Patents: meaning of enablement in anticipation by prior art

By Audrey Horton

09-2019

The Patents Court has considered enablement in relation to anticipation of a claimed monoclonal antibody invention by prior art, and held the patent was invalid for lack of novelty; it was also obvious for lack of technical contribution, and insufficient for ambiguity.

Background

An invention is new if it does not form part of the state of the art. The state of the art comprises everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of a European patent application (Article 54, European Patent Convention) (EPC).
In determining whether a patent claim lacked novelty over the prior art, the House of lords has held there were two separate requirements: disclosure and enablement (Synthon BV v SmithKline Beecham plc [2005] UKHL 59).

For a product which was on public sale to form part of the state of the art, it must be possible for the skilled person to reproduce it without undue burden (Enlarged Board of Appeal in G 1/92 Availability to the Public ).

Where a technical test is required to find out if a product or process is within the claim or not, if the skilled person could not know whether they were carrying out the right test, then the claim would be ambiguous and therefore insufficient Unwired Planet v Huawei [2016] EWHC 576)

Facts

T's product was a formulation of a monoclonal antibody, approved for the treatment of ulcerative colitis and Crohn's disease.

R claimed that T's product infringed R's patent. 

T denied infringement and claimed R's patent was invalid and should be revoked.R argued that for there to be anticipation what had to be enabled was the very thing disclosed in the prior art. T disagreed and argued, relying on Synthon, that as long as the prior art enabled the skilled person to produce something within the claim, the claim would be anticipated. 

Decision

The court held that T's product infringed R's patent, but that R's patent was invalid for lack of novelty, lack of technical contribution and insufficiency.

The purpose of the law of novelty was to prevent the state of the art from being patented again. The fact that other characteristics of a product could not be determined or reproduced did not suddenly mean that no information about the composition at all had been put into the state of the art by the prior use. It would be different if the inability to determine a feature of the product or the inability to reproduce it prevented the skilled person from making their own product at all. However, if the feature which could not be reproduced had nothing to do with the invention and did not prevent a skilled person from making something which, from their point of view, was the product of the prior art for all practical purposes, there was no reason why its absence was relevant to enablement. 

Synthon made it clear that the requirement of enablement was that whatever had been disclosed must be something the skilled person could use to produce a practical result. In the case of a prior use, as long as the information the skilled person could obtain by analysing the old product was enough to enable the skilled person to put it to practical use by making their own version of that

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