Generics (UK) Ltd (trading as Mylan) v Richter Gedeon Vegyeszeti Gyar RT
Jurisdiction | England & Wales |
Judge | The Honourable Mr Justice Sales,Mr Justice Sales |
Judgment Date | 22 May 2014 |
Neutral Citation | [2014] EWHC 1666 (Pat) |
Court | Chancery Division (Patents Court) |
Date | 22 May 2014 |
Docket Number | Case No: HP13B02148 |
[2014] EWHC 1666 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Honourable Mr Justice Sales
Case No: HP13B02148
Piers Acland QC (instructed by Innovate Legal) for the Claimant
Michael Silverleaf QC & Lindsay Lane (instructed by Bristows LLP) for the Defendant
Hearing dates: 6/5/14–8/5/14
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
This is a claim for a declaration that European Patent (UK) no. 1 448 207 B1 entitled "Dosage Regimen and Pharmaceutical Composition for Emergency Contraception" ("the Patent") is invalid and should be revoked. The Patent is for a dosage regimen for use of levonorgestrel as a method of emergency contraception. The regimen for which the Patent is claimed is for use of a single dose of levonorgestrel of 1.5 mg taken within 72 hours of sexual intercourse.
Particular benefits are associated with this form of emergency contraception, in that it does not involve a physically intrusive procedure such as would be required in connection with use of an intrauterine device ("IUD"); is associated with significantly less unpleasant side-effects (such as nausea and gastrointestinal problems) than certain other forms of pill-based hormonal emergency contraceptives using other active ingredients; and is easier to use effectively than the previously established dosage regimen for levonorgestrel, which required two doses of 750 µg taken 12 hours apart. The single dose regimen is broadly equivalent in efficacy to other forms of pill-based treatment.
The grounds of invalidity relied on are (1) obviousness, in that it is claimed that the invention to which the Patent relates does not involve an inventive step (see section 1(1)(b), read with section 3, of the Patents Act 1977) and (2) insufficiency, in that it is claimed that the specification of the Patent "does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art" (section 72(1)(c) of the Act).
The legal framework
Section 1(1) of the Act sets out conditions which have to be satisfied before a patent can be issued. These include, at sub-section (1)(b), that the relevant invention "involves an inventive step".
Section 3 provides:
"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above …."
Section 2(2) provides:
"The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way."
Section 4A provides for the grant of patents in relation to methods of treatment or diagnosis. Section 4A(3) stipulates that in the case of an invention consisting of a substance or composition for use in a method of treatment of the human body, "the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art." Section 4A(4) makes similar provision in the case of an invention consisting of a substance or composition for a specific use in any such method.
Section 72 provides for a power to revoke patents on application, on grounds which include, at sub-paragraph (a), that "the invention is not a patentable invention", and at sub-paragraph (c), that "the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art."
The witnesses
The Claimant's primary case is that the relevant expertise for assessment of the issues in the case, in particular that of obviousness, is that of a clinician with an interest in emergency contraception. The Claimant called as an expert witness a clinician with a strong research interest in emergency contraception, Mr Ali Kubba.
The Defendant's case is that although the expertise of a clinician is relevant, of more importance is expert knowledge of medical statistics. Only someone with such knowledge could assess the novelty and validity of the claim in the Patent, as compared with information in the public domain before the priority date for the Patent. The Defendant did not call an expert clinician in the field of emergency contraception, but instead relied on the evidence of an expert in medical statistics, Professor Bland.
When it emerged that the Defendant would be relying on the evidence of an expert medical statistician rather than an expert clinician to defend the claim, the Claimant sought and was granted permission to adduce reply evidence from another expert medical statistician, Professor Sasieni.
Each of the witnesses had good expertise appropriate to his respective discipline. Each of them gave his evidence in a measured and neutral way, and sought to assist the court as best he could.
The Patent
It is common ground that the priority date for the Patent is November 2001.
The Patent sets out the background of developing views about and research into pill-based methods of emergency contraception, focusing in particular on work carried out by A.A. Yuzpe and co-workers from the 1970s in relation to a two-dose regimen for administering levonorgestrel and ethinyl-estradiol, through to an important trial conducted by Dr Helena von Hertzen under the auspices of the World Health Organisation ("WHO") which examined the effectiveness of a regimen involving a single dose of 1.5 mg of levonorgestrel, as follows:
"[0006] A.A. Yuzpe and his coworkers reported in The Journal of Reproductive Medicine [ 13(2), (1974)] the results of those studies where a pharmaceutical composition containing 100 µg of ethinyl-estradiol and 1.0 mg of norgestrel was used as postcoital contraceptive in a single dose. The composition was administered within five days of the unprotected coitus. Later the method was modified. On the one hand the period of the possible use of the composition was reduced from 5 days to 72 hours, on the other hand the dose was doubled that way that the administration was repeated 12 hours after the first one. [Fertility and Sterility, 28, 932–936, (1977), ibid. 37, 508–513 (1982); International Journal of Gynaecology and Obstetrics, 15, 133–136, (1977)]. This modification increased the success of the method.
[0007] After the studies of A.A. Yuzpe and his coworkers several other trials were carried out to prove the efficacy of this combination. In these studies the total dose of ethinyl-estradiol was 0.2 mg combined with 2.0 mg of norgestrel or 1.0 mg of levonorgestrel. The results of the studies showed that although the above administration (Yuzpe regimen) caused less side-effects than the estrogens used earlier in high doses (mainly in the sixties), the relative incidence of nausea and vomiting was still very high (50 and 20% respectively). These side-effects are due to the estrogen effect and they cause the decrease in compliance, moreover, if vomiting occurs, it decreases the efficacy of the treatment.
[0008] The use of levonorgestrel in emergency contraception was discovered in the 1990s. The results of the studies were reported in two well-documented publications [Lancet, 352, 428–433, (1998) and Human Reproduction, 8(3), 389–392, (1993)]. The efficacy of tablets containing only 0.75 mg of levonorgestrel and the combined tablets of Yuzpe method containing 0.1 mg of ethinyl-estradiol + 1.0 mg levonorgestrel were studied by administering the doses 12 hours apart within 48 as well as within 72 hours of unprotected coitus. The results showed that protection with two tablets containing 0.75 mg of levonorgestrel was better than with the Yuzpe regimen, but the women, who received only levonorgestrel observed less side-effects, which could be due to the lack of ethinyl-estradiol.
[0009] The mechanism of action of levonorgestrel used as postcoital contraceptive was investigated in several studies. Keserü and Garmendia showed that the antiovulatory effect probably depends partly on the time elapsed between taking the last tablet and the time of ovulation, partly on the quantity of the applied hormone [Contraception, 10, (1974)]. According to other authors besides the inhibition of ovulation, other factors can also influence the contraceptive effect [Contraception, 63, 123–129, (2001)]. Levonorgestrel administered in the follicular phase decreased the proliferation activity of the endometrium, while in the luteal phase there was no effect [Contraception, 39(3), 275–289, (1989)].
[0010] Several trials were conducted to show the effect of levonorgestrel on the cervical mucus, which could be observed a few hours after the administration. Levonorgestrel inhibits the sperms getting into the upper genital tract in such a way that it causes the thickening of the cervical mucus almost immediately after the absorption of the hormone. It was also shown that after the administration of 400 µg of levonorgestrel the alkalization of the intrauterine fluid starts already after 4 hours of administration and it lasts for approximately 48 hours. This effect can play a role in the inhibition of the movement of sperms, consequently in the...
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