Genomics
Reference 1 Schuhmacher, A, Gassmann, O, Hinder, M. Changing R&D models in research-based pharmaceutical companies. J Transl Med. 14(1):105 (2016).
The Broad Institute explicitly addresses use of its
CRISPR IP by non-profit institutions as follows: “No licence is necessary for academic and non- profit use. Non-profit institutions and government agencies do not need to receive a written licence from Broad to conduct internal research, including sponsored research to the extent such research does not include the production or manufacture of products for sale or offer for sale or performance of commercial services for a fee. Further, non-prof- it institutions and government agencies may trans- fer materials they generate in the conduct of such internal research to other non-profit institutions or government agencies under the terms of the UBMTA without needing to receive a further writ- ten licence from Broad.” While Broad grants wide use rights to non-profit institutes, for-profit com- panies should clearly understand the implication that acquisition of GEMs or other research tools made using CRISPR from non-profit institutions is not permitted without obtaining additional tech- nology rights. They should also understand that the use of such tools in fee-for-service work at non- profit partners may require additional licences from CRISPR IP owners.
Beyond patents While GEMs can be patented, that is not always the best strategy in terms of commercialisation. Gaining patent protection is expensive and time- consuming and may need to be pursued in multiple countries. From a cost-benefit perspective, invent- ing institutions may be better served through main- taining control of materials rather than obtaining patents. Licences granted to use of materials rather than patent rights can also yield royalties for extended periods of time. While the US Supreme Court held that collection of royalties after patent expiration is unlawful in Brulotte versus Thys Co, licence agreements predicated on access to materi- als do not have legal limitations on the royalty period. Many GEMs are distributed under licences which grant access only to materials and know- how, and this can be a very cost-effective way for inventing institutions to realise revenue from such inventions.
So what’s a drug developer to do? Intellectual property around GEMs can feel a bit like a minefield, but with proper due diligence, these important tools can be used without worry. The most important tactic is simply to be aware and ask questions. When contemplating obtaining a GEM or other research tool from a non-profit institution or collaborator, be sure to inquire as to
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the IP status of the tool. Relevant questions include:
l Where was the tool developed and who devel- oped it? l Were any materials provided by third parties? l Under what terms was the animal model or con- tributing material received? lWhat technologies were used to develop the ani- mal model? l Do you have rights to use the animal model for commercial purposes or only for internal, non- commercial research?
The answers to those questions can identify
problems or turn up the need to obtain additional licence rights prior to use in the planned research. Identifying such issues upfront is always preferable to sorting out a larger problem downstream and can insulate your organisation against expensive lawsuits.
DDW
Dr Megan MacBride is Director, Commercial Models at Taconic Biosciences. She holds a PhD in chemistry from the Pennsylvania State University and has 12 years of experience in product manage- ment across various animal model segments.
Drug Discovery World Fall 2018
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