This Article is written by Manvi Verma of 4th Semester of Law School, University of Jammu, an intern under Legal Vidhiya
ABSTRACT
The 167th Law Commission report on The Patents (Amendment) Bill, 2002 highlights major changes to India’s existing patent legislation, such as product patent protection for medications and agrochemicals, pre-grant opposition, and the creation of the Patent Appellate Board (PAB). It also highlights some of the bill’s possible disadvantages, such as the need for a thorough and inclusive approach to patent law reform that considers the various requirements and interests of all parties involved. The report emphasizes the necessity of a well-reasoned, well-balanced approach to patent law reform, taking into account the intricate and dynamic structure of the Indian patent system. It also highlights the importance of finding a balance between providing access to necessary goods and services and encouraging innovation.
KEYWORDS
Patent legislation, India, 167th Law Commission report, Patent (Amendment) Bill, 2002, TRIPS agreement, innovation, Intellectual Property Appellate Board, public health, civil society, access to medicines, compulsory licensing, Indian Patent (Amendment) Bill, civil society, industry, policymaking, pharmaceutical industry.
INTRODUCTION
The proposed changes to India’s existing patent legislation are carefully reviewed in the 167th legislation Commission report on The Patents (Amendment) Bill, 2002. The report highlights major changes and their possible effects on the nation’s innovation, patent system, and economic growth.
The addition of product patent protection for medications and agrochemicals is one of the bill’s most important changes. It is anticipated that this adjustment will align India with global norms and encourage innovation in these fields. The research does, however, also raise concerns about the possible detrimental consequences on access to necessary medications, as product patents may result in increased costs and less availability of medications that could save lives.[1]
Pre-grant opposition, which enables anybody to submit a representation opposing the issue of a patent before it is granted, is another significant feature of the bill. This clause is thought of as a way to raise the standard of patents and stop the issuance of pointless and excessively general patents. The research does, however, express concern about the possible abuse of this clause, as it can cause needless delays in the process of awarding patents and cast doubt on those who are applying for them.[2]
In addition, the bill suggests creating the Patent Appellate Board (PAB) to consider appeals of Patent Office rulings. Although the report recognizes the necessity of an effective and specialized appellate body, it expresses reservations on the make-up and operation of the PAB. It recommends that in order for the PAB to successfully settle patent disputes, its members should have both technical and legal backgrounds.
The paper also covers the clauses that attempt to strike a compromise between the public interest and patent holders’ rights regarding parallel imports and forced licensing. In the context of public health, the paper highlights the significance of finding a balance between providing access to necessary goods and services and encouraging innovation.
The Patents (Amendment) Bill, 2002 is thoroughly examined in the 167th Law Commission report, which also highlights some of the bill’s possible disadvantages. It highlights how crucial it is to carefully weigh the interests of customers, patent holders, and the general public. The paper advocates for a thorough and inclusive approach to patent law reform that considers the various requirements and interests of all parties involved.[3]
The report of the 167th Law Commission regarding The Patents (Amendment) Bill, 2002 is an important addition to the current discussion regarding the reform of Indian patent law. It offers a thorough examination of the suggested changes and their possible effects on innovation, the availability of necessities, and the nation’s general progress. The paper emphasizes the necessity of a well-reasoned, well-balanced approach to patent law reform, taking into account the intricate and dynamic structure of the Indian patent system.[4]
167TH LAW COMMISSION REPORT
Released in 1999, the 167th Law Commission Report of India covered a number of important legal and judicial matters. Its important recommendations included changes to the electoral system. In an effort to fortify the nation’s democratic base, the report recommended actions to improve the electoral process’s efficiency, fairness, and transparency.[5]
In addition, the 167th Law Commission Report examined legal education. Acknowledging the significance of generating proficient and morally accountable legal practitioners, the report suggested alterations in legal education to tackle modern obstacles. It placed a strong emphasis on raising the standard of legal education overall as well as the curriculum and teaching strategies to make sure that graduates are prepared to handle the complexities of the legal system.
Concerns about contempt of court were also discussed in the report. It looked at how to preserve free speech rights while maintaining the dignity of the legal system. The recommendations were meant to create a just and equitable balance, making sure that contempt cases are handled carefully and don’t violate anyone’s fundamental rights.[6]
The Code of Criminal Procedure (CrPC) was also the subject of recommendations in the 167th Law Commission Report. It suggested changing a few clauses to improve the effectiveness of criminal trials, speed up the court system, and reduce backlogs. [7]
The 1999 publication of the 167th Law Commission Report of India was instrumental in tackling a wide range of legal matters. The report offered insightful recommendations for strengthening the nation’s legal system and judicial procedures, ranging from electoral reforms to enhancements in legal education and suggestions regarding contempt of court. Its all-encompassing strategy demonstrated a dedication to preserving justice and bolstering the rule of law.[8]
WHAT IS PATENT?
An invention is a product or a method that, in general, gives a new way of doing something or presents a novel technical solution to a problem. A patent is an exclusive right granted for such an invention. Technical details of the invention must be made public in a patent application in order to obtain one. [9]
The Patents Act of 1970 contains several provisions that define Indian patent law. This law grants patent rights for new and inventive processes, products, or articles of manufacture that meet the requirements for patent eligibility, which include being novel, having inventive steps, and having the potential for industrial application.[10]
PATENT BILL, 2002
The Patents (Amendment) Bill, 2002, the report of the 167th Law Commission, is a noteworthy document that discusses the suggested changes to the current patent laws in India. The purpose of this report is to assess the bill’s possible effects on the nation’s patent system and analyze its main provisions. It is vital to evaluate the proposed changes’ efficacy in advancing economic growth, preserving intellectual property rights, and encouraging innovation. s: The Patents (Amendment) Bill, 2002’s first significant amendment is the addition of product patents for agrochemicals and pharmaceuticals. In order to bring India’s patent system into compliance with international norms, particularly the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), process patents have been replaced with product patents.[11]
The introduction of product patents will boost the security afforded to novel medications and lure international capital to India’s pharmaceutical sector. Nonetheless, issues with inexpensive medication availability and the possibility of patent infringement by large businesses come up. Second Body Paragraph Furthermore, the creation of the Intellectual Property Appellate Board (IPAB) is suggested by the Patents (Amendment) Bill, 2002. This particular specialty One significant change put forth in the Patents (Amendment) Bill, 2002 is the introduction of product patents for agrochemicals and pharmaceuticals. In order to bring India’s patent system into compliance with international norms, particularly the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), process patents have been replaced with product patents.[12]
The Patents Act of 1970, also known as the principal Act, is intended to be amended by the Patents (Amendment) Act of 2002. India will be better equipped to handle the challenges of globalization under the World Trade Organization (WTO) regime and the Intellectual Property Rights Agreements on Trade Related Aspects of the WTO thanks to the extensive amendment of the main Act. The Act establishes a Controller to grant patent licenses, revoke patent licenses, and regulate the nation’s patent system in accordance with international norms to uphold the caliber of goods, services, and other relevant matters. The Trade Marks Act of 1999 established the Appellate Board, which will have the jurisdiction to hear appeals against Controller orders. The Reviewer For the purpose of deciding cases pertaining to patents under this Act, the Board will take the place of High Courts and any other court. If there is an appeal against an Appellate Board order, it will be heard by the Supreme Court of India. In addition to the mechanism and procedure for granting compulsory licenses, its terms and conditions, the power of the Controller to revoke licenses, and the procedure for handling patent applications, the Act provides for the procedure of the Appellate Board, the performance of the Controller, their authorities and powers in line with the best of the global standards.[13]
With this Act in place, the nation is now prepared to handle any issues pertaining to patents of Indian heritage, goods, and services, including safeguarding its defense and sovereignty.[14]
By introducing product patents, the bill seeks to provide stronger protection for innovative drugs and encourage foreign investment in the Indian pharmaceutical industry. The amendment holds the potential to incentivize research and development in the pharmaceutical sector by granting exclusive rights to the inventor of a new drug. This exclusivity can attract foreign companies to invest in India, leading to technology transfer, job creation, and economic growth. Additionally, stronger patent protection can promote innovation by providing a secure environment for companies to invest in the development of new and improved drugs.[15]
OBJECTIVES OF PATENT(AMENDMENT) BILL, 2002[16]
The primary objectives of patent (amendment) bill, 2002 are as follows: –
- TRIPS Agreement Compliance: – The purpose of the amendment was to align India’s patent laws with the international norms specified in the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS). India was required to offer a greater degree of intellectual property protection, especially in the area of patents, as a signatory to TRIPS.
- A Brief Overview of Pharmaceutical Product Patents: – The goal of the bill was to change the pharmaceutical industry’s patent system from one based on processes to one based on products. This meant that patents would be extended to the actual products rather than just the processes or methods used to make drugs, which would promote innovation in the pharmaceutical industry.
- Encouraging of Innovation: – The amendment sought to strengthen international patent standards by an atmosphere that fosters creativity. It was anticipated that the granting of product patents would encourage R&D endeavors and draw in foreign and domestic capital to the pharmaceutical and associated sectors.
- Mailbox System Implementation: – Pharmaceutical patent applications could be filed prior to the implementation of the product patent regime thanks to the mailbox system. This was a stopgap measure meant to clear up the backlog of patent applications and facilitate a more seamless switch to the new framework.
- The Intellectual Property Appellate Board (IPAB) was established: -Provisions for the establishment of the IPAB, an appeals body tasked with resolving intellectual property disputes, were included in the amendment. The IPAB was established to provide a specialized forum for handling appeals and disputes, with the goal of expediting the resolution of patent-related issues.
- Compulsory Licensing Provisions: The bill included provisions that allowed the government to license other manufacturers as long as they met certain requirements. This system was designed to strike a compromise between the needs of maintaining the availability of necessary medications and the interests of patent holders, particularly during public health emergencies.
- Improved Procedure for Patent Examination: -By simplifying processes to guarantee prompt and efficient review of patent applications, the amendment sought to improve the patent examination process. This was essential to protecting the integrity of the patent system and giving patent applicants clarity.
SALIENT FEATURES OF PATENT (AMENDMENT) BILL, 2002[17]
- Following the enactment of the Patents (Amendment) Act, 2002, the duration of all granted patents was extended to 20 years from the date of application filing.
- A lapsed patent now has an 18-month period to be restored.
- A new definition of “invention” was added, which stated that a product or process covered by a patent could be novel, involve an inventive step, or have industrial application potential.
- The term “inventive step” now has a new definition.
- In light of TRIPS Agreement Articles 27(2)– (3), the negative list of things that were not deemed inventions (i.e., non-patentable subject matter) was expanded and changed.
- The notion of a request for patent application publication was presented.
- In cases where an identical final product was obtained from a patented process, an onus-of-proof provision was introduced, requiring the defendant to demonstrate that its method of obtaining the product in question differed from the patented method.
- The provisions concerning the license of rights were removed, and the chapter on compulsory licensing was replaced with guidelines and practices compliant with the TRIPS Agreement.
- Bolar’s exemption was made available.
- It was decided to import patented goods in parallel.
- The Intellectual Property Appellate Board (IPAB), which was abolished in 2021, was the specialized tribunal to which all appeals under the Act were redirected from the High Courts.
- Provisions pertaining to national security were modified.
PRESPECTIVE OF PUBLIC AND CIVIL SOCIETY[18]
Regarding the Patent (Amendment) Bill of 2002 in India, public and civil society expressed a range of opinions, many of which expressed worries about how the law would affect public health, access to necessary medications, and the harmony between intellectual property rights and larger societal goals.
- Access to Medicines: –
- Concerns: Public interest groups frequently expressed worries about the possible harm to the availability of reasonably priced medications. Concerns were raised by the move to pharmaceutical product patents regarding the possibility that this would restrict the supply of generic medications, which have been crucial in bringing down the cost of medications, especially when it comes to conditions like HIV/AIDS.
- Viewpoint: Civil society organizations stressed how crucial it was to make sure that the revised patent legislation did not unnecessarily impede the development and accessibility of generic versions of necessary medications, particularly for conditions that were life-threatening.
2. Compulsory Licensing: –
- Concerns: Although some groups welcomed the inclusion of provisions pertaining to compulsory licensing, others expressed trepidation regarding the standards and circumstances in which such licenses could be awarded. Finding the ideal balance between defending patent holders’ interests and the necessity of attending to public health needs has been discussed.
- Viewpoint: The civil society pushed for a strong system of mandatory licensing that could be used to guarantee the supply of medications at reasonable costs, especially in times of medical emergency.
3. Influence on Innovation by Indigenous Peoples: –
- Concerns: A few public interest organizations expressed worries that the shift to product patents would result in a situation where multinational companies controlled the market, thereby stunting the rise of local innovation and the creation of technologies that were relevant to the area.
- Viewpoint: To ensure that the revised patent law did not unduly benefit foreign companies over local innovators, civil society called for actions to encourage and support domestic innovation.
4. Public Health Measures to Take: –
- Concerns: To avoid patents being misused in ways that could have a detrimental influence on public health, public interest groups stressed the necessity of strong public health safeguards. This included worries about practices that might postpone the release of generic medications onto the market, such as evergreening, which is the process of extending the life of a patent through small adjustments.
- Viewpoint: To prevent practices that might delay timely access to affordable medicines, civil society pushed for strict regulations. This underscored the significance of striking a balance between the protection of intellectual property rights and public health.
5. The civil society’s role in formulating policy: –
- Concerns: A number of civil society organizations highlighted the need for meaningful participation and representation in conversations about intellectual property laws, voicing concerns about the degree of inclusivity in the policymaking process.
- Perspective: In order to guarantee that a range of viewpoints and concerns were taken into consideration during the development and execution of patent-related policies, public interest groups demanded increased openness and involvement with civil society.
VIEW OF THE INDUSTRIES[19]
The industry’s opinions on India’s Patent (Amendment) Bill of 2002 were largely divided, representing a range of viewpoints within the business community. The transition to a product patent system was largely welcomed by multinational pharmaceutical companies because it strengthened the protection of their inventions and promoted increased R&D spending. According to some, the amendment will bring India into compliance with international intellectual property laws and promote innovation and technology transfer. Nonetheless, some sectors of the Indian pharmaceutical industry—particularly those that focus on generic drugs—voiced worries about possible difficulties in adjusting to the new patent environment. Some were concerned that the emergence of larger multinational corporations would affect the supply of reasonably priced generic medications. Others, however, saw chances for expansion and cooperation because the revised law might encourage local businesses to increase their R&D spending, resulting in a more inventive and competitive pharmaceutical industry in India. All things considered, the industry’s opinions demonstrated a sophisticated comprehension of the possible advantages and difficulties presented by the 2002 patent law amendment.
SUGGESTIONS FOR FURTHER IMPROVEMENT[20]
The Patent (Amendment) Bill of 2002 in India could be improved in a number of ways to address issues with indigenous innovation, medicine access, and striking a balance between intellectual property rights and public health. The following are some essential suggestions:
- Improve Public Health Safeguards: – Intense measures to patent abuse that could postpone the availability of reasonably priced medications.
- Implement policies to promote generic competition and prevent evergreening in order to maintain a balance between public health and patent protection.
2. Inclusive and Transparent Policymaking: –
- Encourage the development of a more transparent and inclusive policymaking process that involves patient advocacy organizations, civil society, and other relevant parties in the creation and assessment of laws pertaining to patents.
Provide procedures for frequent feedback and consultations to guarantee that a range of viewpoints are taken into account during the decision-making process.
3. Enhance Compulsory Licensing Provisions:
- Make the requirements for issuing compulsory licenses more transparent and unambiguous in order to better balance safeguarding patent holders’ interests with meeting public health needs.
- Assure prompt, transparent, and effective implementation of the mandatory licensing procedure, particularly in the event of a medical emergency.
4. Support Indigenous Innovation: – Put laws into place that encourage and support homegrown pharmaceutical innovation by giving Indian businesses a financial boost for their R&D.
- Establish procedures to guard regional innovators’ rights and make sure the patent system does not unduly benefit large conglomerates.
5. Encourage Access to Essential Medicines: – Look into ways to speed up generic drug launches while maintaining accessibility and affordability, especially for life-saving medications.
- To address public health priorities, take into account specific incentives for the production of generic versions of necessary medications.
6. Evaluation and Compliance: –
- In order to make sure that patent holders fulfill their commitments to public health, strengthen monitoring systems and, if needed, take corrective action.
- Strengthen enforcement capacities to stop actions that could violate the spirit of patent law, like infringement or anti-competitive conduct.
7. Capacity Building and Awareness:
- Make investments to help regulatory bodies strengthen their ability to apply and uphold patent laws.
- Run awareness campaigns to inform interested parties—including medical professionals—about the changes to the patent law and how they will affect public health.
8. Review and Adaptation: – Create a regular review procedure to evaluate how the revised patent law affects innovation, public health, and medication accessibility.
- Assure the patent law’s adaptability to evolving domestic and international environments, technological breakthroughs, and new public health concerns.
- By incorporating these recommendations, the Indian patent system may become more responsive and balanced, better meeting the changing demands of innovation and public health while upholding intellectual property rights.
CONCLUSION
In conclusion, a variety of legal issues were addressed in great detail in the 1999 publication of the 167th Law Commission Report of India. The report offered insightful recommendations for strengthening the nation’s legal system and judicial procedures, ranging from electoral reforms to enhancements in legal education and suggestions regarding contempt of court. Its all-encompassing strategy demonstrated a dedication to preserving justice and bolstering the rule of law. India’s approach to intellectual property underwent a sea change when the Patent (Amendment) Bill of 2002 brought the country’s patent laws into line with international norms. In order to reflect the intricate interactions between economic development, public health, and intellectual property rights in the dynamic landscape of India’s pharmaceutical sector, the amendment sought to strike a careful balance between promoting innovation and guaranteeing access to reasonably priced medications.
REFERENCES
- http://www.eparlib.nic.in
- http://ipindia.gov.in
- https://indiankanoon.org/doc/1449261
- https://archive.pib.gov.in/archive/releases98/lyr2002/rjul2002/10072002/r100720021.html
- https://byjus.com/free-ias-prep/indian-patents-act/
- https://www.wipo.int/patent-judicial-guide/en/full-guide/india
- https://ipindia.gov.in/history-of-indian-patent-system.htm
- https://link.springer.com/chapter/10.1007/978-981-13-8102-7_11
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[6]https://indiankanoon.org/doc/1449261
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[8] https://byjus.com/free-ias-prep/indian-patents-act/
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[10] https://byjus.com/free-ias-prep/indian-patents-act/
[11] https://ipindia.gov.in
[12] http://ipindia.gov.in
[13] https://byjus.com/free-ias-prep/indian-patents-act/
[14]https://byjus.com/free-ias-prep/indian-patents-act/
[15] http://ipindia.gov.in
[16] http://www.eparlib.nic.in
[17]https://www.wipo.int/patent-judicial-guide/en/full-guide/india
[18] https://indiankanoon.org/doc/1449261
[19] https://link.springer.com/chapter/10.1007/978-981-13-8102-7_11
[20] https://link.springer.com/chapter/10.1007/978-981-13-8102-7_11
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