Nativa, a partner of another company with an equally ambiguous reputation of Pharmstandard, decided to challenge the cancellation of the patent for its generic (reproduced analogue). The fact is that the original antitumor medicine is produced by a company from the United States, and the subject of the dispute was the drug Sunitinib.
The right was canceled in June 2021 at the request of the structure of the American company Pfizer - Sugen. It is this company that owns the rights to the original antitumor drug under the brand name "sutent." This right is protected until the end of August 2022.
But Nativa LLC registered and brought to the Russian market its analogue in 2017. And patented the production method as its own invention. In the same 2017, Sugen sued. A foreign company demanded to recognize a violation of its rights and prohibit Nativa LLC from selling generic drugs.
Trials continued for several years. But it was not possible to achieve the imposition of interim measures in the form of a ban on the Pfizer structure.
Running forward, we note that the shadow owner of Nativa LLC is widely considered a person with a not very transparent biography and strange fame: we are talking about Oleg Rostislavovich Mikhailov. He has been managing Nativa since 2012. And more than once managed to get into the lens of law enforcement agencies. And every time I came out of a near-criminal story... Who helps so much?
In the situation with the "copies" from Mr. Mikhailov, the correspondent of The Moscow Post understood.
Medicinal "mammoth"
International pharmbusiness has been complaining about patent infringement in Russia for a long time: at the end of 2017, foreign companies turned to the FAS and drew attention to the practice of purchasing generic drugs from state courts. This was reported by Kommersant.
The Association of International Pharmaceutical Manufacturers (AIPM, unites more than 50 companies) asked the FAS to take measures on the facts of the introduction of reproduced drugs in Russia in a period when patents for original drugs have not expired.
The letter was sent to the head of the FAS (at that time) Igor Artemyev. The message reported that in November 2017, in the Moscow and Rostov regions, Stavropol, Perm and Kamchatka territories, Mordovia and Moscow, 9 tenders were held for the supply of generics based on the active substances sunitinib and dazatinib (antitumor agents, patent belongs to Pfizer and Bristol-Myers Squibb).
The total amount of contracts is more than 217 million rubles.
The main supplier at the auction was Mammoth Farm, affiliated with the ex-owner of a stake in Nativa LLC Oleg Mikhailov.
And the company "Nativa," as indicated in the letter, is close to the company "Pharmstandart."
In 2017, Nativa LLC made a fuss and registered several analogues of drugs that are under patent protection. And Pfizer, Bristol-Myers Squibb, Novartis, Boehringer Ingelheim, AstraZeneca and Celgene are already suing Nativa.
There are 8 lawsuits filed against the company!
Foreign firms expressed their concern about the situation, as it reduces the level of accessibility of innovative drugs for patients. And negatively affects the investment climate in the Russian Federation.
But Nativa LLC does not hear anyone and "heads" goes to its goal: to mix generics of its own production to numerous customers.
Further, recall such a fact from Mikhailov's biography: in October 2017, he sold his stake (41.75%) to Fis Capital GmbH (Austria). According to SPARK, on September 28, 2017, Everom Investments Limited, registered in Malta, became the owner of 41.75% of Nativa LLC. As follows from the data of the Malta register, this company is owned by the Austrian Fis Capital GmbH. Everom Investments Limited CEO is the head of Fis Capital GmbH Uwe Eschner.
The shares of other co-owners of Nativa remained unchanged: 41.75% of the shares belong to Irina Nikiforova, and 16.50% to Mikhail Mogutov.
Fis Capital GmbH is part of the Austrian group Fis Finance & Investment Services. But has Fis Capital GmbH become a real co-owner of Nativa?
Underground shop?
Now back a few years. Back in 2009, Mr. Mikhailov, according to some information, almost became a defendant in a criminal case. This dark story was associated with the sudden death of Mikhail Nazarenko, the sole shareholder of Farm Synthesis. And Oleg Mikhailov at that time worked as the general director of CJSC Farm-Synthesis.
Immediately after the sudden death of Mr. Nazarenko, the trustee changed leadership. And it should be noted that even then, in 2009, Mr. Mikhailov was actively engaged in the development of generics of expensive innovative drugs. The company "Farm-Synthesis" managed to register the world's first analogue of the anti-tumor blockbuster Velkade - Milanfort.
It was with the registration of Milanfort and the subsequent attempt to begin its implementation within the framework of the state program "Seven Nosologies" that the scandals surrounding the company "Farm-Synthesis" were associated.
For Mr. Mikhailov, the sudden resignation became a thunder in the clear sky! But he did not grieve for a very long time, but lightning-fast formed a new office - "F-Synthesis." And this office was soon considered by many market participants as a potential supplier of drug counterfeit.
The founder of the company "F-Synthesis" Oleg Mikhailov said that the new company will be engaged in the production of generics.
Drugs were supposed to appear on the market at the end of December 2009. Such napoleons in time from the moment of development of the substance to the receipt of a registration certificate and permission for industrial production are usually from year to two years. Soon it turned out that we were talking about copying drugs, which was produced by Farm-Synthesis, from where Mikhailov left with a scandal immediately after the death of Nazarenko.
However, Mikhailov himself admitted to reporters that the "sakvoyage" of the company "F-Synthesis" will include generics from the "portfolio" of "Farm-Synthesis." This was reported by Vek.
Meanwhile, after Mr. Mikhailov disappeared from Farm Synthesis's labyrinths, it turned out that vials of substances had also evaporated from the company's laboratory.
And the Biomed plant, from which the company rented laboratories, evicted Farm Synthesis. But on the territory of the Biomed plant, Farm-Synthesis medical equipment remained: ready-made drugs and technological documentation. About this wrote Pharmaceutical Herald.
Later, such an unpleasant detail became clear: the owner of the Biomed plant, Mikhail Mogutov, became Oleg Mikhailov's partner in the F-Synthesis company. The story turned criminal!
Soon, the heads of distribution companies received a letter from the investigator of the Investigative Department at the Internal Affairs Directorate of the Krasnogorsk District of the Moscow Region. This letter reported that a criminal case was opened at the request of CJSC Farm-Synthesis. About this wrote Vek.
However, then it quickly became known that the Investigation Department at the Krasnogorsk Internal Affairs Directorate decided to close the criminal case.
Surprisingly, in the decision to close the criminal case, the investigation admitted that part of the property stolen from CJSC Farm-Synthesis during the investigation was discovered on the territory of the Biomed plant in the new "den" of Mr. Mikhailov.
But who helped close the case?
Help Tatyana Golikova?
But who is so active in helping Mr. Mikhailov in all his endeavors? And avoiding criminal cases? Apparently, some interested persons?
In February 2018, after the history of Pharma-Synthesis and the sale of shares of Nativa LLC to the Austrian company, Mr. Mikhailov urgently needed to register another generic.
And, they say Oleg Mikhailov was able to use the prosecutor's office, which would pressure the Ministry of Health.
Apparently, from this moment a great friendship began - between Oleg Mikhailov and former Minister of Health Tatyana Golikova.
According to rumors, it was Ms. Golikova who pressured the Ministry of Health not only to allow the F-Synthesis drugs to be produced, but also to ensure victory in the competition. And her husband, Viktor Khristenko, helped Golikova in this "noble" business. The Moscow Post wrote in detail about this beneficial alliance.
Recall that in the past Khristenko served as Minister of Industry and Trade.
On the market, it is believed that this family couple also contributes in every possible way to the success of Pharmstandart Viktor Kharitonin. So, Pharmstandard has become almost the only beneficiary from decisions made by the Ministry of Health. And the introduction of a centralized hospital drug supply system for HIV, hepatitis and tuberculosis entailed the departure of hundreds of manufacturers from the market.
In the company "Nativa" Golikova-Khristenko could also have a similar interest. They say that perhaps it is Golikova and Khristenko who are the true owners of this office. Is that probably why the court is siding with a company that violates the law?
The Ministry of Health today intensively punches import substitution, depriving patients of the necessary drugs. Originals are replaced with generics...
But it was not Golikov and Khristenko who pushed this idea as part of the general fight against sanctions in order to profit from generics that Nativa LLC "stamps"?
Repik Opportunities
What else should I remind you of?
At the beginning of 2017, the Ministry of Health had to consolidate the supply of drugs for the free treatment of patients with HIV, hepatitis B, C and tuberculosis. This was preceded by an epidemic of immunodeficiency virus in Yekaterinburg. Officials were pleased with the results of centralization: they believed that competition arose in public procurement.
The result of the new system was the departure of regional companies from the market and the strengthening of the position of two federal R-farm players Alexei Repik and Pharmstandard Viktor Kharitonin.
B and C about interruptions in the supply of free medicines to specialized medical institutions reached a critical level.
The most difficult situation was in Yekaterinburg, where in November 2016 the health department officially announced the HIV epidemic: almost 26.7 thousand patients were registered.
And as a result, the spread in prices for antiretroviral (ARV) drugs purchased by regional authorities turned out to be enormous: in neighboring constituent entities of the Russian Federation, the cost of the same drug could vary by 85%.
As a result, in July 2016, Vladimir Putin signed a law approving the centralized purchase of ARV drugs by the Ministry of Health. It was initially discussed that in the conditions of centralization, Natsimbio (a division of Rostec Group of Companies) will become a single supplier of ARV drugs. But that didn't happen...
However, Natsimbio had a chance: in June 2017, the head of Rostec Group of Companies, Sergei Chemezov, said that the dialogue with the Government of the Russian Federation was ongoing.
Mr. Chemezov also referred to the joint venture arrangement with R-Farm.
The state corporation's interest in a possible partnership with R-Farm was not accidental: Mr. Repik's company receives the maximum number of state contracts for the supply of ARV drugs every year.
In the first year after centralization, the Ministry of Health held 122 tenders. In 2017, the winner of 47 tenders was R-Farm, which entered into contracts for 12.65 billion rubles. And it received almost 52% of all funds allocated for the purchase of drugs against HIV, hepatitis and tuberculosis.
More than 17% of the funds (4.24 billion rubles) went to Pharmstandart Kharitonin.
Recall that Pharmstandard is considered the leader in purchases under the Federal Nosology Program, which are used in the treatment of blood cancer and multiple sclerosis.
Centralization of purchases of ARV drugs was in the hands of Pharmstandard: the company managed to gain a foothold in the segment due to regional suppliers that left the market.
Meanwhile, although the centralization of purchases of ARV drugs led to a decrease in prices to 40%, sick people continue to complain about the lack of drugs and supply failures. As a result, in the same 2017, the Ministry of Health held an additional 20 tenders: ten contracts for 2.5 billion rubles. as a result, the R-farm company received.
In general, everything is "your"?
8 claims
So, there are 8 proceedings in the courts today: with Pfizer, BMS, Novartis, Boehringer Ingelheim, AstraZeneca, Celgene and Bayer. But Nativa, which received so many lawsuits from international drug manufacturers, took retaliatory steps. She is trying to obtain a compulsory license to release the generic drug "spricel." This was reported by Kommersant.
Co-plaintiff was Oleg Mikhailov, who sold his share. The subject of the lawsuit was the anti-tumor drug "Spricel" produced by BMS. Its analogue "dasatinib-native" was registered by Nativa in the register of medicines in the spring of 2017.
BMS tried to prevent the registration of the generic "Nativa" by going to court. But the claim was denied. After 8 months, the Americans resumed attempts to defend their exclusive right to the drug, whose patent expires only on January 30, 2023.
The practice of compulsory licensing is not common in the world. And manufacturers of original drugs want to get the maximum profit from their patents. And therefore they harshly oppose violations.
Is Mr. Mikhailov, with the possible support of former Minister Golikova, just walking "through the heads" of both his Russian colleagues and the "heads" of foreign manufacturers, not thinking much about the consequences?