New Law, Control Russian Med Products

07 February 2019

GMP News

The President of the Russian Federation has signed Federal Law no. 511-FZ “On amendments to certain legislative acts of the Russian Federation”

According to the new law, the regulator (Roszdravnadzor) has been granted a new function to carry out controlled purchases from retailers at any time without warning the retailer.

Based on the new law, the aim of controlled purchases will be to identify:

The new law entered into force on January 7, 2019.

The State Duma has Passed in the First Reading the Draft Law on Increasing Liability for E-Commerce involving Counterfeit Pharmaceuticals

The Russian State Duma has passed in the first reading a draft law on strengthening liability for the online sale of falsified and counterfeit pharmaceuticals, biologically active additives (BADs) and medical devices.

The authors of the draft law propose increasing liability for such actions. If the law is adopted, criminal liability may be increased to between five and eight years of imprisonment accompanied with a fine of between RUB 1 million and RUB 3 million. If no features of a criminally punishable offence are established (eg a low degree of danger to public health), administrative liability may be imposed which will be increased as follows: for individuals a fine of between RUB 75, 000 and RUB 200,000; for officers and individual entrepreneurs – a fine of between RUB 150,000 and RUB 800,000; and for legal entities – a fine of between RUB 2 million and RUB 5 million.

Deputies of the State Duma explained the intent of the draft law by declaring a desire to increase efficiency in combatting the market of illegal online sales of falsified and counterfeit pharmaceuticals. The deputies claim that the current situation with such online sales is not acceptable and creates serious concerns to public health.

The Russian Court of Intellectual Rights has Satisfied the Appeal of BMS in the Landmark Dispute against a Generic Medicine Manufacturer

On January 10, 2019, the Russian Court of Intellectual Rights has satisfied the cassation appeal of Bristol-Myers Squibb (BMS). The previous first and second instance court rulings have been reversed, and the case has been remanded to a new hearing to be held by the Arbitrazh Court of the Moscow District.

BMS has been litigating since 2017 in relation to the alleged violation by a Russian company Nativa of BMS’ IP rights to anti-tumor medicine Sprycel. BMS’ patent to this medicine is valid until 2023. Nevertheless, Nativa has procured the state registration of generic medicine called Dasatinib-Nativ in 2017.

The lower instance courts refused BMS’ patent infringement claim. The key ground for such refusals were that Nativa had allegedly referred to its own patent when manufacturing the generic medicine. However, the Court on Intellectual Rights has now reversed those decisions, and the case will be considered anew.

In November 2018 a similar-type of ruling was issued by the Court of Intellectual Rights in favor of Bayer in a similar dispute against Nativa. These developments may signify a trend of Russian courts being more critical to attempts by manufacturers of generic medicines to circumvent the patent rights of big pharma companies.

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