Strategies for intellectual property rights protection in Russian pharmaceutical industry: evidence from the analysis of patent information

Characteristics of the main problems and goals of development of the Russian pharmaceutical industry. Analysis of patent information in the field of pharmaceuticals. Study of basic strategies of russian companies to protect intellectual property.

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Effective patents (applicable for bringing profits) are more likely to encourage licensing among firms short in assets than firms that occupy them (Arora &Ceccagnoli, 2006). In this regard term “complementary assets” is embedded, that generally means other sources of knowledge and development that allow a firm to compete on the Market. Thus, Teece , (1986) argues that licensing is mainly recommended if the innovator enjoys strong patent protection and lacks complementary assets such as manufacturing and marketing. The principal notion that is deducted from Teece's (1986) study is that access to complementary assets is difficult - they cannot be lent, and it takes lot of financial resources and time efforts receiving them. However, by comparing number of patents and related license agreements we claim to detect or deny competition patent protection strategy, and in the last case we would point to the strategy of active application of complementary assets (manufacturing of generics and marketing in the form of brand names).

Another work on a company's assets and its efficiency is discussed mentioning of complementary assets (e.g., market related knowledge, product reputations, distribution channels, and customer contacts) as an additional source of advancing technology and capabilities of a firm to bring new benefits to the market (Nerkar&Roberts, 2004). Regarding the successful implementation of “generic” strategy, it is argued that it could be naturally entered through market and could be valuable for a firm, however “their strategic importance would be limited” (Barney, 1991).

Non-patent means of protection

Except patents there are other valuable means of IP protection that likewise used in pharmaceutical industry, for instance, trademarks (registered trade names of products), and trade secrets, that do not have to be officially publicized (i.e. confidentiality agreements). Ordinarily, such methods also regarded essential for protection of pharmaceutical inventions, however the influence of trade secrets is more difficult to evaluate without conducting a special survey. Consequently, we could not detect the strategies of IP protection other than patents and trademarks since there is no official data source for trade secrets, for example.

Also other formal protective rights are mentioned as trademarks, utility patent, design patent, copyright, as well as informal or contractual protective strategies: measures to keep personnel long-term, confidentiality, time lead over competitors, exclusive customer relationships, form of contracts with suppliers (Blind et al., 2006).

The strategy that outlined by the method of joint applications is discussed in another peer-reviewed article, mentioning the evolution of nature of patenting (Ron, 2012).

Trademark protection offers opportunity for building reputation of the product and firm on the market, because generics are unlikely to compete on grounds of drug's activity and effectiveness. Thus, trademarks present a key value for companies in terms of brand recognition and differentiation of products (Tuominen, 2011).

Turning to the exploration of types of IPR protection strategies, the most applied is comparison between acquiring of patent protection or trade secret status. Most of the papers are devoted to foreign industries, however theoretical ideas could be implemented to the realities of Russian industry too. “The decision to use secrecy rather than patent may be explained by the legal uncertainties surrounding IP rights. The legal process is a major source of costs and uncertainty, mainly because the scope and the validity of the patent may be questioned at that time” (Crampes& Langinier, 2002; Lemley&Shapiro, 2005). The under-funded Patent Office reviews the patent application for an average of 18 hours before deciding whether or not to grant the patent” (Lemley et al., 2006).

In the very recognizable paper on technological innovation Teece refers to the most common type of legal instruments: patents, trade secrets and copyrights, relating it to the nature of technology: product, process, tacit or codified (Teece, 1986). Linking this concept with the appearance of pharmaceutical industry the “regime of appropriability” could be identified, pointing to the environmental factors that form the latest.

Approaching specificities of medicine and pharmaceutical industry the process of IPR protection takes a special place. On behalf of conceptual findings there are debates over social and economic explanation of IPR protection: business groundings meet its opponents from the social welfare advocates, thus the balance between economic value for the developer and moral issues is one of the numerous unsolved dilemmas (Cerón& Godoy, 2009).

Types of novelty of medicines

It is also vital to briefly determine main types of innovation in pharmaceuticals, what further will help with the analysis of the scope and importance of patented invention of Russian pharmaceutical firms. Incremental innovation is featured by enhancement of already existing medicines or “expanding therapeutic classes to increase therapeutic efficacy, safety, and quality” (Innovation in the Biopharmaceutical Pipeline: A Multidimensional View, 2013).

For example, expanding of treatment area of existing drug could be reached by changing the dosing requirement for patents. Such innovation often ensures that reasonable dosage of a drug is used for each treatment case (IFPMA, 2012). “Additionally, despite the type of patent's improvement, whether it is new improved formula, expansion to an existing therapeutic class, or a newly identified medicinal use, incremental innovation involves the same R&D and clinical trial inputs as first-in-class medicines'' (IFPMA, 2010). Types of pharmaceutical innovation: incremental, radical and revolutionary are explained in Figure 4. According to the studies, relative number of first-in-class products is lower than products with incremental changes (2012-2016). However, incremental innovation could be definitely significant as such inventions could enhance properties of existing medicines and increase options for patient's treatment. That is why we should pay attention to the detailed description of patented inventions.

Regarding evaluating of presence and types of IPR strategy protection, the main goals and missions of pharmaceutical companies, provided on their web-sites or other sources of official information, are also highly important. For instance, a company that mainly seeks to raise its profits usually tends to register incremental inventions (Who, 2007). Our of this type of alterations the “secondary” patents strategy revealed when protection is seek to cover protection on several features of a single commercial drug after acquiring a patent on the active ingredient. “Secondary patents may cover peripheral features such as a tablet coating, an intermediate product that naturally results after ingesting the drug, or methods of use; it could also include a different dosage or delivery route” (Ho, 2015). This strategy is widely called “evergreening” in literature devoted to patent's strategies. Moreover, patent application of such nature not only restrain competitors from entering the same area, but pending patents also lower the information disclosure of patent portfolio (Jell, 2011)

Definitions of breakthrough and incremental innovations are used in the overview of shift from individual single breakthrough patents to patents of single patentee that are incremental in essence. Mentioned cluster of patents (Ron, 2012) or patent portfolios (Parchomovsky&Wagner, 2005) had gained an increased value over a single patent of single inventor, especially in pharmaceutical industry.

Strategies of IP protection

In this section different opinions on types of IP protection strategies will be gathered and at the end presented in the form of a picture. Despite the fact that no officially established or recognized IP strategies exist, commonly, options are reduced to several basic varieties.

Intellectual property is interesting to be analyzed in terms of practical positioning within IP Management in innovative firm. Patenting inventions are most commonly associated with establishing exclusivity for an inventor, and also on a more global scale allowing to make particular person or entity be responsible for potential damages (Roemer-Mahler, 2013). Other explanation of importance of intellectual property protection lies within concept of defense against the counterfeiting: defense of a new idea and its commercialization on a priority basis (Participation on the Market and bringing back investments that were spent on R&D are also essential motivation for IPR protection)

(Cohen et al., 2000).

Patent - as discovered in one of the research papers - is a probabilistic right. The incentives to get a patent can be explained by the desire of protection of new developed technology and its sole commercial usage for some period of time. When one makes an application, it is also a disclosure of the technology in exchange of potential acquiring of a right (Roemer-Mahler, 2013).

Still, patents are considered as foremost method of protection in pharmaceutical industry, several other management strategies are proposed to enhance the profit utilization of company's product portfolio. As Cohen et al., (2000) states “such strategic motives as blocking competitors, enabling cross-licensing, and forearming against infringement suits” may be more efficient in following the protection motives. Among strategies of patent protection pending applications are also considered as patent strategy of a firm, thus constraining rivals from fast decisions, and bringing more uncertainty to similar players (Jell, 2012).

Significance of collaboration between firms that may be captured by presence of co-assignees and joint patent application should point to the industry important inventions as firms share expenses for resource allocation and R&D activities. Such are considered as industrially valuable because joint work may be a sign of exchange of important resources that are not available within the firm limit, and even in case possible negative effects of collaboration, competition capabilities are enhanced (Petruzzelli et al., 2015).

Focusing on patent application strategies, some authors simply define it according to different patent dimensions, like: domestic applications, applications abroad;

The dimensions of successful IP management strategy are discussed in the paper devoted to the effective IP strategies in biotechnology sphere, however, some aspects could be applied also for pharmaceutical industry:

(i) Protection optimisation - sharply, “defend ownership and deter competing technology”;

(ii) Maximal value extraction - executing license agreements and law protection of an invention, and

(iii) Alignment with the commercial strategy - evaluation whether IP assets fit in the stated strategic objectives and mission of a firm (Lerer&Bowman, 2011).

A study was conducted via analysis of UK and US pharmaceutical firms in order to investigate the situation over market of generic drugs and strategies of R&D-based companies that invest a lot of money in pharmaceutical innovations. As a result, large R&D-based companies have started to diversify their business with regard to both product portfolio and geographical target markets (Roland Berger Strategy Consultants, 2010). Diversification strategy, including entering the market of generics (by acquiring other forms, building own venture, or partnering) is another path mentioned (Roemer-Mahler, 2010).

So-called “evergreening” strategy mentioned similarly as “follow-on patents” related to desire of an inventor to extend the protection period of its product/process and restrain producers of biosimilar drugs to occur on the market after patent's end. Therefore, assignees do not tend to claim for a broad protection in one application: reciprocally, they “thicken” the original application with followed innovative variations of initial patent. This strategy is referred to defensive strategies and treated as a very important method particularly for pharmaceutical industry (Tuominen, 2011).

Patent strategies are also evaluated through the relation of domestic applications and applications abroad. Such quality determinants are under investigation: the existence of collaboration in patent development, the number of claims, the scope, and the novelty, with the existence of forward citations the patent received (Haley&Haley, 2012).

More generally, the evaluation of patenting strategy (in particular) is identified in the article contributed to studies on the patent portfolio analysis, its indicators, methods, etc. As Grimaldi et al., 2014 define, four types of patenting strategy categorized by strategic positioning are:

o Competitive: patented inventions play a defensive role of the competitive position on the market;

o Business: protection of products relevant for the leading business of a company;

o Defensive: patent protection is exercised in order to limit competitors from market entry, creating strategic difficulties/barriers;

o Not essential: patenting with the sole aim of maintaining reputation on the market (Grimaldi et al., 2014).

Determining strategies in sphere of patenting and trademarking, the next general aspects of IP strategies could be determined: good data on IP protection strategies in pharmaceutical industry is presented on the WIPO web-site, where it is stated that creating an IP portfolio, protecting it and exploiting is incredibly important in forming investments in budget and market opportunities (Intellectual Property Rights for SMEs in the Pharmaceutical Industry, n.d.).Cited web-source relates to the sphere of IP in biotechnology, and lists some components of IP strategies, that in successfully developing firm are all engaged:

-IP Protection strategy (various aspects of patent protection)

-IP exploitation strategy (commercialization, license agreements, cooperation agreements, strategic alliances, cross-licensing, etc)

-IP monitoring (search of the patent and trademark databases on potential contractors and infringers)

-IP enforcement strategy (arbitration and mediation).

The current research implements two first constituents of this offered insight, as only IP protection and exploitation strategy could be detected from the analysis of patent and trademark information, in order to answer the research question of this Study.

Obviously, there are other IP strategies not included in the scope of this Research because they are simply unavailable for identification with our methodology, i.e. compensation payments for generic companies in order to delay their entering of the market, different agreements, employee's policy, etc. In the Master Thesis we compare the official information of companies to the reality of their activities and performance that are analyzed by data on the patent applications, trademarks, and partly on cooperation and license agreements.

Findings

To begin with, this Chapter should start with an overview of the Russian pharmaceutical market, its main participants, share of imported and domestic medicines both in the retail market and hospitals procurement. Governmental initiatives towards regulation of the pharmaceutical market is also in the scope, to evaluate the stated goals in terms of national development programs and real situation that Russian companies encounter. Furthermore, the list of all Russian companies related to pharmaceutical industry by the official activity code is outlined, retrieved from the SPARK system. This assists in determination and explanation of choice of the firms in the sample firms. Then the brief overview of the analyzed firms is presented, followed by the Case-studies thereof.

Russian Pharmaceutical Industry

According to the Russian pharmaceutical healthcare report, the development of pharmaceutical market marked with relatively weak IP enforcement, that is highly underdeveloped (Swiss pharmaceutical Healthcare Report, 2012). Analysis of patent information of Russian pharmaceutical companies will help to understand if there are some advancing in industry development in terms of R&D in Russian pharma and innovations in the sphere in general. Government has conducted many policy reforms in order to spur domestic manufacturing; under these circumstances study of present nature and effectiveness of patents and other IP subjects is definitely important. Still, generic products and imported drugs penetrate Russian market, and what is more, patents that granted in Russian Federation belong chiefly to foreign firms, transnational corporations, and, if Russian assignees, to state organizations or universities (Figure 5).

The central document relating to development of national strong pharmaceutical base is government program Pharma2020. It prescribes firstly such goals as development of innovative production, advancing of export up, development of national innovative pharmaceutical drugs, creation of competitive market atmosphere. Goals are ambitious, and different passports devoted to different areas of development among medical equipment and pharmaceutical production. Now it is the second phase of the Program started, in 2016, and aims of the statements should be accomplished up to 2020. Postulates of the Program can be applied for the analysis of the Program's goals and the current situation on the market of pharmaceuticals of Russian companies. Goals and challenges of the Pharma2020 might be used as issues in analysis of the inventive and product potential of Russian firms to meet the frames of the Program especially in terms of competitive environment, as for 2014 approximately 80% of top-sales were exercised by foreign companies (DSM Analytical Report, 2015).

According to the survey of Deloitte, (2015) measures that pharmaceutical representatives notice on their own business development are:

-restricting or banning foreign (non-localized manufacturers from state purchases (57% of respondents)

-encouraging foreign manufacturers to switch for full-cycle production (56%)

-subsidies for Russian manufacturers (49%).

One of proposed parameters measuring effectiveness of accomplishment of Pharma2020 could be share of economically valuable medicines of companies among all product portfolio. Some other also might be useful, like volume of export (showing own capacities and competitive advantages), production of domestic pharmaceutical and medical products grounded on commercialization of created technologies. Another indicator of possible value is share of life essential pharmaceutical medications that are made by domestic manufacturers: the Program outlines 90% thereof by 2020. However, it is not clarified what exactly “domestic” manufacturing encompasses (national full-cycle production, or just representation by Russian companies).

Attention of Russian government to the Russian healthcare development has risen recently, as over 40 draft laws were issued by the RF State Duma. Main regulation on pharmaceuticals, the Federal Law on Drug Commerce was amended in several parts, mainly relating to the process of drug registration, and in terms of some definitions: “terms that could previously be interpreted in various ways, such as a biological drugs, interchangeable drugs etc.'' (DSM analytic Report, 2015).

Import substitution is positioned as principal objective for development of pharmaceutical market in Pharmaceutical and Medical Industry Development Program for 2013-2020. 130 contracts with Russian firms are made in order to launch national manufacturing of drugs from the List that are not yet produced by Russian firms and that are not covered by patents of foreign companies in Russia.

Additionally, the RF Minpromtorg (Ministry for Industry and Trade) has presented the initiative to set a limit in procurement of foreign-made drugs (DSM Analytic Report). Nevertheless, letting alone all positive considerations of the Program, it is more likely that all goals will not be achieved by 2020, as claimed changes are too complex and there are not enough resources and time for its implementation. To put it another way, in the study on price of innovations authors affirm fundamental importance of accurate time management for implementation of all evaluation and enhancement alterations, including policies. By all means, extensive changes cannot happen within many years, : “In the research-based drug industry, R&D decisions have very long-term ramifications… From both a policy perspective, as well as an industrial perspective, it is therefore important to continue to analyze the components of and trends in the costs of pharmaceutical innovation” (DiMasi et al., 2002).

The grow in size of Russian pharmaceutical market was detected in 2014: up to 1,152 bln roubles in 2014, by 10.1% on the previous year. The government assistance, social expenditures have also been growing, and the major driver for the growth has been inflation. This does not favor the situation for development of Russian pharmaceutical market. “At year-end 2014, Russia is 7th among major global pharmaceutical markets, but for all that, the market was down 8% in USD terms because of the weaker ruble” (DSM Analytical Report, 2015). The Figure below (Figure 5) displays the balance of sales in commercial market segments of Russian and foreign companies.

Figure 5. Balance between the sales of imported and domestic drugs in the retail commercial market of Russia

Source: Monthly retail audit of pharmaceutical market by DSM Group, 2015

Note: the sales are in pharmacy cost prices incl. of VAT. In monetary terms, drugs of national production has accounted for ¼ of the Russian commercial market. In 2014 the share of domestic medicines was 24.3%. At the same time, domestic drugs dominate pharmacy sales in physical terms at 55.3%.

The biggest inputs in to the increase of total worth of the medicinal drugs commercial market in 2014 were presented by the following groups of drugs: for the treatment of gastrointestinal diseases (A), respiratory (R) and cardiovascular therapy (C), which totaled 5.6% or about 50% of the total market growth (DSM Analytical report, 2015).

Figure 6. Weighted increases in drugs retail commercial market by ATC Group

Source: Monthly retail audit of the RF pharmaceutical market by DSM Group.

Notes: The largest contribution to the increase in the total worth of the medicinal drugs commercial market in 2014 was made by the groups of drugs for the treatment of gastrointestinal diseases [A], respiratory [R] and cardiovascular therapy [C], which totaled 5.6% or about 50% of the total market growth.

Among the Top-20 drug manufacturers by volume of sales, in rubles, in the Russian retail commercial market there are only «Valenta» Pharmaceuticals and «Pharmstandard» of Russian companies (18 and 19 positions).

From the survey information of Deloitte, (2015) new trends for companies in 2013-2015 years are presenting new medicines on Russian market and expand new facilities for domestic manufacturing. However, there is no direct association with the own production of purely new medicine (Deloitte report, 2015).

At the same time, regarding the trends of Russian pharmaceutical market, major complexities occur before representatives of the industry are not only current economic situation (26%), but mostly insufficient solvency of individuals and shortcoming of the legal sector (24%) Including pricing, antimonopoly, administrative, etc. (Deloitte Healthcare report, 2015).

What should be taken into account regarding occurrence of new medicines, that 117 new names have been released by Russian national companies, but the greatest share referred to foreign firms in 2014; 3 new drugs made by Russian companies announced in Top-20 new trade names list (by volume of annual sales, package) in Russian commercial market (Table 1).

Data on the top drug sales in the retail market by ATC group will be useful after observing the main areas of patents and trademarks regarding therapeutic activity, to link these features to companies' strategies (Table 2).

Table 2. Share of drugs' sales by ATC categories, volumes of sales in packeges

Nevertheless, negative trends are still followed the Russian market as just 13% of domestic drugs are presented (of the total value), but in physical terms domestic drugs are in front of foreign drugs. In the light of recent economic and political situation, in 2014 sales of domestic and imported units were down by 4% and 12% respectively (DSM Analytic Report, 2015).

Patent activity in Pharmaceutical sector of Russian Federation

15,854 records found out of 3,504,472 in total in the Orbit system, grounded on the query of an Applicant Country (Russia), and technology domain graph “pharmaceuticals”.

1,486 records were found in the Orbit system that apply to the assignee country: Russia, with the Technology domain: pharmaceuticals, against 52,461 patents that are published in the Russian office in the same technology domain. Remarkably, that there are no Russian pharmaceutical company among Top-100 Assignees.

Relatively to the total number of pharmaceutical patents published in RF office, inventive activity of Russian applicants is rather small. Albeit, some inaccuracy of Assignee country counts may be found owing to technical issues.

By filtering the results on the Assignee ground, one of the first in the list is ALLA Chem LLC, which is factually situated in the USA, and LLC «Parapharm», the company focusing on biologically active supplements. Other patents are possessed either by private inventors, scientific laboratories or Institutions. Sample companies «Valenta» Intellekt and «Pharmsintez» showed at the bottom; however, due to possible incorrectness of search in terms on name translation (different forms of writing company organization type or name itself) some results are missed and not displayed correctly. Other companies have no more than 1-2 patent applications, or just even not presented on the list. These facts justify the selection of firms for current analysis. Below is the list of Top-50 assignees in RU office in pharmaceutical technology domain within 1990-2016 years.

Figure 7. Top-50 Applicants in Russian Federation by pharmaceutical technology domain

Next section consists of Case-studies of chosen firms (listed above) focusing on exploration of patent activity in the sphere of pharmaceutical medicines, and other means of IP protection.

Case 1. «Biocad»

Company profile

«Biocad» is pharmaceutical company registered in 2001 and launched in Saint-Peterburg, leading in research and development of world-class facilities, forefront biotech and pharmaceutical production, preclinical and international clinical studies, corresponding to the modern standards. «Biocad» - one of the few in the world companies arranging full cycle drug creation from research molecule to the mass production and marketing support. Drugs developed there intended for the treatment of the most difficult diseases such as cancer, HIV, hepatitis, multiple sclerosis, etc.

The company presented more than 900 people, of whom more than 350 scientists and researchers. Notably, that offices and representatives of the company are situated throughout the United States, Brazil, China, India, Singapore and other countries («Biocad» official web-site, 2016). According to company's web-page, product portfolio consists of 30 products, 8 of which are biotechnological “Biotechnology medicines, often referred to as biotech medicines, are large molecules that are similar or identical to the proteins and other complex substances that the body relies on to stay healthy. They are too large and too intricate to make using chemistry alone. Instead, they are made using living factories--microbes or cell lines--that are genetically modified to produce the desired molecule. A biotech medicine must be injected or infused into the body in order to protect its complex structure from being broken down by digestion if taken by mouth” (What is Biotechnology? AMGEN profile, 2016. Internet source: http://www.biotechnology.amgen.com/biotechnology-explained.html, Last accessed: 14/05/2016). Over 40 medicines are announced to be in the process of development. Manufacturing plants are designed in Moscow and Saint-Petersburg. To enhance its market position the company has sold 20% of its shared to «Pharmstandard» company («Biocad» profited from analogues, 2015). The company's revenue has been rising in 2014 and 2015 years by virtue of two medicines that were launched in 2013 and 2014. Detailed are provided in the Trademark analysis below.

Patent analysis

Only 6 documents are found with an Applicant Closed Joint Stock Company «Biocad», therefore Text analysis and some paramtres are not applicable here, however areas pf patenting and connection with trademarks are to be established.

First is published in 2007, named as Fluid dispensing system, methods and products, status is: non-entry in the European phase. Application country and priority country are WO. Overall, this patent does not contain some valuable information.

-Next patent document applied in 2010 was published in 2012 in WO office, with priority in Russia. This invention presents “New conjugate of polyethylene glycolylated interferon-alpha, useful to treat viral disease (hepatitis C or hepatitis B) and oncologic disease (myeloid leukemia or melanoma) and disease associated with primary or secondary immunodeficiency”, however, is not entered European phase. IPC codes presented are just C07, A61; designated countries except WO received the patent application are AR, BR and CN. This is first indication of international expansion of an invention. No license is detected yet, still the inention is seems to be of exceptional value, as technical new decision included is new “new functionally active, highly stable conjugate of interferon to polyethylene glycol with an activity of interferon alpha, with reduced immunogenicity, with prolonged biological effects and improved pharmacokinetic parameter”. The area of patenting indication is indeed very important.

-Another is also applied in 2010, published in 2012, with several

IPC codes comprising A61K, A61P and C07. The indication again pretends to destine huge recognition: “New conjugate of human granulocyte colony stimulating factor with monomethoxypolyethylene glycol useful for e.g. treating neutropenia of various origins and improving the immune status of patients suffering from AIDS and other infections”.

Countries listed in the patent family are WO, CL, CN and CO. Non-entry in European face is indicated in the legal status graph.

-Recent patent application was submitted to WO office with priority in Russia in 2014, presenting special kind of antibodies, method for producing same and method for use same. The advantage of proposed invention that it is “useful in a composition for treating e.g. asthma, psoriasis or dermatitis”. Patent family countries in this application are RU, WO and TW.

-Patent application applied in 2015 through WO and published in 2016 offers new antibodies that comprise combination of variable domains that are claimed to be used in treatment several diseases including AIDS, osteoarthritis, and stroke. Three IPC codes presented, C07, A61, C12. Patent family countries comprise of WO and RU.

-The last one invention also applied for patenting in 2015, published in 2016 as WO application, title is named as “Novel composition containing a conjugate of peg and interferon-alpha-2beta and providing reduced pain during administration”, with A 61K IPC categories and three A61P classes referring to antiinfective for DNA viruses, antineoplastic agents, specific for leukemia; and claiming as immunomodulatory. Patent family presents by WO and RU offices.

Overall, proposed inventions are applied both to WO and RU offices, and present not only common A61K and A61P categories, but C07 and C012 that mean new chemical combinations. Graphics on IPC codes are nor relevant for this case as number of patents are too small.

Trademark analysis

As was mentioned in first part, «Biocad» releases 30 medicines, and 21 under a tradename. It should be mentioned from the start that company has 7 unique products that do not have analogues on the Russian market, thus considered as valuable medicines. What is more, the company links its success mainly with two products: a preparation of PEGylated interferon to treat hepatitis C (in the third quarter of 2013) and preparation of monoclonal antibody used to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia (in 2014), these medicines refer to one of the patent application with the same substances described and mechanisms of treatment.

Moreover, the first one, according to the company, obtained 61% market share in real terms, replacing imported drugs due to the difference in price of 40%. The second is the biosimilars of rituximab (active ingredient), the purchase of which in the framework of the program "7 Diseases" “The state program "7 Diseases" (Seven nosology) was launched in 2008. Under this federal program, patients suffering from seven rare and most expensive diseases to treat, can look forward to free life-saving drugs. Funding for this project is due to the Russian Federation budget” (The state Program “7 nosology”, 2016. Internet source: http://nativa.pro/statyi/gosudarstvennaya-programma-7-nozologiy, last accessed: 14/05/2016). state spends billions of rubles annually. At the same time, «Biocad» produces 16 medicines included in list of VED.

To add, only 4 out of 21 trademarks are granted by other companies.

Therapeutic indications mainly expressed by areas of HIV treatment and cancer diseases, what is simultaneously align with current emerging patenting strategy (Figure_. Therapeutic areas of trade named medicines of «Biocad»).

Figure 8. Thetapeutic indications, “Biocad” trademarks

Life essential drug proportion: 0,76

Valuable medicines: 2/21 unique on the Russian Market: Teralidgen ® , antituberculosis, and Ingavirin ® , anti-inflammatory.

Cooperations; co-assignees: -

Patenting strategy: -

Main areas of patenting:.-

Main areas of trademarks: Cancer, HIV

Number of corresponding patents and trademarks: 6/21

IPR strategy:

defensive patent strategy;

extensive competitive trademark strategy;

General: business strategy

Case 2. «Valenta»

Company profile

«Valenta» pharmaceutical company is one of the most advanced companies in Russia, and was established in 1997. The company elaborates and promotes severl-type products in most significant areas of healthcare: neurology, urology, gastroenterology, immunology, virusology, etc.

Valenta's portfolio is equally balanced with new-to-Market products and tradenamed generics, possessing over 30 medicaments (Valentapharm company information, 2016). Mission and vision that the company contributes its resources in grounded on professionalism and practice in original medicines development.

Branches of “Valenta” performs full cycle production from manufacturing of remarkably promising own innovative medicines, along with preclinical and clinical exercises for issuing and marketing of exceptionally quality medicines.

?The Company's R&D divisions target determination of public requirements to healthcare and medical aid quality enrichment. Uniquely, “Valenta” develops strategies for the Company's medicines via constant improvement of life cycle production, and provides for extremely valuable research. What is more, “Valenta” official web-site indicates beneficial cooperation's arranged with European and Asian R&D centers (R&D partnership, 2016).

Patent analysis

Number of patents presented via Orbit system: 25, Thomson Innovation® (r): 24, Espacenet: 24. Publication years are presented in the corresponding Graphs (Figure 9), publication activity started from 2005.

Figure 9. Publication year,.countries. “Valenta”

Source: Questel®

Mainly IPC codes are represented by A61K codes, that indicate protection of special constituents of inventions, its nature and chemical/natural compounds. Current IPC classes in the applications mainly are denoted by more than 4 varieties, according to the Figure 10 thus, meaning broadness of patented invention (with more than 4 IPC categories).

Figure 10. Number of IPC categories per patent application, “Valenta“

IPC categories that presented in most patents cover forms of substances (pills, tablets, capsules), nature of ingredients (amines, cellulose). Correspondingly, main IPC sub-classes of therapeutic effect revealed are: neurology (drugs for disorders of the nervous system), drugs for disorder of the respiratory system, and antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics.

Figure 11. Dissemination of IPC categories, “Valenta”

Applications countries are not restricted by Russia and CIS areas, there are some patents published by US patent office, but still the priority country of most inventions is Russia only (40) (Figure 12).

Figure 12. Publication/prioruty countries, “Valenta”

Only 4 out of 25 patents were cited by other applications once, and one of them has 21 Claims: the patent is published by the EP office, and devoted to the antibiotics drugs treating disorders of respiratory system. It should be mentioned that 2 of the citing documents are related to the «Valenta» firm itself. However, taking into account the years of patents and forward citation of all other firm's patents, citation of «Valenta» documents indicate some emergence of knowledge spinoff and value of cited patents.

Regarding the Claims listed in the patent applications, only 7 patents include the mentioned. According to the analysis of Claims presented, that was compared to the Claims of 100 patents in the same technology domain, published from 2010, the situation is as followed:

Title

Number of claims

-Pharmaceutical composition for prophylaxis and treatment of mental, behavioral, and cognitive disorders (US);

-Combination for the prophylaxis and treatment of behavioural, mental and cognitive disorders (EP)

-A pharmaceutical composition for use in the prophylaxis and treatment of mental, behavioral, and cognitive disorders (EP)

10; 3; 10

-Use of glutaryl histamine for the treatment of respiratory tract diseases (US)

-Use of glutaryl histamine to treat respiratory tract infections (EP)

20;

33 - Notes: the range is 1-50 Claims, 10 at average, hence, the invention is regarded with high potential profit value

-Agent for the prophylaxis and treatment of highly pathogenic infectious diseases (EP)

-agent for the prophylaxis and treatment of highly pathogenic infectious diseases (EP)

5; 21

Therefore, in the case of “Valenta” broadness of claims points to the technological patents value and opportunities for value extraction, as to emphasize, other patent applications (of “Valenta” and the rest of companies) do not possess more than 4 claims, or there are no claims at all.

Turning to the Text analysis of the main words and phrases of Abstracts (all languages) the following was icted:

There are 10 most used words in the abstract descriptions: invention, une, des, relate, acceptable, composition, concerne, treatment, respiratory, les. But invention is not significant, but without the word “invention” it is almost the same:

#word

word

Count

%of all words

5

composition

30

1.2%

6

concerne

27

1%

7

treatment

26

1%

8

respiratory

23

0.9%

9

les

21

0.8%

10

agent

Therefore, it could be concluded that the majority of the inventions are patented by the type - composition, claiming that inventions have some therapeutic activity, the most mentioned one is treatment of respiratory system diseases.

Patent analysis pharmaceutical patent intellectual property

Identifying the patenting strategy, it should be mentioned that several similar patent applications are applied by the company, using different names or types of invention, for example, in the patent of treatment respiratory diseases. The same active ingredient is mentioned in 3 applications thereof, first claiming for the Use, the second for the Prophylaxis and Treatment of infections, while the third patent instead of the “infection” used the word “disease” (patent thickets strategy sign).

-Another one application is for combined use of agents for the treatment of different neurology deviances. Simultaneously, there is another application referring to the same active ingredients (memantine, melatonine). The nearest patent also relates to use of the mentioned ingredients, but with protecting the composition of abovementioned. Inventive step comprises in opportunity to raise disease treatment effectiveness.

-The next patent showed is for agents exhibiting virus-tropic and immunogenic activity, however the name of this patent reflects tablet-formed composition that includes glutaryl histamine active ingredient, mentioned also in 3 applications.

-The patent application having in title the name of nootropic agent “pantocalcin” in liquid form, “medicine, in psychoneurological practice and in the pharmaceutical industry”. The technical result achieved is improving the content of the active substance, making its organoleptic properties better. What is more, it corresponds to the Trademark product Pantocalcine® for treatment of neurologic diseases.

-Method for producing a solution of a alimemazine tartare for injection, with abstract describing producing formulations of neuroleptic agents. This invention correlates with the active ingredient and implementation area with Teraligen ® drug, «Valenta» property. The patent claims for the implementation in the sphere of disorders of the alimentary tract or digestive system.

-Another invention also corresponds to the Trademark in the product portfolio of «Valenta», namely Retard tablets containing trimebutine, and the product is Trimedat ® with the same active ingredient and treatment activity. At the same time, the drug is claimed for the use in the sphere of treatment of alimentary tract. In the abstract of an invention it is indicated that it is “cheap to manufacture and ... maintain the necessary concentration of active ingredient during use in the treatment of various illnesses”, meaning that this tablet may be used in various directions in which Trimebutine is prescribed.

-The next invention is for method for producing vitamin complexes in tablet form, another one is claiming novel methods for producing tablet dosage forms of teriflunomide, the active ingredient that is applied in the sphere of treatment of neurologic illnesses, and what is important is that the only product under the trademark with this active ingredient is sold by Sanofi France Company. This active ingredient is included in the list of Life essential drugs.

-Following application confer treating multiple sclerosis, and in title is composition for treating, what opens up in the abstract: in a solid oral dosage form.

-Another invention refers to the already mentioned active ingredients (memantine and melatonine) for treatment in the sphere of psychiatric cognitive and behavioral diseases, patent of the type of pharmaceutical combination contains therapeutically-effective amounts of melatonin and memantine.

-Patented invention for application in the psychopharmacology and neurology sphere as a combination of drugs comprising various active agents, mentioned active ingredients that are not presented by Russian firms on the Market. Thus, the firm has an opportunity to launch a sale of drugs to replace foreign companies.

-Then again we meet mentioning of the active ingredients memantine and melatonine, but in the application with another name as a Combination for the prophylaxis and treatment of behavioural, mental and cognitive disorders.

-Followed invention is composition for treating multiple sclerosis, that in the abstract describes the formula and active ingredients thereof.

-Another application for Composition for treating multiple sclerosis adds different versions of compositions, but with the same active ingredients that were reflected before.

-Again the application is devoted to the Pharmaceutical composition for preventing and treating mental, behaviour and cognitive disorders, mentioning the memantine and melatonine as effective when combined together.

To summarize, the found information about patents, the range of the inventions could be circled by the implementation for treatment of neurologic, respiratory and alimentary tract diseases. At the same time, patents for each category have duplicates that add some effect or presented in another form of pharmaceutical invention.

Trademark analysis

All branded medicines of «Valenta» (25) are found to be owned by the company itself, and what is more, produced also by the company itself. The quantitative research has shown that out of total 25 trademarks 20 are subjects to licensing. Mostly, the company has granted non-exclusive licenses for 5 or more years on a territory of the Russian Federation. Interestingly, that in most cases the licensee is just the other legal entity (branch) of the «Valenta» Pharmaceutical, the most frequent licensees are also Russian pharmaceutical producers NovosibChimfarm and Krasfarma.

The most “popular” trademark is related to the area of neurology, with 7 licensees granted to the Russian pharmaceutical firms, - Phenazepam ™ .

Moreover, it is also curious that some trademarks have bilingual forms, potentially indicating, that trademark is simultaneously protected in some foreign states.

Figure 13. Therapeutic classes of branded medicines, «Valenta»

All trademarks are registered also in WO office, as Trademark database of WIPO display, 3 are already inactive. Interesting, that most of the products are designated to CIS countries, Eastern Europe and Korea (5 trademarks), also Cuba and Singapore. 17 are devoted to Kyrgyzstan and Azerbaijan. The most demanding trade names are for treatment of cardiovascular system and infection diseases. Simultaneously, the main areas of trademarks are Neurology, Antibacterial and Cardiovascular systems (Figure 13).

Figure 14. Designated countries of «Valenta» trademarks

Source: WIPO. http://www.wipo.int/branddb/en/#. Last accessed 27/04/2016

Summing up, contrasting the data from patent and trademark overview, only three inventions correspond to the three branded products of «Valenta» Intellekt: two of the alimentary tract activity and one for the implementation in neurology. From the patent analysis we also assume that the company actively patenting inventions in the neurology sphere, this direction may be enhanced if the firm will patent or register new trademarks, what is easier, concluding agreement with foreign companies in order to set important preparations on the Russian market, at the same time contributing to the development of new drugs and compositions with including the active ingredients from the Life essential drug list, what will be economically beneficial for the firm and the country.

Life essential drugs: 0,6

Valuable medicines: 2 unique on the Russian Market: Teralidgen ® , antituberculosis, and Ingavirin ® , anti-inflammatory.

Cooperations; co-assignees: -

Patenting strategy: defensive, follow-on patents

Main areas of patenting: respiratory system, neurology and infectious diseases

Main areas of trademarks: neurology, infection diseases, alimentary tract

Number of corresponding patents and trademarks: 3/25

IPR Strategy:

defensive strategy (protection optimization);

exploitation strategy; complementary assets strategy: trademarks,

General: value extraction

Case 3. «Veropharm»

Company Overview

From the information of official web-site of a company holders of Pharmacy Chain 36.6 launched «Veropharm» as pharmaceutical manufacturing subsidiary with the largest in Russia retail chain of the same name (Company profile, Veropharm, 2016) Three manufacturing plants are in possession of «Veropharm»: in Belgorod, Voronezh and Pokrov, what is important, european norms of GMP and ISO 9001 are implemented here.

Mainly the production of «Veropharm» is oriented on the national market, however, a representative office was opened in Ukraine in 2004. Furthermore, some offices in other CIS countries are planned to open.

«Veropharm» is considered as “the largest domestic producer of oncology drugs and plasters in Russia” (Aston Consulting, 2012). According to the official information (Aston Consulting, 2012), «Veropharm» holds about 300 generic medicines in its product portfolio. «Veropharm» cooperates with South Korean firm LGLS: a license for production of innovative antibiotic drugs “Factive” brand was acquired, that designated to Russia and the CIS areas.


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