Generics (UK) Ltd v Daiichi Pharmaceutical Company Ltd (Costs)
| Jurisdiction | England & Wales |
| Judge | MR. JUSTICE KITCHIN |
| Judgment Date | 15 October 2008 |
| Neutral Citation | [2008] EWHC 2413 (Pat) |
| Docket Number | Case No: HC 07 COO988 |
| Court | Chancery Division (Patents Court) |
| Date | 15 October 2008 |
[2008] EWHC 2413 (Pat)
THE HONOURABLE MR JUSTICE KITCHIN
Case No: HC 07 COO988
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION PATENTS COURT
Royal Courts of Justice
Strand,
London, WC2A 2LL
James Mellor QC and Michael Tappin (instructed by Messrs. Taylor Wessing LLP) for the Claimant
Andrew Waugh QC and Thomas Hinchliffe (instructed by Messrs. Herbert Smith LLP) for the Defendants
Hearing dates: 9 – 13, 16 – 18, 23 and 25 – 27 June 2008
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
In this action the claimant (“GUK”) seeks a declaration of invalidity of (or rectification of the register in respect of) supplementary protection certificate no. SPC/GB97/085 (“the SPC”) in the name of the second defendant and a declaration that claims 1–2 and 5–7 of European Patent (UK) No. 0206283 (“the Patent”) in the name of the first defendant were invalid. I refer to the defendants collectively in this judgment as “Daiichi”.
The Patent relates to the (-) enantiomer of a racemic compound called ofloxacin. Ofloxacin is a member of the quinolone class of anti-microbial agents. The (-) enantiomer of ofloxacin is called levofloxacin and its structure is shown below, with an asterisk marking the chiral centre:
It was agreed at trial that the claims of the Patent upon which I need to focus are:
Claim 2: to levofloxacin.
Claim 5: to a process for preparing levofloxacin involving the addition of N-methyl piperazine to the intermediate denoted (V) on page 28 of the Patent.
The Patent claims priority from three Japanese filings dated 20 June 1985, 11 October 1985 and 28 January 1986, each of which describes a process for making levofloxacin. They are referred to in the Patent as processes A, B and C respectively. The application for the Patent was filed on 20 June 1986 and it proceeded to grant on 27 January 1993. On 6 June 1997, UK marketing authorisations were granted in respect of levofloxacin. On 23 October 1997, Daiichi lodged the application for the SPC, identifying the Patent as the basic patent, levofloxacin as the product and the UK marketing authorisations in respect of levofloxacin as the first authorisations to place the product on the market. The SPC was duly granted on 13 July 1998. The Patent expired on 20 June 2006, but the SPC is now in force and, subject to this action, will expire on 19 June 2011.
The validity of the SPC is challenged in two distinct ways. First, it is said that the SPC is invalid pursuant to Article 15 of Council Regulation (EEC) No 1768/92 (“the SPC Regulation”) because grounds exist which would have justified revocation of the Patent, or its limitation to the extent that levofloxacin would no longer have been protected by the claims. Second, there is a free standing attack on the SPC (or its duration) based upon earlier marketing authorisations for ofloxacin.
The issues in the action which occupied most of the time at trial were those concerning the validity of the Patent. They are:
i) Lack of novelty over the following two publications by Daiichi concerning the structure, properties and synthesis of ofloxacin:
a) EP 0,047,005 (“the 005 Patent”).
b) DL-8280, Drugs of the Future, vol 8, no. 5 (1983) pp. 395–396 (“Drugs of the Future”).
ii) Lack of novelty over EP application No. 0225552 (“the Bayer application”). This application is cited for novelty purposes only under s.2(3) of the Patents Act 1977 (“the Act”). It was filed on 27 November 1986 and has a priority date of 10 December 1985. It becomes relevant only if the Patent loses its first two priority dates of 20 June 1985 and 11 October 1985.
iii) Obviousness over the above two Daiichi publications (the 005 Patent and Drugs of the Future) and the following further publications by scientists from Riker Laboratories Inc (which was part of 3M) concerning two other quinolones known as flumequine and S-25930:
a) An abstract entitled “Synthesis and antibacterial activity of the optical isomers of 6,7-dihydro-9-fluoro-5-methyl-1-oxo-1H, 5H-benzo[ij] quinolizine-2carboxylic acid (flumequine)” by Gerster et al, (Proceedings of the North American Medicinal Chemistry Symposium, Toronto, 153 (1982)) (“Gerster I”).
b) A paper entitled “Differentiation of fluorinated quinolone antibacterials with Neisseria gonorrhoea isolates” by Rohlfing et al, (Journal of Antimicrobial Chemotherapy, 15, 539–544) (“Rohlfing”).
c) A poster said to be that of Dr Gerster at the 1982 Toronto symposium to which the Gerster I abstract relates (“Gerster IP”). There is a factual issue as to whether Gerster IP was made available to the public.
d) A paper entitled “Stereochemical aspects of the antibacterial activity of S-25930” by Gerster et al, (25th Interscience Conference on Antimicrobial Agents and Chemotherapy, Minneapolis, 29 September – 2 October 1985) ('Gerster II'). Gerster II only becomes relevant if the Patent is not entitled to its first priority date of 20 June 1985.
iv) Added matter. The point is a short one. GUK says claim 5 was not in the application as filed and represents an unjustified generalisation of processes A, B and C.
v) Insufficiency. In summary it is alleged that the enantiomers of ofloxacin were an obvious goal and the claims cover ways of making levofloxacin which owe nothing to the disclosure of the Patent. It is accepted by GUK that following the decision of the Court of Appeal in Lundbeck A/S v Generics UK Ltd [2008] EWCA Civ 311, this attack cannot succeed before this court. But I am nevertheless asked to make findings of fact in case the point is pursued on appeal.
Finally I would note that GUK has sought to establish lack of novelty and obviousness over all the above prior art, save for Gerster IP, by performing experiments purporting to show obvious ways in which the skilled person could have resolved ofloxacin into its enantiomers in 1985. These experiments were the subject of a good deal of evidence and criticism, as I shall explain.
The witnesses
Two experts gave evidence on behalf of GUK, Dr Peter Spargo and Dr Roger Newton.
Dr Spargo gave the primary evidence on the issue of obviousness over the various citations relied upon by GUK. He obtained a First Class Honours degree in Natural Sciences (Chemistry) from Cambridge University in 1983 and was awarded a PhD in Synthetic Organic Chemistry in 1986, also from Cambridge University where he held a non-stipendiary research fellowship. After two years as a NATO Postdoctoral Research Fellow and a Lindemann Trust Fellow at Columbia University, he returned to the UK, joining Pfizer Ltd (Sandwich) in 1988 as a medicinal chemist. Within two years he transferred to Pfizer's Process (now Chemical) Research and Development Department, where he progressed from Laboratory Team Leader to Section Head, then Manager, Director, and ultimately Head of Department (Group Director). During his 15 years at Pfizer, Dr Spargo identified, developed and scaled up a wide range of manufacturing processes for new drug candidates across a number of different therapeutic areas.
Dr Spargo gave his evidence in a forthright, clear and balanced way and he sought to retain his objectivity throughout his extensive cross examination. However it is notable that Dr Spargo was studying for his PhD at the 1985 priority date, did not profess to be an expert in medicinal chemistry and, as he frankly accepted, had no experience of quinolone chemistry before his involvement in these proceedings. It is also relevant that he formed his views of the Patent and the prior art before having read any background materials that would have permitted him to gain an understanding of the common general knowledge in the quinolone field. Nor did he claim to be an expert in HPLC chromatography, an issue of some importance in relation to the experiments. All these are matters which I must take into account in considering the weight to be given to his evidence when assessing obviousness.
Dr Spargo was also subjected to more severe criticism for adopting what was said to be an unreasonably low standard in assessing what amounted to a reasonable expectation of success, displaying an unreasonable determination to want to obtain the enantiomers of ofloxacin and, perhaps most seriously, for revealing a desire to argue GUK's case. I reject all these criticisms. I did not regard any evidence given by Dr Spargo as unreasonable. Nor do I believe he was attempting to argue GUK's case. He expressed his opinions at all times in a measured and sensible way. As I have said, I must consider the weight to be attached to those opinions in addressing the obviousness allegation. But I have no doubt they were all expressed with the intention of assisting the court.
Finally it was said Dr Spargo played an unsatisfactory role in connection with the experiments, that his report was not complete and his advice was deployed in a partial manner. This arose from disclosure given in the course of the trial of attendance notes and other correspondence containing details of the instructions given to and advice received from Dr Spargo as to the reagents and techniques he would suggest for the resolution of ofloxacin. I deal with the experiments later in this judgment and for the moment limit myself to the personal criticism directed at him. I found Dr Spargo to be completely candid in the witness box and I do not believe for one moment he attempted to deceive or mislead the court. In so far as his report gave a less than full account of all his instructions and advice, I am sure that was because he believed he had disclosed all that was relevant. Once again, I...
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