From a strategic IP perspective, Morris Law assists its clients through the entire product life cycle in the complex and heavily regulated industry most life science companies work in.
The innovation phase is characterised by collaboration, either between companies, scientists, academies or individual innovators. The most central issue in this phase is to ensure that every party gets a fair share from the collaboration, while risks and uncertainties are handled in a balanced manner.
”Together with our client we create a foundation from which the innovation can develop into the phase of commercialisation. Already in this phase, there should be a plan for the company’s legal structure, which enables financing through the entire life cycle and/or exit. Establishing a new company for developing the innovation further is often a good solution, especially in collaborations and for not jeopardising the rights to existing products in the owning company,” says Henrik Almström, Associate at Morris Law, working with protection and commercialisation of intellectual assets and IT as well as advice in regulatory and compliance matters with a focus on the life science industry.
”Bring up sensitive issues at an early stage and make sure they’re drafted correctly in the agreements,” urges Caroline Ygge. ”This concerns the entire process, from initial research collaboration and confidentiality to global licensing.” She’s lawyer and partner at Morris Law, and specialised in protection and commercialisation of intellectual property rights and IT, commercial agreements and life science regulatory matters.
Commercialisation and Market Entry
Once the collaboration or innovation has been turned into a product or solution, Morris Law provides legal tools for creating a business model that adheres to and can leverage on the protection enjoyed by the innovation. The fact that a substantial part of a life science company’s revenues stem from public procurements, and that compliance to the complex regulatory environment is necessary, must be built into the business model.
”The innovation’s best selling-points should be able to address the requirements specification of a tender document to increase sales to public sector purchasers. In addition, a correct understanding and application of the regulatory affairs is of greatest importance,” says Caroline Ygge.
Licensing and Distribution
Once on the market, the potential for growth often lies in the innovation’s intellectual character, viz. that it can be reproduced and commercialised without exhausting. Well thought-out licensing and distribution models, covering regulatory demands, spread the risks and costs of commercialisation, while the protection and rights are controlled by the owning company. Marketing issues should also be covered by the agreements in this phase.
Enforcement and Litigation
The greater the success of an innovation, the greater the risk of someone wanting to copy or steal it, or challenge it in some other way. This is something that a company must be prepared for and the legal structure must always be formulated in a way that makes it work when things get tough.
”If you know how the industry works, you may be able to reach a smart settlement. However, it’s not always possible, and whether you like it or not a litigation is a legal tool, which must sometimes be considered to keep one’s market position,” says Henrik Almström.
Alongside the innovation’s commercial development and matureness on the market, there’s a continuous technological development, which must be followed by a preparation for a 2.0 version of the innovation.
”In this phase, the early agreements of research and collaboration are truly put to the test. The risk of discord is often greatest in this phase. To have a well-founded legal plan for the next step is fundamental for this life cycle to be cyclical and not to end with the 1.0 version,” Henrik Almström concludes.