The Chennai Patent Office revoked Hoffmann-La Roche’s patent on its osteoporosis drug Bonviva in response to a post-grant opposition filed by Indian pharmaceutical company Cipla Global Ltd. The drug in question comprises Ibandronate Sodium, used in the treatment of patients suffering from metastatic cancer-related skeletal fractures, osteoporosis, and for the treatment and prevention of osteoporosis in post-menopausal women. The drug is marketed as Boniva in the United States, Bondronat in Europe, and Bonviva in Asia.<\/p>\n
The patent in dispute, bearing number 208,718, was granted by the patent office in 2007 on the basis of an application filed by Roche in 2001. The patent covers an oral pharmaceutical composition of the active ingredient Ibandronate Sodium with a controlled dissolution rate for the treatment of osteoporosis.<\/p>\n
Cipla filed a post-grant opposition in 2008. The patent office refused the opposition in 2010, upholding Roche’s patent. Cipla appealed to the Intellectual Property Appellate Board (IPAB), which set aside the patent office’s order and directed it to reconsider the matter on the basis of expert evidence and the recommendations of the opposition board.<\/p>\n
Following the IPAB’s order, the patent office re-evaluated the case, considered the expert evidence submitted by both companies, and reviewed the recommendations of the opposition board. The order revoking the patent in favour of Cipla was issued on December 19, 2014.<\/p>\n
The revocation was ordered on the grounds of post-grant opposition under section 25(2)(e), on the ground that the invention claimed is obvious and does not involve any inventive step, and 25(2)(f), on the ground that the subject of the invention claimed is not patentable under the Patents Act, 1970. The patent office held that the pharmaceutical composition was a mere admixture, which is not patentable subject matter under Sec. 3(e) of the Patents Act.<\/p>\n
In December 2006, Roche had entered into a marketing agreement with Mumbai-based Elder Pharmaceuticals to sell the drug under the brand name Bonviva in India at a price 35% lower than that prevailing in other countries.<\/p>\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 has revoked Roche\u2019s patent on Bonviva after Cipla challenged its validity, citing a lack of inventive step and patentability. This decision highlights critical aspects of Indian pharmaceutical patent law and its impact on international drug companies.<\/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":[6941,550,6942,42,6943,71,61,6626],"class_list":["post-17765","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-bonviva","tag-cipla","tag-ibandronate-sodium","tag-indian-patent-office","tag-osteoporosis-treatment","tag-patent-revocation","tag-pharmaceutical-patents","tag-roche"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17765","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=17765"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17765\/revisions"}],"predecessor-version":[{"id":149718,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17765\/revisions\/149718"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=17765"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=17765"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=17765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}