PATENT WAVIER FOR COVID-19 RELATED INVENTIONS-- MUCH ADO ABOUT NOTHING??

 

PATENT WAVIER FOR COVID-19 RELATED INVENTIONS-- MUCH ADO ABOUT NOTHING??

Mrs Indira Gandhi’s Famous Speech at WHO

1. As of today, i.e., 8^rd June 2021 there have been 3.76 million confirmed COVID-19 deaths, Undocumented deaths would easily be double the number. Since COVID-19 leads to permanent damage to the lungs and overall immunity, at least another 20 million human lives would have been lost before the end of this year. The scale of death is as immense as in the World Wars. So, rightly there have been demands that given the magnitude of the global pandemic, COVID-19 related inventions should be outside the ambit of patenting. Mrs Indira Gandhi, once declared before WHO that those inventions that save millions of human lives should not be driven for profits and that they must be available to all people around the world at no cost, if not, at an affordable cost. Now it is left to her BJP successor Prime Minister Mr Modi to amplify Mrs Gandhi’s earlier demand, this time at a new forum , viz, WTO. Quite possibly, the present Foreign Minister Mr S Jaishankar would have just joined the Indian Foreign Service when Mrs Gandhi spoke these words at WHO. Supported by South Africa, Thailand, France, India today is spearheading a patent waiver before WTO. Surprisingly, even United States had agreed in principle for a patent waiver. UK, Germany, Norway and possibly Israel are not too enthusiastic about the proposal. As usual China and Russia are ambivalent. It is in this context that we will consider the issue of patent waiver for COVID related inventions.

Pandemic is The Mother of Many Inventions!!

2. COVID-19 is undoubtedly the worst pandemic of the Third Millennium. Even earlier pandemics like Spanish flu, AIDS etc did not cause comparable human deaths in such a short spell of time. One must say that innovators around the world are trying their best to mitigate the number of deaths and suffering of patients. To achieve this objective, there have been different types of inventions around the world such as:

a. New combination drugs from amongst the approved drug molecules of drugs (Chloroquine, Remdesivir, Favipiravir derivatives)

b. Sidda, Ayurveda, Unani and other alternate healthcare and composite health delivery models.

c. Vaccines (deactivated virus vaccine, mildly live vaccine, mRNA vaccine, antibody-based vaccines, etc,) and different methods of administration such as injectable, nasal drops, dermal delivery patch etc.

d. Prophylactic or palliative drugs that will aid in the faster recovery of COVID patients.

e. Diagnostic and testing kits (In fact, it was suggested that even trained dogs can sniff the presence of Corona Virus) Medical devices such as oximeters, thermometers, ventilators, nebulizers etc

f. Protective clothing such as masks and clothing meant for high-risk health care professionals.

h.Public disinfectant chambers, their configuration, appearance, methods of disinfection (ultraviolet rays, chemical germicides etc.)

i. Post-death management items such as stretchers, body bags, methods of disposal and storage.

3. The list is endless. Most importantly more than any other pandemic in the past, the global community had shrunk the response time needed for meeting the situation; within 1.5 years of the pandemic, there are credible vaccines (about 6 are approved and many more in the pipeline.) New drugs are explored. More importantly, alternate methods of healing are being subject to clinical trials and inventions have originated in these areas as well. It is in this context we have to address the issue of patent waiver.

Patenting Covid Related Inventions

4. Mr Bill Gates foresaw that a pandemic of this magnitude is in the realm of possibilities. He predicted that unlike in the past the impact of a pandemic on the global community will be very severe. He admirably has been in the global forefront of the fight against COVID and the earlier pandemics such as SARS and the Ebola virus. He has invested substantially in Pfizer. More or less contemporaneously Astra Zeneca’s Covisheild, Russia’s Sputnik and China’s Sinopharm have received Emergency Regulatory Approvals around the world. This was followed by more efficient (or simply different) Moderna and Johnson and Johnson Vaccines. There are other candidates in the pipeline. Unlike in the past, these companies have indicated their willingness to manufacture the vaccines in different global locations on a voluntary license that was transparently negotiated. To day, the Pharma Majors are willing to consider licenses on mutual consent on terms that are fair, uniform, transparent and not avaricious. This development augurs well. All these vaccines undoubtedly will be in pursuant of multiple patent applications around the world. For the first 12 months, all contents of the patent applications except the title are kept secret. Most of these applications will be published globally within 15 months of the first filing. Thereafter, the applicant would have to make a Request for Examination. Afterwards, the patent office will issue a First Examination Report. If the applicant complies with the requirements of the FER, then the patent will be granted. So in all possibility, patents for corona vaccines will be issued from the end of 2023 and regularly from 2024 onwards. During this period, there is a lot that patent offices around the world can accomplish simply by tightening up the conditions of Patent Grant. Section 3, particularly 3 D Explanation of the Indian Patent Act will have an important role in this regard.  To talk about waiver, even before the patents are granted is akin to naming the baby soon after conception!!  

The table below will give an idea of approved and pending approval vaccines :

Sl no	Company	Vaccine	Mechanism	Current Phase	Price (Rs/per dose)
1	Zydus Cadilla /Dept of Biotechnology, India	ZYCOV-D	DNA	Currently being tested on children	800-1200
2	Serum Institute/ Novovax	NVXCOV-2372	Protein	Phase 3 trial	n/a
3	Genova/HDT, USA	HGCO 19	mRNA	Phase 1 trials	n/a
4	Biological E Ltd/MIT USA	BILOGICAL E VACCINE	Recombinant protein antigen	Phase 3 trials	300
5	Bharath Biotech/TJU USA	BHARATH BIOTECH VACCINE 2	Inactivated rabies	Phase 1/2 trial phase	600-800
6	IISC/Mynvax	MYNVAX	Thermotolerant SARS-CoV-2 spike fragment Receptor Binding Domain subunit-based vaccine	Under development	n/a
7	Serum Institute of India	COVOVAX	protein-based	Production	n/a
8	Bharat Biotech	BBV154	nasal vaccine	Phase I trials	n/a
9	Biological E	CORBEVAX	protein sub-unit vaccine	Phase 3 trials	200
10	Biological E	PTX-COVID19-B	mRNA	Under development	n/a
11	Biological E	JANSSEN	mRNA	Approved for use in US, EU, SA	800

 

COVID-19 and Revolution in New Drug Approval

5. Nowadays it is not unusual for New Chemical Entities (NCE) to receive regulatory approval even before the patent for the NCE is granted. If the Active Chemicals Ingredients of the new candidate drug has already been approved, then the clinical trials will be restricted to assessing the efficacy of the new drug candidate. Most of the new Corona drugs fall under this type. Most vaccines are now being administered pursuant to an Emergency Approval meaning that clinical trials are ongoing. There have been reports of new and more dangerous mutant forms of the coronavirus both in terms of fatalities and a higher rate of spreading. Hence in a couple of years, more data will be available on the efficacy of the different vaccines and the efficacy of the drugs . Then ,there will be more clarity on methods of treatment, the evolution of treatment protocols, the type of drugs that should be used, etc., It would be worthwhile to consider the issue of patent waiver when more credible information is available. In the meantime, there are a lot of things, that patent offices can do by availing the powers that are granted to the Union government under the Indian Patent Act as amended up to date. So, to talk about patent waiver, at this point of time appears a bit premature. Actually, Global Pharma Companies have not exactly found a new drug for treatment of COVID 19.They are still experimenting. In fact, they have not even evolved a Treatment Protocol. Doctors prescribe medication to COVID patients to mitigate the effect of accompanying symptoms and particularly focus on making sufficient oxygen available to patients.

The following table documents the number of new candidates for treatment of COVID 19 :

 

Sl No	Name of company	Drug	Mechanism	Current status	Price Rs/unit
1	Multiple companies	HYDROXYCHLOROQUINE	Oral	Approved in mild cases	65/strip
2	Glenmark	FAVIPIRAVIR	Oral antiviral	Emergency use	75/tablet
3	Gilead sciences	REMDESIVIR	Injectable drug	Emergency use	5400/vial
4	Roche pharma	TOCILIZUMAB	Injectable drug	“Off-label” use in moderate to severe cases	40000-45000/ box
5	Biocon	ITOLIZUMAB	Injectable drug	Approved in moderate to severe cases	8,000/vial
6	Under trial	DEXAMETHASONE	Injectable drug	Approved in severe cases	7/10 ml
7	Eli lilly	BAMLANIVIMAB	Oral	Approved in moderate to severe cases	800/20ml
8	Eli Lilly	ETESEVIMAB	Oral	Approved in moderate to severe cases	N/a
9	DRDO	2-DEOXY-D-GLUCOSE	Powder	Approved in severe cases	600\sachet
10	Merk pharma	MOLNUPIRAVIR	Oral antiviral agent	Phase 3 trial	N/a

Important and Relevant Provisions of the Patents Act 1970

a. Section 2(h) definition of govt undertaking: 2 (h) “Government undertaking” means any industrial undertaking carried on—

          (i) by a department of the Government, or

          (ii) by a corporation established by a Central, Provincial or State Act, which is owned or controlled by the Government, or

          (iii) by a Government company as defined in section 617 of the Companies Act, 1956 (1 of 1956), or

          (iv) by an institution wholly or substantially financed by the Government;

b. Section 47 of patent act, 1970: Grant of patents to be subject to certain conditions. -The grant of a patent under this Act shall be subject to the condition that-

(1) any machine, apparatus or other article in respect of which the patent is granted or any article made by using a process in respect of which the patent is granted, maybe imported or made by or on behalf of the Government for the purpose merely of its own use;

(2) any process in respect of which the patent is granted may be used by or on behalf of the Government for the purpose merely of its own use;

(3) any machine, apparatus or other article in respect of which the patent is granted or any article made by the use of the process in respect of which the patent is granted, may be made or used, and any process in respect of which the patent is granted may be used, by any person, for the purpose merely of experiment or research including the imparting of instructions to pupils; and

(4) in the case of a patent in respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own use or for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the Government or any other dispensary, hospital or other medical institution which the Central Government may, having regard to the public service that such dispensary, hospital or medical institution renders, specify in this behalf by notification in the Official Gazette. ]

 

c. Section 92(a) of patents act1970: Compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances. -

(1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.

(2) The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him.

(3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory license can be exported under any other provision of this Act. Explanation. -For the purposes of this section, 'pharmaceutical products' means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.

 

6. Under Indian patent act there are different types of compulsory licenses, they are:

 a. Compulsory license for not working the patent that results in the local demand not being met at a reasonably affordable cost.

 b. Compulsory license in case of pandemic or health emergency

 c. Compulsory license for meeting the needs of developing countries.

 

In fact, Section 85 specifically forbids revocation without there being an earlier order granting the compulsory license and  a further Finding,that even after the expiration of Two years after grant of compulsory license, the patent abuse could not be stopped. Hence, quite naturally, Norway, England, and Germany had demanded before WTO that all these countries should avail the existing statuary provisions for prevention of patent abuse. They have also insisted that even in such cases, the grant of compulsory license must be accompanied with payment of reasonable royalties.

 

Immediate Needs of Indian Health Care System

7. The Union of India should take measures on war footing to prevent the spread of the COVID virus - lockdowns, improving awareness, increasing the testing rate, imaginative policies for quarantine and aftercare. A patent waiver may not significantly influence the above measures.

8. Governments are working to increase the immunity levels to a point where we can confidently declare that the Indian population had acquired herd immunity against the COVID virus. This can be achieved by vaccination of our entire vulnerable population. I believe that a patent waiver cannot facilitate the acquisition of herd immunity. Most of the objectives on acquisition of herd immunity can be accomplished by an efficient exercise of powers by Pharma regulatory authorities.

9. Already individual states like Delhi and Punjab have tried to acquire vaccines directly from external suppliers. Many of the suppliers were lukewarm in their response. Recently, I read that the State of Haryana will receive Sputnik Vaccines manufactured at Malta. State of Tamil Nadu under  Chief Minister Mr M K Stalin held discussions with Bharath Biotech to explore the possibility of putting up a vaccine manufacturing plant at a Changalpet  District vaccine manufacturing facility which has been closed for some time. Soon after this development, an AstraZeneca representative had a meeting with Tamil Nadu Chief Minister. Considering that Tamil Nadu has a finance minister who understands the International Capital Market very well, I don’t rule out the possibility of vaccine production (multiple varieties) in the state of Tamil Nadu very soon. In fact, there are unconfirmed reports that Tamil Nadu Medical Supplies Corporation is researching on the production of a new COVID vaccine. Furthermore, Tamil Nadu has called for global tenders which are for the supply of COVID vaccines. Market Size of states like Tamil Nadu, Maharashtra, Uttar Pradesh are so big that global competitive tender can lower the prices in the market. For all these developments existence of a patent is not going to be an impediment at all. In fact, as on date there would be very few granted patents on COVID related infections. One should not lose sight of the fact that most of the vaccines that we have today are being administered on an emergency trial basis without any guarantee of quality and any indemnity for deficiency. Hence the global community today is not even aware which of the vaccines is the best and more time is needed to evaluate and conclude which are the best ones. There can be several best ones in view of the differing conditions prevailing in the global vaccine market.

10. Before the Supreme Court, the Union of India has declared that it will try and vaccinate at least 80% of the population before December 2021. From July 2021, The Serum Institute will supply 30 million vaccines in a month. Bharath Biotech may contribute a similar quantum. There are different vaccine candidates in the pipeline and more emergency approvals are expected. In fact, the first batch of Sputnik vaccines have been flown into Hyderabad. Dr Reddy laboratories are expected to launch commercial production of Sputnik vaccines under a voluntary non-exclusive license from the Russian patent holder. Serum Institute of India has received approval from the Union of India for manufacturing Sputnik vaccines in India. So, Serum Institute of India becomes a licensed manufacturer for two competing vaccines belonging to two different patentees. Usually, in such cases there would be a demand for exclusive dealings. More and more foreign research pharma MNCs are contemplating vaccine manufacturing units in India. But, ironically the Indian vaccines Czar has left to England for his usual summer vacation. Not surprisingly, he talks about the idea of establishing a vaccine manufacturing plant in the UK. The regulatory reach of the sovereign authorities can unsettle the actions of well-meaning global entrepreneurs and the demand for a patent waiver is a manifestation of the trend. As pointed out, the cumulative effect of Section 2(h) and Section 47 of the Patents Act will empower the government to use any patent for the hospitals. Hence to achieve this objective, the demand for patent waiver is not necessary.

 The Union of India had by its circular dated 8^th June 2021 fixed the following price.

11. When you consider drug prices, one should look at the base “ex-factory prices minus taxes excluding service charges if any”. As on date, the Government of India sponsored COVAXIN manufactured by patentee Bharath Biotech appears more expensive than the foreign generated yet locally manufactured COVISHEILD vaccine. In fact, the price of Russian owned-Russian manufactured vaccine is cheaper than Indian manufactured COVAXIN. Because Government of India wants to promote the export of Indian vaccines in a big way, it has apparently kept the COVAXIN prices high. In any case, as per the new policy, anyone above 18 will get a free vaccine if he chooses publicly funded health delivery models for vaccination. There is also scope for vaccinations in recognised private hospitals after paying the government fixed prices. Very soon you will find American manufactured vaccines in the market. I will not be surprised that after about 6 months, when the demand for vaccine subsides, there will be a glut of vaccines in the market and a consequent reduction in prices.

Obligations of Union of India under International Treaties

12. India is a member of the Paris Convention on the Protection of Industrial Property and the WTO TRIPS agreement. Both these treaties provide for the compulsory licensing of a patent. Chapter 16 of Indian Patent Act titled “working of patents, compulsory licenses and revocation comprising of Sections 82 to 94 provides for various safeguards before the governmental powers can be exercised to facilitate the more efficient dissemination of technology. Chapter 17 comprising of section 99 to 103 specially deals with powers of the Union government to use the patented invention for its own purposes. In fact, before a patent is revoked, under Section 85 of the Patent Act, the patentee must be given reasonable opportunities to meet the demand of the Indian market at a reasonably affordable price. Therefore, it follows that if the patentees take all steps to produce the vaccines locally and make the patented product available to the public at a reasonable cost, they have a vested interest in the continuance of the patents. Furthermore, even if patents are suspended or revoked in an emergency situation the patentees should be entitled to the “solatium”. Otherwise, it would amount to unjust enrichment. I believe that both the Paris Convention and the WTO TRIPS agreement demand all member countries to avail the existing powers under respective laws before resorting to the most draconian power of the revocation or suspension. In fact, more studies have to be pursued in these areas.

13. We also have to take into consideration the immediate needs of our domestic pharma industry. India today is the generic drug capital of the world. Yet we import most of the essential chemicals which are known as Bulk Intermediate chemicals from China. Naturally China will not lose the opportunity of profiting from the pandemic by increasing the prices of these commodities. Today many Indian companies have an opportunity to become research-driven companies at least in respect of vaccines and other COVID related inventions. A patent waiver will adversely affect the interests of Indian medical devices and equipment companies which admittedly are in a nascent stage. In other words, suspension of patent rights or a full patent waiver is in the nature of a Brahmastra (a weapon of mass destruction). Mythologically, Brahmastras are used only as a last resort. The warrior had to avail all the other normal weapons before resorting to divine Astras. In my opinion, a patent waiver is a Brahmastra. We should wait longer and have more data before pushing this forward aggressively.

This is not to say that the proposal before WTO seeking waiver of some of the rights in patents, copyrights, undisclosed and valuable commercial information is unnecessary and unjust. It is needed India and South Africa took the initiative. UK and Germany have voiced their opposition. But the European Economic Community is expected to support patent waiver. The consensus resulting from the discussions are indeed a welcome development. As pointed out earlier, Mr Modi government today is aggressively pushing forward the earlier proposal of Mrs Gandhi to WHO. That itself is a welcome development for Indian foreign policy. Congress should support this.

As they say, Time is the best healer!!