The role of intellectual property in the pharmaceutical industry

Despite an active automation in all spheres of the social activity, an application of the results of the human intellectual labour can become an engine of any branch of industry. Innovative manufacture methods, unique technologies and materials – the development of industry depends directly on an inventive activity of people. The pharmaceutical industry is not an exception – new medicinal products are also a result of the human creative labour.

The subject matters of intellectual property applied in the pharmaceutical industry

According to the Great Medical Encyclopedia: “The pharmaceutical industry is a branch of the economy that combines the manufacture of drugs and medicinal and preventive means.”[1] Therefore, when considering intellectual property used in this field, it is necessary to consider the subject matters that are used in one way or another in the manufacture and distribution of the medicinal products. These can include:

• Inventions. In this case, the issue is about obtaining a patent for the invention describing directly the medicinal product: its formula, composition, substance, etc.
• Trademarks. When releasing the product to a commercial market, including the drug, it is important for the right holder to individualize and distinguish the product. The most successful solution in this case will be the registration of a trade name as a trademark.
• Industrial designs. If original packaging is used for storing and using the medicinal product, the manufacturer is entitled to register it in the form of an industrial design, thereby defending the exterior design of the product packaging against unfair copying.

The use of the inventions in the pharmaceutical industry

The companies engaged in the manufacture and sale of the medicinal products can be divided into two key groups:

• The enterprises-developers of medicinal products.
• The enterprises-manufacturers of generics.

The activities of the first type of the organizations include: developing, testing and manufacturing new drugs. It is in the interests of such pharmaceutical manufacturers to ensure patenting the invented medicinal products, registering the used names in the form of trademarks, and, if necessary, obtaining a patent for an industrial design. All the processes associated with releasing the medicines to the commercial market are very long-standing and time-consuming, and they also require large monetary costs. It is logical to assume that there are the organizations that do not have the funds to developing, testing the drugs and to their subsequent registering, or the ones that do not wish financing the inventive activities and preclinical and clinical trials. Such firms are engaged in the manufacture and sale of the generics – the copies of the patented medicines or the drugs, the validity period of the patents for which has expired.[2] These enterprises do not bear the financial costs, while patenting the subject matters of intellectual property, as they use other people's inventions after the expiration of the period of their legal protection, but unlike the companies-developers, they are not the creators and they do not have the exclusive rights to the manufactured drug.

In accordance with the provisions of the Russian legislation, the medicinal product may obtain a legal protection in the form of a patent for the invention describing:

• a chemical compound (formula);
• a method of producing the chemical compound (substance);
• a pharmaceutical composition based on the chemical compound;
• a method of the application of the chemical compound or the pharmaceutical composition;
• a method of treatment using the chemical compound or the pharmaceutical composition.[3]

According to Paragraphs 1 and 2 of Article 1363 of the Civil Code of the Russian Federation, the maximum validity period of the patent for the inventions in respect of the medicinal products may be 25 years.

The registration of the trademark for the use in the pharmaceutical industry

The Federal Law “On Circulation of Medicinal Products” defines the trade name of the medicinal product as: “a name of the medicinal product assigned by its developer, holder or owner of the registration certificate for the drug.”[4] The legislation of the Russian Federation lacks the norms stipulating the obligatory registration of the names of the medicinal products as the trademarks. However, the expediency of such actions is obvious – the exclusive rights to the trademark are absolute by their nature, thereby causing a prohibition to other persons to use the designation without a permission of the owner. Otherwise, the unfair manufacturers can apply freely the designation or they can register it as the trademark and use it at their discretion.

There is the 5^th class of the ICGS “Pharmaceuticals” for the registration of the trademarks in respect of the drugs. The period of the protection of the trademarks registered for this class does not differ from the period of the exclusive rights to other trademarks.

The role of intellectual property in the pharmaceutical industry

Reasoning about the importance and place of intellectual property in the pharmaceutical industry, it should be noted that the registration of the manufactured drugs and the used trade names in the form of the subject matters of intellectual property allows ensuring the protection, defense and exclusivity of the rights of the companies-manufacturers of the medicinal products. Essentially, the drug is a result of the human creative labour, and patenting in the form of an invention allows ensuring an exclusive mode of the use and ensuring a monopoly for the manufacture of the medicinal product during the validity period of the rights to the invention. By registering the trade name of the drug in the form of the trademark, the manufacturer ensures the mode of the protection against the unfair competitors that may use the name of the drug to manufacture the counterfeit medicines.

Thus, intellectual property plays a key role in the pharmaceutical industry allowing the companies-manufacturers consolidating the exclusive nature of the rights owned by them and thereby recovering the financial costs incurred during developing and testing new medicinal products.