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Pharmaceutical Patenting In India-Problem Of Public Access To Healthcare

Lives have moved ahead a million squares in the time span of a few decades. Advancement of Science and Technology revealed a new world to the world. Even though progress in all spheres has greatly improved quality of human life, certain outcomes have been undesirable. In a race to provide a set rules and laws for every kind of issue the society could ever face, the lawmaker forgot who is to be benefitted.

This project, as the topic suggests, deals with the Pharmaceutical patenting. With uncountable creative brains come infinite innovations, which leads to patents for each of them. Talking about the Indian situation in terms of healthcare, prior to the 1960s, over 85% medicine was imported from other countries.

In 1970, the Patent Act provided for patent on process, and that immensely helped India to provide cheaper healthcare, as the Indian companies could reproduce them. This position, however, did not stay for long, and the TRIPS agreement provided for a patent to the product as well, along with process.

Currently, any company that gets a patent for their product and process, has the power to dominate the healthcare business and exploit the market. So, through this project, the author wishes to understand whether a patent can be granted to all medicines, if this is the case, then would be its effect on the free healthcare services and if a patent can be denied, what would be the grounds for the same?

Furthermore, with the COVID era, and the vaccination for the same, new questions have surfaced. Since only a few countries have been able to successfully manufacture a efficient and effective vaccine for the coronavirus, can the companies get a patent on the same, considering COVID-19 is a Pandemic which has claimed over 2 millions lives, shouldn't there be any provision to keep the exploitation of market in check, so that the world can fight with a critical issue at hand, instead of ignoring those who can't afford the vaccine.

Research Objectives
  1. To understand how the Indian patent regime (pharmaceutical patents) is in conflict with international regimes.
  2. To understand the subjectivity involved and the law with respect to granting of compulsory license and issues affecting public health at large.
  3. To understand what could be the possible effect on COVID vaccines with regards to patent.

Research Questions
  1. How right to the health of the public has been affected by the pharmaceuticals patent regime in India?
  2. What is the change in trend regarding pharmaceutical patents and in judicial perspective?
  3. How can Pharmaceuticals Innovations and India's Demand for Drug be balanced?
  4. What is the impact of patents on the economic growth of India?
  5. What are the provisions in place for patenting of vaccines for a disease spread worldwide? Suggestions as to what could be the right way forward in such crucial times.

Scope & Limitation
The authors have limited their scope with respect to jurisdiction to India. With respect to subject area authors have limited their scope to Patent Law

The present study is essentially doctrinal study; research undertaken is descriptive in nature with an analytical approach to the topic. Only secondary data has been used for examining the purpose of the research.

The Middle Path To Fundamental Right To Health And Pharmaceutical Patent

The recent time has witnessed the boom in commercialisation of pharmaceuticals which had ultimately leaded the corporations to get the product patented. The boom has lead to the invention of novel verities of drugs which are used to cure many medical infirmities that were earlier almost incurable. In a layman term if we try to understand this we can say that it is a boon to mankind but as the saying goes on that every good thing comes at a cost.

When a pharmaceutical company comes up with any drug the first thing it does is to seek protection for its invention so that other rival companies do not copy the same thing. These companies try to get protection under Intellectual Property Law; more precisely they try to get patent over that product.

Talking about the present time patent can be considered as the most used as well as abused kind of Intellectual property. On one hand patents can be considered a reward for the creativity and hard work and work as a encouragement but on the other hand they may also lead to abuse by the patent holder.[1] It sometimes leads to monopoly. When a company gets patent over a drug it in a way gets the authority to regulate the price of that particular drug.

So, if the price of any drug is kept very high only few people will be in position to get access to that particular drug than what about common mass, how will they get access to those drugs. Our constitution guarantees right to health as fundamental right under Article 21 of the Indian constitution. In this chapter we will discuss that how a balance is to be drawn between fundamental right and pharmaceutical patent so that there is no conflict of interest between the any concerned parties.

  1. The Dynamics Of Right To Health

    Indian constitution came into force in 1950. Back then there was only anticipation on induction of new ideas to the constitution which stands absolutely true.[2] Right to health is nowhere directly mentioned in our constitution but through the course of judicial developments now it can be said that right to health is the part of Article 21 which states that "No person shall be deprived of his life or personal liberty except according to procedure established by law".

    The "Indian Supreme Court has interpreted the constitutional right to life as requiring the State to provide timely medical treatment to preserve human life"[3] and as "including a right to the protection of health at work and freedom from sexual harassment"[4].

    "Bywidening the substantive dimensions of the right to life and liberalizing standing requirements so that any member of the public may seek redress for a legal wrong in the public interest, the Indian judiciary has created a uniquely hospitable litigation culture for pursuing legal claims to the right to health. The right to health also has an important place within international law."[5]

    The Supreme Court in the case of All India drug action network v. Union of India held that the government should take steps in order to facilitate its citizens with lifesaving drugs.

    As per Ayyaangar committee report, there is a high risk factor involved when it comes to granting of patents in countries like India. The patents confer monopolistic rights which in a way are against the interest of majority of population which is poor. This will be against the notion of access to medicines. The report also stated that any policy which has character of granting monopoly right is violative of preamble and also the Article 21 of our constitution.
  2. Pharmaceutical Patents Post TRIPS

    When TRIPS regulation came into force it worked as an encouragement for the private players in the market but the situation was different prior to TRIPS agreement. The patents Act, 1970 was much poorer friendly as it only granted patent on the process and not on the product.

    This was also one of the reasons of development of more generic drug at that point of time. "The domestic players were granted a rapid boost to reproduce and market the newly invented drugs in the Indian market by merely changing the process of production. With such prevailing circumstances, Indian pharmaceutical managed to produce drugs at lower price, thus making the drugs available for the poor sections of society"[6].

    This situation did not prevailed for much longer time. The member countries of WTO were compulsorily made to implement the TRIPS regulations (the maximum time limit within which these regulations were to be implemented was different for developed and developing countries).

    Indian in the initial stage did not implemented the regulations, it was only implemented after US made a complaint against India that:
    "It was not implementing the TRIPS properly by not providing an appropriate procedure for the filing of patent application and secondly, by not providing the exclusive marketing rights."[7] As a result, India finally changed its patent law in the year 2005.

    We can easily conclude from the above discussion that the pre TRIPS era of patent granting in the field of pharmaceuticals was less stringent as the other company was allowed to manufacture the same drug with different process which ultimately lead to less monopoly over the market thus in a way price was within reach of poorer section of the society but the post TRIPS era has lead to different situation all together.
  3. Characteristics Of Right To Health Under Present Patent Regime

    TRIPS cannot be considered very stringent regulation in Toto. Few of its clauses reflect a bit liberal approach towards the developing countries. Some of the articles are given below:

    Article 7 of TRIPS balances innovation and social and economic welfare. It states that "The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations".[8]

    Article 8 provides that "Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public heatlh and nutrition, and promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement."[9]

    Article 27(2) states that "Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law."[10]

    Article 30 of Trips provides that "Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties."[11]

    On one hand post TRIPS patent regime provided for granting of patents not only to the process but also to the product and on the other hand the provisions which are mentioned above provided a kind of flexibility to the country while granting patents. Although, these provisions provide certain flexibilities various countries faced consistent difficulties in interpreting it. To overcome this problem Doha Ministerial Declaration was held on 14 November 2011.

    WTO members laid emphasis on implantation and interpretation of TRIPS agreement in a way so as to promote the cause of access to medicines by all and that to without hampering research and new developments. All the member countries were pressing the motion of interpreting the rules of agreement as per their socio-economic conditions.

    Doha Declaration affirmed that "public health took precedence over private patent rights, and reaffirmed the rights of Governments to use inbuilt WTO public health safeguards and other available measures to gain access to cheap medicines". "The Declaration makes it clear that the Trips agreement's provisions on exhaustion in effect, leave each member free to establish its own regime without challenge but subject to the general TRIPS provisions prohibiting discrimination on the basis of a person's nationality"[12]
  4. Landmark Cases

    • Merck Sharp and Dohme Corporation And anr v Glenmark

      The parent Sitagliptin patent was granted to Merck and Marck had licensed the drug for retailing in India to Sun Pharmaceuticals pvt ltd.

      However, An application for Phosphate salt of Sitagliptin was filed by Merck but it was not able to fulfil the criteria for patentability and thus, was rejected by the Patent Office. Subsequently, The plan to apply for the patent of Phosphate salt in India was deserted by Merck. Glenmark took the advantage of the situation of Merck and applied for a patent for the phosphate salt of Sitaglintin under the name of Zita and Zitamet.

      They wanted a 'safe harbour' for the use of their drug in the lines with Januvia. Although, Merck has been given Indian patent application number but the same was abandoned by Merck, the hon'ble court of delhi while not going into merits of the suit held that this is not a prima facie infringement of any right of Merck as the application is pending before the patent office.
    • Hoffman - La Roche Ltd v. Cipla Ltd [13]

      An application for patent of drug named Tarceva, which was derived from Erlotnib was filed by Roche and Pfizer. This drug was meant for the treatment of cancer. This drug got patented in India and was granted recognition by India authorities. In the meantime Cipla limited announced the manufacturing of same rug with the name Erlocip. Plaintiff filed a suit of injunction and claimed infringement. Cipla argued that their action is in favour of public interest as the drug in question was life saving drug.

      The court denied the injunction petition, citing "the irreparable injury to the public interest that would occur by granting the order. Significantly, the court noted that stopping Cipla's generic production of erlotonib may lead to the shortening of lives of several unknown persons who are not parties tothe suit. This represents an important extension of the reasoning in Novartis AG: not only may courts factor in the right to health in resolving patent disputes, but they also may extrapolate from the parties' concrete harms to the more amorphous right to health injuries that could flow to the public at large".[14]
    • Bayer Corporation v. Union of India [15]

      Bayer and Cipla came into conflict when Bayer challenged attempt of Cipla to get approval from DCGI for a generic version of a drug patented by Bayer by the name of Nexavar. This drug is used for treating liver and kidney cancer. Bayer constantly argued that if approval is given to Cipla it will ruin the patent granted to it. Bayer also stated that patent linkage is necessary for the fulfilment of the purpose of patents act.

      The basically relied on section 48 of patents act 2005. Cipla on the other hand relied heavily upon the Novartis case and argued that this would amount to creation of unwanted impediments for generic competition and derogate public interest and welfare.

      The court rejected Bayer's argument for patent linkage, holding that "linking the regulatory and patent regimes would undermine TRIPS's Bolar early-working exception, stifle innovation and shirk addressing India's public health challenges. It noted that granting marketing approval for development of a drug does not ipso facto amount to a violation of the patent holders rights to make, use, exercise, sell or distribute his invention in India. Rather, the patent holder must formally allege and prove such an infringement before a court of law.

      The court adopted judicially modest posture, deferring to the legislature to link the regulatory and patent regimes. In deciding the case on these grounds, the court implicitly endorsed the importance of India's generic drug industry as an instrument for remedying India's public health challenges. Indeed, had the court sided with Bayer, it would have theoretically exposed every Indian generic drug manufacturer to potential liability for any research and experimentation it conducted on a name-brand drug still under patent.

      This likely would have had an immense chilling effect on India's dynamic generic drug industry, discouraging early experimentation with patented drugs and stalling the release of affordable generic replacements for otherwise unaffordable essential medicines. Because foreclosing future experimentation with patented drugs by generic manufacturers would exacerbate public health challenges, and by extension, undermine the right to health, the court dismissed Bayer's claim and reinforced the wall between India's regulatory and patent systems".[16]

Development Of Pharmaceutical Patents: Judicial Trend

There has been an on-going effort by majority of Nations as well as by International Organizations to be able to provide uniformity to Legislations all over the world, with respect to the Intellectual Property laws. Though, the hustle is in good faith, it has attracted criticism over the fact that pharmaceutical patents have been made a priority while unifying the framework. It is so because the Pharmaceutical companies of the Developed countries have a upper hand over developing nations, with no capital or infrastructure to develop their pharmaceutical industry.[17]

Prior to becoming WTO's member, India had no laws with respect to pharmaceutical patents, and its position was undecided. Patent rights were first recognized in 1856. Later, India became a signatory country to the Paris Convention for the protection of industrial property, 1883 and also, The Patent Co-operation Treaty of 1970, following which India introduced the patent Act, 1970.[18]

With regards to pharmaceutical patent, the Patent Act, 1970, provided for patenting the process of manufacture of drug, and not the drug itself. This was not the position under the Patent and Design Act, 1911, but was later changed in the above-mentioned statute to cut India's dependency on imported drugs.

The lack of Pharmaceutical patent led to widespread reverse engineering of drugs which were patentable/patented around the globe, but not in India, aiding the growth of the industry.. This helped in manufacturing of cheaper alternative to domestically patented drugs and also, internationally patented drugs (once the patent expired). This greatly helped India in establishing its place on the Global charts.[19]

TRIPS as rolled out by WTO, received a major backlash from developing countries, including India, but as it was required for member countries to accept and follow the Agreement, India incorporated the provisions into its Legal Framework. To protect the Later, as according to the TRIPS agreement, India made amendments in the Patent Act, 1970, over the years. The Trade-Related aspects of IPR Agreement, sets a minimum standard for protection of IP. The final amendment to the Patent Act in 2005 marked a new era for India' patent regime.

The Evolution of Intellectual property law can be divided into three phases: firstly, 1999, when India instituted "mailbox" as per the requirement of Article 70.9, which enabled applications for patenting of pharmaceutical/agricultural products. Secondly, 2002, which extended patent validity duration to 20 years so as to be in sync with the requirement of TRIPS agreement. Lastly, India conformed to TRIPS entirely and provided complete protection to pharmaceutical products, by abolishing its previous "process" patent and accepting the Western concept of "product" patent[20].

The 2005 Amendment raised serious concern regarding the affordability of the essential drugs as reverse engineering was illegalized and copycat-drug making companies were made to pay royalty to patent-holder. Furthermore, it also introduce the system of Compulsory licensing for exporting of pharmaceutical drugs to least developed countries.

Compulsory Licensing
Compulsory Licensing is a procedure through which, any company, agency or person can use or manufacture a patented product without taking the consent from the patent-holder. The license can be gained by filing an application to the Controller, under Section 84(1) of the Amended Patent Act of 2005, after 3 years from the grant of a patent.

"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."[21]

Certain requisites are taken into due consideration while assessing the application, such as the capability of the applicant, the invention and the reasonability of the patent granted to the product.

Novartis v. Union of India[22]
Post 2005, when amendment in the Patent Act, 1970 was introduced to comply with the TRIPS agreement, Pharmaceutical Industry went through a critical period trying to adapt to this change and understand how much it affects the healthcare system.

Novartis, one such pharmaceutical company raised the issue of what is patentable and to what degree an MNC can Get protection in the new patent regime. Novartis wished to manufacture a drug against cancer, which would make use of "imatinibmesylate" (glivec). It claimed that the molecule of the substance thus forms a drug which was already patented and protected. Novartis filed for a patent for the drug it wanted to produce as per the Indian requirement.

The case was taken up to the Madras Patent office, which rejected the application citing the reason that requirements under Section 3(d) were not fulfilled, furthermore, the modification was not patentable as it lacked "inventiveness". Novartis appealed against the decision in Madras HC and altogether challenged the validity of Section 3(d) stating that the section was discriminatory in nature and thus, violated Article 14 of the Constituted and it was not even in consonance with the TRIPS Agreement.

High Court upheld the decision of the Patent Office and rejected the appeal, following which Novartis appealed in the Supreme Court of India. The contention of Novartis was that since 'glivec' is a the only substance administered in Cancer drugs, and is a life-saving drug, which must not be put under purview of Section 3(d), as it would make the medicine non-affordable.

The Supreme Court, however, rejected the contention of Novartis and upheld the constitutional validity of Section 3(d). The Hon'ble court agreed with the Patent Office that the application lacked "inventiveness" and held that 'therapeutic efficacy' must be interpreted strictly.

Section 3(d) has helped in prevention of 'ever-greening', which would have resulted in high prices of drug due to monopoly, which in turn would have made India's healthcare non-affordable. Thus, the strict patent protection regime is justified.

Pharmaceutical Patent And Indian Healthcare System: Creating A Balanced Framework

In a bid to balance the need of Pharmaceutical MNCs to be have well protected product patents and India's healthcare system which caters to a diverse population made majorly of people below poverty line, it has been a constant struggle.

Up until 2005, the laws were lenient and allowed for copycat products, which did help in flourishing India's Pharmaceutical industry, but the same won't be feasible today as the developed market demands protection to their products as well. It is however not the case as India amended its Patent Laws in 2005 to allow for TRIPS agreement provisions to be complied with.

Outside pharma organizations presently face a deluge of disincentives in carrying imaginative medications and speculations to India. Innovative work costs for making new medications are excessively high. Clinical preliminaries testing the medication's security and adequacy-which contending generics makers can "free ride" on for administrative endorsement of their own medication items-require huge speculations.

These significant expenses, related to the on-going string of lawful disincentives, could well overall and smother advancement and drive pharmaceutical MNCs for all time away from the Indian market. Considering in thorough challenge from generics makers, pharmaceutical organizations can't recoup Innovative work costs [23]

As per the chief general of the Organization of Pharmaceutical Producers of India, an exchange bunch that speaks to major global medication organizations, the Indian government's strategies "impart an inappropriate sign to the remote speculators about capriciousness of the venture atmosphere in India, the effect of which could be felt even past the pharmaceutical area of the nation."

Equalization must be struck. India must give some confirmation to remote medication organizations that have put billions in new medications that their speculations will be shielded from uncompensated duplicating. To accomplish India's objective of giving minimal effort, open medications to its kin while additionally keeping up some similarity to conviction for MNCs and security to new medications they try to patent, India ought to grow the classifications secured under the "adequacy" necessity of Section 3(d) of the Patents Act as opposed to confine it to items that have a "restorative impact in mending an illness.".

Impact On Economic Development Of India

There is a direct impact of the patent laws on the economic development of the country. We all know that our country has adequate statue governing intellectual property and their protection. This has created a good reputation and trust and ultimately has resulted in multinational companies showing their interest towards research and development in India. There are numerous examples of companies which have initiated the manufacturing process of drugs in India.

These multinational companies when set up their business in any other country, they provide employment to the local population and pay taxes to the government thus indirectly contributing to Indian economy. The most prominent example is of Ranbaxy which is a multinational company. This company was established in year 1961.

As per the reports it employed around 1700 people in 2005 and the number drastically increased in 2012 and a total of 10983 people were employed in this year. Dr. Reddy is also an India Multinational company founded in 1984. It employed 7525 in 2006 and as per current statics the increased to 23524 in 2018. It can be seen that the company witnessed around 200% growth in its number of employees in just 12 years.

More number of employers shows that the company earns a huge profit and it also means more number of taxpayers to the government which is a indirect contribution to economy. "The total revenue generated by intellectual property offices of India was Rs. 608.31 crore in the year 2016-17 while total expenditure was only Rs. 129.8 crore. Total revenue generated by patent office was Rs. 410.03 crore and the remaining were generated by other intellectual property like Trademark, Geographical Indication, Design and Copyright".[24]

Indian pharmaceutical industry is the 3rd largest in the word producing generic drug at inexpensive rates and supplying these drugs to many Asian and African countries. Moreover, cost of production of medicines in India is very less compared to US. As per the report of WIPO, India is 2nd largest country when it comes to applications of pharmaceutical patents and this number increased after 2005, when India allowed product patent. "Indian pharmaceutical industry has grown from 6 billion US Dollar in 2005 to 30 billion US dollar in 2015 and it is expected to go up to 55 billion US Dollar by 2020."[25]

Intellectual Property Regime In India With Respect To Covid 19

  1. The Declaration of Doha.
    Member countries of the World Trade Oorganization on the date of November 14th, 2001 ratified a special WTO ministerial conference at a conference held in Doha popularly named as 'Doha Declaration'. This was done primarily so that WTO member countries acknowledge the importance of public health infrastructure difficulties like tuberculosis, HIV, malaria and all the remaining epidemics which were affecting humanity at a mass scale.

    The Doha declaration is also concerned with the importance of controlling the prices of drugs and at the same times recognising the importance to protect the intellectual property rights of the private pharmaceutical companies. However trips agreement gives right to the member countries to grant 'compulsory license' as and to determine the grounds on which such licenses will be granted.

    This has been done so that the member countries can take appropriate steps to safeguard the rights of the people of the respected countries. Member of the WTO are allowed to authorise the use of patent without the authorization of the owner of the same, only if, such usage falls within the ambit of the exceptions. This right has been vested upon the member countries under A.13 of the TRIPS Agreement.

    The manufacturing which can be done under article 31(f) of the TRIPS Agreement under a compulsory license will only be allowed for the domestic market circulation. A country which does not possess the adequate resources which will be required to manufacture the medicines which will fall under this exception is bound to be answered. Exceptions for those countries which are unable to manufacturer search drugs were given.

    The manufacturers were authorized to export the drugs to the countries which cannot the drugs. However, except the least developed countries, countries need to prove that they are not equipped with manufacturing facilities which can produce medicinal drugs for their own subjects.
  2. Compulsory Licensing and Anti-trust laws: An Analysis
    It can be argued that competition law does not allow a dominant player in an industry to misuse their dominant standing to bend the industry according their own needs. Basically, it exists so that monopolies cannot but intellectual property law protects the monopoly of the companies which are granted with the patents. This is a false understanding of both the laws.

    The principle of harmonious construction is applied in the case of competition law and IPR in such a manner that the patent is "used" and not "misused" by the dominant player under exceptions of the competition law. Hence, IP law and competition law goes hand in hand and helps each other to create a healthy business environment for the pharmaceutical companies in the country. Appropriate provisions allowing for the compulsory licenses are envisaged under the competition laws and also granted in intellectual property laws for public purpose.
  3. Natco v. Bayer
    An application for compulsory anti-cancer drug license was filed by Natco in 2011 for a drug named Nevaxar which was to be produced by Bayer under the Section 84(1). The Controller of patents of Mumbai accorded a compulsory license through an official notification. It was the first license in India which Natco secured. All the appeal which Bayer made to Intellectual Property Appellate tribunal, the High Court and the Supreme Court was dismissed subsequently. Although, the questions of law were remained open.

    According to the Controller of Patents, the Patentee made the medication available to only 2% of qualifying patients in 2009 and 2010 based on the details given by the Patentee under Form-27. As a result, the complaint falls under Section 84 (7) (a) (ii), which asserts that the prerequisites for the proprietary article was not satisfied adequately or on fair terms.

    It was also determined that, in terms of medication pricing, the patentee had been marketing the medicine at 2,80,000 rupees (for a one-month therapy), and it clearly did not made the therapy economical. The Controller General of Patents ruled that Section 84 (7) (e) of the Indian Patents Act, which states that importing prevents or hinders the working of a patented invention on a commercial scale in India, refers to Section 84 (1) (a) of the Act, which states that prerequisites have not been adhered to.

    Till now, only two application has been filed under S.84 Patents Act. The earliest claim which was filed for a drug named "Dasatinib" by BDR Pharmcaeutical for Brisitol-Myer Squibb's Cancer drug. The application was rejecetd as they apparently failed to construct a case which is compulsory according to S.87 of The Patents Act.

    The next appeal which was applied for diabetes drug names, "saxaglintin", by Lee Pharma to be produced by Astrazeneca. This application was also rejected due to lack of evidence.
  4. The Patents Act, 1970
    S.47 of the Patent Act is of significant importance as has certain pre-requisites for the grant of patents. One primordial pre-requisite is that the. "Broadly speaking the basic condition is any machine/apparatus/other article/any process for which patent is granted may be imported/made by or on behalf of the Government for merely of its own use"[26]. This allows the government to lift the protection provided to Patents and make use of the drugs for their own use. It comes with an assumption that governments own use means that it would be used for public purpose.

    Therefore, it is conclusive that the government can use the patterns which are already granted for self-use. This effectively signifies that the state can only utilise the patterns to produce the product for themselves through PSUs or to be manufactured by other private entities but can he used by themselves only.

    The remedy available under the S.47 encompasses a circumstance where the company gets no monetary benefit for drug operation under S.100 of the Act. IT also encompasses a circumstace where the govt will not be able to scale up the operation in case of emergency situations. Therefore, If the government wants to scale its manufacturing operations, it has to resort to the compulsory license which can be granted under S.84 of the Patent Act. If such a case arises., then, license holder will be asked to pay reasonable fees as determined by the Controller and which is further depending on judicial review.

India is a signatory of TRIPS Agreement and Paris Convention, 1883 approved appropriate section under the Patent Act, 1970 due to the reason that India is a member of WTO. India is expected to have a robust health infrastructure to fulfil the obligations that the WTO expects from its member countries. A few exceptions are carved out of the above mentioned laws in order to make sure that these laws do not acts as an hindrance in the exceptional circumstances such as covid era as same time acknowledging the need to protect protection.

This means that a member country can utilise the knowledge within the territory of member nations. Also, they can do the same within their own territory. However, appropriate framework for reimbursing the companies which will suffer due theses exceptions are shut up in place by the law-makers as the interests of the private pharma companies needs to be respected too, i.e., this decision is subjected to the review by judiciary to boost up the morale of the private sector pharma companies.

The biggest cause for concern is the controlling the price of the vaccines. It is true that appropriate sections regarding the same are enshrined in TRIPS Agreement but the effectiveness of such clauses remains to be under dark in a world where the current superpowers are already accused to monopolize the international markets for vaccine doses.

In order to uphold the protection to pharmaceutical industries by providing adequate rights through patenting, but at the same time, to make healthcare accessible and affordable especially to developing countries, it is important to take the following suggestions into consideration:

Firstly, a separate legal framework, focussed on pharmaceutical patenting in order to provide for necessary regulations. The existing patent regulations must be evolved and adapted to the country-wise economic conditions. Secondly, It is pertinent to simplify the concept of compulsory licensing, allowing a more flexible approach towards granting the license to least developed countries. Lastly, quintessential drugs, especially those which are live saving, must be made part of a tiered pricing system, where the developed countries have to pay higher than the set price to compensate for developing countries, which can pay a lower price.

The battle between conflicting interests of developed and developing countries may continue for long, as the complexities in development of patent laws could take up uncountable suggestions, amendments and volumes.

Developing countries are stuck between complying with global agreements and providing their citizens accessible healthcare. India has covered a hue distance backwards where in Pre-TRIPS era, it had less stringent and allowed legal re-production of patented medicines than in the Post-TRIPS era, where India complied with TRIPS and had to illegalize reverse engineering but maintained sufficient leniency upholding right to health, as evident in decisions in the landmark cases.

We need to understand that monetary interest of many big companies comes to stake when the price of a lifesaving drug is regulated but we need to understand that innovation and patents are the two different sides of a coin. This coin needs to be flipped keeping in mind the public health, ultimately innovations in pharmaceutical industry are meant to save life

  1. Kaur A., Chaturvedi R., 'Compulsory Licensing of Drugs and Pharmaceuticals: Issues and Dilemma' [2015] Journal of Intellectual Property Rights ,20, 279-287
  2. KM. Gopakumar, 'Product Patents and Access to Medicines in India: A Critical Review of the Implementation of the TRIPS Patent Regime' [2010] 3 Law&DEV. Review 326, 364-65.
  3. PaschimbangaKhetSamity v. West Bengal, A.I.R. [1996] S.C. 2426, 2426
  4. Vishaka v state of Rajasthan A.I.R. [1997] SC 3011
  5. Ibid
  6. Akshay Anurag, 'Pharmaceutical Patents and Healthcare: A Legal Conundrum' (SCCOnline, 3 September 2019)> as accessed on 16th March 2021
  7. Ibid
  8. TRIPS agreement 1995, Article 7.
  9. TRIPS agreement 1995, Article 8(1).
  10. TRIPS agreement 1995, Article 27(2).
  11. TRIPS agreement 1995, Article 30.
  12. Declaration on TRIPS agreement. as accessed on 16th March 2021
  13. LA 642/2008 in CS (OS) 89/2008 Delhi H.C.
  14. Hoffinann-La Roche Ltd. v Cipla Ltd., LA 642/2008 in CS (OS) 89/2008 Delhi H.C.
  15. LPA [2009] 443
  16. Bayer Corp. v union of India LPA [2009] 443.
  17. JakkritKuanpoth, 'Patent Rights In Pharmaceuticals In Developing Countries: Major Challenges For The Future'(2010)113
  18. Antara Dutta, 'From Free Entry To Patent Protection: Welfare Implications For The Indian Pharmaceutical Industry'[2011] 93 Review. Economics. & States.
  19. Nilesh Zacharias and Sandeep Farias, 'India: Patents and the Indian Pharmaceutical Industry' Nishith Desai (20 November 2019) <> accessed on 18 March 2021
  20. Akshay Khandelwal, 'Pharmaceutical Patent in India: Access to Medcines' (LegalIndia, 9 October 2014) <> accessed on 19 March 2021
  21. The Patents Act, 1970 s 92(a)
  22. (2013) 6 SCC 1
  23. Vindhya S. Mani, 'Divyanshu Srivastava, The India Patent System: A Decade in Review'Cybaris, An Intellectual Property Law Review [2018]
  24. Mohhamad Suleman Palwala,'Impact of patent law on economic growth of India: an analysis' (Mondaq, 18 July 2019) < Of-India-An-Analysis> Accessed on 20th March 2021.
  25. Biswajit Dhar, 'Effect of Product Patents on the Indian Pharmaceutical Industry' Accessed on 20th March 2021
  26. The Patent Act, 1970 s.47

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