The Delhi High Court recently upheld the Controller of Patents’ decision to reject an appeal filed by the Regents of the University of California (hereafter referred to as \u201cRegents\u201d). The appeal was against a July 14, 2022, refusal order for a patent application on a recombinant Salmonella-based live vaccine for preventing enteric bacterial infections. In its ruling, the Court emphasized that the objection under Section 3(c) of the Indian Patents Act, 1970, must be considered in conjunction with objections raised under Sections 10(4) and 10(5).<\/p>\n
The case started with Regents filing a PCT national phase application with the Indian Patent Office on February 17, 2017, titled “Vaccine for Livestock Production Systems” (Patent Application No. 201717005699).<\/p>\n
The Controller of Patents and Designs (hereafter referred to as \u201cController\u201d) issued a First Examination Report (FER), raising multiple objections, including lack of inventive step under Section 2(1)(ja), non-patentability under Sections 3(c), 3(d), 3(e), 3(i), lack of unity of invention under Section 10(5), and insufficient disclosure under Section 10(4) of the Patents Act. Despite Regents\u2019 detailed response, the Controller issued a hearing notice retaining objections from the FER and added a new objection under Section 59(1) of the Patents Act, citing that the amended claims extended beyond the originally filed scope.<\/p>\n
Post-hearing, the Controller issued a refusal order, citing non-compliance with Sections 10(4) and 10(5) due to insufficient disclosure of the recombinant Salmonella<\/em> microorganism-based live vaccine. The order stated that the claims were overly broad and covered naturally mutated Salmonella<\/em> microorganisms, making them ineligible for patent protection under Section 3(c). Further, the Controller asserted that the claims broadly covered permutations of genetic modifications without specifying the organism, gene sequences, or mutations, and rendered the claims unclear and indefinite. Additionally, the Controller noted that the patent applicant failed to deposit the recombinant microorganism with an International Depository Authority as required under Section 10(4)(d)(ii). As a result, the Controller stated that a skilled person would face undue experimentation in attempting to reproduce the claimed invention.<\/p>\n Regents challenged the refusal order and claimed that the Controller’s rejection of their patent application was unjustified. They contended that the claimed recombinant Salmonella<\/em> microorganism does not occur naturally and was artificially engineered. Regents further asserted that the reasoning under Sections 10(4) and 10(5) was flawed, and a biological deposit was unnecessary under Section 10(4)(d) since the Salmonella<\/em> microorganism used in the patent application was publicly available. They also emphasized that the patent had been granted in multiple jurisdictions, including the U.S. and Europe.<\/p>\n The Court stated that the use of the word ‘shall’ in Sections 10(4) and 10(5) signified the mandatory nature of the disclosure and claim-definiteness requirements for a complete specification to be valid under Indian patent law.<\/p>\n Based on its analysis, the Court held that the application had failed to meet the sufficiency of disclosure requirement under Section 10(4)(a) as it did not provide explicit details on insertion and substitution mutations. Furthermore, the Court observed that the lack of complete disclosure made it difficult for a person skilled in the field of microbiology to perform the invention and therefore failed the enablement requirement under Section 10(4)(b).<\/p>\n Citing Novartis AG v. Union of India & Ors<\/em>. (2013), the Court emphasized that the scope of claims must not exceed the actual disclosure in the complete specification. In the present case, the Court noted that the claims were broader than the disclosed invention, particularly by including insertion and substitution mutations that were not explicitly defined in the specification. The Court further stated that a patent monopoly should only be granted in exchange for full public disclosure, ensuring that innovation is genuinely advanced rather than restricted by vague, overly broad claims.<\/p>\n Additionally, the Court observed that the claims in the patent application lacked a clear and precise definition of the full scope of recombinant Salmonella<\/em> organisms, even when read together with the complete specification. Rejecting the set of claims the Court reiterated that the inclusion of insertion and substitution mutations was not fairly based on the disclosed subject matter due to the absence of detailed support or working examples demonstrating these mutations. Consequently, the Court held that the claims failed to meet the requirements under Sections 10(4)(c) and 10(5) of the Act.<\/p>\n Regarding public availability, the Court noted that while the Salmonella<\/em> microorganism itself may have been commonly available, the recombinant Salmonella<\/em> claimed in the patent application was a modified bacterium that was not accessible to the public. Therefore, the Court observed that as per Section 10(4)(d)(ii) of the Patents Act, the recombinant Salmonella had to be deposited in a recognized depository under the Budapest Treaty, which the applicant failed to do.<\/p>\n Finally, the Court reaffirmed that the broad scope of the claims raised concerns that naturally occurring loss-of-function variants of Salmonella<\/em>\u2014whether from spontaneous mutations or regulatory disruptions\u2014could fall within the claimed invention. The Court stressed that without sufficient enabling disclosure and clear claims, there was a serious risk that endogenous mutations covered in the application could have included naturally occurring mutations, making them non-patentable under Section 3(c) of the Act.<\/p>\n The Delhi High Court upheld the Controller\u2019s decision and dismissed Regents\u2019 appeal, affirming that the patent application did not meet the statutory requirements.<\/p>\n Citation:<\/em><\/strong>\u00a0The Regents Of The University Of … vs The Controller Of Patents<\/em> (<\/em>C.A.(COMM.IPD-PAT) 481\/2022) (H.C. Delhi Feb. 21, 2025). Available at: <\/em>https:\/\/indiankanoon.org\/doc\/116699207\/<\/em><\/a><\/p>\n Authored by Dr. Vasundhara Paliwal,<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":" The Delhi High Court recently upheld the Controller of Patents’ decision to reject an appeal filed by the Regents of the University of California (hereafter referred to as \u201cRegents\u201d). The appeal was against a July 14, 2022, refusal order for a patent application on a recombinant Salmonella-based live vaccine for preventing enteric bacterial infections. In … Continue reading “Regents’ Patent on Live Salmonella Vaccine Fails to Meet Disclosure Requirements, Court Rules”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":125150,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":83,"footnotes":""},"categories":[6,5495],"tags":[486,422,6591,6592,6590,6593,6594],"class_list":["post-125138","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-intellectual-property","category-case-reviews","tag-delhi-high-court","tag-indian-patents-act","tag-patent-disclosure","tag-regents-of-california","tag-salmonella-vaccine","tag-section-104","tag-section-3c"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/125138","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=125138"}],"version-history":[{"count":2,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/125138\/revisions"}],"predecessor-version":[{"id":125147,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/125138\/revisions\/125147"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media\/125150"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=125138"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=125138"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=125138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/a>Court\u2019s analysis:<\/h3>\n
<\/a>Conclusion<\/h3>\n