Is the enlarged board of appeal of the european patent office authorised to extend the bounds of the patentable? - The G-3/85 second medical indication/EISAI and G-2/08 dosage regime/abbott respiratory cases

IIC International Review of Intellectual Property and Competition Law

Volumn 42, Issue 3, 2011, Pages 257-271

  Cockbain, Julian ^a   Sterckx, Sigrid ^b  

^a European Patent Attorney and Partner of Dehns   (United Kingdom)

^b VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

Author keywords

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EID: 79957785960     PISSN: 00189855     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (50)

1. According to Roman jurist and Praetorian Prefect AEMILIUS PAPINIANUS (PAPINIAN) (142-212 CE), Definitiones.
2. Roman satirist DECIMUS IUNIUS IUVENALIS (JUVENAL), Satire VI.
3. G-2/08 Dosage regime/ABBOTT RESPIRATORY, 2010 OJ EPO 456-494. See 42 HC 215 (2011).
4. 2010 OJ EPO 514-515.
5. UNITED KINGDOM PATENT OFFICE (2010), available at http://www.ipo.gov.uk/ p-pn-medical.htm [last visited 8 December 2010].
6. For a recent review, see: EDDY D VENTOSE, "Patent Protection for Second and Further Medical Uses Under the European Patent Convention", 6 SCRIPTed 57-74 (2009).
7. For an early review explaining some of the concerns with Swiss-type use claims,
8. see: JEAN M MILLER, "Patentability of a Second Indication of a Pharmaceutical in Europe", 26 IDEA 15-24 (1985-1986). A memorable comment on the Swiss-type use claim format was made by Jacob J in the British Patents Court in Bristol-Myers Squibb v. Baker Norton in 1998: "I must now say something about the general structure of the [Swiss-type use claim at issue]. I daresay that an ordinary skilled man (to whom it is notionally addressed) would find it puzzling, unless he had been initiated in some of the Byzantine logic of patent law and jurisprudence." See Bristol-Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc., RPC 253-281 (1999), at 271.
9. G-5/83 Second medical indication/EISAI, 1985 OJ EPO 64-66. The EBoA rendered the same judgement in six other cases, G-1/83 BAYER, G-2/83 DR KARL THOMAE, G-3/83 CIBA-GEIGY, G-4/83 DR KARL THOMAE, G-6/83 PHARMUKA and G-7/83 CH BOEH-RINGER SOHN.
10. EUROPEAN PATENT OFFICE, Convention on the Grant of European Patents (European Patent Convention), 70, 12th ed. (European Patent Office, Munich 2006). References to Articles in this version, the first version, of the EPC have been supplemented in this paper by the year 1973. References to the current version of the EPC carry no year indicator.
11. 1984 OJ EPO 26-41 - Hydropyridine. Here it should be borne in mind that prior to the EPC coming into effect in 1978, the German courts had a somewhat "relaxed" attitude towards the wording of patent claims, an attitude that was addressed in the Protocol on the Interpretation of Art. 69 of the Convention (see European Patent Office, supra note 8, at 84). To quote from the EBoA decision G-2/88 Friction reducing additive/MOBIL III: "In some countries, in particular Germany, in practice the protection conferred by a patent depended more upon what was perceived to be the inventor's contribution to the art, as disclosed in the patent, by way of the general inventive concept, than upon the wording of the claims." {See MOBIL III, infra note 22, at 98).
12. Swiss FEDERAL INTELLECTUAL PROPERTY OFFICE, Legal advice dated 30 May 1984, OJ EPO 581-584 (1984).
13. In EISAI, the EBoA was clearly tempted to follow the German Federal Supreme Court but drew back stating "It is ⋯ difficult for the [EPO] to follow the practice of a superior court of only a single Contracting State in a matter which has a bearing on questions of infringement and which is regarded as controversial, however eminent that court may be. It is to be regarded as unfortunate that the appellant in the Hydropyridine case withdrew his appeal to the English Courts against a refusal of the United Kingdom Patent Office to grant a patent for the same invention. The decisions of the national courts of two Contracting States tending in the same direction might have had great weight." (EISAI, supra note 7, at 66). The English Patents Court responded to this in John Wyeth's and Schering's Applications (infra note 12, at 559): "we should, we think, make it clear that in our judgement, the reasoning and decision of the [Patent Office in the equivalent UK case] were correct and ⋯ [the equivalent claims in John Wyeth's application] were rightly refused by the [Patent Office] as contrary to section 4(2) [the equivalent of Art. 52(4) EPC 1973]." More recently, in the 2006 Carvedilol II decision, the German Federal Supreme Court has diverged from the EPO's interpretation of the acceptability of second medical use claims, more particularly claims characterised by the dosage regime rather than by a treatment of a new disease. See for example FRANZ-JOSEF ZIMMER & STEVEN ZEMAN, "Applicant Friendliness of the European Patent Office for Second Medical Use Claims: A Mixed Blessing", 26 Biotechnology Law Report 341-347 (2007).
14. John Wyeth and Brother Ltd.'s Application and Schering A.G.'s Application, 1985 RPC 545-568.
15. PHILIP W GRUBB, "Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy" 243 (4th ed., Oxford University Press, Oxford 2004).
16. EUROPEAN PATENT OFFICE, Convention on the Grant of European Patents (European Patent Convention), (13th ed., European Patent Office, Munich 2007).
17. Ibid., at 82.
18. EUROPEAN PATENT OFFICE, "MR/18/00: Basic Proposal - explanatory notes - Article 54(4) and Article 54(5) EPC" (European Patent Office, Munich 2000).
19. SIGRID STERCKX & JULIAN COCKBAIN, "Purpose-Limited Pharmaceutical Product Claims under the Revised European Patent Convention: A Camouflaged Attack on Generic Substitution?", 2010 Intellectual Property Quarterly 88-107.
20. JULIAN COCKBAIN (2009), Amicus curiae brief dated 21 May 2009, available at https://register.epoline.org/espacenet/application?documentId= EOVYKLSM8034154&number=EP94306847&lng=en&npl=false&seql=false [last visited 14 December 2010].
21. SIGRID STERCKX, "Dosage regime claims in the European Patent Office", 2010 European Intellectual Property Review 294-298.
22. ABBOTT RESPIRATORY, supra note 3, at 490.
23. Ibid., at 492.
24. G-2/88 Friction reducing additive/MOBIL OIL III, 1990 OJ EPO 93-113; MOBIL III confirmed that in the EBoA's opinion a known product, found to have a new use or effect which may have been implicit but was unrecognised, could be validly claimed in a pur-(Contd. on page 263) (Contd. from page 262) pose-limited use claim format. This was said to apply even to products which were not medicaments. This decision deprived the public of the freedom to carry out an act described in the prior art in the way described in the prior art and with the only difference being that the previously unrecognised effect was now both recognised and intended. MOBIL III was commented on, with extreme care to avoid the suggestion that it was bad law, by the UK House of Lords in Merrel Dow Pharmaceuticals Inc. and Anr. v. H.N. Norton & Co. Ltd., 1996 RPC 76-93. 23
25. PAUL VAN DEN BERG, "Patentability of computer-software related inventions", in: "Members of the Enlarged Board of Appeal of the EPO, The Law and Practice of the Enlarged Board of Appeal of the European Patent Office During Its First Ten Years" 45 (Carl Heymanns, Cologne 1996).
26. EUROPEAN PATENT OFFICE, supra note 14, Art. 23(3) EPC, at 50.
27. GOVERNMENT OF THE FEDERAL REPUBLIC OF GERMANY, "Minutes of the Munich Diplomatic Conference for the Setting Up of a European System for the Grant of Patents" (Munich, 10 September to 5 October, 1973), 29 (Bundesdruckerei Berlin, Berlin 1973).
28. EISAI, supra note 7, at 66.
29. Ibid.
30. Ibid.
31. John Wyeth's and Schering's Applications, supra note 12, at 565.
32. Ibid., at 567.
33. EISAI, supra note 7, at 66.
34. SIGRID STERCKX & JULIAN COCKBAIN, supra note 17.
35. See JUSTINE PILA, "The Requirement for an Invention in Patent Law" 138 (Oxford University Press, Oxford 2010).
36. EISAI, supra note 7, at 66.
37. GOVERNMENT OF THE FEDERAL REPUBLIC OF GERMANY, supra note 25, at 28.
38. EISAI, supra note 7, at 66.
39. GOVERNMENT OF THE FEDERAL REPUBLIC OF GERMANY, supra note 25, at 29.
40. T-51/93 HCG/SERONO (1994), available at http://legal.european-patent- office.org/dg3/pdf/t930051eu1.pdf [last visited 15 December 2010], at 7. Technical Board of Appeal 3.3.2 disagreed, however, and considered that formulation of a claim explicitly as a process was equally acceptable as formulation as a Swiss-type use. See: T-958/94 Anti-tumoral agent/ THERAPEUTIQUES SUBSTITUIVES, 1997 OJ EPO 241-250; and T-853/94 Benanomicin A/ZAIDAIN (1998) available at http://legal.european-patent-office.org/dg3/pdf/ t940853eul.pdf [last visited 15 December 2010]. This disagreement between the two Boards on second indication claims is reflected in the ABBOTT RESPIRATORY case which resulted from the disagreement on dosage regime claims between decisions from the same two Boards, with Board 3.3.4 in that instance being more generous than Board 3.3.2.
41. ABBOTT RESPIRATORY, supra note 3, at 491 (emphasis added).
42. EUROPEAN PATENT OFFICE, Conference of the Contracting States to Revise the 1973 European Patent Convention - Munich, 20 to 29 November 2000 - Conference Proceedings, 71, MR/24/00 e (European Patent Office, Munich 2003).
43. ABBOTT RESPIRATORY, supra note 3, at 491-492 (footnote and emphasis added).
44. MOBIL III, supra note 22, at 99. That "use", "process", and "method" claims are all of the same type was confirmed by the EBoA in MOBIL III. Ibid., at 98-99.
45. Ibid., at 100.
46. Ibid., at 100.
47. Ibid., at 104.
48. Ibid., at 105.
49. G-1/08 Totnato/ISRAEL (2010), available at http://documents.epo.org/ projects/babylon/eponet.nsf/0/E72204692CFE1DC3C12577F4004BEA42/$File/ G1-08-en.pdf [last visited 9 December 2010], at 32.
50. ABBOTT RESPIRATORY, supra note 3, at 492.