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In last week’s post, “The role and impact of IP rights on innovation and investment in RM,” I discussed the importance of intellectual property (IP) rights in regenerative medicine (RM), highlighting how they drive innovation and secure competitive advantages. The discussion covered various aspects, such as the role of patents in encouraging investment, the need for innovative IP strategies tailored to the complex nature of RM technologies, and the global landscape of patent filings, particularly in North America, Europe and Australia.
This week’s post focuses on IP management strategies, which are a cornerstone of innovation in RM. An effective IP strategy ensures that innovators can secure exclusive rights to their inventions, enhance financial strategies and establish strategic partnerships. Aligning IP strategy with business goals maximizes the value of protected assets and their commercial benefits, ensuring current and future innovations are safeguarded. A robust IP strategy allows companies to plan for future patent filings, covering critical innovations for product development and industry advancement. This strategic foresight positions companies well against competition and provides flexibility to pivot into new products if market conditions change. A comprehensive strategy for developing an IP portfolio involves acquiring and maintaining patents, leveraging licensing agreements, and engaging in patent pooling to foster collaboration and maintain a competitive advantage. By continuously building a broad patent portfolio, companies can protect against reverse-engineered products and reinforce their market position.
Some strategies for developing IP portfolios:
- Enhancing patent life cycles
Once a patent is granted, companies employ various strategies to extend the life cycle of their patents. These strategies may include applying for Supplementary Protection Certificates (SPCs) in regions where these are available. SPCs can extend the protection period for patented products, particularly pharmaceuticals, by up to five years beyond the original expiry date. Moreover, companies may pursue Patent Term Extensions (PTEs), available in certain jurisdictions, which compensate for time lost during the regulatory approval process. These extensions are particularly relevant in RM, where clinical trials and regulatory reviews are lengthy.
- Managing patent expiry challenges
Patent expiry is one of the main challenges within RM. As patents approach expiry, companies face the challenge of maintaining their market position against generic competition. To address this, they may develop next-generation products or technologies that can be patented anew. Additionally, companies can create high barriers to entry by accumulating complementary patents that protect various aspects of their technology platform, making it difficult for competitors to enter the market without infringing on multiple patents.
- Patent pooling and licensing agreements
The creation of a patent pool in the stem cell industry necessitates the identification of a standard. This standard might naturally emerge within the industry or be established by organizations such as a standards-setting organization, or entities like the Stem Cell Consortium at Columbia University, and the California Institute for Regenerative Medicine. The standard could specify methods for preparing embryonic stem cell cultures to ensure consistent research results, such as culturing stem cells without animal feeder cells to avoid viral contamination. Once a standard is defined, any patent essential for implementing it must be included in the patent pool. Integrating these steps ensures that the collective licensing mechanism of patent pooling effectively supports the advancement of regenerative medicine by providing a structured and efficient framework for innovation.
- Licensing agreements in collaborative ventures
Licensing agreements are a common feature in the RM landscape, particularly in collaborative ventures and partnerships. Vladimir Drozdoff and Daryl Fairbairn argue that a license agreement primarily fulfills three key purposes: (1) specifying the extent of rights exchanged between the involved parties; (2) delineating the compensation for these rights; and, (3) establishing a framework for managing the risks each party assumes under the agreement.
To address these purposes effectively, both parties must comprehend the overall objective of the agreement and the specific goals each party aims to achieve, especially in the context of combined R&D and licensing deals. For example, the collaboration between Bluebird Bio and Celgene (now part of Bristol-Myers Squibb) involved a licensing agreement that allowed Bluebird Bio to access Celgene’s IP related to gene editing technologies. This partnership enabled the development of cutting-edge therapies for serious genetic diseases.
- IP clearinghouse strategy for stem cells:
In research done by Karl Bergman & Gregory D. Graff on the global stem cell patent landscape, they discuss an IP clearinghouse strategy that aims to mitigate the barriers created by overlapping and fragmented patents. The proposed clearinghouse model draws inspiration from existing IP exchange mechanisms, such as the Public Intellectual Property Resource for Agriculture (PIPRA). PIPRA is a coalition of over 40 universities and research institutes that aims to facilitate R&D in agricultural biotechnologies by improving the exchange of patent rights. By sharing data on patents available for licensing, identifying IP bottlenecks, and developing patent pools, PIPRA addresses similar challenges in the agricultural sector.
An IP clearinghouse strategy is especially pertinent to public sector and academic institutions deeply engaged in stem cell R&D. These organizations often share concerns about how the patent thicket could hinder investment, innovation and commercialization opportunities. The clearinghouse mechanism is designed to support these institutions by providing two primary functions:
- Enhanced transparency and market discovery:
- The clearinghouse would offer information on patents available for licensing through a common database or other means.
This increased transparency would reduce uncertainties, support market discovery, and facilitate subsequent market exchanges in patent rights.
- Best practices in licensing:
- The clearinghouse would establish principles of best practices in licensing, promoting terms that encourage ethical approaches to stem cell research.
- These practices would help reduce strategic or shortsighted behaviours by participating patent owners and aid research managers in making informed technical decisions for future projects.
Facilitating fair competition and efficient licensing
For stem cell technologies with multiple substitutes, the clearinghouse would play a crucial role in providing a “universal listing” that includes the respective technical characteristics of different technology options. This listing would enable these technologies to compete fairly and transparently. Furthermore, by analyzing patterns of demand for common stem cell research tools and understanding which technologies are most frequently employed in R&D projects, the clearinghouse could identify highly complementary technologies. These technologies could then be pooled and licensed jointly to meet demand more efficiently.
Voluntary participation and negotiation
Participation in any patent pool organized by the clearinghouse would be voluntary and based on negotiations facilitated by the clearinghouse. Technology owners would decide to join pools based on their own commercial or institutional policy considerations. The terms of participation in and disposition of these pools would be negotiated independently from the general governance and activities of the IP clearinghouse.
A solid IP strategy is key to fostering innovation and staying ahead of patent challenges. By effectively managing patents, extending their life cycles, and leveraging patent pooling and licensing agreements, you can enhance your market position and drive continued advancements in RM.
Ensuring that your IP strategy aligns with your business goals will not only protect your current innovations but also pave the way for future developments. Strategic foresight in building a comprehensive IP portfolio helps secure your competitive edge and allows flexibility to pivot as market conditions change.
Now, let’s hear from you: How do you see the role of IP management evolving in the fast-paced world of regenerative medicine? Leave a comment below and join the conversation.
Laya Kiani
Very Informative!
A robust IP management strategy is essential for navigating the complexities of regenerative medicine, enabling innovation while safeguarding competitive advantages.
Thank you for that feedback. Very true.