By Ms. Ayesha Afrose
In 1872, the Patents and Designs Protection Act was passed, and in 1883 the Innovation Protection Act was passed[ i]. Finally, in 1888, these two laws were incorporated into the Inventions and Designs Act[ii]. The Indian Patent and Design Act, 1911 (the "1911 Act") British law established the patent administration system in India under the patent regulator's supervision[iii]. The period of patents under the 1911 Act is sixteen years after the date of filing, in some cases, which may be extended to an additional seven years[iv]. The 1911 Act was in force with some amendments and continued to govern the Indian patent system even after India gained independence from Britain in 1947.
It was eventually repealed by the Patent Act of 1970[v]. All versions of the patent law passed by the British in India allowed product patents in all technology fields, including pharmaceuticals. Even during that period, the courts in British India had to deal with numerous patent infringement disputes. When India finally gained independence from Britain in 1947, it had a vast population of 400 million, representing one-fifth of the world's population. However, at that time, the nation was one of the poorest countries in the world.
The aforesaid Mumbai High Court judgment dealt with a patent infringement case filed by the owners of Indian patents to manufacture new sulfonyl-urea compounds, salts of those compounds, and anti-diabetic drugs containing those compounds[vi]. "One of the chemicals is Dolbutamide, a patented compound, and since 1957 the plaintiffs have been selling it under the trademark 'Rostin' as an anti-diabetic drug in India and around the world[vii]. The main argument raised by the plaintiff is that the plaintiff has infringed their patent by producing, manufacturing, and selling tolbutamide through the use of the invention disclosed in the plaintiff's patent. The first respondent admitted that he had manufactured Dolbutamide, but that it was "manufactured using the procedures specified in another patent," which was conducted by the second respondent, Hoffkine, Bombay. The first defendant raised the counter-claim for revocation of the patent "on the grounds of lack of explanation, lack of novelty, need for innovation action and lack of application. Initially, a committee headed by Justice Tek Chand was appointed by the Government of India in 1949 to review the patent laws in India to ensure that the patent system was in the nation's best interests.
The panel submitted its interim report in 1949, making recommendations to prevent the misuse of patent rights in India. The TechChand report led to a significant amendment to the existing patent law in 1950, which dealt with inventions and mandatory licensing / revocation. "The terms and conditions for the recognition of patents in this license also include the terms' license license'. An application of the Government may enable the Regulator to grant such licenses.
The Iyengar report noted that any patent law's specific provisions should be designed with particular reference to the country's economic conditions, its scientific and technological advances, and its future needs. Despite all the Indian patent system's shortcomings, the Iyengar Report wanted to pursue this system because it was one of the most desirable ways to encourage and reward innovators. The Iyengar Report paved the way for the introduction of the 1965
One of the most critical agreements within the World Trade Organization is the Agreement on Trade in Intellectual Property ("TRIPS"), which mandates that all WTO members adhere to specific minimum standards of IPR protection. In 1986, "when negotiations for the establishment of the World Trade Organization began, India and other developing countries, including Brazil and Argentina, vehemently opposed it because the protection of IPRs was subject to the mandate of the World Intellectual Property Organization (WIPO). Developing countries changed their position. India was isolated in its opposition, so India faced the impossibility of staying completely outside the WTO - forced to sign the TRIPs Agreement and join the WTO in 1995[viii]. In conclusion, this resulted from restricting the effects of the changes initially mandated by TRIPS, which is a well-accepted fact that many of India's objections to the TRIPS Agreement are growing. The goats benefited because they were all given interim periods by the WTO for many years, TRIPS compatible. Although India did not have to comply with TRIPS's product patent requirements until 2005, it was forced to create a mailbox to file patent applications, which will be explored when the 2005 changes take effect.
The entry of the World Trade Organization into India, although a significant step, cannot be said to be the only reason to change its patent / IPR laws. It has to do with the drastic changes in economic policy that began in the 1990s[ix]. Since 1947, when India became independent, it has adopted a closed-economy model, characterized by comprehensive regulation and state intervention, resulting in decades of low growth rates. This continued for more than four decades until 1991 when India was forced to take some concrete economic liberalization steps due to the payment crisis.[x]
Patent amendments post-1995:
TRIPS expedited the multiplication of patent laws in India in 1970, similar to the three amendments. Initially, a mailbox facility was established, which allowed applicants to file pharmaceutical product patent applications. Applicants must be granted exclusive marketing rights ("EMR"), subject to certain conditions, to market the product for a period of up to five years from the date of the grant. The Second Amendment to the 1970 Act was made in 2002[xi]. This amendment was in line with TRIPS in several respects, giving it a twenty-year patent period[xii], "modifying the burden of evidence for process patent infringement and mandatory changes to licensing requirements. According to the Third Amendment in 2005, the 1970 Act provided patent protection for pharmaceutical products, and in this process, substantially with TRIPS Complied with.
Patent's amendment act 1999:
Although India was exempted from enforcing pharmaceutical/chemical product patents until 2005, it was forced to set up a mailbox facility for such product patent applications filed during the TRIPS transition period and set a filing date for each application. Another duty under TRIPS is to deal with the provision of EMR for mailbox applications that meet certain conditions in the Middle Ages. "India initially sought to implement the mailbox facility and issue EMRs by order of the President. The Parliament of India has failed to pass legislation dealing with the mailbox facility and the EMRs for various reasons." The United States urged the use of the WTO dispute resolution mechanism to address India's failure to enforce the law[xiii]. The World Trade Organization's appellate body held in December 1997 that India had failed to comply with its obligations under Section 8 (a) of the TRIPS Agreement as a result of its failure to make timely amendments to its patent laws, which ordered India to "establish an adequate mechanism." Priority for protected innovation and pharmaceutical product patent applications. Finally, in March 1999, the amendment was passed by the Indian Parliament; India has formally implemented the mailbox procedure for pharmaceutical patent applications and has issued the application since January 1, 1995.[xiv]
The patents (amendment) Act, 2002:
The 2002 Amendment introduced new definitions of the Innovation and Innovation Act and other changes aimed at bringing into India's patent law with the TRIPS Agreement, including new exemptions from patented matters such as the guidelines and traditional knowledge. The amendment also changed the burden of certification related to procedural patent infringement cases and streamlined the mandatory licensing structure. The 2002 amendment led to the patenting of microorganisms. The 2002 Amendment provides three reasons for seeking a compulsory patent. The law provides a wide range of reasons to apply for a compulsory patent license if the patented inventions do not work. Such a license can be claimed only after three years of sealing the relevant patent. Second, there is another provision for the issuance of compulsory licenses by the Government of India for declaration in extreme emergencies such as national emergencies or outbreaks of epidemics. Third, there is the provision for compulsory licensing in the case of certain patents necessary for the effective operation of other patented inventions.
The 2002 amendment repealed the concept of licenses. Under this concept, process patents related to drugs and food were considered to be automatically recognized with licenses, which would make them available to all applicants to obtain a compulsory license after three years of patent grant.
The patents (amendment) Act, 2005:
The last phase for India to implement the necessary changes to make its patent law TRIPS compliant took place through the 2005 Amendment. With this amendment, Indian law, for the first time since 1970, allowed patent protection for pharmaceuticals, food, and agrochemicals. The 2005 amendment preceded the 2004 presidential decree[xv]. Following its announcement, there were intense discussions on the purpose of the various provisions, but the Parliament of India passed the 2005 Amendment after making amendments to the Act. The 2005 Amendment contains several controversial features that have caused much controversy. They include detailed rules on what is not considered a patentable subject, a new definition of the "invention-based" criterion for patents, procedures governing pre-and post-grant resistance, and a more liberal framework for compulsory licensing.
Scholars point out that Section 3 (d) is a "bold legislative move" that has the potential to deter illegal "green" patents and may force other countries to follow India's example in trying to prevent such practices[xvi].
Application of Section 3(d)-Novartis Case:
In May 2006, Novartis filed a petition in the Madras High Court, arguing that the patent regulator had erroneously rejected the patent application for the drug beta crystal form of immandin mesylate under section 3 (d) of the Patent Act[xvii]. Novartis also argued that the provision violated Article 14[xviii] of India's Constitution as the extent of discretion granted to the patent regulator would lead to discriminatory decisions[xix]. The case was divided between the Madras High Court and the Intellectual Property Appeals Board ("IPAB")[xx]. The Madras High Court heard the challenges related to the constitution of TRIPS Compliance and Section 3 (d), which delivered the judgment against Novartis[xxi]. The IPAB heard the patent-related issue, which also ruled against Novartis. The High Court had to examine three issues.
First, whether the Indian courts can review the compliance of section 3 (e) with section 27 of the TRIPS and grant notice relief if the section does not comply with the DRPS[xxii]. The second issue was to examine whether Section 3 (d) complies with Section 27 of the TRIPS[xxiii]. The third issue is whether Section 3 (d) violated Article 14 of India's Constitution because it was vague, arbitrary and gave the patent controller an unrestricted option[xxiv].
The Court considers that it has no jurisdiction to adjudicate a domestic agreement as per an international agreement. Therefore, it did not offer any notice relief to Novartis[xxv]. The Court refused to address compliance with Section 3 (d) TRIPS, as it ruled that domestic law had no jurisdiction to determine whether it had breached an international agreement. In the third issue, the Court held that Article 3 (d) did not violate Article 14 of India's Constitution and was neither vague nor arbitrary, and did not give the patent controller unrestricted discretion. The Court agreed with the Government of India's contention that it was its constitutional duty to provide good health care to its citizens through easy access to life-saving drugs. In doing so, the Court agreed that there should be appropriate legislative action to prevent patents from becoming greener, which could have catastrophic consequences for the availability of drugs at affordable prices.
The discussion in this study is that in the face of the Indian patent in the new TRIPS compliance regime's wrath, the transition from a periodic process patent rule to a product patent rule will have many other far-reaching implications. The impact of this change will be apparent in the coming years. In the meantime, Indian businesses need to be prepared to face challenges. It is possible to create a level playing field when there is domain knowledge about patents from all companies in the Indian marketplace. Initially, efforts to balance the rules of the game may be limited to India.
[i] P. Narayanan, Patent Law 6 (3d ed. 1998) [ii] History of Indian Patent System, para. 3, <http://www.ipindia.nic.in/ipr/> accessed 6 February 2021 [iii] Narayanan, Supra Note 2 [iv] Ved P. Mithal, Patents in India, (1948) 69 [v] The Patents Act, No. 39 of 1970, INDIA CODE sec. 162(i) 1998 [vi] Farbwerke Hoechst & Bruning Corp., (1969) A.I.R. 56, at para.1 [vii] Id [viii]Member Information: ''India and the WTO'',<http://www.wto.org/english/thewtoe/countries e/india e.htm> accessed 6 February 2021 [ix] Tushar Poddar & Eva Yi, Goldman Sachs, Global Economics Paper No. 152: "India's Rising Growth Potential" (2007), <http://www.usindiafriendship.net/viewpointsl/IndiasRisingGrowthPotential.pdf> accessed 6 February 2021 [x]Stephen P. Cohen, India:"Emerging Power" (2001) 101 [xi]The Patents (Amendment) Act, 2002, No. 38, Acts of Parliament, 2002 (India), <http://www.ipindia.nic.in/ipr/patent/patentg.pdf> accessed 6 February 2021 [xii] The Patents (Amendment) Act, 1999, No. 17 sec. 24(B)(1)(a)-(b), Acts of Parliament, 1999 (India), <http://ipindia.nic.in/ipr/patent/patact-99.PDF> accessed 6 February 2021 [xiii] Ruth L. Okediji, Public Welfare and the Role of the WTO: 'Reconsidering the TRIPS Agreement', 17 EMORY INT'LL. REV. 819, 890-93 (2003) [xiv] Mukherjee, The Patents (Amendment) Act, 1999, No. 17 sec. 24(B)(I)(a)-(b) Parliament, 1999 (India), <http://ipindia.nic.inlipr/patent/patact_99.PDF> accessed 6 February 2021 [xv] The Patents (Amendment) Ordinance, 2004, No. 7, Acts of Parliament, 2004 (India) <http://lawmin.nic.in/Patents%2OAmendment%200rdinance%202004.pdf> accessed 6 February 2021 [xvi] Rajarshi Sen & Adarsh Ramanujan, 'Pruning the Evergreen Tree or Tripping up Over TRIPS?- Section 3(d) of the Indian Patents Act, 1970', 41 INT'L REV. INTELL. PROP. & COMPETITION L. 170, 186 (2010) [xvii] Novartis AG v. Union of India, (2007 A.I.R. 24759) (Madras H.C.) para. 1 (2007); The Patents (Amendment) Act, 2005, No. 15 sec. 3(d), Acts of Parliament, 2005 (India), <http://ipindia.nic.in/ipr/patent/patent2005.pdf> accessed 6 February 2021 (excluding derivatives of known substances from being issued to a patent) [xviii] Article 14 of the Indian Constitution deals with equality before law; it states that the State shall not deny to any person equality before the law or the equal protection of the laws within the territory of India. (Indian Constitution Art 14) [xix] Novartis AG, 2007 A.I.R. at para. 6 (India) [xx] Novartis Case: Background and Update - Supreme Court of India to Recommence Hearing, LAWYERS COLLECTIVE (Sept. 5, 2011), <http://www.lawyerscollective.org/news/126-novartis-case-backgroundandupdate-supreme-court-of-india-to recommence-hearing.html> accessed 6 February 2021 [xxi] Novartis AG, 2007 A.I.R. 24759 (India) [xxii] Novartis AG, 2007 A.I.R. at para. 5(a) (India) [xxiii] Id. at para. 5(b) [xxiv] Id. at para. 5(c) [xxv] According to the Court, a declaratory relief cannot be given where it would serve no useful purpose to the petitioner. Moreover, a declaration that "the amended provision is not in discharge of India's obligation under Article 27 of "TRIPS" would not "compel the Parliament to enact a law," thus the petitioner would not receive any relief -