This article has been written by Ms. Manisha Rahman , a LL.B. 3 years student of J.B. Law College, Guwahati, Assam.
INTRODUCTION
The rich history of India’s traditional knowledge in herbal medicine and indigenous formulations has been a source of healing for centuries. In recent years, there has been an increased interest in patenting these indigenous formulations within the Indian pharmaceutical industry. This endeavor, however, comes with its own set of challenges and considerations. India, with its diverse flora and traditional medicinal practices, acknowledges the importance of protecting indigenous knowledge. The country’s patent laws, guided by the Patents Act of 1970 and subsequent amendments, seek to strike a balance between promoting innovation and safeguarding traditional wisdom. Across the globe, indigenous communities have cultivated a wealth of traditional knowledge, including unique formulations and remedies passed down through generations. As modern science increasingly recognizes the value of these indigenous formulations, the question of patenting arises, posing both opportunities and challenges. As the pharmaceutical industry seeks to harness the therapeutic potential of these age-old remedies, a delicate balance must be struck between protecting intellectual property and respecting the roots of traditional knowledge. Pharmaceutical corporations are among the most common perpetrators of biopiracy, owing to the medicinal character of much traditional knowledge. Consumers frequently have drug allergies or just want to avoid the negative side effects of such medications. As a result, the market for traditional knowledge-based pharmaceutical treatments is expanding, and pharmaceutical companies are looking to capitalize. Traditional cures for prevalent medical ailments are routinely discovered by these companies, who then commercialize and patent various forms of such remedies for their own advantage.
PATENT
A Patent is an exclusive right granted for an invention, which is a product or a process that provides, in general a new way of doing something or offers a new technical solution to a problem.
The Essence of Indigenous Formulations:
Indigenous formulations encapsulate the unique knowledge passed down through generations within various cultures. These formulations often involve a harmonious blend of locally sourced plants, herbs, and minerals, each chosen for its therapeutic properties. The holistic approach of indigenous medicine encompasses not only the physical but also the spiritual and cultural dimensions of well-being.
The Patent Conundrum:
Patenting these formulations introduces a multifaceted challenge. On one hand, the intellectual property system provides a means to protect innovations, encourage research, and promote economic development. On the other hand, it raises ethical questions surrounding the commercialization of traditional knowledge and the potential for misappropriation.
“INTELLECTUAL PROPERTY RIGHTS” IN INDIAN CONTEXT
The Indian IPR section is grossly categorized into patents, designs, trademarks, and geographical indices. If we see the history of Indian “IPR” section, it can be divided into three definite eras: pre-independence, post-independence (before Trade Related Aspects of Intellectual Property Rights or TRIPS), and post-independence (after TRIPS) era.
Pre-independence era
In India, the history of IPR dates back to Pre independence era. In 1856, India witnessed the first legislation regarding patent (Act VI), which was subsequently replaced in 1857 and 1859. In 1872, the act was renamed as “The Patterns and Designs Protection Act.” The 1911 act (Act II) replaced all previous acts which bought patent administration under the “controller of patents,” which was further amended in 1920, 1930, and 1945.[2]
Post-independence era (before TRIPS)
In the Post independence era, mainly multinational companies governed Indian medicine market. The drugs were imported at a higher cost, and in terms of drug price, India ranked among the highest priced nations in the world. It was seen that the old “Indian Patents and Designs Act, 1911” was not fulfilling the requirements of the Indian population. Hence, Justice (Dr.) Bakshi Tek Chand committee was constituted for a detailed evaluation of the pros and cons of the Indian patent system. The committee rightly pointed out that the patent act should contain clear recommendation to ensure Indian population’s needs with regard to food, medicines, and medical devices and these should be made available to public at the cheapest price commensurate, at the same time honoring patentee with a reasonable compensation. These recommendations are the basis of two major changes; the 1950 (Act XXXII of 1950) amendment (emphasis on working of inventions and compulsory license [CL]/revocation) and the 1953 bill (Bill No. 59 of 1953). Although this bill was introduced in the parliament in 1953, it was allowed to lapse. In 1957, Government of India took two significant steps; first is the establishment of Hindustan Antibiotics Limited (As per agreement with UNICEF) and the second is appointment of Justice Rajagopala Ayyangar Committee, for revision of patent law and development of a locally sustainable market. The report of this committee (1959 report) served as the basis of the IPR revolution in India with major changes such as the “process only patent framework” and is the backbone of the “Patents Act, 1970” (brought into force since 1972) which replaced all previous patent laws (except designs). This revised act remained in place for next 24 years till the year 1994.
Post-independence era (after TRIPS)
The Patents Act 1970 introduced the “process patent” system, which came out to be very advantageous to Indian Pharmaceutical sector. As per this act, patents were valid for 7 years. In 1994, India became a signatory to General Agreement on Tariffs and Trade (GATT), and consequently, India had to follow the IPR component of GATT, i.e., the “TRIPS” component of the “Uruguay round” of the “GATT Treaty.” Noncompliance with TRIPS could lead to loss of membership of India from WTO.[2,5,6,7] Following this treaty, an ordinance was passed with certain changes in the Indian patent system on December 31, 1994, but it ceased to operate after 6 months. Although “TRIPS” was brought into action since January 1, 1995, but till 1999, no change was noticed in Indian patent regulations. In 1997, the “United States” took the matter of entitlement of only “process patent” in the field of “food and drugs” in India to the WTO. The “dispute settlement body” of WTO concluded that India breached the article 70.8 (a) (requirement of “product patent system” in pharmaceutical and agricultural field) and 70.9 {exclusive marketing rights (EMR) to be provided since 1995}. In conjunction with this, India had to modify its existent patent rule and the amended act came out in 1999. Section 5 (2) of the new amended act of 1999 had the provision of mailbox application and details of EMR were included in Chapter IVA.
Although this act was enacted in 1999, it had retroactive effect from January 1, 1995. This amendment had the provision of mailbox applications under the Section 5(2), where a party could apply for product patent in some special areas such as pharmaceutical and agricultural sectors (also known as WTO applications or mailbox applications). Such applications were only to be analyzed after December 31, 2004. However, the applicant could also apply for EMR as specified in Section 24A and 24B, but obtaining “EMR” did not guarantee for obtaining a patent.
Hence, the GATT treaty and consequent compliance with “TRIPS” had two giant effects on Indian IPR sector; first, India moved to the “product patent” system and the “patent protection period” increased from 7 to 14 than to 20 years. To fully comply with this “product patent” system, India was given time till 2005. After 2005, India became fully compliant under “Product patent system” as per TRIPS.
CURRENT PATENT LAWS
As per the Indian Patent Act, 1970, a patent is “a grant or a right to exclude others from making, using or selling one’s invention and includes right to license others to make, use or sell it.” The “Patent Act 1970” and amendment (2005) clearly defined the intellectual properties, which are patentable and more specifically, it also clearly states which intellectual properties are “not patentable” in India. “Substance may not be patentable which does not result in the enhancement of the efficacy of that substance or the mere discovery of any new property or new use of 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. Modest changes like 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 will be not patentable as per Section 3(d), 3(e), and 3(i).” There is no term called “universal or global patent.” The patent protection provided to the applicant is only for the country applied and is boundary specific. However, the patentee may apply in different countries simultaneously to get patent protection in those countries.
CRITERIA FOR PATENTING INDIGENOUS FORMULATIONS
To secure a patent, formulations must meet standard criteria such as novelty, inventive step, and industrial applicability. However, applying these criteria to traditional knowledge presents unique challenges. Establishing the novelty of a formulation that may have been in use for centuries requires a nuanced understanding of both traditional and modern medicinal practices. To be eligible for a patent, an indigenous formulation must meet certain criteria. It should demonstrate novelty, involve an inventive step, and be capable of industrial application. However, the challenge lies in proving the novelty of traditional knowledge that has been passed down through generations. Essence of a community’s cultural and medicinal heritage. They are a testament to the intimate relationship between people and their natural surroundings. As these formulations gain attention for their potential therapeutic benefits, the need to protect them through patents becomes a critical consideration.
Guarding Against Biopiracy:
Concerns about biopiracy—the unauthorized commercial use of biological resources—loom large in the context of indigenous formulations. Nations and communities rich in traditional knowledge are increasingly implementing legal measures to protect their resources. This includes obtaining prior informed consent, benefit-sharing agreements, and creating databases of traditional knowledge. Bio Piracy Of Pharmaceutical Industry In India”Developed countries exploit biotechnology patents to expropriate the biological or genetic heritage of less developed countries,” according to the term “biopiracy.” Biopiracy is usually defined as the stealing of traditional knowledge that would otherwise be held by indigenous people. Within a single indigenous society, there are several examples of significant applications of local flora or animals. Corporations may become aware of these applications and want to patent and market them for their own benefit. Companies frequently try to patent indigenous knowledge, as well as the products and processes produced from it. As a result, the patentee may obtain substantial monetary recompense for their patent rights while the indigenous group receives no benefit.
Bio piracy in the Pharmaceutical Industry.
Global Perspectives and Challenges:
As indigenous formulations attract attention globally, navigating the diverse landscape of international patent laws becomes crucial. What may be considered traditional knowledge in one region could be deemed novel and patentable elsewhere. Bridging these gaps requires collaboration, dialogue, and a nuanced understanding of cultural contexts. Different countries have varying approaches to patenting indigenous knowledge. Legal frameworks must consider the cultural, ethical, and social aspects associated with these formulations. Strides have been made in creating mechanisms to prevent misappropriation, but challenges persist in ensuring fair compensation and recognition for indigenous communities. While India’s efforts in protecting traditional knowledge within its borders are commendable, challenges arise when seeking global recognition. The criteria for patentability may differ between countries, making it essential to navigate a complex international landscape.
Given the global nature of intellectual property rights, considerations extend beyond national borders. Collaborative efforts on an international scale can foster a shared understanding of how to protect indigenous knowledge while promoting innovation. Mechanisms like the Traditional Knowledge Digital Library (TKDL) in India serve as valuable resources for global patent offices.
Collaborative Approaches:
One promising avenue is fostering collaboration between traditional practitioners and scientific researchers. By combining traditional wisdom with modern scientific methodologies, a stronger case for patentability can be built. This collaborative approach not only respects the roots of indigenous knowledge but also enhances the credibility and acceptance of these formulations in the scientific community. Collaboration between pharmaceutical companies and traditional healers, along with rigorous documentation of the entire development process, can strengthen patent claims. Transparency in sharing the benefits arising from these formulations is not only a legal requirement but also contributes to ethical business practices.
The Role of Documentation:
Robust documentation is a linchpin in the journey of patenting indigenous formulations. Detailed records of the formulation’s history, usage, and its unique contribution to the field are essential. This documentation not only strengthens the patent application but also serves as a historical record for future generations.
Towards Ethical Commercialization:
Balancing commercial interests with ethical considerations is paramount. Transparent benefit-sharing mechanisms and sustainable business practices can ensure that the communities holding this invaluable knowledge are not only acknowledged but also receive fair compensation for their contributions.
Overcoming Obviousness and Prior Art Challenges:
Establishing the non-obviousness of an indigenous formulation poses a unique hurdle. Many traditional remedies have been in use for centuries, and proving their inventive step requires a nuanced approach. Leveraging a combination of ancient texts, documented evidence, and modern scientific studies becomes crucial in this context.
The journey to patenting indigenous formulations is not without hurdles. One of the primary challenges lies in meeting the criteria set by patent offices. The requirement for novelty and an inventive step can clash with the fact that many traditional remedies have been in use for centuries. Striking a balance between tradition and innovation is a delicate task.
- Protecting Traditional Knowledge:
To address concerns related to biopiracy and misappropriation, India has implemented measures to protect traditional knowledge. Prior Informed Consent (PIC) and mutually agreed terms (MAT) are integral components, ensuring that the benefits of any commercial exploitation are shared with the communities that hold this knowledge.
- Preserving Biodiversity and Traditional Knowledge:
Indigenous formulations often rely on unique plant species and natural resources. The patenting process should not only consider the formulation itself but also address the conservation of biodiversity and sustainable harvesting practices. This holistic approach ensures the preservation of ecosystems that are integral to the traditional knowledge being patented.
Community Involvement and Consent:
An ethical dimension to patenting indigenous formulations involves engaging with the communities holding this knowledge. Prior Informed Consent (PIC) and mutually agreed terms (MAT) are essential to ensure that the benefits of commercialization are shared equitably. Inclusivity and respect for cultural nuances play a pivotal role in this collaborative process.
Balancing Commercialization and Cultural Integrity:
When bringing indigenous formulations into the mainstream market, it is crucial to strike a balance between commercial interests and cultural integrity. Companies venturing into this space must approach it with sensitivity, acknowledging the cultural significance of the formulations and avoiding exploitative practices.
The Role of Traditional Knowledge Digital Library (TKDL):
India has established the Traditional Knowledge Digital Library to prevent the grant of patents on traditional knowledge at the international level. This database serves as a valuable resource by providing evidence of prior art, making it more challenging for patent offices abroad to issue patents based on traditional knowledge.
CRITICISMS OF THE CURRENT INDIAN PATENT SYSTEM
Effect of product patent on Indian pharmaceutical sector
As Indian patent system was a “Process patent-” driven system, the transition to “product patent” system was expected to be devastating to the pharmaceutical industry, and the early reaction was full of panic.[5] The expected outcomes were “unexpected rise in drug price” and subsequent destruction of Indian Pharmaceuticals Industry. However, the Indian pharmaceutical sector copped up with the new regulatory changes and the indigenous R&D sector started growing.
Patent protection period of 20 years
Granting of “patent” is a way to encourage innovation, which allows patentees to enjoy monopoly over the patented product for a period of 20 years from the date of filing. The effect of this monopoly can be very severe in pharmaceutical sector, more so in the case of lifesaving drugs.
Compulsory licensing (CL)
To counteract this monopoly-associated damage, the Patents Act, 1970, has some specific provisions to balance the situation. This act also has a provision that the patented products to be available to end users at sufficient quantity, and at the same time, the price should be in affordable range. If the patentee fails to do so, the Government of India can give CL to interested parties so that the patented product fulfills the requirement of the product. Although the first CL was issued in the year 2012 (Bayer’s patented drug Nexavar to Natco Pharma Limited), the history of compulsory licensing is not new. In Section 22 of the Patents and Design Act, 1911, it is mentioned that, after the expiration of 3 years of a patent life (day 1 being the date of sealing of the patent), any interested person can apply for CL if the following grounds are not satisfied, for example, the commercial angle of the patent is not fully worked out, the Indian population demand/requirement regarding the patented property is not met adequately and the demand of the “patented product” has to be fulfilled substantially by importing it from other countries. The “Patents Act,” 1970 (section 84), also kept the provision of CL if the reasonable requirements of Indian population with respect to the “patented invention” are not satisfied or the “patented invention” is not available to public at a reasonable price. In 2002, another ground was amended which states that CL can be applied if the “patented invention has not worked in territory of India.” In 2005, CL covered both “manufacture and export” of pharmaceutical products (section 92A) to any country which do not have manufacturing capacity of have insufficient manufacturing capacity to address its public health issues. Although lots of controversies came after India’s grant of first “CL” to NATCO and subsequent grants, the trend seems to be an unbiased one, with a critical balance between the interest of generic manufacturers, intention of the patentee, and the interest of the population.
Lots of patent and no clinical translation
Although the number of patents granted is increasing, the translational gap is quite huge in the pharmaceutical sector. Among these, lots of the patents are from academic institutions and are part of academic thesis work. Other important issues are lack of orientation toward clinical translation and deficient funding.
Evergreening
“Evergreening,” refers to a strategy by which additional “secondary patent,” is applied by minor formulation or other changes of the parent patented molecule, of which patent period is going to expire. Indian Patent Act counteracts evergreening measures by inclusion of Section 3(d), which distinguishes between “discovery and innovation” and clearly defines which is not patentable. Although a criticism like non agreement to TRIPS came in the NOVARTIS case with regard to GLIVEC, the Honourable Court cleared its stand on “evergreening” and discouraged such strategies.
- Slow work process
High workload compared to patent office of other countries and less workforce are implicated in the delay in the patent process.
CONCLUSION
Patenting indigenous formulations in the Indian pharmaceutical industry is a delicate dance between honoring centuries-old wisdom and meeting modern legal requirements. With a proactive approach, collaboration between stakeholders, and adherence to legal frameworks, it is possible to strike a balance that encourages innovation while respecting and protecting the invaluable heritage of traditional knowledge. As the industry evolves, continued efforts to refine and adapt these legal mechanisms will be crucial for ensuring the sustainable and ethical development of indigenous formulations in the global pharmaceutical landscape.
As we navigate the complex terrain of patenting indigenous formulations, it is essential to approach this endeavor with a blend of legal acumen, cultural sensitivity, and environmental stewardship. The synthesis of tradition and innovation can yield benefits not only for the communities holding this knowledge but also for the broader scientific and medical community. By establishing ethical frameworks, encouraging collaboration, and respecting the interconnectedness of nature and culture, we can embark on a journey where the preservation of heritage goes hand in hand with progress.
Although lots of patent applications are from pharmaceutical sector, their clinical translation is very less. Logically speaking, right now Indian Pharmaceutical Market is dominated by the generic market and invention has a very little share in its expansion. The main reason behind this seems to be segregatory work in each field, lack of proper multidisciplinary work between the preclinical and clinical scientists, deficient funding, heterogeneous interests of the involved sectors, lack of systematic training of workforce, and lack of visionary. Industry-academia collaboration and establishment of quality control bodies can be valuable in this regard.
Till now, the Indian Patent System is balancing the delicate balance between the interest of the patentee and Indian population. There are several stories such as imatinib (Novartis), tadalafil (Eli Lilly), rosiglitazone (GlaxoSmithKline) etc. regarding the product patent, EMR, off-patent products, and how the inventor company tries to save their inventions from generic marketing. Effective lesions learned from these events allowed us to understand the limitations of current IPR system and subsequently to make the system more strong.
References
https://www.wto.org/english/tratop_e/trips_e/intel1_e.htm .
https://www.ipindia.nic.in/history-of-indian-patent-system.htm .
http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_113_1_The_Patents_Act_1970_._Updated_till_23_June_2017.pdf .
Midha S. Strategies for drug patent Ever-greening in the pharmaceutical industry. Int J Pharm Sci Bus Manage
https://www.deccanherald.com/opinion/india-s-pharma-industry-patent-