Vaccine Development Process Map

Freedom to Operate

Summary of the area

Freedom to Operate is determining whether a particular action, such as testing or commercialising a vaccine, can be carried out without infringing valid intellectual property (IP) rights of others. Since IP rights are specific to different jurisdictions, a freedom to operate analysis should relate to particular countries or regions where you wish to operate. If you want to commercialise a new vaccine in your own country you might have complete freedom to operate if there are no patents, technologies, trademarks or other IP rights covering the vaccine, the process used to make it or the way you wish to market it or in your country.

A Freedom to Operate search will generally be conducted by specialist professionals (usually lawyers) with an expertise in Intellectual Property Law and Management. The search will involve a thorough review of all the materials, technology and methodology to be used in developing the vaccine with a view to ensuring that there are no legal reasons or prior patents that would restrict work within this area. This will generally be carried out before the instigation of significant work on the project and prior to the filing of any patent applications. The time required to complete this search will be dependent on the complexity of the proposed work but it is likely to take a minimum of 3-6 months.

What are the critical steps within the process?

The critical steps in Freedom to Operate will be 1) conducting a comprehensive and thorough search of all public disclosures of information related to the new vaccine development (including patents, publications, reviews, talks, etc), 2) reviewing the outcome of these searches and their likely impact on the proposed activities, 3) assessing whether there are any legal restrictions to conducting the research and development, and finally 4) recommending an appropriate course of action.

Are there any bottlenecks within this process? Who owns the bottleneck?

A Freedom to Operate analysis invariably begins by searching patent literature for issued or pending patents, and obtaining a legal opinion as to whether a product, process or service may be considered to infringe any patent(s) owned by others. Large institutes and commercial organisations are likely to have their own IP support infrastructure. Many private law or IP firms also offer such analyses as part of their legal services to clients. Some national IP offices also offer such services for a fee. As a result this should not prove to be a significant bottleneck for vaccine development providing that suitable support can be identified.

How could the bottlenecks be resolved?

Ensure that suitably trained specialist IP lawyers can be consulted.

Are there any rate limiting capacity issues?

Specialist skills are required but there are currently a number of such trained individuals within private law firms.

Additional comments

A Freedom to Operate analysis based on the search of patent literature is just the first step. If the patent search reveals that one or more patents do limit an individual’s or company’s freedom to operate, then they must decide how to proceed, to prevent this becoming a major rate-limiting step. This could involve gaining access to the relevant IP so the technology can be used in the vaccine R&D process. If this isn’t possible, to take the vaccine development further it might be necessary to invent an alternative technical approach. Developers must bear in mind that this can result in modifications to the TPP and therefore FTO considerations should happened early on in the development process.