Before biotechnology firms enter into a research collaboration, it is important for them to consider not only their research and commercialization objectives but also whether their development and marketing goals can be achieved with the intended partner.
The ability to influence the development of inventions resulting from research will depend on an entity’s ownership stake in the intellectual property (IP). If collaborations involve parties with very different missions and objectives, like government agencies, academic institutions, and for-profit companies, then influence on development and setting milestones can be critical to achieve those objectives.
Success in such diverse collaborations hinges upon entering clear collaboration agreements prior to initiating work. Depending on the IP ownership, it may also be necessary to compromise on some of your objectives.
Understanding where various parties have flexibility and where they are restricted can save time, money, and relationships. We attempt to explore a couple of the common issues, including publications and patent strategies between different types of collaborators.
Then we consider how differing IP ownership stakes may prescribe a party’s influence over the development path to commercialization. For the purposes of this article, we define commercialization as bringing the product to market whether for profit or at cost for the public good.
Development Stage to Reach Before Exit
A small biotech may seek to move its technology further up the value chain prior to monetization, whereas government and academics with well-developed IP may prefer partnering with larger companies as soon as possible to move products into the commercial space for public good.
In contrast, a research institute with a clinical center may want to run its own clinical trials, and then commercialize its technology. It could be beneficial to have various combinations of government, academic, non-profit, and commercial entities to partner with to accelerate commercialization of a product for the public good. Without collaborations, inventions may not be commercialized.
For example, in the case of rare diseases, small patient populations and therefore potentially smaller profits may be a disincentive for commercial entities to tackle research/technology development alone.
Research Publications and Patent Strategy
Universities, research institutions, and foundations often live by the idiom “publish or perish,” which may conflict with keeping trade secrets, a form of IP protection that can be valuable to companies.
The drive to publish quickly must be managed carefully by for-profit partners when IP protection, and particularly patents are desired. Invention disclosures should be followed with timely patenting decisions and filings prior to public disclosures.
On balance, the need to publish should not encourage premature patent filing, as this could be detrimental during patent prosecution and it could reduce the market exclusivity period of a product on the market. The challenge involves striking a balance between the needs of the researcher and the requirements of developing a promising technology.
Patent strategies between collaborators may differ further based on desired cost control, speed to issuance, breadth, and geography. Small companies often seek to obtain a granted patent as quickly as possible to help them raise funding in exchange for equity. Potential investors favor granted patents, because applications carry the risk of not being granted.
Conversely, universities with limited patent budgets may try to delay examination of patent applications and the costs associated therewith. Some academic establishments are judged by the metric of the number of patents filed and granted and therefore they may prefer multiple incremental filings over a single broad filing.
This tension regarding research publications as well as the timing and number of patent filings should be acknowledged and managed in a research collaboration.
Influence of IP Ownership on Technology Development Strategy
Where patents and other intellectual property is solely owned, the owner has the utmost influence over technology development as they have full control over the asset. This influencing ability decreases as ownership in the IP decreases. See Figure 1.
Co-owners of jointly owned technology may have differing perspectives on the development of the technology. In some instances those perspectives could differ significantly based on various factors such as their status as private or public entities, their technology pipelines, the time and the resources that they may commit.
Where the technology is jointly owned, and one collaborator may also own the background IP, that collaborator could have a significant advantage and ability to influence the technology development. In that case, they may want greater control over the development. But the other collaborator may have know-how or other background rights in manufacturing that they can bring to the table. With a solid IP position around the technology and development, practically speaking they could be the sole entity to commercialize the technology.
In either case, it may be beneficial for collaborators to compromise in developing the technology as both collaborators have something to contribute to development. In cases where one collaborator does not have any IP stake, they may have little to no ability to influence the development of the technology.
This ability will depend on whether they can crucially contribute to the development through access to patient populations or manufacturing facilities. With that being said, there could be some deference given to know-how or non-IP assets that enable the technology in some way.
Usually, the ability to influence technology development is directly proportional to the ownership stake in IP. For this reason, joint ownership of IP, if not managed appropriately with an agreement between the parties that clearly outlines how the IP will be shared, managed, and commercialized, can result in various pitfalls. On the other hand, a joint venture with the appropriate partner under suitable terms can lead to achieving success that may have been unachievable alone.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Ami Gadhia, JD, LL.M., CLP, serves as a technology transfer and patenting specialist in the Office of Strategic Alliances at the National Center for Advancing Translational Sciences, where she facilitates the collaborations of NCATS/NIH scientists.
Anji Miller, M.Sc Ph.D CLP RTTP, is a U.K. technology transfer professional with over 12 years’ experience of working in the academic and not for profit sector.
Shu Hui Chen, PhD, is a scientific program specialist with over 6 years of technology transfer and policy experience working in the academic and government sectors.
Brian Coblitz, Ph.D., manages commercialization of life sciences technologies for the George Washington University.
The authors would like to acknowledge Sury Vepa, PhD, JD, National Center for Advancing Translational Sciences, for his contributions to the figure.
The views expressed in this article are those of the authors and do not necessarily represent the views of the National Center for Advancing Translational Sciences; the National Institutes of Health; the U.S. Department of Health and Human Services; or the George Washington University.