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Patenting of Drugs and BAA

19 Dec 2017 (updated at 04 Jun 2021)
Patent Attorney / Chemical Specialist

It should be noted that the applicant faces a lot of difficulties in connection with the protection of the results of the intellectual activity aimed at patenting drugs and biologically active additives (BAA).

Initially, the pharmaceutical company, which is receiving a patent for a new drug, spends a lot of money and years conducting various studies in chemical and biological laboratories, testing the claimed medication with the aim to prove its effectiveness in treating a particular disease and the absence of serious side effects.

Having received the data of the conducted researches, the developers of a new drug face the question of what exactly from the result of their work can and should be patented as an invention. Under the legislation of the Russian Federation, the patent protection of medications is possible by obtaining a patent for:

– a chemical compound (formula);

– a method of obtaining a chemical compound (substance);

– a pharmaceutical composition based on a chemical compound;

– a method of using a chemical compound or a pharmaceutical composition;

– a method of using a chemical compound or a pharmaceutical composition.

In the majority of cases the applicants prefer to combine several subject-matters of patenting, for example, by claiming both a pharmaceutical composition and a method for its preparation. However, it should be noted that the patent for a chemical compound still provides the largest scope of the protection, since the subject-matter of the protection according to it is the general structural formula of a new chemical compound, wherein it can cover several substances at once. But, it should be noted that in this case the formula should not be too wide.

For a better understanding, let us consider the following example. Patent of the Japanese applicant No. 843695 is issued with the following claims: “... the composition containing an active principle based on a diphenyl ether derivative and an additive selected from the group consisting of a solvent, an emulsifier, a dispersant, wherein in order to enhance the activity and selectivity of the action it contains as a diphenyl ether derivative the compounds of the general formula

(a total of 66 structures at different R and X) in the amount of 0.1-99%.

As you can see, the indication about additives and the amount of the active principle are only a tribute to the form (composition). The additives are indicated in an unspecific manner and may be any substances, that is, there are no restrictions, and therefore it is not essential what substances have been chosen as additives. The amount of an active principle is also practically unlimited and varies from the pure diphenyl ether (99%) to the content which in chemistry is called impurity. Such claims protect the composition very broadly, but, nevertheless, the scope of the protection flowing from them is inadequate to the scope of a direct absolute protection of the chemical compound and is almost equivalent to a direct protection limited by the purpose. Thus, having such broad claims, on the one hand it is easy to prove the fact of the violation of the patent for a chemical compound, on the other hand, it is simply to hold the patent invalid (to cancel it).

Therefore, the developers of new drugs, first of all, seek to obtain a patent for a chemical compound, considering the rest methods of patenting as auxiliary ones.

The patent for an invention for a medication may be granted a protection for the term of up to 25 years. This is because for a medication there is a possibility of extending the term of patent (the standard term of patent is 20 years), in case if its subsequent clinical studies and the state registration are delayed for the term of more than five years. In such cases, the term of patent may be extended for the period that has elapsed before the day of obtaining the authorization to use the invention minus five years.

After the expiration of the term of patent, the invention becomes the public domain, and here the developer faces new difficulties, as any pharmaceutical company can produce legally an analogue of the drug, give it its name and set its price.

At the same time, it will not have to allocate funds for all of the above. The ready technologies, advertising, etc. give the possibility to produce the drug without significant costs. At the same time the drug form can also be different: tablets, gels, ointments, etc., but they all have in their composition the same active substance. Thus, these drugs-analogues, otherwise called generic drugs, having a lower cost, constitute an undeniable competition to initially patented originals. Examples include the well-known original patented drugs “No-Spa” and “Mezym” and their analogues – generic drugs “Drotaverine” and “Pancreatin”, respectively.

In the Russian Federation there is a state register of drugs, which is kept by the Ministry of Health. But it does not contain an indication to the fact that the registered drug is under the patent protection. A number of specialists believe that it is also necessary to introduce a special register of patented drugs, so that it would be clear which drug-analogues have been released or are being prepared for the release to the market illegally.

But in fact such a register already exists. The Federal Service for Intellectual Property (Rospatent) has established national registries, which include all subject-matters of the intellectual property. These registers are regularly updated. After the proceedings on the examination of the application have been completed and the positive decision on granting a patent has been obtained, Rospatent files each patent in the appropriate register. And further any interested department, the Ministry of Health or others can send a request there and get the information, whether the drug is patented or not. The register is also available for any citizen.

A very strange situation has developed in Russia regarding a BAA. The status of a BAA to food has become ambiguous: they have begun to combine in one product two essentially different products simultaneously – a food product and a medication. This situation required additional measures on the state regulation. The hygienic requirements for the safety and nutritional value of food products have been put into operation. The examination practice has also revealed a similar problem. Notably, when filing an application for a BAA in a number of cases in the claims the applicants along with the nutritional purpose (a biologically active additive to food) also indicate the therapeutic purpose (the specific name of the disease which the BAA treats cures is given). It should be noted that the lack of definite classification headings for a BAA to food, the terminological uncertainty, the contradictory information about the status of a BAA complicate the understanding and definition of the purpose of such inventions. As a result of the conducted researches, the concept of the consideration of the applications with a “double” purpose was offered. In accordance with it, the standard letter shall be sent to the applicant, stating that the combination of two different purposes of the subject-matter (a food product and a medication) in one application indicates a clear violation of the unity of the invention and the impossibility of granting one patent for such an invention.

In order to eliminate the violation of the unity of the invention, the applicant is offered to inform which of the subject-matters should be considered within the framework of this application and to clarify in the claims one of the purposes of the offered product: a BAA to food or a drug. When considering the subject-matter as a BAA to food, it is offered to exclude the information about the therapeutic effect from the application documents. In this case, the invention will be classified according to another class of the International Patent Classification.

Thus, the developer filing applications for the invention in the field of medicine and pharmaceuticals faces a lot of complex issues caused by the specifics of the subject-matters and the requirements of the legislation, therefore when patenting the inventions in this field we recommend to apply for the competent and qualified assistance to patent attorneys.

Patent Attorney / Chemical Specialist