Novartis loses a Glivec patent case in Turkey

The Turkish Constitutional Court has ruled that there has been no violation of the property rights due to the invalidation of one of "Glivec®" patents of Novartis in Turkey.

The Swiss pharmaceutical giant Novartis filed an international patent application (International patent application no. PCT/EP2003/004151) designating, among others, the European Patent Office (EPO) on 22 April 2003, the active agent of which is "imatinib mesylate", for use in the treatment of chronic mycloid leukaemia and gastrointestinal stromal tumours. The patent case is related to one of the patents for the drug trademarked "Glivec®" (as known in Europe) and "Gleevec®" (as known in the USA).

Novartis proceeded to the regional phase at the EPO and the EPO granted the patent (European patent no. EP 1 501 485 B1) for that and mentioned the grant in 2007 in the European Patent Bulletin. After the EPO’s grant, Novartis duly validated the European patent in Turkey, one of the contracting states of the European Patent Convention (Turkish Patent No. 2007 06715).

The invalidation of the patent requested

A competitor company has taken invalidation action against Novartis’ patent before the Turkish IP Court, i.e. Istanbul Intellectual and Industrial Property Rights Court, in 2008. The competitor argued that the subject matter of the patent was already known in the art and disclosed by the patents granted in 1992 and 1998. Therefore, it claimed that the use of the substance of the patent is not novel for use in the treatment of leukaemia and the preparation of the tablet according to the dosage for use should not be considered as “invention”.

The court in charge received an expert report issued by a panel of experts consisting of two pharmaceutical professors and a chemical engineer. The report argued that the methods described in the patent did not exceed the state of the art, and were lack of novelty and inventive step. Novartis raised objection against the report and the Court received a supplementary expert report from the same panel of experts. The supplementary report has confirmed the main report. On 24 January 2013, the Court accepted the case based on the expert report and invalidated the patent due to the lack of novelty and inventive step.

Novartis filed appeal against the first instance decision before the 11th Chamber of the Supreme Court of Appeals but the Supreme Court approved the decision of the first instance court in 2014.

Individual application

Novartis filed an individual application at the Constitutional Court in 2015 claiming that the right to property was violated by the invalidation.

It also filed a complaint alleging that the right to a fair trial was violated because of the refusal of compensation action that it has filed against the experts on the grounds that they had issued a false report.

Opinion of the Ministry of Justice

The Constitutional Court asked an opinion from the Ministry of Justice. In the opinion regarding the individual application that the Ministry of Justice sent to the Constitutional Court, it was said that the decision of invalidity had been aimed at the public interest.

Novartis stated that the Ministry had overlooked the fact of issuance of a false report by the experts, and the Judges who gave the decision have been arrested for other crimes out of the case.

No violation of property rights

The Constitutional Court concluded that the property rights had not been violated. The allegation of violation of the right to a fair trial was not accepted due to the lapse of time.

The Constitutional Court has stated that patent protection is not provided for every invention as they can be only patented provided that they are novel and have inventive step and industrial applicability pursuant to Industrial Property Law No. 6769.

The Constitutional Court has also said that the public authorities had no direct interference with the property rights of Novartis in a dispute between the private entities. The Court has also opinioned that in the disputes between the private entities, the legislator and the courts of instance have the power to judge on which parties would come superior and this should be made by balancing the interests of the parties as much as possible.

In the reasoned decision, the following judgment took place:

"It is for sure that the patent invalidation has led to a burden in terms of the applicant company, but it has been prescribed that the inventions in the field of technology may be patented provided that they are novel and involve an inventive step and industrial applicability. Keeping the inventions, which are determined to be incompatible with these conditions, out of the scope of the patent protection is important in terms of protecting the rights and interests of the third parties, as in the present case. Particularly, it should be noted that the public authorities have wide power of assessment in determining the scope of the patent rights. Considering the facts that the public authorities have a certain discretion over which inventions need to be taken under the scope of patent protection and the determination of this scope significantly affects the rights and interests of the third parties, it was concluded that the positive obligations of the state have been fulfilled in relation to property rights in respect of the case where the patent rights were invalidated on the grounds that the conditions prescribed under the Patent Law have not been met."

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