Before you invest in development, partner a programme or launch a product, you need to know whose patents stand in your way. At Evolve, we carry out freedom to operate (FTO) analyses for pharma and biotech products and give clear, actionable advice on the risks we find.
Freedom to operate and patentability are different questions
A patent gives its owner the right to stop others, not the right to use the invention. An invention can be new and inventive, and so patentable, yet still fall within the scope of someone else’s broader patent. In biotech this comes up all the time. A new antibody to a known target can be patentable but still covered by an earlier patent to any antibody binding that target. A new antibody may rely on an Fc modification or multispecific format owned by someone else. A new medical use of a known drug can be patented while the product patent is still in force (Evolve Insights).
Breaking the product into its parts
Complex products combine several technologies, each with its own patent landscape. A single CAR-T product, for example, brings together the cell, a gene editing platform, a delivery vector, the CAR construct and the manufacturing process. We break your product down into its components and assess the risk for each, so that the licences you may need, and the risk of royalty stacking, are visible early (Evolve Insights).
Not every granted patent is enforceable
Broad, field-blocking patents can look alarming, but some will expire before your product reaches the market and others may not survive a validity challenge. In the US, decisions such as Juno v Kite and Amgen v Sanofi have raised the bar for broad biologics claims, so many older patents may now be vulnerable (Evolve Insights). We assess validity alongside scope, so that you understand the real level of risk.
Start early
FTO is not a late-stage legal check. Investors and partners expect it to be built into research and clinical planning from the start, while design choices, licences and challenges can still be planned. Because the best route to both freedom to operate and strong patents is innovative science rather than minor design-arounds, early FTO work also helps shape a stronger patent position.
A high-level view when you need it
Not every decision needs a full clearance opinion. When you need a fast, strategic view of which third-party rights matter and how strong they really are, for example before a term sheet or an investor meeting, we can provide a focused high-level review at a fraction of the cost, and go deeper only where a particular risk warrants it.
Focused searches and analysis
We define the scope of the analysis around your product, how it is made and used, and the territories that matter to you. We search granted patents and pending applications, assess the claims that could be relevant, and prioritise the results so that you can see quickly which families really matter.
Pending applications and monitoring
Many FTO risks sit in pending applications whose claims may change before grant. We assess the likely scope of these applications and can monitor the families that matter, so that grants calling for action are flagged while there is still time to respond.
Clearing the path
Where a risk is real, we help you choose the right response. That may be designing around, challenging validity through third-party observations or oppositions, taking a licence, or timing your launch around patent expiry, SPCs and regulatory exclusivities.
FTO in deals
FTO is central to licensing, investment and acquisition. We provide FTO analysis tailored to a transaction as part of our due diligence work, from a rapid initial view to an in-depth review.
Fractional IP counsel
Our fractional IP counsel model places a named senior patent attorney inside your team as your head of IP, keeping freedom to operate under review as your programmes develop, monitoring the families that matter and dealing with risks before they become urgent.
Why fractional IP counsel for freedom to operate? Freedom to operate is not a one-off opinion but a risk that changes as your product and the patent landscape develop. A fractional head of IP from Evolve brings the real-world industry experience that you only get working in-house, keeps FTO under review alongside the development plan and reports it to the board in plain terms. Behind them is a team that can clear every component of a complex product and, where needed, bring an opposition, supported by Albert. A traditional IP firm or a lone consultant rarely offers that continuity, or such a global strategic approach.
Contact us today to discuss your freedom to operate.
Evolve AI
Albert: Validity, oppositions and competitive intelligence
Albert sets out a patent’s data, construes the claims and finds the weak points so that we can get to the analysis quickly.
In pharma, validity nearly always comes down to the data. Albert is a set of modules, one for each question we tend to ask of a patent, whether it belongs to a competitor, a licensing target or one of our own clients. It prepares:
- Data: each embodiment matched to its effect, the experiments behind it and the claims it supports, with a score for how good the evidence is
- Basis, support, novelty, inventive step and priority: claim by claim, against the application as filed, the data and the prior art
- Sequences and Markush formulae: lead sequences checked, generic formulae drawn out, expanded or compared with a real compound
- Construe: each claim term read against the specification
We use Albert for competitive intelligence, freedom to operate, oppositions and diligence. Albert gets us to a strategic view quickly, and we go deeper only where a particular risk warrants it. More on Albert and Albert Construe.
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