G 1/83, G 5/83 and G 6/83 explained

G 1/83, G 5/83 and G 6/83

Enlarged Board of Appeal of the European Patent Office

decisions issued on 5 December 1984
Board composition
Chairman: Romuald Singer
Members: O. Bossung, P. Ford, R. Kämpf, M. Prélot, G. Szabo, J. van Voorthuizen
Headwords
zweite medizinische Indikation/BAYER
second medical indication/EISAI
deuxième indication médicale/PHARMUKA
G 1/83, G 5/83 and G 6/83 are landmark decisions issued on 5 December 1984 by the Enlarged Board of Appeal of the European Patent Office (EPO) on the patentability of second or further medical use of a known substance or composition.[1] [2] [3] They deal with patent claims directed to such second or subsequent medical use, and, as explained in reason 22 of decision G 5/83, the Enlarged Board held that patent claims directed to such substances or compositions were allowable under the European Patent Convention (EPC) when worded as purpose-limited product claims, which are also referred to as "Swiss-type use claims".[4] These decisions are the first decisions issued by the Enlarged Board of Appeal.[5] [6]

Background

See main article: article, European Patent Convention and Novelty under the European Patent Convention. The European Patent Convention (EPC) is a multilateral treaty instituting the legal system according to which European patents are granted. Its version applicable before December 13, 2007 contained a provision, namely, reading as follows:

The EPC also contains provisions regarding novelty, with providing that "[a]n invention shall be considered to be new if it does not form part of the state of the art." Article 54(2) to (4) EPC 1973 also define what the state of the art comprises. Further, provided the following exception:

In other words, "Article 54(5) EPC [1973] exempts from the operation of the earlier paragraphs of that Article any substance or composition comprised in the state of the art for use in a method according to Article 52(4) EPC [1973]."[7] Thus, besides the general concept of novelty, Article 54(5) EPC 1973 (now corresponding to) "introduces, in respect of substances and compounds used in surgical and therapeutic treatment and in diagnostic processes carried out on humans and animals, a special concept of novelty unknown in other technical fields (T 128/82, OJ 1984, 164)".[8]

The question then arose as to whether use claims would have to be treated any differently from method claims when it comes to Article 52(4) EPC 1973, i.e. when it comes to a claimed method or claimed use "for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body". Another question also arose as to "the possibility of protecting second (and subsequent) medical indications by means of a claim directed to the use of a substance or composition for the manufacture of a medicament for a specified (new) therapeutic application",[9] as Article 54(5) EPC 1973 appears to literally deal only with first medical indications.

Questions referred to the Enlarged Board of Appeal

The referrals to the Enlarged Board of Appeal lie from interlocutory decisions T 17/81,[10] T 92/82,[11] and T 24/82[12] from Technical Board of Appeal 3.3.1 (the sole Technical Board of Appeal for Chemistry at that time[13]).

The question asked in decision T 17/81 and leading to decision G 1/83 is:

The question asked in decision T 92/82 and leading to decision G 5/83 is:

The question asked in decision T 24/82 and leading to decision G 6/83 is:

In other words, "[t]he question of law referred to the Enlarged Board relate[d] to therapeutic use claims for substances and compositions in general".[14] The Enlarged Board also considered that "the problem of the protection of inventions of the so-called "second medical indication"" was the central question in these cases, and therefore chose "to examine all aspects of that problem".[14]

Answers to the referred questions

The Enlarged Board of Appeal answered the question asked in decision T 17/81 as follows:

The Enlarged Board of Appeal answered the question asked in decision T 92/82 as follows:

The Enlarged Board of Appeal answered the question asked in decision T 24/82 as follows:

In summary, the Enlarged Board of Appeal held that use claims and method claims must be treated in the same manner if the purpose of the claimed use or method, respectively, is the "treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body". There is no difference in substance, these method claims and use claims are not patentable under, and no patents can be granted for those.[15] Further, the Enlarged Board also held that novelty of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application was to be acknowledged by virtue of "the new therapeutic use of the medicament" regardless of whether the new therapeutic use is the first pharmaceutical use of the medicament or a second (or further) pharmaceutical use of the medicament.[16] The Enlarged Board's decisions were thus a response to a gap, i.e. a lacuna, in the law.[17]

Application of the Vienna Convention on the Law of Treaties

In its decision, the Enlarged Board also held that the Vienna Convention on the Law of Treaties was not in force at the time of conclusion of the European Patent Convention (EPC).[18] [19] Consequently, the Vienna Convention does not apply to the EPC by operation of law (ex lege).[19] The Enlarged Board still held that due to a number of convincing precedents, the EPO should apply the rules of the Vienna Convention.[20] More specifically, it held that Articles 31 and 32 of the Vienna Convention are each relevant to the interpretation of the EPC.[21]

Analysis

The type of claim referred to in the answers provided by the Enlarged Board of Appeal in G 1/83, G 5/83 and G 6/83 is called a "Swiss-type claim" or "Swiss-type use claim". The EPC 2000 removed the need for Swiss-type claims. According to decision G 2/08, a claim deriving its novelty from a new therapeutic use shall no longer come as a Swiss-type claim.[22]

External links

Notes and References

  1. Book: Ahn . Hyewon . Second Generation Patents in Pharmaceutical Innovation . Pharmaceutical Inventions, Innovations & Products . 2014 . Nomos Verlagsgesellschaft mbH . 978-3-8487-0874-1 . 28–58 . 1 . j.ctv941t5f.5 . The first medical use of a known substance can be patented, and has come to be regarded as a product patent. Moreover, if one can prove a second medical use for a substance, which was known to have a first therapeutic effect, it is possible to claim a second medical use as well. For a second medical use, the applicant would have exclusivity only on the second medical use in Europe. The practice was derived from the EPO's G 5/83 decision (...).
  2. Book: Donghi . Monica . Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? . 2014 . Nomos Verlagsgesellschaft mbH . 978-3-8487-0991-5 . 42–72 . 1 . Discussion . j.ctv941vfr.9 . Patent protection of new indications is available in most jurisdictions. In EU such possibility exists since 1985 when the Enlarged Board of Appeal of the EPO granted to Eisai a patent (in the so-called Swiss-type claim form) for a second pharmaceutical use of a known compound..
  3. Holtz . Beatrice . Vial . Lionel . A Brief History of Swiss-type Claims . Managing Intellectual Property . 2008 . 180 . 82 . (...) the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) gave another, less strict, interpretation of Article 54(5) EPC 1973 in its famous Second Medical Indication Decision, G 5/83 of December 5, 1984 (...).
  4. Cockbain . Julian . Sterckx . Sigrid . 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 . International Review of Intellectual Property and Competition Law . 2011 . 3 . 257–271 .
  5. Web site: Decision of the Enlarged Board of Appeal dated 25 March 2015 G 2/12 . www.epo.org . European Patent Office . en . The Enlarged Board ruled in its first decisions (G 1/83, OJ EPO 1985, 60, and G 5/83, OJ EPO 1985, 64, Reasons, points 1, 3, 4 and 6) that: ....
  6. https://www.epo.org/law-practice/case-law-appeals/pdf/g830005ep1.pdf G 5/83
  7. https://www.epo.org/law-practice/case-law-appeals/pdf/g830005ep1.pdf G 5/83
  8. "First medical use - introduction"

  9. G 5/83, point 19.
  10. https://www.epo.org/law-practice/case-law-appeals/recent/t810017dp1.html (Nimodipin) Decision T 17/81 of 30 May 1983
  11. https://www.epo.org/law-practice/case-law-appeals/recent/t820092eu1.html Decision T 92/82 of 20 June 1983
  12. https://www.epo.org/law-practice/case-law-appeals/recent/t820024fu2.html Decision T 24/82 of 20 June 1983
  13. https://www.epo.org/law-practice/case-law-appeals/pdf/g830005ep1.pdf G 5/83
  14. https://www.epo.org/law-practice/case-law-appeals/pdf/g830005ep1.pdf G 5/83
  15. https://www.epo.org/law-practice/case-law-appeals/pdf/g830005ep1.pdf G 5/83
  16. G 5/83, points 21 and 23.
  17. https://www.epo.org/law-practice/case-law-appeals/recent/g080002ex1.html G 2/08
  18. Romuald Singer, Margarete Singer, Dieter Stauder, Europäisches Patentübereinkommen - Kommentar, Präambel, page 12, 5th edition, Carl Heymanns Verlag, 2010.
  19. https://www.epo.org/law-practice/case-law-appeals/pdf/g830005ep1.pdf G 5/83
  20. G 5/83, point 4.
  21. G 5/83, point 5.
  22. Kaisa Suominen, Peter de Lange, Andrew John Rudge, VISSER'S ANNOTATED EUROPEAN PATENT CONVENTION,, chapter 2.3, page 103, Wolters Kluwer, 2022.