Patent litigation ? from start to finish (including appeal) in nine months
Patent litigation ? from start to finish (including appeal) in nine months
Article by Nick Beckett Free Weekly Newsletters
26 April 2005
The Court of Appeal has rendered its decision in the case of Mayne Pharma v Pharmacia. This is the first decision in which the Courts have applied the new principles of construction of patents pronounced by the House of Lords in the Kirin-Amgen case at the end of last year. Jacob LJ provides a "practical working guide" to the construction of patents summarising the principles set out in his earlier decision in Rockwater v Technip. The case is also the first to come to appeal under the new streamlined procedure. From start to finish (including appeal), the case took just nine months and demonstrates the huge benefits that the new procedural changes provide to Court users in greatly reducing the time, complexity and expense of patent litigation in appropriate cases.
This was the first decision in which the Courts have applied the new principles of construction pronounced by the House of Lords in Kirin-Amgen. Giving the patent a purposive construction, Mayne Pharma were held to infringe the patent in suit and Pharmacia's appeal was allowed.
Mayne wished to sell an injectable solution of an anti-cancer drug ? Epirubicin hydrochloride. Pharmacia were proprietor of a patent covering Epirubicin hydrochloride, the main claim of which required that the solution "has not been reconstituted from a lyophilizate". Lyophilization is freeze-drying. The reason for avoiding lyophilization is to reduce contact with the compound which is extremely toxic and can have serious risks to medical staff. The patent-in-suit was directed to an "injectable, ready-to-use, sterile, solution". Mayne's product involved a lyophilization process at an earlier stage in the production of the raw material ? i.e. "upstream" of the use of the formulation itself in the hospital. The claim was issued on 17 May 2004 and subjected to the streamlined procedure. The first decision was rendered on 1 November 2004 with Roger Wyand QC finding non-infringement. Pharmacia appealed. The decision of the Court of Appeal was given on 17 February 2005.
The only issue was one of construction ? whether the earlier "upstream" lyophilization process rendered Mayne's product non-infringing.
The Court of Appeal applied the principles to construction set out by the House of Lords in Kirin-Amgen. Jacob LJ considered that these had already been adequately summarised (save for one minor matter) in his earlier decision in Rockwater v Technip. Jacob LJ suggested as a "practical working guide" a summary of his earlier decision:
(a) The first, overarching principle, is that contained in Art 69 itself.
(b) Art 69 says that the extent of protection is determined by the terms of the claims. It goes on to say that the description and drawings shall be used to interpret the claims. In short the claims are to be construed in context.
(c) It follows that the claims are to be construed purposively the inventor's purpose being ascertained from the description and drawings.
(d) It further follows that the claims must not be construed as if they stood alone the drawings and description only being used to resolve any ambiguity. Purpose is vital to the construction of claims.
(f) Nonetheless purpose is not the be-all and end-all. One is still at the end of the day concerned with the meaning of the language used. Hence the other extreme of the Protocol a mere guideline is also ruled out by Art 69 itself. It is the terms of the claims which delineate the patentee's territory.
(g) It follows that if the patentee has included what is obviously a deliberate limitation in his claims, it must have a meaning. One cannot disregard obviously intentional elements.
(h) It also follows that where a patentee has used a word or phrase which, acontextually, might have a particular meaning (narrow or wide) it does not necessarily have the meaning in context.
(i) It further follows that there is no general "doctrine of equivalents".
(j) On the other hand purposive construction can lead to the conclusion that a technically trivial or minor difference between an element of a claim and the corresponding element of the alleged infringement nonetheless falls within the meaning of the element when read purposively. This is not because there is a doctrine of equivalents: it is because that is the fair way to read the claim in context.
(k) Finally purposive construction leads one to eschew what Lord Diplock in Catnic called (at p.243):
"the kind of meticulous verbal analysis which lawyers are too often tempted by their training to indulge."
It was agreed that a "purposive construction" should be given and that the claims should be read in context. There were two possible purposes of the patent ? either (on Pharmacia's case) to produce "an injectable ready-to-use solution" or (on Mayne's case) to avoid lyophilization completely.
The Court preferred Pharmacia's construction. Accordingly the upstream process relating to the production of the raw material was not relevant.
Of note this was the first case to have come through the streamlined procedure all the way to appeal. The entire proceedings took less than 9 months.
The application of the Amgen principles to construction and the "practical working guide" provided, will be a useful tool in future.
In all cases, the underlying "purpose" of the invention will be critical in appropriately construing the claims.
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Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 11/04/2005.
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