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

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G 1/83, G 5/83 and G 6/83
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Enlarged Board of Appeal of the European Patent Office

Contents

ECLI:EP:BA:1984:G000183.19841205
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 [notes 1] 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. [3] [4] [5] 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". [1] These decisions are the first decisions issued by the Enlarged Board of Appeal. [6] [7]

Background

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 Article 52(4) EPC 1973, [notes 2] reading as follows:

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

The EPC also contains provisions regarding novelty, with Article 54(1) EPC 1973 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, Article 54(5) EPC 1973 provided the following exception:

The provisions of paragraphs 1 to 4 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52, paragraph 4, provided that its use for any method referred to in that paragraph is not comprised in the state of the art.

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]." [9] Thus, besides the general concept of novelty, Article 54(5) EPC 1973 (now corresponding to Article 54(4) EPC) "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)". [10]

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", [11] 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, [12] T 92/82, [13] and T 24/82 [14] from Technical Board of Appeal 3.3.1 (the sole Technical Board of Appeal for Chemistry at that time [15] ).

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

Kann für die Verwendung eines Stoffes oder Stoffgemisches zur therapeutischen Behandlung des menschlichen oder tierischen Körpers ein Patent mit auf die Verwendung gerichteten Patentansprüchen erteilt werden?

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

Can a patent with claims directed to the use be granted for the use of a substance or composition for the treatment of the human or animal body by therapy?

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

Un brevet comportant des revendications d'application peut-il être délivré lorsque celles-ci portent sur l'utilisation d'une substance ou d'une composition chimique à des fins thérapeutiques concernant l'homme ou l'animal?

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". [16] 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". [16]

Answers to the referred questions

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

(1) Ein europäisches Patent kann nicht mit Patentansprüchen erteilt werden, die auf die Verwendung eines Stoffes oder Stoffgemisches zur therapeutischen Behandlung des menschlichen oder tierischen Körpers gerichtet sind.

(2) Ein europäisches Patent kann mit Patentansprüchen erteilt werden, die auf die Verwendung eines Stoffes oder Stoffgemisches zur Herstellung eines Arzneimittels für einebestimmte neue und erfinderische therapeutische Anwendung gerichtet sind.

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

(1) A European patent with claims directed to the use may not be granted for the use of a substance or composition for the treatment of the human or animal body by therapy.

(2) A European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application.

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

(1) Un brevet européen ne peut pas être délivré sur la base de revendications ayant pour objet l'application d'une substance ou d'une composition en vue du traitement thérapeutique du corps humain ou animal.

(2) Un brevet européen peut être délivré sur la base de revendications ayant pour objet l'application d'une substance ou d'une composition pour obtenir un médicament destiné à une utilisation thérapeutique déterminée nouvelle et comportant un caractère inventif.

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 Article 52(4) EPC 1973, and no patents can be granted for those. [17] 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. [18] The Enlarged Board's decisions were thus a response to a gap, i.e. a lacuna, in the law. [19]

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). [20] [21] Consequently, the Vienna Convention does not apply to the EPC by operation of law (ex lege). [21] The Enlarged Board still held that due to a number of convincing precedents, the EPO should apply the rules of the Vienna Convention. [22] More specifically, it held that Articles 31 and 32 of the Vienna Convention are each relevant to the interpretation of the EPC. [23]

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. [24]

Notes

  1. ↑ The Enlarged Board of Appeal issued the same judgement in seven cases, i.e. G 1/83, G 2/83, G 3/83, G 4/83, G 5/83, G 6/83, and G 7/83, [1] after examining "the point of law in each of the cases at the same time". [2] Only decisions G 1/83, G 5/83 and G 6/83 have been published in the EPO Official Journal in German, English, and French respectively, the three official languages of the EPO.
  2. ↑ Article 52(4) EPC 1973 has been moved to Article 53(c) EPC in the EPC 2000 which entered into force on December 13, 2007. The move did not alter the substance of the provision. [8]

Related Research Articles

The patentability of software, computer programs and computer-implemented inventions under the European Patent Convention (EPC) is the extent to which subject matter in these fields is patentable under the Convention on the Grant of European Patents of October 5, 1973. The subject also includes the question of whether European patents granted by the European Patent Office (EPO) in these fields (sometimes called "software patents") are regarded as valid by national courts.

<span class="mw-page-title-main">European Patent Convention</span> International patent treaty

The European Patent Convention (EPC), also known as the Convention on the Grant of European Patents of 5 October 1973, is a multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to which European patents are granted. The term European patent is used to refer to patents granted under the European Patent Convention. However, a European patent is not a unitary right, but a group of essentially independent nationally enforceable, nationally revocable patents, subject to central revocation or narrowing as a group pursuant to two types of unified, post-grant procedures: a time-limited opposition procedure, which can be initiated by any person except the patent proprietor, and limitation and revocation procedures, which can be initiated by the patent proprietor only.

The European Patent Convention (EPC), the multilateral treaty instituting the legal system according to which European patents are granted, contains provisions allowing a party to appeal a decision issued by a first instance department of the European Patent Office (EPO). For instance, a decision of an Examining Division refusing to grant a European patent application may be appealed by the applicant. The appeal procedure before the European Patent Office is under the responsibility of its Boards of Appeal, which are institutionally independent within the EPO.

In certain jurisdictions' patent law, industrial applicability or industrial application is a patentability requirement according to which a patent can only be granted for an invention which is susceptible of industrial application, i.e. for an invention which can be made or used in some kind of industry. In this context, the concept of "industry" is far-reaching: it includes agriculture, for instance. An example of invention which would not be susceptible of industrial application is "a method of contraception [...] to be applied in the private and personal sphere of a human being".

G 1/03 and G 2/03 are two decisions of the Enlarged Board of Appeal of the European Patent Office (EPO), which were both issued on April 8, 2004.

Article 84 of the European Patent Convention (EPC) specifies that the "matter" for which patent protection is sought in an application - the purported invention - shall be stated ("defined") in the claims. This legal provision also requires that the claims must be clear and concise, and supported by the description. The function, form and content of the claims are defined by Article 84 supplemented by Rule 43 EPC.

Article 123 of the European Patent Convention (EPC) relates to the amendments under the EPC, i.e. the amendments to a European patent application or patent, and notably the conditions under which they are allowable. In particular, Article 123(2) EPC prohibits adding subject-matter going beyond the content of the application as filed, while Article 123(3) EPC prohibits an extension of the scope of protection by amendment after grant. In addition, Rule 80 EPC limits the types of amendments that can be done during opposition proceedings before the European Patent Office (EPO), and Rule 139 EPC relates to the correction of errors in documents filed with the EPO.

Under case number G 3/08, the Enlarged Board of Appeal of the EPO issued on May 12, 2010 an opinion in response to questions referred to it by the President of the European Patent Office (EPO), Alison Brimelow, on October 22, 2008. The questions subject of the referral related to the patentability of programs for computers under the European Patent Convention (EPC) and were, according to the President of the EPO, of fundamental importance as they related to the definition of "the limits of patentability in the field of computing." In a 55-page long opinion, the Enlarged Board of Appeal considered the referral to be inadmissible because no divergent decisions had been identified in the referral.

G 2/06 is a decision by the Enlarged Board of Appeal of the European Patent Office (EPO), which issued on 25 November 2008. In its answer to question 2, the Enlarged Board of Appeal ruled that "Rule 28(c) EPC forbids the patenting of claims directed to products which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims." In short, a patent under the European Patent Convention (EPC) cannot be granted for an invention which necessarily involves the use and destruction of human embryos. The decision notably refers to the provisions of EU Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions, referred to in Rule 26(1) EPC.

Under the European Patent Convention (EPC), European patents shall be granted for inventions which inter alia are new. The central legal provision explaining what this means, i.e. the central legal provision relating to the novelty under the EPC, is Article 54 EPC. Namely, "an invention can be patented only if it is new. An invention is considered to be new if it does not form part of the state of the art. The purpose of Article 54(1) EPC is to prevent the state of the art being patented again."

During the grant procedure before the European Patent Office (EPO), divisional applications can be filed under Article 76 EPC out of pending earlier European patent applications. A divisional application, sometimes called European divisional application, is a new patent application which is separate and independent from the earlier application, unless specific provisions in the European Patent Convention (EPC) require something different. A divisional application, which is divided from an earlier application, cannot be broader than the earlier application, neither in terms of subject-matter nor in terms of geographical cover.

G 1/07 is a decision of the Enlarged Board of Appeal of the European Patent Office (EPO), which was issued on February 15, 2010. The Enlarged Board of Appeal notably decided that, under the European Patent Convention (EPC),

G 1/21 is a decision issued on 16 July 2021 by the Enlarged Board of Appeal of the European Patent Office (EPO) regarding the legality of holding oral proceedings at the EPO by videoconference without the consent of the parties. Namely, the Enlarged Board of Appeal held that "[d]uring a general emergency impairing the parties' possibilities to attend in-person oral proceedings at the EPO premises, the conduct of oral proceedings before the boards of appeal in the form of a videoconference is compatible with the EPC even if not all of the parties to the proceedings have given their consent to the conduct of oral proceedings in the form of a videoconference." The reasoning in the written decision further indicates that, if a party so requests, oral proceedings must be held in person at the EPO premises, except in absolutely exceptional cases.

G 1/10 is a decision issued on 23 July 2012 by the Enlarged Board of Appeal of the European Patent Office (EPO), holding that Rule 140 EPC cannot be used to request corrections of the text of a European patent.

G 2/10 is a decision issued on 30 August 2011 by the Enlarged Board of Appeal of the European Patent Office (EPO) on the subject of disclosed disclaimers. It lies from decision T 1068/07 by Technical Board of Appeal 3.3.08, who referred a question to the Enlarged Board.

G 1/09 is a decision issued on 27 September 2010 by the Enlarged Board of Appeal of the European Patent Office (EPO), holding that, following refusal of a European patent application, the application remains pending until the expiry of the time limit for filing a notice of appeal, so that a divisional application under Article 76 EPC may be filed even after the refusal of an application. More specifically, the divisional application may be filed until expiry of the time limit of two months for filing a notice of appeal under Article 108 EPC.

G 2/08 is a decision issued by the Enlarged Board of Appeal of the European Patent Office (EPO) on 19 February 2010. The decision deals with the patentability of medications. More specifically, the decision deals with claims directed to second medical use. Second medical use claims pertain to medications to be used for particular conditions or diseases. In the case at issue, the second medical use pertains to a new dosage regime of a known substance.

G 9/93 is a decision issued on 6 July 1994 by the Enlarged Board of Appeal of the European Patent Office (EPO). Unlike the revised European Patent Convention 2000, there used to be no explicit provision in the former European Patent Convention 1973 that allowed a patent proprietor to have one's own patent revoked. A patent proprietor may, however, seek a revocation of one's own patent. For example, the patent proprietor may want to avoid costly revocation proceedings concerning a patent owned by that proprietor. In an earlier decision G 1/84, the Enlarged Board of Appeal dealt with the issue of a patent proprietor opposing one's own patent and held such oppositions admissible. The Enlarged Board of Appeal dealt with the same issue again in later decision G 9/93 and it overruled its earlier decision G 1/84 thereby holding oppositions against one's own patents inadmissible.

References

  1. 1 2 Cockbain, Julian; Sterckx, Sigrid (2011). "Is the Enlarged Board of Appeal of the European Patent Office Authorised to Extend the Bounds of the Patentable? The G-3/85 [ sic ] Second Medical Indication/EISAI and G-2/08 Dosage Regime/ABBOTT RESPIRATORY Cases". International Review of Intellectual Property and Competition Law (3): 257–271.
  2. ↑ G 5/83, points I and 7.
  3. ↑ Ahn, Hyewon (2014). "Pharmaceutical Inventions, Innovations & Products". Second Generation Patents in Pharmaceutical Innovation (1 ed.). Nomos Verlagsgesellschaft mbH. pp. 28–58. ISBN   978-3-8487-0874-1. JSTOR   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 (...)
  4. ↑ Donghi, Monica (2014). "Discussion". Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? (1 ed.). Nomos Verlagsgesellschaft mbH. pp. 42–72. ISBN   978-3-8487-0991-5. JSTOR   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.
  5. ↑ Holtz, Beatrice; Vial, Lionel (2008). "A Brief History of Swiss-type Claims". Managing Intellectual Property. No. 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 (...)
  6. ↑ "Decision of the Enlarged Board of Appeal dated 25 March 2015 G 2/12". www.epo.org. European Patent Office. 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: ...
  7. ↑ G 5/83, point 2.
  8. ↑ G 2/08, reasons 5.4.
  9. ↑ G 5/83, point 10.
  10. ↑ Legal Research Service for the Boards of Appeal, European Patent Office, Case Law of the Boards of Appeal of the EPO (10th edition, July 2022), i.c.7.1.1 : "First medical use - introduction"
  11. ↑ G 5/83, point 19.
  12. ↑ (Nimodipin) Decision T 17/81 of 30 May 1983
  13. ↑ Decision T 92/82 of 20 June 1983
  14. ↑ Decision T 24/82 of 20 June 1983
  15. ↑ G 5/83, point I.
  16. 1 2 G 5/83, point 9.
  17. ↑ G 5/83, points 11-13.
  18. ↑ G 5/83, points 21 and 23.
  19. ↑ G 2/08, reasons 5.9 and 5.10.1.
  20. ↑ Romuald Singer, Margarete Singer, Dieter Stauder, Europäisches Patentübereinkommen - Kommentar, Präambel, page 12, 5th edition, Carl Heymanns Verlag, 2010.
  21. 1 2 G 5/83, point 3.
  22. ↑ G 5/83, point 4.
  23. ↑ G 5/83, point 5.
  24. ↑ Kaisa Suominen, Peter de Lange, Andrew John Rudge, VISSER'S ANNOTATED EUROPEAN PATENT CONVENTION, Article 54(5) EPC, chapter 2.3, page 103, Wolters Kluwer, 2022.
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