Patent analysis

During the patent search, there are no results regarding the «Veropharm» company, or «Veropharm» in the Thomson Innovation® (r) Search Tool, but in the FIPS Russian system there are 20 of them. Espacenet finds 5 results of the «Veropharm» Applicant, and Patentscope: 5 results by entering «Veropharm», and 11 by entering «Veropharm». Orbit system shows 13 patents, and what is important, all of them are revoked. One patent of «Veropharm» is lapsed, Pain-relieving formulation for topical use. Nevertheless, the analysis of patents, even revoked, is important, because some companies create patent application just to block competitors for some time, with no further goal of protect its inventions. After the compilation of all the found results, the picture with unique patents is the following:

-First two inventions that are recorded in 1999-2000 years are pepper plaster and corn plaster, that bring enhanced effectiveness, decreased time of effect onset and increased patient body heating. IPC codes are the same for these two inventions, and the patents are expired (from 2005).

-The next patent is Uroantiseptic agent, reflcting Four (4) claims. However the patent protection was also expired in 2005. Uroantiseptic agent comprises pipemidic acid as an active component, with the use in treatment of urinary system. Effect that was claimed by this invention is improved properties and effectiveness of an agent. Importantly, that Orbit patent search shows that no Russian company designates a patent in Russia in the sphere of treatment urinary system, mentioning the pipedimic acid as an active ingredient.

-The next application is simialr to the previous one, and concerns solid medicinal form of antiulcer agent. Six (6) claims are registered for this invention of gastroenterology sphere, with the abstract indicating that invention involves development of solid medicinal form that comprises ranitidine as active component and other accessory components. The technical decision is justified by the improved and valuable properties of drug. The patent also has lost the protection in 2005, as previous ones. Notably, 8 granted out of 11 patents are presented by Russian Assignees, and no company from our sample is on this list.

-Up the next is solid medicinal form of antibacterial agent that has expired in 2006. Having 5 claims for the inventions, the patent was comprising ofloksatsin as active component and other necessary components. The effect that was achieved is improved and valuable properties of agent. Just 3 patens, and only 1 granted are owned by Russian assignees (from the results of Russia as an assignee country, containing ofloksatsin and antibacterial in Title/claims. etc), 4 alive patents from other countries, that are not presented on the Russian pharmaceutical market.

One generic enclosing mentioned active ingredient are sold by «Veropharm», along with 350 generics of other firms.

-Detoxication medicinal product application has only one record in FIPS with the notification of withdrawal of the patent due to incomplete portfolio of requested documents. No records in other databases are found.

-Another invention that is recorded only in FIPS is pharmaceutical composition for treatment of viral infection; similarly, it was pulled because of violation of payment rules for patent adminestring.

-The next patent is solid dosage forms for vaginal use consisting of: itraconazole. Unfortunately , the data on current status about the application from 2001 year is absent, that could mean (along with the absence in other sources) the invalid status of the patent. However, the medicine Irunin ® is registered from 2008, that comprises of the mentioned active ingredient.

-Another patent lacking update information, and that is included only in FIPS, is Antibacterial plaster, application for invention published in 2001 and still no records on a current status.

-The next invention is again lost its protection, the sedative and hypnotic agent: zopiclone as an active component and some other special accessory components. Mentioned Agent is used in treatment of insomnia, hardened fall sleeping, and different sleep disturbances in psychic disorders. Reported effect that could be registered is valuable medicinal properties of agent. «Veropharm» does not possed a trademark in this area. However it has the generic of mentioned nature in its product portfolio, that is produced also by another 5 frims, and presenting by 31 generic medicines. Significantly, that 517 patents, that mention zopiclone as active ingredient and insomnia as area of application, are presented only by foreign companies.

-The following patent published in 2001 was expired in 2005, the agent with cardiovascular effect, having 6 claims. It relates to the development of pharmaceutical agent that comprises dipyridamole as an active component and special accessory components: with an effect of valuable medicinal properties of agent. Over 2000 patents enclosing this active ingredient and implemented in cardiovascular diseases present in Russia, and only 6 Russian Assignees are marked. What is more, among these assignees is only «Vertex» pharmaceuticals as big pharm company. Remarkably, that only two foreign firms represent related trade names (along with 171 generics).

Interesting, that there are 3 valid recent applications published in 2009 (pharmaceutical composition for contraception, pain-relieving formulation for topical use, and Cosmetic agents with antimicrobial properties) of «Veropharm» that are listed via Espacenet, all published by EAPO. However, they are not displayed in other search tools due to the fact that in 2015 the name of a proprietor was changed.

During the Text analysis the most frequent IPC codes encountered are A61K31 (8 times); and A61K47 (4 times), meaning that the main IPC codes for protection are particular forms of substances and its origin. However, from such small number of application this information hardly could be found relevant.

However, text analysis of abstracts of invalid patents also could bring some supportive statistical information. The major IPC code for the area of treatment is Drugs for disorders of the urinary system.

Overall, we observe the patent activity of «Veropharm» starting from 1999, however all of the patents were revoked because of the violation of payment rules. All patents were subjected to the Russian Federation only. Intersting, that 2 revoked patents are related to generic products that «Veropharm» sells, and to one registered trade name, hence, it could be supposed that patenting goal was to block Russian competitors.

Trademark analysis

Despite the fact that there are 19 products that are sold under a tradename, all of these medicines are copies of foreign non-registered in Russia products. Taking into account the fact that approximately 137 products are sold also without registered trademarks, «Veropharm» specializes mostly in development of generic medicines. Since Abbott acquired «Veropharm», 4 trademarks are related to Abbott company, and represented by «Veropharm», however, 15 trade names are owned and produced by «Veropharm» itself. One generic medicine (substance for it) that company issues is produced by a partner in India - Hetero Labs. Evaluating the competitive medicines and products of other firms, just three of «Veropharm» could be considered as important for the Russian market, according to the number of firms-competitors, quantity of generics and branded medicines

Key areas of therapeutic activity of trademarked products are Neurology and Antineoplastic (Figure 15).



Figure 15. Therapeutic areas of trademarks, “Veropharm”

There are 11 active trademarks registered of «Veropharm» in the World Trademark Office, all from 2011-2012 years, including two pictures of the name of the Company. Among the trademarks are plaster Doctor Pepper, other plasters, contraception Sensex, plaster Salipod that is also sold in RF but does not have a trademark, and just one medicines - Veromistin, in the area of gynecology. What is important to mention, the information about big plaster producers is confirmed because «Veropharm» almost solely presents this type of medicine on the Russian Market (along with 2-3 firms).

Summarizing patent and trademark analysis, the intellectual property protection strategy is almost absent in «Veropharm» company, as products are protected alone by trademarks, and the firm's market strategy is supported by production and selling of generics.

Life essential drugs: 0,6

Valuable medicines: 3/25

Cooperations; co-assignees - None

Main forms of patents: not applicable

Main areas of patenting: not applicable

Main areas of trademarks: Neurology, antineoplastic

Number of corresponding patents and trademarks: 3

IPR Strategy:

not essential patent strategy;

competitive trademark registration;

General: business strategy

Case 4. «Pharmstandard»

Company profile

«Pharmstandard», founded in 2004, is the most famous Russian pharmaceutical group of companies that holds position in Top-20 firms on the Russian pharmaceutical Market by the volume of annual sales (DSM analytical report, 2014). The major shareholder of «Pharmstandard» is foreign company Augment Investments Limited (Pharmaceutical News, 2014). «Pharmstandard» is distinguished by well established domestic network and growing CIS presence (Russia Pharmaceuticals and Healthcare Report Q3 2012).

There are 8 Russian plants in ownership of the company, what grants it producing of 1,7 mlrd medicines a year; 6 production lines of JSC "«Pharmstandard»-Leksredstva" received certificates of compliance with European standards, European Union Good Manufacturing Practice (European standards of good manufacturing practice).

In 2010, «Pharmstandard» was positioned as the leading domestic pharmaceutical company in Russia: precisely, it is the second biggest company overall, having 4% share of the total drug market and a 5% share of the retail market (Aston Consulting, 2012).

The mission and innovation statements that the Company promotes are

"development and production of modern medicines that meet the expectations of patients and health requirements" with “the early introduction of new scientific developments in medicine and pharmacology, in close cooperation with domestic and foreign scientists” (Pharmstandard finished the consolidation of Domelle, 2013). However, in terms of innovative production there is no indication of innovative medicines development.

The company mainly focuses on the advancing of famous and important brands aiming at increasing of sales and profits. From the basic information about «Pharmstandard» the strategy of production and advancing generic products that are already known to the market is implemented.

Significantly, the company has approx. 7 projects with foreign companies that focus on development of joint brand names.

Overall, the Company issues over 250 medicines, and what is important within the scope of current research is that over 100 are included in the list of vital and essential drug list, “equivalent to 50.5% of the company's organic sales” (Business Monitor International, 2013). However, Pharmstabdard is not aimed at research and development of new drugs, rather it produces the same famous medications for which date of patents has expired.

Patent analysis

Thomson Innovation® (r) Patent search does not display any result on the patents of «Pharmstandard», Farmstandard or Farmstandart/Pharmstandart, the same is for Espacenet and Orbit system. Only three inventions are described in the Russian system of companies SPARK, and one on the official web-site of WIPO - polyvitamins preparation for women, 2010. However, FIPS database shows 4 inventions.

-The first is published in 2004, the status is pending from 2005: Method of quantitative analysis of multicomponent drugs antipyretic , analgesic , anti-cold action.

-Another application was published in 2007, The method for determining the number of members of the multicomponent drug antipyretic, analgesic, anti-cold action " Pentalgin FS ", and the same application for the “Pentalgin-N”. Notably, that these medicines both are produced and presented by the company. Controversially, this drug is unlikely to be valuable in terms of innovative decision because 123 medicines of the same components are presented in Russia.

-To finish, last patent application is also mentioned in WIPO, Multivitamin preparations for women (Options) and set based on ITS. The application has been pending from the publication year of 2011, and now the application is under consideration of the request for substantive examination.

Under those circumstances, no significant information about patents and patenting strategy is upheld, as «Pharmstandard» does not enjoy some significant patented inventions.

Trademark analysis

There are 39 trademarks composed from the official web-resource Vidal, SPARK system and official web-site of «Pharmstandard».

4 main areas of trademarks are related to Vitamins, treatment of nervous system dysfunctions, endocrine system problems and circulatory system. Some are obtained by acquisition of other firms' product portfolio, whereas some granted by license agreements. Analogues exist in this section, however, for example, Afabozol® is the most well-known amongst them, and there are approximately 20 inventions published in RU office that cite it in their descriptions of inventions.

Regarding the next primary area, namely regulation of circulation system, there are 6 of them, 2 of which are granted; and there are several analogues on the market, for this reason none of thesemedicines could be defined as valuable. Interesting, that one of it is granted by the Indian Firm under the exclusive license.

Another important area presented refer to medications for the endocrine system, here are 12 analogues with the same active ingredient metformin. It is the most widespread ingredient for the preparation of medications related to the problems of diabetics, first mentioning of which is in the article of 1957, USA, and many patents containing thereof issues in Canada in USA: consequently, there are a lot of similar products with these active ingredient.

Regarding the antiviral and immune products there are 3 of them, owned by the company itself, with conclusion of there non-exclusive licenses. Most of the agreement are related to expansion of Arbidol® trademark, famous preparation that is used in treatment of the viral colds and flues.

Important to highlight that almost all medicines of «Pharmstandard» have no more than 10 analogues, presented chiefly by foreign firms (approx. 40% of all product portfolio). Overall, strong strategy of registering trademarks could be identified in social valuable spheres, along with license and cooperation agreements with foreign firms, and M&A deals in order to acquire product and patent portfolios of other companies.

Life essential drugs:0,6

Main competitors:

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: not applicable

IPR strategy:

not essential patent strategy;

trademark registration as market competitive strategy;

IP exploitation strategy;

General: business strategy

Case 5. «Akrikhin»

Company overview

«Akrikhin» is one of the founders of Russian pharmaceutical industry. The company was founded in 1936, when the first industrial lot of Akrikhin drug was issued for the treatment of malaria, which gave the company name and eliminated this dangerous disease. During 1950-1990 «Akrikhin» was considered as one of the main producers of substances, providing 24% of the emission of substances in the country. The substances were supplied by 44 companies of the Soviet Union. The list of products exporting countries were listed for 54 countries worldwide, including economically developed countries (USA, Canada, England, Italy, etc.). Thus, in that times «Akrikhin» was a global pharmaceutical company, that still manufacture pharmaceuticals of full-cycle production.

In 1992 the company was reorganized into open joint stock company. It was decided to restructure the company to work with the chemical synthesis of substances in the manufacture of finished pharmaceutical products. A policy of import substitution was also proclaimed as a company strategy - mainly in terms of active development and production of generics (copies). The company has set up marketing and medical service representatives, quality management system, open and certified as GMP standards, new production areas.

Four years in a row the company ranked first in the "ranking of the most influential subjects of the Russian pharmaceutical market" annual and three times received the most prestigious award in the industry "Platinum Ounce" in the "Company of the Year”, wthat confirms the leading position of «Akrikhin» in the Russian pharmaceutical industry.

2007 year was marked as the beginning of a strategic partnership with the largest Polish pharmaceutical company Polpharma. The partnership involves close cooperation between the companies in the development, production, promotion and distribution of drugs.

Updating and development of the product portfolio - one of the company's strategic objectives, seeks to provide consumers with products that meet the latest achievements of medicine and pharmacology in the treatment of various diseases.

"«Akrikhin»" - one of the few Russian producers, which has its own Center for research and development. It is an inendent research, analytical and technology center, equipped with the most modern laboratory equipment and analytical instruments, which employs highly qualified specialists, including candidates and doctors of sciences, the leading search and research in the following areas:

-development of generics;

-development of modified generics (with original features)

-development of new forms and dosages.

In the period from 2000 to 2014 «Akrikhin» developed and put on the market more than 70 drugs, including such high-tech and socially important areas as cardiology, tuberculosis, diabetes. Up to 10 or more new products each year are included in the range of company's product portfolio. Currently research work carried out on more than 50 new drugs. In October 2010, the company entered into an agreement with companies Emcure Pharmaceuticals Ltd (India) and Celon Pharma Ltd (Poland) in order to expand its product portfolio a group of drugs for the treatment of HIV / AIDS. In August 2011, agreement with Biocon (India) was concluded.

«Akrikhin» actively replenishes the product portfolio, working in the field of research and development with foreign pharmaceutical companies and leading Russian research institutes and laboratories.

Patent analysis

Through the patent search via Thomson Innovation® (r) 41 patents of inventions were found, while the Russian search tool shows 25 of them, and WIPO Patentscope displays 49, and Orbit system shows 35 alive and 1 expired patents. However, it should be said that the pure number of patent can be lower, because some of them just identical applications to different patent offices, or mistakes can occur due to misspelling of firm name. Main publication and priority countries are displayed in the Figures in the corresponding annex (Figure 12 and 13), it is significant that pick years were 2000 (15 patents) and 2012 (13 patents). 90% patents are published exclusively in RF, and in 2% cases priority countries are detected from WO office (Figure 16).

Figure 16. Publication countries, “Akrikhin”

Source: Questel ©, 2016

Another key point is that there is two Co-assignees of «Akrikhin» defined: LLC Virus RUS in one patent application, and 25 patents that were jointly applied with Khim Farmats AOOT.

Similarly significant, patents related to the anti-tuberculosis treatment, relate primarily to Russian applicants and inventors (along with 3-4 applications from Japan inventors). According to the data from web-site devoted to the Pharma2020, “Akrikhin” developed the combination for treatment of tuberculosis in alliance with Russian scientists and Indian pharmaceutical company M.J.Biopharm (its old partner) («Akrikhin» press-release, 2011). Indian firm and Akrihin has an agreement, titling «Akrikhin» as the holder of exclusive rights on this medication in Russian and CIS countries. Notablt, that there is no analogues to this patented combination in terms of technical decision and effectiveness.

Main IPC codes could be reflected by Graph 17, 12,22% of which count for antiinfectives treating tuberculosis (A61P-031/06), 8,88% for antidiobetics (A61P-003/10) and 7,7% for dermatology disorders (A61P-017/00).

Figure 17. IPC codes, “Akrikhin”

Source: Questel©, 2016

-First analyzed patent application is pharmaceutical composition for treating skin diseases, composition for atopic dermatitis and vaginal candidiasis and method of preparing it, claim for A61K 31/00 (Medicinal preparations containing organic active ingredients), and at the same time have Priority dates in Russia, and only RU application.

-The important invention could be revealed by analysis of the patent: combined antituberculosis composition and combined anti tuberculosis preparation are presented in EA (30.08.2012 publication date) and WO (2011 year). Also claimed codes are wider, and not only A 61 K is defined, but also A61P - therapeutic activity of chemical compounds or medicinal preparations already classified as such in subclasses A61K, “In this subclass, the term "drugs" includes chemical compounds or compositions with therapeutic activity”, what is wider.

The IPC code that relates to the antiinfectives medicines, exactly for treatment of tuberculosis, holds the first position among the other IPC codes of A61P.

-One of the invention with more than 4 IPC codes represents composition with anticonvulsant and psychotropic action, and the effect of composition provide for “composition stability during storage period, release profile reproducibility of active substance, satisfactory pharmacokinetic characteristics, and high strength of the tablets”.

-For one of the inventions that is valid from 2015 year the license agreement was concluded with the Russian representative of global Brand Actavis, Actavis Russia. The patent ¹ 2299070 claims the invention for Treatment and prophylaxis of vessel and tissue pathological injure, referring to the patent applied in Russia Venogepanol , applied in 2003. The new technical decision is constituent of application of the active basis of specified substances in the one medical dosage form.

-One of the famous medication is related to the syrup of Bromhexinum (international non-patent name) that debates underdevelopment of previous tablet forms of the medication and offers new free of alcohol preparation.

Through the reading of the claims most of the patents do not cover the invention of purely new substance of a drug - it is either the enhancement of bioactivity, prolonging of effect, changing the proportions of ingredients, or lowering the risk of side effects. For the antibacterial section in the paragraph describing effect we can see new decision for strengthen the activity, or easiness of active ingredients eliciting.

Detailed overview of all patents is not necessary for the case of overall analysis, and also the number of patent application is great for this. For the purposes of qualitative analysis main therapeutic areas were captured, namely antidiabetics, antibacterial, anti-tuberculosis, and medications for treatment dermatology disorders. Regarding each section there are small alterations in the formula presented, and composition is applied as a combination and method of preparation thereof.

Abstract text analysis reveals only “composition” as significant key word (49 mentioning ,2,1% of all text), and tablet. thus. nothing really essential was not obtained through the text search. However, analyzing abstract information, chief claimed effects of contemplated inventions are improved preparing method, increasing of efficiency, valuable medicinal properties of composition, etc. Therefore, secondary patent strategy is implemented there, nevertheless, the conclusion about pure value of inventions for R&D could not be incurred just from the fact of incremental innovative patents.

Trademark analysis

The range of trademarks is very broad, there are 54 products sold under a tradename. Notably, that many trademarks are granted (50,6%), and due to the search most license agreements are concluded with the Swiss pharmaceutical company in 2015 till 2019. The non-exclusive license guarantees the right to use the Swiss pharma trademarks within Russian Federation and sale its production.

According to the trademark analysis, the main directions of applications are medications related to endocrine system, dermatology, neurology and anti-tuberculosis preparations. ? of diabetics, ? dermatological and ? anti-tuberculosis are granted licenses of Swiss pharmaceutical company.

Figure 18. Therapeutic areas of «Akrikhin» trademarks

Combining the obtained information of patents and trademarks, some essential conclusion could be drawn. In case of dermatology and anti-tuberculosis preparations we see active patenting (and not only in Russian office) and registration of trademarks in this directions. 17/54 medicines are correlated to patent documents that were analyzed before. Obe medicine is for treatment of tuberculosis, containing Ethambunol active ingredient that also mentioned in three patent applications. All published in 2005, inventions claimed for increased assortment of antituberculous drugs as technical effect. In principle, different combinstions of different substances involved, all interacting with mentioned active ingredient. Vitally, that there is another drug that incurs another active ingredient, also mentioned in these patents, and presents another own medicine.

Another medicinal drug that corresponds with patent application in therapeutic area and active ingredient has hypotensive effect, and the patent aims at protection of “combined medicinal agent used in treatment of arterial hypertension”. Not entering into further details, some inventions released into 2-3 medicines according to the analysis, and thus, «Akrikhin» indeed follows elaborated business strategy, applying all possible forms of IPR protection. Over half of the product are included in the list of VED.

According to the company news presented on the official web-site, the product portfolio of «Akrikhin» will be widened further.

The main factor that can have a significant positive impact on the activity of «Akrikhin» is an accelerated renewal of the product portfolio. Realizing this, the issuer's management pays particular attention to how to develop their own products, as well as licensing and other forms of cooperation with foreign partners, has a significant potential for innovation. In August 2011, the Issuer entered into an agreement by Biocon (India). cooperation will result in a withdrawal of the Russian market a drug used in transplantation and included in the state program "7 nosology high cost."

Life essential drugs: 0,66%

Valuable medicines: 5/54

Cooperations; co-assignees - Yes

Main areas of patenting: antituberculosis, neurology

Main areas of trademarks: antituberculosis, neurology

Number of corresponding patents and trademarks: 17/54

IPR strategy:

competitive patent strategy,

competitive trademark strategy;

exploitation strategy;

General: maximum value extraction strategy

Case 6. Farmsintez

Company profile

Farmsintez was created by the reorganization from LLC to Closed JSC in 2001, when it was controlled by the Group of Companies “Baltic pharmaceutical society”. After some time in 2001 99,99% shares were acquired by the Estonian company “Efag”. In 2010 after the reorganization into the Open JSC public shares were marketed on the stock exchange, and shares of “Efag” were lowered. In 2011 and 2012 Farmsintez acquired 100% of shares of the “Kevelt AS”, Estonia, and “LifeBio Laboratories” LLC (Delaware, USA). In 2013 Fharmsintez issued 50,725,149 shares, 37,137,994 of which were acquired by the Rosnano corporation. Also in 2013 the company bought 100% shares of few other Russian companies.

Notably, that «Farmsintez» focuses on manufacturing of active pharmaceutical substances, but also develops finished pharmaceutical products. “Farmsintez” positions developing and producing of innovative pharmaceutical products as a primarily strategic goal. The company distinguishes in three areas: laboratory investigations and development of new drugs, development of original substances and drugs, and launching medicines to the Market. The recent project that company bolsters devoted to setting of unique drugs for treatment of oncologic diseases and disseminated sclerosis.

According to the internal financial international statement, data for the non-material capital was as followed: trademarks were 9,7 times higher in initial price than those of patents, while the residual value were 11,826 mln rubles against 70 thousand respectively (what is 1,5 lower than results at the end of 2013)(Inendent pharmaceutical expertize, 2014). As we can draw a conclusion from these numbers, amount from the intangible assets not entered into exploitation is not far from the reciable value of trademarks and patents taken together. At the same time, spending on the research and development in 2013 and 2014 were almost 5 times lower than spending on the administrative and sales issues (Inendent pharmaceutical expertize, 2014)

Patent Analysis

29 Patents were found by the Thomson Innovation® (r), by Applicant name «Pharmsintez» and “Farmsintez”, among them there are 10 unique valid patents, that comprises in patent families.

Regarding the active ingredients that identified in the abstracts and claims, there is no one that refers to the active ingredients of the trademarks that Pharmsintez protects on the market. It is rare if two IPC categories of A61P is met in one patent application, almost there are usually one A61P and several A61K codes.

-First application is from 2008, that presents New quinoline derivatives, a method for the production and the use thereof for treating microbacterial infections and a pharmaceutical composition based on said derivatives. Thus, the invention seeks to extensively protect this result of RIA. Key information about this patent is that its objective is to find the new derivatives of the aminoquinoline compound that may show antimycobacterial activity, method of its preparation and use in treatment of tuberculosis and other infection diseases.

Advantage is revealed by administering to the patient a therapeutically efficient amount of the compound claimed. Application was filed to PCT, WO and RU offices.

-In 2010 the application presented was Pharmaceutical composition for treating central and peripheral nervous system diseases of vascular, traumatic, toxic, hypoxic and autoimmune origin. Object of an invention is treating several types of central and peripheral nervous system diseases, pointing to the advantage of evolutionarily fixed protein-peptide concentrations ratios, and lower tissue-specific neuroregenerative activity and pharmacologic effect stability. Application published by PCT, RU, EP, EAPO offices.

-Method of producing a biologically active complex,biologically active protein/polypeptide complex, published in EP, WO, RU EAPO offices. Advantages are justified by necessary standardization and effective concentrations ratios of ingredients.

- In the patent Method for treating acute cerebral and spinal blood flow disorders of an ischaemic or haemorrhagic nature, there are two IPC categories specifying areas or treating ischaemic or atherosclerotic diseases, and of more general nature - for the nervous system. However, no claims are counted for this invention. Published offices are RU, PCT, EP and EAPO. The invention relates to the new ischemic and hemorrhagic character cerebral and spinal circulation accidents treatment method using the neuroprotective drugs, again, as in previous application, pointing to inaccuracy in determination of efficient concentration ratios of protein/polypetide complex, therefore, this application plays a “secondary patent” role, extending the influence of previous invention.

-Octapeptide, radiopharmaceutical agent based thereon and method for diagnosing tumors invention is applied to RU, PCT, EP and DE offices, , what is important, there are 4 claims only for application of EP office , as for the WO patent document, it was applied with priority in Russia, and it is the most earliest one - in 2011, as for the others - 2014 and 2015. Claimed advantage of the invention is in development of new imaging agents with improved imaging properties ensuring enhanced imaging quality for somatostatine receptors expressing tumours, meaning the increasing of detectability of tumor.

-Three similar applications were applied on the same same, all designated for RU, WO and EP offices: Protein-polypeptide complex with a specific effect on skin tissue, process for preparing same and pharmaceutical composition on the basis thereof; the same complex with specific activity on the nervous system, also outlining process of preparing and pharmaceutical composition thereof; and similar to the first mentioned but with a “specific activity on skin tissue”. Advantage: “The cardinal object of the invention is production of an effective natural protein/polypeptide complex complying with current international safety requirements to pharmaceuticals”. Advantage of the second invention is in “stimulating physiological and reparative regeneration of nerve tissue, intended for use in medicine production for central and peripheral nervous system diseases, hypoxic states, in disaster and sports medicine, the method for production of the same “, and for the first one additional is including implementation in the beauty industry: “production of a biologically active complex stimulating physiological and reparative regeneration of skin tissue for treatment of skin diseases and traumatic injuries, and a pharm composition for use in medicine production in aesthetic medicine and beauty therapy, impacting skin tissue aging'. These applications are examples of extensive protection of an inventions that extremely close af for the active ingredients and sphere of implementation, and “follow-on” patent strategy is detected here.

-The next application from 2011 repeats application from 2008, presenting Quinoline derivatives and methods of producing and use thereof. In this case published offices are only PCT and RU, and advantage of claimed invention is presented as changing one of the agents in the formula, providing reproducible practical output, and also with the improved antibacterial activity. Notably, that the patent for this invention was granted only in Russia.

-The last patent information is devoted to the similar to one previous inventions and called Cyclic octapeptide, radiopharmaceutical agent based thereon and method for using a radiopharmaceutical agent to produce medicinal (pharmaceutical) agents for the treatment of neoplasms which express somatostatin receptors. Application aims at covering several aspects of the invention simultaneously, and advantage of the proposed invention encompasses possibility to reveal more "effective" configurations of the molecules, what strengthen biological effect or they make with its more prolonged.

Overall, the offered inventions are characterized by extensive claims (several possible directions) and secondary patents that change some aspect in previous similar inventions. Unfortunately, none of these patents were engaged in license agreements.

Chief IPC codes of the company are in the sphere of disorders of the nervous system (counted for 9); other in descending order are in the A61K class, and 7 are for the drug for dermatological disorders.

Publication years are focused mainly around 2012-2014, and key publication offices are RU, WO and EP according to the Heat Figure 19.



Figure 19. Publication years/countries,“Pharmsintez”

Sorce: Questel©

Trademark analysis

Most of its products Pharmsintez puts on market without a brand name, and only 5 trademarks are found via special internet resources and company product profile. 2 trademarks relate to the sphere of immunomodulatory medicines, 1 for treating urinary system illnesses. There is one pharmaceutical medicine aiming at treating tumor, and what should not be missed, that it is valuable on the Russian market because it is represented solely by Pharmsintez; while another company sell similar generic without a trademark.

1 another pharmaceutical drug is for treatment of tuberculosis, that also regarded as competitive on the market, as there are only 5 other firms that issue generics similarly to the discussed product. 4/5 drugs are included in the list of VED.

Life essential drugs: 0,8

Valuable medicines: 0,4

Cooperations; co-assignees - None

Main forms of patents: composition

Main areas of patenting: not applicable

Main areas of trademarks: not applicable

Number of corresponding patents and trademarks: -

IPR strategies:

defensive patent strategy;

not essential trademark strategy;

General: defensive IP strategy

Case 7. «Nizhpharm»

Company overview

«Nizhpharm» has joined international STADA CIS pharmaceutical company since January 2005 to manufacture and represent some of STADA brands. However, “Nizhpharm” engaged concurrently in pharmaceutical market as an inendent participant. Over the past 90 years it develops, manufactures and offers drugs of different areas. In 2007 it concluded a deal to buy Makiz Pharma Company (Company profile, Nizhpharm, 2016).

To date, combined product portfolio of the holding includes up to 100 names of medicines produced by both Russian and European markets of STADA Group (Pharmaceutical healthcare report, 2016).

«Nizhpharm» locates in Nizhny Novgorod, focusing on production of various forms of pharmaceutical products from ointments and creams, to tablets and suppositories, etc. Production is exercised on modern high-tech equipment using raw materials in accordance with modern technologies. The company from Nizhny Novgorod also play a warehouse role for finished products owned by the company, which complies with international GMP quality standards. Compliance with sanitary-epidemiological, environmental and fire safety standards ensures the quality of the finished products (Company profile, Nizhpharm, 2016).

Patent analysis

The first results of patent search found that Patentscope search tool presents 11 patents of the Company, and Espacenet 14 thereof, however Orbit shows only 2 alive patents (from 2001 publication year), and one revoked of 1998 publication year. Thomson Innovation® (r) does not display any result. This could happen due to the change in the proprietor's name, what is reflected in Espacenet legal status graph. Nevertheless, the aim of the research is inventive capacities evaluation of assessed firms: with regard to simultaneous analysis of trademarks of «Nizhpharm», patent analysis was conducted after all.

Most applications claimed in the office of Russian Federation (8), some in EAPO 3). IPC codes presented belong to A61K mostly (10), and only 2 covers A61P categories.

-First invention from 1998, however invalid, “Drug for treatment of patient with proctologic diseases”: invention offers opportunities to exploit proposed medicinal agent "Nigepan" in “treatment of acute inflammatory pain anal syndrome”. Preparation shows good tolerance and could be implemented for several forms of sicknesses. Advantage of this invention claims for enhanced effectiveness of drug.

-One of another invention is “Medico-prophylactic agent having antibacterial and spermicidal activity, for use in gynecology sphere”. In the description the focus is devoted to the comfortable and stable “form of a tablet for the purpose of a treatment”, and technical decisions that are listed in the application are of cosmetic nature: improve efficiency by increasing the bioavailability of active ingredients and the improved consumer properties.

-The other invention is Pharmaceutical composition with antifungal activity and method for preparing thereof, that can be used for producing soft dosage form for the treatment of various skin fungal infections. In the description the authors refer to several similar by the activity medicines like Lamizil gel, and overview of possible substances that could be used as active ingredients of the named invention.

Technical result distinguished this invention is enhancement of antibacterial and anti-inflammatory properties of the drug. 12 claims are presented capturing different forms of invention aspects. Only A61K is presented in the IPC codes. No information about status is available (presumably invalid).

-Another one is “Terbinafine hydrochloride solid medicine form”, related to solid dosage form, indicating means for fungal diseases treatment. The technical solution embedded in the invention is possibility to use less scarce and more affordable ingredients and reducing the cost of the drug. This invention corresponds to one of the previous by the treatment and active ingredient.. A61K is again the sole IPC claimed code; patent family comprises RU, EAPO, UA countries.

-Another invention has in title the name of the substance, it relates to a “ medicinal form as suppository containing erythromycin. Drug has erythromycin and a base - solid confectionery fat on the basis of plasticized hydrogenated fat or "Vitepsol" at the following content of components. Invention provides high therapeutic effectiveness, and high antibacterial effect. The proposed drug shows high stability at storage and retains physical-chemical properties for 2-2.5 years without alternations. Advantage: enhanced effectiveness of an agent. Two IPC codes are and claims were presented with regard to this invention. No information about status is available (presumably invalid).

-Composition for hirsutism treatment has four (4) A61K IPC codes and the abstract gives the following information: “may be used in endocrinology and dermatology as remedy for hirsutism treatment. The active substance mentioned is naphthalide, and proposed composition is effected for external use for removing hair from face skin, and also from skin of legs and arms. Advantage: higher efficiency. No significant claims were applied to. No information about status is available (presumably invalid).

-Method of corticosteroid ointment preparing is the other invention to be analyzed, that has 4 A61K codes, it shows antiinflammatory, antiallergic and antibacterial effect, storage stability, homogeneous structure and can be used in dermatology. Advantage: improved method of preparing, enhanced effectiveness of ointment. The patent has become invalid in 2015 due to delaying in payment of administration fees.

-Other invention that stands only for two (2) IPC codes is to some extent repeats the previous one and called Method of preparing an ointment for superlative local wound treatment. The years of application is close (1995-1997). The abstract describes method involving preliminary preparing methyluracil concentrate; the prepared ointment shows antibacterial, antiinflammatory, osmolytic and necrolytic effects. Ointment inhibits the development of suppurative inflammatory process. Advantage: enhanced effectiveness of ointment, improved method of preparing. No information about status is available (presumably invalid).

-Another application in the Patentscope database is again repetitive to another two of «Nizhpharm»: Ointment for suppurative-inflammatory processes treatment, claiming for two (2) IPC codes, explaining in the abstract the substance containing antibacterial active component and additional active components - dibunol, and anesthesin. This ointment presents antibacterial, analgesic, antiinflammatory and wound-healing effects. Ointment is not toxic and does not show allergic effect. No claims applied for this invention, and the technical decision is in enhancing of quality and effectiveness of ointment. No information about status is available (presumably invalid).

-Another invention that is displayed via Espacenet search database is Pharmaceutical composition for treating joint diseases, that shows 5 IPC codes, published in the Latvian patent office with the priority date of 2006 year. Unfortunately, no deeper information is presented via the existent databases. No information about status is available (presumably invalid).

Next two consecutive inventions related to the same direction of protection, that relates to treatment of joint disorders: Pharmaceutical composition for treating joint diseases, Agent for treatment of joint disease. All published in the Latvian office, and slightly differ in IPC codes. However, No information about status is available (presumably invalid).

-The second valid patent, published in 2003-2004 years in RU, EAPO, UA and GEP offices presents Pharmaceutical composition possessing antimycotic activity and method of its production.

Through the text analysis the most frequent words in the title are antibacterial, agents, drug and composition, while text analysis of abstracts icts:

Table 3. Word count in abstracts of «Nizhpharm» patents.

base	24	1.2%
substance	18	0.9%
preparation	18	0.9%
effect	16	0.8%
agent	15	0.7%
prepare	15	0.7%
joint	13	0.6%

Source: http://istio.com/rus/text/analyz/#myform

Notes: first column responses for quantity, second for % of word mentioning at all abstract texts.

The word “joint” in this case related to “joint diseases”, like osteoporosis, thus supporting evidence of joint diseases as one of the main indication for pharmaceutical development of «Nizhpharm».

Overall, after overlooking of all the patents, no citing documents of these inventions were detected, as well as no cooperation, agreement or licensed relevant. From the 14 patent documentation two areas could be identified as essential - antibacterial ointments and preparations for treatment joint diseases. However, patenting strategy is not supported for protection, as 9 patents became invalid, and 2 valid have transferred to another patent holder, and what is more, IPC codes corresponding to therapeutic activity were not assigned to any of the valid patents.

Trademark analysis

There are 65 trademarks of «Nizhpharm» that were obtained by the official web-site of the company 35 of which are already represented by STADA CIS. Almost all trademarks are owned by «Nizhpharm», some are obtained. Major production of trade named products is executed in Russia, and only 5 medicines are made abroad (Book of pharmaceuticals, 2016).

Distribution of spheres of treatment refers to patents as followed:

Two antifungal medicines include the active ingredient claimed in two inventions, one medicine in the sphere of treatment alimentary tract and metabolism refers to the one patent thereof, one ointment of antimicrobial effect corresponds to one invention with the same active ingredient, and also that presented in the form of Ointment. Total number of trademarks referring to active ingredients in patent documentation is 7.

Figure 20. Therapeutic directions of trademarks, “Nizhpharm”.

Turning to the discourse on trademarks listed in the world trademark database, there are 24 of them, 5 are inactive. Essentially, 9 trademarks are also registered in Estonia, and 15 in Moldova, thus expanding influence in close companies abroad.

Life essential drugs: 0,07

Valuable medicines: 3/65

Cooperations; co-assignees - None

Main areas of patenting: joint diseases, anti-microbial

Main areas of trademarks: anti-inflammatory, anti-microbial

Number of corresponding patents and trademarks: 3/65

IPR strategy:

defensive (blocking) patent strategy;

competitive trademark protection with expansion to foreign markets;

exploitation strategy;

General: value extraction strategy

Case 8. «Vertex»

Company overview

«Vertex» is a developing Russian pharmaceutical company that set up in Saint-Petersburg and has its own production plant. In 2012, the company signed a contract with the general innovation and the production of the complex with an Irish company PM Group Vostok. Product varieties of JSC «Vertex» includes 134 names of products, 43 of them are included in the list of vital and essential drugs. The company's portfolio of 12 own brands: prescription and non-prescription medicines and cosmetics. With the launch of innovative-industrial complexit is planned to double the number of positions in the portfolio and to significantly increase the volume of the finished products.

According to the company, the expansion of production capacity was originally planned in view of projects under third-party customers, in addition, import substitution objective is one of the strategic goals of a company. «Vertex» considering the possibility of cooperation with companies interested in the creation and development of the production of medicines in Russia (Dombrova, 2014).