On behalf of the Russian Federation

DECISION OF THE SUPREME ARBITRATION COURT OF THE RUSSIAN FEDERATION

of October 6, 2011 No. BAC-9394/11

About recognition invalid Item 10.3 of Administrative regulations of execution by Federal Service for Intellectual Property, to patents and trademarks of the state function on implementation in accordance with the established procedure prolongation of effective period of the patent for the invention relating to means which application requires receipt of permission of the body authorized on it in accordance with the legislation of the Russian Federation, effective period of the patent for industrial design, evidences (patent) for useful model, the registration certificate of the trademark, service mark, the certificate on right to use by the name of the place of goods origin, and also recovery of action of the patent for the invention, useful model, industrial design stopped in connection with failure to pay at the scheduled time of duty on its maintenance in force, утв. The order of the Ministry of Education and Science of 29.10.2008 No. 322

The substantive provisions of the decision are announced on September 30, 2011.

The complete text of the decision is made on October 6, 2011.

The Supreme Arbitration Court of the Russian Federation as a part of the chairman G. G. Popova, E. M. Moiseyeva's judges, V. V. Popov, in case of taking the minutes with use of means of audio recording by the assistant judge N. N. Martina, considered in meeting case on the statement specified by rules of Article 49 of the Arbitral Procedure Code of the Russian Federation and accepted by court of Zhirnov Oleg Petrovich (living to the address: Dedovsk, Ulitsa Glavnaya, 8, sq. 80) to the Ministry of Education and Science of the Russian Federation, about recognition invalid Items 10. 3, 10.5, 10.6, 10. 12, 10.13 Administrative regulations of execution by Federal Service for Intellectual Property, to patents and trademarks of the state function on implementation in accordance with the established procedure prolongation of effective period of the patent for the invention relating to means which application requires receipt of permission of the body authorized on it in accordance with the legislation of the Russian Federation, effective period of the patent for industrial design, evidences (patent) for useful model, the registration certificate of the trademark, service mark, the certificate on right to use by the name of the place of goods origin, and also recovery of action of the patent for the invention, useful model, industrial design stopped in connection with failure to pay at the scheduled time of duty on its maintenance in force the Ministry of Education and Science of the Russian Federation approved by the Order of 29.10.2008 No. 322, No. 26 published in the Bulletin of regulations of federal executive bodies of 29.06.2009 (further - Administrative regulations).

Other persons participating in case: the third party who is not declaring independent requirements concerning matter in issue, - Federal Service for Intellectual Property.

Representatives took part in judicial session:

from the applicant - Zhirnov O. P. (the passport <...>);

from the defendant - Fedorov O. V. (the power of attorney of 29.12.2010 No. AF-660/17, the certificate of 24.09.2010 No. 0682);

from the third party - Razumova G. V. (the power of attorney of 24.03.2011 No. 01/25-155/41, the certificate of 15.07.2009 No. 340-30), Robinov A. A. (power of attorney of 24.03.2011 No. 01/25-156/41, certificate of 04.04.2011 No. 372-30).

The court established:

The millstone Oleg Petrovich appealed to the Supreme Arbitration Court of the Russian Federation with the statement specified according to the procedure of Article 49 of the Arbitral Procedure Code of the Russian Federation and accepted by Arbitration Court to the Ministry of Education and Science of the Russian Federation (further - the ministry) about recognition invalid Items 10. 3, 10.5, 10.6, 10.12, 10.13 Administrative regulations regarding medicine determination as not corresponding to the Federal Law of 12.04.2010 No. 61-FZ "About drug circulation" (to Item 1 of Article 4).

According to Article 51 of the Arbitral Procedure Code of the Russian Federation the Federal Service for Intellectual Property is involved in participation in case in quality of the third party who is not declaring independent requirements concerning matter in issue (further - Rospatent).

Arguments that the fresh wording of determination of medicine containing in article 4 of the Federal Law of 12.04.2010 No. 61-FZ "About drug circulation" (further - the Law of 12.04.2010 No. 61-FZ), enters additional criteria into concept of medicine and determines it as set of substance in its dosage form corresponding to method of contact with human body for achievement of medical effect are stated in the application. Specifies that in article 4 of earlier existing Federal Law of 22.06.1998 No. 86-FZ "About medicines" the concept of medicine did not come method into contact with human body and did not determine dosage form of medicine. Discrepancy of concept of the medicine containing in the disputed Items of Administrative regulations, to the new determination established in article 4 of the Law of 12.04.2010 No. 61-FZ, and application of controversial points do not allow to estimate precisely and correctly the inventions relating to medicines.

Besides, the applicant specified that application by Rospatent not corresponding to the Law No. 61-FZ of regulations of Administrative regulations led of 12.04.2010 to violation of its rights and legitimate interests as by the decision of 29.04.2010 it was refused prolongation of effective period of the patent No. 2054180 for the invention granted to it "Method of treatment of viral raspiratorny infections, aerosol for its implementation" (the patent No. 2054180). Believes that article 4 of the Law No. 61-FZ grants of 12.04.2010 the right to qualify its invention as medicine, and the disputed Items of Administrative regulations on the content create obstacles for prolongation of patents and realization of the rights of inventors.

The ministry in response and in judicial session did not recognize the declared requirements, having explained that the applicant does not specify the rights and legitimate interests which are violated by the disputed Items of Administrative regulations. Also the defendant believes that the applicant did not reason what rules of law are not met by Items 10 disputed by him. 5, 10.6, 10.12, 10.13 Administrative regulations.

Rospatent in response and in judicial session specified the statement that the disputed Items of Administrative regulations do not violate the rights and legitimate interests of the applicant as by the decision of Rospatent of 29.04.2010 it was refused to Zhirnov O. P. prolongation of effective period of the patent No. 2054180 for the invention, but at the same time at the time of filing of application and adoption of the controversial decision the old Federal Law of 22.06.1998 No. 86-FZ "About medicines" was effective. Besides, of 31.05.2011 the specified decision of Rospatent is cancelled by the decision of Dorogomilovsky district court of Moscow which took legal effect, the court obliged Rospatent to extend the patent validity.

Believes arguments of the applicant unreasonable as the medicine definition given in the new law as well as the definition given in earlier existing law does not contain specifying on dosage form. The concept of dosage form was entered by the Law of 12.04.2010 No. 61-FZ as medicine condition, but not medicine as the applicant mistakenly believes.

Besides, the defendant reported that from coming into force of the new law (01.09. 2010) Rospatent applies regulations of Administrative regulations taking into account new determination of the medicine containing in the Law of 12.04.2010 No. 61-FZ.

Having considered case papers, having researched the produced evidence and having heard explanations of representatives of persons participating in case, the Supreme Arbitration Court of the Russian Federation considers that the statement is subject to satisfaction partially on the following bases.

According to part 1 of Article 192 of the Arbitral Procedure Code of the Russian Federation citizens, the organizations and other persons have the right to appeal to Arbitration Court with the statement for recognition invalid the regulatory legal act accepted by state body, local government body, other body, the official if believe that the disputed regulatory legal act or its separate provisions do not correspond to the law or other regulatory legal act having big legal force and violate their rights and legitimate interests in the field of business and other economic activity, illegally assign to them any obligations or create other obstacles for implementation of business and other economic activity.

As appears from Item 1 of part 1 of Article 29 of the Arbitral Procedure Code of the Russian Federation, Arbitration Courts consider according to the procedure of administrative legal proceedings the economic disputes and other cases connected with implementation by the organizations and citizens of business and other economic activity about contest of regulatory legal acts arising from administrative and other public legal relationship including in the field of patent laws.

According to part 4 of Article 194 of the Arbitral Procedure Code of the Russian Federation by hearing of cases about contest of regulatory legal acts the Arbitration Court in judicial session performs check challenged the act or its separate provision, establishes compliance to its Federal constitutional Law, Federal Law or other regulatory legal act having big legal force, and also powers of the body or person who adopted the disputed regulatory legal act.

According to Item 2 of the Regulations on the Ministry of Education and Science of the Russian Federation approved by the Order of the Government of the Russian Federation of 15.05.2010 No. 337 (operating at the time of approval of the disputed Administrative regulations), the ministry exercises coordination and control of activities of the Federal Service for Intellectual Property which is under its authority, to patents and trademarks.

According to Item 5.2.40 of the specified Provision the ministry on the basis and in pursuance of the Constitution of the Russian Federation, the Federal constitutional Laws, the Federal Laws, acts of the President of the Russian Federation and the Government of the Russian Federation independently adopts number of regulatory legal acts, including, about procedure for prolongation of effective period of the patent for the invention, useful model or industrial design.

The presidential decree of the Russian Federation of 24.05.2011 No. 673 (further - the Decree) the Federal Service for Intellectual Property, to patents and trademarks is renamed into Federal Service for Intellectual Property.

According to Item 3 of the Decree on Rospatent, including, function on control and supervision in the field of legal protection and use of the results of intellectual activities of civil, military, special and dual purpose created within budgetary appropriations of the federal budget and also control and supervision in the established field of activity concerning the state customers and the organizations - contractors of the public contracts providing carrying out research, developmental and technological works is assigned.

Thus, the disputed regulation is adopted by authorized body.

According to the disputed Item 10.3 of Administrative regulations medicine is understood as medicine as it is determined in article 4 of the Federal Law of 22.06.1998 No. 86-FZ "About medicines", namely: medicines - the substances applied to prevention, diagnostics, treatments of disease, prevention of pregnancy received from blood, blood plasma and also bodies, tissues of the person or animal, plants, minerals, by methods of synthesis or using biological technologies. Also the substances of plant, animal or synthetic origin having pharmacological activity and intended for production and production of medicines (pharmaceutical substances) belong to medicines".

Of 12.04.2010 No. 61-FZ "About drug circulation" the specified Federal Law of 22.06.1998 No. 86-FZ "About medicines" is declared by the law invalid from 01.09.2010.

According to article 4 of the Law of 12.04.2010 No. 61-FZ "for the purposes of this Federal Law the following basic concepts are used:

1) medicines - substances or their combinations coming into contact with human body or animal, getting into bodies, the body tissues of the person or animal applied to prevention, diagnostics (except for substances or their combinations which are not contacting to human body or animal), treatments of disease, rehabilitation, for preserving, prevention or termination of pregnancy and received from blood, blood plasma, from bodies, body tissues of the person or animal, plants, minerals by methods of synthesis or using biological technologies. Pharmaceutical substances and medicines belong to medicines;

2) pharmaceutical substances - the medicines in the form of active ingredients of biological, biotechnological, mineral or chemical origin having pharmacological activity, intended for production, production of medicines and determining their efficiency;

3) excipients - the substances of inorganic or organic origin used in production process, production of medicines for giving of necessary physical and chemical properties to them;

4) medicines - the medicines in the form of dosage forms applied to prevention, diagnostics, treatment of disease, rehabilitation for preserving, prevention or termination of pregnancy;

5) dosage form - the medicine condition corresponding to methods of its introduction and application and providing achievement of necessary medical effect".

As the Law of 12.04.2010 No. 61-FZ from 01.09.2010 is effective, the disputed Item 10.3 of Administrative regulations containing determination of medicine from the invalid Federal Law of 22.06.1998 No. 86-FZ "About medicines" is subject to recognition not corresponding to article 4 of the Law of 12.04.2010 No. 61-FZ and invalid.

Discrepancy of determination of medicine to the become effective new law violates the rights and legitimate interests of interested persons in the field of patent laws.

The applicant also disputes Items 10. 5, 10.6, 10.12, 10.14 Administrative regulations of the following content:

"10.5. The invention belongs to medicine, pesticide or agrochemical if in invention formula it is characterized in the form of connection or group of the connections described by general structural formula and of the description of the invention the possibility of its use as active ingredient of medicine, pesticide or agrochemical follows.

10.6. The invention belongs to medicine, pesticide or agrochemical if in invention formula it is characterized in the form of composition of medicine, pesticide or agrochemical.

10:12. Check of possibility of reference of the invention characterized in the form of connection (group of the connections described by general structural formula) to medicine, pesticide or agrochemical for which use permission is got consists in comparison of the connection characterized in independent Item of formula of the invention with active ingredient of the medicine, pesticide or agrochemical specified in permission. At the same time it is checked whether the description of the invention contains information that connection has such activity which allows to use it in the specified medicine, pesticide or agrochemical. The considered invention belongs to the medicine, pesticide or agrochemical specified in permission if connection is active ingredient of such medicine, pesticide or agrochemical and the description of the invention contains information stated above.

10:13. Check of possibility of reference of the invention characterized in the form of composition to medicine, pesticide or agrochemical for which use permission is got consists in comparison of the characteristic of the patented composition and the characteristic of composition of the medicine, pesticide or agrochemical specified in permission (appointments, structure, form if it is brought in formula of the invention or follows from structure of composition). The considered invention belongs to medicine, pesticide or agrochemical if the independent Item of formula of the invention includes the characteristic of the medicine specified in permission, pesticide or agrochemical".

Does not follow from the definition given in article 4 of the Law of 12.04.2010 No. 61-FZ that medicine is set of substance in its dosage form corresponding to method of contact with human body. In case of application of controversial points it is necessary to proceed from definition of the medicine given in article 4 of the specified Law.

Considering the decision of Dorogomilovsky district court of Moscow of 31.05.2011 about prolongation of effective period of the patent, the applicant's argument about violation of its subjective civil laws and legitimate interests in the field of business and other economic activity by the disputed Items of Administrative regulations is unreasonable.

Having analyzed the Items of Administrative regulations stated above, having checked their compliance to the current legislation, the court comes to conclusion that the Administrative regulations are approved by the ministry within the powers conferred to it and its Items 10. 5, 10.6, 10.12, 10.13 do not contradict the Federal Law or other regulatory legal act having big legal force therefore in this part the statement is not subject to satisfaction.

According to Article 110 of the Arbitral Procedure Code of the Russian Federation and taking into account partial satisfaction of the declared requirements from the ministry for benefit of Zhirnov Oleg Petrovich court costs on payment of the state fee in proportion to the met requirements in the amount of 100 rubles are subject to collection.

solved:

Recognize Item 10.3 of Administrative regulations of execution by Federal Service for Intellectual Property, to patents and trademarks of the state function on implementation in accordance with the established procedure of prolongation of effective period of the patent for the invention relating to means which application requires receipt of permission of the body authorized on it in accordance with the legislation of the Russian Federation, effective period of the patent for industrial design, evidences (patent) for useful model, the registration certificate of the trademark, service mark, the certificate on right to use by the name of the place of goods origin, and also recovery of action of the patent for the invention, useful model, industrial design stopped in connection with failure to pay at the scheduled time of duty on its maintenance in force the Ministry of Education and Science of the Russian Federation approved by the Order of 29.10.2008 No. 322, No. published in the Bulletin of regulations of federal executive bodies of 29.06.2009 26, not corresponding to the Federal Law "About Drug Circulation" of 12.04.2010 No. 61-FZ and invalid.

In other part of the declared requirements to refuse.

Exact from the Ministry of Education and Science of the Russian Federation for benefit of Zhirnov Oleg Petrovich 100 rubles in expense recovery on payment of the state fee.

The decision can be appealed in the Supreme Arbitration Court of the Russian Federation by filing of application about review of court resolution according to the procedure of supervision within three months from the date of its acceptance.

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