Ratiopharm GmBh and another v Napp Pharmaceutical and another

JurisdictionEngland & Wales
CourtCourt of Appeal (Civil Division)
JudgeLord Justice Jacob
Judgment Date01 Apr 2009
Neutral Citation[2009] EWCA Civ 252
Docket NumberCase No: A3/2009/0297 & 0311 and A3/2009/0291 & 0310

[2009] EWCA Civ 252

IN THE SUPREME COURT OF JUDICATURE

COURT OF APPEAL (CIVIL DIVISION)

ON APPEAL FROM THE HIGH COURT OF JUSTICE

PATENTS COURT

THE HON MR JUSTICE FLOYD

HC07 CO3453/HC07 CO3478

Before: Lord Justice Jacob

Lord Neuberger

Lord Justice Lawrence Collins

Case No: A3/2009/0297 & 0311 and A3/2009/0291 & 0310

Between:
Napp Pharmaceutical Holdings Ltd
Appellant
and
ratiopharm GmbH
and
And between:
and
Napp Pharmaceutical Holdings Ltd
and
Sandoz Ltd
Respondent

Michael Tappin (instructed by Messrs Powell Gilbert LLP) appeared

for Napp Pharmaceutical Holdings Ltd

Michael Silverleaf QC and Piers Acland (instructed by Messrs Nabarro LLP)

appeared for ratiopharm GmbH

Michael Silverleaf QC and Mark Chacksfield (instructed by Messrs S J Berwin LLP)

appeared for Sandoz Ltd

Hearing dates: 10/11/12 March 2009

Lord Justice Jacob

Lord Justice Jacob:

1

This is the judgment of the court to which all members have contributed.

2

We have an appeal (argued by Mr Michael Tappin) and cross-appeal (argued by Mr Michael Silverleaf QC) from a judgment of Floyd J of 16 th December 2008. The appeals were expedited because the generic medicine parties, ratiopharm GmbH and Sandoz Limited (collectively “r/S”), are about to receive a marketing authorisation. Determining a case on its full merits quickly generally means that there is no need for any provisional measures or the legal costs and time which would otherwise be devoted to them. That was so here.

3

The patentees are Napp Pharmaceutical Holdings Ltd. Napp owns the two patents in suit, Nos. EP (UK) 722730 and 1258246. The Judge held both patents valid but not infringed by the tablets which r/S wish to sell, a product made by Cimex AG (now Acino AG). Below it was called “the Cimex product” and we will do the same.

4

The patents relate to controlled release formulations of a painkiller called oxycodone. Napp sells such a formulation under the trade mark OxyContin. Its importance is shown by its sales figures – of the order of £32 million per annum in the UK alone.

5

OxyContin is a painkiller used as an alternative to morphine for moderate to severe pain. It has certain advantages as compared with morphine. r/S's own expert witness, Professor Bennett said, as recorded by the Judge at [258], that “it formed a valuable weapon in the armoury of the pain management clinician working in palliative care or otherwise.”

6

Even if the decision that the Cimex product does not infringe were upheld it would be necessary to consider validity. Bifurcation of the issues of infringement and validity would serve no useful purpose. This is because Sandoz has another product in the pipeline which it is said infringes some of the claims of the 730 patent. We do not know whether it does or not: there is an infringement action pending.

Divisional Patents

7

The two patents have, for practical purposes, the same text because they are “divisionals.” The differences lie in their respective claims, and in variations of the text consequential upon the dividing out process. For present purposes it is common ground, as it was below, that we can work mainly from the text of 730.

8

We should say a word about “divisionals.” The basic procedure for applying for a patent is laid down in Art. 75 of the EPC. This allows an inventor to apply for a patent by filing his/her application at the EPO (or a national office of an EPC member if the law of that state allows it). The relevant date for the purposes of judging patentability (the “priority date”) will be the date of that application, though an earlier priority date may be claimed if the patentee has made an earlier (but within one year) application in a Paris Convention country. The application can be made to the EPO via the machinery of the Patent Co-Operation Treaty (PCT). That was used to make the application leading to the patents in suit in this case.

9

However Art 76 of the EPC allows for an elaboration of the basic procedure. It goes by the jargon “divisional”. Art 76 says:

76(1) A European divisional application must be filed directly with the European Patent Office at Munich or its branch at The Hague. It may be filed only in respect of subject-matter which does not extend beyond the content of the earlier application as filed; in so far as this provision is complied with, the divisional application shall be deemed to have been filed on the date of filing of the earlier application and shall have the benefit of any right to priority.

10

So what a patentee can do, having made an initial application, is to apply for a divisional patent. Provided the subject-matter of this does not extend beyond the content of the earlier application, he can get a free-standing patent for the divisional application. Because the date of filing is deemed to be that of the “parent” as the jargon goes, a patentee cannot extend the period of protection by applying for a divisional.

11

Sometimes the EPO will say to a patentee that he has got too much in a single application (an application can only cover a single invention or group of inventive concepts, Art.82) and he must divide out or cut down. But a divisional can be sought by a patentee even if the Office does not require it. Then the patentee's purpose is to break up his/her original application into a cluster of sister patents – each having the same basic disclosure but with different claims. Much the same could be achieved by just adding these claims to the original application, but there are both real and perceived advantages in using divisionals. Firstly each patent will stand or fall on its own merits whereas otherwise there is a risk of the complications of a partially valid patent – complications with potentially different results in different Member States. Secondly a possible infringer can be sued on just the divisional(s) relevant to what he does. Thirdly if the patentee is having trouble with the examination process in respect of part of his invention, he may divide out the portion which the Office accepts is all right so that it gets early grant of that, and meanwhile he can pursue his argument with the Office in respect of the remainder.

12

It is fair to say that a clutch of divisionals is likely to make the position more difficult to assess for third parties. Here for instance there are no less than nine divisionals stemming from the original application. It is perhaps questionable as to whether the current voluntary aspect of the divisional system should continue to be permitted. That is particularly so since one of its justifications has now gone or is of less significance. A patentee need no longer fear that by having all his claimed eggs in one basket, he will lose his patent if even one egg turns out to be bad: central amendment of a granted patent is now possible pursuant to the provisions of Art.105a of the EPC (introduced by amendment pursuant to the EPC 2000).

13

One of the features of the divisional system is that each divisional must have claims which are different: the patentee cannot have the same claim in different patents. So filing a divisional involves a dividing up process: what is claimed in the divisional must be excluded from the claims of the patent from which it has been divided out. That dividing out process may, perhaps, itself add subject-matter – it is said to have done so in this case.

Technical Background

14

The Judge describes this uncontroversially at [8] to [25]. To summarise:

i) Extended release formulations of pharmaceuticals for oral administration were well known. The tablet is designed so that the drug is released slowly over a period of time rather than immediately. The idea is to keep the level of drug in the body near constant.

ii) Various methods were used to achieve this: in particular (a) a tablet consisting of a matrix containing the drug where the matrix dissolves slowly, releasing the drug as it does so and (b) a tablet containing the drug contained in granules surrounded by a barrier – the drug leaches slowly through the barrier.

iii) A particular form of the barrier type tablet involves coating “non-pareil” sugar beads with the drug and adding the barrier on top. There are other well-known ways of enclosing the drug.

iv) Opioid analgesics were well-known. These act on opioid receptors. They consist of the naturally occurring alkaloids (including morphine and codeine), the semi-synthetic opioids (made from naturally occurring substances – they include heroin, the drug of interest in this case, oxycodone, and others), fully synthetic opioids and opioid peptides.

v) Some opioid analgesics are stronger than others. The “gold standard” for pain killing was morphine, but it had significant side effects, including dependence. Moreover the dose appropriate for a particular patient had to be found by a lengthy process of trial and error (called “titration”), there being considerable variation from patient to patient.

vi) There was a strong desire for an alternative to morphine with less side effects and easier titratability.

The Patents

15

Broadly, the two patents in suit are for a 12-hour controlled release form of oxycodone. The claims alleged to be infringed by the Cimex product are for barrier-type controlled release forms. The barrier-type form specifically described is made by the use of extrusion spheronisation, one of a number of well-known way of making small spherical particles. The description also includes matrix-type forms – no doubt they form the subject of one or more of the divided out patents as well as some claims of the 730 patent.

16

The Judge describes the 730...

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