Avoiding pitfalls: Protection for new uses in Europe at the interface of therapy and non-therapy

Avoiding pitfalls: Protection for new uses in Europe at the interface of therapy and non-therapy

Claims to a new use can be a valuable part of a patent portfolio in Europe, allowing patentees to obtain protection for a product even if the product is already known for a different use. Such use claims, which may relate to either a therapeutic use or a non-therapeutic use, can provide additional protection for products already covered within a patent portfolio or provide applicants with new protection for innovations relating to new uses of a known product.

Across a series of two articles on this topic, we consider issues that can arise when a claim is deemed to encompass both therapeutic and non-therapeutic uses or when a claimed medical use is not considered therapeutic.
 
In this, our first article, we provide a practical guide to consider when drafting and prosecuting applications. Our second article then provides a deep dive into the EPO case law to help illustrate the pitfalls applicants may face.
 

Part (I): Practical guide to consider when drafting and prosecuting applications
 

Background: Protection is available for therapeutic and non-therapeutic uses

Under European practice, patent protection may be obtained for a known substance or composition not previously used in therapy or for a new use of a non-therapeutic product, allowing applicants to gain protection for products where the specified therapeutic or non-therapeutic use of the product is new and inventive.
 
Therapeutic and non-therapeutic use claims provide valuable protection where it can be shown that the product has been sold or used with the intention of providing the claimed purpose, making them valuable claims to include within a European patent portfolio.

 
What can go wrong?

Problems can arise when a claim, perhaps unintentionally, encompasses both non-therapeutic and therapeutic uses or when the incorrect claim format has been used. Issues include applicants being unable to pursue a non-therapeutic use claim when the non-therapeutic use inevitably provides a therapeutic benefit. Situations may also arise where applicants are unable to demonstrate a claimed use is novel when an unallowable therapeutic use claim is interpreted as a claim to the compound being merely suitable for the specified use.
 
Missing the opportunity to build a case for the specified use when drafting the application and/or pursuing the wrong type of use claim may ultimately lead to a failure to patent the new use.

 
Practical points to consider

Typical claim formats used for claiming a new therapeutic use include specifying compound X for use in the treatment of a human or animal body and compound or substance X for use in the treatment of disease Y, with the inclusion of the “for use” language providing a purpose-limited product claim. In contrast, claims directed to a new non-therapeutic or cosmetic use are typically drafted to specify use of X for purpose Y. The claimed subject matter will be novel if purpose Y has not previously been made available to the public in the context of product X.
 
The assessment of whether an intended use will be considered therapeutic or non-therapeutic will depend on the specific circumstances of each case, but the disclosure in the application as filed and the practical application of the invention can be pivotal in deciding whether or not a use claim or medical use claim is considered patentable.
 
Practical points to consider when claiming a new use are:

  • When drafting an application consider all possible uses of the composition of interest. Where applicants only wish to claim the non-therapeutic or cosmetic use of a composition avoid any suggestion that a therapeutic effect may also be obtained. Be explicit that the composition is for non-therapeutic or cosmetic use and clearly define the group of consumers that would benefit from the non-therapeutic or cosmetic use of the composition. Consider defining the consumer as healthy or not suffering from specific conditions that a therapeutic use would treat. Include data showing the non-therapeutic benefits of the composition in the relevant consumer group and avoid the inclusion of data demonstrating a therapeutic effect.
     

  • For claims focussed on the therapeutic use of a composition, consider whether the composition may be used by a consumer group who achieve no therapeutic benefit and thus whether a medical use claim is the correct claim format to use. Ensure the application includes a description of specific patient groups that would benefit from receiving the composition for therapeutic purposes, define the disease(s) to be treated, and include data evidencing the therapeutic effect of the composition.
     

  • When therapeutic and non-therapeutic uses will both be claimed in a single application, ensure the description describes each use individually and take care to draw a distinction between the therapeutic and non-therapeutic uses disclosed. Clearly define patient groups and consumer groups for the different uses of the composition. For the therapeutic uses ensure the disease(s) to be treated are defined and for the non-therapeutic uses define the consumer as healthy or not suffering from specific conditions that a therapeutic use would treat. Include data showing the therapeutic effect and non-therapeutic benefits of the composition in the clearly defined patient and consumer groups.
     

  • For key commercial products, consider separating therapeutic and non-therapeutic uses into separate applications.


Conclusions 

Before claiming a new therapeutic or non-therapeutic use careful consideration should be given to the intended market for the composition. As set out in our practical points above, when drafting a new application we recommend defining possible patient and/or consumer groups, defining any disease to be treated and including data showing the therapeutic effect and/or non-therapeutic benefits of the composition in the defined patient and consumer groups.
 
These practical points are distilled from our deep dive into the EPO case law in this area. For those seeking more detail relating to the EPO’s approach to therapeutic and non-therapeutic use claims, please see deep-dive part (II) of our article series.
 
If you would like to discuss claiming a new therapeutic or non-therapeutic use in Europe please do reach out to Sophie Evans or your usual Kilburn and Strode contact.

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