Intellectual Property Rights MCQs for Judiciary, Page 5

Correct answer: C. A divisional application must be based entirely on subject matter disclosed in the complete specification of the parent application (no new matter may be introduced); the divisional application shares the priority date of the parent application, and the claims of the divisional application must not overlap with claims that have already been allowed in the parent

Section 16 of the Patents Act, 1970 governs divisional applications. The key principles are: (a) a divisional application is permitted either on the applicant's own motion (where the applicant recognises that the original application contains claims to multiple distinct inventions) or upon the Controller's direction; (b) the divisional application must be founded entirely on disclosures already contained in the parent application - no new matter may be introduced, as this would amount to extending the priority date to cover new inventions; (c) the divisional application retains the priority date of the parent application, giving the same effective filing date as the parent; (d) to avoid double patenting, the claims of the divisional application must be directed to a different invention from that claimed in the parent (claims for the same invention cannot coexist in both parent and divisional applications). Divisional applications are commonly used when a patent application contains broad claims that the examiner finds lack unity - the applicant can divide the claims into separate applications, each pursuing distinct inventive concepts.

Source note: Section 16, Patents Act 1970

Correct answer: B. 20 years from the date of filing of the application for the patent in India

Section 53(1) of the Patents Act, 1970 (as amended by the Patents (Amendment) Act, 2002, effective January 2005) provides that the term of every patent granted in India shall be twenty years from the date of filing of the application for the patent. Prior to the 2002 Amendment (which brought India into compliance with TRIPS Agreement Article 33), the term was fourteen years from the date of filing of the complete specification. The 2005 amendment standardised the term at twenty years for all categories of inventions, including pharmaceutical and agrochemical patents. This was required by TRIPS Article 33, which mandates a minimum patent term of twenty years from filing. The twenty-year term runs from the date of filing even in cases where a divisional or continuation application has been filed; it also applies to patents granted on the basis of convention applications under Section 135, in which case it runs from the international filing date. Annual renewal fees (Section 53(2)) must be paid to maintain the patent in force throughout the twenty-year term.

Source note: Section 53, Patents Act 1970; Article 33, TRIPS Agreement

Correct answer: A. A method of cloning human beings for reproductive purposes, on the ground that such a technology's primary purpose would violate established ethical norms, public morality, and human dignity

Section 3(b) of the Patents Act, 1970 excludes inventions contrary to public order, morality, or prejudicial to human, animal, or plant life or health or to the environment. This provision is intended to prevent the patent system from incentivising technologies that are fundamentally incompatible with societal values or that cause serious harm to life or the environment. A method for human reproductive cloning clearly falls within this exclusion because human reproductive cloning is universally condemned on ethical grounds, involving the creation of human beings as means rather than ends, violating human dignity, and contrary to public morality. Indian patent law thus encodes a public policy override that aligns with the TRIPS Agreement's Article 27(2), which allows WTO members to exclude inventions from patentability where it is necessary to prevent their commercial exploitation that would be contrary to ordre public or morality. An approved herbicide or a weapon system produced for defence would not necessarily fall within Section 3(b) if their intended use is lawful and controlled.

Source note: Section 3(b), Patents Act 1970; Article 27(2), TRIPS Agreement

Correct answer: C. The inventor who files their patent application first at the Indian Patent Office, subject to the application satisfying all requirements of patentability

India follows the 'first to file' (as opposed to 'first to invent') system for determining priority between competing patent applications for the same invention. Under Section 34 of the Patents Act, 1970, where two or more applications claim the same invention, the Patent Office will examine the applications to determine the order of filing and will grant the patent to the applicant who filed first (provided all requirements are met). The United States was the last major patent system to adopt first to file (through the America Invents Act, 2011, effective 2013). The advantage of first to file is administrative certainty and simplicity: there is no need for complex and often unreliable enquiries into the dates of conception and reduction to practice. The first to file rule creates a strong incentive for inventors to file patent applications promptly after completing their invention, without delay. This is reinforced by the requirement to maintain confidentiality before filing, since public disclosure before filing destroys novelty in most jurisdictions.

Source note: Section 34, Patents Act 1970

Correct answer: A. A new drug compound itself (the pharmaceutical substance), provided it meets the other requirements of patentability including Section 3(d)

Section 3(i) of the Patents Act, 1970 excludes from patentability 'any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.' This exclusion covers: (a) surgical procedures (option A); (b) therapeutic treatment methods including dosage regimens (option B); and (c) diagnostic methods performed on the human or animal body (option D). However, the exclusion does not apply to substances and compositions (i.e., the drugs and devices used in treatment). A new pharmaceutical compound that treats a disease is potentially patentable as a product per se (subject to the additional requirement of Section 3(d) regarding enhanced efficacy for new forms of known substances). The distinction is between the substance itself (patentable if novel and non-obvious) and the method of using it to treat a human being (not patentable). This distinction is consistent with TRIPS Article 27(3)(a), which permits WTO members to exclude diagnostic, therapeutic, and surgical methods from patentability.

Source note: Section 3(i), Patents Act 1970; Article 27(3)(a), TRIPS Agreement

Correct answer: D. A hypothetical person who has ordinary skill in the technical field of the invention, is familiar with all prior art in that field, but lacks inventive ability and cannot make creative leaps beyond what the prior art would suggest to a skilled practitioner

The 'person skilled in the art' is a legal construct central to the assessment of inventive step (non-obviousness) in patent law worldwide. As interpreted by Indian courts and consistent with international standards, this person is a hypothetical skilled practitioner in the technical field of the invention who: (a) possesses ordinary skill (not genius or extraordinary expertise) in the relevant field; (b) has comprehensive knowledge of all the prior art in that field as of the priority date; (c) but crucially lacks any inventive capacity and cannot make creative leaps beyond what the prior art would logically suggest to a skilled practitioner. The question is whether such a person, looking at the prior art as a whole, would have been led to the claimed invention without any inventive effort or flash of creative insight. This test prevents both over-protection (where obvious combinations of known elements receive patent monopolies) and under-protection (where genuinely inventive advances are denied protection because they use known components or techniques). The economic significance limb in Section 2(1)(ja) is India's addition, which is not present in all patent systems.

Source note: Section 2(1)(ja), Patents Act 1970

Correct answer: A. Would have been obvious to a person skilled in the art at the date of filing, having regard to all the prior art documents that were publicly available at that date; the test is whether the skilled person would have arrived at the claimed invention without undue burden or inventive effort, and not whether it was actually predicted or specifically suggested in the prior art

The 'Hoffman test' for inventive step, adopted in several Delhi High Court decisions including patent matters involving pharmaceutical and technology inventions, requires the court to assess obviousness from the perspective of a person skilled in the art at the relevant date. The test is essentially a 'could have' or 'would have' enquiry: could the skilled person, using routine methods and knowledge known in the art, have arrived at the claimed invention without making any inventive leap? If the answer is yes (i.e., the skilled person would have arrived at the invention through routine application of known techniques to known materials in pursuit of known goals), the invention lacks an inventive step. The test does not require that the prior art documents explicitly suggest the combination; ex post reasoning (hindsight) must be avoided. The Delhi High Court has directed re-consideration of inventive step by the Patent Office in several cases where the examiner's reasoning appeared to rely on hindsight analysis rather than the proper perspective of a skilled person at the filing date.

Source note: Delhi High Court patent judgments applying the Hoffman test; Section 2(1)(ja), Patents Act 1970

Correct answer: C. The previous imprisonment penalty for unauthorised claims of patent rights under Section 120 of the Patents Act has been removed; the offence is now treated as a compoundable civil offence with an enhanced monetary fine (up to ten lakh rupees), with disputes resolved before an adjudicating officer rather than a criminal court

The Jan Vishwas (Amendment of Provisions) Act, 2023 decriminalised several minor offences under the Patents Act, 1970 as part of the government's ease of doing business initiative. Section 120 of the Patents Act, which previously provided for imprisonment for falsely claiming that goods were patented or that a patent application was pending, had its imprisonment penalty removed. The offence is now addressed through monetary fines administered by an adjudicating officer, with an appeal mechanism. The penalty for such misrepresentation was enhanced to ten lakh rupees. Similar decriminalisation was applied to other minor offences. The rationale was that imprisonment for what are essentially commercial misrepresentation offences was disproportionate and contrary to the global trend of decriminalising minor regulatory non-compliance. Criminal sanctions were retained for serious offences involving fraudulent conduct. The amendment also introduced provisions for composition of offences (allowing offenders to pay a fine and have the matter settled without prosecution), reducing the burden on criminal courts.

Source note: Jan Vishwas (Amendment of Provisions) Act, 2023; Section 120, Patents Act 1970

Correct answer: A. The High Court having jurisdiction over the matter; for patent revocation applications, the High Court is the competent forum under Section 64 of the Patents Act, 1970.

The Tribunals Reforms (Rationalization and Conditions of Service) Act, 2021 abolished the Intellectual Property Appellate Board (IPAB), which had been the statutory appellate body for decisions of the Controller General of Patents (and also for trade mark, design, and copyright decisions). Following the IPAB's abolition: (a) appeals from the Controller's decisions in patent matters (pre-grant and post-grant oppositions, examination decisions) now lie to the High Court; (b) revocation petitions under Section 64 continue to be filed before the High Court as they were before even when the IPAB existed; (c) trade mark appeals and rectification petitions now go to the relevant High Court; and (d) copyright disputes before the erstwhile Copyright Board have been transferred to Commercial Courts and the IP Divisions of High Courts. The Delhi High Court's IP Division established pursuant to the 2022 IPD Rules is the de facto primary venue for most significant IP litigation in India, given its specialised expertise and case management infrastructure.

Source note: Tribunals Reforms Act, 2021; Section 64, Patents Act 1970; Delhi IPD Rules 2022

Correct answer: B. The application is kept secret (not published or processed in the usual way), the applicant must not communicate information about the invention to anyone without permission, and the application is forwarded to relevant government authorities; while the direction is in force, no patent is granted but the applicant's rights are preserved

Sections 35 to 42 of the Patents Act, 1970 deal with secrecy of certain inventions and prohibitions on patenting. Under Section 35, where the Controller General is satisfied, on the advice of a government department, that a patent application relates to an invention capable of being used for the defence of India or in connection with atomic energy, they may issue a secrecy direction. The consequences of a secrecy direction include: (a) the application is not published and is treated as secret; (b) the applicant is prohibited from communicating information about the invention without written permission; (c) the application is referred to the relevant government department (Ministry of Defence, Department of Atomic Energy); and (d) the applicant may appeal against the direction but must comply while it is in force. Sections 39-40 also restrict Indian residents from filing patent applications in foreign countries for inventions that could be prejudicial to national security, without prior written permission from the Patent Office. These provisions balance the patentee's private rights against the state's overriding interests in national security.

Source note: Sections 35-42, Patents Act 1970

Correct answer: A. The beta-crystalline form of Imatinib Mesylate was not a new substance but a new form of a known compound, and Novartis had not demonstrated that this new form resulted in significantly enhanced therapeutic efficacy beyond that of the known compound, as required by Section 3(d) of the Patents Act, 1970

In Novartis AG v. Union of India (2013) 6 SCC 1, the Supreme Court engaged in a comprehensive analysis of Section 3(d) of the Patents Act, 1970 and upheld the rejection of Novartis's application for a patent on the beta-crystalline (polymorph) form of Imatinib Mesylate, the active ingredient in the cancer drug Gleevec. The court interpreted 'efficacy' in Section 3(d) to mean specifically therapeutic efficacy in the context of pharmaceutical compounds: a new form must demonstrate significantly improved therapeutic effectiveness (better bioavailability, enhanced curative effect) rather than merely improved physical or chemical properties (such as better solubility, greater stability, or ease of storage). The beta-crystalline form had demonstrated improved flowability and reduced hygroscopicity, but Novartis had not demonstrated that these properties translated into significantly enhanced therapeutic efficacy. The court upheld the Intellectual Property Appellate Board's conclusion that the requirements of Section 3(d) were not satisfied. This case established India's firm stance against pharmaceutical evergreening and significantly influenced global access to medicines discourse.

Source note: Novartis AG v. Union of India, (2013) 6 SCC 1; Section 3(d), Patents Act 1970

Correct answer: B. The invention forms part of the state of the art, which includes any matter that has been made available to the public anywhere in the world through any mode of disclosure, including prior publications, prior use, oral communication, or prior patents, before the date of priority of the application

Section 2(1)(l) of the Patents Act, 1970 defines 'new invention' and Section 13 provides for examination against prior art. The 'state of the art' in Indian patent law comprises all matter (whether in the form of a written publication, oral description, prior use, or in any other form) that has been made available to the public anywhere in the world before the priority date. A patent application will be refused if any element of the claim is anticipated by any single piece of prior art that discloses all the essential features of the claimed invention. A single item of prior art (an 'anticipation') destroys novelty completely. This is to be contrasted with the 'inventive step' requirement, where a combination of prior art references may be consulted to demonstrate that the claimed invention would have been obvious to a person skilled in the art. Section 31 of the Patents Act provides a grace period for certain disclosures (such as in officially recognised international exhibitions) that does not destroy novelty; disclosure in option D therefore would not destroy novelty if within the grace period.

Source note: Sections 2(1)(l) and 13, Patents Act 1970

Correct answer: B. Making, using, offering for sale, selling, or importing the patented product in India without the patentee's consent

Section 48 of the Patents Act, 1970 confers the exclusive rights of the patentee. For a product patent, the patentee has the exclusive right to prevent third parties who do not have the patentee's consent from: (a) making the patented product; (b) using the product; (c) offering the product for sale; (d) selling the product; and (e) importing the product into India. For a process patent, the equivalent rights cover the use of the patented process, as well as the use, offering for sale, sale, and importation of the product directly obtained by that process. Section 47 provides important limitations on these exclusive rights: government use for purposes of government (Section 47(1)), importation of patented products by the government (Section 47(2)), and experimental or research use by any person for purposes other than commercial exploitation (Section 47(3)) are not infringement. Section 107A provides a further exception (the Bolar provision or research exemption) for experimental or research activities related to developing information needed for regulatory approval, allowing generic drug manufacturers to conduct bioequivalence studies before the patent expires.

Source note: Sections 47, 48, 107A, Patents Act 1970

Correct answer: B. The amendment reduced the examination request period from three years to thirty-one months from the date of priority or filing (whichever is earlier), to streamline prosecution and reduce pendency

The Patent Rules (Amendment) Rules, 2024 introduced several procedural changes to the Indian patent prosecution framework, driven by concerns about the growing backlog of unexamined patent applications at the Indian Patent Office and the need to reduce overall pendency. Among the key changes was the reduction of the time limit for filing a Request for Examination from three years to thirty-one months from the date of filing or priority date. This change aligns the Indian timeline more closely with international practice and creates pressure on applicants to prosecute their applications more promptly. Additional changes included revised timelines for filing responses to examination reports and for entering the national phase of PCT applications. These amendments were part of a broader effort to modernise the Indian patent administration system, improve transparency, and reduce the time from application to grant. The CGPDTM also introduced additional fee structures under the amended rules.

Source note: Patent Rules (Amendment) Rules, 2024

Correct answer: B. Form 27 (Statement as to Working of Patented Invention), required to be filed annually in respect of every patent in force; failure to file Form 27 or filing a false Form 27 is punishable with a fine; the statement provides the Controller with data about whether the patent is being commercially exploited in India, which is relevant to compulsory licensing applications under Section 84

Section 146 of the Patents Act, 1970 imposes a statutory obligation on patentees and licensees to submit statements detailing the commercial working of patented inventions in India. Form 27 (prescribed under Rule 131 of the Patent Rules, 2003) must be filed on an annual basis for each patent in force. The form requires disclosure of: the commercial working status of the invention in India; the quantum and value of product manufactured or services rendered using the invention; whether the patented invention is worked in India or not; and, if not worked, reasons for non-working. This working statement data is publicly available and plays a crucial role in compulsory licensing proceedings under Section 84 (where non-working is a ground for compulsory licence). The Jan Vishwas Act, 2023 increased the penalty for filing false or incomplete Form 27 statements significantly. The CGPDTM periodically publishes data on Form 27 filings, revealing the extent to which granted patents are actually being commercially exploited in India.

Source note: Sections 146, 122, Patents Act 1970; Rule 131, Patent Rules 2003; Form 27

Correct answer: B. A new chemical compound with a previously undisclosed molecular structure that demonstrably treats a specific disease and involves a non-obvious synthesis process

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.' The three requirements for patentability are: (a) novelty (new, not forming part of the state of the art); (b) inventive step (non-obvious to a person skilled in the art); and (c) industrial applicability. A new chemical compound with a novel molecular structure that treats a disease and involves a non-obvious synthesis process satisfies all three criteria. Mathematical algorithms are excluded under Section 3(k) as 'mathematical methods' or 'abstract theories.' Business methods are excluded under Section 3(k) as 'business methods as such.' Naturally occurring gene sequences are excluded under Section 3(c) as 'the discovery of any living thing or non-living substance occurring in nature.' While the isolation and characterisation of a naturally occurring sequence involves considerable scientific work, the mere discovery of something existing in nature (even if newly identified) does not constitute a patentable invention under Indian patent law.

Source note: Sections 2(1)(j), 3(c), 3(k), Patents Act 1970

Correct answer: D. Grants the applicant a single international filing date and allows examination to proceed internationally; however, the actual grant of national patents is decided by each designated national patent office independently according to its own law

The Patent Cooperation Treaty (PCT), administered by WIPO, provides an internationally recognised filing system that simplifies the process of seeking patent protection in multiple countries. A PCT application filed at a Receiving Office (such as the Indian Patent Office for Indian applicants) establishes an international filing date and allows the applicant to proceed with a single application in one language, paying one set of fees. The international phase includes an international search (producing an International Search Report) and, optionally, an international preliminary examination. However, the PCT does not result in a 'world patent' or a 'WIPO patent': the grant of a patent remains a national decision. After the international phase, the applicant enters the 'national phase' by filing national phase applications in the designated countries within 30 or 31 months of the international filing date (or priority date). Each national patent office then examines the application according to its own national law and decides whether to grant a patent. The PCT effectively extends the time available to the applicant to decide in which countries to pursue protection and provides valuable prior art information before committing to national phase fees.

Source note: Patent Cooperation Treaty; Sections 138-140, Patents Act 1970

Correct answer: A. Save, use, sow, resow, exchange, share, or sell their farm produce including seed of a protected variety in the same manner as they were entitled to do before the variety was protected, except that they cannot sell branded seed of a protected variety

The Protection of Plant Varieties and Farmers' Rights Act, 2001 is India's unique implementation of TRIPS Article 27(3)(b), which allows member states to protect plant varieties through an effective sui generis system rather than patents. Section 39 of the PPVFR Act expressly preserves farmers' traditional rights by providing that notwithstanding anything in the Act, a farmer may save, use, sow, resow, exchange, share, or sell his farm produce including seed of a variety protected under the Act in the same manner as he was entitled to before the coming into force of the Act, subject to the condition that he shall not sell such seed as branded seed of any variety registered under the Act. This 'farmers' privilege' protects subsistence farming practices and traditional seed-saving systems that are fundamental to Indian agriculture, ensuring that plant variety protection does not disrupt the informal seed exchange that occurs among farming communities. India's PPVFR framework is more farmer-friendly than the UPOV (International Union for the Protection of New Varieties of Plants) Convention, which India has not joined.

Source note: Section 39, PPVFR Act 2001; TRIPS Article 27(3)(b)

Correct answer: A. The grounds for post-grant opposition under Section 25(2) are substantively similar to those for pre-grant opposition under Section 25(1); however, the procedures differ: pre-grant opposition is typically by way of representation before the Controller, while post-grant opposition is inter partes proceedings before an Opposition Board, with full pleadings, evidence, and hearing; additionally, the post-grant stage allows more detailed evidentiary examination because the technical subject matter has been examined and published

Sections 25(1) and 25(2) of the Patents Act, 1970 provide for pre-grant and post-grant opposition respectively. The grounds for opposition under both provisions are substantively very similar, including: anticipation (lack of novelty), obviousness, non-patentable subject matter under Section 3 or 4, prior claiming, insufficient disclosure, and non-disclosure under Section 8. However, the procedural framework differs significantly. Pre-grant opposition (Section 25(1)) is filed by way of a representation to the Controller before the patent is granted; it is heard by the Controller and does not involve a separate Opposition Board. Post-grant opposition (Section 25(2)) involves more formal inter partes proceedings: it must be filed within one year of publication of grant, is referred to an Opposition Board comprising three examiners for recommendation, and the Controller then decides based on the Board's recommendation after hearing the parties. The post-grant process is akin to inter partes proceedings with fuller evidentiary and procedural rights for both parties, making it more suitable for substantive challenges than the pre-grant representation.

Source note: Section 25(1), (2), Patents Act 1970

Correct answer: A. The applicant has not fulfilled the requirement of working the invention in India within three years of grant

Section 25(1) of the Patents Act, 1970 provides the grounds on which any person may file a pre-grant opposition (also called a representation) within the period of public notice of the application. The grounds for pre-grant opposition include: anticipation (lack of novelty); prior claiming in another Indian application; secret use; obviousness (lack of inventive step); non-patentable subject matter under Section 3 or 4; insufficient disclosure in the specification; non-disclosure or false suggestion in the application; not being the true and first inventor; and wrongful obtaining. The working of the invention in India is a post-grant obligation under Section 83 of the Patents Act (which reflects the public interest requirement that patentees must actually exploit their patents in India). Non-working is a ground for compulsory licence applications under Section 84, not a ground for pre-grant opposition before the patent has even been granted. Post-grant opposition under Section 25(2) has substantially the same grounds as pre-grant opposition and can be filed within one year of publication of grant.

Source note: Section 25(1), Patents Act 1970

Correct answer: C. Two separate Indian patents cannot contain claims covering the same invention; if the same inventive matter has already been claimed in an earlier-priority patent application that proceeds to grant, the later patent (which was filed by the same or a different applicant) may be revoked to prevent double patenting - the granting of two valid monopoly rights in the same invention

Section 64(1)(b) of the Patents Act, 1970 codifies the double patenting prohibition. The underlying principle is that the patent system grants only one monopoly in respect of one invention: two different patents in force simultaneously, each claiming the same invention, would give the holder two separate monopoly periods that could be used consecutively to extend effective exclusivity beyond the single twenty-year term. This would undermine the fundamental patent bargain. The provision applies regardless of whether the two patents are owned by the same or different entities: if a valid claim in an earlier-priority patent covers the same subject matter as a claim in a later-granted patent, the later patent is revocable on this ground. In practice, divisional applications must be carefully drafted to ensure that the claims of the divisional do not overlap with those allowed in the parent, precisely to avoid this double patenting issue. The 'earlier priority date' requirement means that the revocation ground applies only where the earlier patent has a genuine priority advantage.

Source note: Section 64(1)(b), Patents Act 1970

Correct answer: D. The invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India

Section 64 of the Patents Act, 1970 provides an exhaustive list of grounds on which any person interested may petition for revocation of a patent before the High Court, or the Central Government may make an application to the High Court for revocation on public interest grounds. The grounds for revocation under Section 64(1) include, among others: (a) anticipation (the invention was known or used before the priority date); (b) prior claiming in an earlier patent; (c) obviousness; (d) non-patentable subject matter under Section 3 or 4; (e) insufficient disclosure in the specification; (f) the specification claims are broader than the disclosure; (g) false suggestion or representation in the application; (h) the applicant was not entitled to apply; (i) failure to disclose information required by Section 8; and (j) non-patentability as being traditionally known. Prior claiming (option B) is one of the classic grounds for revocation: if two separate patents cover exactly the same claim, the later patent is revocable because the grant of two exclusive rights in the same invention would be contrary to the fundamental patent bargain of one monopoly for one invention.

Source note: Section 64, Patents Act 1970

Correct answer: D. New forms of a known substance (such as salts, esters, polymorphs, isomers, or new combinations of known substances) unless the applicant demonstrates that these new forms exhibit significantly enhanced efficacy as compared with the known substance

Section 3(d) of the Patents Act, 1970 (substituted by the Patents (Amendment) Act, 2005) is one of the most significant and internationally noticed provisions in Indian patent law. It provides that the mere discovery of a new form of a known substance which does not result in enhancement of the known efficacy of that substance is not patentable. The provision lists specific examples of new forms that are presumptively not inventions: salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance. A new form can qualify as patentable only if the applicant demonstrates that it results in significantly enhanced therapeutic efficacy. This provision was validated by the Supreme Court in Novartis AG v. Union of India (2013) 6 SCC 1 ('Gleevec Case'), where the court upheld the rejection of Novartis's patent application for a beta-crystalline form of Imatinib Mesylate (a cancer drug), finding that the new polymorph did not show significantly enhanced efficacy over the known base compound.

Source note: Section 3(d), Patents Act 1970; Novartis AG v. Union of India, (2013) 6 SCC 1

Correct answer: D. A naturally occurring microorganism in its natural state, or the mere isolation and identification of a naturally occurring gene, is not patentable as a 'discovery'; however, a modified microorganism, a recombinant DNA construct, or a biotechnological process that involves human inventive intervention and is not merely a product of nature may be patentable if it meets the other requirements of patentability

Section 3(c) of the Patents Act, 1970 draws the important distinction between 'discovery' and 'invention' in the context of biotechnology. A naturally occurring microorganism, enzyme, gene sequence, or other biological material that merely occurs in nature cannot be patented merely on the basis of its isolation and characterisation; such isolation is a discovery, not an invention. However, once human beings intervene to create something that does not exist in nature as such, the product of that intervention may qualify as an invention. For example, a genetically modified microorganism in which specific genes have been altered, inserted, or deleted to give it new properties does not 'occur in nature' and may be patentable if the modification involves an inventive step. Similarly, a novel synthetic DNA construct, a chimeric antibody, or a modified enzyme created through genetic engineering techniques may be patentable as a product of human creative intervention. The distinction between discovery and invention in biotechnology is thus contextual and requires careful examination of the degree of human creative input involved in arriving at the claimed product.

Source note: Section 3(c), Patents Act 1970