Monday, March 18, 2024

Novartis

 Novartis was accused of hosting tens of thousands of speaker programmes and social events that were supposedly to provide educational content but were actually deemed to be a means of bribing doctors.

These events took place over a period of 10 years. Many were allegedly little more than dinners at pricey restaurants with minimal talk about healthcare, and others never even took place.

It was a decade ago when federal prosecutors first targeted Novartis in two investigations over alleged kickbacks to doctors and Medicare-related charity donation fraud. Now, the Swiss drugmaker can finally put those charges behind it—by paying hundreds of millions of dollars.

Novartis agreed to pay $729 million to settle allegations that it offered kickbacks to doctors and illegal copayment support to Medicare patients to boost its drugs’ sales. The dollar amount matches what the company last year said it had set aside for potential settlement.

In a statement in 2020, Novartis CEO Vas Narasimhan labeled the settlements as “an important milestone on our journey to build trust with society,” stressing that it’s a different company now “with new leadership, a stronger culture, and a more comprehensive commitment to ethics embedded at the heart of our company.”

Back in 2017, South Korea fined Novartis $50 million and temporarily suspended reimbursement of Exelon and Zometa, accusing the company of using medical journals to offer kickbacks to doctors. A scandal alleging Novartis paid Greek government officials to earn favorable pricing status also dragged on for years. And the 2018 revelation of a $1.2 million payment to President Trump's former lawyer Michael Cohen served as a watershed moment that prompted Narasimhan to launch an ethics and compliance shakeup.

Earlier there were other cases too:

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.

Upheld the rejection of the patent application (1602/MAS/1998) filed by Novartis AG for Glivec in 1998 before the Indian Patent Office.

In Novartis v. Union of India & Others the decision was made on 1st April 2012. Application for patent by appellant denied by Assistant Controller of Patents and Designs on 25 January 2006; Intellectual Property Appellate Board (IPAB) partially reversed the decision by the Assistant Controller but still denied patent on 26 June 2009.

The New York Times quoted Chip Davis, the executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America, the industry trade group: "It really is in our view another example of what I would characterize as a deteriorating innovation environment in India. The Indian government and the Indian courts have come down on the side that doesn’t recognize the value of innovation and the value of strong intellectual property, which we believe is essential."

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