A pharmaceutical patent is a global asset. A product’s loss of exclusivity is decided country by country, and every major market applies its own patent law. At Evolve, we draft patent applications for worldwide protection, taking account of US, European and other key jurisdictions’ law from the first filing, so that one application can support strong claims in every market that matters.
Why global drafting matters
Patents are the main source of market protection for a medicine. The loss of exclusivity date drives revenue forecasts, clinical investment, deal terms and royalties, and it is set separately in each country (Evolve Insights). An application drafted with only one patent system in mind can leave gaps in key markets, and those gaps are usually found when it is too late to fix them. We draft so that the claims cover the product as it will be developed, approved and marketed, in every territory you need.
Meeting US and European requirements together
The US and Europe test the same application in different ways. In the US, claims must satisfy the written description and enablement requirements, and the courts have applied these strictly to broad genus, functional and platform claims in the life sciences (Evolve Insights). At the EPO, the application must make the claimed technical effect credible on the filing date, and later data cannot fill a gap in the application as filed (Evolve Insights). We draft claims and supporting disclosure that satisfy both systems, with a layered claim set running from broad claims down to the lead candidate.
Definitions and claim construction
Definitions in the description can narrow claims unexpectedly, and courts and patent offices do not always read them the same way. In Alnylam v Moderna, a definition in the description narrowed the US claims (Evolve Insights), and in Wyeth v AstraZeneca a definition contributed to an enablement problem (Evolve Insights). With the EPO’s Enlarged Board now confirming the role of the description in claim interpretation and description amendments (Evolve Insights), we choose and define terms so that they work under each system.
Building in basis for future amendments
Claims will need to change during prosecution, opposition and litigation, and the EPO’s test for added matter is one of the strictest in the world (Evolve Insights). We build in clear basis for fallback positions, including combinations of preferred features and specific embodiments, so that you can amend in Europe, the US and elsewhere without losing your filing date.
Supporting the claims with data
In pharma and biotech, patentability increasingly turns on data. We advise on which experiments and results to include, how to present them, and when it is worth waiting for more data before filing, balancing the strength of the data against the risk of being overtaken. The US gives a one-year grace period for your own disclosures, but Europe does not, so filing before any publication remains essential.
Patent term and regulatory exclusivity
Good drafting also looks ahead to the end of a patent’s life. Patent term extensions and SPCs depend on the marketing authorisation, and the rules for them differ from country to country. We draft with these in mind, so that your claims can support term extensions for the approved product wherever possible, and we keep track of changes to the regulatory framework that may affect your period of market protection.
Technology specialists
A patent application can only be as good as the drafter’s understanding of the science. Knowing what the data really shows, which variations a competitor could make and what the prior art is likely to teach is what turns an invention into claims that are both broad and defensible. Our attorneys have scientific backgrounds in the fields they draft in, and many have worked in research or in-house at pharma and biotech companies. That means we can engage directly with your scientists, spot the inventive contribution quickly and anticipate the objections an examiner or opponent will raise.
We draft across small molecules, biologics and antibodies, cell and gene therapies, nucleic acid medicines, formulations, dosage regimens, medical uses and manufacturing processes, including sequence listings and Markush claims.
Fractional IP counsel
Our fractional IP counsel model places a named senior patent attorney inside your team as your head of IP, deciding what to file, when and where, and working with your scientists to capture inventions as they arise.
Why fractional IP counsel for patent drafting? The best applications are drafted by people who know which inventions are worth filing and how the claims will later be used. Our patent directors have built portfolios from inside pharma and biotech companies, and bring the real-world industry experience that you only get working in-house to the decision of what to file and when. Our drafting team, supported by Darwin and Gilbert, then turns that into strong applications quickly, which a consultant working alone, or a traditional firm without that in-house view, struggles to match. Every filing is planned with a global strategic approach.
Contact us today to discuss your next patent application.
Evolve AI
Darwin: Patent drafting
Darwin drafts the claims, the specification and the sequence listing alongside the attorney, one decision at a time.
Drafting a pharma application means working out what the data will support before you decide what to claim. Darwin is built around that order of events, for small molecules, biologics and cell and gene therapy. It prepares:
- Claims: from the data, with the attorney choosing the claim format and the drug definition at each step
- Claim iteration: amendments added to an existing set without disturbing it, and the numbering tracked
- Specification: each section written from the claims and the data, with the figures pulled out and labelled
- Sequence listing: a compliant ST.26 file produced in code rather than by a language model, because the listing has to match the data exactly
Gilbert then reads the whole application through. The attorney settles what the data supports and what the business needs the patent to do. See how we work with start-ups and established pharma, or read how to read a biotech patent.
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