The CRISPR/Cas system enables breakthroughs in some of the most critical industries for the wellbeing of human kind. From agriculture, healthcare with an emphasis on advanced therapeutics and various biotech research tools. According to some data, the market value will surpass 6.3 billion EUR by 2026. Yet the technology can be exploited only if the accompanying legal aspects are taken into consideration.
An ongoing dispute between the Broad Institute of MIT & Harvard and CVC (University of California-Berkeley, the University of Vienna, and Emmanuelle Charpentier) regarding ownership of the fundamental patents has some impact on the industry. In the earliest years of commercialisation, the Spin-out companies that out-license the fundamental intellectual property, such as Editas, Intellia Therapeutics or CRISPR Therapeutics, experienced significant fluctuation of shares price based on the decision of PTAB. Regardless of this insecurity about the ownership, the potential of the technology is so significant that all companies continued with work, out-licensing, either exclusive or non-exclusive, the patent rights that translate into novel products. Thus, the CCEdit’s mission, aligned with its innovation of an improved CRIPSR/Cas system, was to provide a workshop explaining the intersection of market, product and legal aspects – intellectual property, in the context of biotech industry.
Considering these three segments may be vital to success of a biotech company. Specifically in the therapeutics’ industry, assets are based on intellectual property protected with patents. When engineering a product, companies need to understand if they can practice freedom-to-operate or not. In case they interfere some IP rights, they need to look for an option to in-license the IP or engineer the product around it. However, by using different components of the final product, they may change some of its characteristics and this can translate into a different healthcare economics profile. Consequently, the business case and market-access strategy & pricing may need to be changed.
The case-study was provided by Dr David Hampton, our business advisor and a co-founder, Director and CSO of medtech company Camstent. With a strategy of in-licensing certain technology, they were able to develop a product that can address an unmet need and capture a significant market value.
We concluded with a presentation made by Dr Gabriela Staber, a Partner in the law firm CMS, specialised in the Life Sciences and pharmaceutical industry. The CMS programme equIP enables young biotech companies to obtain affordable legal services, which are needed on the path from incorporation to a potential exit – an acquisition or IPO. Acting with due diligence in mind, resolving questions about newly created and used intellectual property, increases chances of business success and provides new therapeutic options to healthcare systems.