Pharmaceutical patents cover a substance or composition (molecule patents) and the use of this substance or composition in the treatment of a disease (indication patents). The new and non-obvious use of a known substance or composition for the manufacture of a medicament to treat a specific disease is called a 'second medical use' or 'further medical use' patent. The clearest example of a second medical use patent is a medicament with an active substance X that is known to be effective in the treatment of hypertension and is also found to be effective in the treatment of a common cold following further research.
Pharmaceutical products have been protected under Transitional Article 4 of Decree-Law 551 on the Protection of Patents since January 1 1999.
Turkey signed the European Patent Convention 1973 (which protects pharmaceutical patents) on October 5 1973, but it entered into force only on July 12 2000, following the publication of the law for accession and its annexes in the Official Gazette.(1)
The European Patent Convention 2000, which revised the 1973 convention, was signed following a diplomatic conference in November 2000.(2) Turkey signed the revised convention, which came into force on December 13 2007.
Article 54(5) of the European Patent Convention 2000 explicitly states that the specific use in any method referred to in Article 53(c) of the convention is patentable, provided that it does not comprise the state of the art. According to this provision, the use of a prior art substance and composition in the treatment of a new disease is allowed.
Despite the 1973 convention's lack of provision regarding the patentability of second medical use patents, the European Patent Office (EPO) Enlarged Board of Appeal's G5/83 decision stated that the use of a known substance or composition for the manufacture of a medicament for a new and inventive therapeutic application is patentable.(3)
There have been claims that the Enlarged Board of Appeal's decision is not binding for contracting states and that second medical use patents granted before December 13 2007 (ie, before the European Patent Convention 2000 came into force) may be invalid.(4)
Contrary to these opinions, it is believed, as far as Turkey is concerned, that the Enlarged Board of Appeal's decisions and opinions are inseparable from the European Patent Convention 1973, as Parliament acknowledged recent developments relating to the convention and ratified it on January 29 2000 with no reservations. This is seen as indisputable evidence of Parliament's determination to protect patents that cover second and further medical use on the basis of international legislation to which Turkey is a signatory.
Decree-Law 551 does not mention second medical use patents. They are not acknowledged as being patentable or non-patentable and there is no provision stating that second medical use patents are not subject to protection, nor any distinction between first and second medical use patents. Hence, the Turkish Patent Institute grants second medical use patents provided that they meet the patentability criteria.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) does not prohibit the protection of second medical use patents.
There is no provision in the European Patent Convention 1973 that restricts the patentability of inventions on second medical use.
According to Article 52(1) of the 1973 convention, "European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step".
Paragraph 2 of the same article states that:
"The following in particular shall not be regarded as inventions within the meaning of paragraph 1:
(a) discoveries, scientific theories and mathematical methods;
(b) aesthetic creations;
(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
(d) presentations of information.
(3) The provisions of paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.
(4) 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."
As understood from Article 52(4), this provision will not apply to methods of treatment for humans or animals by surgery or therapy and diagnostic methods practised on humans or animals. This provision excludes the medical use of a substance or composition from non-patentable subject matter. There are no distinctions between first and second medical use patents.
In Article 53 of the 1973 convention the following subjects are not patented:
"(a) inventions the publication or exploitation of which would be contrary to 'ordre public' or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof."
According to the article's provisions, second medical use and medical use in general are not listed among subjects that are not patented. Thus, there are no provisions which state that inventions subject to second medical use will not be protected under the scope of the 1973 convention.
Article 54 of the 1973 convention states as follows:
"(1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.
(3) Additionally, the content of European patent applications as filed, of which the dates of filing are prior to the date referred to in paragraph 2 and which were published under Article 93 on or after that date, shall be considered as comprised in the state of the art.
(4) Paragraph 3 shall be applied only in so far as a Contracting State designated in respect of the later application, was also designated in respect of the earlier application as published.
(5) 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."
Paragraph 5 of this article accepts the use of a known substance or composition in a therapeutic application on the condition that it is new and inventive.
The EPO Enlarged Board of Appeal's G5/83 decision is referenced in Articles 52 and 54 of the 1973 convention.(5) The decision explains in detail how to interpret Articles 52(4) and 54(5) of the convention and that a claim for the use of a known substance or composition in the manufacture of a medicament for a new therapeutic application is patentable.
Parliament hopes that the interpretation of Articles 52 and 54 will be made in light of the G5/83 decision, which is an obvious annex of the agreement to which Turkey is a party. A contrary approach would go against national legislation, international conventions in force in Turkey, Article 90/5(6) of the Constitution and Article 4 of Decree-Law 551.(7)
For further information on this topic please contact Muazzez Korutürk, Muhlise Aydin or Okan Çan at Deris Attorneys At Law Partnership by telephone (+90 212 252 6122) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Deris website can be accessed at www.deris.com.tr.
(1) Official Gazette, 24107, July 2 2000. For further information please see www.resmigazete.gov.tr/eskiler/2000/07/20000712m1.htm&main=http://www.resmigazete.gov.tr/eskiler/2000/07/20000712m1.htm.
(2) Act Revising the Convention on the Grant of European Patents. For further information please see http://documents.epo.org/projects/babylon/eponet.nsf/0/879B3BBE83D923B0C12572AE004FE772/$File/act_revising_epc_en.pdf.
(3) European Patent Office Official Journal, 1985, p60 (G1/83 German, G5/83 English, G6/83 French). For further information please see http://documents.epo.org/projects/babylon/eponet.nsf/0/5891FCEDA0C96A07C12572C8006C5110/$File/g830001.pdf.
(4) Hazal Zengingül, Ankara 2012, Fikri Mülkiyet Hukuku Yilligi 2011 and Ikinci Tibbi Kullanim Patentleri (Second Medical Use Patents), 447. Av Ece Sarica, Nisan 2015, Istanbul Barosu Dergisi Mart – Nisan 2015, Türkiye'de Ikinci Tibbi Kullanimin Patentlenmesi ve Korunmasi (Patenting and Protection of Second Medical Use in Turkey), 392.
(5) The G5/83 decision is listed in the Index of Decisions and Opinions of the Enlarged Board of Appeal published in the EPO's Official Journal. The index of decisions and opinions was published as Annex-I of the European Patent Convention 1973 in the Official Gazette on July 12 2000 and relates the decision and opinion of the Enlarged Board of Appeal to the articles of the European Patent Convention 1973.
Index of Decisions and Opinions of the Enlarged Board of Appeal published in the Official Journal of the EPO
Case number, date, publication
December 5 1984
European Patent Office Official Journal 1985, 64
"Second medical indication/EISAI"
Interpretation of EPC/Vienna Convention – use claims regarding treatment
Articles 52(1), 52(4), 54(5), 57
Articles 31, 32 of the Vienna Convention
"International agreements duly put into effect have the force of law. No appeal to the Constitutional Court shall be made with regard to these agreements, on the grounds that they are unconstitutional. In the case of a conflict between international agreements, duly put into effect, concerning fundamental rights and freedoms and the laws due to differences in provisions on the same matter, the provisions of international agreements shall prevail."
"Where International Agreements having entered into force according to the laws of the Republic of Turkey, contain provisions which are preferential/more favorable to those of this present Decree-Law, the persons referred to in Article 2 may request to benefit from such preferential/more favorable provisions."
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