Ukrainian Forecast. Compulsory Licensing of Intellectual Property in Pharmaceutics

The issue of intellectual property compulsory licensing in the pharmaceutical industry has not yet attracted attention in Ukraine, although it already has all bases proceeding from both foreign and domestic practice trends.

Within this article, we tried to predict will global trends in compulsory licensing in the pharmaceutical industry influence Ukraine, should pharmaceutical companies expect certain events in Ukraine and what issues may arise concerning compulsory licensing in this sphere in the near future.

Foreign practice

Natco against Bayer. The Indian Patent Office has issued a compulsory license for generic version of the drug Nexavar (INN - Sorafenib). As stated, Bayer was not able to satisfy the needs of patients in specified medication also the drug exorbitant cost was emphasized. Generic version was put on market with nearly 16-time price reduction.

The Indian courts are more loyal to national producers and are not so unbiased. So, «Big Pharma" companies are on the losing side in the Indian courts when trying to protect their monopoly rights on original drugs manufacture and sell. In that case the Indian pharmaceutical companies carry a case and come into the market with the following generic copy of the drug-blockbuster.

It should be mentioned that compulsory licensing is not the only way. Indian courts are often on the side of domestic producers, a striking example of this is the last process in which F. Hoffmann-La Roche tried to assert their rights to the drug Tarceva (INN - Erlotinib) against Cipla and lost a case. Another ongoing struggle for the Novartis drug Gleevec (INN - Imatinib), although predictions are not in favor of Novartis.

But whether India is a pioneer in compulsory licensing? Not at all.

Brazil

F. Hoffmann-La Roche company met the government halfway, resulting in the introduction of 40% reduction of the Viracept price (INN - Nelfinavir) and the compulsory licensing of the mentioned drug was avoided.

A special decree was issued by the Brazilian government in 2003. According to this document an importation of the generic antiretroviral drugs, in particular, Lopinavir, Efavirenz and Nelfinavir is allowed.

The Brazilian government issued a compulsory license for the drug company Merck & Co. (INN - efavirenz)in 2007.

This is not an exhaustive statement of events in Brazil regarding compulsory licensing. Also should be noted that the compulsory licenses granting by the Brazilian government has caused considerable tension in international relations, in particular, with the United States.

It seems that the medicines compulsory licensing is practiced only in developing countries, with low living standards. But practice shows that situation is different.

Canada

Apotex company received a permission from the Canadian government on generic copy of the drug Cipro produced by Bayer company (INN - Ciprofloxacin) which was sold at a price almost twice lower than original. The motivation was Bayer inability to produce enough of these medications as protection against possible terrorist attacks using biological weapons, including anthrax pathogen.

The United States

A similar process has ended with the agreement on significant price reduction, but the generic companies received substantial compensation for not releasing their product on the market and refusal to challenge dispute a patent on the Cipro drug.

Ukraine

What prospects have manufacturers in the sphere of innovative medicines in Ukraine?

Article 30 of the Law of Ukraine "On Protection of Rights to Inventions and Utility Models" provides three cases in general where the patentee shall grant a license to use the invention or a compulsory license:

1. When the invention is not used or used insufficiently in Ukraine;
2. When it is impossible to use a patented invention without the use of another invention;
3. To ensure public health, national defense, environmental safety and other public interests.

The last case coincides with the subject of this article, although the previous ones can be used for obtaining compulsory licenses for inventions relating to medicines.

Paragraph 11 of Article 9 of the Law "On Drugs" states that "In order to ensure the health of the population in case of drug registration The Cabinet of Ministers of Ukraine in accordance with the law may allow the use of a patented invention (utility model) relating this product by defined person without the consent of the patent holder, "which is the exact rule that allows The Cabinet of Ministers of Ukraine to act in this manner.

The decree of the Cabinet of Ministers of Ukraine "On Approval of the Procedure of the Cabinet of Ministers of Ukraine permission to use the patented invention (utility model) or registered topography of integrated circuits" dated January 14, 2004 establishes the procedure for the provision of such compulsory licenses, which also indicates social need presence verification.

Another relevant document is the Decree of the President of Ukraine № 526/2012, which entered into effect the decision of the National Security and Defense Council of Ukraine dated May, 25 2012 "On the provision of high quality and affordable medicines." The penultimate paragraph of this document stipulates "the Ministry of Health of Ukraine, the Ministry of Justice of Ukraine is entrusted to study the issue of adaptation of Ukraine to the Directive 2001/83/EU of the European Parliament and Council dated November 6, 2001 on the Community code on medical products intended for people and implementation of the Agreement on trade-Related Aspects of Intellectual Property Rights of the implementation to protect public health and promote accessibility of medicines for compulsory licensing in relation to drugs. "

Summarizing, we can say that such decisions implementation complexity and their significance relating the pharmaceutical industry restrains the government from such activities but the market development dynamics, in particular pharmaceutical sphere is that you can make assumptions about the proximity of the moment when Ukraine will join the "pharmaceutical Robin Hoods "club and provide compulsory licenses on innovative drugs. We may say with certainty that the legal framework is already prepared, and the political situation makes us think about the ratings.