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Friday, 3 April 2009

Appeal judges awake to Napp patent issues

On Wednesday, while much of the IP world was amusing itself with April Fool pranks, the Court of Appeal (England and Wales) had more serious matters to resolve when it gave its decision in Napp Pharmaceutical Holdings Ltd v ratiopharm GmbH/Napp Pharmaceutical Holdings Ltd v Sandoz Ltd [2009] EWCA Civ 252. In what is now becoming something of a regular occurrence a Lord of Appeal in Ordinary dropped down from the House of Lords to sit with the Lords Justices of Appeal, the court consisting of Lord Justice Jacob (who delivered a judgment to which all members of the court contributed), Lord Neuberger himself and Lord Justice Lawrence Collins.

In short (you can read the background to the appeal in greater depth where the IPKat covers the trial decision here) this case involves actions concerning two of Napp's divisional patents (246 and 730) for oxycodone ("a known opioid killer").  The trial judge held the patents valid but not infringed. Both parties appealed. 


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?

5 comments:

Curiosity killed the said...

Can anyone explain this 'dropping down from the House of Lords' business? Why do they do it? Just for fun, a change of scenery?

Anonymous said...

Reading this claim I would also have attacked it based on Art.83 EPC - insufficient disclosure and Art.56 EPC (lack of inventive step). The argumentation goes something like this:

Claim 1 of 246 reads: "a coating on said matrix controlling the release of said oxycodone salt". Assuming that the technical problem to be solved by the claimed subject matter is in fact the controlled release of the active agent - viz oxycodone, the only way in which the skilled person (in this case an expert in gallenics) could carry out the invention as defined in this claim would be because it is obvious to him which substances on the coating would provide controlled release. This would mean that the claim lacked inventive step. Since the proprietor clearly wishes the claim to be considered inventive, this means that the way in which the problem is solved is not evident to the skilled person and cannot be repeated by him based on the disclosure of this claim. Therefore the claim is not sufficiently disclosed in respect of its entire scope as required by Art.83 EPC.

This argumentation could also be turned on its head - whereby the claim is considered to be sufficiently disclosed (if the skilled person could easily find out how to control the rate of release of the active agent), which would conversely mean that the claim is not inventive as required by Art.56 EPC.

Either way, this claim is caught in an inescapable trap between Art.83 EPC and Art.56 EPC.

The only possible escape route might be to argue that since there would have been working examples of the coating, these support the disclosure of the claim, although this might not work because the examples would be technically limited and would be unlikely to be considered to provide sufficient disclosure over the whole claimed scope.

Basically claim 1 of this patent is drafted as "as solution to the technical problem [controlled release of the drug] characterised in that it solves the problem".

MaxDrei said...

A question for that Anonymous. Can he offer a comment to distinguish from EPO jurisprudence that follows a case called Kawasaki Steel. This is the week-end and I can't remenmber the T number, but he/she will surely be familiar with the case, and its progeny. Thanks in advance.

Anonymous said...

Re: Max Drei, the decision in question was T595/90. This decision related to the sufficiency and inventive step of a product known to be desirable (a type of steel), which had several desirable properties which until the invention in question could not be achieved simultaneously in the same steel product since improving one caused the other to deteriorate. The alleged invention in this case was the process for producing this product, which to date, had not yet been produced. However, since it was known that the product in question would have advantageous properties, what had to be assessed was the inventive step of the process for making it. If this were inventive, then the product would have also been inventive, since this would have meant that in order to make this product based on the prior art (which indicated that the product was desirable) the skilled person would still have had to exercise an inventive step (with regard to the process) in order to make it available.

The case subject to the current posting differs in that it relates to the relationship between the ability of the skilled person to recognize which known products would have a particular desirable property, irrespective of any process for their production and without defining their technical features (i.e. their chemical composition or structure). Since the chemical composition of the coating is not defined, by definition it must be known to the skilled person what it is, and how to make it, or the claim does not fulfill the sufficiency requirement according to Art.83 EPC.

In a nutshell the present posting relates to the inventive step/sufficiency of a technical feature defined in terms of a desirable property where the structural technical features of that feature are not defined (only the function), whereas the T595/90 case defines a product technically (defining the technical features of the steel product) and where the sufficiency and inventive step derive from the allegedly inventive process for making it.

I would be interested to hear your take on T595/90 and on so called "free beer claims" where the contribution to the art is defined in terms of the problem. This is sometimes acceptable, where the problem itself was not recognized, but I that is not the case here, since the controlled release of drugs is a well known technical problem/objection. Furthermore, the claim is also unclear, since what constitutes controlled release, which rate of release and under which conditions would fall within this definition?

MaxDrei said...

Thanks Anonymous. I would have to re-visit Kawasaki, and read Napp for the first time, to do justice to your enquiry about free beer. But here's my in haste, off the cuff, reaction to your summary of Kawasaki:

On your summary, it looks to me like the Kawasaki Board mixed up obviousness and insufficiency. If I am not mistaken, Lord Hoffmann in Conor warned us against that. I had thought that DG3 (as a matter of principle) would have heartily endorsed that warning, which makes me wonder whether Kawasaki is set to lose authority, especially in these days of cropping back the scope of protection awarded to inventors. Lord Hoffmann found in favour of the owners of the Conor product claim, but would he have found against the owners of the Kawasaki product claim?.

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