In today's rapidly evolving business landscape, innovation has become a cornerstone for gaining and maintaining competitiveness.
From the Copenhagen Global Innovation Round Table Conference in November 2024, the top themes that emerge as priority challenges for organisations include:
- Culture & Leadership for Innovation and Agility
- Game-changing Innovation; New business models & foresight
- Managing, Measuring & Accelerating R&D
- Digital Innovation & Transformation; and
- Startup Collaboration, Open Innovation & Ecosystems.
It is clear that collaborations for innovation are vital for competitiveness and competitive advantage. Based on my 25 years of devising commercially-focused IP strategy with client companies, I like to consider competitive advantage in terms of organisational resilience. This has parallels with personal resilience where, for example, we can build resilience by working to ensure that we have all the personal tools and insights that we need to handle any life event. In organisational resilience, we plan and put in place, all the resources for an organisation to actively plan to identify market opportunities and to be agile enough to act (not re-act) around/to events in the marketplace.
Here, I explore the critical importance of a well-structured innovation management system for building organisational resilience and highlight the indispensable role of Intellectual Property (IP) strategy in supporting that push for market success.
Key Elements of Innovation Management for Pharma and Biopharma companies
1. Regulatory Landscape:
- Navigating Complex Regulations: The pharma and biopharma industries are subject to stringent regulatory hurdles. It is crucial that the innovation management system in place must be aligned with regulatory requirements to ensure timely market entry while balancing with building a collaborative culture for enabling cross-functional innovation and breakthrough ideas.
- Leveraging Regulatory Exclusivity: IP strategies need to maximize the value of regulatory exclusivity, such as patent term extensions using Supplementary Protection Certificates (SPCs) and data exclusivity, to protect and strengthen your market position.
2. Research and Development (R&D) Focus:
- Prioritizing High-Potential Projects: Effective innovation management involves identifying and prioritising R&D projects with the highest potential for commercial success, while balancing, sometimes on a knife-edge, factors such as market-need, technological feasibility, and the IP and Freedom-to-Operate (FTO) landscape.
- Encouraging Open Innovation: Collaborations, partnerships, and licensing agreements can accelerate innovation and access diverse expertise. IP strategies must be designed to support such collaborations while safeguarding proprietary knowledge.
3. IP Portfolio Management:
- Building a Strong IP Portfolio: A well-managed and commercially focused IP portfolio (i.e. focused on both present and future revenue streams) is crucial for safeguarding innovations and maximizing their commercial value. Of course, this includes patents, trade marks, trade secrets, and know-how.
- Strategic Patent Filing: Patents should be strategically filed to cover core inventions and critical aspects of the technology, considering factors like patentability, enabling disclosure requirements and timing of available data to support an enabling disclosure, patent term, scope of protection, and potential challenges from competitors using the Opposition procedure of the European Patent Office (EPO) and/or the emerging case law that might make revocation at the Unified Patent Court ( UPC) look like an attractive option.
- Monitoring the IP Landscape: Staying informed about the latest technological developments and the IP landscape is essential to identify potential infringement risks and opportunities for licensing, merger or acquisition.
4. Risk Mitigation:
- Identifying and Mitigating Risks: IP risks including risks of patent infringement as well as risks of challenges to key patents, must be proactively identified and a plan of action readied for appropriate action and timing.
- Contingency Planning and organisational resilience: Having a well-defined IP strategy, including contingency plans for potential legal disputes, is crucial for protecting investments and minimizing liabilities.
5. Commercialization Strategy:
- Maximizing IP Value: A comprehensive commercialization strategy, including licensing, joint ventures, and strategic partnerships, can maximize the value of IP assets. This can only be achieved by understanding the legal principles and practicalities of the Patent and SPC systems and building team knowledge and team mindset on which the organisation’s IP strategy can be anchored.
- Balancing IP Protection and Market Access: Striking the right balance between IP protection and market access is essential to ensure timely commercialization and competitive advantage.
- Facilitating Partnerships: Collaborations with other organizations can be facilitated through strategic IP licensing and joint ventures.
- Driving Innovation: A relevant and agile IP strategy encourages innovation by providing a framework for protecting and commercializing new ideas.
Conclusion
By effectively implementing the key elements of innovation management and integrating IP strategy, organizations can unlock their full potential for growth and success. Innovation is not a one-time event but an ongoing journey that requires continuous adaptation and improvement. By effectively integrating these considerations into innovation management, pharma and biopharma companies can drive innovation, protect their IP, and achieve sustainable growth in a highly competitive market.
Marie Walsh, European Patent Attorney, Chartered UK Patent Attorney and Registered Irish Patent Attorney, is presenting two new training courses for IPI Academy:
These events are running on various dates across 2025. Join Marie to learn more about these complex areas and gain from her experience.
Published on Jan 03, 2025 by Marie Walsh