[Ip-health] Israel issues government use Permit for the importation of Kaletra

Thiru Balasubramaniam thiru at keionline.org
Mon Mar 23 01:58:44 PDT 2020


Israel issues government use Permit for the importation of Kaletra

Posted on March 23, 2020 <https://www.keionline.org/32503> by Thiru

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,

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

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:

Doc1 <https://www.keionline.org/wp-content/uploads/Doc1.docx>

The unofficial English translation of the Permit can be found here

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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