The Patent Review 2013 - 2014: Allowability of Product by Process Claims

15 April 2015

Neil Jenkins, Audrey Horton

Hospira UK Ltd v Genentech Inc [2014] EWHC 3857 (Pat), Birss J.

Genentech's patents related to formulations of the breast cancer drug sold under the name Herceptin. The active ingredient of Herceptin is an antibody known as trastuzumab. Patent protection for trastuzumab itself had expired. The patents related to lyophilised (freeze-dried) formulations of certain antibodies one of which was trastuzumab.

Genentech had applied to amend the claims of both patents and did not defend the validity of the unamended claims as granted.

Hospira argued that all of the claims (as proposed to be amended) were obvious, or, if not obvious, were insufficient. Hospira also contended that proposed amendments should not be allowed on four grounds: extension of the scope of protection; a specific point on product by process claims; lack of clarity; and added matter.

The Judge held that the proposed amendments were not allowable because of the specific point on product by process claims as well as added matter and in any event the claims as proposed to be amended lacked inventive step.

In the course of dealing with the proposed product by process claims, the Judge considered the case law of both the UK courts and the EPO from which he derived the following principles:

"(i) A new process which produces a product identical to an old product cannot confer novelty on that product. To be novel a product obtained or obtainable by a process has to have some novel attribute conferred on it by the process as compared to the known product.

(ii) This rule is a rule of the law of novelty. It is not a principle of claim construction. Although in effect the rule treats “obtained by” language as “obtainable by” language, nevertheless as a matter of claim construction a claim to a product “obtained by” a process means what it says. That will be the relevant scope of the claim as far as infringement and sufficiency are concerned.

(iii) Although normally a patent was drafted by the inventor in words of his own choosing, the EPO will not permit overt product by process language unless there is no other alternative available. By no other alternative, they meant no other way of defining a particular characteristic of the product in question."

The Judge also held that because by virtue of section 75(5) of the Patents Act he was required to have regard to any relevant principles applied under the EPC in considering whether to allow an amendment; in considering the proposed amendments in this case to create product by process claims, he should follow the principles applied by the EPO as to whether to allow a product by process claim. In doing so, the Judge held on the facts that the proposed amendments should be refused because they did not allow the reader to identify all the attributes of the product conferred by the process conditions. To identify one attribute was not sufficient if the reader would understand there was likely to be an indefinite class of further attributes to which the product by process language also applied.

Appeal floating May – November 2015