Glaxo Group Ltd v Patents Act

JurisdictionIreland
CourtHigh Court
JudgeMr. Justice Charleton
Judgment Date26 Jun 2009
Neutral Citation[2009] IEHC 277

[2009] IEHC 277

THE HIGH COURT

[No. 3 PAP/2008]
Glaxo Group Ltd, In Re
IN THE MATTER OF IRISH PATENT NO. 65535 ENTITLED "INHALATION MEDICAMENTS FOR TREATING RESPIRATORY DISORDERS" FILED ON 7 TH SEPTEMBER, 1990 AND REGISTERED IN THE NAME OF GLAXO GROUP LIMITED
IN THE MATTER OF IRISH SUPPLEMENTARY PROTECTION CERTIFICATE NO. 1999/007 GRANTED ON 12 TH AUGUST, 2003 AND REGISTERED IN THE NAME OF GLAXO GROUP LIMITED
IN THE MATTER OF THE PATENTS ACT 1992
AND IN THE MATTER OF COUNCIL REGULATION (EEC) NO. 1768/92 OF 18 TH JUNE, 1992 CONCERNING THE CREATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE FOR MEDICAMAL PRODUCTS PAB

EUROPEAN PATENT CONVENTION 1973 ART 56

EUROPEAN PATENT CONVENTION 1973 ART 89

EUROPEAN PATENT CONVENTION 1973 ART 54(2)

PATENTS ACT 1977 S130(7) (UK)

EEC REG 1768/92 ART 15(1)

PATENTS ACT 1992 S18(2)

PATENTS ACT 1992 S20

PATENTS ACT 1992 S9(1)

PATENTS ACT 1992 S58

PATENTS (AMDT) ACT 2006 S16

PATENTS ACT 1992 S11(1)

PATENTS ACT 1992 S13

PATENTS ACT 1992 S11(2)

CIPLA LTD v GLAXO GROUP LTD 2004 RPC 43

CONOR MEDSYSTEMS INC v ANGIOTECH PHARMACEUTICALS INC 2008 RPC 28

DAVIE v EDINBURGH CORP (NO 2) 1953 SC 34 1953 SLT 54

BIOGEN INC v MEDEVA PLC 1997 RPC 1

GENERICS (UK) LTD v H LUNDBECK A/S 2007 RPC 32

POZZOLI SPA v BDMO SA 2007 FSR 37

UNION CARBIDE CORP v BP CHEMICALS LTD 1998 RPC 1

DYSON APPLIANCES LTD v HOOVER LTD (NO 1) 2001 AER (D) 41 2002 RPC 22

RANBAXY LABORATORIES LTD & ORS v WARNER-LAMBERT CO UNREP CLARKE 10.7.2007 2007/53/11270 2007 IEHC 256

BRITISH ORE CONCENTRATION SYNDICATE LTD v MINERALS SEPARATION LTD 1909 26 RPC 124

GENERAL TIRE & RUBBER CO LTD v FIRESTONE TYRE & RUBBER CO LTD 1972 RPC 457 1971 FSR 417

NOVARTIS AG v IVAX PHARMACEUTICALS UK LTD 2006 EWHC 2506 (PAT)

MEDICAL PREPARATIONS (LICENSING ADVERTISEMENT & SALE) REGS 1984 SI 210/1984

BRUGGER v MEDICAID LTD (NO 2) 1996 RPC 635

PATENTS ACT 1992 S38

PATENTS (AMDT) ACT 2006 S11

EUROPEAN PATENT CONVENTION 1973 ART 69

PATENTS ACT 1992 S38(7)

EUROPEAN PATENT CONVENTION 1973 ART 123(2)

BONZEL v INTERVENTION LTD (NO 3) 1991 RPC 553

VECTOR CORP v GLATT AIR TECHNIQUES LTD 2008 RPC 10 2007 EWCA CIV 805

RICHARDSON-VICKS INC'S PATENT 1995 RPC 568

EUROPEAN CENTRAL BANK v DOCUMENTS SECURITY SYSTEMS INC 2007 EWHC 600 (PAT)

INTELLECTUAL PROPERTY

Patents

Validity - Revocation - Application to revoke patent - Want of inventiveness - State of art - Obviousness depriving patent of protection at priority date - Principles to be applied - Whether patent for drug combination involved inventive step - Whether combination of two drugs into single preparation obvious - Pozzoli SPA v BDMO SA [2007] EWCA Civ 588, [2007] FSR 37 approved; Cipla Ltd v Glaxo Group Ltd [2004] RPC 43 distinguished; Connor Medsystems v Angiotech Pharmaceuticals [2008] RPC 716, Generics (UK) Ltd v Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] RPC 729,Johns-Manville Corporation's Patent [1967] RPC 479, Brugger v Medic-Aid Ltd [1996] RPC 635, Union CarbidevBP Chemicals Ltd [1998]RPC 1, Dyson AppliancesLtdvHooverLtd[2001]All ER (D)37, Ranbaxy Laboratories Ltd v Warner Lambert Co [2007] IEHC 256 (Unrep, Clarke J, 10/7/2007), British Ore Concentrate Syndicate Ltd v Minerals Separation Ltd [1909] 26 RPC 124, General Tire and Rubber Co v Firestone Fire and Rubber Co Ltd [1972] RPC 457, Vovartis AG v Ivax Pharmaceuticals UK Ltd [2006] EWHC 2506 (Pat), Davie v Magistrates of Edinburgh [1953] SC 34, SS Bogota v SS Alconda [1923] SC 526, Biogen Inc v Medeva plc [1997] RPC 1, Bonzel v Intervention Ltd (No 3) [1991] RPC 553, Vector Corp v Glatt Air Techniques [2007] EWCA Civ 805, Ricardson v Vicks Patent [1995] RPC 568, European Central Bank v Documents Security Systems [2007] EWHC 600 (Pat)considered - Council Regulation (EEC) No 1768/92 - Patents Act 1992 (No 1) - Patents (Amendment) Act 2006 (No 31) - Patent disallowed (2008/3PAP - Charleton J - 26/6/2009) [2009] IEHC 277

Re Glaxo Group Ltd

1

1. The petitioner, Ivax International B.V. trading as Ivax Pharmaceuticals Ireland Limited, whom I will call Ivax, brings these proceedings to challenge an Irish patent for an asthma medicine that, when purchased in a chemist's, is commonly called Seretide. The patent is held by the respondent Glaxo Group Limited, whom I will call Glaxo.

2

2. The application for the patent was filed in Ireland on 7 th September, 1990 and was granted on 12 th October, 1995. Glaxo is entitled to a priority date as of 8 th September, 1989. That priority date, I understand, arises by virtue of the filing in the United Kingdom patent office. In any event, the date is not in dispute. It is, however, very important as I have to look at the issues in this case as of that time. Glaxo obtained an extension of the term of the protection under the patent to 6 th September, 2013 by reason of the grant on 12 th August, 2003 of supplementary protection certificate number 1999/007.

3

3. Seretide is one of the best selling drugs in the world. It is administered by breathing in while firing a liquid to gas inhaler, or a dry powder inhaler, held in one's mouth. This gives a precise dose. It consists of a mixture, as opposed to a compound, of two solid but ground-up products; salmeterol xinafoate and fluticasone propionate. Both are in a carrier; lactose in the dry powder inhaler and a liquid which becomes gas on firing in the other. Fluticasone propionate is a steroid, specifically a medication which reduces inflammation in the lining of the trachea, a condition which is typical in asthma. Salmeterol xinafoate is a β 2-agonist and it relaxes the involuntary muscular spasm in the trachea that is also typical. In asthma, both spasm and inflammation are characteristic. In this preparation, it takes the salt form of salmeterol xinafoate, but other salt forms of salmeterol are also covered by the patent.

4

4. To be effective, steroids need to be taken regularly over a period of time, be it days or weeks or months. One is always given a prescription of a steroid to be taken regularly, like twice a day, for some period of time. This particular medication, fluticasone propionate, reduces inflammation only when taken regularly for some days; five was the estimate in evidence before me for the compound in issue. A β-agonist, like salmeterol xinafoate on the other hand, relaxes muscle spasm quickly. You use it when breathless. The evidence that I was given was that it is now understood that salmeterol xinafoate is effective within about twenty minutes. However, Ullman and Svedmyr [1988] saw "no significant differences in the time of onset between … salmeterol" and its analogue salbutamol. Salmeterol last for about twelve hours. Salbutamol, which I must mention again, has a swift onset but lasts for only about four hours. One is not always given a prescription by your doctor to take a β-agonist regularly. This is a central controversy in this case. The pharmaceutical preparation Seretide, which is covered by the patent in suit, is one that is to be taken regularly over a period of time for people with ongoing asthmatic problems. Taken twice daily, the inflammation of the trachea is reduced and the possibility of muscle spasm is both relieved and held off. When a medicine is prescribed to be taken once or twice or more per day this is referred to in scientific terms as regular use; or that expression can be replaced by saying twice daily or any number of times daily, meaning the same thing.

5

5. Ivax claims that Glaxo should never have been granted the patent for this preparation of the compounds. Glaxo hold, in addition to the patent for the drug combination in issue here, namely Seretide, the patents for the individual medicaments that make it up. There is no argument against these two individual patents for those components; salmeterol and fluticasone propionate. All are agreed that the development of fluticasone propionate and the long acting β 2-agonist salmeterol were inventive contributions to asthma medication. The issue is against the patent granted for putting them both into a single preparation. The argument by Ivax, essentially, is that the combining of these two medications into one product for use by those with ongoing asthma problems was obvious. In other words, that combining the two known drugs did not involve an inventive step. That is the crux of this case.

Patents Legislation
6

6. This case is to be decided under the Patents Act 1992 ('the 1992 Act'), as amended by the Patents (Amendment) Act 2006 ('the 2006 Act'). The provisions within the Act are mainly derived from the European Patent Convention of 1973, to which Ireland became a contracting party in 1992. There is thus a common system of substantive law of European patents. Our law is aligned to it, as is that of the United Kingdom. In this judgment I am relying extensively on principles developed within the jurisdiction of the neighbouring kingdom, principally under the Patents Act 1977, though the question of obviousness depriving a patent of protection goes back well before that particular legislation.

7

7. Article 56 of the European Patent Convention states that an invention "shall be considered as involving an inventive step, if, having regard to the state of the art, it is not obvious to a person skilled in the art". Articles 89 and 54(2) make it clear that everything made available to the public anywhere in the world before the priority date may become part of the state of the art as of the priority date; though whether it does or not is a matter for judicial determination. The United Kingdom Act of 1977, as to its material parts, are declared by s. 130(7) to have been framed as nearly as practicable to the corresponding provisions of the European Patent Convention. The supplementary protection certificate granted to this patent, and which extended its life, is governed by Article 15(1)...

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5 cases
  • Gilead Sciences Inc.
    • Ireland
    • High Court
    • 11 October 2019
    ...unsurprising that a clinician would not understand every line of a patent of this kind. As Charleton J. observed in Re. Glaxo Group Ltd [2009] IEHC 277 at p. 39, the person skilled in the art in almost all pharmaceutical cases will be a team. In my view, that observation very obviously appl......
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    • 2 February 2021
    ...be expected to have as part of their general knowledge which they would have had as of the priority date. 38 In Re Glaxo Group Limited [2009] IEHC 277, the High Court (Charleton J.) held that the common general knowledge attributed to the skilled person is any knowledge that a skilled perso......
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    ...claim in question, and if it cannot readily be identified, it should be construed. In his judgment in the Re Glaxo Group Limited case [2009] IEHC 277, Charleton J., at paragraph 27, referred to the "problem and solution approach" adopted by the European Patent Office which involve......
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