The peculiarities of the extension of the validity period of a patent for a drug

According to Article 1363 of the Civil Code of the Russian Federation, “The validity periods of the exclusive rights to an invention, a utility model, an industrial design,” the exclusive right to an invention, a utility model, an industrial design and a patent certifying this right shall be valid subject to the compliance with the requirements established by the Code from the date of filing an application for the grant of the patent with the Federal Executive Authority on Intellectual Property (FIPS) or, in the case of dividing the application (Paragraph 4 of Article 1381), from the date of filing the initial application: twenty years – for inventions; ten years – for utility models; five years – for industrial designs. The defense of the exclusive right certified by the patent may be exercised only after the state registration of the invention, the utility model or the industrial design and the grant of the patent (Article 1393).

Due to the fact that a pharmaceutical product can be defended with regard to the subject matters of the patent law listed in Paragraph 1 of Article 1350 of the Civil Code of the Russian Federation only by the patent for an invention, the standard validity period of the exclusive rights to the pharmaceutical product is twenty years from the date of filing the application for the patent.

However, according to Paragraph 2 of Article 1363 of the Civil Code of the Russian Federation, if more than five years have passed from the date of filing the application for the grant of the patent for the invention related to such product as a drug, a pesticide or an agrochemical, the usage of which requires obtaining a permission due to the order stipulated by the law, before the date of obtaining the first permission for the usage, then the validity period of the exclusive right to the corresponding invention and the patent that certifies this right shall be extended at the patent holder’s request filed with the FIPS. The above period shall be extended for the period that have passed from the date of filing the application for the grant of the patent for the invention before the date of obtaining the first permission for the usage of the product minus five years, but not more than for five years.

The application for the extension of the period shall be filed by the patent holder within the validity period of the patent before the expiration of six months from the date of obtaining the first permission for the usage of the product or from the date of the grant of the patent, whichever of these periods expires later.

Some additional materials may be requested from the patent holder, if the application cannot be considered without them. The additional materials must be submitted within three months from the date of sending such a request. If the patent holder fails to submit the requested materials within this period, or if he fails to submit the request to extend the period, the application shall not be satisfied. The period stipulated for submitting the additional materials may be extended by the FIPS for no longer than ten months. Upon the extension of the validity period of the exclusive right based on unnumbered paragraph one of this Paragraph, an additional patent shall be granted, which has the claims containing a combination of the features of the patented invention, which characterizes the product, for the usage of which the permission is obtained.

Thus, the validity period of the patent for the pharmaceutical product can be extended from 20 years to 25 years.

The issues of the extension of the validity period of the patent for the invention are also regulated by the relevant Administrative Procedure, according to which the extension of the patent is possible only with relation to a new compound or a group of compounds having a pharmacological activity, or with relation to a pharmaceutical composition.

However, the conflict of interests in the pharmaceutical market had led to the situation, as a result of which the patent holders started to look for weak points in the patent legislation. The disputes on the interpretation of the wording: “the invention relating to a drug” arose.  The applicants started to interpret that formulation widely. For example, a method of treatment based on the usage of the pharmaceutical product became equated to the invention relating to the drug.

In addition, the FIPS started to receive the applications for the extension of the patent not only for the methods of treatment that used a new drug or the new compositions of the known drugs, but also for the devices for administering both the new and the known drug, as well as for other subject matters of the invention, in which the drug was indicated as one of the features included in the claims.

Therefore, in order to solve the issue of extending the validity period of such patents, it is necessary to determine clearly, whether they relate to the drug.

We shall further give some examples and help to understand in which case it is possible to extend the validity period of the patent for the pharmaceutical product.

 After a number of the court decisions regarding the disputes arising, it was determined clearly that Paragraph 2 of Article 1363 of the Civil Code of the Russian Federation did not allow the extension of the validity period of the patent for any invention having any relation to the drug, the pesticide or the agrochemical; and it followed clearly from Paragraphs 10.5 and 10.6 of the Procedure that the invention related to the drug, the pesticide or the agrochemical, if the drug, the pesticide or the agrochemical, or their active ingredient as such was protected as the invention.

Thus, currently, the patent cannot be extended neither for the methods of treatment nor for the devices, in which the claims contain the features characterizing the drug.

However, currently, such inventions that contain the independent claims regarding the usage continue to create a particular difficulty in considering the application for the extension of the validity period of the patent. The simplest case is the invention, in which the claimed group includes the independent claims regarding a new substance, the usage of this new substance according to the purpose that is determined by its biological activity, and a pharmaceutical composition. In this case, there is no doubt about the possibility of extending the validity period of the patent regarding the independent claims both for the new substance itself and the pharmaceutical composition, and for the usage of this new substance according to its claimed purpose. In this case, the subject matter of the usage can be considered as a clarification of the characteristics of the claimed new substance.

But what is to do, if the claims are characterized, for example, in the following way: “The usage of the pharmaceutical composition to obtain a drug for administering in a certain way.”

As in accordance with Paragraph 1 of Article 1350 of the Civil Code of the Russian Federation, the technical solution relating to a product or a method, including to the usage of the product or the method according to a certain purpose is protected as an invention, then in order to solve the issue of the extension of the validity period of the patent for an invention characterized as the usage, it is necessary to determine what subject matter it essentially relates to. When analyzing the above claims, it can be concluded that the essential features of the invention characterize the method of treatment with this substance, but they do not relate to the substance as such. In this regard, the patent cannot be extended.

Thus, if the independent claim is formulated as the usage of the pharmaceutical composition as, for example, an analgesic, then the independent claim can be related to the product – the analgesic. In addition, if the indicated purpose of the pharmaceutical composition is new and it is confirmed by the exercised clinical trials followed by obtaining a permission of the Authorized Body for this new and previously unknown purpose, then the validity period for such patent can be extended.

If the independent claim for the usage of the pharmaceutical composition contains the essential features that characterize the features of the method, for example, the method of the preparation, the administration of the claimed composition, the duration of its administration, the dose, the concentration of the active substance after a certain time of its administration, etc., then the claimed subject matter of the invention should be related to the method, and, consequently, the validity period for such patent cannot be extended.

In addition, the subject matters characterizing the sets cause certain difficulties at the consideration. For example, “A set for the prevention or treatment of the diseases caused by a certain disease, which includes Composition A and Composition B, for administering in a certain way.” The essentially independent claim contains two active ingredients – Component A and Component B, the administration of which can be performed in a certain way, i.e., essentially, a combination of two independent substances is represented. The Registration Certificate indicates that the characteristic of the drug as an active substance contains Component A and Component B. Taking into account the fact that the independent claim under consideration does not relate to one compound or one composition, but it is a combination of two active ingredients, which is claimed as a set, the comparison of the characteristics of the formulation of the drug characterized in the Registration Certificate with the set under consideration, cannot be carried out, and, therefore, it cannot be concluded on the possibility of the extension of the patent.

In the case of the invention for the set, in which the drug and the instruction for its use are indicated in the independent claim, the general purpose of the invention subject matter under consideration does not relate to the drug characterized as a compound or a drug composition, such patent cannot be extended.

Summing up, based on the different situations, it is possible to conclude that while patenting an invention for a pharmaceutical product, it is necessary to choose properly a subject matter of patenting and to identify a generic concept, as well as the essential features of the independent claim, following strictly the  Administrative Procedure, which regulates the issues of extending the validity period of a patent, according to which, when deciding on a possibility of extending the validity period of the patent and granting a new patent, the identity of the drug or the drug composition indicated in the independent claim to the substance or composition, for which the Registration Certificate is obtained, must be taken into account. And then, after the decision of the FIPS on the possibility of extending the patent, the applicant will be granted the new patent with the claims containing the combination of the features of the patented invention, the permission for the use of which is obtained from the Authorized Body. The new patent will be granted only for the substance that has undergone the clinical trials and which is indicated in the permission of the Authorized Body.