Gedeon Richter Plc (A Company Incorporated Under the Laws of Hungary) v Bayer Pharma AG (A Company Incorporated Under the Laws of Germany)
| Jurisdiction | England & Wales |
| Judge | Lord Justice Kitchin and Sir Robin Jacob,Lord Justice Mummery |
| Judgment Date | 07 March 2012 |
| Neutral Citation | [2012] EWCA Civ 235 |
| Docket Number | Case No: A3/2011/1096 |
| Court | Court of Appeal (Civil Division) |
| Date | 07 March 2012 |
[2012] EWCA Civ 235
The Rt Hon Lord Justice Mummery
The Rt Hon Lord Justice Kitchin
and
Sir Robin Jacob
Case No: A3/2011/1096
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Floyd
Royal Courts of Justice
Strand, London, WC2A 2LL
Simon Thorley QC and Joe Delaney (instructed by Bird & Bird LLP) for the Appellant
Andrew Waugh QC and Thomas Hinchliffe (instructed by Simmons & Simmons LLP) for the Respondent
.
Hearing dates: 7/8 February 2012
Introduction
This is an appeal against a decision of Floyd J in a patent action concerning inventions in the field of oral contraceptives.
The appellant, Gedeon Richter plc ("Richter"), is a generic pharmaceutical company. At trial it sought revocation of two patents owned by the respondent, Bayer Schering Pharma AG, which was formerly known as Bayer Schering Pharma AG ("Schering"): EP (UK) Nos. 1,380,301 ("301") and 1,598,069 ("069"). They were granted on divisional applications based upon the same parent application WO 01/15701 ("the parent application").
Both patents relate to immediate release formulations of the steroidal hormones drospirenone ("DSP") and ethinylestradiol ("EE"). DSP is a gestagen and EE is an estrogen. In such a formulation contraceptive reliability is mainly provided by the gestagen and the estrogen acts to increase the ovulating inhibitory effect of the gestagen and to ensure cycle stability.
The judge held:
(a) Claims 1 and 19 of 069 were invalid for obviousness over two items of prior art. However, he permitted Schering to amend the patent to delete claims 1–5 and make claim 19 dependent on claim 6.
(b) Claim 6 of 069 was not invalid for obviousness. This claim is now amended claim 1.
(c) Claim 1 of 301 (as amended) was not invalid for obviousness.
(d) 301 (as amended) and 069 were not invalid for added matter.
On this appeal, Richter challenges findings (b), (c) and (d). The judge refused permission to appeal against his findings of non-obviousness. Lord Neuberger of Abbotsbury MR subsequently granted permission to appeal against these findings, albeit with "considerable scepticism" as to the likely success of any such appeal.
Technical background and common general knowledge
Formulation of an oral contraceptive is critically important. The dosage must be such that the contraceptive is wholly effective at inhibiting ovulation. On the other hand, too high a dosage may result in undesirable side-effects.
In this regard, DSP presented particular challenges. First, it is poorly soluble, which carries with it the risk of poor absorption. The skilled team would have known of various techniques for dealing with this problem, two of which, micronisation to reduce the drug particle size and application of the drug to very small inert carrier particles, are expressly discussed in the parent application. The second is that DSP has a tendency to change into an inactive isomer under the acid conditions found in the stomach. It was also well known that steps taken to increase the solubility of such a drug by, for example, micronisation, would be likely to increase the rate of degradation.
The judge described the common general knowledge in relation to these issues at [25] – [26]:
"25. Low solubility APIs present particular difficulties for the formulator. Such APIs run the risk of incomplete absorption. Steps can be taken to improve the dissolution properties of poorly soluble APIs. Those of particular relevance to this case are (a) reducing particle size by micronisation, i.e. fine milling of the drug to produce a higher surface area (for example, icing sugar as against granulated) and (b) applying the API onto the surface of inert carrier particles. These are, however, only examples of the techniques which the skilled formulator would have in his armoury for dealing with poorly soluble drugs as part of his common general knowledge.
26. A skilled person would be aware that, in the case of a drug which is sensitive to stomach acid, taking steps to increase solubility would be likely to increase the rate at which the drug degraded. This was particularly notable in the case of the antibiotics penicillin G and erythromycin which are highly unstable in the gastric environment, but it is a factor which the formulator would have in mind for any acid labile drug."
The parties were agreed that during the pre-formulation testing stage a pharmaceutical formulator would subject a new candidate active pharmaceutical ingredient ("API") to a series of in vitro tests in order to establish its solubility and stability in different environments. Should these tests reveal the API to be acid labile, the formulator would know that it is possible to protect it by using an enteric coat, as the judge explained at [31] – [36]:
"31. If studies show that a drug has a tendency to degrade in acid conditions, it is possible to protect the drug from the acid environment in the stomach by means of an enteric coating. The coating is designed to be insoluble in acid conditions. The formulation is therefore discharged without dissolution from the stomach by the stomach emptying process into the more alkaline environment of the small intestine. The coating is designed to dissolve in those conditions, and the drug is then released for absorption at that stage.
32. Enteric coatings are also used to protect the stomach lining from the action of a drug, but that application is not directly relevant here. As at 1996 there were 261 drugs on the market with enteric coats, about one third of which were so formulated to protect the drug from acid.
33. A consequence of the mode of action of the enterically coated drug is that there is a delay in the onset of action while the formulation is discharged from the stomach.
34. Whilst there is no doubt that enteric coatings overcame the problem of acid degradation in the stomach, they undoubtedly had some problems of their own. The first is the delayed onset of action which I have already mentioned. This is a particular problem in a drug for which there is an urgent need for immediate onset.
35. A second and related problem with the enteric coating is that the period of delay will be the subject of inter- and intra-patient variability because of the differences in gastric emptying times to which I have referred. One reference suggests that the residence time for a delayed dosage form is between 30 minutes and 4.5 hours. Examples were found of drugs which were delayed even longer, one by up to 12 hours.
36. By the priority date, however, these problems had been met to a large degree by providing enterically coated granules. Their small size enabled them to pass through into the intestine at a faster and less variable rate. The notion of providing enterically coated granules in a hard gelatine two-part capsule was well established by the priority date. Compressing the granules into a tablet was a slightly different matter. Professor Buckton did not accept that these tablet formulations were part of the common general knowledge, and I conclude that it was not."
With this background we can now turn to the particular issues arising on this appeal.
Added matter
The test for added matter was explained by Aldous J in Bonzel v Intervention (No 3) [1991] RPC 553 at 574; by this court in Vector v Glatt Air Techniques [2007] EWCA Civ 805, [2008] RPC 10 at [4] – [9]; and again by this court in Napp Pharmaceutical Holdings v Ratiopharm [2009] EWCA Civ 252, [2009] RPC 18 at [71] and [98] – [99].
Mr Simon Thorley QC, who appeared on the appeal on behalf of Richter, particularly emphasised the following aspects of the guidance given in those cases.
First, the task for the court in a case such as this is (1) to ascertain through the eyes of the skilled addressee what is disclosed, both explicitly and implicitly in the application; (2) to do the same in respect of the patent; (3) to compare the two disclosures and decide whether any subject matter relevant to the invention has been added whether by deletion or addition. The comparison is strict in the sense that the subject matter will be added unless such matter is clearly and unambiguously disclosed in the application.
Second, it is appropriate to consider what has been disclosed both expressly and implicitly. The addition of a reference to that which the skilled person would take for granted does not matter. On the other hand, it is to be emphasised this is not an obviousness test. A patentee is not permitted to add matter which would have been obvious to the skilled person from the application.
Third, the idea underlying the prohibition is that an applicant should not be allowed to improve his position by adding subject matter not disclosed in the application, which would give him an unwarranted advantage and could be damaging to the legal security of third parties relying on the original disclosure.
Fourth, it is important to avoid hindsight. Care must be taken to consider the disclosure of the application through the eyes of the skilled person who has not seen the amended specification and consequently does not know what he is looking for. This is particularly important where the subject matter is said to be implicitly disclosed in the application.
Finally, it is important to distinguish between the disclosure of...
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