Israel Issuing Compulsory License During The Time Of Covid 19 Pandemic

COVID-19

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is the name given to the 2019 novel coronavirus. COVID-19 (Corona Virus Disease 2019) is  the name given to the disease related to the virus. COVID 19 is a new sort of virus belonging to the family of corona viruses, that has not been previously identified in humans.

COVID 19 was first identified in China in December 2019 in the city of Wuhan. This disease is a sort of respiratory illness and its symptoms include cold, cough, fever, sore throat and difficulty in breathing.

INTERNATIONAL EFFORTS TO HANDLE COVID-19

There is no such vaccine available within the market, as this disease has never before been identified in physical body before the outbreak in December 2019. The WHO(World Health Organisation) has declared Covid-19 as a pandemic and has openly sought help from all countries to try and develop a vaccine for it but till date no such vaccine has been developed.

At present, all eyes have turned to the prospect of developing a vaccine, because only a vaccine can prevent people from getting sick. World over, various organizations are functioning overtime so that a vaccine/ treatment is available within the market at the soonest. About 35 companies throughout the world have been trying their best to develop a vaccine, and out of the 35, till date, only 4 companies have started testing on animals. The first company was Boston based biotech firm Moderna which is working to develop a vaccine and can enter human trials. Another company, Maryland-based Novavax is functioning to develop vaccine of Sars-CoV-2 that can be available for human trials this spring.

Covid-19 vaccines are being tried and tested and few of them are using new technologies to develop vaccine. NOVAVAX is using new technologies which involve ordering for the protein spike on the surface of Sars-CoV-2, which is a part of the virus presumably to impress an immune response in humans, and pasting it into the genome of a bacterium or yeast – forcing these microorganisms to churn out large quantities of the protein.

Certain drugs have shown be effective in treating Covid-19. The drugs include remdesivir, lopinavir and ritonavir in combination; lopinavir/ritonavir plus interferon-beta; and chloroquine and hydroxychloroquine. Since COVID-19 has infected a staggering number of people worldwide, these drugs, including few other candidates, are going to be tested on humans on a global scale (called WHO’s SOLIDARTY TRIAL).

Companies which have manufactured these drugs are having patents over those medicines and if any of the company features a monopoly on the utilization of the medicines for Covid-19, the market position instead of production costs will determine the worth.

EFFORTS BY ISRAEL TO HANDLE COVID-19

Some countries, particularly Israel, has taken certain preventive measures to improve the research and availability of drugs and/or vaccines for COVID-19;  few of them are –

On 19^thMarch 2020, Israel issued a Permit (a compulsory license) to the importation of generic versions of Abbvie’s patents associated with lopinavir/ ritonavir branded as Kaletra for treating of Covid 19. This medicine is essentially for treating of HIV patients but now it’s being tested for Covid 19. MPP (Medicines Patent Pool) has also informed that now there will not be any restriction for supplying of Kaletra anywhere within the world for any purpose.

Back in 1970 Israel had also granted compulsory licenses for medicines until 1995 for 7 products for providing domestic production. Now, Israel, for the first time invoked section 104 and section 105 of Israeli Patent Law, 1967. Section 104 and section 105 of Israeli Patent Law states as under:

Section 104 of the Israeli Patent Law- “that a minister designated by the govt “may permit the exploitation of an invention by Government Departments or by any enterprise or agency of the State, albeit a patent has already been granted for it or applied for, if it appears to the Minister that it’s necessary so to try to to within the interests of the defence of the State or the upkeep of essential supplies and services”

Section 105- “the Minister may, if it appears to him that it’s necessary to try to to so for the needs mentioned in section 104, grant a permit there under section to an individual operating under a contract with the State, with a view to making sure or facilitating the execution of that contract and for the wants of the State only.”

According to Israel Patent law if the permit is given under section 104 & 105 of Israel Patent law the State must pay the patentee royalties as agreed by them. If the same is not agreed by them the royalty rate will be determined by a committee known as Royalties and Compensation Committee and the said committee member includes the former Justice of the Supreme Court, the Patents Commissioner, and a member of the academia. Thus, Abbvie will be getting some benefits even after issuing compulsory license.

Such a decision taken by the government of Israel is intended to help the nation in fighting COVID-19, but this can also have consequences with wider global ramifications. Abbvie, patent holder on a vital drug against a pandemic, was unable to meet the requirements for the drug, and therefore nations are stepping-in to ensure their requirements are met despite the rights of the patent holder. National government as well as patent holders have to tread cautiously and ensure there is no un-reasonable ‘over-stepping’.

Israel is also trying to get approval for 8 more drugs for treatment of Covid 19 those are: 1) chloroquine, 2) remdesivir, 3) Kaletra, 4) Rezolsta (Darunavir/cobicistat), 5) Xofluza, 6) Favipiravir, 7) Hyperimmune globulin, and 8) Interferon alfa-2b

IMPLICATIONS OF ISRAEL’S ACTION

After Israel taking such decision at least two things happened after the said notice was issued by the government of Israel on 20^thMarch 2020, (i) the Education, Culture, Science and Technology Commission of the National Assembly in Ecuador asked the Minister of Health to issue Compulsory Licenses over patents associated with coronavirus technologies, and (ii) Abbvie said that they’re going to provide necessary steps to get rid of potential barriers to supply the drug publicly.

At this stage, Abbvie’s actions and assurances on Kaletra may be viewed as too little too late. Nations may not be willing to act with restraint and patience while on the other hand Abbvie letting go of its patents rights will only allow generic drugmakers to intensify production and dramatically increase supply capacity. That this drug is within the list of WHO to be tested in Solidarity Trial will only ramp up demand on which Abbvie would not stand to gain much. That SOLIDARITY Trial” was announced by WHO on 18^th March 2020 for the treatement of Covid 19 and as of now there are 522 trials listed on WHO’s  list for the test of Covid 19.

Till date Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand have confirmed they will join the solidarty trial.

One very basic approach available to patentees is to guard their intellectual property rights be aware of the prevailing situation. It is important to ensure sufficient availability of a drug that are potentially effective against the Coronavirus and to meet the requests of a government/ authority. These measure are essential but the ,question may still remain (which everyone wants to know) as how soon will the technologies to tackle this pandemic be developed and how soon will it be  available in the market.

Author: Aishani Singh – Litigation Associate and Arindam Purkayastha – Patent Attorney, at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at [email protected].