Unfortunately, such a license can hardly count on another Pharmasynthez drug intended for the treatment of no less dangerous, but not such a "promoted" disease of hepatitis C. Moreover, contrary to the law, logic and common sense, Rospatent keeps in force over and over again a legal monopoly on the production of the drug for the American company "Gilead".
Ten years ago, hepatitis C, transmitted with blood infected with the virus, was practically a death sentence. A "gentle killer" could infect you after any medical or cosmetic procedure and asymptomatically destroy the body until extensive liver damage has developed: chronic hepatitis C in 50 to 80% of cases leads to cirrhosis and hepatocellular carcinoma - cancer. The therapy with interferon and ribavirin was very long - up to 72 weeks - and was accompanied by such severe side effects that in some cases the treatment had to be discontinued. At the same time, the efficiency did not even reach 50%. However, the situation changed 10 years ago: American scientists Raymond Skinazi and Dennis Liotta embarked on the third stage of research on sofosbuvir, a pangenotypic direct-acting antiviral drug (DAA). In human clinical trials, it has shown high efficacy against the hepatitis C virus, allowing up to 95% of those infected to be cured within 12 to 24 weeks.
Already in the next 2011, the company of inventors Pharmasset was bought by the biopharmaceutical giant Gilead Sciences ("Gilead") for 11.2 billion US dollars, but released the drug on the market at such a price that the deal paid off very quickly. Gilead earned $ 58.6 billion from sales of Sovaldi-branded sofosbuvir from 2013 to 2018 alone. Nonprofit medical and patient organizations protested the lack of access to treatment. For example, Doctors of the World launched the “Medicines should not be a luxury” campaign, calculating that the cost of sofosbuvir - $ 1,000 per pill - makes each gram of the drug 67 times more expensive than gold. Under pressure from the global community, in 2014, Gilead signed an agreement with major generic manufacturers in India, which allowed these companies to produce sofosbuvir for developing countries at a price of about $ 100 for the entire course of the drug. However, Russia was not included in the original list of 91 countries. Meanwhile, according to the Rospotrebnadzor reference center, about 5.8 million people in the Russian Federation are carriers of the hepatitis C virus.
Since 2015, there has been a wave of challenging patents for sofosbuvir around the world - in China, India, Brazil, Argentina, the EU, Russia, and Ukraine. The objections are based on the fact that the degree of novelty of the active substance in comparison with the already patented forms is not sufficient for the grant of a patent. I-MAK succeeded in challenging patents in China, resulting in more than $ 50 million in savings. Currently, the list of countries where the manufacturer has allowed the sale of generics includes all EAEU countries, except for Russia (Armenia and Kazakhstan were included in the agreement in 2019).
Sofosbuvir was registered in the Russian Federation in March 2016 under the trade name Sovaldi. According to Gilead, Russia is an upper middle-income country, so there are no plans to issue licenses to local manufacturers for the release of generic drugs. In a similar situation, Malaysia, for example, was forced to follow the path of compulsory licensing in order to ensure that its citizens can receive treatment for hepatitis C at affordable prices.
In Russia, the Humanitarian Action Foundation and Pharmasintez filed objections to patents protecting sofosbuvir. In 2017, Pharmasintez managed to partially cancel the patent protection of Sovaldi in Russia. However, in June 2020, the Intellectual Property Court (IPC) restored the monopoly of Gilead and its Russian licensee Pharmstandard on the production and sale of sofosbuvir in the Russian Federation. Lawyers of the Russian manufacturer, Pharmasintez JSC, filed a cassation appeal with the Supreme Court of the Russian Federation against the decision of the SIP and the ruling of the Presidium of the Intellectual Property Rights Court. They insist that the court recognized as legitimate the circumvention of the current legislation, which does not allow the "double patenting" of the same drug, as well as the restoration and extension of the legal protection of a drug that has passed into the public domain.
As the representative of Pharmasintez, Deputy Chairman of the RSPP Committee on Intellectual Property and Creative Industries Anatoly Semyonov said, “SIP actually approved the formal use by Rospatent of the patent renewal procedure for the actual registration of a selective invention by isolating a specific substance from the structural formula of a patent without checking its patentability. It should be noted that the courts in the case established that the compound according to paragraph 1 of the claims under the patent 2 651 892 for sofosbuvir is a composition (mixture), and the application for renewal of the patent was filed for an individual chemical compound. This is, relatively speaking, as if you were patenting the recipe for borscht, and at the same time for the cabbage that is included in this dish. And this focus was supported by Rospatent, which has already issued three patents to Gilead with a formulation that leaves loopholes for the continued protection of a vital medicine."
As a sign of abuse of the right and unfair competitive tactics of the rightholder, the expert also points to the fact that Gilead still supports application RU2018103329 in the office of Rospatent, which is separated from application 2 012 152 811, which, in turn, is separated from the application RU2009139968, according to which the controversial patent 2 651 892 was obtained, thereby preserving the possibility of one more introduction into the scope of the rights of the substance declared in claim 1 of the claims of patent 2 651 892 (that is, granting protection to sofosbuvir for the third time). This is reminiscent of the situation from the cartoon "Last year's snow was falling": "He went to the Christmas tree for the third time."
This is patent 2651892, which was issued as a result of partial cancellation of the previous patent 2478104. By the decision of Rospatent, clauses 8-14 were excluded from it, while the Office retained clause 1 of the formula with an ambiguous clause, which retained legal uncertainty regarding the protection of sofosbuvir. In the opinion of Pharmasynthez, which successfully challenged the patent for sofosbuvir, this position of Rospatent continued the threat of prosecution of generic drug manufacturers due to the possible ambiguous interpretation of the remainder of the patent. The applicant filed a complaint with the Intellectual Property Rights Court (case SIP-422/2018) to eliminate the contradiction, but the SIP upheld the decision of Rospatent. Taking advantage of this uncertainty, the patentee simultaneously applied for an extension of the remainder of patent 2,651,892. As a result, the patent extension request was granted, but instead of renewing the remainder of the patent, an additional patent was issued for sofosbuvir, the protection of which had been previously discontinued. That is, Rospatent turned back and pretended that "we play here, we don't play here, we wrap the herring here." This is completely unacceptable in a situation concerning a cure for a deadly disease that is taking the lives of tens of thousands of Russians right now.
Sofosbuvir, included in the list of vital and essential medicines (VED), is sold to Russia for about 223.5 thousand rubles (excluding VAT) per course. At the same time, in Kazakhstan, the price of the drug for 12 weeks of therapy is about 7 thousand rubles at the current rate. In 2020, the federal budget for the procurement of drugs for hepatitis C amounted to about 2 billion rubles. At current rates, this amount is enough to cure 15.6 thousand people. This is less than 0.5% of the total estimated number of patients with chronic hepatitis C in 2019, according to the annual report of the Treatment Preparedness Coalition, which monitors purchases of drugs for the treatment of hepatitis C in Russia. 91% of the total cumulative budget in 2019 was spent on the purchase of direct-acting antiviral drugs (DAAs), which includes sofosbuvir. The weighted average cost of treatment with drugs recommended for the treatment of hepatitis C by WHO, sofosbuvir and daclatasvir as of June 1, 2020 is 392 thousand rubles for a course of 12 weeks. Access to generic DAA drugs would at least provide therapy for all newly diagnosed patients with hepatitis C.