Patent decision

BL number

O/202/21

Concerning rights in

GB1809729.5

Hearing Officer

Dr L Cullen

Decision date

26 March 2021

Person(s) or Company(s) involved

4D Pharma Research Limited

Provisions discussed

Section 14(3), 14(5)(c)

Keywords

Sufficiency, Support

Related Decisions

None

Summary

This application relates to a composition comprising the bacterial strainEubacterium contortum MRX050isolated from the mammalian digestive tract and its use in the treatment of an inflammatory disease or condition mediated by the Th17/IL-17 pathway. This bacterial strain is shown, using a mouse model, to have a therapeutic effect on uveitis, an inflammatory condition of the eye. It was isolated from a single human volunteer and is not genetically modified or altered in any way. The skilled team would be aware that different strains belonging to the same bacterial species demonstrate a high level of identity, and as such, one strain ofE. contortumcan serve as an example of how other strains will behave. This was supported by later filed evidence. The hearing officer (HO) was satisfied that it was not mere assertion or speculation to extend the claim to include strains other thanMRX050.

The HO, taking note of the Supreme Court decision inWarner-Lambert Company LLC v Generics (UK) Ltd (t.a. Mylan) & Anor. [2018] UKSC 56,found that the claim to include conditions other than uveitis that also involved the Th17 / IL-17 pathway was not speculative or mere assertion. It was plausible based on the experimental evidence provided in the application as filed and the explanation and reasoning provided therein. As set down inWarner-Lambert, the effect on the disease process can be demonstrated bya priorireasoning, it does not necessarily need experimental data. Here we have some experimental data in relation to uveitis which shows that the MRX050 strain ingested into and residing in the gut has a systemic effect on a condition in the eye. The proposed basis for this systemic effect is mediation of the Th17 / IL-17 pathway. This pathway is known to be involved in a number of other conditions from the prior art, thus the skilled team would consider it plausible that this strain will be likely to have an effect on these other conditions.

The HO concluded that the application as filed does disclose the invention in a manner which is clear enough and complete enough to enable it to be performed by a person skilled in the art and so satisfies Article 14(3) of the Act. The HO also found that the claims were fully supported by the description, and Section 14(5)(c) of the Act was satisfied.

A number of extensions to the compliance period were made under rule 108(3), one of which was not accompanied by the appropriate form. However, as it was filed electronically and as no fee was required under the temporary waiver of fees in response to the impact of the COVID-19 pandemic, the request could be allowed since the requirement to use a form was deemed not to apply and all the information required was provided in the electronic communication.

The application was remitted to the examiner for completion of the grant process under Section 18(4) of the Act.

Full decisionO/202/21  437Kb