New Chemical Entities (NCEs) &

Synthetic Methods

The discovery of a brand new compound (or class of compounds) with useful biological properties opens up the possibility of obtaining what is arguably the most robust form of pharmaceutical patent protection – a patent for the drug product per se. Such a patent provides a monopoly over manufacture, sale and use of the drug for any medical use, including potential future uses which might be identified during the lifetime of the patent.

Our team of pharmaceutical chemistry specialists have extensive experience in the drafting, filing and prosecution of patents for NCEs. We can advise on strategic aspects such as when to file and issues relating to the provision of supporting data, as well as on substantive issues of patentability.

Within our chemistry team there is also a wealth of experience in synthetic organic chemistry, with many of our team having backgrounds in natural product synthesis or synthetic methodology.

A further aspect of pharmaceutical innovation is the development of synthetic routes to the drug compounds. The discovery of a new synthetic pathway may provide access to further new compounds, or it may be a step towards an optimised manufacturing route to an already-discovered drug. Patent protection for a validated (GMP) manufacturing process can be a further useful tool for innovators seeking to safeguard their investment.

For a number of on-market pharma products we have handled all aspects of worldwide patent prosecution on behalf of large multi-national pharma clients. We also have substantial expertise in freedom-to-operate searching and due diligence in this area.

Validation_Strategies_for_Pharmaceutical_Patents_in_Europe-Compressed (1) copy

Special Report

Validation Strategies for Pharmaceutical Patents in Europe

The decision on where to validate a pharmaceutical European patent is a big one. With costs often precluding an “everywhere” approach for small- to medium-sized companies, research institutions and universities, it is necessary to choose from the long list of available countries. The choice typically factors in costs, business interests, likely markets and market size, possible manufacturing and import locations and the regulatory framework in Europe.

This report explores these choices and factors using publicly available data, seeking to answer questions such as:

  • Which countries are most commonly picked by patent holders at the EPO?
  • Is the distribution the same for pharmaceutical patents?
  • Where does “big pharma” choose to validate?
  • What factors might affect the choice of countries?
DOWNLOAD THE REPORT

Read our Blogs

General Court confirms Glaxo Inhaler 3D mark is invalid

General Court confirms Glaxo Inhaler 3D mark is invalid

by Rebecca Anderson-Smith

In July 2025, the European Union General Court rejected an appeal against an earlier decision of the Board of Appeal (reported on in our previous article Cipla Europe NV v Glaxo Group Ltd: can a 3D ...

Molecular Glue Degraders (MGDs): what they are, how they work and key IP Issues

Molecular Glue Degraders (MGDs): what they are, how they work and key IP Issues

by Tim Nash

Molecular glue degraders (MGDs) are small molecules that induce or stabilise protein–protein interactions, often by recruiting an E3 ligase to a target protein and triggering its ubiquitination and ...

Orforglipron FDA Approval: Why the First Small-Molecule GLP-1 Pill Matters

Orforglipron FDA Approval: Why the First Small-Molecule GLP-1 Pill Matters

by Andrew Pitts

The GLP-1 landscape changed on 1 April 2026, when the FDA approved Eli Lilly's orforglipron under the brand name Foundayo as the first non-peptide, small-molecule GLP-1 receptor agonist (GLP-1RA) ...

PROTACs reach the market: what the first regulatory approval means for drug discovery and the patent landscape

PROTACs reach the market: what the first regulatory approval means for drug discovery and the patent landscape

by Andrew Pitts

Just as the attention of the pharmaceutical industry appeared to have shifted over the past few years towards biologics with blockbuster potential, a new and exciting therapeutic modality has emerged ...

Most opposed patents of 2025

Most opposed patents of 2025

by Katherine Green

Writing this year’s overview prompted déjà vu and a quick check of 2024’s most opposed patents confirmed that the same innovators feature at the top of the list: patents in the name of Novartis (for ...

Hope, Healing, and a New Horizon for Psychedelic Therapies

Hope, Healing, and a New Horizon for Psychedelic Therapies

by Sarah Morrow

When we published our New highs for psychedelics in the clinic (2023), it looked like Lykos Therapeutics’ MDMA-assisted therapy for PTSD was soon going to make waves.

Learn More
ME Forward Masthead White 2