Mayne Pharma PTY Ltd & Anor v Pharmacia Italia SPA

A patent claim is construed purposively, through the eyes of the skilled person and in the context of the description, drawings and common general knowledge. The terms of the claim nevertheless delineate the monopoly.

A claim excluding a ready-to-use solution which has been reconstituted from a lyophilizate excluded reconstitution as the step producing that solution. It did not exclude a product merely because lyophilization had occurred further upstream in the history of its raw material. The product therefore fell within the claim.

Mayne sought a declaration that its injectable epirubicin hydrochloride solution did not infringe Pharmacia’s UK patent. Pharmacia counterclaimed for infringement. The product used epirubicin hydrochloride which had undergone bulk lyophilization before Mayne dissolved and processed it into the final solution.

A Deputy Judge of the Patents Court held that the product did not infringe claim 1 because the claim excluded a solution whose production involved lyophilization at any stage. Pharmacia appealed. The central issue was whether the words “solution … which has not been reconstituted from a lyophilizate” excluded upstream lyophilization of the starting material or only reconstitution immediately producing the ready-to-use solution.

1. The appeal was allowed unanimously. Jacob LJ delivered the judgment, with which Hooper LJ and Dame Elizabeth Butler-Sloss P agreed. Properly construed, claim 1 covered Mayne’s product.

2. Patent claims must be construed purposively in their context. Article 69 makes the terms of the claims determinative of the extent of protection, while requiring the description and drawings to be used in interpretation. The inventor’s purpose is important, but the language chosen continues to delineate the monopoly. The court followed Kirin-Amgen [2004] UKHL 46 and applied the working principles summarised in Technip SA’s Patent [2004] RPC 919.

3. The claim was addressed to a pharmaceutical manufacturer possessing knowledge of both the use and manufacture of the product. Such a reader would understand the patent’s real teaching to be the provision of a stable, ready-to-use solution which avoided the lyophilization and reconstitution previously required for the product supplied in vials.

4. The words excluding a solution “reconstituted from a lyophilizate” referred to reconstitution as the step producing the ready-to-use solution. If reconstitution immediately produced that solution, there was no infringement. Upstream lyophilization of the active ingredient did not prevent infringement because the nature of the raw material was not part of the relevant formulation process.

5. The product claim and process claim did not compel identical limits. Although a patented process may be expected to produce the patented product, it does not follow that the product must be made only by that process. The issue always depends on the language used in context. Claim 31’s express requirement that the starting salt was not a lyophilizate therefore did not impose the same restriction on claim 1.

1. Court of Appeal (Civil Division): Allowed Pharmacia’s appeal unanimously and held that Mayne’s product fell within claim 1.
2. High Court, Chancery Division (Patents Court): Mr Roger Wyand QC, sitting as a Deputy Judge, held on 1 November 2004 that the product did not infringe and granted permission to appeal.