One of the contested questions in Indian patent law is whether Section 3(d) of the Patents Act constitutes an extension of the inventive step analysis, or whether it operates as a distinct and independent enquiry. The answer carries significant implications for India’s compliance with the non-discrimination obligations of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).<\/p>\n
Article 27.1 of the TRIPs Agreement provides:<\/p>\n
\nSubject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.<\/p>\n<\/blockquote>\n
The provision requires that all inventions be treated equally and not be discriminated against on the basis of the field of technology, place of invention, or importation status. Industry bodies including the USCC, PhRMA and BIO have argued that Section 3(d) imposes an additional patentability requirement specific to the fields of Pharma and Chemistry, thereby treating those fields differently and giving rise to non-compliance with the TRIPs Agreement.<\/p>\n
The Rebuttal: Section 3(d) as Inventive Step Extension<\/h2>\n
The primary rebuttal, advanced by IPA, FICCI and Professor Srividya, is that Section 3(d) does not add any new requirement but is merely an extension of the inventive step or non-obviousness analysis. In support, parallels are drawn to secondary considerations used by United States courts in non-obviousness determinations, including by reference to a decision concerning a salt form of Amlodipine.<\/p>\n
Judicial Pronouncements<\/h2>\n
The Novartis decisions at the level of the Intellectual Property Appellate Board (IPAB) and the Supreme Court had answered this question with some clarity. Both the Supreme Court and the IPAB pointed out that the analysis under Section 3, which enumerates non-patentable subject matter (exclusions), is a distinct enquiry from the question of what constitutes an “invention” under Section 2(j), which involves the inventive step analysis. The Supreme Court explicitly held that Section 3(d) is not an extension of the inventive step analysis.<\/p>\n
This two-pronged approach to patentability \u2014 determining first whether a subject matter qualifies as an invention, and then whether it falls within any excluded category \u2014 may in some formulations extend to a third limb of enablement. These are analytically separable, even if they are not always treated in practice as entirely distinct.<\/p>\n
The Case for Interaction<\/h2>\n
Notwithstanding the judicial position, scholars have noted that the assessments are far from being mutually exclusive, watertight compartments. They converge and interact at multiple levels.<\/p>\n
First, it is not always possible or necessary to treat them as fully separate exercises. For instance, in assessing whether a claimed subject matter is a product of nature, many countries apply the hand-of-man test. That determination \u2014 whether there is a human contribution that distinguishes the claim from its natural counterpart \u2014 engages analysis that also forms part of novelty and inventive step enquiries.<\/p>\n
Secondly, the inventive step or non-obviousness requirement is of comparatively recent vintage. Before it was codified as a formal requirement, similar analysis was conducted under novelty or subject matter provisions in countries including India. Section 3(e), which disallows patents for mere admixtures unless a synergistic effect is demonstrated, and Section 3(f), which disallows patents for re-arrangements of known products unless they produce a combined effect, are both provisions that perform non-obviousness-like analysis \u2014 even if they were not described in those terms.<\/p>\n
The Field-Specificity Problem<\/h2>\n
The question remains whether Section 3(d) can be reconciled with TRIPs Article 27.1 on the basis that its principle, though largely applicable to pharmaceuticals and chemistry, is stated in general terms. A useful parallel can be drawn to gene-sequence patentability. The Supreme Court of the United States held in the Myriad Genetics case that genomic DNA sequences are not patentable because they exist in nature. The product-of-nature doctrine applied in that decision is a general doctrine applicable across fields, yet its practical relevance is predominantly to biological inventions. If India were to enact a Section 3(a) providing that gene sequences would not be patentable unless there is a hand of man, the question of whether such a provision would be non-compliant with the TRIPs Agreement would ultimately depend on how an Indian court characterised it.<\/p>\n
The debate, therefore, does not admit of a simple answer. The characterisation of Section 3(d) \u2014 whether as an inventive step extension, a separate exclusion, or a field-specific carve-out \u2014 carries consequences both for TRIPs compliance and for the practical administration of pharmaceutical patent prosecution in India.<\/p>\n
Disclaimer: This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"
This post critically examines whether Section 3d serves as an extension of the inventive step analysis or as a separate requirement under Indian patent law. It discusses the legal and judicial perspectives on TRIPs compliance and the nuanced challenges in pharmaceutical patentability.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":32,"footnotes":""},"categories":[6,14],"tags":[163,83,84,50,61,520,6839,1881],"class_list":["post-13164","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-indian-patent-law","tag-inventive-step","tag-non-obviousness","tag-patent-law","tag-pharmaceutical-patents","tag-section-3d","tag-supreme-court-decisions","tag-trips-agreement"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/13164","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=13164"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/13164\/revisions"}],"predecessor-version":[{"id":149698,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/13164\/revisions\/149698"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=13164"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=13164"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=13164"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}