendations 

1. Creation of systems for IP creation, utilization, and monetization 
2. Developing best practices for ensuring traceability and optimal IP asset management 
3. Risk mitigation strategies to ensure IP compliance with laws-of-the-land 
4. Enter farm services segment for effective launch of the product as it required such a service to compliment the offering. 
5. Build a data warehouse to archive farmer profiles for development of new targeted product and service offerings. 

Impact/Result/Client Benefit 

The output of this engagement immensely benefited our client in terms of developing a mindset of awareness towards importance of IP assets under current global scenarios, understanding regulatory complexities of the seed business, robust organizational practices and systems, as well as best practices to be followed in order to ensure freedom-to-operate in a complex business landscape.