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16 March 2021Big PharmaJian Siang Poh and Angus Fairbairn

Patent filing strategies for pharma startups

The development of any new drug requires considerable investment of time and resources into extensive research and development (R&D), even in the hit to lead and pre-clinical stages. While larger pharmaceutical companies with deep pockets are used to managing the costs associated with drug development, pharmaceutical startups and small and medium-sized enterprises (SMEs) may encounter more difficulty in balancing their budgets, particularly when it comes to allocating funds for generating patent portfolios.

In this article, we provide an insight into the patent filing trends of pharmaceutical startups and SMEs, in terms of the jurisdictions that are prioritised when seeking patent protection.

Patents play a crucial role in establishing rights that pharmaceutical startups and SMEs need to reap the reward of their R&D and to secure further investment. As a result, patent protection is typically considered and applied for at a very early stage in the drug development process.

In a global marketplace, it will be tempting to file patent applications in as many countries as possible. However, since patents are prosecuted and granted on a national or regional basis, the costs associated with obtaining granted patents and their maintenance post-grant will be substantial if broad territorial protection is to be pursued in multiple jurisdictions.

This presents a particular dilemma for pharmaceutical startups and SMEs focused on R&D and early stage drug development. Such companies may have limited budgets to allocate to obtaining and maintaining patents, but still wish to secure geographically broad patent protection for their products or processes. In these circumstances, compromises may need to be made in terms of the countries to be selected for obtaining patent protection.

What does the filing data show?

We explored the international (Patent Cooperation Treaty) patent filing trends of pharmaceutical startups based in the US, Europe (Germany, France, and the UK), China and Japan, by analysing their patent families by jurisdictional coverage.

The proportions of patent family members across specific jurisdictions were assessed to extrapolate general trends for obtaining patent protection in those jurisdictions, with high proportions being indicative of commercially relevant jurisdictions. Lower proportions (25% or less) were disregarded, these being taken to indicate niche filing strategies that may be specific to a particular applicant and therefore less relevant for consideration (see Note on methodology below).

These data are summarised in Figures 1 to 4, categorised into US, European, Chinese and Japanese applicants.

Europe a close second to the home market in the US

For pharmaceutical startups based in the US (Figure 1), the European patent (EP) appears to be the most popular choice when considering expansion of a patent portfolio overseas. Subject to validation requirements, the EP offers a cost-effective way to obtain patent coverage in 38 European countries, including Germany, France, and the UK, as well as the possibility to extend coverage to other extension/validation states (see map).

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Europe
31 May 2013   The definition of what constitutes a co-pending patent filing in Europe has recently been rewritten to include patent applications from within the same patent family. Jane Wainwright of Potter Clarkson investigates the decisions leading to this change.
Americas
7 May 2020   The US Patent and Trademark Office will allow plant patent applications to be filed online due to the COVID-19 pandemic, it has announced.
Big Pharma
14 April 2022   The ‘joint applicants’ approach to PCT applications would provide an elegant solution to issues of who is entitled to priority claims in PCT applications, suggests Chiara Banas of EIP.

More on this story

Europe
31 May 2013   The definition of what constitutes a co-pending patent filing in Europe has recently been rewritten to include patent applications from within the same patent family. Jane Wainwright of Potter Clarkson investigates the decisions leading to this change.
Americas
7 May 2020   The US Patent and Trademark Office will allow plant patent applications to be filed online due to the COVID-19 pandemic, it has announced.
Big Pharma
14 April 2022   The ‘joint applicants’ approach to PCT applications would provide an elegant solution to issues of who is entitled to priority claims in PCT applications, suggests Chiara Banas of EIP.