Second medical use claims provide the required protection for originator companies to recoup research investments in therapeutic use based on the original chemical compound. The claim provides additional 20 years protection after the expiry of the original patents that provide product protection for the medical substance. Second medical use claims are an important strategy for patent holders to prevent generic drugs from entering the market by extending the life of the patented molecule. To achieve this result, the originators claim the use of the molecule as a new product or process patent or different dosage for treatment. Of course, the claims must be again be novel for this use, have an inventive step and industrial applicability. Turkey, a member of the European Patent Convention (EPC), follows a parallel path with the European Patent Office (EPO) on second medical use in the context of the post-EPC2000 (entered into force in 13 December 2007) period. It is possible to be granted for a second medical use, if the claim meets the legal requirements of the EPC, from Turkish Patent Office.
EPC and EPO Board of Appeals Decisions
The implementation of EPC2000 and changes in Article 54 was, however, not enough to clarify the new purpose-limited product claim. In the former EPC 1973, applicants would circumvent the Convention by filing “Swiss-type” claims (decision G 5/83 of EPO Board of Appeals) in the format: “Use of compound X for the manufacture of a medicament for therapeutic application Z”, which were previously accepted by the EPO. Within the new framework of EPC2000, the subject-matter of a claim is considered novel only by a new therapeutic use of a pharmaceutical. Articles 54(4) and (5) provide for an exception from the general principle that product claims can only be obtained for novel products. Where a substance or composition is already a state of the art, it may still be patentable under Art. 54(5) for any second or further use in a method provided that said use is novel and inventive. Additionally, therapeutic uses of a substance/composition may be based not only on the treatment of a different disease but also on the treatment of the same disease by a different therapeutic method differing for example in the dosage, administration regime, group of subjects or route of administration. The interpretation of Article 54 came after decision G2/08 of European Patent Office Board of Appeals, in which further therapeutic use claims are expected to indicate the illness/disease to be treated, the nature of the therapeutic compound used for that purpose and, if relevant for establishing novelty and inventive step, the subject to be treated. . If the further therapeutic use relates to a different therapy of the same disease using the same substance/composition, the claim must also define all technical features of the therapy giving rise to the desired technical effect. At the date of filing, the claimed compound must not necessarily have already been tested in clinical trials, let alone have been approved as a drug. However, preferably, animal data in a relevant disease model should be filed to support the therapeutic effect. If animal data is not available, even in vitro data may be sufficient to render a therapeutic effect plausible if there is a clear and accepted established relationship between the observed physiological activities and the disease. In each individual case a balance must be struck between the requirement for sufficient disclosure of the therapeutic effect – potentially delaying application filing – and the need for early filing. Broad functional definitions of the compound for use in a therapeutic application are problematic before the EPO and other EPO Member State jurisdictions.
With the G2/08 decision, applications and patents pre-dating 29 January 2011with Swiss-type claims are accepted only as patentable subject-matter, given that they relate to a different subject matter (decision T1021/11 EPO Technical Board of Appeals).
Turkish Legislation and Jurisdiction
In Turkish law, in order to use a substance in the method of treatment, this item must be new under the Industrial Property Code (IPC), since 2017. The IPC has been enacted in accordance with EPC2000 Art. 55 (4) and (5). According to IPC, even if the originators substance is part of the state of the art, if the substance is found novel, industrially applicable and is in accordance with the inventive step criterion, it will be granted patent protection and patented use for treatment methods and diagnostic procedures. However, as in the case of EPC the IPC does not directly state second medical use for patentability and jurisprudence plays a key role for defining, in which circumstances the second medical use can be patented.
In the Turkish jurisdiction invalidation cases regarding patented inventions prior to 29 January 2011 caused fragmentation in the jurisprudence. An Istanbul IP Court invalidated a Swiss type claim for non-patentability. Upon patent holder’s appeal, the Court of Appeal overturned the IP Court’s decision and considered pre-EPC2000 Swiss-type second medical use claims patentable. The Court of Appeal acknowledged that while EPC2000 Art. 54’s second medical use claims lead to legal clarification of their patentability, the previous EPC1973 did not explicitly refer to non-patentability of second medical use claims. Therefore, the validity of second medical use claims without deferring to court-appointed experts for a technical examination under the Code of Civil Procedure cannot be decided by the IP Court. The decision removed the uncertainty regarding the patentability and enforceability of second medical use claims granted by the EPO and validated in Turkey before the EPC2000. However, the Court of Appeal did not comment on the IP Court’s reasoning that Turkey, as a member of European Patent Convention, is bound only by the written provisions of the EPC, and not by case law of the EPO Board of Appeal. This led to further rejection of Court of Appeal’s decision by the Istanbul IP Court, reasoning that second medical use patent had been granted relying on case law of the EPO Enlarged Board of Appeal, based on the EPC 1973. Because decisions of the EPO Boards of Appeal and the Enlarged Board of Appeal were not binding on Turkish courts and the subject matter of the invention was a medical treatment method and the grant of a patent for medical treatment methods is prohibited by EPC1973 Article 52(4) the patent was again found invalid. Furthermore, the Court stated that, since the patent in question was a second medical use patent relating to dosing and posology constitute medical treatment methods under the EPC1973 and prohibited from patentability the grant of a patent for medical treatment methods is prohibited. In the second appeal by the patent holder, the Supreme Court Assembly of Civil Chambers is expected to follow the same reasoning of Court of Appeal’s by revoking the invalidation of second medical use patent.
Author: Sinan Erkan