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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Domestic cancer drugs to be produced and patented

The following is the translation of the news published on Turkish daily "Sabah" on March 05, 2018. Please click here to find the original publication.

Turkey has given a start for the domestic production of cancer drugs. The world-wide famous pharmaceutical companies have been invited for the cancer drugs that will be produced locally from molecules to patent.

The government, after defence industry and renewable energy, will give Turkey's biggest incentive for domestic production of the drugs to the pharmaceutical industry.

Health  Economic Coordination Committee chaired by Deputy Prime Minister Mehmet Simsek has decided to invite the world's pharmaceutical giants for domestic production and partnership.

Turkey imports cancer drugs, including the side treatments, of 2.5 billion Turkish liras each year. Domestically producing the cancer drugs, for which there is currently 100% dependency on the foreigners, Turkey would make a leap on the world drugs market and the dependency on such strategic product would end. 

The Government will call the world's pharmaceutical giants to Turkey for their producing domestic cancer drugs. The world's big pharmaceutical companies like Novartis and Roche will be invited to found factories in Turkey for producing cancer drugs in Turkey. The Government will give the purchase guarantee to the firm which gives the best offer. The R&D of the pharmaceutical industry will be developed. Turkish engineers will take place in the R&D works. "Know-how" environment will be created to allow domestic firms to produce cancer drugs. If pharmaceutical is patented in Turkey, it will be deemed to be as Turkey's export, without regarding where it was sold around the world. Thus, Turkey would become among the countries exporting high-tech products in the pharmaceutical industry.

The Health Economy Coordination Board has already put the blood plasmas, which were among imported products, into the domestic production, for a 7-year purchase guarantee. Thanks to the domestic plasmas production made with the domestic partner, it is expected that it would be shortly among the export items, coming out of import items. After the vaccines, cancer drugs, the patent of which will belong to Turkey, may be domestically produced. Turkey is allocating a budget of 25 billion dollars for the drug each year and more than half of it is imported from abroad. Turkey aims to become the most powerful production centre in the Middle East with its domestic pharmaceutical industry.

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Its domestic was 11,00 TRY, but now 303,00 EURO

The following news was published in Turkish daily "Vatan" on 19 February 2018 (please click here to see the original publication) and should not be associated with the owner of the blog. The translation of the news is presented in this blog for information only and does not necessarily mean that we agree with the arguments made thereby.

As the bureaucracy, about whom President Recep Tayyip Erdogan told "they fasten our feet in shackles," could not show the national and domestic reflexes as in the defence industry, the pharmaceutical market has been overtaken by US and European pharmaceutical companies. Turkey spends 25 billion TRY on pharmaceutical a year. 95 of the 100 pharmaceuticals that have the highest turnover are imported. They earn 7 billion Turkish Lira over 100 products yearly.

Pharmaceutical cartels are comfortable enough to prevent local manufacturers by obtaining new patents and licenses, ie claiming that leukaemia medicine is good for stomach cancer. The domestic producer is trying to survive despite bureaucratic obstacles.

Those who fail to resist either sell their factories or become a subcontractor. The practices of Turkish Pharmaceuticals and Medical Devices Agency (TİTCK) cause the reactions.

The Medical Bureaucracy's regulations affecting the pharmaceutical market since 2016 have brought the domestic leap made during the last 15 years to the ending point.

The new regulations, general guidelines, guidelines for harmonisation with the EU, which contradict the AK Party's national and national policies and government programs, left the players of the domestic sector helpless against the global corporations.

In view of the Global Pharmaceutical  Report, prepared to guide the global pharmaceutical companies that are monopolised in the world, the bureaucracy taking the steps projected between 2017 and 2021 one by one served Turkey to the global players.

Since the positive discrimination to the domestic pharmaceuticals has come to end, some of the domestic companies either became a subcontractor or they came out from the industry by selling foreign factories as they could not compete with global companies.

Global companies are now pulling out any pharmaceuticals out of the market and the citizens who do not the truth wail and confront the government. On the other hand, they are making billions.

LOCAL PRODUCTS TO BE COLLECTED

Since Turkey's Pharmaceuticals and Medical Devices Agency (TİTCK) put "the Guideline for the Procedures and Principles of the Priority Assessment Board for Human and Medical Products" into force in 2016, the domestic pharmaceutical industry is having a hard time.

While domestic firms were given priority as from 2002 upon the order of President Recep Tayyip Erdogan, the special inspections were applied against the imported products. This reversed, however, with the effects of the guidelines issued two months before the July 15 coup attempt in 2016. Domestic producers became unable to take priority in the authorisation process.

The marketing authorisations which were granted on the domestic producers before are being invalidated by the introduction of the marketing authorisation regulations and applications in compliance with Europe on the grounds of harmonisation with the EU and many pharmaceuticals produced by the domestic firms due to the lapse of patent term is under the risk of confiscation.

EU HARMONIZATION PROCESS' COMPLETED

Turkey, which started to accession negotiations with EU on 3 October 2005, had fulfilled its obligations relating to the Health Chapter and that chapter has been closed with success. In fact, a much better health system was established than in European countries.

However, since May 2016, EU harmonisation, the bureaucratic claim that "domestic industry is creating unnecessary workload by taking unnecessary marketing authorisations " and the amendments related to re-applications for authorisation, all these have made Turkey's pharmaceutical policy dependent on the foreigners. With the slot application which only allows applying for authorisation during certain months of the year, the access to the pharmaceutical authorisation of the domestic industry is prevented.

LICENSE CHARGES SOARED

It is stated that the pricing procedures applied in the process of pharmaceutical marketing authorisation, especially, have hit R&D investments. With the price list published in September 2017, the fees paid at the end of the authorisation proceedings were started to be received at the beginning of the proceedings.

This will put domestic producers, who pay fees for the pharmaceuticals that are not certain to get authorisation, into even more difficulty.

In the price list published in 2018, it is required exorbitant consultation fees, which are not even required in Europe. TICKK added a fee in the tariff under the name of "Scientific Advisory Fee", which amounts to 50.000,00 TRY per consultation.

The same fee being received for the pharmaceutical, total turnover of which is expected around 100.000,00-200.000,00 TRY, and the pharmaceutical making billions turnover, a box of which is 100.000,00 TRY, has immediately daunted the domestic pharmaceutical producers.

TWO DIFFERENT PRICES FOR THE SAME PRODUCT

Each medicine has a patent life of 20 years. While the domestic firm is preparing the product the patent terms of which lapsed, the foreign company is getting a second patent claiming that the pharmaceutical recovers a different disease as well. In this way, the patent term is extended and the domestic firms are prevented to produce. The most important example of these patent games is Glivec-named cancer pharmaceutical.

For Glivec presented to the market for patients with leukaemia, no difference is received from the patients and the entire cost of the medicine is covered by SGK. However, the company is collecting the price difference, it can not get from leukaemia patients, through "secondary indications usage patents".

TIME EXTENDED UNDER THE PRETEXT OF CANCER

Novartis, the manufacturer of the pharmaceutical , has obtained patent for secondary use of the same pharmaceutical, which is claimed to be good for the gastrointestinal cancer as well, at the Patent Office and asked a new price for the pharmaceutical for the uses of gastrointestinal cancer patients by filing application with Turkey Pharmaceuticals and Medical Devices Agency. The company, whose application was accepted, started to get a difference of 397,00 TRY from stomach cancer patients. Glivec is sold to the state for 2 thousand by 384,00 TRY.

SGK is paying the entire price of the pharmaceutical while purchasing it for leukaemia patients. In the case of stomach cancer subject to the second use indications patent, the state pays 1.987,00 TRY. The difference of 397,00 TRY is collected from the citizen.

The fact that the 2017-2021 Global Pharmaceutical Report (IMS), prepared to guide global pharmaceutical companies for their actions around the world, has mentioned in respect of Turkey that it is expected that global products will be given priority for accelerated licensing period, brought the allegations that the law and regulations of "prioritisation" implemented since 2016 and hitting the domestic pharmaceuticals have been prepared by lobbying activities of the consulting firms in Turkey of the global companies.

ITS DOMESTIC WAS 11,00 TRY, AND NOW 303,00 TRY

One of the most concrete consequences of the bureaucracy's surrendering to the global pharmaceutical companies and the current situation of the domestic pharmaceutical is the Mestinon named pharmaceutical.

Until a few years ago when the domestic production in Turkey was encouraged and the importation was subject to the tight sanctions, the license of  Mestinon tablets produced in Turkey by Roche was sold to the Sweden company "Meda".

Well after the import barriers are removed, Meda has finalised its production in Turkey and started to produce the product in its factories abroad and sell to the pharmacies in Turkey.

  

When the alternative payment channel only allowing the importation for emergency situations is expanded, the company has cut off the importation.

The product sold for 11,00 TRY when it is produced in Turkey can be only brought through an alternative payment channel. The price of one box of the product is 303 euro.

ONE BOX COSTS 49.000,00 TRY

There are 6328 pharmaceutical items in Turkey's pharmaceutical market. When these pharmaceuticals are arrayed from the expensive to the cheap, one box of the cheapest of the first 20 pharmaceuticals cost 11,00 TRY. Harvoni 90 Mg / 400 Mg 28 Film Tablet, the first in the row, is priced at 49.750,00 TRY as of today. We need to pay more than 6.000,00 TRY today for a box of this medicine sold to 44.000,00 TRY yesterday.

Despite the sale of only 162 boxes of this pharmaceutical, 6.700.000,00 TRY turnover was obtained in 2017. It is stated that the cost of this pharmaceutical used by advanced hepatitis C patients does not even reach 1.500,00 TRY. Today it is reported that there are more than 500000 patients who may have benefit from the use of this medicine. This means that we will spend a much higher amount tomorrow for Hepatitis C patients at baseline we cannot treat today because of the inhibition of the development of the domestic pharmaceutical industry.

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