Israel authorizes the use of generic drug, where a patent has not expired yet


Legal Advisor to the Government of Israel Avihai Mandelblit for the first time authorized the use of generic drugs, where a patent for the original drug has not yet expired. Mandelblit justified his decision with the fight against the coronavirus COVID-2019. Now, generics of the antiretroviral medication Kaletra (lopinavir + ritonavir) from AbbVie can be imported into the country.

AbbVie's patent on Kaletra in Israel expires in 2024. The drug is known as antiretroviral, but the Israeli Ministry of Health has concluded that the drug may be effective in the treatment of COVID-2019. AbbVie and the official distributor of Kaletra are not able to supply the required volume of the drug due to the increased demand for it around the world, so it was decided to bypass the patent, the Israeli Ministry of Justice explained.

You can import generic drugs from countries where the patent for Kaletra is no longer valid. For example, from India. According to Bloomberg, Israel took this opportunity for the first time since 1967, when a special rule came into force.

As of 20th of March, there are 705 cases of coronavirus confirmed.

Lopinavir + ritonavir is also mentioned in the thematic recommendations of the Ministry of Health of the Russian Federation along with ribavirin and interferon beta-1b. But the agency emphasizes that medicines that have proven their effectiveness against coronavirus have not yet been found.

The combination of lopinavir + ritonavir was the leader among purchased ARVs in the first eight months of 2019: Russian Ministry of Health spent 8.2 billion rubles on the purchase of drugs with this INN. The first generic Kaletra registered in Russia is Calidavir from Pharmasyntez. Vikram Punia's company was able to circumvent the patent and register its version of the combination in 2017, although the AbbVie patent for Kaletra expires in 2024.

In Russia, a legislative norm may also be introduced that allows the manufacture of medicines under a patent in the country in the interests of "protecting the life and health of citizens". For this, it is necessary to amend the Civil Code. The relevant amendments are being prepared for consideration in the first reading.

Source: Vademecum