Research ArticleIPR

Pharmaceutical Patenting in India


Author: Valusa Abhigna, BBA.LL.B, 2nd year student at Amity University, Mumbai. 

Abstract

Intellectual Property Rights may be gained in the pharmaceutical sector via Patents. Trade mark, industrial design, geographical indication and copyright are several other IPR’s accessible in India. Patent rights in India are enforced under the Patents Act, 1970. Major reforms including provision of product Patents and raise in the length of Patent to 20 years were implemented in the Indian Patent law, after India signed TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement in 1995. Research paper offers an outline of Indian growth of Patent law as a result of TRIPS and the significance of Patent law in India. The conditions for patentability and the types of Patents being awarded in India are defined to provide a set of information for the researchers. Also, several other regulations relevant to the patenting of pharmaceuticals including compulsory licenses are clarified.

Introduction

Intellectual Property (IP) is a property that is a product of human intelligence or human initiative; therefore it is an intangible property. Intellectual property rights are the rights generated due to the creation of intellectual property. These privileges are inherited from the rights of the creator of these properties. Although intellectual property is intangible, it should be remembered that the material form of intellectual property which is tangible may only be protected by IP Rights. Intellectual property is also an asset that may be purchased, leased, mortgaged, registered, traded or gifted to someone in the same manner as other properties are. The intellectual property owners are the only one that can legally utilize the property they make, so people can’t use the property without the owners’ permission.

Patent, trademark, industrial design and copyright are some of the most popular types of intellectual property rights in India. A trademark is a graphical representation (logo) which is used for the purpose of separating the products and services of one individual or company from that of another. Copyright means the exclusive right to do or allowing from doing such actions in relation to literary, theatrical, musical or creative works, sound recordings and cinematographic video. From all the forms of intellectual property rights, Patents are most the important within the pharmaceutical industry.

The Indian pharmaceutical industry is a successful, high-technology-based industry that has witnessed consistent growth over the past three decades. The current industry players comprise several privately owned Indian companies that have captured a substantial share in the domestic pharmaceutical market due to factors such as favourable government policies and limited competition from overseas. However, the liberalisation of the Indian economy is revolutionising Indian industries as they begin to emerge from domestic markets and gear up for international competition.

The Indian pharmaceutical industry is a prime example of an industry that is being forced to revisit its long-term strategies and business models as India opens its markets to global trade. Factors such as protection of intellectual property are increasing in significance due to the growing recognition of the need to ensure protection of valuable investments in research and development (R&D). Efforts are being made in India to curb problems of weak enforceability of existing intellectual property legislations, and the Indian government is moving towards establishing a Patent regime that is conducive to technological advances and is in keeping with its global commitments.

Patent Law in India

Patents are issued for the security of innovations. Patent is a civil privilege granted to the maker of an innovation by the state. A Patent can be applied by the inventor or by an assignee approved by the inventor. It’s the right to stop rivals from producing, utilizing, agreeing to sell, distributing, or importing the innovation. Patents are a form of intellectual property rights that empowers the patentee (Patent owner) to prohibit or stop the usage or selling of the innovation by third parties without the patentee’s permission. A Patent grants the patentee the right to license others to develop, use, and/or sell the copyrighted device.

A Patent is an agreement between an applicant/inventor and the government under which the government gives the applicant a fixed term of exclusive protection after the disclosure of the innovation by the applicant.[1]

In case of Patents, there is a technological approach for a technical problem. A Patent is only given to certain inventors who can reasonably show that their innovation meets the conditions of patentability. Patents will be issued for a fixed period of twenty (20) years from the date of filing the Patent application. A Patent is a property right issued by the sovereign, and its compliance is restricted to the country where it was granted. Therefore, a valid agreement against any misuse or breach of a Patent will be taken in the place where the Patent was initially issued. In order to gain Patent rights abroad, Patent applications have to be made in each county. Patent Cooperation Treaty (PCT) offers a way to register a single international Patent application that would be approved by a wide range of jurisdictions.

Patent rights in India were implemented in 1856 and the Patents Act was enacted in 1970 which repeals earlier legislation. Every innovation that is new, non-obvious and beneficial will be the subject matter of a Patent under the Patents Act. Any of the non-patentable innovations under the Patents Act include methods of cultivation or horticulture; procedures for the medical, clinical, curative, prophylactic or other care of human beings, animals or plants; substances acquired by means of mere admixture, resulting in the accumulation of the properties of the ingredients, etc.

In relation to pharmaceuticals, in terms of substances meant for use or worthy of being used as food, medicines or narcotics or substances created by chemical methods, Patents are not issued for the substances themselves, but rather for the processes of manufacturing. As a result, pharmaceuticals are not patented in India till 2005.

The Patent law for India is the Patents Act, 1970. Initially, according to the terms of the Patent Act of 1970, no product Patent but only method Patents may be issued for innovations related to food, medicines and chemicals. However, product patenting is permitted in India since 2005.

Types of Pharmaceutical Patents in India

The Pharma sector includes a number of various “knowledge oriented” activities. Pharmaceutical analysis needs a large expense, owing to the unpredictability Results of the research might lead in a fresh, usable product or method. In this extremely competitive market, it is imperative for the pharmaceutical industry to safeguard their creations against any illegal commercial usage through obtaining Patent rights on the invented product or method. Pharmaceutical patenting can be categorized under the following classifications:[2]

·       Drug compound Patents

·       Formulation/ composition Patents

·       Synergistic combination Patents

·       Technology Patents

·       Polymorph Patents

·       Biotechnology Patents

The Impact of the World Trade Organization on Pharmaceutical Patents

The creation of the World Trade Organisation (WTO) propelled global trade to unparalleled heights. The deal on Trade Related Aspects of Intellectual Property Rights (TRIPS) was concluded during the Uruguay Round negotiations of the General Agreement on Tariffs and Trade (GATT) and was “one of the primary reasons for incorporating intellectual property issues into the GATT framework was the pharmaceutical industry”[3]. India signed the GATT, thereby granting it the duty to comply with the requirements of the GATT, including the agreement on TRIPS.

India shall follow minimum requirements under the TRIPS agreement in the pharmaceutical sector with respect to Patents. India would need to include the Patent laws with requirements for the availability of medicinal Patents as well as the processes of innovations. Patents for pharmaceuticals are to be given for a minimum 20-year period to every medicine or drug-related procedure that fulfils specified requirements.

Compulsory licensing scheme

In the Patents Act of 1970, there were already requirements to authorize compulsory licensing, and the scheme was normalized further by the Patent (Amendment) Act of 2002 and 2005. The compulsory license scheme provides a better opportunity for Patent holders to sign voluntary licensing agreements with pharmaceutical firms from other nations.

In India, after the expiration of three years from the date of the filing of a patent, any qualified party can apply to the Controller. A person who wants a compulsory license must first negotiate with the patentee to receive a voluntary license. If the request is not procured within 6 months after its original submission, the applicant has the ability to continue with a compulsory license application.

Case Laws

India faces the same patterns found in other countries across the world, but the amount of Patent litigation has risen only after the year 2007. The High Court of Delhi has been the busiest court in terms of Patent cases in recent years, followed by the High Court of Bombay and the High Court of Madras. The Supreme Court of India has been a hub for Patent litigation, which has affected Patent law in India. It has been being recognized not only by other federal courts but also in foreign forums. The recent judgments have identified India as a strong enforcer of intellectual property regime.

In F.Hoffmann-la Roche Ltd. V. Cipla Ltd., the Delhi High Court noticed that Cipla, a generic maker, was violating the Swiss drug manufacturer Hoffmann-La Roche’s licensed drug Erlotinib Hydrochloride. Likewise, in Merck Sharp & Dome V. Glenmark Pharmaceuticals Ltd., the Delhi High Court banned Glenmark Pharmaceuticals Ltd., a Mumbai based firm, from offering a anti-diabetes drug variant of Merck’s licensed drug Sitagliptin. It is noteworthy that the decision was enacted in fewer than two years.

Novartis V. Union of India

  • In this instant case, Novartis, a Swis pharma corporation, pursued a Patent for the beta crystalline type of Imatinib mesylate (Gleevec). Patent allegations were denied by CIPLA and other generic drug makers. A writ petition was filed in the Madras High Court after the Patent application was dismissed by the Indian Patent office.
  • The Madras High Court: Section 3(d) of the Patent Act has been criticized by Novartis as being illegal. In response, Novartis argued that the word “efficacy” in section 3(d) of the Patent Act is undefined and confusing, and therefore goes against the Article 14 of the Constitution of India. However, The Madras High Court rejected the writ petition and ruled that section 3(d) of the Patent Act is constitutional.
  • An appeal was made to the Intellectual Property Appellate Board (IPAB), which upheld the novel and novelty elements of Novartis’s lawsuit, but considered the patentability of the claim under section 3 to be not valid (d). The IPAB order was questioned in a SLP filed before the Supreme Court of India.
  • But in 2013, the Supreme Court of India has not allowed the SLP and observed that the Novartis arguments were unconstitutional according to sections 2(j), 2(ja), 2(l) and section 3(d) of the Patent Act.
  • Since, the Supreme Court of India exemplifies the precarious relationship between the right of Patent holders and the right of public. It was rendered clear that Patent holders are not entitled to evergreen Patents and cannot manipulate the general public or the rivalry of competing companies.
  • Indeed, this judgment was affirmed by the Supreme Court of India in the aforementioned ruling, in which it was rendered explicit that section 3(d) is valid and does not disallow the right to Patent on incremental invention, providing that the incremental innovation fulfills the conditions of patentability.

SYMED Labs Vs. Glenmark Pharmaceuticals

  • Two of SYMED Labs’ Patents, were reportedly being infringed by Glenmark Pharmaceuticals Laboratories: IN213062 & 213063. SYMED took judicial proceedings against Glenmerck in the Delhi High Court.
  • There was a prima facie argument in favor of SYMED. Furthermore, the Delhi High Court decided that damages would be an insufficient solution for SYMED, and therefore, immunity to the Patent mechanisms should be given to SYMED. This means that there would be failure and harm that cannot be reversed because of the Patent infringement by Glenmerck. Additionally, it was observed that balance of convenience favored SYMED. In lieu of the temporary restraining order granted, Glenmark was not permitted to import, distribute, offer for sale, advertise or deal in the development of Linezolid. Therefore, SYMED’s licensed Patents were successfully resolved by the court.

 

Major Amendments in Patent Act regarding Pharmaceutical industry

  • 1999 Amendment

According to Article 70.8 of the TRIPS Agreement, participants who have not provided Patent protection to pharmaceuticals and agricultural chemical products as of the date of entry into force of the WTO Agreement are expected to provide a means by which applications for Patents for those innovations can be submitted as of the date of entry into force of the WTO Agreement: to submit the requirements for patentability as laid down in the TRIPS Agreement as if such criteria were being enforced on the date of filing, and to provide Patent protection from the grant of the Patent and for the duration of the Patent period, determined from the filing date. The object of the TRIPs Agreement is to preserve the novelty and priority of Patent applications. This is often called the “mailbox” framework method and is utilized by developing countries throughout the transition era.

  • 2002 Amendment

The Patents (Amendment) Act was promulgated on June 25, 2002.  To reach TRIPS expectations, a number of provisions in the Patents Act, 1970 were modified, including the concept of innovation, the purpose of Patent protection, the Patent word, the conditions of Patent application, compulsory licenses, and the Bolar Exemption.

Under the Agreement on Trade-Related Dimensions of Intellectual Property Rights (TRIPS), Patents shall be valid for all innovations, whether items or methods, in all fields of technology, providing that they are new, require an innovative process, and are capable of industrial use.[4] Therefore, the 2002 Amendment stipulates that an innovation is a product or method that requires an inventive phase, and further describes an inventive step as something that is not apparent to a person skilled in the art.[5]

  • 2005 Amendment

The Patents (Amendment) Act, 2005, came into effect on April 4, 2005. Though certain particular provisions came into operation on the dates fixed by the Central Government, the majority of the provisions came into effect on January 1, 2005, the day India ended its transition phase. The amendment of 2005 is important for India to meet its commitments under the TRIPS agreement.

The most significant reform made by the Amendment is the omission of Section 5 of the Patents Act, 1970,[6] which specified that no Patent shall be “issued in respect of claims for substances intended for use or capable of being used, as food or as medicine or drug or relating to substances prepared or created by chemical processes.”[7] The Amendment did not contain Chapter IVA, which was introduced through the Amendment of 1999.[8] This implies that, until the end of the transition period, in compliance with the TRIPS requirement,[9] Patents shall be valid for all innovations, including products or methods, in all fields of technology.

Conclusion

The Patent law in India is an example of a fair piece of legislation that balances the needs of both the public and Inventors. After India introduced its Patent scheme, a large number of medicinal items were became patentable. Until filing for the Patent the researchers must closely evaluate the patentability of the innovation and consider consulting a Patent attorney. When Patent rights are obtained, they may be passed by assigning or licensing. Due to a lack of production and marketing capabilities, organisations such as colleges and universities utilize Patents as a credible method of technology transfer.

The Patent system in India has taken up various controversy concerns pertaining to both the public health interests and the economic rights of the Patent holders. It is also expected to limit availability to allopathic medicines to only the wealthy, accessible and more privileged class of citizen in India and other countries in the near future. No doubt that it is a challenging task for those who are in the protection of public health to maintain the balance between the rights of the Patent holders and the public health.  It is the function of the State to plan and organize the Patent law so and the conflict in rights pertaining to rights of intellectual property owners and the right to health of human beings are minimized while balancing the prevalent hierarchy of human rights for achieving the social and economic objectives. They need to maintain a good balancing act between the conflicting interests of both Patent Holders and general public health is the spirit of Paten Law.

Patent law in India is largely established by the Indian Patent Act 1970, which was last amended in 1999, 2002, and 2005 to follow WIPO and TRIP guidelines on Patents. After 2005 reforms, several claims have been lodged alleging Patent rights violations, and therefore Patent jurisprudence has developed through the years through several rulings reached by the High Courts and Supreme Court. Innovativeness and patentability of Patent are being reviewed on the Patent validity.


References

[1] Draft manual of patent practice and procedure. Controller General of Patents, Designs & Trade Marks, Mumbai, India 2008.

[2] Vipin Mathur “Patenting of Pharmaceuticals: AnIndian Perspective”, Int. J. Drug Dev. & Res., July-September 2012, 4(3): 27-34

[3] Zafar Mirza, WTO/TRIPs, Pharmaceuticals and Health: Impacts and strategies, The Society for International Development, SAGE Publications.

[4] Article 27.1 of the TRIPS Agreement.

[5] Section 3(f) of the Patents (Amendment) Act, 2002.

[6] Section 5 of the Patents Act, 1970.

[7] Section 4 of the Patents (Amendment) Act, 2005.

[8] Section 21 of the Patents (Amendment) Act, 2005.

[9] Article 27.1 of the TRIPS Agreement.

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