Editing Novartis (section)

==Controversies and criticism==
===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 />

===Sexual discrimination===
On 17 May 2010, a jury in the United States District Court for the Southern District of New York awarded $3,367,250 in [[compensatory damages]] against Novartis, finding that the company had committed [[sexual discrimination]] against twelve female [[sales representative]]s and entry-level [[Management|managers]] since 2002, in matters of pay, promotion, and treatment after learning that the employees were [[pregnancy|pregnant]]. Two months later the company settled with the remaining plaintiffs for $152.5&nbsp;million plus attorney fees.<ref>{{Cite web |last=Voris |first=Bob Van |date=14 July 2010 |title=Novartis Reaches $152.5 Million Sex-Bias Settlement |url=http://www.washingtonpost.com/wp-dyn/content/article/2010/07/14/AR2010071405346.html |access-date=29 January 2021 |via=www.washingtonpost.com |archive-date=18 May 2018 |archive-url=https://web.archive.org/web/20180518041449/http://www.washingtonpost.com/wp-dyn/content/article/2010/07/14/AR2010071405346.html |url-status=live }}</ref>

===Marketing violations===
In September 2008, the US [[Food and Drug Administration]] (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of [[Focalin]] XR, an [[ADHD]] drug, in which the company overstated its efficacy while marketing to the public and medical professionals.<ref>{{Cite web |date=2008-09-25 |title=Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules CII |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048118.htm |url-status=live |archive-url=https://web.archive.org/web/20120210144438/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048118.htm |archive-date=10 February 2012 |access-date=2009-08-05 |website=Warning Letters |publisher=[[Food and Drug Administration|US Food and Drug Administration]] |df=dmy}}</ref>

In 2005, federal prosecutors opened an investigation into Novartis' marketing of several drugs: [[Trileptal]], an antiseizure drug; three drugs for heart conditions—[[Diovan]] (the company's top-selling product), [[Exforge]], and [[Tekturna]]; [[Sandostatin]], a drug to treat a growth hormone disorder; and [[Zelnorm]], a drug for irritable bowel syndrome.<ref name=NYTtrileptal/> In September 2010, Novartis agreed to pay US$422.5&nbsp;million in criminal and civil claims and to enter into a [[corporate integrity agreement]] with the US Office of the Inspector General.<ref>{{Cite web |date=2010-09-30 |title=Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office |url=http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml |url-status=dead |archive-url=https://web.archive.org/web/20131017111251/http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml |archive-date=17 October 2013 |access-date=2012-01-16 |publisher=Novartis |at=Media Releases |type=press release |df=dmy-all}}</ref> According to ''The New York Times'', "Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing."<ref name="NYTtrileptal">{{Cite news |last=Wilson |first=Duff |date=2010-09-30 |title=Novartis Settles Off-Label Marketing Case |work=[[The New York Times]] |url=https://www.nytimes.com/2010/10/01/health/policy/01novartis.html |access-date=2012-01-16 |archive-date=16 November 2018 |archive-url=https://web.archive.org/web/20181116215913/https://www.nytimes.com/2010/10/01/health/policy/01novartis.html |url-status=live }}</ref> In the same New York Times article, Frank Lichtenberg, a Columbia professor who receives pharmaceutical financing for research on innovation in the industry, said off-label prescribing was encouraged by the American Medical Association and paid for by insurers, but [[off-label use|off-label marketing]] was clearly illegal. "So it's not surprising that they would settle because they don't have a legal leg to stand on."

In April 2013, federal prosecutors filed two lawsuits against Novartis under the [[False Claims Act]] for off-label marketing and kickbacks; in both suits, prosecutors are seeking [[treble damages]].<ref name="NYTapril2013">{{Cite news |date=2013-04-26 |title=U.S. Sues Novartis Again, Accusing It of Kickbacks |work=The New York Times |url=https://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?_r=0 |access-date=2013-04-27 |archive-date=5 October 2019 |archive-url=https://web.archive.org/web/20191005140435/https://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?_r=0 |url-status=live }}</ref><ref name="DOJ2013">{{Cite web |date=2013-04-26 |title=United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs |url=https://www.justice.gov/opa/pr/2013/April/13-civ-481.html |url-status=live |archive-url=https://web.archive.org/web/20140413062711/http://www.justice.gov/opa/pr/2013/April/13-civ-481.html |archive-date=2014-04-13 |access-date=2013-04-26 |publisher=The United States Department of Justice}}</ref> The first suit "accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts".<ref name=NYTapril2013/> In the second, the Justice Department joined a ''[[qui tam]]'', or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: [[Lotrel]] and [[Valturna]] (both [[hypertension]] drugs), and the diabetes drug, [[Starlix]].<ref name=DOJ2013/> Twenty-seven states, the District of Columbia and Chicago and New York also joined.<ref name=NYTapril2013/>

===Avastin===
Outside the US, Novartis markets the drug [[ranibizumab]] (trade name Lucentis), which is a [[monoclonal antibody]] fragment derived from the same parent mouse antibody as [[bevacizumab]] (Avastin). Both Avastin and Lucentis were created by [[Genentech]] which is owned by Roche; Roche markets Avastin worldwide, and also markets Lucentis in the US. Lucentis has been approved worldwide as a treatment for wet [[macular degeneration]] and other retinal disorders; Avastin is used to treat certain cancers. Because the price of Lucentis is much higher than Avastin, many ophthalmologists began having [[compounding pharmacies]] formulate Avastin for administration to the eye and began treating their patients with Avastin.<ref>Andrew Pollack for ''The New York Times''. 28 April 2011 [https://www.nytimes.com/2011/04/29/business/29eye.html?_r=0 Cheaper Drug to Treat Eye Disease Is Effective] {{Webarchive|url=https://web.archive.org/web/20180916202106/https://www.nytimes.com/2011/04/29/business/29eye.html?_r=0 |date=16 September 2018 }}</ref> In 2011, four trusts of the [[National Health Service]] in the UK issued policies approving use and payment for administering Avastin for macular degeneration, in order to save money, even though Avastin had not been approved for that indication.<ref name="BBClucentis">{{Cite news |last=Jeffreys |first=Branwen |date=2012-05-06 |title=Using Avastin for eye condition wet AMD 'could save NHS £84m' |publisher=bbc.com |url=https://www.bbc.co.uk/news/health-17956425 |url-status=live |access-date=2012-05-06 |archive-url=https://web.archive.org/web/20131106060449/http://www.bbc.co.uk/news/health-17956425 |archive-date=2013-11-06}}</ref> In April 2012, after failing to persuade the trusts that it was uncertain whether Avastin was as safe and effective as Lucentis, and in order to retain the market for Lucentis, Novartis announced it would sue the trusts.<ref name=BBClucentis/><ref name="copleyreuters2012">{{Citation |last1=Copley |first1=Caroline |title=Novartis challenges UK Avastin use in eye disease |date=24 April 2012 |url=https://www.reuters.com/article/us-novartis-britain-idUSBRE83N0GM20120424 |df=dmy |editor-last=Potter, Mark |archive-url=https://web.archive.org/web/20130522203804/https://www.reuters.com/article/2012/04/24/us-novartis-britain-idUSBRE83N0GM20120424 |publisher=Reuters |access-date=2012-04-29 |archive-date=22 May 2013 |last2=Hirschler |first2=Ben |url-status=live}}</ref> However, in July Novartis offered significant discounts (kept confidential) to the trusts, and the trusts agreed to change their policy,<ref>Ben Adams for Pharmafile. 26 July 2012 [http://www.pharmafile.com/news/173606/lucentis-price-cut-ends-pct-novartis-dispute Lucentis price cut ends PCT-Novartis dispute] {{webarchive |url=https://web.archive.org/web/20131019124934/http://www.pharmafile.com/news/173606/lucentis-price-cut-ends-pct-novartis-dispute |date=19 October 2013 }}</ref> and in November, Novartis dropped the litigation.<ref>Ben Adams for Pharma Times. 3 October 2012. [http://www.pharmatimes.com/Article/12-10-03/Novartis_to_drop_legal_case_against_NHS_body.aspx Novartis to drop legal case against NHS body] {{webarchive |url=https://web.archive.org/web/20131019132110/http://www.pharmatimes.com/Article/12-10-03/Novartis_to_drop_legal_case_against_NHS_body.aspx |date=19 October 2013 }}</ref>

===Valsartan===
In the summer of 2013, two Japanese universities retracted several publications of clinical trials that purported to show that [[Valsartan]] (branded as Diovan) had cardiovascular benefits, when it was found that statistical analysis had been manipulated, and that a Novartis employee had participated in the statistical analysis but had not disclosed his relationship with Novartis but only his affiliation with Osaka City University, where he was a lecturer.<ref name="WSJaug">Kana Inagaki for ''The Wall Street Journal''. 11 August 2013 [https://online.wsj.com/news/articles/SB10001424127887323838204579000403952581982 Novartis Hit by Scandal Over Japanese Drug Studies: Probes Uncover Altered Research Data; Swiss Giant Stands by Heart Medicine Diovan] {{webarchive |url=https://web.archive.org/web/20131013192537/http://online.wsj.com/news/articles/SB10001424127887323838204579000403952581982 |date=13 October 2013 }}</ref><ref>Kana Inagaki for ''The Wall Street Journal''. 12 August 2013. [https://blogs.wsj.com/japanrealtime/2013/08/12/novartis-drug-studies-in-japan-tracing-back-the-questions/ Novartis Drug Studies in Japan–Tracing Back the Questions] {{webarchive |url=https://web.archive.org/web/20131018005314/https://blogs.wsj.com/japanrealtime/2013/08/12/novartis-drug-studies-in-japan-tracing-back-the-questions/ |date=18 October 2013 }}</ref> As a result, several Japanese hospitals stopped using the drug, and media outlets ran reports on the scandal in Japan.<ref name=WSJaug/> In January 2014 Japan's Health Ministry filed a criminal complaint with the [[Tokyo]] public prosecutor's office against Novartis and an unspecified number of employees, for allegedly misleading consumers through advertisements that used the research to support the benefits of Diovan.<ref>{{Cite news |date=10 January 2014 |title=Japan Criminal Probe Could Spell More Trouble for Novartis |work=The Wall Street Journal |url=https://online.wsj.com/news/articles/SB10001424052702303933104579307443220022558 |url-status=live |archive-url=https://web.archive.org/web/20140302153955/http://online.wsj.com/news/articles/SB10001424052702303933104579307443220022558 |archive-date=2014-03-02}}</ref> On 1 July 2014 the prosecutor's office announced it was formally charging the company and one of its employees.<ref name="NovartisJapan">{{Cite news |title=Data manipulation by staff gets Novartis into legal mess in Japan |publisher=Japan Herald |url=http://www.japanherald.com/index.php/sid/223435459/scat/c4f2dd8ca8c78044/ht/Data-manipulation-by-staff-gets-Novartis-into-legal-mess-in-Japan |url-status=dead |access-date=2014-07-02 |archive-url=https://web.archive.org/web/20140829181210/http://www.japanherald.com/index.php/sid/223435459/scat/c4f2dd8ca8c78044/ht/Data-manipulation-by-staff-gets-Novartis-into-legal-mess-in-Japan |archive-date=29 August 2014 |df=dmy-all}}</ref>

===Corruption===
In January 2018, Novartis began being investigated by US and Greek authorities for allegedly bribing Greek public officials in the 2006–2015 period, in a scheme which included two former prime ministers, several former health ministers, many high ranking party members of the [[Nea Dimokratia]] and [[PASOK]] ruling parties, as well as bankers.<ref name="greece.greekreporter.com">{{Cite web |title=Greek Officials Hit Back at Novartis Bribery Allegations {{!}} GreekReporter.com |url=http://greece.greekreporter.com/2018/02/06/greek-officials-hit-back-at-novartis-bribery-allegations/ |access-date=2018-02-07 |website=greece.greekreporter.com |date=6 February 2018 |archive-date=1 November 2020 |archive-url=https://web.archive.org/web/20201101105708/https://greece.greekreporter.com/2018/02/06/greek-officials-hit-back-at-novartis-bribery-allegations/ |url-status=live }}</ref> The manager of Novartis' Greek branch was prohibited from leaving the country.<ref>{{Cite web |title=Greek officials ban Novartis manager from leaving the country amid widening bribery probe: report {{!}} FiercePharma |url=https://www.fiercepharma.com/legal/greek-officials-ban-novartis-manager-from-leaving-country-amid-widening-bribery-probe-report |access-date=2018-02-07 |website=www.fiercepharma.com |date=6 February 2018 |archive-date=9 November 2020 |archive-url=https://web.archive.org/web/20201109030126/https://www.fiercepharma.com/legal/greek-officials-ban-novartis-manager-from-leaving-country-amid-widening-bribery-probe-report |url-status=live }}</ref> The minister's deputy described the allegations as "the biggest scandal since the creation of the Greek state", which caused "annual state expenditure on medicine to explode".<ref>{{Cite news |date=2018-02-05 |title=Greek Govt Alleges Official Ties to Drug Bribery Scandal |work=The New York Times |agency=Associated Press |url=https://www.nytimes.com/aponline/2018/02/05/world/europe/ap-eu-greece-pharma-scandal.html |access-date=2018-02-07 |issn=0362-4331 |archive-date=16 November 2018 |archive-url=https://web.archive.org/web/20181116220159/https://www.nytimes.com/aponline/2018/02/05/world/europe/ap-eu-greece-pharma-scandal.html |url-status=live }}</ref> Most of the ministers involved in the scandal have denied the allegations and sought to paint the case as "political targeting" and "fabrication" by the [[Syriza]] opposition party.<ref name="greece.greekreporter.com" /> However, the Greek Judicial Council ruled that the scandal was real.<ref>{{Cite web|title=Ν. Ηλιόπουλος: Και με τη βούλα της Δικαιοσύνης υπαρκτό το σκάνδαλο Novartis|url=https://www.capital.gr/politiki/3644684/n-iliopoulos-kai-me-ti-boula-tis-dikaiosunis-uparkto-to-skandalo-novartis|access-date=27 July 2022|website=capital.gr|archive-date=27 July 2022|archive-url=https://web.archive.org/web/20220727183534/https://www.capital.gr/politiki/3644684/n-iliopoulos-kai-me-ti-boula-tis-dikaiosunis-uparkto-to-skandalo-novartis|url-status=live}}</ref> Besides bribery that involves artificial increases in the price of several medicines, the case also involves money laundering, with suspicions of "illegal funds of more than four billion euros ($4.2&nbsp;billion)" were involved.<ref>{{Cite web|title=Novartis under investigation for bribery in Greece|url=http://www.dw.com/en/novartis-under-investigation-for-bribery-in-greece/a-37230558 |access-date=2018-02-07 |website=DW.COM |archive-date=12 November 2020 |archive-url=https://web.archive.org/web/20201112035506/https://www.dw.com/en/novartis-under-investigation-for-bribery-in-greece/a-37230558 |url-status=live }}</ref>

In June 2020, Novartis reached settlements with the [[US Department of Justice|US Department of Justice (DOJ)]] and the [[U.S. Securities and Exchange Commission|US Securities and Exchange Commission (SEC)]] resolving all [[Foreign Corrupt Practices Act|Foreign Corrupt Practices Act (FCPA)]] investigations into historical conduct by the company and its subsidiaries. As part of the resolutions, Novartis and some of its current and former subsidiaries would pay US$233.9&nbsp;million to the DOJ and US$112.8&nbsp;million to the SEC.<ref>{{Cite web |title=SEC.gov {{!}} SEC Charges Novartis AG with FCPA Violations |url=https://www.sec.gov/news/press-release/2020-144 |access-date=2020-06-25 |website=www.sec.gov |archive-date=18 January 2021 |archive-url=https://web.archive.org/web/20210118142324/https://www.sec.gov/news/press-release/2020-144 |url-status=live }}</ref><ref>{{Cite web |date=2020-06-25 |title=Novartis Hellas S.A.C.I. and Alcon Pte Ltd Agree to Pay over $233 Million Combined to Resolve Criminal FCPA Cases |url=https://www.justice.gov/opa/pr/novartis-hellas-saci-and-alcon-pte-ltd-agree-pay-over-233-million-combined-resolve-criminal |access-date=2020-06-25 |website=www.justice.gov |language=en |archive-date=13 January 2021 |archive-url=https://web.archive.org/web/20210113193734/https://www.justice.gov/opa/pr/novartis-hellas-saci-and-alcon-pte-ltd-agree-pay-over-233-million-combined-resolve-criminal |url-status=live }}</ref>

===Michael Cohen===
[[File:REPORT White House Access for Sale Michael Cohen and Novartis.pdf|thumb|upright|[[Senate Finance Committee]] report on [[Michael Cohen (lawyer)|Michael Cohen]]'s dealings with Novartis, entitled "White House Access for Sale"]]
Novartis paid $1.2&nbsp;million to Essential Consultants, an entity owned by [[Michael Cohen (lawyer)|Michael Cohen]], following the 2017 inauguration of Donald Trump. Cohen was paid monthly, with each payment just under $100,000. Novartis claims it paid Cohen to help it understand and influence the new administration's approach to drug pricing and regulation.<ref>{{Cite news |title=Novartis admits $1.2m in payments to Trump lawyer |work=[[Financial Times]] |url=https://www.ft.com/content/61e2cca8-5363-11e8-b3ee-41e0209208ec |access-date=2018-05-10 |archive-date=9 November 2020 |archive-url=https://web.archive.org/web/20201109004049/https://www.ft.com/content/61e2cca8-5363-11e8-b3ee-41e0209208ec |url-status=live }}</ref>

In July 2018, the [[US Senate committee]] report "White House Access for Sale" revealed that Novartis Ag's relationship with Cohen was "longer and more detailed". Novartis initially stated that the relationship ceased a month after entering the US$1.2&nbsp;million contract with Cohen's consulting firm since the consultants were not able to provide the information the pharmaceutical company needed. Later, it became clear, however, that then-CEO [[Joseph Jimenez]] and Cohen communicated via email multiple times during 2017, which included ideas to lower drug prices to be discussed with the president. According to the report, several of the ideas appeared later in Trump's drug pricing plan, released in early 2018, in which pharmaceutical companies were protected from reduced revenues.<ref>Emma Court (16 July 2018.) [https://www.marketwatch.com/story/novartis-had-longer-and-more-detailed-relationship-with-trump-lawyer-michael-cohen-senate-report-finds-2018-07-13 Novartis had 'longer and more detailed' relationship with Trump lawyer Michael Cohen, Senate report finds] {{Webarchive|url=https://web.archive.org/web/20201115035934/https://www.marketwatch.com/story/novartis-had-longer-and-more-detailed-relationship-with-trump-lawyer-michael-cohen-senate-report-finds-2018-07-13 |date=15 November 2020 }}. ''[[MarketWatch]]''. Retrieved 21 August 2018.</ref><ref>[https://www.finance.senate.gov/imo/media/doc/REPORT%20White%20House%20Access%20for%20Sale%20Michael%20Cohen%20and%20Novartis.pdf White House Access for Sale: Michael Cohen, Novartis and the bid to sell access to the Trump administration] {{Webarchive|url=https://web.archive.org/web/20201113040406/https://www.finance.senate.gov/imo/media/doc/REPORT |date=13 November 2020 }}. Retrieved 21 August 2018.</ref>

=== AveXis data integrity ===
Having already received approval for Zolgensma in May 2019, on 28 June AveXis (a Novartis company) voluntarily disclosed to the FDA that some data previously submitted to the agency as part of the Biologics License Application (BLA) package was inaccurate. Specifically, the data manipulation related to an ''in vivo'' murine potency assay used in the early development of the product but the issue the FDA and wider community has taken is that AveXis was aware of the data manipulation as early as 14 March 2019, almost two months before the BLA was approved. To compound the problem in early August it emerged a senior manager sold almost $1&nbsp;million worth of stock immediately before the FDA probe became public on 6 August, but after the company had informed the FDA of the problem. As of September 2019, the FDA was still preparing its response to the scandal. {{citation needed|date=January 2021}}