A busy year for pharma

In the second half of 2012, intellectual property issues were mostly discussed in the context of Russia’s accession to the World Trade Organization (WTO).

There have been many such discussions involving a wide range of participants. This may seem strange because when Russia joined the WTO, its IP legislation had already been fully brought into conformity with minimum contained in the Agreement on the Trade-related Aspects of IP Rights (TRIPS).

However, a range of issues need additional legal regulation. One example is the issue of protecting data exclusivity. In 2010, the Federal Law On the circulation of medicines was adopted. This law established a prohibition on the disclosure of pre-clinical trials of medicines and clinical trials of medicines for a period of six years from when the medicine is registered.

This legislative stipulation corresponds to the provisions of Article 39 of the TRIPS agreement. When it comes to applying the law effectively, it is not sufficient to have a single, sweeping stipulation. It may be set out in detail in subordinate regulations. In particular, these may be administrative regulations relating to expert reviews of applications for inventions and published information about applications for inventions, and concerning patents issued for an invention.

It is important to note that the administrative regulations dealing with expert reviews of applications for inventions restrict third party access to additional materials containing information about pre-clinical or clinical trials if they are set out in the form of a separate document.

In the future, it would be reasonable for regulatory legal acts that develop the provisions of items of legislation (including international treaties) to include provisions that (1) exclude clinical trial data for pharmaceuticals from information that is published, and (2) provide for the relevant data to be set out in the application as an independent but integral part of the description which may be disregarded (excluded) when documents are prepared for publication.

“THE HOLDER OF THE RELEVANT PATENT TO THE METHOD OF TREATMENT MAY NOT EXERCISE THE POWER TO PROHIBIT A SUBSTANCE BEING USED WHICH IS NOT PROTECTED BY ITS PATENT.”

Such an approach is aimed at protecting the interests of those performing the trials and subsequent rights holders. However, we are speaking about the need to maintain a balance of the interests of all parties, with the protection of public health as the ultimate objective, so it seems proper for the Association of Russian Pharmaceutical Producers to have raised the issue of the need to establish defined exceptions from the fairly harsh legislative rules that govern the circulation of medicines in cases where using information (data) from the registration dossier of medicines and the results of clinical trials of medicines is necessary in the interests of protecting public health.

The fourth part of the Russian Civil Code contains no provisions that would prevent such a rule being implemented by way of measures to protect public health.

Another issue that is often discussed is restricting the ability to patent methods of treatment. A proposal to introduce such a restriction is justified because it seems that protecting a treatment that uses a substance taken (provided) after the expiry of the patent for a medicine will in essence extend the term of the patent for the medicine. We believe that this logic is flawed.

First, the Civil Code does not refer to methods of treatment which cannot be protected by a patent. Second, the scope of the exclusive right to the method of treatment, as to an invention, is determined by the formula of the invention contained in the patent.

To interpret the formula of an invention, a description of the invention may be used. No other items or indicators may be included in the protectable exclusive right to the method of treatment. Accordingly, the holder of the relevant patent to the method of treatment may not exercise the power to prohibit a substance being used which is not protected by its patent.

It is also important to bear in mind that there are provisions in current IP legislation that restrict the effect of monopoly patent law in particular situations. It is not currently justified for Russia to introduce a legislative bar on patenting a method of treatment. The lack of such а provision in no way affects the development of the Russian pharmaceuticals industry.

Another topical issue is the relationship between trademarks and international non-patent names (INNs). The Russian regulator Rospatent has been attempting to resolve this difficulty for a while, since there have been attempts by bad-faith applicants to register INNs as trademarks from the late 1990s onwards.

The result of its efforts was the regulation for using databases of the All-Russian Health Protection Organisation (ARHPO), containing information on INNs. The ARHPO database is recommended for use as an additional source of information, and state members of ARHPO assume a range of obligations, including the obligation to prevent INNs, or names derived from them, from being used as parts of trademarks.