Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. Novartis started its journey in Bangladesh in 1973 as Ciba Geigy (Bangladesh) Limited and Novartis (Bangladesh) Limited took birth from the merger of Ciba-Geigy and Sandoz AG in Bangladesh in 1996.

Novartis was created in 1996 through the merger of Ciba-Geigy and Sandoz and has a rich history spanning over 200 years.

Novartis (Bangladesh) Limited is a joint venture between Novartis AG (60%) and Bangladesh Chemical Industries Corporation (40%) of Government of People's Republic of Bangladesh. ¹⁾²⁾

For patients, the drug needs to be taken lifelong”. For this reason, along with the fact that 95% of Indians do not possess private health insurance, its pricing plays a critical factor in cancer patients’ ability to access a continuous supply of Glivec for effective treatment.

What is important to bear in mind, is that there is a significant price gap between the patented version of Glivec and its generic copy, as a *monthly dose of the former can cost as much as USD $5,000 in the U.S., whereas a monthly dose of the latter can be purchased for just USD $200 in India*. In 2006, the Indian Patent Office rejected Novartis’ patent application for Glivec under Section 3(d) of the Indian Patents Act, stating that the drug was a modification of an existing substance, imatinib, and therefore represented a case of ‘evergreening’

Novartis’ attempts to patent Glivec in India span well over a decade (see Figure 1). In 1993, Novartis filed patents worldwide for imatinib, the precursor for the current version of its drug Glivec. However, it did not do so in India as India at the time did not offer product patent protection.

In 1997, when Novartis developed the beta crystalline form of imatinib – imatinib mesylate – which it found to have 30% more bioavailability than its non-salt form (i.e., absorbed 30% more easily into the bloodstream), the company applied for a second round of patents, this time including India. The patent application was received under India’s ‘mailbox’ provisions, a scheme which allowed companies to request patents while the Indian government transitioned towards a revised intellectual property legal system in 2005 at the behest of the World Trade Organization.

However, Indian generic producers were manufacturing and selling Glivec at less than 10% of the patented version’s price, compelling Novartis to put pressure on the Indian government to take a stance on intellectual property protection. In response, the Indian government granted the company Exclusive Marketing Rights (EMR) until its application came up for review. This decision put a stop to the majority of the production of generic versions of Glivec in India, thereby resulting in massive access barriers for individuals seeking affordable cancer treatment.

Several generic companies and not-for-profit organizations such as the Cancer Patients Aid Association (CPAA) rallied together to protest against Novartis’ EMR status, and filed an opposition against the company’s patent application, which was due for examination in 2005, the year when India would officially begin to look at both new and ‘mail-boxed’ patent requests. In 2006, pursuant to Section 3(d) of the Indian Patent’s Act, the Indian Patents Office rejected Novartis’ patent application for its drug Glivec, citing that it did not demonstrate any significant changes in therapeutic effectiveness over its pre-existing form, which was already patented outside India.

In rebuttal, Novartis filed two legal challenges against the Indian government later that year – one appealing the rejection of its patent request, and the second contesting Section 3(d) of the Indian Patents Act, claiming that it did not comply with TRIPS, which India had ratified in 1994. In August 2007, the Madras High Court ruled against Novartis’s attempt to overturn Section 3(d), and in 2009, the Intellectual Property Appellate Board in India rejected the company’s appeal against the rejection of its patent application. Novartis then filed a new case with the Indian Supreme Court, disputing the basis of these decisions, and the final decision came out in early April 2013.³⁾

The Genomics Institute of the Novartis Research Foundation (GNF) serves as a bridge between basic science and preclinical drug discovery for Novartis’ global research organization, the Novartis Institutes for BioMedical Research (NIBR). GNF’s nearly 500 scientists and engineers are committed to pushing the boundaries of science in pursuit of new medicines.^{4) 5)}

Violation Tracker Parent Company Summary Novartis publicly traded (ticker symbol NYSE- NVS) Headquartered in Switzerland

Penalty total since 2000 - $2,711,283,570 ⁶⁾⁷⁾

• Number of records; 40
• Top 5 Offense Groups (Groups Defined) Penalty Total Number of Records
• competition-related offenses $1,090,950,000 10
• government-contracting-related offenses $823,474,307 12
• healthcare-related offenses $514,508,250 7
• employment-related offenses $282,061,595 5
• financial offenses $168,500 1
• Top 5 Primary Offense Types Penalty Total Number of Records
• False Claims Act and related $823,474,307 12
• kickbacks and bribery $504,800,000 4
• off-label or unapproved promotion of medical products $501,638,250 5
• Foreign Corrupt Practices Act $370,800,000 3
• price-fixing or anti-competitive practices $215,350,000 3