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 | Mr Justice Floyd |
| Judgment Date | 17 March 2011 |
| Neutral Citation | [2011] EWHC 583 (Pat) |
| Docket Number | Case No: HC09 C0 4031 |
| Court | Chancery Division (Patents Court) |
| Date | 17 March 2011 |
[2011] EWHC 583 (Pat)
Before: The Hon Mr Justice Floyd
Case No: HC09 C0 4031
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Simon Thorley QC and Joe Delaney (instructed by Bird & Bird LLP) for the Claimant
Andrew Waugh QC and Thomas Hinchliffe (instructed by Simmons & Simmons LLP) for the Defendant
Hearing dates: 22 nd -25 th, 28 th February, 1 st March 2011
Mr Justice Floyd :
Introduction
| Paragraph numbers | |
| Introduction | 1–3 |
| Issues | 4 |
| Expert Witnesses | 5–7 |
| Fact Witnesses | 8–9 |
| The skilled addressee or team | 10–11 |
| The common general knowledge | 12 |
| Law | 12–14 |
| The CGK in this case | 15–37 |
| The Parent Application | 38–49 |
| The Patents | 50–59 |
| The claims in issue | 60–66 |
| Issue of construction | 67–70 |
| Added Matter | 71 |
| Law | 71 |
| The allegations | 72–83 |
| The prior art citations | 84 |
| Oelkers | 84–88 |
| Krause I | 89–97 |
| Krause III | 98–101 |
| Lachnit | 102–107 |
| Obviousness | 108 |
| Law | 108–115 |
| In the light of Oelkers alone | 116–132 |
| Combining Oelkers and Krause | 133–142 |
| In the light of the combination | 143–150 |
| The Schering story | 151–173 |
| The construction argument | 174–178 |
| Other claims | 179–182 |
| The CAFC decision | 183 |
| Conclusions on obviousness | 184 |
| Overall conclusions | 185–6 |
By this action, the claimant, Gedeon Richter plc ("Richter"), seeks the revocation of two patents belonging to the defendant Bayer Schering Pharma AG ("Schering"). The two patents in suit are European Patent (UK) Nos. 1,380,301 and 1,598,069 ("the 301 patent" and "the 069 patent" or "301" and "069" respectively). They are both entitled "Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive".
Both the patents are under opposition in the EPO. Schering is not seeking to maintain 301 in the form in which it was granted. It has therefore proposed unconditional amendments in this action in order to bring the claims into line with those it is seeking in the EPO. Schering has also put forward a second set of amendments to 301 in this action which are conditional on an added matter attack being successful.
Ethinylestradiol ("EE") and drospirenone ("DSP") are two steroidal hormones. EE is an estrogen hormone; DSP is a gestagen hormone. Each of these hormones regulates the female menstrual cycle. DSP has a propensity to isomerise (rearrange its atoms into a different configuration) under the acid conditions in the stomach. The patents are directed to the problem of finding a suitable pharmaceutical formulation of the drugs. Mr Simon Thorley QC and Mr Joe Delaney appeared for Richter. Mr Andrew Waugh QC and Mr Tom Hinchliffe appeared for Schering.
Issues
There are the following issues:
i) Obviousness of each of the patents in the light of four items of prior art:
a) "Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance and lipid metabolism", Oelkers et al Journal of Clinical Endocrinology and Metabolism (1995) 80:1816–1821 ('Oelkers').
b) "Determination of plasma levels of Spirorenone, a new aldosterone antagonist, and one of its metabolites by high performance liquid chromatography", Krause and Jakobs, Journal of Chromatography, 230 (1982) 37–45 ("Krause I").
c) "Pharmacokinetics of the new aldosterone antagonist, Spirorenone, in healthy volunteers after single and repeated daily doses", Krause et al Eur. J. Clin. Pharmacol (1983) 25 231–236 ("Krause III").
d) US Patent 5,756,490 ("Lachnit").
ii) Added matter in each of the patents over that contained in the application for the parent patent, WO 01/15701 ("the Parent Application").
Expert witnesses
Richter called Professor Graham Buckton who is a Professor of Pharmaceutics at the School of Pharmacy at the University of London. He is a Fellow of the Royal Pharmaceutical Society, the Royal Society of Chemistry, the American Association of Pharmaceutical Scientists and the Academy of Pharmaceutical Sciences of Great Britain. In 2000 he formed Pharmaterials Ltd, a company that provides contract services in the areas of physical form of pharmaceutical materials, materials science, formulation and analytical development.
Schering called Professor Martyn Davies. Professor Davies is a Professor in Biomedical Surface Chemistry at the School of Pharmacy at the University of Nottingham. Over his career he has primarily taught in the field of pharmaceutical technology, physical formulation and advanced drug delivery. He is the founder and chairman of Molecular Profiles Ltd, which is a pharmaceutical development and characterisation company which provides analytical support and consultancy to help find solutions for difficult drug substance and formulation issues.
Both sides criticised the other side's expert. Mr Waugh made criticisms of Professor Buckton's approach to the issues, whereas Mr Thorley said that Professor Davies exhibited a self-confidence in his views which would not be that of the ordinary skilled person. I think these questions are better considered in the context of the issues themselves, rather then as ad hominem attacks on the witnesses. Each expert recognised the expertise and academic distinction of the other. Both witnesses were doing their best to give reasons for their genuinely held views about inventiveness. It is for me to form a view as to how closely their reasoning would reflect that of the ordinarily skilled person.
Fact witnesses
Schering also called two fact witnesses, Dr Tack and Dr Hümpel to give an account of the work conducted at Schering on the pharmaceutical formulation and testing of EE and DSP. At the relevant time, Dr Tack was working in the galenics (pharmaceutical formulation) department of Schering. He was the person given the task of formulating a combination of DSP and EE for Schering's clinical trials. Dr Hümpel was the head of Schering's Department of Pharmacokinetics during the development of Schering's DSP and EE combination formulation. Both witnesses gave their evidence fairly.
Richter also called unchallenged evidence, through a witness statement of their solicitor Abby Minns, reporting on communications with Professor Barry Potter a medicinal chemist at the University of Bath. Professor Potter was asked about whether DSP can form a salt, one of the ways in which one might seek to overcome the acid lability of DSP. Professor Potter's unchallenged view was that there was no practical way of usefully protecting the molecule by this means. That evidence closed off that particular avenue, and I need say no more about it.
The skilled addressee or team
There was not much dispute as to the identity of the skilled team. The patents are both addressed to a team involved in the development of an oral contraceptive. The team would have included a pharmaceutical formulation scientist as well as a clinician with an interest in contraception (and possibly other sex steroid related indications). The formulator would be likely to have a degree in pharmacy (or a related discipline) and would have some industrial experience in pharmaceutical formulation. The clinician would have a good knowledge of sex steroids and their use as contraceptives.
The role of the pharmaceutical formulation scientist, or "formulator" is to design a suitable dosage form of an active pharmaceutical ingredient or API. The goal is to choose a form in which the API can be administered safely and effectively and in a way in which it will become bioavailable for its intended purpose.
The common general knowledge
Law
The law about the distinction between matter which is part of the common general knowledge, and matter which is merely known or even widely known is stated in Beloit v Valmet [1997] RPC 494–495, relying on the well known judgment of the Court of Appeal in General Tire v Firestone. The matter must be "generally accepted as a good basis for further action", what Jane Austen would have called "a truth universally acknowledged", at least within the universe of those skilled in the art. The distinction is important in the law of obviousness because, although it is in general permissible to combine the contents of an individual published citation with matter which is part of the common general knowledge, it is impermissible to make so-called mosaics of individual citations (unless it would be obvious to do so).
Matter which the skilled person would uncover as a matter of routine in the course of work based on a particular disclosure does not form part of the common general knowledge. In ratiopharm v Napp [2008] EWHC 3070 I said this at paragraph 159, relying on what Kitchin J had said in Generics v Daiichi:
"Finally, the common general knowledge does not include knowledge which does not inform the skilled person's approach from the outset. As Kitchin J said in Generics (UK) v Daiichi Pharmaceutical [2008] EWHC 2413 (Pat):
"I can readily accept that, faced with a disclosure which forms part of the state of the art, it may be obvious for the skilled person to seek to acquire further information before he embarks on the problem to which the patent provides a solution. But that does not make all such information part of the common general knowledge. The distinction is a fine one but it may be important. If information is part of the common general knowledge then it forms part of the stock of knowledge which will inform and guide the skilled person's approach to the problem from the outset. It may, for example, affect the...
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