Over the last several decades, the Indian pharmaceutical industry has witnessed a robust and remarkable revolution. Considering profits and competitiveness drive the pharmaceutical business, each business strives to be the first to discover cures for specific ailments. The industry is anticipated to remain to adapt and evolve in the long term. This has been made feasible by strong scientific and technical manpower, as well as innovative process development efforts. Owing to circumstances such as supportive regulatory strategies and deficient competition externally, the contemporary industry participants encompass numerous privately held Indian corporations that have acquired a significant proportion of the national pharmaceutical market. The expansion of India’s pharmaceutical industry may be divided into four phases. The first phase is the time before 1970 when foreign corporations regulated the Indian market with minimal indigenous engagement. The time between 1970 and 1990 is the second phase. Several domestic enterprises commenced operations at this time. During this time, the Indian Patent Act of 1970 was implemented, and export endeavors were initiated. The third phase lasted from 1990 until 2010. During this time, liberalization prompted Indian companies to establish a presence in other nations.
The TRIPS agreement:
Developing an ingenious medicine and delivering it to the marketplace is a tremendously costly errand. Patenting products is always a concern for companies introducing new medications to safeguard their commercial and financial interests. It is essential for the industry’s success that investors feel comfortable putting their money in the field and pharmaceutical businesses get that assurance because of patent law. Patents are prevalent forms of Intellectual Property Rights (IPR) in the pharmaceutical sector. After India signed the Trade Related Aspects of Intellectual Property Rights (TRIPS) pact in 1995, substantial improvements occurred in India’s patent law. Intellectual property (IP) frameworks in most World Trade Organization member nations have evolved with the inception of Trade-Related Aspects of Intellectual Property Rights (TRIPS). The agreement constructed the prerequisites for intellectual property legislation that each of its member nations must adhere to. As a signatory to the TRIPS agreement, India was legally bound to modify its Patent legislation to comply with regulations of the agreement.
Evolution and amendments of Patent Laws In India:
Until 1972, India’s pharmaceutical sector was entirely reliant on imports, with the majority of pharmaceuticals deemed costly. The Patent Act of 1972 and the Drug Price Control Organization (DPCO), 1970, among other political and policy events in the early 1970s, laid the groundwork for India’s robust pharmaceutical sector. The Patent Act of 1972, however, prohibited product patents in medications, and the Drug Price Control Organization (DPCO) placed a substantial number of products under cost controls and patents were only granted for a term of seven years under this Act. Before TRIPS, the lack of product patents allowed for local manufacturing of patented pharmaceuticals at a fraction of the original value. Process patents pushed generic businesses to lower medication manufacturing costs. India’s total compliance with the TRIPS regulation, which enables product patents, transformed the competitive alternatives available to Indian pharmaceutical companies. Because the unavailability of patent protection in India coincided with significant growth in the local pharmaceutical business, TRIPS was deemed as a serious threat. India took the maximum amount of time permitted for developing countries to patent medicinal inventions, which was 2005. However, the Patents (Amendment) Act, 1999 was the first in this series of amendments, and it provided mainline protection until the government began issuing product patents for pharmaceutical inventions. The Act established provisions asserted under Section 5 (2) for submitting mailbox applications for product patents in the sectors of medicines and agrochemicals, as well as the awarding of Exclusive Marketing Rights (EMRs) on those patents. Only after December 31, 2004, were such applications to be examined. The applicant might, however, file for EMR as described in Sections 24A and 24B, although acquiring “EMR” did not ensure a patent. Despite the fact that this legislation was passed in 1999, it had retroactive effect from January 1, 1995. Further, India modified the Patents Act, 1970 with the Patents (Amendment) Act, 2002 to meet with the second set of TRIPS provisions. This amendment established a 20-year standardized patent term for all categories of innovations, i.e., patents have a 20-year restricted duration starting from the date of filing the patent application. The Patents (Amendment) Act, 2005 established the third set of patent law modifications. The Indian Patents Act, 1970, was revised in 2005 to offer patent protection for pharmaceutical products and pharmaceuticals.
Under specific conditions, the mere invention of a new form, new property, or new use of a known substance was made patentable, pre-grant and post-grant opposition regulations were altered, and a regulation for the allowance of a compulsory license for the export of patented pharmaceuticals was initiated.
Patents are only issued to discoveries that meet a set of requirements known as patentability criteria. A patentable innovation is defined as “a novel product or technique incorporating an innovative step and capable of industrial application,” according to the Indian Patent Act. As a result, each innovation must meet the following criteria to be patentable: novelty, inventive step, and industrial applicability. The Patent Act of 1970, amended in 2005, explicitly defines which intellectual properties are patentable in India and, more particularly, which intellectual properties are not patentable. A drug may not be patentable if it does not amount to an increase in quality in its effectiveness or the mere innovation of any new property or new use of a known substance, or the simple use of a known process, machine, or apparatus, unless the known process produces a new product or uses at least one new reactant. The applicant’s patent protection is limited to the nation in which it is applied and is not cross-border. The patentee, on the other hand, may seek for patent protection in many nations at the same time.
The Contentious Section 3 (d):
In 2005, India made it feasible for pharmaceutical products to be patented. When doing so, the Indian government introduced a contentious implementation into the patent law, Section 3(d), which attempts to restrict the grant of “secondary” pharmaceutical patents, i.e. patents on novel forms of existing drugs and molecules. In other words, 3(d) prohibits patents from becoming “evergreen.”
Section 3(d) has caused a great deal of controversy. The Indian Patent Office‘s (IPO) decision to deny a secondary patent on Novartis’ cancer medication “Gleevec”, which referenced Section 3(d) as one of the grounds for denial, was a high-profile case that brought 3(d) to the world’s notice. Novartis contested legality of Section 3(d) and opposed the IPO’s ruling, prompting health advocates to launch a campaign against Novartis and in favor of the clause. The validity of 3(d) was affirmed, and the decision to refuse the Gleevec patent was affirmed by the Intellectual Property Appellate Board in 2009, and then by the Indian Supreme Court. However, the criticism and debate surrounding 3(d) has not been restricted to only one medicine. In India, and more widely in poor nations acquiring pharmaceutical patents in conformity with TRIPS, the clause has prompted fierce and diverse opinions on pharmaceutical patents. Many law experts, civil society organizations, and international organizations, on the other hand, have praised India’s policy choice, citing 3(d) as a noteworthy example of a country adhering with its contractual obligations while preserving generic competition. 3(d) is regarded with scorn by many international governments and the international pharmaceutical sector. 3(d) is frequently cited by the US government as one of the grounds for India’s inclusion on the “Priority Watch List.” Their worry that 3(d) makes it tough to get a patent in India is well-documented in academic literature as well.
Patent Linkage of Generic Drugs with Patents:
The term “patent linkage” alludes to a relationship between the patent registration process and drug regulatory clearances, which does not exist in the Indian law. Patent Linkage is the exchange of information between national regulatory agencies and the Patent Office in order to prevent the approval of generic pharmaceuticals until patents protecting the drug product or its permitted use have expired. The Indian Patent Office issues patents, and the Drug Controller General of India (DCGI) offers marketing licenses without consulting the other divisions. Between or among India’s national regulatory bodies, there is a patent relationship. This approach necessitates that “second applicants,” generally generic pharmaceutical businesses desiring marketing authorization, clarify that the pharmaceutical product for which they are requesting is not safeguarded by a valid patent. National regulatory bodies are required under this type of legislation to ban the registration and marketing of generic medications when the product is covered by a patent. Furthermore, the DCGI does not keep track of patented medications. As a result, a generic producer who enters the Indian market with a new medicinal product does so at their own responsibility and without necessarily being aware of any patent disputes.
The Indian patent system is an excellent demonstration of patent legislation that strives to align the interests of both regular folks and innovators. A broad spectrum of pharmaceutical items can now be patented in India due to the implementation of the product patents act. Whenever filing for a patent, organizations should carefully evaluate the patentability criteria, and the expertise of a patent specialist is strongly recommended in this aspect. Patent rights can be assigned or licensed to other people or corporations once they have been obtained. Analysis proves that the Indian pharmaceutical business is currently dominated by generics, with creativity playing a little role in its progression. Until date, the Indian Patent System has maintained a careful balance between the patentee’s and the Indian public’s interests.