Company overview

«Geropharm» is group of 3 companies, one plant is responsible for full-cycle manufacturing based on approved foreign substances. The company is settled in the special economic zone of Saint-Petersburg. «Geropharm» started to work from 2001, and to present dates it ranked with 16 place in national pharmaceutical manufacturers list according to the volume of own production (About Geropharm Company, 2016).

«Geropharm» is higly growing company that involved in development and production of high-quality medicines for domestic market, together with contributing to technological development and the provision of innovative pharmaceutical environment. Currently, company's efforts are focused on the creation of critical technologies, that is, of complex technologies with high social significance that promote drug security. Identically, “Geropharm” is currently implementing a project of constructing a new production complex in Pushkin.

The mission and values that the this pharmaceutical company incorporates are “impeccable quality, professionalism and conscious responsibility, innovation and openness”, which proclaimed to embrace corporate policies and enhance «Geropharm» competitive positions in the comprehensive Russian pharmaceutical market.

Patent analysis

Thomson Innovation® displays only two results of «Geropharm» Company, and 4 alive and 1 dead patents are presented by Orbit system.

-The patent from 2001 presents Tertapeptide stimulating functional activity of neurons, that had three A61K IPC codes and two A61P: in the sphere of disorders of the nervous system, more precisely for treatment of central nervous system. Significantly, that this patent was cited in 29 other patent documents, by foreign and Russian companies.

Tetrapetide is claimed as the main active component of this invention, that should enhance activity of neurons and normalize metabolism of impaired nervous tissue.

-Another patent of 2011 year stands for Injection for treatment of acute ischaemic insult and cranium-brain trauma containing, that has two IPC codes: A61K and A61P, relating to treatment of ischaemic or atherosclerotic diseases. The patent basically claims for increasing of effectiveness of an active substance heptapeptide by new method of production of an injection, that applied in medicine for treatment of disturbed nervous system. Also the period of storing of the injection has been increased.

No information on licensing or other forms of cooperation was found for all 4 patents.

Trademark analysis

»Geropharm» issues 10 medicines, 9 of which are registered under trade names. Neurology is presented with 4 pharmaceuticals, 2 relate to the treatment of endocrine system diseases, one each is for ophthalmology and gynecology. Almost all medicines are listed as life essential products (7/10), and two medicines for treatment in neurology sphere are presented only by «Geropharm» as Russian company. However, despite the importance of overviewed drugs, the firm does not develop some unique products.

Some trademarks were also registered in other countries, and from the medicines only two are stayed active - Rinsulin, for the endocrine system, and Cortexin, applied in neurology. Application years are reflected in the corresponding graph, started from 2005 (2 trademarks), with the highest activity in 2008 (5).

Countries: one trademark designated to Estonia, and another to Belarus and Kazakhstan. It should be said that trademarks that had expired were designated to WO and had their presence in different participating countries.

Moreover, not all medicines are produced by the company itself, and Biosulin ™ (for treatment of diabetus) is owned by the «Pharmstandard» company (Ufa-vita division), and produced in India. Another medicine for treatment in neurology sphere is produced in Island, and Memantinol ™ , also in the area of neurology, however, other 7 preparations under trademarks are owned and produced by «Geropharm» itself.

Therefore, existing patents do not correspond to the registered trademarks and products that «Geropharm» possesses, and there is no information about the commecialization of related inventions. Therefore, it could be deducted that «Geropharm» primarily use trademark protection as IP strategy for competition on the Russian pharmaceutical market, by selling medicines from the list of life essential pharmaceutical products. What is more, two medicines are presented under Russian trademarks in Estonia, Belarus and Kazakhstan, what could indicate the goal of expansion on the close to Russia territories. Presence of company's products covers 13 countries.

Life essential drugs: 0,55

Valuable medicines: -

Cooperations; co-assignees - None

Main forms of patents: not applicable

Main areas of patenting: not applicable

Main areas of trademarks: not applicable

Number of corresponding patents and trademarks: none

IPR strategy:

not essential patenting strategy,

competitive trademark strategy,

General: business strategy

Discussion

Overview of total companies' results

Discussion of obtained results chiefly concerns general overview of firm's strategies according to methods of patenting (countries, scope, cooperation) and trademark registration, including the information about relatedness of claimed inventions and products under a tradename. Patent and trademark strategies firstly described separately, then possible directions of IP Management are outlined, concluding on presumed IPR protection strategies.

Given these points, number of patent applications (including granted patents) is 222 for all firms in the sample. Most intensive publication years of patent information are 2011-2015, what could point to the emergence of pharmaceutical development in the end of 1990^s.

Figure 24. Patent Publication years. Data from the sample

Generally, companies from the sample exploit strong trademark registration with intention to gain competitive positions on the Russian market and likewise abroad (mostly in CIS countries), while patenting strategies remain more of defensive nature (not for profit extraction), or not essential.

Figure 24. Patent/TM strategies. Data from the Sample

On these conditions, in view of IP management strategies of chosen firms, several parameters of patents and trademarks were jointly assessed in order to say whether there is a IP strategy at all, how existed resources are used and transferred (IP exploitation), if IPR were subjected to opposition and litigation (IP enforcement), or whether taken all determinants together IP strategy is rather weak. It should be said, that only two companies showed exceptional results regarding strong patenting strategies and trademark registration, including close connections between patented inventions and products sold with assigned tradename: «Biocad» JSC and «Akrikhin» LLC. Other companies are generally attributed with rising trademarking activity (mainly within generics market), or not essential TM strategy, as considerable number of products are sold without a trade name.

At present times, the environment over intellectual property of top Russian pharmaceutical firms occupies mostly sphere of trademark registration of generic medicines or medicines on which there is no protection of foreign firms. Diagram below presents the distribution of patents, trademarks and valuable pharmaceutical drugs of all analyzed companies:

Figure 25. IP forms, data from all sample firms

In essence, even if the comparatively big number of trade named medicines is possessed by a company, the share of de facto valuable medicaments is significantly low.

Equally important, the construed method for this research establishing links between patent applications and registered trademarks, concerning simultaneously other patent parameters, portrays that patents are not successfully commercialized and exploited by big Russian pharmaceutical firms. However, it should be stated that some firms firstly register a trademark for some medicines, and also apply for a patent protection, so the strategy of protection of products and defensive strategy are reflected in those actions.

Figure 26. Interrelation of patents and TMs of all companies

Although this may be true, taking into account years of companies' existence, emergence of some IP protection activities could be identified, especially with regard to expansion of products portfolios with new trademarks designated to Russia and foreign countries, mostly CIS. Coupled with development of licenses of trade named products, M&A with national and foreign companies, these factors favor appearance of intellectual property management in Russian pharma industry. On the contrary, without effective changes in IP regulation and legislation of pharmaceutical industry, as well as with no endeavors of firms itself, accomplishments of state development programs is unlikely to occur by 2020. Markedly, cooperation activity is indicated in 6/10 of sample companies, what deducted from R&D cooperation according to the company web-sites profiles, and licensing activity via trademarks.

Conversely, by overviewing of all available patent information, the results in terms of quantity and as well as quality of protected pharmaceutical products is not sufficient. Indicators of “Akrikhin”, the leading innovation company, is not far from other companies that were established in our time. Henceforth, presence of relating to industry and policy barriers exists that hasten fruitful development of Russian pharm market in terms of innovative drugs and valuable medications.

Next section outlines possible solutions for enhancement IP management in companies and on governmental level, improving pharmaceutical industry indicators in Russia in terms of domestic manufacturing, import substitutions and original medicines R&D.

IP management in Russia. Possible solutions

Conclusions, Limitations and Further research

In the final analysis, problems with IP regulations, investments and human resources in Russia are key decisive factors for the weak IPR strategies of Russian companies, also weak sides of the Pharma2020 exposed. Even if 50% of consumed products will be domestically produced, it does not guarantee the development of inendent national pharmaceutical market, rather it will increase foreign participation. By the same token, some foreign companies now are afraid of contracting with Russian firms for the production of brand medicines due to the several unpleasant reasons mentioned through the current investigation. Above all, the bright sides of the state programs is acknowledgment of R&D centers development close to the universities, in cooperation with some business participants. This could lead to raising of the potential of development the pharmaceutical full cycle-production of domestic pharmaceutical companies.

At the same time. public welfare of patent protection for pharmaceutical products (including vaccines) are evidenced.

Today, more than 90% of prescription drugs and vaccines available on the market are the result of applied research, that is likely to occur by stimulus of patent protection, provided that exclusive rights benefits market sales.

Patent protection establishes the necessary balance between the natural tendency of inventors to recoup their costs and society's need for new, effective and safe medicines.

At a high level of patent protection to producers it becomes impossible to produce pharmaceutical drugs of low quality that can cause serious injury.

Effective patent protection gives manufacturers the time needed for training professionals the appropriate use of new drugs and treatments.

Presently, in times of rapid technological developments, the transparent trend of tightening patent protection regimes has been emerged (Beck, 2013). Specifically, it forms new tendencies in pharmaceuticals sphere, where at the expense of numerous and ongoing costs of new medicines creation, as well as with notably excessive legal risks, defense of company's inventions is indeed important. In parallel with this ongoing debates over the "excessive rigidity" of patent law in the field of medicines, that limiting, as for opinions of poor countries, access to the latest technologies. Thus, the problem of protection of pharmaceutical patents has a number of closely interconnected economic, social, political and ethical dimensions.

Most compelling evidence of IPR enforcement insufficiency in Russia, despite the high level of the Russian patent law, that it does not oblige the Ministry of Health to check the purity of the registered patent medicines. Moreover, the Ministry does not have the right to refuse the registration, even if the development company announces the current Russian patent for its drug (Yablokova, 2015). In other words, they are allowed to sell products that violate existing patents of original drug manufacturers. For example, about a dozen copies of omeprazole have been reported in Russia after one foreign company received the Russian patent for the respective original product.

Thus, patent protection of pharmaceutical products, as a security element of intellectual property rights, is inevitable forming factor the medical science progress and health welfare. Alternatively, there would be constraints to establishing majority of highly efficient drugs that form the basis of modern pharmacotherapy. Without it, development of the worldwide pharmaceutical connections and corporations, that Russia is seeking for, would be hard to achieve.

To create an effective global strategy to guarantee access of all the world's population to essential medicines needed balance the rights of private firms, patent and national interests of countries in the world to find ways of mutually beneficial compromises in the existing international copyright protection system.

The value of this work for policy-makers highlights the necessity in changing the intellectual property laws in the country in order to favor Russian companies in their R&D activities, and at the same time provides incentives for international cooperation, as a lot of life essential medicines are imported, and own production facilities of Russian companies do not always capable of full-cycle development of medicines.

Looking beyond

All things considered, several shortcomings of current paper outlined in next few paragraphs.

To begin with, focus of the study concerned on pharmaceutical industry solely, without considerations of other industries. Hence, some bias in the qualitative analysis may occur, given that “interactions between industries may turn into changes in another industry, and Cross-Impact analysis is one of the key method for this” (Altuntas at al., 2014).

Point that should not be overlooked, that existing evaluation approaches do not consider a patent's life cycle, an important and unique characteristic of pharma and bio- tech patents. Moreover, assuming scope and research question of the study and investigation of IP strategies in general, comprehensive methods of patent analysis are ignored. Conclusions on patent's parameters made are chiefly of descriptive nature. Independent path for the research could be in the form of deep analysis of company's patent portfolio, with comparison of patents determinants of other similar countries.

What is more, in further research parameters for comparison of patent information among similar countries may be established, with focusing on applications for inventions and patents separately.

Identically significant, that in order to clarify IPR protection strategies of companies' official data outputs may not be enough: a comprehensive anonymous survey of top-managers involved in processes of R&D and legal protection is necessary to support or deny obtained results, and also acquire deep insights in technological activities.

On the whole, the topic of this study could be benefited from other investigations close to the current research question; we hope that this work will contribute for the purposes of evolution Russian pharmaceutical industry technological capacities and will create new directions in discussions of intellectual property protection strategies globally and nationally.

Table 1. Top-20 new trade names list (by volume of annual sales, package) in Russian commercial market (Table 1).

Figure 2. Areas of state regulations needing improvements

Source: Delloitte report, 2014: http://ru.investinrussia.com/data/files/sectors/EN-Trends-and-practical-aspects-2013.pdf

References