VACCINATION IN THE PLAYGROUND OF PATENT LAWS: AN INDIAN CONTEXT

Vaibhav Jain

Author:

ABSTRACT

Since 1970, India has played a prominent role in Intellectual Property Rights (IPR) and Medicine. Over these years, there have been many changes made in Intellectual Property (IP) laws and their implications. They're believed to be two of the major changes which India has seen so far, first was the 2001 DOHA DECLARATION in which India made WTO waive patent over HIV/AIDS drugs and let them available to the world and second was the 2005 amendment in Indian patents act in compliance with the TRIPS agreement. These two DEVELOPMENTS have changed Indian IP laws completely. Now in the year 2021 as we all know the world is suffering from a pandemic named COVID-19 we can see one more major change in the IP LAWS because India is asking to grant patent waiver over COVID-19 VACCINE. Can WTO grant the waiver and what are the legalities for the same are discussed in the article.


VACCINATION IN THE PLAYGROUND OF PATENT LAWS: AN INDIAN CONTEXT 

INTRODUCTION 

WHAT IS TRIPS? 

OBJECTIVE OF TRIPS 

ROLE OF TRIPS 

WHAT ALL CAN BE PATENTED? 

SECTION 3 & 4 TALKS ABOUT THOSE INVENTIONS WHICH ARE NOT PATENTABLE

SOME FEATURES ADDED BY THE 2005 AMENDMENT 

REQUIREMENT FOR THE GRANT OF THE PATENT 

CAN A PHARMA COMPANY FILE FOR THE EVERGREENING OF THE PATENT OVER THEIR PRODUCT/ MEDICINE? 

CAN A VACCINE GET A PATENT? 

WHAT IS CURRENT SCENARIO REGARDING COVID19 VACCINE AND DEMAND FOR WAIVER 

OPPOSITION OF THE MOVE

WHY IS THE DEMAND TO WAIVE PATENTS ON COVID VACCINES ARE SO IMPORTANT? 

EFFECTS OF WAIVING THE PATENT 

SOME OTHER ISSUES 

CONCLUSION 

INTRODUCTION -

Since our childhood, we rarely talk about medicines and their requirements in the country but the year 2020 has changed everything. Medical equipment and medicines became part of our day to day conversation, we started talking about vaccines and medical equipment and why they should be the utmost priority for the world and India as well. We all heard stories from our parents, grandparents regarding all these diseases[1]Polio, Tetanus, The Flu (Influenza), Hepatitis B, Hepatitis A, Rubella and their vaccines. A vaccine has the same germs that cause the infection in a body.

In 2020 we all get affected and completely uprooted by the pandemic called COVID-19[2]. According to the historians and doctors of the world, this virus is the deadliest one which is spreading with touch and just by getting in contact with the infected person.

The nation (CHINA) from where this virus originated discovered its first case on  Nov. 17, 2019, and The 1st case of COVID-19 infection in India reported in Kerala On January 27, 2020. The virus has caused approx 3,819,658 deaths across the world till now.

While the world is fighting and battling with this deadly virus, on the other side health workers, scientists and pharmaceutical companies across the world are finding a way to deal with and cure this global pandemic. And they successfully made vaccines that can restrict the virus to harm the human body.

In these hard times when counties needed vaccines desperately to cure their people, these companies demanded patents over these vaccines.

This article focuses on patents over those vaccines which are made by foreign pharmaceuticals companies. Recently the demand for a patent waiver over those vaccines have been made by is India and South Africa together. As we all know covid-19 is a global crisis and these extraordinary conditions require extraordinary steps to cure it.

Patent laws and TRIPS have a very important role in IP protection all around the world. Let's discuss it further.


WHAT IS TRIPS?

History - Bretton Woods conference held in 1944 to govern international monetary policy after that two institutions were created i.e.

  1. IBRD in the year 1945

  2. IMF in the year 1946

GATT was established to harmonize world trade in 1994 and after the last GATT round is also known as Uruguay Round, WORLD TRADE ORGANISATION was established in 1994. TRIPS is one of the most important agreements of WORLD TRADE ORGANISATION. It came into effect on 1 January 1995.

OBJECTIVE OF TRIPS -

  1. Provides a common set of rules for the protection of IP globally      under the WTO system.

  2. It also said provision      that deals with domestic procedure and remedies for the enforcement of      IPR.

  3. Member countries have to prepare necessary national laws to      implement the TRIPS provision.

  4. Signing TRIPS agreement means countries have to modify their IP      laws in accordance with provisions of the TRIPS agreement.

  5. In India, the government      made major amendments to the 1970 patents act in 2005 to accommodate the      TRIPS provision.

ROLE OF TRIPS -

TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS. The agreement requires all its signatory countries to enact domestic law, which guarantees a minimum standard of IP protection.

What is the use of TRIPS -

It helps innovators to monetise their IP in multiple countries without any fear of legal obligations.

Now let's talk about the patent under Indian laws and how TRIPS play a role in making IP protected all around the world.

WHAT IS A PATENT?

Patents are one of the oldest forms of intellectual property protection and, as with all forms of protection for intellectual property, a patent system aims to encourage economic and technological development by rewarding intellectual creativity/ invention. To get a patent, technical information about the invention must be disclosed to the public in a patent application[3]

In simpler words, if we say a patent is a contract between an applicant or inventor and the government where the government provides the right of protection of the invention for a limited period of time after the full disclosure of the invention by the applicant or by the inventor of that invention.

Under indian patents act 1970 section 2 (I) stats that "new invention" means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.eThe subject matter has not fallen in public domain or that it does not form part of the state of the art; and if the invention fall under all the requirements then it will be patented under the indian patents act 1970 which says that "patent" means a patent for any invention granted under this Act.

WHAT ALL CAN BE PATENTED?

  1. The subject matter of the patent should be new.

  2. It should involve inventive steps.

  3. The invention must be capable of being used in industry.


SECTION 3 & 4 TALKS ABOUT THOSE INVENTIONS WHICH ARE NOT PATENTABLE-

● Discovery is not patentable. Example- law of gravity

● Any method of agriculture is not patentable.

● Any process for medical, surgical-treatment is not patentable.

SOME FEATURES ADDED BY THE 2005 AMENDMENT -

  1. Extension of product patent protection to products in the sector      of drugs, foods, chemical & microorganisms.

  2. The term for protection of product patent shall be for 20 years.

  3. Section 3 (d)[4]     regarding patentability: discovery of the new form of the existing known      substance is not patentable.


REQUIREMENT FOR THE GRANT OF THE PATENT -

  1. application should be      made at the Indian Patent office.

  2. any person i.e. Indian or foreigner individuals , companies or      the government can file patent applications.

  3. the person applying for a      patent shall be the true and first inventor of the invention proposed to      be patented.

  4. a patent application can      be made for a single invention only.

CAN A PHARMA COMPANY FILE FOR THE EVERGREENING OF THE PATENT OVER THEIR PRODUCT/ MEDICINE?

Evergreening of patents means that sometimes the owner of some patented product makes minute changes in that particular product before the expiry of a period of 20 years and then again apply for patent so that their product won't fall into the public domain.

In the case of “ NOVARTIS VS. UOI & OTHERS” Civil Appeal No. 2706-2716 of 2013[5]

FACTS

Novartis, the world's leading pharma company filed an application for grant of patent for an Anti-Cancer drug in 1998. The drug name was GLIVEC. In 1998 when they applied for it in India there was a different patent Regime in India, no patent was granted to Pharma products . so the company was told that their application for grant of patent would be considered later. In the year of 2005 when India changed its patents act in order to be in compliance with the TRIPS agreement , India started granting patents on pharma products. So in 2005 patent application was taken into consideration. Then in 2006 Madras patent office rejected the patent application of NOVARTIS stating that GLIVEC 400 mg did not exhibit any major changes in therapeutic effectiveness over its pre-existing form. This decision was based on Section 3(d)[6]of Indian Patent Act 2005 which provides that a known substance can only be protected if it's new forms exhibits enhanced efficiency. After that 2 writ petitions were filed by the said company which were rejected by the MADRAS HC.

- The case prevents the pharmaceutical industries from evergreening their patents.

-  The term of obviousness / inventive step was interpreted in this case.

- The Court held that It did not have jurisdiction to determine whether a domestic law is in contravention to International treaty, so it cannot decide whether section 3(d) is in compliance with TRIPS. and as far as section 3(d) is considered, the objective of the amending Act was to prevent “evergreening” and to make easy access to life saving drugs to the citizens. Therefore it cannot be considered to be vague and arbitrary.

CAN A PATENT BE TRANSFERRED?

When a patent for an invention is granted the patent holder , owner or patentee can transfer the patent in two forms:

  1. Assignment

  2. license

Assignment- the term is not defined under the patents act but the owner can assign whole or a part of his patent to the assignee. It can be in three ways -

  1. Legal assignment

  2. Equitable assignment

  3. Mortgages

License- By the way of agreement a patent holder can grant license to anyone under the section 70[7]indian patents act. It permits licensees to use , sell or exercise the invention. The license should be in writing. A contract signed by the licensor and the licensee in writing can be called a license.

Licenses mainly of four types namely,

  1. Voluntary License

  2. Compulsory License

  3. Exclusive/Limited License

  4. Express/Implied      License

For the purpose of this article we have to understand what is compulsory license , ‘compulsory license’ defined under section 84[8]of the indian patents act 1970. In simpler terms we can say that When manufacturers create new medicines they receive a patent with the promise that for a limited time only they can produce the medicine. This encourages the Investment and continued research so that new Medicines are constantly being developed but with compulsory licensing regulators can break that promise , they allow other companies to sell copies of the medicine before the patent expires.

Quick cheap drugs sound appealing but there are real consequences to compulsory licensing -

  1. medicines      copies made from a compulsory licence may not have been produced with the      same quality standards. just because A company has a compulsory licence      does not mean it has the background knowledge or the capacity to reduce      the medicine with the same efficiency and safety as the original

  2. compulsory licensing undermines the      development of new treatments. manufacturers rely on patents to help recoup their Investments new medicines to people who need them without this income they may      have to cut new research short      halting medical innovation and ;

  3. Compulsory licensing discourages      manufacturers from doing clinical trials in countries that don't honor      patents. This is a loss for patients who miss a chance. It is also a loss for local economics which would      otherwise get a boot from having clinical trials in a region.

A better option for long term patent Access is a voluntary licence arrangement where one patent holder partners with other companies sharing expertise about how we make the medicine in question. arrangements that prioritise the long-term well being of patients, not short sighted cost cutting are the best bet for patients , their health and the regional economy where they live.

Case laws on COMPULSORY LICENSE -

BAYER CORPORATION VS. CIPLA, UOI ” 2014 (60) PTC 277 (Bom)[9]

- This case is related to the topic of “compulsory license”. Section 84[10]The act states that after 3 years from the date of grant of patent , a person can apply for compulsory license.

- For getting a compulsory license 3 conditions are required-

1. The reasonable requirement of the public has not been satisfied.

2. The patent invention is not available to the public at a reasonable price.

3. The invention does not worked in india.

- The court held that ‘medicine has to be made available to every patient at reasonable cost , the petitioner was required to pay royalty to the patent holder against compulsory license’.

CAN A VACCINE GET A PATENT?

In the case of  “DIMMINACO A.G. VS CONTROLLER OF PATENT DESIGN” (2002)[11]

Facts

- The material facts of the cause are that the said Patent Applicant filed by the appellant involved, according to the appellant, an invention relating to a process for preparation of infectious Bursitis Vaccine. The said Patent Application was examined by the Patent Office Examiner under section 12 of P.A. On such official examination, the Examiner gave a finding that what is claimed in the said Patent Application does not constitute an invention under section 2(i)(i) of P.A. The said Examiner further stated that the invention is one of the classes as specified in section 5(a)/5(b) of P.A. as the substance prepared by the process is capable of being used as Food/Drug. However, the said examination report shows that the same does not constitute an invention under section 2(i)(i) of P.A. as noted 2 above. In the said impugned decision under appeal, the authority concerned also proceeded on that decision of the examiner

- After examination Under section 12[12] of the Indian patents Act 1970 it was reported that the vaccine not an invention under section 2 (j)[13].

- Court held that “the process for preparation of the vaccine was new, novel and included inventive steps , if the and productive new article it is patentable”.

WHAT IS A PATENT WAIVER?

A patent waiver refers to the government’s waiver of rights in an invention for a temporary or permanent time period. In the recent past after the covid 19 breakdown INDIA kept on asking in WTO to withdraw the IP protection from the covid 19 vaccine because we all know that in these

extraordinary conditions if we want to provide vaccines all over the world then extraordinary steps from the WTO will be needed. This is not the first time that India is initiating such a thing. In 2001 during Doha declaration India did it for HIV. Since 1970 India has played a leading role in IPR and medicine. Lower income middle income for developing countries like India having the effect of pandemic that suspension will surely help india. India is called the “generic hub of medicine”.

HOW CAN A PATENT WAIVER BE INITIATED?

- To grant patent waiver on an invention all 164 World Trade Organisation members have to agree on the draft of IPR waiver provided that any one member can VETO.

-  Some years back India VETOED “ trade facilitation agreement”.


WHAT IS CURRENT SCENARIO REGARDING COVID19 VACCINE AND DEMAND FOR WAIVER -

India and South Africa seek waiver in global IP agreements regarding patents over vaccines and to ensure uninterrupted flow of vaccine amid the ongoing pandemic.

Under the trips exemptions for suspending of weaving patent protection on medicines used in the emergency can be made. India and South Africa did it in the past in the year 2001 for drugs to treat HIV. After all these PM Modi talked about it over a phone call with US President biden on 26th April. Official statement issued from Indian site states that Modi emphasized the need to ensure a smooth and open supply chain of raw materials and inputs required for the manufacture of vaccines , medicines.

The draft proposal, which was presented by India and south Africa, to the TRIPS Council, on October 2nd 2020 , stats that “it is important for WTO members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and all the medicines or manufacturing and supply of medical products essential to combat Covid-19”.

Apart from the USA , BRICS also supported India in this move . Brics members on 2nd june 2021 agreed in a meeting to support this measure in order to ensure a fast, affordable, and equitable access to medicines, vaccines and health products and technologies, and their components, in order to fight the pandemic.

OPPOSITION OF THE MOVE-

However, developers of Covid-19 vaccines such as AstraZeneca, Pfizer and Johnson & Johnson have opposed any waiver for doses made by them , saying that they are capable of producing adequate jabs to satisfy the demand. They even stated that the small nations which are tagged as developing nations don't have the skills and technology to produce such vaccines. The opposition of the move made by India and South Africa to waive patent over vaccines can be said as ‘business oriented opposition’. This, despite the fact that WHO chief Tedros had said that lifting patents doesn't mean the innovators won’t get anything — they will surely get royalty for the products they manufacture.

Drug manufacturers and governments in the US, UK and Europe are strongly opposing the patent waiver. But the biden administration now supported india and EU has also issued the statement in support of this india as well. The major reason behind the biden administration support can be related with the year 2001 , when during the meeting in doha a very declaration was made by TRIPS and WTO regarding HIV/AIDS drugs. At that time the US supported that move by being on the side of the developing countries. now biden , not explicitly but said that the vaccine should be available to the whole world.

Besides having such dangerous variants , outbreaks , waves still these companies are opposing it. Pharma giants have been arguing that vaccine quality and safety depend on maintaining exclusive intellectual property rights over them. They have been further arguing that they’ve spent so much of their time , efforts , money on making them and lifting of patents would be a huge demoralisation to them.


WHY IS THE DEMAND TO WAIVE PATENTS ON COVID VACCINES ARE SO IMPORTANT?

At present, only pharma companies which own patents are authorised to manufacture Covid-19 vaccines. Lifting of patents will make them share their data to any company which has the required technology and infrastructure to produce vaccines. It will produce the cheaper and more generic versions of Covid vaccines which will be more affordable and this will lead other countries to get over from vaccine shortage.

EFFECTS OF WAIVING THE PATENT -

The waiver is probably going to have 2 important trigger effects

  1. Firstly, of course, it      would remove barriers of access to Covid-19 drugs, vaccines and other      treatments. Relaxing Article 31[14] The      TRIPS law would lead developing countries with insufficient or no      manufacturing capacity to freely import pharma products.

  2. The secondly related effect      would be that countries like India will be eligible to make sufficient      doses for their people which will ultimately lead to vaccination of a      large number of the population. This will take us to make things normal at      ground level and set us free to run the country as normal.

EVEN IF THE PATENT WAIVER GRANTED BY THE WTO STILL THERE WILL BE SOME ISSUES WHICH INDIA HAVE TO FACE IN THE PROCESS OF MAKING THE VACCINES. THE ISSUES ARE DISCUSSED FURTHER.

SOME OTHER ISSUES -

FPMA has pointed out that apart from IPR waiver There are some real challenges in scaling up production and distribution of covid-19 vaccine. Namely-

  1. Trade barriers.

  2. Bottlenecks in the supply      chain.

  3. Scarcity of raw materials      and ingredients.

  4. Unwillingness of rich      countries to share doses with poor countries.

TO SOLVE THESE ISSUES HERE ARE SOME SUGGESTIONS -

  1. The      Government of India must enable Indian vaccine manufacturers to expand      production.

  2. Encourage patent holders to voluntarily      licence their patent to manufacturers.

  3. Bring administrative      efficiency in vaccine input procurement and distribution.


CONCLUSION -

Innovation of Drug Discovery is a very expensive, time-consuming and risky process. Industries spent huge money on that so that they have the right to say that they have to recover that cost so that they can put it back into innovation. However, in a situation like a world pandemic, temporary suspension of IPR protection is to be there by mechanism. Developing countries like India and other countries who have lower income and middle income are having a large effect of the pandemic and this suspension will surely help them to grow again. India is such a technological platform we can use this waiver to produce MRNA vaccine in bulk and with that, the vaccine cost will be less.

[1]centers for disease control and prevention,

https://www.cdc.gov/vaccines/parents/diseases/forgot-14-diseases.html (last visited 8th may 2021)

[2]world health organisation , https://www.who.int/health-topics/coronavirus#tab=tab_1 (last visited 8th may 2021)

[3]wipo , https://www.wipo.int/patents/en/ (last visited 8th may 2021)

[4] the patents act 1970

[5]  novartis vs. uoi & others,  manu/sc/0281/2013.

[6] the patents act 1970

[7] the patents act 1970

[8] the patents act 1970

[9] bayer corporation vs. uoi ,manu/de/1756/2009.

[10] the patents act 1970

[11]dimminaco a.g. vs controller of patent design,  i.p.l.r. 255 (cal)

[12] the patents act 1970,

[13] the patents act 1970

[14]world trade organisation , https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm (last visited 13th may )

Vaibhav Jain