Significance of Indian pharmaceutical patent laws
The Indian pharmaceutical business is a profitable, high-tech-based industry that has grown steadily over the last three decades. Due to factors such as favorable government policies and minimal competition from abroad, the present industry players include several privately-owned Indian corporations that have taken a significant share of the domestic pharmaceutical markets. However, as Indian businesses begin to emerge from domestic markets and prepare for international competitiveness, the liberalization of the Indian economy is transforming them. As India's markets open up to global trade, the pharmaceutical industry in India is a prime example of an industry that is being compelled to reconsider its long-term strategy and business models. Factors such as intellectual property protection are becoming more important as the necessity to secure costly investments in research and development becomes more apparent (R&D). In India, efforts are being made to address issues with the enforceability of existing intellectual property laws, and the government is working to develop a patent regime that is conducive to technical advancements and in line with its international commitments.
Patent Law in India:
In the pharmaceutical sector, patents are one of the most common types of Intellectual Property Rights (IPRs). After signing the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement in 1995, India's patent system underwent significant changes. As a signatory to the TRIPS agreement, India has a contractual obligation to alter its patent laws to comply with the pact's terms. The Patents (Amendment) Act of 1999 was the first in this series of amendments, to give pipeline protection. Until the country begins to grant product patents for pharmaceutical inventions. It established provisions for filing product patent applications in the fields of medicines and agrochemicals as mailbox applications, effective January 1, 1995, and introduced the issuance of Exclusive Marketing Rights (EMRs) on those patents. India revised the Patents Act, 1970 with the Patents (Amendment) Act, 2002 to meet the second set of TRIPS commitments. This amendment provides for a 20-year uniform term. The concept of a patent for all types of inventions was introduced, with patents having a 20-year term starting from the date of submitting 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 items and pharmaceuticals. However, this change merely made medicinal substances patentable to the extent that patents would apply to novel chemical entities.
A new form of a known substance, new property / new use for a known material, and the mere use of a known procedure are not patentable and are not regarded as distinct from the known substance, according to Section 3(d) of the Patents Act, 1970. According to this principle, inventions involving well-known chemicals are not patentable unless the putative invention, for example, exhibits a significant increase in efficacy. Despite protests from the generic pharmaceutical industry and other innovators, section 3(d) still governs patent eligibility. Several patents for salts, ethers, esters, polymorphs, and other "derivatives of known material" as defined in the clause are still being awarded. This is because Indian law allows for the patenting of such variants provided they improve efficacy. As a founding member of the World Trade Organization (WTO), India consented to the opposition more than ten years ago. Oppositions are primarily pre-grant, in which an objection can be made until the date of grant of the application; post-grant, in which an opposition can be filed until one year from the date of grant; and revocation, which can be filed after one year from the date of grant.
Nonetheless, few companies make effective use of these opposition protections, and only a small percentage of awarded patents are challenged. It must be conceded that in India, the opposition can get annoying. A pre-grant opposition does not preclude the same or another party from filing a post-grant opposition and, later, a revocation petition. This causes delays in patent execution, which is a major source of concern for multinational corporations (MNCs), as a patent's term begins on the date of submission of the application. The Indian Patent Office, on the other hand, usually decides oppositions significantly faster than many other countries.
Protection of Pharmaceutical Rights:
Section 3 of the Patents Act, 1970, specifies the inventions which are not patentable subject matter, even if such inventions qualify the patentability criteria. In the context of pharmaceutical inventions, Section 3(d) of the Patents Act, 1970, demands special attention, as it states: Section 3 of the Patents Act, 1970, outlines the inventions that are not patentable subject matter, even if they meet the patentability standards. In the context of pharmaceutical inventions, Section 3(d) of the Patents Act of 1970 demands special attention, since it states:
“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation - For this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
The major goal of Section 3(d) of the Patents Act of 1970 is to ban the ever-greening of pharmaceutical patents and to bring inventions, particularly those relating to drugs or chemical compounds, within the purview of patenting. This section states that an invention claiming a new form of a known substance or second and subsequent use of a known substance with established medicinal activity is treated as the same substance and is not patentable unless the invention significantly improves therapeutic efficacy concerning that known compound.
In its decision in Novartis AG v. Union of India & Ors. the Hon'ble Supreme Court of India emphasized the true legislative intent of Section 3(d) of the Patents Act, 1970, stating that "Section 3 (d) is meant especially to deal with chemical substances and more particularly pharmaceutical products." The modified section 3(d) clearly establishes the second layer of qualifying conditions for chemical substances or pharmaceutical goods in order to keep the door open for authentic and genuine inventions while also preventing "repetitive patenting or patent term extensions on specious grounds." Also, in interpreting the term "efficacy," the Court stated that "efficacy" in the context of pharmaceutical patenting refers to the ability to make a product work. In addition, the Court stated that "efficacy" in the context of pharmacological patenting involves the ability to generate a desired or intended effect. As a result, "improved therapeutic efficacy" is not defined as "a change in the form of an already recognized form with inherent qualities of that form." A new form must specifically demonstrate medicinal efficacy, or it will be precluded from patentability. It is crucial to note that the Indian Patent Office when reviewing applications gives applicants the chance to submit supplementary documentation or experimental tests to verify the invention's "therapeutic efficacy," which was not mentioned in the specifications at the time of filing.
Section 3(e) of the Patents Act, 1970, is about patenting of combination inventions, in the field of chemical as well as biotechnological sciences and states –
“a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance” is not patentable”
It is a well-established tenet of Indian patent law that the mere combination of many components that do not require the exercise of any inventive faculties and performs its purpose independently is not patentable. The subject matter is regarded patentable if the working interrelations caused by the collocation of these components are linked to produce novel or improved results. The Indian Patent Office typically objects to claims relating to pharmaceutical compositions under Section 3(e) of the Patents Act, 1970, since they relate to a known composition or a simple mixing of known components that does not entail any synergistic effects. The difficulty in comprehending terms like "mere mixing" and "aggregate of the qualities" of Section 3(e) of the Patents Act, 1970 is one of the most prominent causes for objections to such patent applications.
In Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah, the Hon'ble Bombay High Court defined "mere admixture" as "where a person merely admixes the known ingredients with the hope of getting an additive effect of both substances." When a person experiences more than the expected additive effect, the admixture is referred to as a synergistic composition. It is impossible to prepare an admixture of an unknown substance when neither its composition nor its qualities are known. As a result, the chemical compositions of the novel drug or compound cannot be called a "mere admixture," because neither the compounds of such composition nor any attributes were known in the preceding arts.
In the case of Bhabha Atomic Research Centre v. Union Of India, it was determined that a simple juxtaposition of features that were already known before the priority date and arbitrarily chosen from among several different combinations is not a patentable invention and amounts to the aggregation of properties.
Section 3(i) of the Patents Act, 1970, states – “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” is not a patentable invention.
In the world of medicines, method of treatment claims is frequently made under the pretense of composition claims. It is important to remember, however, that in India, any claim connected to treatment is not a patentable subject matter. Surgical, medicinal, or diagnostic devices or apparatus, on the other hand, may be granted a patent.
Transfer of the Patent Rights:
Because a patent is a type of property, the rights vested in it can be transferred from the patentee to anyone else by assignment or licensing. According to the Indian Patent Act, a patent assignment or license must be in writing, with all terms and conditions affecting the parties' rights and obligations explicitly stated.
A.) Patent Assignment: In general, an assignment is an act of transferring ownership of one's property to another, which includes the property's interests and rights. The transfer of all or part of a patentee's right, title, and interest in a patent or patent application to another person is known as a patent assignment. The assignee of a patent right is known as the assignee, and the person who assigns the right is known as the assignor.
B.) Patent licenses: By granting a license, a patentee can allow others to create, use, or exercise an innovation that would otherwise be prohibited. A patent license gives you a set of rights that are time, geographical, and scope of use limited. It is possible to obtain a patent license either voluntarily or voluntarily.
i.) Voluntary license: A voluntary license occurs when the patentee, at his or her discretion, authorizes another person to create, use, or exercise the patented invention through a written agreement. In such a license, neither the Indian patent office nor the central government plays any part.
ii.) Compulsory license u/s 84: A compulsory license is a statutory license that the Controller of Patents can award to a third party if certain requirements are met. A compulsory license under the Patent system is an involuntary contract imposed and enforced by the government between a willing buyer and an unwilling seller. Compulsory licenses allow someone else to manufacture a patented product or process without the patent owner's permission. Compulsory licenses may be granted on the following grounds, as stated in section 84 of the Patents Act, 1970: I the public's reasonable requirements for the patented invention have not been met, (ii) the patented invention is not available to the public at a reasonably affordable price, or (iii) the patented invention is not worked in the Indian territory. Compulsory licenses, on the other hand, can only be awarded after three years have passed since the patent was granted.
iii.) A compulsory license for the export of patented pharmaceutical products u/s 92A: According to Section 92A of the Patents Act of 1970, a compulsory license may be issued for the manufacture and export of patented pharmaceutical products to any country that has granted a compulsory license or allowed the importation of patented pharmaceutical products from India and has insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems. The Controller may award a compulsory license solely for the manufacture and export of the concerned pharmaceutical product to such nation under the stated terms and conditions after receiving an application in the required way. This provision addresses the public health concerns of countries with limited or no pharmaceutical manufacturing capacity to execute the TRIPS council's decision in paragraph 6 of the Doha Declaration on TRIPS and Public Health. According to this law, the compulsory license is only accessible for (a) patented pharmaceutical products, (b) manufacturing and export to any country with insufficient or no pharmaceutical manufacturing capacity, and (c) products that address public health problems in that country.
The Indian patent law is an excellent example of patent legislation that seeks to balance the interests of both ordinary people and inventors. A wide range of pharmaceutical items can now be patented in India thanks to the implementation of the product patent regime. Before filing for a patent, researchers should carefully analyze the patentability criteria, and the guidance of a patent specialist is highly recommended in this regard. Patent rights can be assigned or licensed to other people or companies once they have been acquired. Patents can be a useful instrument for technology transfer for organizations such as research institutions and universities that lack substantial manufacturing or marketing capabilities. These companies can outsource their patented products/processes to other parties and receive cash to recoup their investment in the development of those products/processes. Compulsory licenses give patented products the opportunity to be sold under specific conditions.
The article first published on Lexology.com and the same can be accessed here.
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