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 | New indications | Platform technologies | Lipid nanoparticles
Formulation patents protect how a medicine is presented: its excipients, concentrations, pH, particle size, release profile, stability and route of administration. They are a core part of life cycle management, and become especially important when the active ingredient is old, well known or difficult to protect (Evolve Insights).
Formulation development can look routine to a patent office. Patent offices around the world ask whether a new formulation would have been obvious. The EPO, for example, expects a technical effect over the closest prior art, and where a concentration or range is the only difference, selection invention case law and the need for an unexpected effect come into play (Evolve Insights). Planning comparative stability, bioavailability or tolerability data early can make the difference.
Formulation claims are often defined by a property, such as stability or a dissolution profile. When an effect is written into the claim, the EPO treats a failure to achieve it across the whole claim as a sufficiency question, and functional language can also be harder to enforce (Evolve Insights). We balance structural and functional definitions so that the claims are both valid and enforceable.
Opponents often argue that a prior formulation inevitably contained the claimed feature. In a recent pertuzumab formulation case, the Board of Appeal rejected arguments that a claimed antibody variant was implicitly disclosed (Evolve Insights). Careful characterisation of your formulation in the application helps to defend novelty.
Unlike the dose, a formulation is not always fixed by the label, so a generic may be able to reformulate. Formulation patents are strongest where the formulation is hard to change, for example where it is essential to the stability, bioequivalence or approved presentation of the product. Even then, they need a clear technical effect. A Wegovy patent claiming a specific dose and pH was found obvious despite the product’s commercial success (Evolve Insights).
Some formulation and process know-how is best kept as a well-managed trade secret, and some is worth patenting. We help you decide which (Evolve Insights).
Generic and biosimilar competition arrives market by market, and formulation patents are examined differently in the US, Europe, Japan, China and elsewhere. We coordinate formulation filings across the markets that matter, so that protection lines up with where the product is sold and where generics are likely to launch first.
Our fractional IP counsel model places a named senior patent attorney inside your team as your head of IP, planning formulation filings alongside development and making sure the data needed to support them is generated and captured.
Why fractional IP counsel for formulation work? Formulation inventions are made in development labs, often long before anyone thinks about patents. Our patent directors bring the real-world industry experience that you only get working in-house to spotting them early and making sure the comparative data is generated to support them. With our team and AI tools behind them, they offer a continuity that a traditional IP firm or a lone consultant rarely can, with a global strategic approach to where generics are likely to launch.
Albert, our validity agent, sets out the data behind competitor formulation patents and finds their weak points, and Darwin, our drafting agent, helps the attorney build claims around your formulation data. Our attorneys still make every judgement call. Read more about Evolve AI.
Yes, if the formulation is new and has a technical effect that would not have been expected, such as improved stability, bioavailability or tolerability, supported by data in the application. Read more: Selection inventions (T 1356/21)
Sometimes. The dose is usually fixed by the label but the formulation may not be. Formulation patents are most valuable where the formulation is essential to the approved product.
Usually both, in a layered claim set. Functional claims can be broad but need support across their scope and can be harder to enforce. Compositional claims are narrower but more robust. Read more: Functional formulation claims (T 2130/22)
Once you have the data that show the advantage, and before any publication, poster or regulatory disclosure that could become prior art.
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.