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: Formulations | Dosing regimens | New indications | Antibodies
The loss of exclusivity date drives revenue forecasts, clinical investment, deal terms and royalties. It is set country by country, by the patents, regulatory exclusivities, patent term extensions and SPCs that protect the product in each market (Evolve Insights).
Life cycle protection starts with the composition of matter patent and builds outwards: formulations, dosing regimens, routes of administration, new indications, patient subpopulations, combinations and manufacturing processes. Each needs to be filed at the right time, with the right data, so that it adds real protection rather than just patent numbers.
Small molecule generics can launch on the loss of exclusivity date, causing a steep patent cliff. Biologics are harder to copy, so biosimilar competition tends to arrive more gradually, while in-class fast followers may arrive much earlier (Evolve Insights). Life cycle strategy has to reflect the type of product and the real competition. Read more on our antibodies page.
Patent term extensions and SPCs depend on the marketing authorisation, and the rules differ between countries. The law is also still developing, for example on whether a new use of a known active ingredient can support an SPC in Europe (Evolve Insights). We plan extensions alongside the patent estate and keep track of changes that may affect your protected period.
Life cycle patents attract challenges from generics and biosimilars, and they need a clear technical effect to survive. A Wegovy patent to a specific dose and pH was found obvious despite the product’s commercial success (Evolve Insights). By contrast, a patent to empagliflozin in patients with impaired kidney function was upheld, even though the patentee’s own press releases had reported phase III success in the wider population (Evolve Insights).
Life cycle management starts long before launch. Much of the data that supports later filings is generated during development, and your own study protocols, abstracts and press releases can become prior art if filings are not timed with care (Evolve Insights).
Loss of exclusivity is decided separately in each market, under different patent laws, extension rules and regulatory exclusivities. A follow-on patent that is strong in one country may be weak or unavailable in another. We plan life cycle filings across the US, Europe, Japan, China and the other markets that matter for each product.
Our fractional IP counsel model places a named senior patent attorney inside your team as your head of IP, forecasting loss of exclusivity market by market and planning life cycle filings alongside the clinical and regulatory plan.
Why fractional IP counsel for life cycle management? Life cycle management is a long game played across clinical, regulatory and commercial teams. Our patent directors have run it in-house, so they bring the real-world industry experience that you only get working in-house to forecasting loss of exclusivity and planning follow-on filings. With our team and Ammonite charts behind them, they can show the whole picture to your board, something a traditional IP firm or a consultant working alone rarely provides, always with a global strategic approach.
Our Ammonite charts show a portfolio’s patent term, extensions and loss of exclusivity at a glance, and Albert, our validity agent, assesses the strength of life cycle patents, both yours and your competitors’. Our attorneys still make every judgement call. Read more about Evolve AI.
During clinical development. The data behind most life cycle filings is generated before launch, and filing too late risks your own disclosures becoming prior art.
They can, if they cover features the generic cannot avoid. Dose patents are particularly valuable because the dose usually forms part of the label. Patents a generic can design around add much less. Read more: EPO pharma case law trends 2025: Clinical inventions
Yes. Press releases, conference abstracts and trial registrations are prior art. They do not always destroy a later filing, but they need to be planned around. Read more: Empagliflozin subpopulation patent (T 1437/21)
An SPC can extend protection for the product covered by the marketing authorisation, but the rules are complex and still developing. We plan SPCs alongside the patent estate from the start. Read more: The Santen referral
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.