The Ministry of Health of the Russian Federation has declared the auctions on state procurement of Lenalidomide as void due to lack of documents confirming the patent protection of Lenalidomide submitted for supply within the bid documentation.
On June 5, the Ministry of Health of the Russian Federation planned to hold auctions on state procurement of Lenalidomide. The bids submitted for participation in the auctions included the original brand-name medicinal product, Revlimid, and its generic, Lenalidomide-Nativ. Due to the lack of information on the patent protection of the medicinal product in the participants’ bids, the Unified Commission of the Ministry of Health of the Russian Federation took a decision to deny both bids.
Celgene, the manufacturer of the original medicinal product under Revlimid brand-name, which active ingredient, Lenalidomide, is under the patent protection in the territory of the Russian Federation, and Pharmstandard, localizing Revlimid in the territory of the Russian Federation, consider the decision taken by the Ministry of Health of the Russian Federation on the auction cancellation as correct. As a result of the taken decision, the bid of potentially counterfeit medicinal product has not been allowed to participate in the auctions.
“The requirement of the Ministry of Health of the Russian Federation to compulsory specify information on patent protection of a medicinal product means that the Ministry considers it is important to comply with the legislation of the Russian Federation on intellectual property rights. We support this approach,” commented Grigory Potapov, CEO of JSC “Pharmstandard”.
“The decision of the Ministry of Health is significant not only for Celgene Representative Office in Russia, but also for the Russian pharmaceutical market as a whole. Such precedents reinforce the confidence of all its participants that the Russian Federation lays down favourable conditions for further development of international partnerships in the pharmaceutical industry and makes tremendous efforts to support an attractive investment climate. In addition, it confirms that the decision to localize Celgene manufacturing in Russia at Pharmstandard`s facilities is strategically correct,” noted Victor Ferkovich, General Manager of Celgene Representative Office in Russia.
“Unfortunately, situations where auctions on procurement of vital and essential drugs are postponed due to participants` unfairness, manufacturing generics of patented medicines, are not rare. That leads to the fact that patients in need of treatment are left without medicines. However, the fact that the state and the Ministry of Health refuse to procure generics, which circulation is illegal, means that patients in Russia will receive high-quality and effective therapy,” said Svetlana Karimova, President of the National Association of Patients with Rare Diseases '"Genetica".
The original brand-name medicinal product, Revlimid (INN – Lenalidomide), is registered in the Russian Federation by Celgene International Sàrl (Switzerland) in accordance with all the requirements of the current legislation on the basis of a full set of preclinical studies and clinical trials conducted by the international standards and is under the patent protection in the Russian Federation (the legally effective patent for the molecule). Within the frames of the Strategy for the Russian Pharmaceutical Industry Development to 2020 (Pharma-2020) the innovative medicinal product, Revlimid, has been localized by Celgene in Kursk at Phs-Leksredstva JSC.
Lenalidomide is on the list of essential drugs (VED) and the list of drugs intended for medication provision of people suffering from hemophilia, mucoviscidosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, post-transplantation of organs and ( or) tissues.