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PHARMACEUTICAL INDUSTRY AND PATENT REGULATION IN INDIA.

“Inventors are honorable not because they make difference, but because they want to make a difference against all odds”

~ Kalyan C. Kankanala


INTRODUCTION


A patent is a form of Intellectual Property right that is granted to the inventor by the state for their valuable invention for a limited period of time in lieu of public disclosure of details and working of their invention. The intent behind granting a patent is to encourage and develop new technology and industry[1]. A patent is the major form of IPR that is available to the pharmaceutical industry and medical device companies. Technological advancements have initiated rapid growth in the pharmaceutical industry. India is one of the leading countries in the pharmaceutical industry be it manufacturing or exporting and has been consistently growing. Protecting one’s Intellectual Property Rights has become a matter of significant importance owing to the valuable development and investment in the field of research and technology.


The pharmaceutical sector works for the betterment and welfare of society as result it is a dynamic and research-intensive sector. The Law of patents in India is governed by the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005. India is also the signatory to the Trade-Related Aspects of Intellectual Property Rights which makes it mandatory for India to make compliance with the provisions of the agreement. The 2005 Amendment, introduced the concept of “Product Patentability” in India for adhering to the provisions of the TRIPS Agreement. The Indian Pharmaceutical Industry is dominated by private-owned companies having a substantial share in the domestic market.


ELIGIBILITY FOR GRANTING PATENT


According to The Patent Act, 1970 a patentable invention is defined as “a new product or process involving an inventive step and capable of industrial application”. The inventor should be the true and first inventor of the invention. There is a certain requirement that needs to be fulfilled for obtaining a patent are mentioned below:-


1. Novelty- The subject matter of the invention should be new and not known to the public before the date of filing a patent application. If the invention is already known to the public it would defeat the objective of the Patent Act i.e. to provide economic benefits to the inventor in lieu of disclosing his invention to the public. The innovation should not be made public in the country or outside even by the inventor itself, before the date of patent filing.


2. Inventive Step- An invention that is obvious to the inventor or a skilled person cannot get a patent. The invention should involve technical advancements in making the new product or invention subsequently making the invention not obvious to the art of the inventor.


3. Industrial Applicability- The invention should be capable of being used and manufactured in the industry. The question that arises here is whether the invention is capable of being made with the compliance and information that is mentioned in the patent and not on the usefulness of the invention.


PATENT LAW IN INDIA


In India Patent Act was introduced in 1970 repealing all the previous legislation and the act has been constantly amended further. The first amendment was made in the year 1999 for giving pipeline protection to the inventor till the time India introduces a regime for product patents. This amendment introduced the filing of the patent products as mailbox applications only in the field of drugs and agrochemical and granted them Exclusive Marketing Rights for the patent.[2] The second amendment was made in the year 2000 it exceeded the term of the paten to 20 years in all the sector and made it uniform. The third amendment was made in the year 2005 and it is one of the crucial amendments as it introduced the concept of “Product Patenting” in India. It also introduced the granting of compulsory licensing under some conditions for the export of patentable pharmaceutical products. [3]


Under the product patent regime, the sole drug can be patented and the other manufactures can be abstained from manufacturing the same drug, earlier only the process of making the drug could get a patent. Section 3 of the Patent Act laid down the inventions that could not get a patent. The mere use of a substance that is already known to the public and which does not result in any enhancement of the efficacy of the already known substance, cannot be considered as a new invention.[4] These provisions help in abstaining the companies from using the “Ever-greening Strategies” where they tend to make minor changes in their patentable product or the existing drug in order to receive financial gains. Section 3(d) has made it difficult for the companies to secure a patent for the already patentable products. The companies need to demonstrate that their new version of the product is “therapeutically more beneficial than earlier versions on which patents had expired.”


Novartis AG V Union of India[5]


This is one of the most important cases concerning section 3(d) of the Act and the concept of an ever-greening patent. The Swiss pharmaceutical company ‘Novartis’ filed an application in India for getting a patent for their anti-cancer drug “Glivec” but the application was rejected as it was the unpatentable modification of the already existing drug (imatinib), and it did not show any therapeutic efficiency over its earlier form. The Madras Patent office held that the drug “Glivec” lacks the novelty and inventiveness that is basic criteria for getting a patent. Novartis argued that Section 3(d) of the Act is not in compliance with the TRIPS Agreement and said that it amounts to the violation of Article 14 of the Indian Constitution as they are discriminating against Novartis. Subsequently, Madras High Court and Intellectual Property Appellate Board held that the question of section 3(d) being violative of the TRIPS Agreement does not come under their jurisdiction, the question should be in front of WTO and adhered to the decision of the Patent office.


Novartis reached the Supreme Court, but the result was the same. The apex court held that ‘Glivec did not comply with the provisions of Section 3(d) of the Act and hence it is not eligible to get a patent. It failed to demonstrate the therapeutic efficacy of the substance which is a prerequisite for getting a patent and mere making of minor changes in the already known substance does not make it a new invention. Further, the court said that in the cases of pharmaceutical drugs which are life-saving the more stringent provisions need to be applied as it is for the welfare and interest of society. The judgment for not granting the patent to Glivec had an impact in the country as well as internationally as the price fell from 1,50,00 to 6000 which subsequently help to save the lives of many patients who were not able to purchase the medicine earlier[6]. The court state that it is not necessary to have a single definition for enhanced efficacy also the judgment rendered in the case of Novartis cannot be taken as a prohibition for all the patents concerning the “incremental inventions of chemical and pharmaceutical substances[7] The factor of an affordable drug is an important aspect that was considered by IPAB while giving the decision. Section 3(b)of the Act states“patents cannot be granted to an invention, the primary or intended use or commercial exploitation of which could be contrary to public order, or morality, or which causes serious prejudices to human, animal or plant life or health or to the environment.”[8]The court said that it lacked the enhanced efficacy as well as it was beyond the reach of the common man i.e. it was not in compliance with section3(b).


CONCLUSION


The Patent Act, 1970 safeguards the interest of the companies by granting them patent for their valuable invention which further encourages the development and growth in the country. The technique of the ever-greening patent is used by many companies like Novartis as discussed above should be condemned as it is hampering moral rights and is against the interest and welfare of society. The Country’s major duty is to protect the interest of society and the welfare of the people. Indian patent laws have subsequently been amended to be in compliance with the TRIPS agreement. There is a need for the regulations for proper application of the Novartis guidelines as they are not being used properly. It is important to maintain a balance between the innovation and affordability of pharmaceutical drugs as low-cost medicine is a necessity of a country.


[1] P. Narayanan, Intellectual Property Law, 3rd ed., Eastern Law House, New Delhi (2017)

[2]Dr. Rajeshkumar Acharya, The Global Significance of India’s Pharmaceutical Patent Laws, American Intellectual Property Association

[3]VipinMathur, Patenting of Pharmaceuticals: An Indian Perspective, International Journal of Drug, Development and research (2012)

[4] Sec. 3(d), The Patent Act, 1970

[5](2007) 4 MLJ 1153

[6]Patralekha Chatterjee, Five Years After the Indian Supreme Court’s Novartis Verdict, Intellectual Property Watch (2018)

[7] William J. Bennett, Indian Pharmaceutical Patent Law and the Effects of Novartis AG v Union of India, Vol. 13, Washington University Global Studies Law Review. (2014)

[8] Sec. 3(b), The Patent Act, 1970


Navin Kumar Jaggi

Bhavya Bhasin

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