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Intellectual Property in Pharmaceutics.State Policyю.

A new track, Pharmaceutics, was added to the business programme of the IX St. Petersburg International Legal Forum. The participants of one of the track’s sessions discussed the current situation around the protection of intellectual property in pharmaceutics, as well as the state perspective on the subject.

Liubov Kiriy, Deputy Director General, Federal Service for Intellectual Property, moderated the session. Aleksey Belozerskiy, Head of the Legal Department at Novartis Pharma LLC, Yoshiyuki Takagi, Assistant Director General, World Intellectual Property Organization, Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation, Dmitriy Morozov, Chief Executive Officer, CJSC Biocad, Vadim Kukava, Executive Director, Association of Pharmaceutical Companies Innovative Pharma, Natalia Putilo, Head of Social Legislation department, the Institute of Legislation and Comparative Law under the Government of the Russian Federation, Aurelia Cheban, Eurasian Patent Organization, Dmitriy Fedorov, Vice President of legal support, Pharmasyntez JSC participated in the session as speakers.

In her welcome address moderator Liubov Kiriy emphasized from the outset that the matter of intellectual property in pharmaceutics is as relevant as ever.  The expert believes that this primarily stems from the rapid development of the Russian pharmaceutics sector that has put its own products on the market. Kiriy affirmed, “This is a pressing issue given that up till now foreign companies were the leaders in intellectual property rights ownership in the Russian Federation. The situation is changing, with issues of protection, acquisition, and challenging of patents coming to the forefront.”

Sergey Tsyb, First Deputy Minister of Industry and Trade, agreed with her, stating that protection of intellectual property is a key challenge. The expert pointed out, “At the same time, intellectual property rights, just like any legal instrument, have a whole range of features that require fine-tuning and adjustment. We have already seen that in some cases an imbalance in rights protection may actually serve as a restraint rather than a driver for development.”

A disruption in the balance between private and public interests in pharmaceutics and health care, as well as evergreen patents were mentioned by Sergey Tsyb as some of the most pressing issues in the sector. He said, “Evergreen patents are a sensitive topic in this field. This happens when in pursuit of his own financial interests a manufacturer strives to remain a monopolist on the product’s market,” adding that this causes negative consequences, by, for example, limiting access to technologies, preclinical testing and other procedures, as well as discourages the development of new drugs. The Deputy Minister also reported that an agreement was reached to create an inter-ministerial working group, some of whose decisions may be reflected in the Strategy of development of the pharmaceutical industry until 2030.

Yoshiyuki Takagi, Assistant Director General, World Intellectual Property Organization, underscored the importance of protecting intellectual property. He pointed out that his organization has noted a significant improvement in the understanding of the role of intellectual property and the patent system over the last 20 years. The expert believes, however, that law enforcement challenges remain, and overcoming them requires a concerted international effort, as well as establishing close cooperation on patents.

In addition to that, Yoshiyuki Takagi accentuated the topic of developing public private partnerships in pharmaceutics. He believes that this cooperation model may be highly effective. The speaker asserted, “There is a remarkable trend: PPPs have started to emerge in the sector over the past 2–3 years. This is caused by a whole range of factors and initiatives in the pharmaceutical industry where accommodating the need for essential drugs is imperative. The development of drugs for treatment of rare health conditions should also be taken into consideration.”

The possibility of creation of a single patent registry was also under discussion. Liubov Kiriy, the moderator of the discussion, brought up the initiative. According to her, such a registry will have a whole range of advantages. It would, for example, establish a record of exclusive rights for an invention related to a reference drug, and allow for a delay in the circulation of a generic drug until the patent on the reference drug expires. Moreover, it could also enable users to promptly receive information about drugs where patented active ingredients are used and to prevent infringement on property rights on a reference drug in case a generic drug is circulated prematurely. “The information will be publicly available. This will allow members of the public to respond to drug regulation and patent processes. This is in line with the state policy on the utmost transparency of federal authorities,” underscored the moderator, giving her colleagues an opportunity to comment this initiative.

Aurelia Cheban of the Eurasian Patent Organization expressed her opinion, saying that “The registry is a wonderful initiative that facilitates the process of informing the public, third parties, and especially manufacturers of generics about existing rights and their expiration dates. This is also something that manufacturers need to plan their actions in advance.”

In addition to the registry, the speakers addressed other topics. Thus, Aleksey Belozerskiy, Head of the Legal Department at Novartis Pharma LLC, brought the participants’ attention to the concept of the ‘importance of a technological advancement.’ He stated, “Who is to decide and based on what criteria? Is it just an additional modification or a considerable improvement? It can hardly be said that any patent can be considered an important technological advancement. We believe that the importance should stem directly from the patent and elaborate on an existing patent, and not just be an advantage based on the requirements of the law.”

Vadim Kukava, Executive Director of the Association of Pharmaceutical Companies Innovative Pharma reminded those attending the session that promoting and protecting national innovative drugs is an important objective. According to the expert, this objective was mentioned by the President of the Russian Federation Vladimir Putin in last year’s Direct Line session. Vadim Kukava stated, “Companies will stop putting innovative drugs on the Russian market in the medium term if intellectual property rights are not respected in Russia.”

In conclusion the moderator of the session thanked the participants of the discussion and regretted that the allocated time was not sufficient for the experts to fully express their opinions.

The St. Petersburg International Legal Forum takes place in the Eastern Wing of the General Staff Building of the State Hermitage from May 14 to 18. The Forum is organized by the Ministry of Justice of the Russian Federation under the auspices of the President of the Russian Federation.