Evolve is a specialist pharmaceutical and biotechnology IP firm. Our team includes scientific experts in chemistry, biochemistry and pharmaceutical science, and we have managed IP strategy for products at every stage of the pipeline, including on-market medicines.
Related technologies: Dosing regimens | Life cycle management | Formulations | Antibodies
Every major market allows new uses of known medicines to be protected, but in different ways. The US allows method of treatment claims, Europe and Japan use purpose-limited product claims, and China uses use claims in the Swiss style. These differences affect how claims are drafted, what data is needed and how the patents can be enforced, so we plan new indication filings market by market. Anyone can file for a new use, including a party that does not own the product patent, which creates its own freedom to operate questions on both sides (Evolve Insights).
Patent offices differ on how much data a new use needs. The EPO requires the claimed therapeutic effect to be credible from the application as filed. The bar can be low, and pre-clinical or mechanistic data may be enough (Evolve Insights). But the low bar cuts both ways, because speculative prior art suggesting the same use can also be used against you (Evolve Insights).
Post-published data can support inventive step, as in the ribociclib and letrozole combination case (Evolve Insights). It cannot fill a gap in the application as filed, and later trial results that cast doubt on the effect can sink a patent (Evolve Insights).
A new patient group can be a new use. A patent to empagliflozin in patients with impaired kidney function was upheld even though the patentee had already reported phase III success in the wider population (Evolve Insights). Combinations can be inventive where they show synergy or another unexpected effect, and the timing of the filing matters (Evolve Insights).
Infringement of a second medical use claim depends on how the product is made, labelled and marketed, and the UPC has now begun to set out its approach (Evolve Insights). In Europe, a new use of a known active ingredient generally cannot support a new SPC, although the Court of Justice has been asked to revisit this. Other markets, including the US and Japan, apply their own rules to extensions (Evolve Insights).
Our fractional IP counsel model places a named senior patent attorney inside your team as your head of IP, spotting new uses as they emerge from research and clinical data, and making sure they are filed before anything is disclosed.
Why fractional IP counsel for new indications? New uses often emerge from research and clinical data before anyone recognises them as inventions. Our patent directors bring the real-world industry experience that you only get working in-house to spotting them, and Franklin helps make sure they are filed before they are published. With our team behind them, they offer more than a traditional IP firm or a consultant working alone, with a global strategic approach to how new uses are protected in each market.
Franklin, our invention spotting agent, reads what your scientists are about to publish and flags new uses and other inventions before they are disclosed. Read more about Franklin. Our attorneys still make every judgement call. Read more about Evolve AI.
Yes. A third party can patent a new use of your product, but cannot practise it without a licence while your product patent is in force, and you cannot use the new indication without a licence from them. Read more: Freedom to operate versus patentability
Enough to make the therapeutic effect credible from the application as filed. Pre-clinical or mechanistic data can be enough at the EPO, other offices may expect more, and stronger data makes the patent more robust everywhere. Read more: Mechanistic insights (T 1601/22)
In Europe, generally not, if the active ingredient has already been authorised, although the Court of Justice has been asked to revisit the question. Other markets have their own rules, so we plan extensions market by market. Read more: The Santen referral
They are prior art, so they must be planned around. They do not always destroy a later filing for a specific subpopulation. Read more: Empagliflozin subpopulation patent (T 1437/21)
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.