Editing Novartis (section)

===Challenge to India's patent laws===
{{Main|Novartis v. Union of India & Others}}

Novartis fought a seven-year, controversial battle to patent [[Imatinib|Gleevec]] in India, and took the case all the way to the [[Indian Supreme Court]], where the patent application was finally rejected. The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the [[World Trade Organization]] and to abide by worldwide intellectual property standards under the [[TRIPS]] agreement. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.<ref name=NYTimesIndiaDecision/>

The patent application<ref>Note: The Indian patent application No.1602/MAS/1998 does not appear to be publicly available. However, according to [https://www.scribd.com/doc/133340456/IPAB-Order-Dated-26-Jun-2009-in-Novartis-v-Union-of-India the decision of the IPAB on 26 June 2009] (page 27) discussed below, "The Appellant's application under the PCT was substantially on the same invention as had been made in India." {{webarchive |url=https://web.archive.org/web/20131022185309/http://www.scribd.com/doc/133340456/IPAB-Order-Dated-26-Jun-2009-in-Novartis-v-Union-of-India |date=22 October 2013 }}</ref><ref name="PCT">{{Cite web |title=Crystal Modification of a N-Phenyl-2-Pyrimidineamine Derivative, Processes for Its Manufacture and Its Use |url=https://patentscope.wipo.int/search/en/detail.jsf?docId=WO1999003854 |url-status=dead |archive-url=https://web.archive.org/web/20131022201745/http://patentscope.wipo.int/search/en/detail.jsf?docId=WO1999003854 |archive-date=22 October 2013 |access-date=29 January 2021}}</ref> claimed the final form of Gleevec (the beta crystalline form of imatinib [[mesylate]]).<ref>Staff, European Medicines Agency, 2004. [http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000406/WC500022203.pdf EMEA Scientific Discussion of Glivec] {{Webarchive|url=https://web.archive.org/web/20180920171821/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000406/WC500022203.pdf |date=20 September 2018 }}</ref>{{rp|3}} In 1993 before India allowed patents on products, Novartis had patented imatinib, with [[Salt (chemistry)|salts]] vaguely specified, in many countries but could not patent it in India.<ref>{{Cite web |title=Patent US5521184 - Pyrimidine derivatives and processes for the preparation thereof |url=https://patents.google.com/patent/US5521184 |website=google.com |access-date=11 November 2016 |archive-date=15 December 2020 |archive-url=https://web.archive.org/web/20201215153432/https://patents.google.com/patent/US5521184 |url-status=live }}</ref><ref>{{Cite web |title=Espacenet - results view |url=https://worldwide.espacenet.com/searchResults?query=EP0564409 |access-date=29 January 2021 |website=worldwide.espacenet.com |archive-date=17 November 2018 |archive-url=https://web.archive.org/web/20181117063255/https://worldwide.espacenet.com/searchResults?query=EP0564409 |url-status=live }}</ref> The key differences between the two patent applications were that the 1998 patent application specified the [[counterion]] (Gleevec is a specific salt—imatinib mesylate) while the 1993 patent application did not claim any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of Gleevec—the way the individual molecules are packed together into a solid when the [[active ingredient|drug itself]] is manufactured (this is separate from processes by which the drug itself is [[Pharmaceutical formulation|formulated]] into pills or capsules)—while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta crystalline.<ref>[http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 Indian Supreme Court Decision] paragraphs 5-6 {{webarchive |url=https://web.archive.org/web/20130706085312/http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |date=6 July 2013 }}</ref>

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR was granted in November 2003.<ref name="Decision8-9">{{Cite web |title=Novartis v UoI, para 8-9 |url=http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |url-status=dead |archive-url=https://web.archive.org/web/20130706085312/http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |archive-date=6 July 2013 |access-date=29 January 2021}}</ref> Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India.<ref name=SpicyIP1/> Novartis set the price of Gleevec at US$2666 per patient per month; generic companies were selling their versions at US$177 to 266 per patient per month.<ref>Staff, LawyersCollective. 6 September 2011 [http://www.lawyerscollective.org/news/archived-news-a-articles/126-novartis-case-background-and-update-supreme-court-of-india-to-recommence-hearing.html Novartis case: background and update – Supreme Court of India to recommence hearing] {{webarchive |url=https://web.archive.org/web/20131021011059/http://www.lawyerscollective.org/news/archived-news-a-articles/126-novartis-case-background-and-update-supreme-court-of-india-to-recommence-hearing.html |date=21 October 2013 }}</ref> Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.<ref name="WSJ">R. Jai Krishna and Jeanne Whalen for ''The Wall Street Journal''. 1 April 2013 [https://online.wsj.com/news/articles/SB10001424127887323296504578395672582230106 Novartis Loses Glivec Patent Battle in India] {{Webarchive|url=https://web.archive.org/web/20141026192715/http://online.wsj.com/news/articles/SB10001424127887323296504578395672582230106 |date=26 October 2014 }}</ref>

When examination of Novartis' patent application began in 2005, it came under immediate attack from [[Opposition proceeding|oppositions]] initiated by generic companies that were already selling Gleevec in India and by advocacy groups. The application was rejected by the patent office and by an appeal board. The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. That section, Paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy."<ref name="SpicyIP1">Shamnad Basheer for Spicy IP 11 March 2006 [http://spicyip.com/2006/03/first-mailbox-opposition-gleevec.html First Mailbox Opposition (Gleevec) Decided in India] {{webarchive |url=https://web.archive.org/web/20131021162820/http://spicyip.com/2006/03/first-mailbox-opposition-gleevec.html |date=21 October 2013 }}</ref><ref name="Appellate">{{Cite web |title=IPAB Order Dated 26-Jun-2009 in Novartis v. Union of India &#124; Patent Application &#124; Patent |url=https://www.scribd.com/document/133340456/IPAB-Order-Dated-26-Jun-2009-in-Novartis-v-Union-of-India |url-status=dead |archive-url=https://web.archive.org/web/20131022185309/http://www.scribd.com/doc/133340456/IPAB-Order-Dated-26-Jun-2009-in-Novartis-v-Union-of-India |archive-date=22 October 2013 |access-date=29 January 2021 |website=Scribd}}</ref> At one point, Novartis went to court to try to invalidate Paragraph 3d; it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal.<ref name="2007Decn">{{Cite web |title=W.P. No.24759 of 2006 |url=http://judis.nic.in/judis_chennai/qrydispfree.aspx?filename=11121 |url-status=dead |archive-url=https://web.archive.org/web/20131020071414/http://judis.nic.in/judis_chennai/qrydispfree.aspx?filename=11121 |archive-date=20 October 2013 |access-date=29 January 2021}}</ref> Novartis did appeal the rejection by the patent office to India's Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.<ref>{{Cite web |title=Supreme Court rejects bid by Novartis to patent Glivec |url=http://spicyipindia.blogspot.co.uk/2013/04/supreme-court-rejects-bid-by-novartis.html |url-status=live |archive-url=https://web.archive.org/web/20131217091420/http://spicyipindia.blogspot.co.uk/2013/04/supreme-court-rejects-bid-by-novartis.html |archive-date=2013-12-17}}</ref>

Although the court ruled narrowly,<ref>{{Cite web |title=Novartis v UoI, Para 191 |url=http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |url-status=dead |archive-url=https://web.archive.org/web/20130706085312/http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |archive-date=6 July 2013 |access-date=29 January 2021}}</ref> and took care to note that the subject application was filed during a time of transition in Indian patent law,<ref name="Decision24">{{Cite web |title=Novartis v UoI, Para 24-25 |url=http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |url-status=dead |archive-url=https://web.archive.org/web/20130706085312/http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 |archive-date=6 July 2013 |access-date=29 January 2021}}</ref> the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing, innovation with affordability etc.<ref>{{Cite web |title=How the Indian judgment will reverberate across the world |url=http://www.firstpost.com/world/how-the-indian-judgment-on-novartis-will-reverberate-across-the-world-684767.html |url-status=dead |archive-url=https://web.archive.org/web/20140118172854/http://www.firstpost.com/world/how-the-indian-judgment-on-novartis-will-reverberate-across-the-world-684767.html |archive-date=2014-01-18}}</ref><ref>{{Cite web |title=Patented drugs must be priced smartly |url=http://articles.economictimes.indiatimes.com/2013-04-03/news/38248707_1_patent-protection-glivec-indian-patent-act |url-status=dead |archive-url=https://web.archive.org/web/20131020222337/http://articles.economictimes.indiatimes.com/2013-04-03/news/38248707_1_patent-protection-glivec-indian-patent-act |archive-date=2013-10-20}}</ref><ref>{{Cite web |title=Patent with a purpose, Prof. Shamnad Basheer, Indian Express, 3 April 2013 |url=http://www.indianexpress.com/news/patent-with-a-purpose/1096741/0 |url-status=dead |archive-url=https://web.archive.org/web/20130526074830/http://www.indianexpress.com/news/patent-with-a-purpose/1096741/0 |archive-date=26 May 2013 |access-date=29 January 2021}}</ref>

Had Novartis won and had its patent issued, it could not have prevented generics companies in India from selling generic Gleevec, but it could have obliged them to pay a reasonable royalty under a grandfather clause included in India's patent law.<ref>Kevin Grogan for PharmaTimes. 27 February 2012 [http://www.pharmatimes.com/article/12-02-27/Novartis_explains_stance_over_India_patent_law_challenge.aspx Novartis explains stance over India patent law challenge] {{webarchive|url=https://web.archive.org/web/20141216001159/http://www.pharmatimes.com/article/12-02-27/Novartis_explains_stance_over_India_patent_law_challenge.aspx |date=16 December 2014 }}</ref><ref>[[Erklärung von Bern]]. 8 May 2007 [http://www.evb.ch/en/p25012749.html Short questions and answers about the court case initiated by Novartis in India] {{webarchive |url=https://web.archive.org/web/20131021190810/http://www.evb.ch/en/p25012749.html |date=21 October 2013 }}</ref>

In reaction to the decision, Ranjit Shahani, vice-chairman and managing director of Novartis India Ltd was quoted as saying "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."<ref>{{Cite web |title=Shift in Novartis Strategy, The Telegraph |url=http://www.telegraphindia.com/1130402/jsp/business/story_16736700.jsp#.UV3-TcV49_M |url-status=dead |archive-url=https://web.archive.org/web/20130511194923/http://www.telegraphindia.com/1130402/jsp/business/story_16736700.jsp#.UV3-TcV49_M |archive-date=11 May 2013 |access-date=29 January 2021}}</ref> He also said that companies like Novartis would invest less money in research in India as a result of the ruling.<ref name=NYTimesIndiaDecision/> Novartis also emphasised that it continues to be committed to good access to its drugs; according to Novartis, by 2013, "95% of patients in India—roughly 16,000 people—receive Glivec free of charge... and it has provided more than $1.7&nbsp;billion worth of Glivec to Indian patients in its support program since it was started...."<ref name=WSJ />