Arrow Generics Ltd v Akzo NV
| Jurisdiction | Scotland |
| Judgment Date | 20 May 2008 |
| Docket Number | No 38 |
| Date | 20 May 2008 |
| Court | Court of Session (Inner House - First Division) |
Court of Session Inner House First Division
Lord President (Hamilton), Lord Kingarth, Lord Clarke
Intellectual property - Patents - Construction of patent - Novelty - Obviousness - Patents Act 1977 (cap 37), secs 1(1), 2(1), (2), 3
The Patents Act 1977 (as amended) provides, inter alia, "1.-(1) A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say- (a) the invention is new; (b) it involves an inventive step; and references in this Act to a patentable invention shall be construed accordingly. 2.-(1) An invention shall be taken to be new if it does not form part of the state of the art. (2) 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. 3. 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".
The petitioner sought revocation of claims 1 to 3 and 5 of European Patent 0 389 035 granted to the respondent. The patent had as its active ingredient the steroid known conventionally as tibolone. That compound had been known since the 1960s and, since about 1988, had in one composition been marketed as Livial. In tablet form, it was used for treating menopausal complaints, for modulating the immune system and for combating osteoporosis. The patent was concerned with tibolone in a high degree of crystalline purity. The priority date of the patent was 18 March 1989. Claims 1 to 3 were claims to a product, while claim 5 was a claim to a process, namely for the preparation of the monoclinic crystalline form referred to in claim 3. The petitioner challenged the validity of the patent on grounds both of anticipation and of obviousness. The Lord Ordinary (Glennie) upheld the challenge on the basis of anticipation but rejected it on the ground of obviousness, and revoked the patent. The respondent reclaimed. The respondent contended that, properly construed, the patent was not anticipated by any relevant prior art. The petitioner cross-appealed, contending that the Lord Ordinary erred in holding that the invention was not obvious.
Held that: (1) the construction of claims was a matter for the court; if a judge of first instance failed to construe the claims or misinterpreted them, that was an error in principle which was open to review by an appeal court; and in the absence of any clear indication that the Lord Ordinary had taken into account the whole integers of claims 1 to 3, his interlocutor was open to review (paras 92, 93, 138, 142); (2) taking account of the whole integers, the claims imported a combination of a pharmaceutically suitable solid carrier with tibolone in a crystalline purity of more than 90 per cent (claim 1), 95 per cent (claim 2) or of a particular crystalline form (claim 3) (paras 99, 138, 148, 149); (3) the prior art, as interpreted by the skilled man, did not disclose the invention claimed in claims 1 to 3 (paras 100-102, 138, 151); (4) while the prior art enabled the skilled person to take certain steps, it did not enable him to perform the invention in claims 1 to 3 (paras 104-107, 138, 152); (5) the terms of claim 5 involved more than the use simply of bench acetone, and that claim was not anticipated by the prior art (paras 111, 112, 138, 151); (6) the Lord Ordinary's treatment of obviousness was flawed and open to review (paras 115-117, 138, 153); (7) (diss Lord Clarke) in challenging, in a matter of obviousness, either the primary findings of the trial judge on the technical evidence or his secondary findings by way of inference from them, an appellant faces a formidable task, and the petitioner's challenge to the findings of fact and to the Lord Ordinary's conclusion on obviousness failed (paras 130, 131, 139-141); (8) (diss Lord Clarke) the arguments on obviousness fell to be rejected (paras 132-136, 138); and reclaiming motion allowed and cross-appeal refused.
Dissenting (per Lord Clarke) claims 1 to 3 had to be read as embracing a pharmaceutical composition containing a single crystal of tibolone, and the evidence provided adequate support for the petitioner's contention that what was embraced in claims 1 to 3 involved no inventive step (paras 148, 149, 160-163).
Arrow Generics ltd presented a petition under the Intellectual Property Cause Rules in the Court of Session seeking revocation of claims 1 to 3 and 5 of European Patent 0 389 035 of which the registered proprietor was Akzo NV on the grounds that the alleged invention was not a patentable invention in that it lacked novelty and was obvious and involved no inventive step. The petition and answers called before the intellectual property judge (Lord Glennie) for a proof on 17 to 20 and 24 to 27 January, 13 to 16 February and 14 to 17 March 2006. At advising, on 15 September 2006, the intellectual property judge indicated his intention to grant the prayer of the petition and revoke claims 1 to 3 and 5 of the patent, and put the case out by order ([2006] CSOH 146). On 25 October 2006 the intellectual property judge revoked the patent in its entirety unless the respondent amended it within eight weeks. The respondent reclaimed and the petitioner cross-appealed.
Cases referred to:
Asahi Kasei Kogyo KK's Application (Re)UNK [1991] RPC 485
Biogen Inc v Medeva plcUNKUNK [1997] RPC 1; 38 BMLR 149; 20 (1) IPD 20001
Buchanan v Alba Diagnostics LtdUNKUNK 2001 SCLR 307; [2001] RPC 43
Buchanan v Alba Diagnostics LtdUNKSCUNK [2004] UKHL 5; 2004 SC (HL) 9; 2004 SLT 255; 2004 SCLR 273
Conoco Speciality Products Inc v Merpro Montassa LtdUNK 1992 SLT 444; [1994] FSR 99
Designers Guild Ltd v Russell Williams (Textiles) LtdWLR [2000] 1 WLR 2416
Electric and Musical Industries Ltd v Lissen LtdUNKUNK [1938] 4 All ER 221; [1939] RPC 23
General Tire and Rubber Co v Firestone Tyre and Rubber Co LtdUNKUNK [1971] FSR 417; [1972] RPC 457
Generics (UK) Ltd v H Lundbeck A/SUNK [2007] RPC 729
Halliburton Energy Services Inc v Smith International (North Sea) LtdUNKUNK [2006] EWCA Civ 185; [2006] RPC 25
Hill v Evans (1862) 31 LJ Ch (NS) 457
Inhale Therapeutic Systems Inc v Quadrant Healthcare plcUNK [2002] RPC 419; (2001) 24 (1) IPD 24075
ITP SA v Coflexip Stena Offshore Ltd 2003 SLT 1197
Kirin-Amgen Inc v Transkaryotic Therapies Inc sub nom Kirin-Amgen Inc v Hoechst Marion Roussel LtdUNKUNKUNKENRUNK [2004] UKHL 46; [2005] 1 All ER 667; [2005] RPC 169; 28 (7) IPD 28049 and [2002] EWCA Civ 1096; [2003] ENPR 4; [2003] RPC 3; (2002) 25 (11) IPD 25076
Lilly ICOS Ltd v Pfizer Ltd (No 1) sub nom Pfizer Ltd's Patent (UK) (No 0702555)UNKUNK [2001] FSR 201; (2001) 59 BMLR 123; (2001) 24 (1) IPD 23006
Merrell Dow Pharmaceuticals Inc v HN Norton & Co LtdUNKUNK [1996] RPC 76; (1997) 33 BMLR 201; (1996) 19 (1) IPD 19004
Palmaz v Boston Scientific Ltd sub nom Boston Scientific Ltd v Palmaz; Re Palmaz's European Patents (UK)UNK [1999] RPC 631; (2000) 23 (6) IPD 23043
Pharmacia Corp v Merck & Co IncUNKUNK [2001] EWCA Civ 1610; [2002] ENPR 10; [2002] RPC 775
Pozzoli SpA v BDMO SAUNK [2007] FSR 872; 30 (8) IPD 30051; [2007] Bus LR D117
Sabaf v MFI Furniture Centres LtdUNKUNK [2004] UKHL 45; [2005] RPC 209; (2004) 148 SJLB 1217
Saint-Gobain Pam SA v Fusion Provida LtdUNK [2005] EWCA Civ 117; (2005) 28 (6) IPD 28043
SmithKline Beecham plc v Apotex Europe LtdUNKUNK [2004] EWCA Civ 1568; [2005] FSR 524; (2005) 28 (2) IPD 28003
Socit Technique de Pulverisation STEP v Emson Europe LtdUNK [1993] RPC 513
Synthon BV v SmithKline Beecham plc (No 2) sub nom SmithKline Beecham plc's (Paroxetine Methanesulfonate) PatentUNKUNKUNKUNK [2005] UKHL 59; [2006] 1 All ER 685; [2006] RPC 323; 6 BMLR 130
Technip France SA's PatentUNKUNK [2004] EWCA Civ 381; [2004] RPC 46; 27 (7) IPD 27066
Tera Pharmaceutical Industries Ltd v Instituto Gentili SpA sub nom Merck & Co Inc's PatentsUNKUNK [2003] EWCA Civ 1545; [2004] FSR 330; 27 (3) IPD 27021
Unilever plc v Chefaro Proprietaries LtdUNK [1994] RPC 567
Valensi v British Radio CorpUNKUNK [1972] FSR 273; [1973] RPC 337
Wheatley v Drillsafe LtdUNK [2001] RPC 7
Windsurfing International v Tabur Marine (GB) LtdUNK [1985] RPC 59
Textbooks etc. referred to:
Declercq, J-P, Van Meerssche, M and Zeelen, FJ, Conformational Alaysis of 3-oxo 5(10)-unsaturated Steroids: Single-crystal X-ray Structure of 17-hydroxy-7-methyl-19-nor-17-pregn-5(10)-20-yn-3-one (Org OD 14), Journal of the Royal Netherlands Chemical Society, 103/5 (1984)
Terrell, T, The Law of Patents (16th Thorley et al ed, Sweet and Maxwell, London, 2006), paras 6.59, 6.68, 6.103-6.106, 7.53
The cause called before the First Division, comprising the Lord President (Hamilton), Lord Kingarth and Lord Clarke, for a hearing on the summar roll on 8 to 11 and 15 to 18 January 2008.
At advising, on 20 May 2008-
Lord President (Hamilton) -
[1] In these proceedings the petitioner (the respondent in the reclaiming motion), which I shall refer to as 'Arrow', seeks revocation of claims 1 to 3 and 5 of European Patent 0 389 035 ('the patent') granted to the respondent (the reclaimer in this reclaiming motion), which I shall refer to as 'Akzo'. Akzo is represented in Scotland by Organon Laboratories Ltd. The patent has as its active ingredient the steroid known conventionally as tibolone. That compound has been known since the 1960s and, since about 1988, has in one composition been marketed as Livial. It has combined oestrogenic, progestagenic and androgenic characteristics. In tablet form, it is used for treating menopausal complaints, for modulating the immune system and for combating osteoporosis. The patent is concerned with...
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