The recently released Mewburn Ellis IP Guide for SMEs sets out IP priorities for businesses at four different stages in their life cycle. The IP Guide is aimed at businesses in all technological fields, but these IP priorities are especially important to businesses developing cellular products and therapeutics.
Although businesses developing cellular products operate on a range of different business models, these models typically involve the development of therapeutic assets. In order to produce a consistent, clinical grade therapeutic product and successfully overcome the high regulatory barriers required to bring it to market, a cell therapy business will typically need to collaborate or license with, or be acquired by, a larger entity, such as a big pharmaceutical company.
Even getting to this stage is likely to be an expensive endeavour. Multiple rounds of fund raising may be needed to progress a cellular therapeutic asset to a stage where it is sufficiently attractive for a larger entity to get involved. Once involved, the larger entity will then need to invest resources and money to take the asset through clinical trials into the marketplace.
All this investment relies on the parties being able to reap a sufficient reward if the asset is marketed successfully. If competitors can generate competing products as soon as a cellular therapeutic becomes successful, then the potential reward for its development is diminished: there may be no incentive for investors or larger entities to finance the asset or the business developing it. It is therefore crucial for cell therapy businesses at all stages to ensure that their assets have the best possible IP protection to attract the investment and collaboration required for success.
Given the central role played by IP in cell therapy business models, many businesses in the sector will be launched with an existing portfolio of background IP. This background IP may, for example, protect a platform technology or a biological target that the business is proposing to use.
Although at this “launch stage” the asset may not be its final form, or indeed any tangible form, the background IP defines the exclusive technical space in which the business intends to operate. Because early stage businesses are unlikely to have the resource to hire in-house legal counsel at this early stage, managing this background IP can be a challenge. However, systems and plans need to be put place from the outset to control costs and ensure the management of the IP is aligned with the objectives of the business. This may also be a convenient time to carry out some due diligence to check that all the paperwork relating to the background IP is in place and there are no awkward problems that might be unearthed by a potential investor or competitor who later comes to review the IP.
After launch, cell therapy businesses typically use the technology defined by the background IP to develop their asset to a stage where it can be tested in the clinic. At this “growth stage”, the cell therapy business may file further patent applications to protect different aspects of a cellular product as it is developed, for example improvements to antigen receptors, co-expressed factors that improve performance and changes to the cell genotype that confer advantageous properties.
Keeping track of the expanding IP portfolio and deciding what to protect and how, whilst at the same time controlling costs, may be a considerable challenge. Patent landscaping may be helpful in identifying which potential aspects of a cellular product are most likely to be free of competitor IP and therefore most promising to take forwards.
Promising cellular products that are identified in the initial development phase are likely to require further development to generate a potential therapeutic. This corresponds to the “expansion stage” of the IP Guide for SMEs. Potential cellular therapeutics and their methods of production are the key assets on which the value of the cell therapy business is likely to be based.
In particular, the development of cellular therapeutics typically has a heavy emphasis on the development and optimisation of production processes. Modification and optimisation of the production process can have a significant effect on the cells that are produced. As they impact on the commercial prospects of the cellular therapeutic, these process modifications are often the subject of further patent applications and provide another layer of protection around the cellular therapeutic. In some cases, particularly where the cellular therapeutic is very similar to a natural cell, patents directed to production processes may be the only layer of protection around the product. Careful planning may be needed to maximise the value of the IP portfolio protecting a cellular therapeutic. Any IP that does not provide coverage for the cellular therapeutic in its commercial form might be out licensed or dropped altogether. For example, there may be no need to maintain IP around production processes that have been superseded or dropped during optimisation.
Freedom to operate exercises will also be important in establishing that none of the features of a cellular therapeutic infringe third party IP, ensuring that the business will be able to fully exploit their asset and maximise its value. Exploring and investigating the possible uses and applications of a cellular asset may require collaborations with academic institutions, pharmaceutical companies and/or other life sciences businesses. Legal agreements will be needed to support these collaborations. Where any barriers to the exploitation of the IP are identified, work will be required to assess the risk to the cell therapy business, and work will be required to address that risk. Careful planning and well-judged legal agreements may be needed to steer the business around these barriers.
As the cellular therapeutic asset enters preclinical and clinical testing there may be opportunities to add further IP to the protection around the key asset. For example, new formulations, production methods, administration schedules, biomarkers or patient groups relating to the cellular therapeutic may be the subject of further patent applications. IP filed at this stage may extend the period of exclusivity beyond the expiry of the initial patent filings and so adds particular value to the IP portfolio, and by extension to the business also. At this maturity stage, many cell therapy businesses will be planning their exit. Regardless of how this exit is achieved, this is likely to require the IP portfolio to be due diligence-ready and a host of legal agreements to be put in place.
The different stages of the development lifecycle of cell therapy businesses therefore pose different IP challenges. Given the importance of IP in extracting value in the cell therapy space, successfully meeting the IP challenges of each different stage is crucial in achieving the commercial objectives of any business in this field.
Mewburn Ellis works extensively with cell therapy businesses in all stages of their development, from foundation and spin-out to growth and later acquisition. We have also worked with investors and acquisitive life sciences businesses, giving us a key insight into their demands and expectations of early and developing businesses in the sector. We have unrivalled experience in guiding companies through the four stages of business development, providing pragmatic and timely advice throughout the business evolution. Working with us, you can be sure of Forward Looking IP to protect your cell therapy innovations.
Read more about cell therapy on our blog.
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