This comprehensive blog delves into the world of pharmaceutical patents in India. It covers different types of drug patents, the impact of Section 3(d) on polymorph patents, and provides clear answers to common questions about patenting life-saving drugs, patent percentages, and the time it takes to patent a drug.
Overview : A Detailed Guide to Patent of Drug in India
The field of patent of drug is dynamic and complex, particularly in a country as diverse as India. Understanding the types of pharmaceutical patents and the nuances of patent law, including the infamous Section 3(d), is critical for anyone navigating this space.
Over the past three decades, the high-technology-based Indian pharmaceutical business has experienced sustained expansion. The contemporary industry participants are made up of a number of privately held Indian businesses. They have gained a sizable share of the domestic pharmaceutical market. This is due to favourable government regulations and little competition from outside, among other things. The first patent rights were granted in India in 1856, and all earlier laws were repealed with the passage of the Patent Act 1970 (“the Patents Act”) in 1970. Additionally, India has ratified both the 1970 Patent Cooperation Treaty and the 1883 Paris Convention for the protection of Industrial Property.
According to the Patents Act, any invention that meets the requirements of newness, non-obviousness, and utility may be the subject of a patent. Patent rights grant them an exclusive entitlement from excluding others from using, selling, and distributing those creations for at least 20 years from the date the statement of claim was submitted.
Meaning and Characteristics of Patents
Patents play a crucial role in protecting intellectual property, and this holds true for drugs as well. This article aims to provide a comprehensive overview of drug patents, covering their meaning, characteristics, and significance in the pharmaceutical industry. Additionally, we will explore the development of patent law in India, various types of pharmaceutical patents, the role of Section 3(d) in polymorph patenting, the process of awarding patents to inventors, and the transfer of patent rights through assignment and licensing. We will also highlight important case laws that have shaped the landscape of drug patents. By the end, you will have a well-rounded understanding of the subject.
To start, we will delve into the definition and essential features of patents, focusing on their purpose in safeguarding inventors’ rights and encouraging innovation. We will explore the requirements for patentability, including novelty, inventive step, and industrial applicability, and discuss the exclusivity granted by a patent.
Objectives of Patent Act
The objectives of the Patent Act can be summarized as follows:
- Granting Statutory Right: The Patent Act aims to provide the patent holder with a legal and exclusive right for a defined period. This right allows the patent holder to prevent others from utilizing, selling, or developing the invention for commercial purposes.
- Disclosure and Practice of Invention: Another objective is to encourage the disclosure of inventions. By obtaining a patent, inventors are required to share the details of their inventions with the public. This disclosure not only promotes scientific research but also enables others to learn from and build upon the invention, contributing to technological advancement.
- Stimulation of New Inventions: The Patent Act seeks to stimulate innovation by offering inventors a temporary monopoly over their inventions. This temporary exclusivity encourages individuals and organizations to invest time, effort, and resources in developing new inventions of practical value.
- Transition to the Public Domain: After the expiry of the patent’s duration, the invention enters the public domain. This objective ensures that innovations eventually become available for anyone to use, fostering continued innovation and allowing society to benefit from the accumulated knowledge.
- Sole Ownership: The Patent Act provides inventors with the opportunity to have sole ownership of their inventions. This ownership recognizes the inventor’s creative efforts and allows them to control how their invention is used for a limited period.
- Ensuring Commercial Returns: The Act aims to reward inventors for their investment of time, money, and effort in developing new products. By granting exclusive rights, inventors can reap commercial benefits from their inventions, which serves as an incentive for further innovation.
In essence, the Patent Act serves as a balancing mechanism between granting inventors temporary monopolies to encourage innovation and ensuring that these innovations eventually become part of the public domain, benefiting society as a whole.
Evolution of Patent Law in India
Pharmaceutical enterprises allocate substantial funds to research and develop novel drugs each year. Statistics reveal that, among a thousand potential drugs, merely 3-5 make it to clinical trials, and only one ultimately garners approval for market distribution. These pioneering drugs are patented by pharmaceutical firms, granting them exclusive marketing rights for a span of 20 years. The expenses incurred in the drug’s research and development are recuperated through its pricing, borne by the general populace.
Once a pharmaceutical company successfully registers a drug under the Patent Act, they gain an exclusive 20-year ownership of both the patent and the associated marketing rights. This exclusivity renders any other drug manufacturer ineligible to produce or replicate the same drug during this two-decade period. Upon the completion of the 20-year term, the patent ceases to be in effect. Consequently, other pharmaceutical companies are then permitted to engage in the manufacture and sale of the identical drug.
During the early 1970s, the Indian Patent Act exclusively acknowledged process patents, neglecting product patents. This provision empowered Indian pharmaceutical entities to produce the same drug using alternative processes, colloquially known as reverse engineering. Nonetheless, it wasn’t until the 2005 amendment act that India sanctioned product patenting for pharmaceutical innovations.
Pharmaceutical Patent Types in India
Pharmaceutical patents in India broadly fall under three categories: Product Patents, Process Patents, and Formulation Patents.
1. Product Patents:
A product patent protects the chemical compound of a drug. It grants the patent holder exclusive rights to manufacture, sell, or distribute the patented drug. Such patents ensure that no generic version of the drug can be produced without the patent holder’s permission.
2. Process Patents:
These patents protect a unique method of creating a drug. It means that others can manufacture the same drug using a different process without infringing on the patent rights.
3. Formulation Patents:
Formulation patents protect the specific combination of active ingredients and excipients (non-active ingredients) that create a unique formulation of a drug. It means others can create a similar drug with a different formulation.
Section 3(d)’s Role in Polymorph Patenting Patents
Polymorph patents cover different crystalline forms of an existing drug compound that offer specific advantages such as improved stability or bioavailability. Section 3(d) of the Indian Patents Act plays a critical role in polymorph patents. It prohibits the patenting of new forms of known substances unless they demonstrate enhanced efficacy. This provision is unique to Indian patent law and was notably applied in the Novartis Glivec case, where the Indian Patent Office denied a patent for a new form of the drug imatinib, citing Section 3(d).
Granting of a Patent to the Inventor: Section 21 of the Indian Patent Act, 1970, outlines the process by which an individual receives a patent subsequent to submitting a patent application. To secure a patent, the inventor must formally request the government by providing a written description of the invention, commonly referred to as a patent application. The grant of a patent is contingent upon the absence of any prior opposition to the application. Once granted, the patent holder can potentially earn royalties from the invention.
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Transfer of Patent Rights
The rights associated with a patent can be transferred from the original patent holder to another individual through assignment or as stipulated by legal provisions. This transfer can also take the form of a license. The owner of the patent has the authority to license or assign it; in cases of co-ownership or joint ownership, such action necessitates the consent of the other owner. The fundamental distinction lies in the fact that, in a license, the licensor retains a vested interest in the property being licensed, while an assignment involves the relinquishment of rights to the assigned property. An assignment entails a complete transfer of ownership and title, whereas a license entails a contractual permission to engage in activities that would otherwise infringe upon patent rights.
Patent Assignment
This section emphasizes the necessity for written agreements and proper execution for such assignments to be considered valid. The agreement must be reduced to a formal document outlining all rights, obligations, and stipulations between the parties involved.
There are three primary types of assignments: legal assignments, equitable assignments, and mortgages.
Patent Licensees
Section 70 of the act permits patent holders to grant licenses via formal agreements. These licenses authorize the licensee to utilize, make, or implement the patented invention. A written format is imperative for the validity of a granted license. The agreement, duly signed by both the licensor and licensee, encapsulates the mutually agreed-upon terms, including the payment of royalties for the production of items covered by the patent.
The Effect of the World Trade Organisation on Pharmaceutical Patents
The formation of the World Trade Organisation (WTO) has resulted in a radical change. The pharmaceutical industry was one of the main reasons for incorporating intellectual property issues into the GATT framework, according to the agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS).
It was negotiated during the Uruguay round trade negotiations of the General Agreement on Tariffs and Trade (GATT). India ratified the GATT on April 15, 1994, making it obligated to abide by its terms, including the TRIPS agreement.
As a result, India must adhere to the TRIPS Agreement’s minimum requirements for patents and the pharmaceutical sector. The availability of patents for both pharmaceutical items and process inventions must now be addressed under India’s patent laws. Any discovery of a pharmaceutical product or technique that satisfies established requirements is entitled to a patent for a minimum of 20 years.
Validity of Patents
The Indian pharmaceutical business expanded quickly by creating less expensive versions of certain medications that had domestic patents. After the domestic patents on these medications expired, the industry then aggressively entered the global market with generic medications. The Patents Act also includes a number of measures to stop the infringement of patent rights and to improve access to medicines.
For processes or methods of making substances that are intended for use as food, medicine, or drugs or have the potential to be used in those ways, a patent is valid for seven years from the date of filing or five years from the date the patent was sealed, whichever comes first. All other invention patents are awarded for 14 years from the date of filing, barring evidence that the patent is defective.
Licensing Requirements
Article 31 of the TRIPS Agreement allows the country to grant regulatory approval for specific reasons to promote human safety. A licensing agreement is a licence given to a 3rd person by an administrative agency to commercialise an innovation without the permission of the patented invention. This licence is usually referred to as a quasi licence because the patent owner has not given permission.
The primary goal of compulsory licenses is to encourage new drug research and innovation. In India, though, such licenses are entitled to an acceptable payment. A compulsory program enables the license holder to start producing a generic version of the product for sale in the local farmers’ market at a lower price than its competing product, provided the entrepreneur has made sufficient attempts to seek a certificate of registration from the patented invention on acceptable terms and within a reasonable period.
Implications Of Pharmaceutical Drug Licensing
- Medical copies obtained under a required license may not meet the same quality standards as originals. A mandatory license often does not indicate that the firm’s background information is sufficient to cause the pharmaceuticals as efficiently as the originator.
- Mandatory licensing could hinder the development of novel medicines. Pharmaceutical companies will depend on specific copyrights to make money by producing copies of patented drugs and will never be able to stay focused on developing new medications.
- The patent system deters firms from conducting experiments in countries where patents are not respected. For individuals who miss out on therapy, this is a setback. It’s also a blow to regional industries, which would benefit from having clinical studies in their area.
FAQs on Patent of Drug in India:
1. Can life-saving drugs be patented in India?
Yes, life-saving drugs can be patented in India, provided they meet the patentability criteria of novelty, inventive step, and industrial application. However, the Indian government has the right to issue compulsory licenses for such patents under certain conditions to ensure affordable access to essential medicines.
2. What is the percentage of pharmaceutical patents in India?
Over 18 percent are pharmaceutical patents in India.
3. How long does it take to patent a drug?
Drug patents are granted for a duration of 20 years from the drug's initial invention. However, in many instances, this period is reduced to 10 years from the drug's introduction to the market after successful testing. Generally, patents are approved within a few years following the submission of the patent application.
Conclusion
The Committee for Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been influential in suspending specific requirements of the TRIPS agreement, even though the World Trade Organisation has warned that the epidemic will cause unparalleled damage to the world economy.
Regarding government enforcement, India should leverage the mandatory licensee’s potential as a tool by interacting with other Indian drug manufacturers and asking if they can utilise their manufacturing capacity to make these vaccinations and reliability items. Even giving compulsory licenses for export vaccinations, Indian private pharmacological companies should participate in this phase. The administration will circle such private pharmaceutical companies of lawsuit costs and other legal implications.
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