Friday, 23 May 2014

7 Points on the UK Decision Actavis v Lilly [2104] EWHC 1511 (Pat) (15 May 2014)

This is a very long decision with many different points considered, including procedural ones.  The points below focus on the take-home messages rather than going through why the judge came to each conclusion.  The points also focus on the claims interpretation parts of the decision.

1.  This concerns a request by Actavis for a Declaration of Non-Infringement in respect of a patent (EP 0432677) covering use of pemetrexed disodium in a cancer treatment and a corresponding SPC.  There have already been previous decisions on the case confirming the UK Court could consider validity of the French, German, Italian and Spanish designations. The Declaration for Non-Infringement is in respect of Actavis using the diacid, ditromethamine and dipotassium versions of pemetrexed. So the main claim interpretation issue concerns whether the claims of the patent can be construed to cover use of chemical compounds which are similar but not the same as the specifically mentioned compound.

2.  The two sides had very different opinions on the skilled person or team. There was also the suggestion that the skilled team could be different for different claims or different grounds (sufficiency and infringement).

3.  Though the Protocol on the Interpretation of Article 69 EPC refers to equivalents the Judge did not view these as leading to a US-style doctrine of equivalents.

4.  Claim interpretation, to ask which variants fell in the scope of the claims, was carried out using the Improver questions and Kirin-Amgen (what the person skilled in the art would have understood the patentee to be using the language of the claim to mean).

5.  The judge uses prosecution amendments and even considers the problems of anticipating technology evolution as part of analysing the claims, which seem similar to a US style Festo analysis.

6. After considering many scientific and legal points as part of the Improver questions the judge decides on non-infringement based on the principles of fair protection for the patentee and reasonable certainty for the third parties, saying that there is nothing in the specification or in the common general knowledge that would make ‘pemetrexed disodium’ mean anything other than what is conventionally means.

7.  The judge used legal experts provided by the parties to carry out claim construction and infringement analysis for other designations and the decision describes the relevant tests that were used.

The decision can be found here.  The previous High Court decision on whether the UK Court could consider the French, German, Italian and Spanish designations can be found here, and the appeal can be found here.

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