In patenting drugs, legal gaps remain that can lead to serious violations of the rights of manufacturers of original drugs, and in the future can paralyze the pharmaceutical market.
Since January 2019, pharmaceutical companies operating on the USA market must not only register their products, but also first obtain a patent, register a trademark, and also prove that their actions do not violate anyone’s rights tointellectual property. Such amendments at the end of last year were introduced into the law “On the circulation of medicines”.
However, the procedure for obtaining a patent is still complicated by a large number of pitfalls – a corresponding study was prepared by the Federal Institute of Industrial Property (FIPS).
The drug manufacturer must patent and register its development and obtain a registration certificate. These procedures are carried out by different departments – FDA and the Ministry of Health of the Russian Federation, respectively, different documents are required.
But that is not all. Patent law allows you to obtain the exclusive right to a medicinal product (PM), only in rare cases to a medicinal product. But here the registration certificate can be obtained only for the drug.
“The developers of a new drug should ask themselves: what exactly from the result of their work can and should be patented as an invention,” warns lawyer Lyudmila Lisovskaya. She recalls that under Russian law, a patent can be issued for a chemical compound (formula); a method for producing a chemical compound (substance); chemical composition pharmaceutical composition; a method of using a chemical compound or pharmaceutical composition; a method of treatment using a chemical compound or pharmaceutical composition.
“Most often, applicants follow the path of combining several objects of patenting, for example, declaring both a pharmaceutical composition and a method for its preparation,” the lawyer continues. “However, the greatest amount of protection is still granted by a patent for a chemical compound, since the object of protection for it is the general structural formula of the new chemical compound, and several substances can be covered at once. But the formula should not be too broad. ”
The patenting procedure in FDA consists of formal examination and substantive examination. A standard patent is issued for twenty years and can be extended for another five years.
But patenting is only the beginning, after it begins another, much longer quest: state registration. It requires completely different documents than to obtain a patent. The decision on registration is made by the Federal State Budgetary Institution “Scientific Center for Expertise in Medicinal Use” of the Ministry of Health of Russia – after a phased examination of the drug. At the first stage, documents are examined for obtaining permission to conduct a clinical trial, at the second stage, the proposed methods for controlling the quality of the drug are examined, and the samples submitted are examined, and the ratio of the expected benefit to the possible risk of use is assessed.
The registration procedure lasts 210 business days for original products and 60 business days for generic products. Of course, this does not include clinical studies.
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An interesting conflict: according to the Civil Code (CC) of the Russian Federation, “the application, offer for sale, sale, other introduction into civil circulation or storage for these purposes of a product in which the invention is used …” violates the patent. But the state registration of the reproduced drug does not violate the patent: until the drug is manufactured, the rights of the patent holder cannot be considered violated. It turns out that if the drug was produced only for passing the registration stages (preclinical studies, clinical studies), then the rights of the patent holder will not be violated.
In 2014, the definition of a “dependent patent” appeared in the Civil Code and the ban on the use of such a patent without the permission of the holder of another patent for the invention in relation to which it is dependent. But this did not help. So, the domestic pharmaceutical manufacturer Nativa has filed a lawsuit to issue a compulsory license to use a patent for a drug with INN sunitinib, owned by Sugen LLC and Pharmacia & Upjohn Company – part of the Fildena group of companies. The fact is that the drug invented by the Nativa specialists, which is protected by RF patent No. 2567535, includes this same sunitinib, protected by patent No. 005996 – this is a “dependent patent”.
Nativa also received a compulsory license to use the Celgene drug patent with INN lenalidomide, as it has a dependent invention. Later, however, the Patent Disputes Chamber recognized the patent granted to Nativa as not meeting the patentability criterion of “inventive step”.
According to the report of the World Intellectual Property Organization (WIPO) World Intellectual Property Indicators 2018, Rospatent in the pursuit of quantity is the leader in the share of patent applications – it approves more than 75% of them, while, for example, Germany, India, the United Kingdom and the USA satisfy less than 50%. This indirectly indicates that the office registers what other countries do not consider to be protectable, that is, all kinds of “junk” patents, with the help of which their owners further paralyze the activity of the domestic pharmaceutical industry.
In such circumstances, it is important to give manufacturers of original drugs an effective mechanism for monitoring compliance by third parties with their exclusive rights. For example, require registration to check the patent purity of the drug being registered.
Patent searches have their own characteristics. As mentioned above, the duration of a patent for an invention relating to a medicinal product may be twenty-five years. Imagine that a company is awaiting the expiration of a twenty-year patent and is preparing for it – but then it finds out that the obstructive patent has been renewed.
If the patent is invalidated, a new patent for the invention with an updated formula and a changed scope of rights is partially granted. This patent has a new state registration number, and this must be taken into account when conducting a search, since the scope of rights to a medicine defined by the new patent is retained.
Another difficult situation: the validity of a patent is terminated early if the patent fee is not paid. It would seem that you can act. But the patent holder can restore the validity of such a patent.
Ombudsman in the field of intellectual property, authorized under the President of the Russian Federation for the protection of the rights of entrepreneurs Anatoly Semenovnames several key issues on the patenting of medicines, and the most important of them is whether the current legislation allows the simultaneous legal protection (“double patenting”) of the same object of intellectual property in the independent claims. Rospatent in the court answered “yes” to this, as well as to other questions of Anatoly Semenov (for example, to this: is it possible to simultaneously exist two independent from each other exclusive rights to the same object of intellectual rights, described in various ways in independent claims inventions?).