Evolve is a specialist pharmaceutical and biotechnology IP firm. Our team includes scientific experts in immunology, antibody engineering and biologics, and we manage global antibody patent portfolios from discovery to on-market products.
Related technologies: ADCs | T cell engagers | CAR-T | Formulations | Life cycle management
Antibodies can be protected in many ways: by their sequence, their target and epitope, their function, their format, their therapeutic use and their manufacture. Bispecific and multispecific antibodies, T cell engagers and the binders used in cell therapies add further layers (Evolve Insights).
The market for an antibody is global, and loss of exclusivity is decided country by country (Evolve Insights). We manage global antibody patent portfolios, coordinating strategy and prosecution across the US, Europe, Japan, China and other key markets. Claims, filing timing and supporting data are planned for all of them from the first filing, and we keep the position consistent so that arguments made in one office do not weaken the portfolio in another.
In the US, the Supreme Court in Amgen v Sanofi confirmed that broad functional antibody claims, such as claims to any antibody that binds a target and blocks its function, can fail for lack of enablement (Evolve Insights). In Europe the problem is often the opposite. Making antibodies to a known target is considered routine, so broad functional claims may be sufficiently disclosed but struggle to show an inventive step. The UPC Court of Appeal has broadly followed the EPO’s approach (Evolve Insights). Japan, China and other markets take their own approaches to antibody claims and supporting data, so we plan the claims and the data package for each of them.
Epitope claims are now very hard to obtain in the US, but the EPO has continued to uphold broad epitope-defined claims where the application gives the skilled person enough guidance, as in T 0326/22 (Evolve Insights). US decisions such as Teva v Eli Lilly suggest there may still be room for method of treatment claims to an antibody genus (Evolve Insights). We draft claim sets that use the opportunities in each jurisdiction, from functional and epitope claims down to sequence claims to the lead antibody.
Where the target is already known, a new antibody usually needs to show a surprising technical effect over existing antibodies, such as better affinity, potency, safety or developability. Planning the comparative data early, and including it in the application, can make the difference. Your own later data can also undermine a broad claim if it shows that parts of the claimed scope do not work (Evolve Insights).
Sequence identity claims, CDR definitions and combinations of features taken from different lists are common targets for attack at the EPO (Evolve Insights). We draft definitions and fallback positions carefully, so that the claims cover the clinical antibody and the variants a competitor would try next.
Antibody IP strategy is different from small molecule strategy. A generic small molecule can launch on the loss of exclusivity date, causing a steep patent cliff. Antibodies are harder to copy and more expensive to make, so biosimilar competition tends to arrive more gradually, while in-class fast followers with different sequences may arrive well before your patents expire (Evolve Insights). Protection therefore has to reach beyond the exact sequence, and it works alongside regulatory exclusivities, patent term extensions and SPCs. We plan follow-on protection, such as formulations, dosing regimens, routes of administration and new indications, as part of life cycle management from the start.
In oncology, value often lies in combinations, lines of therapy, biomarker-defined patient groups and dosing schedules, and competition from other modalities can matter as much as competing patents. In autoimmune and inflammatory disease, antibodies are often used long term and across several indications, so new indications, dosing intervals, subcutaneous formulations and delivery devices can support long-lasting follow-on protection. We tailor the strategy to the therapeutic area and its competitive landscape.
Cell lines, culture conditions, purification steps and formulation know-how are hard to reverse engineer and can give a lasting advantage, particularly against biosimilar developers who must build their own processes. Some of this is best kept as a well-managed trade secret and some is worth patenting. We help you decide which, and make sure know-how is documented and protected in supplier and manufacturing agreements (Evolve Insights).
Today’s antibody may become tomorrow’s bispecific, ADC, T cell engager or CAR-T binder, and half-life extension or new formats can extend a franchise. We draft so that the value of your binders carries into next-generation products, and plan filings so that they are not undermined by your own earlier disclosures.
Antibody patents usually cover the antibody as such, so they can block not only competing antibodies but also ADCs, bispecifics and CAR-T products that use the same binder. Platform patents on formats and Fc modifications add further layers (Evolve Insights). Read more about our freedom to operate work.
Our fractional IP counsel model places a named senior patent attorney inside your team as your head of IP, building the portfolio around your lead antibodies, managing format and platform in-licences, and keeping the strategy aligned with the clinical plan.
Why fractional IP counsel for antibody companies? Antibody portfolios are global, long-lived and constantly tested by biosimilars and fast followers. Our patent directors have managed them in-house, so they bring the real-world industry experience that you only get working in-house to life cycle planning, format and platform licences, and board reporting. With our team and AI tools behind them, including sequence checks by Albert and Gilbert, they offer more than a traditional IP firm or a consultant working alone, with a global strategic approach.
Albert, our validity agent, sets out the data, claims and weak points in competitor antibody patents, and its sequence module checks lead sequences against the claims. Gilbert, our quality agent, checks whether the claims really cover the lead sequence before anything is filed. Our attorneys still make every judgement call. Read more about Albert and Evolve AI.
It depends on the market. In Europe sometimes, in the US rarely, and other major markets such as Japan and China apply their own standards. The EPO and UPC will accept functional and epitope claims if the application enables the whole scope, but they must also be inventive, which is hard where the target is known. In the US, Amgen v Sanofi makes broad functional claims very difficult to sustain. Read more: Amgen v Sanofi
Yes, if it shows an unexpected technical effect over the antibodies already known, such as better affinity, potency, safety or manufacturability, and the application includes data to show it.
Yes. Sequence claims to the lead antibody and close variants are the most robust protection in every jurisdiction, and they cover the product even if broader claims fall.
Usually yes. Claims to an antibody as such cover products containing it, so freedom to operate for an ADC, bispecific or CAR-T has to include antibody patents on the same target. Read more: Freedom to operate versus patentability
Formats and platforms are often patented separately from the binders, so both need clearing. A new format, or a new combination of targets with an unexpected effect, can also be patentable in its own right.
Often, yes. Each patent office applies its own standards to functional claims, inventive step and supporting data, and the timing of national filings matters. We coordinate global prosecution so that claims stay as consistent as possible across markets, and so that arguments made in one office do not weaken the position in another.
Patents are only one layer. Regulatory exclusivities, patent term extensions and SPCs, manufacturing know-how and the cost of developing a biosimilar all play a part. We forecast loss of exclusivity market by market, against both biosimilars and in-class fast followers. Read more: Why patents matter
We are happy to have an informal conversation about your programme, with no obligation. You can read more about our team, and we also write a regular newsletter on pharma and biotech IP.