ADVERTISEMENTS

The Claim 1 of 246 was for

'a controlled release oxycodone dosage form for oral administration to human patients, comprising: (a) oxycodone salt in an amount equivalent to 10 mg to 160 mg of the oxycodone hydrochloride salt; (b) a matrix incorporating said oxycodone salt; (c) a coating on said matrix controlling the release of said oxycodone salt'.

Claim 6 of 730 was for

'a controlled release oxycodone formulation for administration to human patients, comprising: (a) an analgesically effective amount of spheroids comprising oxycodone or a salt thereof and a spheronising agent; (b) each spheroid being coated with a film coating which controls the release of the oxycodone or oxycodone salt at a controlled rate in an aqueous medium'. 

Napp said that the defendants' Cimex tablets infringed these claims. They had small particles which were made up of a number of layers, where an external layer contained around 20% of oxycodone salt which they released immediately. It was common ground that the release of the remaining 80 per cent was controlled by the film coating. 

Sandoz and ratiopharm said the patents were invalid in respect of added matter under Article 123 of the European Patent Convention ("(2) A European patent application or a European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed") and under the Patents Act 1977 ("Since our provisions mean the same as Art 123(2) there is no point in referring to them"). The argument of invalidity was that parts of the specification and/or claims of 730 had not been disclosed clearly and unambiguously in Napp's PCT application and/or that they did not provide a technical contribution. 

The Court of Appeal allowed Napp's appeal and held the patents infringed, but dismissed the generics companies' challenge to their validity.  Their Lordships however emphatically endorsed the statement of the trial judge that

"[122] ... the test for added subject matter remains that set out in the Convention and the Act. The reason that disclaimers of accidental and deemed anticipations do not offend is that they do not add subject matter relevant to the invention. If a disclaimer introduced by a divisional application does not add subject matter relevant to the invention, but merely excludes subject matter from protection, then it too will not offend against the provision."

The IPKat notes that the same patents are currently being litigated in Germany, where (see paragraphs 63 to 67) the litigation has taken a rather different turn and the patent claims have been given a different construction.  Is this yet another example of a justification for a unified approach to patent litigation in Europe, or  -- as Merpel wonders -- just an inconvenient blip that can be overlooked since it's just a small price to pay for the efficient localisation of expensive and complex litigation?

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