This article is written by Prateek Jindal, from Vivekananda Institute of Professional Studies (VIPS), GGSIPU.
Table of Contents
Abstract
Patent is one of the major forms of Intellectual Property Rights (IPRs) used in the pharmaceutical industry governed in India under the Patents Act, 1970 (hereinafter referred to as “The Act”). Significant changes introduced in the Indian patent law, after India signed TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement in 1995, criteria of patentability, different types of pharmaceutical patents currently being granted and other relevant provisions related with patenting of pharmaceuticals are included here with special reference to the current global pandemic caused by COVID-19 virus having regard to the fact that India manufactures 60% of the world’s vaccine and according to a new report by IMARC titled “Indian Vaccine Market Report and Forecast 2020-2025” (see here), the Indian vaccine market reached a value of INR 94 Billion in 2019.
Introduction
Throughout history, nothing has killed more humans than the bacteria, viruses and parasites that causes diseases. Not the natural disasters like earthquakes, volcanoes or tsunami nor the war, not even close (see here). And now one of such virus, known as COVID-19 (hereinafter referred to as “the virus”) caused by the virus SARS-CoV-2, originated from Wuhan, China, has caused a global pandemic as declared by the World Health Organisation (or WHO) on 30th January 2020 (see here). There are as of now 2,99,16,191 cases and 9,42,478 deaths caused worldwide (see here) because of which there is need of vaccines and medicines to immunize against the virus and cure the same respectively, because of which it becomes appropriate to understand the patent protection as regard to medicines in Indian legal framework.
Development of patent protection in India
Pre-TRIPS agreement
The principal law for patenting system in India is the Patents Act, 1970. According to the statute initially introduced, no product patents but only process patents could be granted for inventions relating to food, drugs and chemicals, this implied for drugs that a pharmaceutical company only could protect the process used by it to manufacture it and not the drug itself, thereby giving another party a chance to reverse-engineer the product and manufacture the same drug but following a different process. The patents were valid for seven years from the grant of protection.
Post-TRIPS agreement
In 1994, the World Trade Organization (or WTO) was setup and India being the party to it became the signatory to General Agreement on Tariffs and Trade, 1994 (or GATT, 1994) as well as to the Trade Related Aspect of Intellectual Property Right Agreement (or TRIPS Agreement) in 1995 because of which India was under a contractual obligation to amend its Patents law to bring them in compliance with the provisions of the agreement.
Patents (Amendment) Act, 1999
This was the very first amendment in this statute of the series of amendment yet to come which brought the following changes:
- A pipeline protection till authorities initiated granting product patents;
- Provisions for filing of applications for product patents in the field of drugs and agrochemicals w.e.f. 1st January 1995 were added; and
- Introduction of Exclusive Marketing Rights (EMRs) on above-mentioned patents.
Patents (Amendment) Act, 2002
To comply with the second set of obligations under TRIPS further amended were introduced in the Patents Act, 1970. This amendment introduced provisions of:
- 20 years uniform term of patent for all categories of invention;
- Definition of “invention” was made compliant with TRIPS agreement; and
- Reversal of burden of proof in case of process patent infringement suit, among other changes.
Patents (Amendment) Act, 2005
Through this amendment:
- Finally the product patent regime was introduced.
- It made patentable, subject to certain prescribed conditions, mere discovery of new form, property or use of a known substance.
- Modification were made to the provisions related to pre grant and post grant oppositions.
- provision were introduced for the grant of compulsory license for export of patented pharmaceutical products in certain conditions (see here).
Criteria of patentability
Sec 2(1)(m) of the Act defines “patent”[1] as “means a patent for any invention granted under this Act” thus implying that patent is granted for the protection of a “invention”, which is defined as “means a new product or process involving an inventive step and capable of industrial application”[2]. Therefore, there can be carved out 3 essentials requirements for an invention to be patentable:
- Newness or new invention: to be patentable the subject matter of the invention must not be in the public domain, that is it should not be published in any document or used anywhere in the world or be known in any other way before the date of patent filing.[3]
In F. Hoffmann-La Roche Ltd. v. Cipla Ltd.[4]the court stated that “the relevance of the provision of “new invention” lies in the fact that it gives a flavour of the invention of the Legislature. Section 2(1)(l) when read in conjunction with sec 2(1)(j) also clarifies as to what is considered to be not new in the terms of the Act”.
In Novartis AG v. Union of India[5]the Supreme Court stated that
“in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject matter must pass, in addition to clauses (j) and (ja) of section 2(1) of the Act, the test of enhanced efficacy as provided in section 3(d) read with its explanation”[6].
- Inventive step: an invention should involve technical advancement as compared to existing knowledge or have economic significance or both, making it non-obvious to a person skilled in the art.[7]
In CTR Manufacturing Industries Ltd. v. Sergi Transformer Explosion Prevention Technologies Pvt. Ltd.[8]the court stated that “the degree of inventiveness is irrelevant. Slight alterations or improvements may yield dramatically important results and might be the result of very great ingenuity”.
The term “obvious” has not been defined under the Act, it can be safely stated to be circumstance where on going through the specification a person of skill in the field would complete the product.
- Industrial Applicability: the invention must be capable of being made or used in an industry.[9]
In F. Hoffmann-La Roche Ltd. v. Cipla Ltd.[10]the court stated that “Section 2(1)(ac) stipulates that an invention [as defined in Section 2(1)(j)] is ‘capable of being made or used in an industry’- thereby necessitating that an invention must have commercial use or manifestation… Thus, it is not the product which is the focus of attention but the actual physical substance created which has the potential of a commercial manifestation”.
Ever-greening strategies
Since the Patent (Amendment) Act, 2002 the period of protection is 20 years, which implies that once the period expires the drug as well the process to manufacture the drug will become available in the public domain and hence other producers can copy the same and sell drugs at cheaper price as they do not have to incur the cost of Research and Development, Marketing, clinical trials etc. that too drugs having same dosage, intended use, effects, route of administration, strength even the same side effects, risks and safety as the original drug.
Therefore in order to protect their financial interest, many companies came up with a strategy known as “ever-greening.” In the case of ever-greening companies makes one or the other insignificant change to the already existing product, like isomers which have same formula but different structure and having same properties provided they belong to same functional group, adding an inactive ingredient in the drug which don’t change the effect of the drug, etc. These kinds of strategies enable them to obtain the patent again for the same medicine thus maintaining the high price of the medicines and making them difficult to afford for the middle class and poor patients even after the expiry of the original period of protection.
The Supreme Court of India refused to grant a patent to Novartis, in the case of Novartis AG v. UOI, Novartis is a Swiss company and wanted to get their drugs, Glivec used for curing cancer, patented. Indian Companies raised an objection stating that a very similar product, Imantinib was already patented by the Company, and hence, this particular drug could not be patented. Novartis contended that it was a new invention since there were certain changes made to the drug but in reality the subject matter was merely a beta-crystalline form of the earlier patented drug. The Court stated that “In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of Section 2(1) and Section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed”. The Apex Court observed that Section 3 (d) was valid and also opined that “an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data”.
Compulsory licensing
Compulsory Licensing mechanism is one of the main features of any patent law. Section 84 of the Act states that
“(1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:—
(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
(b) that the patented invention is not available to the public at a reasonably affordable price, or
(c) that the patented invention is not worked in the territory of India.”
The application “shall contain a statement setting out the nature of the applicant’s interest together with the prescribed particulars and the facts upon which the application is based”. The Controller “may grant a compulsory license upon such terms as he may deem fit”, if he is satisfied that there exists any of the aforesaid conditions.
The first compulsory license in India was granted in the case of Bayer Corporation v. Union of India[11]. In the case, the petitioner, a U.S. Corporation got a patent for the drug Nexsaver in India which is used in the treatment of patients suffering from Kidney cancer and Liver cancer.
Later, Natco a drug manufacturer in India approached the Controller for granting of compulsory license for the purpose of manufacturing and selling the patented drug in India at a price less than Rs. 10,000/- per month of therapy as against the price of Rs. 2,80,428/- charged by the petitioner. Natco also stated that the fact that the petitioner had not with regard to the patented drug met the reasonable requirement of public as availability was of 5279 packets which can in no way could meet the annual requirements of the patients nor was it reasonably priced, nor was it worked in the territory of India. In the appeal finally the license was upheld provided that Natco comply with the direction of paying 7% of its net sales from the patented drug as royalty.
Drugs for COVID-19
Since the global outbreak of the virus, many counties are trying to come up with a medicine to cure the person infected with the virus or prepare its vaccine, but till now no drug as of now has shown complete effectiveness in curing the patients with the virus and many of proposed drugs are under clinical trials and so is the vaccine for the virus. Following are the drugs which are being studied for treating the person infected with the virus or given to the patients infected with the same:
Remdesivir
Remdesivir is an antiviral that is intravenously infused to the patient. It was previously shown to be somewhat effective against SARS, MERS, and Ebola in cell and animal models. In a recent in vitro study remdesivir prevented human cells from being infected with SARS-CoV-2, making it one of the top contenders in race of finding/inventing medicine to treat COVID infected patients. Though this has not been approved by the FDA for use yet, and is being tested in carefully controlled environments.
While initial findings have supported the use of remdesivir for hospitalized COVID patients, the researchers have reached the conclusion that treatment with remdesivir alone is likely not enough. This is because those who got the medication still experienced a high death rate.
Dexamethasone
It is a steroid medication that has been used for many years to treat various health conditions, such as autoimmune conditions and allergic reactions. RECOVERY, a clinical trial in the UK, is studying this medicine among others to see their effectiveness against COVID-19.
Tocilizumab (Actemra)
It is a disease-modifying anti-rheumatic drug (DMARD) recommended for rheumatoid arthritis and juvenile idiopathic arthritis. Different studies conducted worldwide reached mixed conclusions, in France it reported that patients were less likely to require ventilation or die on treatment with this medicine and in Italy it was found that those who were given tocilizumab had a lower death rate. Whereas, it did not help COVID-19 infected patients with early-stage or severed pneumonia.
Plaquenil & Aralen (Antimalarial Drugs chloroquine and hydroxychloroquine)
Hydroxychloroquine and chloroquine have been weapons to fight malaria for centuries. These drugs have proved to be lifesaving in the event of lupus flares and rheumatoid arthritis. These drugs had been used during the SARS crisis and showed promise, but were never widely used. This drug gain wide popularity in treating COVID patients very early on in the pandemic so much so that the India exported its consignment to many countries excluding US but it has turn out to have adverse effect on patients treated with it, because of which US FDA directed hospital in the country to stop prescribing this medicine to COVID patients.
According to recent statement by Junior Health Minister, Ashwini Choubey the Chloroquine was allowed to be used on patients as it has proved to be clinically beneficial in small single centre studies[12].
Kaletra (HIV drugs: lopinavir and ritonavir)
This HIV drug being one of the many studied early as a possible COVID-19 treatment had many fanfare but a study conducted in china over 199 COVID patients showed “no additional benefit as such compared to standard care”, though in theory, this medication could have been helpful by reducing the viral load of those infected. It had been studied in the treatment of both SARS and MERS coronaviruses, but the studies were flawed.
Avigan (Anti-Flu Drug favipiravir)
This is the drug which got green light from China for treating symptoms of COVID-19 patients very early on. It has also got approval in Japan for investigational use into this virus. Favipiravir has been reported to help the patients in “recovery quickly and with milder chest symptoms”, according to Chinese officials. In Boston, United States the first U.S. clinical trials is set to start for favipiravir. (see here)
COVID-19 vaccine trials
There are 36 potential COVID-19 vaccines being tested in human clinical trials and another one hundred and forty five being explored and are in early stages. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), has stated that we are likely twelve to eighteen months away from the vaccine.
Out of all the vaccines currently in Phase 1 of clinical trials two which are from India are:
- Zydus by Cadila Healthcare Limited: They have completed phase 1, and results showed the vaccine was well-tolerated. They began phase 2 on August 13.
- Covaxin by Bharat Biotech: Phase 1 and 2 trials began in July.
Other vaccines in Phase 1, 2 and 3 of Clinical Trials worth mentioning are:
- ChAdOx1 by the University of Oxford in collaboration with AstraZeneca and Serum Institute of India: Phase 3 trials in the UK and India were halted earlier this week after one participant developed transverse myelitis. Serum Institute of India, which has been running the trials in India, has also been asked to stop recruitment of volunteers for Phase 2 and 3 trials. However, AstraZeneca resumed trials after it received approval from the UK health regulator but not the US.
- Investigational COVID vaccine by Janssen Pharmaceutical Companies in collaboration with Johnson & Johnson: Few of the volunteers from its Spain human trial dropped out recently after AstraZeneca’s vaccine news.
- Sputnik V by Gamaleya Research Institute (Russia): Early results from phase 1 showed the vaccine was safe and produced an immune response. Russia has approved the vaccine, even though researchers have not completed phase 3 trials. The company recently contracted with Dr. Reddy for distribution of 100 million doses of the vaccine in India. (see here)
Since, almost all of the drugs are known substances, that is, they exist in the public domain and curing the patients infected with COVID-19 virus is merely discovery of new property of known substance thereby as per Section 3(d) of the Patents Act, 1970 they are not patentable inventions. However, for the vaccines which are in clinical trial phase, when they come out will amount to an invention eligible for patent protection as it will fulfil all the three essentials for an invention to be patentable.
Note: When a company in India wants to manufacture/ import a new drug it has to file for a license from the licensing authority that is Drugs Controller General of India (DCGI) by filing Form 44 and submitting the data as prescribed in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945. It has to conduct clinical trials commensurate with the guidelines stipulated in Schedule Y and submit the report of such clinical trials in specified format in order to prove its efficacy and safety in Indian population as it is not enough to provide the data of the tests conducted in foreign country, if the company has done so that is many companies from different countries are conducting or aiming to conduct tests in India so that they can get permission to produce it here, because as mentioned India especially Hyderabad is the vaccine hub on the world.
But a provision is there in Rule- 122A of Drugs and Cosmetics Act 1940 and Rules 1945 that the licensing authority may waive certain trails if he considers that in the interest of public health he may grant permission for import of new drugs basing on the data of the trials done in other countries and this provision can be of great significance in providing vaccines worldwide without conducting tests separately in each and every country.
The stages of drug discovery and development (see here):
Life-saving drugs
Since the Patent is the right to exclude others from unauthorized making, using, offering to sale, selling or importing the invention, this makes the drugs expensive as it seeks to balance between the intellectual production and intellectual consumption so as to enable the Patentee to reap the benefits of his intellectual consumption, and as well as to recover the cost which in case of drugs includes the cost of clinical test, marketing, research and development etc.
But considering the global nature of the effects of the virus and rising death count, it will not at all be suitable to charge from the patients infected with the virus a high amount which he might not be able to afford thereby causing the death of such patients. Therefore to counter such situation, India has in place the framework of “Essential Medicines” which was given by the WHO, which provides for formulating a national list of essential medicines over which the National Pharmaceutical Pricing Authority (NPPA) has the power to fix and monitor ceiling or retail price of drugs mentioned in it by invoking Para 19 of Drug Prices Control Order (DPCO), 2013. So, the government can add the drugs and vaccines effective against the virus in the list of Essential Medicines in order to control and monitor their prices considering the situation of pandemic caused due the virus despite any of them being protected under the Patent law.
Conclusion
An invention being a result of intellectual creation is provided protection under the patent laws so that the inventor can reap the fruit of his invention by being granted the exclusive rights to make or manufacture, offer to sale, sale or import which can be regulated by the patentee through the system of licenses. Also for chemicals, especially drugs an inventor has to perform the additional steps before he can sell the drugs in the market, to make them safe for consumption or use by performing clinical tests as required by the government.
The COVID-19 virus is wreaking havoc on the humans as can be seen from the statistics of persons infected with it and of death toll because of which a situation of worldwide pandemic has been declared and lockdown is in force almost everywhere, in such a situation there is a need for coming up with a drug which can cure the patients infected with the virus as well for a vaccine to immune the others, obviously they being an invention (besides the drugs already known whose new property is to help with this virus) will be eligible for patent protection. However, considering the need for the hour, any new drug in this regard will be most likely to be included in the list of Essential Medicines to regulate its prices. Besides the drugs and vaccines, the medical institution also implemented plasma or antibodies therapy where plasma is extracted from the blood of the survivors of the virus to use the antibodies to cure the patients still infected.
According to a study conducted by Indian Council of Medical Research (ICMR) it showed adverse reaction on the health of the patients but neither it reduced mortality nor did it prevent progression so the government may review guidelines as to its review.[13] Hence it can be seen that due to the spreading of the virus, it has led to a challenge in front of the medical institutes and research laboratories to come up with efficient cure and vaccines for the virus.
Bibliography
Primary Sources
Bare Acts
- The Patents Act, (Act 39 of 1970)
Secondary Sources
Books
- K. Ahuja, Law relating to Intellectual Property Rights (Lexis Nexis, Haryana, 3rd edn., 2019)
[1] Patent is the right to exclude others from unauthorized making, using, offering to sale, selling or importing the invention. Patent includes right to license others for the purpose of making, using or selling the patented invention.
[2] The Patents Act, (Act 39 of 1970), s. 2(1)(j)
[3] Ibid, s. 2(1)(l)
[4] 2016 (65) PTC 123 (HP)(DB)
[5] (2013) 6 SCC 1
[6] the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
[7] Ibid, s. 2(1)(ja)
[8] 2016 SCC Online Bom 5538
[9] Id, s. 2(1)(ac)
[10] (2015) 225 DLT 391 (DB)
[11] Writ Petition No. 1323 of 2013
[12] Mohua Chatterjee, “HCQ was found beneficial: Govt”, Times of India, Sept 16, 2020
[13] “ICMR: Some adverse reactions to plasma”, Times of India, Sept 16, 2020
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