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Patents and Public Health

An exclusive intellectual right for an invention that can either be a product or process that offers a new solution to a technical problem issued by a government office is a Patent. The owner of the patent has the legal right to exclude others from using or selling that invention but this right is also for a limited period. The main reason to design such a patent system to promote innovations in almost all fields of technology and ensuring welfare to the population worldwide from that invention and also protect the patent holder from exploitation.

Health means to live a life without sickness or pain and also a state with complete well-being not just physically but mentally and socially. Healthcare according to WHO, on the other hand, is defined to prevent, treat, or manage any illness through the goods and services designed and offered. Various international conventions like UDHR in Article 27(2) and ICESCR in Article 15 (1)(c) link IPR's and human rights and provides the basis for human rights for patent rights or other forms of IPR's[1].

This will not just motivate new inventions but also improve the well-being of a developing or underdeveloped country as these innovations could be used for social or public welfare. The Indian Constitution also indirectly under Article 14 and 21 directs the state to take effective measures to improve the health care of the population. The patent law grants limited monopoly with the objective of public benefit and not merely to import inventions.

A new and important international framework especially in the health sector for IPR was introduced in the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement[2]. According to the agreement the protection of the invention is only limited for 20 years. All the member countries of WTO are obligated to follow the provisions of the TRIPS Agreement. However, the countries are free to make their patent and IP laws according to their developmental needs and legal system.

After the TRIPS agreement certain obligations which all the members had to follow were:

  1. To grant patent rights to the holder for at least 20 years from the date of application
  2. To give recognition to inventions in all fields of technology through patents but with limited exceptions
  3. To enforce patent law and rights to patent holders productively
  4. And to compulsory licensing with limited restrictions and conditions.
One of the most critical issues of developing or underdeveloped is the protection of public health and the development of necessary drugs. India has been one of the countries facing a health crisis with inadequate healthcare facilities and accessibility of medicines. The lawmakers of India being a developing country with a large part of the population under the poverty line added Section 3(d)[3] in the Patent Act in 2005 and achieved a balance between the TRIPS Agreement and availability of medicines for the poor at manageable rates which made India a leader in the pharmaceutical industry.

India became one of the important suppliers of pharma products at low prices in the form of a generic drug. The landmark decision of the Supreme Court in the Novartis Case[4] received media coverage not only from India but also internationally which explained the scope of enhanced efficiency mentioned under section 3(d) prevents evergreening of patents.

The supreme court said that enhanced efficiency means therapeutic efficiency and said that minor improvement in the drug does not result in enhanced efficiency and rejected the patent application of the Novartis company upholding the decision of the patent office.

The supreme court also said that there should be enhanced efficiency in the new invention to patent an already existing drug. Novartis had applied for exclusive rights for their drug named Gleevec which was rejected because India was now shifting to a product patent system instead of a process patent system according to the provisions of the TRIPS Agreement. This decision was marked as a premium on decisions of public health and pharma patent laws.

Availability of medicines at low prices in developing nations:

  • Compulsory licensing:

    Article 31 of the TRIPS Agreement authorizes the member countries of WTO to provide compulsory licensing including the government use licensing in respect of patents which authorizes any other person to use the patent other than the patent holder. This will not only enhance public health but also motivate to develop new inventions as adequate remuneration would be provided to the patent holder[5]. But this provision can only be used in case of extreme emergency or urgency. According to the Indian Patent Law, compulsory licensing can only be provided after 3 years from the grant of patent but in case of any national emergency, it could be granted earlier also. The Doha Declaration also outlines the rights of the government for the compulsory licensing of patents.
     
  • Parallel import:

    goods are produced under the protection of patents and placed into one market and then imported to the second market without the consent of the patent holder this is known as parallel importation. But this has become a condemnatory issue in the global trading network and many advocates support a global policy of banning parallel import. However, it is argued that an open regime of parallel import is necessary for the availability of the purchase of drugs at the cheapest prices.
     
  • Generic Buying:

    A generic drug is a drug that contains the same chemical substances used in the original patent drug. After the expiry of patents of the original drug consumers or authorities are allowed to purchase the off-patent drug. This, in turn, leads to competition which often leads to the accessibility of medicines in the market at lower prices.
     
  • Price Negotiation:

    With the introduction of new drugs which sometimes are extremely costly it becomes difficult to purchase such drugs especially the developing countries. Thus, the countries make an effort to negotiate with the patent holder to offer discounts for those drugs. For example, many pharma companies offered medicines at the lowest price to poor countries to treat HIV-AIDS.

Coronavirus: Patent rights and public health

With the outbreak of COVID-19 a deadly disease caused by the novel coronavirus across the world, there has been constant tension to balance between patent rights and protection of public health.

If patents for drugs are not available researchers and innovators will be discouraged. A Clinical trial of two medicines Remidisivir, which was originally developed to treat EVD and Fevipriavir is undertaken to see if they can be regenerated for the treatment of COVID-19. These drugs are patent protected in India and could be used to produce low- cost medicines in a very short time unless the patent holders insisted upon their patent rights.

Some counties like Germany and Israel have even issued orders for compulsory licensing for any patent-protected drugs which could be used for the treatment of the deadly disease. Global organizations like WHO and WIPO suggested that the WTO countries should invoke security exception mentioned under Article 73 of the TRIPS Agreement[6] necessary for security interests in such a threatening time to secure necessary medical products and technologies to face such an emergency and should support the developing countries to suspend their IP rights which may create hindrance for manufacturing of products to protect their population and public welfare.

Conclusion:
Generally, long-term research, expensive clinical trials, and heavy investment is required for the development of a new drug. Exclusive rights given to the patent holder is an incentive given to the innovator. Public health goals can be attained when both public, as well as private sectors, are included in the field of innovation which is necessary for developing countries. Worldwide co-operation would help in easy access to healthcare facilities and promote general health.

The TRIPS Agreement comes into picture here which has tried to make a balance between the access to medicines along with preserving the IP rights. This motivates pharmaceutical companies to increase their research and develop new drugs. The outbreak of various diseases like malaria, influenza, and tuberculosis which created trouble in many countries of the world were resolved due to improvement in the scientific, technological, and patent system.

However, these innovators should not forget that the true aim of drug innovation is not profit-making but saving lives and enhancing public health profit should be just the means and not the end. If this principle is kept in mind then achieving proper health situations for the population would not be difficult at a global level.

Being one of the leading producers of pharmaceutical products after adopting a provision of the TRIPS agreement the government of India should take active steps to ensure healthcare facilities and make insurance schemes in the health sector for the poorest of poor and also should invest in research and development at all levels and try to come up with more drugs which are economical. The government should also encourage the public sector to deal with and encourage research in all fields of technology.

End-Notes:
  1. J Millum, are pharmaceutical patents protected by human rights? 34 Journal of Medical Ethics, e25-e25 (2008)
  2. WTO AND THE TRIPS AGREEMENT https://www.who.int/medicines/areas/policy/wto_trips/en/
  3. Section 3 in The Patents Act, 1970 https://indiankanoon.org/doc/874310/
  4. Novartis AG v. Union of India, 6 SCC 1: (2013) SCC (Civ) 227: (2013) SCC OnLine SC271 SCC OnLine SC271
  5. Surabhi Shekhawat, Compulsory Licensing of Pharmaceutical Patents, Surabhi Shekhawat, “Compulsory Licensing of Pharmaceutical Patents, 5 Madras Law Journal 36 (2014) 5 Madras Law Journal 36 (2014)
  6. WTO | intellectual property (TRIPS) - agreement text - institutional arrangements etc Wto.org, https://www.wto.org/english/docs_e/legal_e/27-trips_09_e.htm

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