Drug Regulation Patent

Pharma Update: Russia Grants First Compulsory License for Anti-Myeloma Drug Revlemid, As German Supreme Court Upholds CL for HIV Drug Isentress


Nativa was granted Russia’s First Compulsory License

In moves that should have significant global impact on public health, an Arbitration Court in Moscow, Russia, granted Russia’s first Compulsory License for Lenalidomide (trade name Revlemid). In a similar development this month, the German Federal Supreme Court upheld a preliminary Compulsory License granted by a lower court for the HIV drug Isentress.

The Russian License

Unlike in India, the Russian judiciary has the exclusive authority to issue compulsory licenses. The CL is an outcome of the suit filed in 2017 by Celgene against Russian pharma manufacturer Nativa, which was producing generic version of the anti-cancer drug Revlemid. The court instead allowed Nativa’s counterclaim for the issue of a compulsory license. The patent on Revlemid, held by US pharmaceutical company Celgene, will now be produced by Russian Manufacturer Nativa under the terms of the license granted by the Court.

Nativa had asked for the CL because it produced a dependent patent, i.e. a patent which could not be worked without the use of a prior patent. As per Russian law, a compulsory licence could be granted, where it is proven that the dependent invention is an important technical achievement and has significant economic advantages over the invention of the first patent. The court accepted both these points, and found that there was significant public interest in the grant of the CL, and consequently admitted the application for compulsory licensing. Interestingly, the terms of the license require Nativa to pay a whopping 30% of the revenue as royalty to the patent holder. In comparison, the compulsory license granted in India for Nexavar, required Natco to pay 6% in royalty.

The German License

In 2017, a Federal Patent Court heard a challenge against Merck by Japanese pharmaceutical Shinogi, against Merck’s manufacture of its HIV drug, Raltegravir (trade name Isentress). According to the press release by the German Supreme Court, the CL was upheld on grounds of public interest and the threat to public health posed by an injunction. The press release reads:

“The Federal Court also shares the assessment of the Federal Patent Court that a public interest in the granting of a compulsory license is credible. It is true that not every HIV or AIDS patient is required to be treated with raltegravir at any time. There are, however, patient groups that needed raltegravir to maintain the safety and quality of treatment. These include, in particular, infants, children under 12, pregnant women, people who need prophylactic treatment because of the risk of infection, and patients who are already treated with Isentress and who are threatened with significant side effects and interactions when switching to another drug.”

The lower court decision of the German Federal Court was well covered in a guest post on this blog here.

The global use of compulsory licensing is encouraging particularly for developing countries which regularly face public health crises due to unavailability of medicines, in which patent rights have a large role to play. Even as the developed world, particularly the USA, pressurises developing countries like India against utilizing legitimate TRIPS flexibilities like compulsory licensing, the use of such provisions by other developed nations like Russia and Germany should lend greater credence to the legitimacy of its use and hopefully incentivise more nations to utilise such flexibilities in favour of public health.

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