It is crucial for innovators and entrepreneurs to understand patent law, the the patentability criteria. India's patent system provides strong protection for real inventions while also making sure that certain exclusions, such as abstract software patents or minor modifications in pharmaceuticals, keep the balance between encouraging innovation and safeguarding public interest. By managing these well, inventors can enhance their protection of intellectual properties and further contribute to India's vibrant innovation landscape.
Patentability Criteria in India
Patentability is established through well-defined legal criteria under the Patents Act, 1970, primarily under Sections 2, 3, and 4. In India, an invention must fulfill three core criteria to qualify for patent protection: novelty, inventive step, and industrial applicability. Besides, there are provisions on what can be regarded as patentable subject matter and what cannot. Below is a comprehensive explanation of these basic criteria.
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Novelty (Section 2(1)(j))
Definition of Novelty: An invention will be novel if it is not included within the prior art. Prior art includes all publicly accessible information existing prior to the date on which the application for patent was filed, including patents or applications for patent, publications, or public releases, as well as public demonstrations of an invention. An invention disclosed in any form to the public-on publication, public use, or prior patent filing-will not be novel.
For an invention to be novel, it must:
Be new: The invention has not been disclosed before by any other source.
Not have been anticipated: It must not be identical or obvious in light of previous disclosures.
Determining Novelty: Prior Art Search
A prior art search is one of the steps that determine whether an invention is novel. Such a search would involve patents, scientific literature, and other publicly available sources, which may contain disclosures prior to the newness of the invention. The patent office usually conducts a substantive examination to ensure novelty, although applicants are encouraged to conduct an extensive prior art search on their own before filing.
Prior art can be: Published patents, articles, product catalogs, conference papers, and even disclosures made in scientific journals, online publications, and on the internet.
Effect on Novelty: If one piece of prior art discloses all elements of an invention as claimed in a patent application, then the invention will fail the novelty test.
Case Study on Novelty
In F. Hoffmann-La Roche AG v. Cipla Ltd. (2015), the Delhi High Court addressed the issue of novelty on the facts of a patent application for a cancer drug where Cipla challenged the patent claim by Roche under the grounds that the formulation of the drug was not novel since there were prior patents disclosing the same compound. The court ruled for Cipla by stressing that novelty has to be determined based on the whole corpus of prior art, which includes patent applications, scientific literature, and other information publicly known.
Also, Check out What are the Secrecy Directions under Section 35 of the Patents Act, 1970
Inventive Step (Section 2(1)(ja))
Definition of Inventive Step: An invention has to involve an inventive step. It must not be obvious to a person having technical knowledge or experience in the particular field, which means that the person skilled in the art would not arrive at the same conclusion. An invention will not be considered patentable if, in view of prior art, it is evident to a person skilled in the relevant technical field. The inventive step is one of the key tests to prevent granting patents for trivial or obvious modifications of existing inventions.
Non-Obviousness Test (Person Skilled in the Art)
The non-obviousness test forms an important element in the determination of the inventive step. This tests whether the invention involves some kind of inventive leap which would not be obvious for a person skilled in that relevant technology or industry.
Factors to be considered in applying the test:
Person skilled in the art: A person who has knowledge of the prior art and a normal degree of skill in the given field.
Obviousness: The invention is regarded as obvious if it logically or obviously follows from earlier art.
Case Study on Application of the Obviousness Test
In Bristol-Myers Squibb Co. v. Anand (2006), the Indian Patent Office rejected an application for an anti-cancer drug, stating that the subject matter was devoid of an inventive step. This was based on the fact that the drug formulation was simply an obvious variation of known compounds and thus failed to satisfy the inventive step. The patent was held to be a refinement and not inventive enough to be granted protection.
Industrial Applicability (Section 2(1)(ac))
Definition of Industrial Applicability: An invention must have industrial applicability to qualify for patentability. This indicates that the invention should be capable of being made or used in any kind of industry, such as manufacturing, agriculture, healthcare, or in any other commercial or industrial application. The invention must have practical utility and not simply be a theoretical or abstract concept.
The invention must be useful in some tangible form.
Relevance to industry: The invention should be capable of being reproduced consistently in an industrial process or used in an industrial setting.
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Relevance to Technological Advancements
Industrial applicability is the essence that ensures patents act as a means of moving practical, commercially viable inventions forward. It ensures patents are granted for inventions that may have a meaningful impact on industry and society, thus facilitating economic growth and technological development.
Case Study on Patent Granted for a Pharmaceutical Process
An example of such an industrial application is a patent granted to a pharmaceutical company for an innovation process for manufacturing a new drug. In Bayer v. Natco Pharma, the Indian Patent Office had granted a patent for the synthesis of a particular active pharmaceutical ingredient (API) in an efficient manner. This process satisfied the industrial applicability requirement because it had practical utility in the production of the drug on an industrial scale with higher yield and lower cost.
Patentable Subject Matter
What is Patentable?
Patentable inventions generally belong to two broad categories:
Products: Inventions that are tangible in nature, such as machines, devices, chemical compounds, and new materials.
Processes: Methods or processes, such as manufacturing techniques, chemical reactions, and industrial procedures.
Examples of patentable subject matter include:
Machines and Devices: Any new technologies, mechanical or electronic devices.
Chemical Compounds: Any chemical composition of pharmaceuticals or chemicals that are novel applications.
Manufacturing Processes: Any processes of making or performing something with more efficiency, or environmental concern.
Also, Read about Patent in Intellectual Property Rights
Non-Patentable Inventions (Section 3)
The Patents Act, 1970 excludes certain categories from patentability under Section 3 so that inventions which are not truly novel or might be harmful to public interests are not granted patents. The exclusions include the following:
Discoveries, Scientific Theories, and Mathematical Methods: These are not patentable as they do not involve a practical application or an inventive process.
Business Methods: Purely abstract business methods or ideas, such as financial models or management strategies, are not patentable.
Software (in certain cases): While some inventions related to software may be patentable if they present a technical solution to a technical problem, pure software or algorithms are generally excluded, particularly if they do not contribute to a tangible invention.
Medical and Surgical Methods: Patents cannot be granted for methods of medical treatment or surgery, as such inventions are considered to be within the public domain to ensure that medical professionals can freely perform their duties.
Plant and Animal Varieties: While some exceptions exist, generally, inventions related to plant and animal varieties, including genetically modified organisms (GMO), are not patentable under Indian patent law.
Controversial Subject Matter Cases
Software Patents: Indian Patent Office has seen various cases on the patentability of software-related inventions. Yahoo! Inc. v. Controller of Patents in 2015, the Bombay High Court held that merely software algorithms are not patentable unless they are related to a hardware component or provide a solution to a technical problem.
Business Methods: In Google Inc. v. Controller of Patents (2021), the Indian Patent Office rejected a patent application for a business method involving an online search algorithm, stating that business methods, irrespective of their technical nature, are excluded from patentability under Section 3.
Get to Know What are the Grounds & Procedure for Patent Revocation under Section 64 of Patents Act, 1970
Leading Case Laws on Patentability Criteria
1. Novartis AG v. Union of India (2013)
The judgment delivered by the Supreme Court of India is considered to be landmark for changing the perception about the patentability of pharmaceutical products in particular relating to Section 3(d) of the Patents Act that talks about incremental innovations in the pharmaceutical field.
Case Overview: Novartis had filed a patent for Glivec, a cancer drug. The company claimed that the patent was for a new crystalline form of the active ingredient imatinib mesylate. The Indian Patent Office rejected the patent application holding that the invention did not meet the requirement of novelty and inventive step under Section 2(1)(j) and Section 2(1)(ja).
Section 3(d) and its implications on pharmaceutical patents: The Court stressed that Section 3(d) bars the grant of a new form of a known substance as a patentable invention except where there is an evident enhancement of efficacy. Here, the court held that the change in the imatinib mesylate form did not establish enhanced therapeutic efficacy over the known form.
Impact: This case clarified the strict interpretation of Section 3(d), particularly for pharmaceutical companies seeking patents on minor modifications to existing drugs. It reinforced the principle that patent law is designed to prevent the evergreening of patents—where companies extend patent protection by making minor, non-patentable changes to existing drugs to delay the entry of generic versions.
Key Takeaway: This decision emphasized that a patent shall be granted to any new invention that meets significant criteria of therapeutic effectiveness and a technical advance, as compared with the known substance that such invention does not have simple routine or trivial changes.
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2. Bristol-Myers Squibb Co. v. Anand, 2006
BMS and Anand Pharmaceutical companies litigated over the validity and ownership of the Dasatinib anti-cancer drug patent.
The Dasatinib patent application, filed by BMS in the Indian Patent Office, had been rejected primarily on issues related to lack of inventive step and lack of novelty. According to the office, since the substance was obvious within prior art, including known compounds from early dates with similar chemical structures that showed anti-cancer properties.
Decision: The decision clearly established that a patent application would go against if the invented thing is only an obvious improvement or mere extension of a known art. Indian Patent Office mostly relies on the test of obviousness-person skilled in the art-and lack of novelty in claims.
Key Takeaway: This case is an important reminder that the inventive step demonstrated should not be a mere extension or obvious adaptation of known knowledge. It also brings to the fore the importance of having strong evidence that an invention is novel and non-obvious.
In Summary,
The Patents Act, 1970, and judicial decisions have provided the parameters for patentability in India. These criteria play a crucial role in promoting true innovation, growth of the economy, and balancing the interest of patent holders with the public. In order to successfully negotiate the patent landscape, inventors, entrepreneurs, and legal professionals need a good understanding of these criteria. This concluding section will summarize the salient patentability criteria, outline the evolving landscape of patent law in India, and look forward into patentability trends in emerging technologies.
The Indian patent law has undergone tremendous transformations over the last few decades, both in response to the requirements of aligning with international agreements like TRIPS and to respond to the demands of a fast-growing knowledge-based economy. At this point, as India develops into an innovation leader across the world, emerging technologies such as AI, blockchain, biotechnology, and green technologies will bring further challenges for patent law.
Patentability Criteria in India FAQs
Q1. What is the process for filing a patent in India?
Filing a patent in India involves several steps, from initial application to the grant of the patent. Here's an outline of the key stages: Before filing, it is advisable to conduct a prior art search to assess the novelty and inventiveness of your invention. File a patent application with the Indian Patent Office (IPO). The application can be filed as a provisional application (if you are still refining your invention) or a complete application (if the invention is fully developed). Your application will be published in the Patent Journal 18 months after the priority date. You may request for early publication so your application could be processed sooner; it is not required, however. You have to request examination within 48 months from the filing date of your application. If you have not requested examination, the IPO will not examine your application automatically. The examiner examines the patent application for the patentability criteria- novelty, inventive step, industrial applicability. If the patent office raises objections (called an office action), you have to respond to them within some time. Objections can be on grounds of the invention not being novel, for lack of inventive step, or in the application itself. If your application passes the examination phase, the patent will be granted. You will receive the patent certificate. If refused, you can appeal against the patent office decision.
2. Can software be patented in India?
Software itself cannot be patented in India. Nonetheless, there are a few exceptions where inventions based on software can be patented under certain conditions. if such software includes a technical solution to a technical problem.
3. How does India assess the novelty of an invention?
Novelty is one of the significant conditions of patentability in India. Indian Patent Office carries out novelty search for prior art before giving any grant of patent that no information regarding such invention has come out anywhere in the prior patents, publications, and publicly known information before filing.
4. What is a product patent, and how does that differ from a process patent?
A product patent and a process patent differ according to the subject matter they protect under the patent. A product patent provides protection for a new product, such as a new chemical compound, machine, pharmaceutical composition, or material. A process patent protects the method or process by which a product is made. This is important in industries like pharmaceuticals, chemicals, and manufacturing where the process of making a product is novel and valuable.
5. What are the consequences of patent infringement in India?
Patent infringement occurs when an individual or organization makes, uses, sells, or offers to sell a patented invention without authorization from the patent owner. In India, patent infringement can have consequences both civil and criminal.
