Patent exclusions

Patent exclusions

Syllabus
GS Paper 3 – Awareness in the fields of IT, Space, Computers, Robotics, Nano-technology, Bio-technology and issues relating to Intellectual Property Rights

Context
In the patent landscape, including pharmaceutical patents, defining precise boundaries for patent protection is vital for communicating the granted rights of specific inventions to stakeholders. However, complications arise, especially with provisions like those in Section 3 of the Patent Act, necessitating focused clarification.

Source
The Hindu | Editorial dated 13- December 2023


  • Intellectual Property Rights (IPR) encompass legal entitlements granted to individuals for their creative outputs, such as inventions, literary and artistic works, and commercial symbols.
  • IPR serves as a mechanism to bestow exclusive rights to creators and innovators, allowing them to control and benefit economically from their creations for a defined period.
  • Intellectual property (IP) is the result of significant investments in terms of time, energy, skill, and resources, providing a secure environment for various professionals like investors, scientists, artists, and designers to foster innovation.
  • The global importance of IPR is evident in the contemporary scenario of globalization, making it a cornerstone in international trade practices and vital for a country’s innovation and development goals.
  • Article 27 of the Universal Declaration of Human Rights underscores the right to benefit from the protection of both moral and material interests arising from creative endeavors.
  • The recognition of the significance of intellectual property dates back to the Paris Convention for the Protection of Industrial Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886), both administered by the World Intellectual Property Organization (WIPO).
  • Patents:
    • Exclusive rights for inventions.
    • Criteria: Usefulness, Novelty, Non-obviousness.
    • Protection for 20 years, allowing creators to control and economically benefit from their innovations.
  • Trademarks:
    • Identifies goods or services with a distinctive sign.
    • It comprises words, letters, numerals, safeguarding brand identity and preventing confusion in the marketplace.
  • Copyright and Related Rights:
    • Legal rights for literary and artistic works.
    • Creators sell rights for payment (royalties), ensuring fair compensation for their creative endeavors.
  • Geographic Indications of Source:
    • Sign on goods with specific geographical origin.
    • Linked to qualities or characteristics of the origin, preserving the unique identity and reputation of products.
  • Industrial Designs:
    • Creative activity for ornamental appearance.
    • Design rights for registered designs, offering protection for the aesthetic aspects of a product.
  • Trade Secrets:
    • Confidential business information for a competitive edge.
    • Protection without registration, enabling businesses to safeguard valuable information without the need for formal procedures.
  • Semiconductor Integrated Circuit Layout Designs (SICLD):
    • Protection for integrated circuit layouts.
    • Empowers registered proprietors for commercial use, encouraging investment in innovation within the electronics industry.
  • Protection of Plant Varieties & Farmer’s Rights:
    • Recognizes farmers’ role in agro-biodiversity.
    • Rewards farmers and stimulates R&D for new plant varieties, ensuring a sustainable and diverse agricultural landscape.
  • Protection of Biological Diversity:
    • Covers traditional knowledge and associated knowledge.
    • Benefit claimers include conservers and creators of biological resources, acknowledging their crucial role in biodiversity conservation and sustainable resource management.
  • International Affiliations:
    • Indian IPR laws align seamlessly with the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) under the WTO, demonstrating India’s commitment to international standards and cooperation.
    • Active participation in the World Intellectual Property Organization (WIPO), a global body dedicated to promoting and safeguarding intellectual property rights worldwide.
  • WIPO-Administered Treaties and Conventions:
    • India is a party to several crucial WIPO-administered international treaties and conventions, including the Budapest Treaty, Paris Convention, Berne Convention, Patent Cooperation Treaty, Madrid Protocol, and others.
    • Commitment to treaties such as the Washington Treaty on Intellectual Property in respect of Integrated Circuits, Nairobi Treaty on the Protection of the Olympic Symbol, and Marrakesh Treaty for facilitating access to published works by visually impaired persons underscores India’s dedication to diverse aspects of intellectual property.
  • About TRIPS:
    • Part of the international legal order on trade within the World Trade Organisation (WTO).
    • Negotiated in 1995 at the WTO.
  • Aim of TRIPS:
    • Guarantee minimum standards of intellectual property (IP) protection.
    • Ensure legal consistency for innovators to monetize their IP in multiple countries.
  • Covered Areas:
    • Copyright and related rights.
    • Trademarks, including service marks.
    • Geographical indications, including appellations of origin.
    • Industrial designs.
    • Patents, including protection for new plant varieties.
    • Layout-designs of integrated circuits.
    • Undisclosed information, encompassing trade secrets and test data.
  • Role of TRIPS:
    • Central role in facilitating trade in knowledge and creativity.
    • Resolving trade disputes over IP.
    • Assuring WTO members the latitude to achieve their domestic policy objectives.
  • Benefits Under TRIPS:
    • Governments, under the agreement, can compel companies to license patents to other manufacturers, even if the offered price is considered unacceptable, during a public health emergency.
  • Evolution of India’s IPR System:
    • The roots of India’s IPR system trace back to the British colonial era, where initial frameworks were established.
    • Post-independence, India retained and adapted these structures, aligning them with the changing landscape.
    • During the liberalization era in the 1990s, India made further adjustments to meet the evolving needs of both domestic and international stakeholders.
  • National IPR Policy of India 2016
    • Government Initiative: Adopted in May 2016, the IPR Policy marks a significant initiative by the Government of India to ignite creativity and foster innovation.
  • Vision Statement:
    • Envisions an India where Intellectual Property stimulates creativity and innovation for the benefit of all.
    • Aims for intellectual property to drive progress in science, technology, arts, culture, traditional knowledge, and biodiversity resources.
    • Seeks to transform knowledge ownership into shared knowledge, making knowledge the main driver of development.
  • Policy Objectives:
    • IPR Awareness – Outreach and Promotion:
      • Create public awareness about the economic, social, and cultural benefits of Intellectual Property Rights (IPRs) across all segments of society.
    • Generation of IPRs:
      • Stimulate the generation of IPRs by tapping into India’s extensive talent pool in scientific and technological fields.
    • Legal and Legislative Framework:
      • Establish strong and effective IPR laws that balance the interests of rights owners with broader public interests.
    • Administration and Management:
      • Modernize and fortify service oriented IPR administration.
    • Commercialization of IPR:
      • Extract value from IPRs through effective commercialization strategies.
    • Enforcement and Adjudication:
      • Strengthen mechanisms for enforcing and adjudicating IPR infringements.
    • Human Capital Development:
      • Enhance human resources, institutions, and capacities for teaching, training, research, and skill-building in IPRs.
    • Integration into National Development Plans:
      • Aims to position IPR as a pivotal policy and strategic tool in national development plans.
  • India’s Global Innovation Index (GII) ranking surged from 81st in 2015 to an impressive 52nd position in 2019, reflecting significant strides under the new IPR policy.
  • Institutional mechanisms for IP protection and promotion have been fortified, contributing to a more robust framework.
  • Government efforts to augment technical manpower have led to a substantial decrease in the backlog and pendency of IP applications.
  • Noteworthy increases in patent filings (almost 7%) and trademark filings (nearly 28%) during the initial eight months of 2018-19 compared to the corresponding period in 2017-18.
  • Notification of revamped Trade Marks Rules in 2017 for enhanced efficiency.
  • Conducting IPR awareness programs in academic institutions, including rural schools through satellite communication.
  • Targeted programs for industry professionals, law enforcement, customs officials, and the judiciary to enhance understanding.
  • Safeguarding Creators’ Rights:
    • Intellectual Property Rights (IPRs) protect the rights of creators, fostering a conducive environment for innovation and creativity.
  • Promotion of Innovation:
    • IPRs stimulate the development and distribution of new products and services, particularly benefiting start-ups and SMEs by providing tools to compete with larger companies.
  • Economic Contribution:
    • IPRs contribute significantly to the economy, enabling direct and indirect revenues through licensing, fostering an environment for financial growth.
  • Cultural Enrichment:
    • Copyright, a component of IPRs, plays a crucial role in the creative sectors, ensuring economic rewards for creators and contributing to cultural heritage and diversity.
  • Dissemination of Technical Information:
    • Patents, a key element of IPRs, serve as a prolific source of technological information, promoting the sharing of knowledge and avoiding duplication of research efforts.
  • Facilitating Technology Transfer:
    • IPRs, especially patents, facilitate technology transfer through accurate descriptions of technologies in licensing and similar agreements.
  • Supporting Open Source Mechanisms:
    • Even in open-source mechanisms, IPRs play a role, such as copyright licenses, ensuring compliance with conditions while promoting sharing and collaboration.
  • Collateral for Financing:
    • Intangible assets like IPRs, especially patents, play a crucial role in convincing third parties to provide financing to SMEs, contributing to their valuation.
  • Ensuring Product Quality and Safety:
    • IPR enforcement, including trademarks and designs, prevents counterfeit products from entering the market, ensuring consumer safety and product quality.
  • The Copyright Act, 1957
  • The Patents Act, 1970
  • The Trade Marks Act, 1999
  • Designs Act of 2000
  • The Geographical Indications of Goods (Registration and Protection) Act, 1999
  • The Copyrights Act of 1957
    • Administrative Body:
      • Copyright Office under the Ministry of Human Resource Development.
    • Nature of Copyright:
      • A bundle of rights granted to creators of literary, dramatic, musical, and artistic works, as well as producers of cinematograph films and sound recordings.
    • Rights:
      • Rights of reproduction of the work
      • Communication of the work to the public
      • Adaptation of the work and translation of the work.
    • International Copyright Protection:
      • Works from countries listed in the International Copyright Order are protected in India as if they are Indian works.
      • Copyright term in a work aligns with that in its country of origin.
    • Acquisition of Copyright:
      • Automatic upon creation, requiring no formality.
      • Certificate of registration serves as evidence in disputes; registration can be done in the Copyright Office.
    • Computer Software Registration:
      • Software can be registered as a ‘literary work,’ including source code.
      • Registration ensures compliance with Internet Treaties (WCT and WPPT).
    • Duration of Copyright:
      • Varies based on the type of work.Literary, dramatic, musical, and artistic works: Author’s lifetime + sixty years.
      • Anonymous, pseudonymous, posthumous works, cinematograph films, sound records: 60 years from first publication.
  • Patents Act of 1970
    • Administrative Body:
      • Department for Promotion of Industry and Internal Trade (DIPP), Ministry of Commerce and Industry.
    • Objective of Patent Law:
      • Purpose: Encourage scientific research, new technology, and industrial progress.
      • Trade-off: Monopoly grant for 20 years in exchange for invention disclosure.
    • Principles of Patent Law:
      • Patents granted for inventions demonstrating novelty and utility.
      • Improvement must go beyond mere workshop enhancement, requiring an inventive step and producing a new result.
    • Product and Process Patent:
      • Amendment 2006: Allows both product and process patents; earlier, only processes were patentable.
      • Infringement Clarification: No infringement if the same product is manufactured using a different, non-patented process.
  • Trademark Act of 1999.
    • Administrative Body:
      • Department for Promotion of Industry and Internal Trade (DIPP), Ministry of Commerce and Industry.
    • Definition of Trademark:
      • Components: Name, word, phrase, logo, symbol, design, image, or their combinations.
      • Non-conventional Trademarks: Include elements like color, smell, or sound (e.g., jingles).
      • Restriction: Trademarks cannot be offensive.
    • International Engagement:
      • Madrid Protocol, 2013: India joins the Madrid System for the International Registration of Marks.
      • Advantages: Offers a cost-effective, user-friendly, and streamlined method for global trademark protection and management.
  • Designs Act of 2000.
    • Administrative Body: Department for Promotion of Industry and Internal Trade (DIPP), Ministry of Commerce and Industry.
  • Definition of Industrial Design:
    • WIPO Perspective: An industrial design constitutes the ornamental or aesthetic aspect of an article.
    • Characteristics: Can involve three-dimensional features (shape of an article) or two-dimensional features (patterns, lines, or color).
  • Design Rights and Intellectual Property:
    • Design Right: Novel or original design accorded to the proprietor of a validly registered design.
    • Protection Scope: Owners have the right to prevent third parties from making, selling, or importing articles substantially copying the protected design for commercial purposes.
  • Geographical Indications of Goods Act, 1999.
    • Administrative Body: Department for Promotion of Industry and Internal Trade (DIPP), Ministry of Commerce and Industry.
  • Definition of Geographical Indication (GI):
    • Characteristics: A sign used on products with a specific geographical origin, possessing qualities or a reputation due to that origin.
    • Identification: Must identify a product as originating in a specific place, with qualities linked to that place.
  • Functionality of Geographical Indication:
    • Right Implications: Enables rights holders to prevent third-party use of the indication for products not meeting applicable standards.
  • Limitations of Protection:
    • Scope: Protection does not prevent the use of the same techniques outlined in the standards for that indication.
    • Acquisition of Rights: Obtained by acquiring a right over the sign representing the indication.
  • Applicability and Use of Geographical Indications:
    • Typical Use: Found in agricultural products, foodstuffs, wine and spirit drinks, handicrafts, and industrial products.
  • Section 3(d) Limitations:
    • Section 3(d) of the Indian Patent Act restricts patents for new forms of known substances unless significantly different in efficacy.
    • Hindrance to evergreening, leading to concerns among pharma companies.
  • Need for Clarity in Patent Scope:
    • Clarity on exclusions to patentability, especially those outlined in Section 3 of the Patents Act, is crucial.
    • Lack of bright-line rules in interpreting exclusions beyond the Novartis judgment on enhanced therapeutic efficacy.
    • Lack of clarity impacts access to medicines and innovation in the pharmaceutical sector.
    • Ambiguity in patent protection boundaries hampers stakeholders’ understanding of permissible scope.
  • Compulsory Licensing (CL) Issues:
    • Concerns among foreign investors over CL misuse to replicate their products.
    • Affects India-EU Free Trade Agreement (FTA) negotiations.
  • Coordination Challenges:
    • Lack of coordination between DPIIT and Central Drugs Standard Control Organization.
    • Absence of patent linkages or an effective notification system.
    • Invites abusive infringing activities affecting the commercialization and enforcement of IPR.
  • Cost Barrier for Initial IPR Filing:
    • High expenses associated with the first filing for any process or product under intellectual property rights (IPR) pose a challenge.
  • Persistent Piracy Despite IPR Protection:
    • Ongoing challenges with piracy persist even after implementing IPR protection measures.
  • Quality Erosion Over Time:
    • The aging of IPR can lead to a compromise in the quality of protection over time.
  • IPR as a Hurdle in Pandemics:
    • During the initial stages of the COVID-19 vaccine distribution, IPR restrictions were considered a hindrance. This prevented low and middle-income countries from manufacturing vaccines domestically, impacting accessibility.
  • Regressive Steps:
    • In April 2017, the Ministry of Health removed the requirement to inform about patents during manufacturing license filing.
    • Contrary to India’s National IPR Policy, which emphasizes better central and state coordination on IP issues.
  • Price Controls Concerns:
    • Threat of price controls for patented pharmaceuticals.
    • National Pharmaceutical Pricing Authority’s efforts to issue price control orders for non-scheduled drugs, including patented ones.
    • Uncertainty and opacity in Trade Margin Rationalization formula application for price monitoring.
    • 2019 amendment exempts manufacturers of new drugs patented in India from price controls for five years, but concerns persist over implementation.
  • Data Exclusivity Demands:
    • Indian law lacks protection against unfair commercial use of test data submitted for market approval.
    • Foreign investors and MNCs call for a Data Exclusivity law.
  • Weak Enforcement of Copyright Act:
    • Enforcement of the Copyright Act is weak, leading to widespread piracy of copyrighted materials.
    • India remains on the USTR’s ‘Priority Watch List’ for alleged IPR violations.
  • Promoting Innovation:
    • Rebooting academic curricula to foster innovation in schools.
    • Creating an environment that encourages innovation, aligning with flagship programs like Make in India and Start-up India.
  • Resolution Mechanism:
    • Establishing a robust resolution mechanism for IPR-related issues to streamline processes.
  • Addressing Gaps in IP Laws:
    • Recognizing that India must address gaps in its IP laws and regulations to fully leverage the transformative benefits of a strong IP system.
  • Awareness Campaign:
    • Increasing awareness about the creation, protection, and enforcement of IPRs to encourage innovation and ensure protection within the Indian industry.
  • Government Initiatives:
    • Acknowledging the government’s efforts to strengthen the National IPR policy, enhance the IP appellate tribunal, promote e-governance, and uphold commitments to international agreements like TRIPS, contributing to a positive global perception of India.

The Hindu
Intellectual property in India
PIB


Practice Question

Examine the evolution and significance of Intellectual Property Rights (IPR) in India, considering the changes introduced through various legal acts and amendments.

Leave a Reply

Your email address will not be published. Required fields are marked *