Israel issues compulsory license to allow the government to import generic versions of Kaletra

(More on COVID-19 here: https://www.keionline.org/coronavirus)

On Wednesday, 18 March 2020 (22nd of Adar, 5780), Israel’s Minister of Health, MP Rabbi Yaacov Litzman, issued a Permit to the State to Exploit an Invention Pursuant to Chapter Six, Article Three of the Patents Law 5727-1967 for the importation of Kaletra (lopinavir 200mg/ritonavir 50mg) for the sole purpose of medicinal treatment of covid-19 patients. Knowledge Ecology International (KEI) has obtained the original Permit (published in Hebrew). Ariel Katz, Associate Professor at the Faculty of Law, University of Toronto, kindly provided KEI an unofficial translation of Israel’s Permit authorizing the importation of Kaletra for the sole purpose of treating patients with covid-19. This authorization is the first time Israel invoked Section 104 and Section 105 of the Israeli Patents Law, 1967 for public non-commercial use.

The World Intellectual Property Organization (WIPO) database, “WIPO Lex” contains a copy of the Israeli Patents Law, 1967.

Article Three: Use of Inventions in the Interest of the State

    Section 104

    Right of State to exploit invention

    104. The Minister may permit the exploitation of an invention by Government departments or by an enterprise or agency of the State, whether a patent for it has or has not already been granted or has or has not already been applied for, if he finds that that is necessary in the interests of the National security or of the maintenance of essential supplies and services.

    Section 105

    Right of State to permit exploitation of invention

    105. The Minister may, if he finds that that is necessary for the purposes enumerated in section 104, grant a permit under that section to a person who operates under contract with the State, in order to ensure or facilitate the implementation of that contract and for the requirements of the State only.

At the time of the issuance of this Permit, the Health Ministry endeavored to obtain Kaletra directly from Abbvie and its authorized importer but was notified by Abbvie and its authorized importer that they would not be able to supply the requested quantities of Kaletra in requested time frame. Israel determined that the exigent circumstances of the covid-19 pandemic dictated the need to invoke Section 104 and Section 105 of the Israeli Patents Law, 1967 for public non-commercial use.

The Permit is narrowly drafted to authorize K.S. Kim International Ltd. (the importer) the right to import Kaletra from Hetero (based in India). The unofficial English translation of the Permit states:

    In accordance with the power vested in me under Cabinet Decision #4888 from March 13, 2020 pursuant to Section 112 of the Patents Law 5727-1967 (hereinafter –the Law), I hereby grant permission,in accordance with Sections 104 and 105 of the Law,to the Emergency Department at the Ministry of Health and to K.S. Kim International Ltd. to exploit the invention protected in patents numbers 173939, 207260, 185390 by way of importation of the lopinavir 200mg/ritonavir 50mg medication manufactured by Hetero, for the sole purpose of medicinal treatment of Corona patients (Novel Coronavirus 2019, pursuant to a Notice of a Dangerous Infectious Disease, under the Public Health Ordinance, 1940, dated 27.1.20). The permission to exploit is necessary in the interest of the maintenance of essential supplies and services.

A Jerusalem Post article, Health Ministry approves experimental treatments for coronavirus, published on 16 March 2020, provides more context into the Israeli Health Ministry’s response to the covid-19 pandemic. The Jerusalem Post reported that Israel’s Ministry of Health had fast-tracked the approval of up to eight treatments for the treatment of covid-19 including: 1) chloroquine, 2) remdesivir, 3) Kaletra, 4) Rezolsta (Darunavir/cobicistat), 5) Xofluza, 6) Favipiravir, 7) Hyperimmune globulin, and 8) Interferon alfa-2b.

Health Policy Watch provided the following insights into the WHO SOLIDARITY trial (WHO Announces New International Trial To Search For COVID-19 Treatments, 18 March 2020):

    “The World Health Organization announced on Wednesday a global “SOLIDARITY Trial” to generate a large, robust study comparing potential treatments for COVID-19. Currently there are 522 trials listed on WHO’s Clinical Trial registry under “COVID-19.”

    “Multiple small trials with different methodologies may not give us the clear, strong evidence we need about which treatments help to save lives,” WHO Director General Dr Tedros Adhanom Ghebreyesus told reporters Wednesday.

    “WHO and its partners are therefore organizing a study in many countries in which some of these untested treatments are compared with each other.”

    So far, Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand have confirmed they will join the trial, and the Director-General expressed hope that others would soon join.”

As reported by Health Policy Watch, the participating countries in the SOLIDARITY trial can choose among the five treatment arms:

  1. Standard of care available in the country, which will serve as a ‘control’ arm that the efficacy of other treatments will be compared with.
  2. Remdesivir, an antiviral drug with activity against Ebola, highlighted as one of the most promising potential treatments
  3. Lopinavir/ritonavir, a combination of two common HIV/AIDS antivirals
  4. Lopinavir/ritonavir and the anti-inflammatory drug interferon beta
  5. Chloroquine, an antimalarial drug, or its less toxic derivative, hydroxychloroquine

On Sunday, 22 March 2020, Science published a detailed feature on the WHO SOLIDARITY Trial (WHO launches global megatrial of the four most promising coronavirus treatments), that provides more insight into WHO’s pioneering work in the covid-19 response.

Science observed the following:

    “The design of the SOLIDARITY trial can change at any time. A global data safety monitoring board will look at interim results at regular intervals and decide whether any member of the quartet has a clear effect, or whether one can be dropped because it clearly does not. Several other drugs, including the influenza drug favipiravir, produced by Japan’s Toyama Chemical, may be added to the trial.

    To get robust results from the study, several thousands of patients will likely have to be recruited, says Henao-Restrepo. Argentina, Iran, South Africa, and several other non-European countries have already signed up. WHO is also hoping to do a prevention trial to test drugs that might protect health care workers from infection, using the same basic protocol, says Henao-Restrepo.

    The trial’s European counterpart, Discovery, will recruit patients from France, Spain, the United Kingdom, Germany, and the Benelux countries, according to an INSERM press release today. The trial will be led Florence Ader, an infectious diseases researcher at the University Hospital Center in Lyon.”

Israel’s Permit, authorizing the importation of Kaletra for the sole purpose of treating patients with covid-19, can be found here:

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The unofficial English translation of the Permit can be found here: https://www.keionline.org/wp-content/uploads/A-Permit-to-the-State-to-Exploit-an-Invention-Pursuant-to-Chapter-Six-Article-Three-of-the-Patents-Law-5727-1967.pdf