Contract research organisations (CROs) and contract development and manufacturing organisations (CDMOs and CMOs) sit at the heart of the pharmaceutical value chain. The data you generate and the processes you run can make or break your clients’ patents, and your own platforms, methods and know-how are valuable IP in their own right. At Evolve, we help CROs and CMOs protect their innovations, manage freedom to operate and keep IP terms with clients clear.
Our fractional IP counsel model gives you a named senior patent attorney who works inside your team, reviewing client agreements, managing freedom to operate and protecting your platforms and processes, without the cost of a full in-house IP function. Our own AI tools, developed by our attorneys specifically for pharma and biotech IP, let us map the patent landscape around your services quickly and in depth, while our attorneys make the judgement calls.
Protecting your platforms, processes and know-how
Proprietary assays, disease models, screening platforms, data and AI tools, formulations, purification steps, cell lines, scale-up methods and analytical techniques can all be protected, by patents, trade secrets or a combination. Process patents can be hard to enforce, so for some innovations a well-managed trade secret is the stronger option. We help you choose the right approach, and capture and document your know-how so that it remains protectable and differentiates your services.
IP terms in client agreements
Who owns the results of a study, or a process improvement developed during a client project, and who can use it for other clients? We review and negotiate ownership of results, background and foreground IP, improvements to your own platforms, licences and confidentiality obligations in master services, development and supply agreements, drawing on our team’s experience negotiating IP terms in high value pharma transactions.
Freedom to operate
Research tools, reagents, cell lines, assays and manufacturing processes can themselves be patented, and running a client’s project can infringe third-party patents even when the product belongs to the client. We assess freedom to operate for your services, platforms and processes, and help you manage and allocate that risk through licences and contract terms.
Generating data that supports patents
Patent offices, particularly the EPO, increasingly expect experimental evidence of a technical effect. The design of a study and the way its data is recorded and reported can therefore matter for your clients’ patents. We can advise on study design and reporting so that data supports patentability, and help avoid premature disclosure of results.
Advanced therapy development and manufacturing
Cell and gene therapy is a particularly active area for IP, with valuable inventions in vector production, cell processing, analytics and quality control. Our team includes cell and gene therapy specialists who understand both the science and the IP landscape.
Fractional IP counsel
Why fractional IP counsel for CROs and CMOs? Contract organisations face IP questions in every client agreement, but rarely need a full in-house IP team. A fractional head of IP from Evolve brings the real-world industry experience that you only get working in-house, having sat on the client side of the table, and knows which terms really matter. Our team covers freedom to operate, process protection and disputes, supported by our own AI tools, giving you more than a traditional IP firm or a lone consultant can, with a global strategic approach.
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