The Indian Patent Office on December 31, 2014 set aside its earlier order granting a patent to Abbott Biotechnology for its drug Humira, a formulation of human antibodies used in the treatment of rheumatoid arthritis. The decision followed a pre-grant opposition filed by Glenmark Pharmaceuticals.<\/p>\n
Abbott filed patent application No. 526\/DELNP\/2005 in November 2003 for the Humira formulation. Glenmark filed a pre-grant opposition to that application in September 2008. Because the opposition had not been brought to the notice of the Controller, Patent No. 234,555 was granted to Abbott in June 2009.<\/p>\n
In July 2009, Glenmark brought the discrepancy to the Controller’s attention. The Controller cancelled the patent grant with immediate effect through a letter dated October 30, 2009. Glenmark had also filed a Writ Petition before the Delhi High Court against the original grant order, but the Court disposed of that petition as infructuous in light of the Controller’s cancellation order of October 30, 2009.<\/p>\n
Abbott, aggrieved by the Controller’s cancellation, filed a Writ Petition before the Delhi High Court challenging the order. The Court initially stayed the cancellation. However, in its order dated September 9, 2010, the Delhi High Court set aside the Controller’s order of October 30, 2009 and directed that Glenmark’s pre-grant opposition be treated as a petition to review the original grant, with the Controller required to examine the matter on merits.<\/p>\n
In the review proceedings, Glenmark contended that Humira was not novel and lacked inventive step. Glenmark submitted that the claims of Application No. 526\/DELNP\/2005 did not comply with the requirements of an invention under Section 2(1)(j) of the Patents Act, 1970. Glenmark also alleged insufficiency of disclosure and failure to meet statutory requirements under Section 8 regarding the disclosure of foreign applications.<\/p>\n
Glenmark further pointed out that Abbott had filed an application before the Indian Patent Office in November 2003 with claims similar to those in the present application, which Glenmark argued constituted prior art. Glenmark additionally raised the issue of double patenting, alleging that Abbott was seeking two patents for substantially the same invention.<\/p>\n
K.S. Kardam, Senior Controller of Patents and Designs, reaffirmed the cancellation of the patent grant and held Patent No. 234,555 to be void. The Controller observed:<\/p>\n
… I firmly conclude that the impugned invention as disclosed in the specification and claimed in the claims is obvious to a person skilled in the art and hence lacking inventive step. I am also of the opinion that the description of the impugned invention is also insufficient and ambiguous as described in the specification.<\/p><\/blockquote>\n
Context<\/h2>\n
The Humira formulation has been the subject of patent disputes in multiple jurisdictions. In July 2014, the New York Federal Court invalidated several of Humira’s patent claims upon a suit filed by AbbVie Inc., a global pharmaceutical company.<\/p>\n
Disclaimer<\/h2>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Indian Patent Office set aside Abbott Biotechnology’s Humira patent after Glenmark’s pre-grant opposition, citing lack of inventive step and insufficient disclosure. This legal dispute underscores ongoing challenges to Humira patents both in India and globally.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":38,"footnotes":""},"categories":[6,14],"tags":[6934,6025,6933,42,6935,609,1453,6936],"class_list":["post-17726","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-abbott-biotechnology","tag-glenmark-pharmaceuticals","tag-humira","tag-indian-patent-office","tag-patent-cancellation","tag-patents-act-1970","tag-pre-grant-opposition","tag-rheumatoid-arthritis"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17726","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=17726"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17726\/revisions"}],"predecessor-version":[{"id":149716,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17726\/revisions\/149716"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=17726"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=17726"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=17726"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}