(..4..)
QUESTION BANK
1. What are the rights of patentee under Indian Patent Act? Explain the provisions relating to infringement of patent?
2. Explain procedure to obtain patent.
3. What is meant by infringement of patent?
4. Discuss various defenses available against infringement of patent.
5. Discuss rights and obligations of patentee.
6. Write note on history and development of patent law in India?
7. Explain in detail Biotechnological patents, licenses of patents.
8. Explain the concept of patent. Discuss the procedure for obtaining patent.
Short Notes
1. Patentable invention.
2. Medical patent.
SYNOPSIS
II. Meaning and Concept of ‘Patent’
III. History and Development of Patent Law
1. International Efforts to Protect Patents
IV. Patentable and Non-Patentable Inventions
1. Novelty
2. Non-obviousness
3. Industrial Application (Usefulness)
B. Non-Patentable Inventions
V. Procedure for Obtaining a Patent
1. Filing of Application (Sections 6 to 11)
a) Who can file an application for a patent (Section 6)
c) International Patent Applications (Sections 7(1A) and 7(1B))
d) Special provisions for foreign applicants (Section 8)
2. Filing of Provisional and Complete Specification (Sections 9 and 10)
3. Publication and Examination of the Application (Sections 11A to 14)
ii) Examination (Section 11B)
4. Opposition to Grant of Patent (Section 25)
5. Grant of Patent (Sections 43 and 47)
VI. Rights and Obligations of the Patentee
1. Right to Exploit the Patent (Sections 48 and 50):
2. Right to Transfer the Patent (Section 70):
3. Right to Surrender the Patent (Section 63):
4. Right to Sue for Infringement (Sections 104 to 109):
B. Limitations on the Rights of a Patentee
1. Use of Invention by the Government (Sections 99 to 103)
2. Acquisition of Invention and Patent by Government (Section 102)
3. Compulsory Licenses (Sections 84 to 94)
4. Use of Invention for Defense Purposes
5. Revocation for Non-Working of Patents (Section 85)
C. Obligations or Duties of the Patentee
(i) Duty to Satisfy Public Requirements:
(ii) Duty to Furnish Information (Section 122 & 146):
VII. Infringement of Patent
2. What Acts Amount to Infringement?
a. Colourable Imitation:
b. Immaterial Variations:
c. Mechanical Equivalents:
d. Taking Essential Features:
3. Acts Which Do Not Amount to Infringement (Sections 47 and 107A)
a. Government Use of Articles:
b. Government Use of Processes:
c. Experimental and Research Use
d. Public Healthcare Importation:
e. The Bolar Exception (Section 107A(a)):
f. Parallel Imports (Section 107A(b)):
4. Defences Available Against Infringement (Section 107)
VIII. Remedies for Infringement
1. Injunction
(a) Temporary or Interlocutory Injunction
(b) Final or Permanent Injunction
2. Damages or Account of Profits
3. Delivery-Up or Destruction of Infringing Goods
Short Notes
2. Biotechnological Patent
3. Patents in Respect of Medicine and Drugs
*****
Engaging in innovative pursuits is a fundamental instinct of human beings, and newness serves as a defining indicator of societal and technological growth. Without continuous innovation, human life would stagnate into absolute monotony. Innovation directly enhances human welfare, simplifies daily tasks, and elevates the standard of living. Consequently, organized societies across all historical eras have established frameworks to encourage people to invent and innovate.
However, meaningful innovation demands immense intellectual effort, alongside the substantial consumption of time and financial resources. True innovation is rarely possible without the pain of prolonged and rigorous developmental exertion. Therefore, it is critical that the individual who undertakes such labour should exclusively enjoy the economic fruits of their innovation.
Conversely, innovation must not be allowed to be infringed upon or free-ridden by third parties for their own commercial gain. No innovator would willingly permit their proprietary invention to be exploited commercially by another person without express consent. To address this need, the legal framework for protecting innovators' rights through the grant of patents emerged globally.
A patent is a statutory right granted to a person who has invented a new and useful article, a significant improvement of an existing article, or a novel process for manufacturing an article, designed to safeguard them against the unauthorized infringement of their intellectual creation. Through this legal shield, the inventor can securely reap the economic benefits of their innovation. Extensive efforts have been made at both international and national levels to establish standard norms for protecting innovations through patent laws.
A patent is a statutory monopoly right granted by the state to a person who has invented:
1. A new and useful article,
2. A non-obvious improvement of an existing article, or
3. A novel process of manufacturing an article.
Thus, a patent is a distinct form of industrial intellectual property. It fundamentally consists of the exclusive legal right to manufacture, use, exercise, sell, or offer for sale the patented innovative articles or processes.
Section 2(1)(m) of the Patents Act, 1970 (as amended by the Patents (Amendment) Act, 2005) provides a concise definition, stating that a "patent" means a patent for any invention granted under the Act. This statutory definition is structural rather than exhaustive, meaning the true scope of a patent must be understood by reading it alongside the definition of an "invention" under the Act.
The individual or entity to whom the patent is formally granted is legally termed the "patentee". The Patents Act invests the patentee with substantive exclusionary rights, thereby securing valuable monetary and commercial privileges. The patentee can enforce these rights to their competitive advantage, either by directly exploiting the invention themselves or by transferring these privileges to third parties through legal instruments.
The evolution of patent law can be analysed through its dual progression: international alignment and domestic statutory development.
The foundational step toward the global harmonization of patent protection was taken with the conclusion of the Paris Convention for the Protection of Industrial Property in 1883. To streamline cross-border patent filings, the Patent Cooperation Treaty (PCT) was incorporated in 1970, establishing a system where an inventor can protect an invention in multiple signatory countries by filing a single "International Application" or "PCT Application". Countries that are signatories to these frameworks are recognized as "Convention Countries" under Section 133 of the Indian statute, with India being a functional member. Under these rules, when a basic application is filed in a convention country, the applicant receives a 12-month priority window to file corresponding applications in other member states.
Further international developments include the Rio Convention on Biological Diversity (CBD) of 1992, which addressed sovereign rights over genetic resources. This was followed by the landmark Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994, which fundamentally reshaped global patent standards by mandating uniform minimum standards of protection, including the protection of product patents across all fields of technology.
During the latter half of the 19th century, industrial inventions relating to new processes, artistic methods, and manufacturing techniques increased tenfold. Inventors became deeply concerned with securing their rights to ensure their intellectual creations were not copied or infringed upon by competitors. To protect these commercial interests, the British administration introduced formal patent legislation to India.
The first statutory framework was Act VI of 1856, which was closely modelled on the British Patent Law Amendment Act of 1852. This Act was subsequently modified and re-enacted in 1859, 1872, and 1883. In 1888, the prevailing provisions were consolidated into the Inventions and Designs Act. This was later replaced by the Indian Patents and Designs Act, 1911.
Following India’s independence, the rapid pace of the domestic industrial revolution, combined with shifting global economic and political dynamics, necessitated a comprehensive overhaul of the law. This led to the enactment of the Patents Act, 1970, which serves as the bedrock of modern Indian patent law. To meet its global commitments under the TRIPS Agreement, India progressively amended the 1970 Act in 1999, 2002, and 2005, introducing a strict product patent regime while maintaining public health safeguards.
Not every technological development or modification is worthy of a patent grant. To qualify for patent protection, an invention must satisfy three core criteria: it must possess novelty, involve an inventive step (non-obviousness), and be capable of industrial application (usefulness). Furthermore, the underlying invention must not fall within the categories of non-patentable subject matter expressly prohibited under Sections 3 and 4 of the Act.
Section 2(1)(j) of the Patents Act, 1970 defines an “invention” as a new product or process involving an inventive step and capable of industrial application. Section 2(1)(ja) further clarifies that an “inventive step” means a feature of an invention that involves a technical advance as compared to the existing knowledge, or has economic significance, or both, and that makes the invention non-obvious to a person skilled in the art.
Novelty is an absolute prerequisite for the grant of a patent. The product or process must be newly discovered or formulated. Section 2(1)(l) defines a "new invention" as any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the patent application with complete specification; that is, the subject matter must not have fallen into the public domain or formed part of the state of the art.
If a particular item of knowledge or a similar device is already actively known, documented, or used within a specific field, it enters the public domain, and a patent will be denied for lack of novelty. A prime example of this principle occurred when the United States Patent and Trademark Office (USPTO) revoked a patent previously issued for the wound-healing properties of turmeric (Haldi) following a formal objection by India’s Council of Scientific and Industrial Research (CSIR). The CSIR successfully demonstrated that the medicinal properties of turmeric had been well-known and documented in India for centuries, meaning the claim lacked absolute novelty. Similar challenges successfully protected traditional knowledge associated with Neem and Basmati Rice from foreign patent monopolies.
The Basmati Rice Patent Dispute (RiceTec Inc., 1997–2001)
In September 1997, the USPTO granted US Patent No. 5,663,484 to an American corporation, RiceTec Inc., covering broad biological characteristics and lines of "Basmati rice". Because Basmati is a distinct, highly prized aromatic crop traditionally cultivated exclusively in the Indo-Gangetic plains of India and Pakistan, the patent threatened a multi-million dollar export economy and amounted to biopiracy of traditional knowledge. In April 2000, India’s CSIR aggressively challenged the patent by producing extensive documentary evidence of prior art. Consequently, the USPTO struck down or forced the withdrawal of 15 of RiceTec’s 20 claims, successfully safeguarding the export rights of South Asian farmers and highlighting the critical necessity of Geographical Indication (GI) protections under the TRIPS agreement.
In the case of Mariappan v. A.R. Safiullah, 2008 (38) PTC 341 (Mad),
The Madras High Court examined the boundaries of novelty and inventive steps. The case concerned a patent granted for a manual load-carrying device worn on the back and secured to the forehead with a leather belt to haul agricultural produce. The patent was legally challenged on the ground that the device was an imitation of the traditional bamboo basket known as a “Kilta,” which has been used for generations by tea-plantation workers in Assam and Himachal Pradesh to carry loads. The patentee had simply substituted the traditional bamboo material with molded plastic. The Court cancelled the patent, ruling that the mere replacement of bamboo with plastic did not introduce a technical advance or change in function sufficient to constitute an “inventive step” under Section 2(1)(ja). The Court affirmed that the mere duplication or material substitution of traditionally known components does not entitle an applicant to a patent monopoly.
Patents are not intended to reward trivial advancements or routine adjustments that naturally occur during ordinary manufacturing. Minor improvements are classified as simple mechanic work rather than true inventions. A development is not patentable if it represents a mere obvious extension, routine optimization, or predictable modification of prior designs. "Obvious" improvements are those that can easily be made to an article by any person possessing ordinary skill in that specific trade field, whereas a "non-obvious" step requires a significant, unexpected technological leap.
In Bajaj Auto Ltd. v. TVS Motor Company Ltd., 2007 (35) PTC 446 (Mad).,
The Madras High Court observed that the test for “obviousness” is satisfied if a person of ordinary skill in the specific technical field, when reviewing the prior art and available specifications, would naturally be led to complete or construct the product in question without exercising independent inventive ingenuity.
To be patentable, an invention must be capable of industrial application. Section 2(1)(ac) defines "capable of industrial application" in relation to an invention as meaning that the invention can be made or used in an industry. This requires that the invention can be physically manufactured or practically deployed within a branch of economic, industrial, or commercial activity. The invention must possess actual, real-world utility. Purely abstract theories, mathematical equations, or intellectual creations that cannot be reduced to a physical process or product are completely excluded from patent protection.
The Patents Act explicitly identifies specific categories of subject matter that are excluded from patentability, even if they satisfy the criteria of novelty, utility, and non-obviousness. Sections 3 and 4 provide a comprehensive list of non-patentable inventions:
(a) Frivolous Inventions: Inventions that are frivolous or make claims completely contrary to well-established natural laws (e.g., perpetual motion machines).
(b) Inventions Contrary to Law or Morality: Inventions whose commercial exploitation goes against public order, prevailing social morality, or causes serious prejudice to human, animal, or plant life, or to the environment.
(c) Discovery of Scientific Principles: The mere discovery of a scientific principle or the formulation of an abstract theory, as these are discoveries of nature rather than inventions.
(d) Mere Discovery of New Forms of Known Substances (The Anti-Evergreening Provision): The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, 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. For the purpose of this clause, derivatives of a known substance—such as salts, esters, ethers, polymorphs, metabolites, pure forms, particle sizes, isomers, mixtures of isomers, complexes, and combinations—are legally considered the same substance unless they show significant differences in properties regarding therapeutic efficacy.
(e) Mere Admixtures: A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components, or a process for producing such a substance. This must be strictly distinguished from a synergistic combination invention where the components interact to produce a new, unexpected result.
(f) Mere Arrangement or Rearrangement: The mere arrangement, rearrangement, or duplication of known devices, each functioning independently in a known way.
(h) Methods of Agriculture or Horticulture: Traditional or modern methods deployed for cultivating land or growing plants.
(i) Medicinal or Treatment Processes: Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of human beings, or any process for similar treatment of animals to render them free of disease or to increase their economic value.
(j) Plants and Animals: Plants and animals in whole or any part thereof, other than micro-organisms, but including seeds, varieties, and species, and essentially biological processes for the production or propagation of plants and animals.
(k) Mathematical Methods and Software Per Se: A mathematical or business method, a computer program per se, or algorithms.
(l) Literary and Artistic Works: A literary, dramatic, musical, or artistic work or any other aesthetic creation whatsoever, including cinematographic works and television productions, which fall under copyright law.
(m) Mental Acts and Games: A mere scheme, rule, or method of performing a mental act or a method of playing a game.
(n) Presentation of Information: Any method or format for presenting data or information visually or audibly.
(o) Integrated Circuits: The topography of integrated circuits, which is protected under independent legislation.
(p) Traditional Knowledge: An invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known components.
(q) Atomic Energy: Inventions relating to atomic energy are completely non-patentable under Section 4, as they fall within the strategic security domain of the state.
To secure a valid patent, an applicant must adhere strictly to the statutory procedures detailed in the Patents Act, 1970. Unlike copyright protection, which vests automatically upon the creation of a work, a patent is never granted automatically upon invention. It requires formal application, rigorous examination, and state approval through the following steps:
The process begins with the formal submission of an application to the Patent Office and concludes with the grant or rejection of the patent.
An application for a patent may be submitted by an individual inventor either alone or jointly with others. Under the law, the application can only be filed by:
i. Any person claiming to be the true and first inventor of the invention.
ii. Any person who is the legal assignee of the true and first inventor regarding the right to make such an application.
iii. The legal representative of any deceased person who was entitled to make such an application immediately prior to their death.
If an invention is made by an employee during their employment, the right to apply belongs either to the employee or to the employer, depending on the explicit terms and covenants contained in their employment contract.
Every application must cover only one distinct invention, must be made in the prescribed official form, and must be submitted to the appropriate branch of the Patent Office. If the application is filed by an assignee, the applicant must furnish proof of their legal right to apply (such as an assignment deed) either at the time of filing or within the prescribed period.
The application must declare that the applicant is in physical possession of the invention and must state the name of the true and first inventor. If the applicant is not the inventor, a formal declaration must be included affirming the applicant's belief that the person named is indeed the true and first inventor.
Applications filed by Indian citizens must be accompanied by either a provisional specification or a complete specification. However, if the application is filed by a foreign national under a reciprocal treaty or international convention, it must be accompanied by a complete specification rather than a provisional one.
Where an international application is filed under the Patent Cooperation Treaty (PCT) of 1970 designating India, it is legally treated as a domestic application under the Indian Patents Act, provided the applicant files the corresponding national phase application before the Controller within the prescribed timeframe. The filing date of such an application is recognized as the international filing date accorded under the PCT. This framework operates on strict international reciprocity.
If an applicant is prosecuting an application for the same or substantially the same invention in any country outside India, they are required to file along with their Indian application, or within the prescribed time:
i. A statement setting out detailed particulars of all foreign applications (filed via Form 3).
ii. A formal undertaking that, up to the date of the grant of the patent in India, they will keep the Controller informed in writing of the progress and details of every other foreign application relating to the same invention. The Controller also retains the power to demand details regarding the final disposal or examination reports of applications filed in foreign jurisdictions at any time prior to the grant.
A patent specification is a detailed technical document that describes the invention in full. A complete specification must disclose the invention with sufficient clarity and detail to enable any person skilled in the relevant art to reproduce and practice the invention independently. The main legal objective of requiring a complete specification is to ensure that, upon the expiry of the 20-year patent term, the technical knowledge enters the public domain so that the general public can freely manufacture, use, and sell the invention.
[Patent Application Filed with Provisional Specification]
│
▼
(Must file within 12 Months)
│
▼
[Filing of Complete Specification] ───► (If not filed, application is Abandoned)
If an application is initially accompanied by a provisional specification, the applicant must file the complete specification within twelve months from the date of filing; if the complete specification is not submitted within this window, the application is legally deemed to be abandoned. Conversely, if an applicant mistakenly files a complete specification, they can request the Controller within twelve months to treat that document as a provisional specification and proceed accordingly.
Under Section 10, a complete specification must contain:
a. A clear title sufficiently indicating the technical subject matter.
b. A full and particular description of the invention, its operation, and the method by which it is performed.
c. A clear disclosure of the best method of performing the invention known to the applicant.
d. A set of clear, succinct claims defining the precise scope of the monopoly protection sought. The claims must relate to a single invention or a group of closely linked inventions forming a single inventive concept.
e. A concise technical abstract summarizing the invention.
f. A formal declaration regarding the inventorship of the design. The Controller may also require explanatory drawings to be attached, which then form an integral part of the specification.
A patent application is kept strictly confidential and is not open to the public for a statutory period of 18 months from the date of filing or priority date, whichever is earlier. However, the applicant can accelerate this process by submitting a formal request to the Controller for early publication. Once the 18-month period expires, the Patent Office must publish the application within one month, except under the following circumstances:
(1). Where a secrecy direction has been imposed under Section 35 due to national defence considerations.
(2). Where the application has already been abandoned under Section 9 for failing to file a complete specification.
(3). Where the application was formally withdrawn by the applicant at least three months prior to the scheduled publication date.
The publication must include the application date, application number, the name and address of the applicant, and the technical abstract. From the date of publication until the final grant, the applicant enjoys the same privileges and rights as if the patent had been granted on the publication date. However, the applicant is not entitled to institute any infringement proceedings in a court of law until the patent is formally granted.
No patent application is automatically examined by the Patent Office. The applicant or any other interested party must submit a formal Request for Examination (RFE) within 48 months from the date of priority or date of filing. If no request is made within this window, the application is treated as withdrawn. If a secrecy direction was issued under Section 35, the request may be made after publication but must be submitted within 48 months from the filing date or within six months from the date of revocation of the secrecy direction, whichever is later.
Upon receiving an examination request, the Controller refers the documents to an examiner, who conducts a thorough investigation into whether the application meets all statutory criteria, whether the claims have been anticipated by prior art, and whether any lawful grounds for objection exist.
The examiner submits a formal report to the Controller. If the report contains objections or requires amendments, the Controller communicates a gist of the objections to the applicant as expeditiously as possible. The applicant must address these objections within the prescribed period, and the Controller must provide an opportunity for a formal hearing before disposing of the application.
Once an application is published but before the patent is formally granted, any person can file a pre-grant opposition in writing before the Controller. The opposition can be raised on the statutory grounds enumerated under Section 25(1), which include:
a. The applicant wrongfully obtained the invention from the opponent.
b. The invention was prior-published or publicly used in India before the filing date.
c. The invention is obvious and lacks an inventive step.
d. The subject matter is non-patentable under Sections 3 or 4.
e. The complete specification fails to describe the invention clearly or properly.
If the application successfully survives opposition proceedings and is found to be in order, the Controller will formally grant the patent as expeditiously as possible, provided it does not contravene any provisions of the Act and has not been refused under the Controller's discretionary powers.
The patent is issued under the seal of the Patent Office, and its specific details are entered into the Register of Patents. Upon granting the patent, the Controller publishes the fact of the grant to allow public inspection. Any adverse decision made by the Controller against an applicant can be appealed before the appropriate judicial authority. Under Section 53, the statutory term of every patent is fixed at twenty years from the date of filing, after which the monopoly expires.
The grant of a patent endows the patentee with a powerful bundle of statutory rights for the 20-year term:
1. Right to Exploit the Patent (Sections 48 and 50): The patentee receives the exclusive right to commercially exploit the invention. They can legally exclude all third parties who do not have their express consent from making, using, offering for sale, selling, or importing the patented product or process into India for commercial purposes.
2. Right to Transfer the Patent (Section 70): A patentee has the absolute power to assign, grant licenses, lease, or otherwise deal with the patent for valuable consideration. The patentee can divide these rights, limiting a license to a specific geographic area, a limited duration, or a distinct industrial undertaking.
3. Right to Surrender the Patent (Section 63): A patentee can voluntarily offer to surrender their patent at any time by giving formal notice to the Controller. Upon receiving such an offer, the Controller must publish the notice and notify all third parties whose names appear on the register as having an interest in the patent (such as licensees or assignees). This step protects the contractual interests of partners whose businesses depend on the patent's continuation. If no valid objections are raised, the Controller may revoke the patent.
4. Right to Sue for Infringement (Sections 104 to 109): The patentee has the right to initiate civil legal action to restrain any unauthorized exploitation of their invention during the subsistence of the patent term. Additionally, if a patent certificate is lost or destroyed, the patentee has the right to obtain a duplicate copy from the Controller under Section 154.
The rights granted to a patentee are not absolute; they are bounded by public interest, national security, and healthcare requirements through the following statutory exceptions:
An invention is considered used for the purposes of the government if it is manufactured, deployed, or exercised for the explicit needs of the Central Government, a State Government, or a government-owned undertaking. While the government must generally respect patent rights, it retains the sovereign power to use, import, or acquire any patented invention for its own use under specified circumstances. In such cases, the government must pay the patentee adequate remuneration, determined by the economic value of the deployment.
If the Central Government is satisfied that it is necessary for a public purpose that a specific invention or pending patent application be acquired, it can publish a notification to that effect in the Official Gazette. Upon publication, all proprietary rights in the invention or patent automatically transfer to the Central Government. The government must pay the patentee mutually agreed compensation; if no agreement can be reached, the final amount is determined by the High Court under Section 103.
To prevent the abuse of patent monopolies, the Controller can grant a compulsory license to any qualified applicant after the expiration of three years from the date of the grant of a patent, if any of the following grounds are met:
(i) The reasonable requirements of the public regarding the patented invention have not been satisfied.
(ii) The patented invention is not available to the public at a reasonably affordable price.
(iii) The patented invention has not been worked commercially within the territory of India.
Additionally, the Central Government can issue a compulsory license at any time during a national emergency, extreme urgency, or for public non-commercial use.
Bayer Corporation v. Union of India & Ors., 2014 (60) PTC 277 (Bom)
In 2012, the Indian Patent Office granted India's first-ever compulsory license to Natco Pharma, a Hyderabad-based generic drug manufacturer. The license covered Nexavar (Sorafenib Tosylate), an advanced kidney cancer drug patented by the multinational corporation Bayer. The Controller found that Bayer had failed to meet the reasonable requirements of the Indian public, as it did not manufacture the drug locally to a reasonable extent. Furthermore, Bayer sold the drug at an exorbitant price of approximately ₹2.8 lakhs for a month's course (120 tablets). Natco committed to making the identical generic version available for just ₹8,880 per month—nearly 31 times cheaper. The Controller granted the license, ordering Natco to pay Bayer a fixed royalty of 6% on net sales.
Following the 2005 TRIPS amendments, the introduction of a strict "product patent" regime eliminated generic competition for newer drugs, creating market monopolies that could drive up healthcare costs. To safeguard the public, statutory mechanisms like compulsory licensing ensure life-saving medicines remain available to the general population at affordable prices.
Applications for inventions that are relevant to national defense or atomic energy are kept strictly secret in the interest of national security. These applications are not published, and no patent can be issued without the prior written consent of the Central Government. Any violation of these secrecy directions results in criminal liability and renders the application void. However, the innovator may receive financial solatium from the government to mitigate the hardship caused by the secrecy order.
If, two years after the grant of a compulsory license, the patented invention still has not been commercially worked in India, or if the drug remains unaffordable or unavailable, the Controller can completely revoke the patent for non-working.
The Act imposes corresponding obligations upon a patentee in exchange for their monopoly:
(i) Duty to Satisfy Public Requirements: The patentee must ensure that the reasonable requirements of the public regarding the invention are satisfied, that the product is available at an affordable price, and that the patent is actively worked within India.
(ii) Duty to Furnish Information (Section 122 & 146): The patentee is legally required to submit regular statements (Form 27) detailing the commercial extent to which the patent has been worked in India. Failure to furnish this information to the Central Government or the Controller within the specified period attracts penalties.
A patent grants a 20-year monopoly right to prevent third parties from making, using, selling, or importing the protected product or process without the patentee's express consent. Any unauthorized act that interferes with this exclusive statutory right constitutes an infringement of the patent. The Act specifies which activities constitute infringement, provides exceptions that do not amount to infringement, and establishes judicial remedies.
The following activities constitute patent infringement when performed without a license:
a. Colourable Imitation: Where an infringer introduces superficial modifications to a process or product but substantially copies the essential, core features of the patented invention.
b. Immaterial Variations: Incorporating minor, insubstantial variations that do not alter the fundamental mechanism or function of the patented innovation.
c. Mechanical Equivalents: Using close mechanical or chemical substitutes for specific features to achieve the identical functional result for the same purpose as the patentee's design.
d. Taking Essential Features: Copying the essential claims or core innovative steps of the patent, even if surrounding non-essential elements are altered.
The law carves out specific statutory exemptions where the unauthorized use of a patent does not constitute infringement:
a. Government Use of Articles: When a patented article is imported or manufactured by or on behalf of the government solely for its own internal use.
b. Government Use of Processes: When a patented manufacturing process is deployed directly by the government for public purposes.
c. Experimental and Research Use: When a patented article or process is used by any person purely for experiment, scientific research, or for imparting technical instruction to students.
d. Public Healthcare Importation: When a patented medicine or drug is imported by the government solely for its own use or for free distribution across government-run hospitals, clinics, and medical dispensaries.
e. The Bolar Exception (Section 107A(a)): Making, constructing, using, selling, or importing a patented invention solely for uses reasonably related to the development and submission of data required under any regulatory law in India or a foreign country (e.g., securing drug approvals from the FDA before the patent expires).
f. Parallel Imports (Section 107A(b)): Importing a patented product into India from a foreign seller who is duly authorized under the law of that country to produce and distribute the product.
In a civil suit for infringement, the defendant can raise any ground upon which a patent may be revoked under Section 64 as a valid defense. These statutory defenses include:
(a) The invention was already claimed in a valid claim of an earlier priority date in another Indian patent.
(b) The patentee was not legally entitled to apply for the patent under the Act.
(c) The patent was obtained wrongfully in contravention of the rights of the true inventor.
(d) The subject matter does not constitute a statutory "invention".
(e) The invention lacks novelty, having been publicly known or used in India before the priority date.
(f) The invention is obvious and lacks an inventive step based on prior art.
(g) The invention is not useful or lacks industrial application.
(h) The complete specification fails to sufficiently or fairly describe the invention or the best method for its performance.
(i) The claims are ambiguous or not fairly based on the description.
(j) The patent was secured through a false representation or fraudulent suggestion.
(k) The subject matter is non-patentable under Sections 3 or 4.
(l) The invention was secretly used in India before the priority date.
(m) The applicant failed to disclose foreign application details required under Section 8 or provided false details.
(n) The applicant violated a statutory secrecy direction.
(o) Permission to amend the specification was obtained via fraud.
(p) The specification wrongly states or omits the geographical origin of biological material used in the invention.
(q) The invention was anticipated by traditional knowledge available within local or indigenous communities.
(r) The acts complained of fall within the permitted exceptions under Section 47.
Under Section 104, a suit for patent infringement must be instituted in a court not inferior to a District Court holding appropriate territorial and pecuniary jurisdiction. However, if the defendant files a counterclaim seeking the revocation of the patent, the District Court loses jurisdiction, and the entire suit must be transferred to the High Court for final adjudication under Section 64.
Section 108 provides the following civil remedies against patent infringement:
An injunction is a judicial order prohibiting an infringer from continuing their unauthorized acts, or directing them to halt an ongoing injury to the patentee’s rights. It is a preventive and protective remedy designed to secure future compliance. Injunctions are divided into two categories:
A temporary injunction is an interim order that remains in force during the pendency of the litigation or until further orders from the court. The plaintiff can apply for an interim injunction at the commencement of the suit to instantly restrain the defendant from continuing the alleged infringement.
When evaluating an application for a temporary injunction, the court balance three core principles:
i. Whether the plaintiff has established a prima facie case.
ii. Whether the balance of convenience tilts heavily in the plaintiff's favor.
iii. Whether the patentee will suffer irreparable financial or reputational loss if the injunction is denied.
In Hind Mosaic and Cement Works & Anr. v. Shree Sahjanand Trading Corporation, 2008 Supreme (Guj) 464
The Gujarat High Court referenced the landmark English case American Cyanamid Co. v. Ethicon Ltd. (1975). The Court observed that in complex patent matters, courts do not need to settle the final validity of the patent at the interim stage; rather, if there is a serious question to be tried and the balance of convenience favors the patentee, a temporary injunction can be granted.
A permanent injunction is granted at the conclusion of the trial within the final judgment. A permanent injunction remains active for the remaining duration of the 20-year patent term.
In M.C. Jayasingh v. Mishra Dhatu Nigam Limited (Midhani) & Anr., 1993 (13) PTC 150 (Mad)
The Madras High Court rejected a claim for a permanent injunction. The Court ruled that even if the general functional aspects of two metallurgical processes are similar, an injunction cannot be granted if the final articles are not structurally identical or deceptively similar in their essential technical claims.
The court can award the successful plaintiff either financial damages or an account of profits. These are alternative remedies, and the plaintiff must choose between them. Damages are calculated to compensate the patentee for the actual commercial losses suffered due to the infringement. An account of profits requires the infringer to surrender the net profits they earned through the unauthorized exploitation of the patented invention.
The court can order that all infringing goods, alongside the specialized machinery, molds, and implements predominantly used to create them, be seized, forfeited, or destroyed without any right to compensation. Alternatively, the court may order the physical delivery of the infringing material to the plaintiff for destruction.
In Farbenfabriken Bayer A.G. v. Unichem Laboratories & Ors., [AIR 1969 Bom 255]
The Bombay High Court confirmed that a successful plaintiff is entitled to an order directing the delivery-up and destruction of all infringing chemical compositions and articles currently within the defendant's physical possession.
A license is a formal permission granted by a patentee to a licensee, empowering them to make, use, exercise, or sell the patented invention under specified terms. Performing these activities without such permission constitutes statutory infringement. In a licensing arrangement, the absolute ownership of the patent remains with the patentee (licensor); only a temporary, partial right to exploit the technology is transferred. The license agreement details all contract terms, royalty rates, and working conditions. There are two main types of licenses:
a. Voluntary License: A written contractual authority granted voluntarily by the patent owner to a third party under mutually agreed commercial terms and royalty rates.
b. Compulsory License: A mandatory license imposed upon the patentee by the Controller under public interest or healthcare grounds, as detailed under Section 84.
Biotechnology plays a critical role in the fields of medicine, agriculture, fertilizers, bio-energy, and environmental remediation. It involves applying human ingenuity to living organisms—such as plants, animals, and micro-organisms—as well as non-living biological materials like seeds, cells, enzymes, and plasmids.
India’s biotechnology industry is the third largest in the Asia-Pacific region. Given the extensive public and private research conducted locally, securing patent protection in this domain is highly important. Following the Patents (Amendment) Act of 2002, inventions relating to micro-organisms became explicitly patentable in India, provided they meet standard patent criteria. The TRIPS Agreement similarly mandates that member states must protect micro-organisms and non-biological or microbiological processes for producing plants or animals. A biotechnological patent is a patent granted on an invention in biology, covering modified genetic material, gene technologies, and recombinant products.
(a) Section 3(d) often bars applications on the ground that the claim represents a "mere discovery of a new form of a known substance" without demonstrating significantly enhanced therapeutic efficacy.
(b) The lack of a clear boundary between a patentable invention and a mere non-patentable discovery of nature creates ongoing legal challenges.
In the landmark US case of Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303 (1980)
A microbiologist created a genetically engineered bacterium capable of breaking down multiple components of crude oil, which was useful for treating oil spills. The patent examiner initially rejected the application, ruling that micro-organisms are products of nature and that living organisms are inherently non-patentable. The US Supreme Court reversed this decision, holding that while naturally occurring organisms cannot be patented because human ingenuity did not create them, an artificially modified living organism is a product of human creativity and skill, making it eligible for patent protection.
The Indian pharmaceutical industry is a highly successful, technology-driven sector that has grown consistently over the past three decades. During the COVID-19 pandemic, the industry served as the "pharmacy of the world," supplying affordable, effective life-saving drugs to over 150 nations. Developing a new chemical entity and bringing it to market requires extensive research, high technology, and substantial financial investment. Naturally, pharmaceutical companies require robust patent protection to recover these developmental costs, and India maintains a balanced framework to protect both innovations and public health.
Following the 1999 and 2005 amendments, India transitioned to a full product patent regime for pharmaceuticals, allowing medicine and drug compounds to be patented. During the transition phase, applicants were permitted to file applications and secure Exclusive Marketing Rights (EMR) to distribute their inventions. Today, pharmaceutical patent applications are evaluated under the standard criteria of novelty, utility, and non-obviousness, subject to the strict anti-evergreening filters of Section 3(d).
In the landmark case of Novartis AG v. Union of India & Others, (2013) 6 SCC 1,
A foreign pharmaceutical company sought a product patent for its cancer drug, Glivec. Indian generic manufacturers objected, demonstrating that the drug was simply a modified beta-crystalline form of a previously known compound (Imatinib Mesylate). Novartis argued that the new form offered better absorption rates, representing a patentable invention. The Supreme Court of India rejected the patent application, ruling that a mere change in form or enhanced bioavailability does not satisfy the strict test of increased therapeutic efficacy required under Section 3(d) of the Act. The Court affirmed that India's patent laws strictly prohibit the "evergreening" of expiring patents on known medicines unless there is a significant, verified step forward in actual healing capability.
*****