Novelty (Section 13(1)(a))

For an invention to be eligible for patent protection in India under the Patents Act, 1970, it must satisfy certain substantive requirements. The first and most fundamental requirement is that the invention must be novel. Novelty is a universal patentability criterion found in almost all patent laws worldwide, including the TRIPS Agreement.

Not anticipated by prior publication or public knowledge

In the context of patent law, novelty means that the invention must be new and must not have been publicly known or publicly disclosed anywhere in the world before the date of filing the patent application in India (or before the priority date, if applicable). Section 13(1)(a) of the Patents Act, 1970, states that the Controller of Patents shall cause an investigation to be made to ascertain whether the invention claimed in any specification has been anticipated by any prior publication or prior claim.

What Constitutes Prior Art?

To assess novelty, the invention is compared against the "prior art". Prior art includes everything that has been made available to the public anywhere in the world before the relevant date. This includes:

• Prior Publication: Information disclosed in any document (patent specifications, scientific journals, books, conference papers, etc.) published anywhere in the world.
• Prior Public Knowledge/Use: Information that has become publicly known or used anywhere in India.
• Prior Claim: Information contained in earlier patent applications filed in India and published subsequently, which claim the same invention (Section 13(1)(b)).
• Prior Public Display/Use: Public demonstration or use of the invention before the filing date.

The "Absolute Novelty" Standard

India follows an absolute novelty standard. This means that any public disclosure or publication of the invention, anywhere in the world, before the filing date will destroy its novelty. Even disclosure by the inventor themselves before filing can render the invention non-novel, with limited exceptions (e.g., disclosure at certain government-approved exhibitions under Section 31). This "absolute" standard differs from "local novelty" (new only within the country) or "relative novelty" (allowing a grace period after disclosure). For example, if an invention was described in a obscure journal published only in Germany, or demonstrated at a public event in the USA, or even sold publicly in Japan before the Indian filing date, it would likely lack novelty in India.

Tests for Novelty

The test for novelty is whether the prior art "anticipates" the claimed invention. Anticipation means that the prior art discloses *every single feature* of the claimed invention, either explicitly or inherently. If a single feature of the claimed invention is not disclosed in the prior art (taken individually or sometimes in combination with other prior art for assessing inventive step), the invention might be considered novel.

Establishing novelty requires a thorough search of existing patents, scientific literature, and other publicly available information worldwide. An invention lacks novelty if it is already part of the state of the art.

Inventive Step (Non-obviousness) (Section 2(1)(j))

Even if an invention is novel (not previously disclosed), it must also demonstrate an inventive step to be patentable. This requirement, often referred to as non-obviousness, ensures that patents are granted only for inventions that represent a genuine advancement and are not merely trivial variations or obvious combinations of what is already known.

Not obvious to a person skilled in the art

Section 2(1)(j) of the Patents Act, 1970, defines "invention" as a new product or process involving an inventive step and capable of industrial application. It defines "inventive step" (also called "patentable ingenuity" or "non-obviousness") in Section 2(1)(ja) as:

"a feature of an invention that involves technical advancement as compared to the existing knowledge or having economic significance or both and that does not make the invention obvious to a person skilled in the art."

The Test for Inventive Step

Assessing inventive step involves comparing the claimed invention to the "existing knowledge" or "prior art" and determining whether the invention would have been obvious to a hypothetical "person skilled in the art" at the time the invention was made (or the filing date).

• "Person skilled in the art": This hypothetical person is presumed to have average knowledge and skill in the relevant technical field. They are not a genius, nor are they completely ignorant. They are aware of all publicly available prior art.
• "Obvious": An invention is obvious if it would have been readily apparent or could have been easily deduced or arrived at by this person skilled in the art, based on the existing knowledge. This could involve a simple combination of known features, a straightforward substitution of known equivalents, or merely applying a known technique to a different material or area without any unexpected result.
• Technical Advancement or Economic Significance: The Indian definition also explicitly requires that the invention involve "technical advancement" compared to existing knowledge or have "economic significance or both". This means that even if an invention is non-obvious, it must also demonstrate some form of progress or utility to qualify for an inventive step.

Indicators of Inventive Step (Secondary Considerations)

Courts and patent offices often consider secondary factors when assessing non-obviousness, as they can indicate whether an invention was truly non-obvious at the time it was made. These include:

• Solving a long-felt want or problem.
• Achieving surprising or unexpected results.
• Commercial success of the invention (though this should be viewed cautiously).
• Failure of others to arrive at the same invention despite trying.
• The invention goes against established technical prejudice.

For example, combining a known motor with a known pump is likely obvious. However, combining them in a novel way that solves a long-standing efficiency problem or achieves an unexpected reduction in size might involve an inventive step. Inventive step is a more subjective test than novelty and is often a key point of dispute in patent litigation.

Industrial Applicability (Section 2(1)(ac))

The third substantive requirement for patentability is that the invention must be capable of industrial application (also known as "utility" or "usefulness"). This criterion ensures that patents are granted only for inventions that have a practical use and can be made or used in some kind of industry.

Capable of being made or used in an industry

Section 2(1)(ac) of the Patents Act, 1970, defines "capable of industrial application" in relation to an invention as that the invention is capable of being made or used in an industry.

Meaning of "Industry" and "Capable of Being Made or Used"

• "Industry": The term "industry" is interpreted broadly and is not limited to manufacturing. It includes any kind of useful activity, such as agriculture, fishing, trade, services, etc.
• "Capable of being made or used": This means the invention must be functional and reproducible. It must be possible to produce the invention and use it for the purpose described in the patent application. A theoretical concept or a mere possibility that cannot be practically implemented is not considered capable of industrial application.

Distinction from Other Criteria

While related to novelty and inventive step, industrial applicability is a distinct requirement:

• An invention might be novel and non-obvious but lack industrial applicability if it serves no practical purpose or cannot be produced or used in any industry (e.g., a perpetual motion machine that violates laws of physics).
• It ensures that patents are not granted for abstract ideas, scientific theories, or inventions that are purely speculative or theoretical without any concrete practical application.

The requirement for industrial applicability is generally not as frequently challenged as novelty or inventive step, as most inventions that are novel and non-obvious tend to have some form of practical application. However, it remains a necessary condition for patentability.

Subject Matter Not Excluded from Patentability (Section 3 & 4)

Even if an invention meets the criteria of novelty, inventive step, and industrial applicability, it must also fall within the scope of patentable subject matter as defined by the Patents Act, 1970. Sections 3 and 4 of the Act explicitly list categories of inventions or discoveries that are not patentable in India, regardless of whether they are novel, involve an inventive step, or are capable of industrial application.

These exclusions reflect specific policy considerations, aiming to balance innovation incentives with public interest concerns, particularly in areas like public health, agriculture, and fundamental scientific knowledge.

Discoveries, scientific theories, mathematical methods (Section 3(c))

Section 3(c) excludes: "the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature."

• Mere Discovery: Discovering something that already exists in nature is not patentable. A patent protects an *invention*, which involves human intervention to create something new or a new process. Discovering a new property of a known substance or a substance occurring in nature is a discovery, not an invention (e.g., discovering that a plant extract has medicinal properties is a discovery, but a process for isolating or synthesising the active compound might be patentable).
• Scientific Theories and Mathematical Methods: Abstract theories or mathematical formulas are not patentable because they are considered part of fundamental knowledge or tools of thought, not practical applications that can be made or used in industry in the patentable sense.

Mere discovery of a scientific principle (Section 3(c))

This point reiterates the exclusion of *mere* discoveries. While a new application of a known scientific principle might be patentable if it results in a novel and inventive product or process, the principle itself is not.

Method of agriculture or horticulture (Section 3(h))

Section 3(h) excludes: "a method of agriculture or horticulture."

• This means that processes for growing plants or cultivating crops are not patentable in India. For example, a new method of irrigating fields or a new way of pruning trees cannot be patented.
• However, new agricultural machinery or new processes for treating crops after harvesting (e.g., food processing methods) might be patentable if they meet the other criteria. India's decision to exclude methods of agriculture reflects specific policy choices regarding the free availability of farming techniques.

Inventions relating to atomic energy (Section 4)

Section 4 of the Patents Act explicitly excludes inventions relating to atomic energy from patentability. This is a complete exclusion for security and strategic reasons, ensuring that developments in this critical sector remain under state control and are not subject to private monopolies. This aligns with India's Atomic Energy Act, 1962.

Plants and animals other than micro-organisms (Section 3(j))

Section 3(j) excludes: "plants and animals in whole or in any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals."

• This means that higher-level life forms (plants and animals) themselves are not patentable in India. Essentially biological processes (like cross-breeding plants) are also excluded.
• Micro-organisms, however, are patentable if they are novel, inventive, and industrially applicable (e.g., a genetically modified micro-organism).
• Plant varieties can be protected under the *sui generis* system established by the Protection of Plant Varieties and Farmers' Rights Act, 2001, rather than under patent law.

This exclusion reflects concerns about the patenting of life forms and the need to protect traditional farming practices and biodiversity, while still allowing for the patenting of micro-organisms and providing a separate system for plant varieties.

Process for medicinal, surgical, curative, prophylactic diagnostic or therapeutic treatments (Section 3(i))

Section 3(i) excludes: "any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or animals to render them free of disease or to increase their economic value or that of their products."

• This excludes methods of treatment applied directly to the human or animal body. For example, a new surgical technique, a method of therapy, a diagnostic method performed on the body, or a new way of administering a known medicine are not patentable processes.
• The rationale is to allow medical professionals to use the best available treatment methods freely without fear of infringing patents.
• However, the products used in such treatments (like a new drug, a surgical instrument, or a diagnostic kit) *are* patentable if they meet the patentability criteria and are not otherwise excluded. This is a significant distinction – the method of *using* the drug or instrument on a patient is not patentable, but the drug or instrument itself might be.

Other important exclusions under Section 3 include (but are not limited to):

• Inventions frivolous or contrary to well-established natural laws (Section 3(a)).
• Inventions contrary to public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment (Section 3(b)).
• The mere discovery of a new form of a known substance which does not result in the enhancement of that known efficacy, or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant (Section 3(d)). This is a critical provision in India, particularly significant for preventing the "evergreening" of pharmaceutical patents by slightly modifying existing drugs without significant therapeutic improvement (*Novartis v. Union of India* case clarified the interpretation of this section).
• A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance (Section 3(e)).
• A mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way (Section 3(f)).
• Methods of performing mental act or method of playing game (Section 3(k)).
• Presentation of information (Section 3(l)).
• Topography of integrated circuits (Section 3(m)).
• Traditional knowledge or aggregation or duplication of known properties of traditionally known components (Section 3(n)).

Understanding these exclusions is as important as understanding the positive requirements for patentability, as they define the boundaries of what can be protected by a patent in India, reflecting the country's specific policy objectives regarding innovation, public health, and traditional knowledge.

Types of Patents

The Patents Act, 1970, in India provides for the protection of inventions through patents. While the core concept is the "invention," patents can be categorised based on what aspects of the invention they cover (product or process) or based on the stage and nature of the application filed (provisional vs. complete specification). Understanding these types is essential for navigating the patent system.

Invention Patents

This is the general term for patents granted under the Act. An invention patent protects a new product or process that meets the criteria of patentability (novelty, inventive step, industrial applicability) and is not excluded from patentability. The term "invention" itself is defined broadly in Section 2(1)(j) of the Patents Act, 1970, as "a new product or process involving an inventive step and capable of industrial application." All patents granted for such qualifying subject matter are essentially invention patents, which can then be further classified into product or process patents based on the nature of the claim.

Product Patents

A product patent grants exclusive rights over a specific physical product. If a product patent is granted, the patent owner has the right to prevent others from making, using, selling, or importing that particular product, regardless of the method or process used to create it. For example, a patent on a new drug molecule is a product patent. Anyone wanting to manufacture or sell that specific molecule requires the patent owner's permission, even if they invent a completely different and novel process to synthesise it.

Prior to a significant amendment in 2005 (to comply with the TRIPS Agreement), India primarily granted only process patents in certain sectors like pharmaceuticals and agrochemicals. The 2005 amendment introduced product patents in these critical fields, significantly changing the landscape for innovation and access in sectors like healthcare.

Process Patents

A process patent grants exclusive rights over a specific method or process for creating a product or achieving a result. If a process patent is granted, the patent owner has the right to prevent others from using that specific *process*, but they cannot prevent others from making the same product using a different, non-infringing process. For instance, a patent on a new method for purifying a chemical compound is a process patent. Others are free to purify the same compound using a different purification method.

Process patents are particularly important in industries where multiple ways exist to arrive at the same end product. Historically, process patents were favoured in some countries, including India before 2005 in certain sectors, to encourage local manufacturing using alternative processes, even if the final product was the same as one patented elsewhere.

Provisional and Complete Specification

These terms refer to types of patent *applications* and the accompanying documentation, crucial steps in the process of obtaining a patent:

• Provisional Specification: This is an initial application document that can be filed when an invention has been developed to a certain stage but is not yet complete or ready for commercialisation. It describes the invention in a preliminary manner but does not need to include claims. The primary purpose of filing a provisional specification is to secure an early filing date (a "priority date"). This priority date is crucial for novelty assessment, as any public disclosure after this date will not count as prior art against the invention. Filing a provisional specification gives the applicant 12 months to further develop the invention and file a complete specification. It allows inventors to disclose their work publicly (e.g., in journals or conferences) after filing the provisional application without jeopardising novelty, provided they file the complete specification within the 12-month period.
• Complete Specification: This is the comprehensive patent application document that provides a full and detailed description of the invention, enabling a person skilled in the art to perform the invention. It must clearly define the scope of protection sought through claims. The complete specification must be filed within 12 months from the date of filing the provisional specification, or it can be filed directly as the first application. The examination of the patent application by the Patent Office is conducted based on the complete specification. A patent can only be granted after a complete specification has been filed and examined.

Filing a provisional specification followed by a complete specification is a common strategy, particularly in fast-moving technical fields, as it allows securing a priority date early while providing time for further development and refinement of the invention.

Patent Application Procedure

Obtaining a patent in India is a multi-step process governed by the Patents Act, 1970, and the Patents Rules, 2003. The procedure involves interaction between the applicant, the Patent Office, and potentially third parties. The Indian Patent Office has branches in Chennai, Delhi, Kolkata, and Mumbai.

Filing of application

The process begins with the filing of a patent application at the appropriate Indian Patent Office. The application must be filed by the true and first inventor or their assignee (e.g., a company). It can be filed either directly with a complete specification or initially with a provisional specification followed by a complete specification within 12 months.

• Documents Required: The application must include Form 1 (Application for Grant of Patent), the provisional or complete specification, abstract, drawings (if any), and proof of the right to apply (if the applicant is not the inventor). Fees must be paid.
• Priority Date: The filing date of the first application (either provisional or complete in India, or a foreign application from which priority is claimed under international treaties like the Paris Convention) establishes the crucial priority date for assessing novelty and inventive step.

Publication of application

Once a patent application is filed with a complete specification, it is generally kept confidential for 18 months from the date of filing or the priority date, whichever is earlier. After this period, the application is automatically published in the official Patent Office Journal (Section 11A).

• Early Publication: The applicant can request early publication of their application (usually within 1 month), which can be beneficial if they want to seek licensing or investment early.
• Purpose of Publication: Publication makes the technical information contained in the application publicly available. This adds to the pool of prior art for future inventions and allows third parties to view the details of the claimed invention. Upon publication, the applicant gains certain rights to claim damages for infringement that occurred after publication, although the right can only be enforced after the patent is granted.

Request for examination

Publication of the application does not automatically lead to its examination. The applicant (or any interested third party) must file a request for examination (RFE) (Form 18) within 48 months from the date of filing the application or the priority date, whichever is earlier (Section 11B). If no RFE is filed within this timeframe, the application is deemed to be withdrawn.

• Purpose of Examination: The examination is the substantive review stage where the Patent Office assesses whether the invention claimed in the complete specification meets all the requirements of the Patents Act, including novelty, inventive step, industrial applicability, and whether the subject matter is patentable.
• First Examination Report (FER): After the RFE is filed, the application is assigned to an examiner who conducts a search of prior art and prepares an FER. The FER lists any objections regarding patentability or formal requirements.

Examination and grant of patent

Upon receiving the FER, the applicant must respond to the objections raised by the examiner within 6 months (extendable by another 3 months) from the date of issuance of the FER (Section 21). The applicant can amend the claims or specification to overcome the objections, provided the amendments do not expand the scope of the invention beyond what was initially disclosed.

• Controller's Decision: The examiner's report and the applicant's response are considered by the Controller of Patents, who makes the final decision on whether the invention is patentable.
• Opposition: The Patents Act allows for both pre-grant opposition (filed by any person after publication but before grant, Section 25(1)) and post-grant opposition (filed by any 'interested person' within 12 months after grant, Section 25(2)). Opposition proceedings involve hearings and submissions from both sides.
• Grant or Refusal: If the Controller is satisfied that all objections have been met and the invention is patentable, the patent is granted and published in the Patent Office Journal. If the objections are not overcome, the application is refused.

The process from filing to grant can take several years, depending on factors like the backlog at the Patent Office, the complexity of the invention, and the number of objections and oppositions raised.

Duration of Patent (Section 53)

The duration of a patent is the period for which the exclusive rights granted by the patent remain in force. This is a critical aspect of the balance between incentivising innovation and promoting the public domain.

20 years from the date of filing of the application

Section 53 of the Patents Act, 1970, as amended to comply with the TRIPS Agreement, specifies the term of a patent in India:

The term of every patent granted under this Act shall be twenty years from the date of filing of the application for the patent.

• Date of Filing: This refers to the date on which the complete specification was filed in India, either directly or after filing a provisional specification. If the application is an international application filed under the Patent Cooperation Treaty (PCT) designating India, the filing date is generally considered the international filing date. If priority is claimed from an earlier foreign application under the Paris Convention, the 20-year term is still counted from the Indian filing date (or PCT international filing date), not the foreign priority date.
• Uniform Term: The 20-year term applies uniformly to all types of patents (product and process) granted under the Act.
• Subject to Renewal Fees: The patent right is maintained by paying periodic renewal fees to the Patent Office. Failure to pay renewal fees within the prescribed time can lead to the patent lapsing (ceasing to be in force) before the full 20-year term expires.

Once the 20-year term expires, or if the patent lapses due to non-payment of fees, the invention enters the public domain, meaning anyone is free to use, make, or sell the invention without needing permission from the former patent holder.

Compulsory Licensing (Section 92)**

Compulsory licensing is a mechanism provided in patent law that allows a government to authorise a third party to use a patented invention without the patent holder's consent. This mechanism is intended to balance the exclusive rights of the patentee with the broader public interest, particularly in critical areas like public health and national security. The TRIPS Agreement (Article 31) permits compulsory licensing under certain conditions.

In India, Sections 84 to 92 of the Patents Act, 1970, deal with compulsory licenses. Section 92 specifically addresses compulsory licensing in circumstances of national emergency, extreme urgency, or public non-commercial use.

Grounds and Procedure under Section 92

Section 92 of the Patents Act, 1970, grants the Central Government the power to order the grant of compulsory licenses under specific emergency situations:

• Grounds: The Central Government can issue a notification in the Official Gazette directing the Controller to grant a compulsory license with respect to a patent if satisfied that it is necessary to do so:
  • In circumstances of national emergency: For example, a war or a major internal disturbance.
  • In circumstances of extreme urgency: Such as a widespread epidemic or a natural disaster requiring urgent access to patented technology or products.
  • For public non-commercial use: Where the patented invention is required for government use or use by a third party specified by the government for public, non-commercial purposes.
• Who Grants: The license is granted by the Controller of Patents upon receiving directions from the Central Government.
• Scope and Terms: The Controller determines the terms and conditions of the compulsory license, including the scope and duration of the license and the amount of royalty or other remuneration to be paid to the patentee. The guiding principle is to provide adequate remuneration in the circumstances, considering the economic value of the authorisation.
• No Hearing Requirement (in urgency): In situations of national emergency or extreme urgency, the requirement for the prospective licensee to have made prior efforts to obtain a voluntary license from the patentee on reasonable terms (as usually required under Section 84) may be waived. However, the patentee must still be notified as soon as reasonably practicable.

Section 92 provides a mechanism for the government to act swiftly to ensure access to patented inventions deemed essential for public welfare during crises or for government functions, overriding the patentee's exclusive rights for a defined purpose and period, subject to compensation.

Distinction from Section 84

Section 84 of the Patents Act, 1970, provides for the grant of compulsory licenses on more general grounds after 3 years from the date of grant of a patent, if the reasonable requirements of the public with respect to the patented invention have not been satisfied, or the patented invention is not available to the public at a reasonably affordable price, or the patented invention is not worked in the territory of India. Applications under Section 84 are typically filed by interested parties, and the Controller conducts hearings before deciding. Section 92 is specifically for government-initiated action in emergencies or for public non-commercial use, allowing for quicker action in urgent situations.

A well-known instance involving compulsory licensing in India was the decision in 2012 by the Controller of Patents to grant a compulsory license under Section 84 to Natco Pharma for Bayer Corporation's patented cancer drug Sorafenib Tosylate (Nexavar). This decision was based on the grounds that the drug was not available at a reasonably affordable price and the public requirement was not met, illustrating the application of compulsory licensing provisions to enhance access to essential medicines. This case, while under Section 84, highlights the potential use of compulsory licenses to balance patent rights with public health needs.

Compulsory licensing, particularly under Section 92 in emergency contexts, is a powerful state tool reflecting the understanding that IP rights are not absolute and can be subject to limitations in the interest of public welfare, consistent with international agreements like TRIPS which acknowledge such flexibilities.