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.

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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?
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Mewburn Ellis

FORWARD MAGAZINE

Mewburn Ellis Forward is a biannual publication that celebrates the best of innovation and exploration. Through its pages we hope to inform and entertain, but also to encourage discussion about the most compelling developments taking place in the scientific and entrepreneurial world. Along the way, we’ll engage with the IP challenges that international organisations face every day.