Activists from Morocco, Thailand, and Vietnam have filed patent oppositions to challenge drug manufacturers Incyte and Eli Lilly over the monopoly of WHO-approved COVID-19 drug baricitinib.
International Treatment Preparedness Coalition-Middle East and North Africa (ITPC-MENA), the national network of people living with HIV in Thailand (TNP+), and the Vietnam Network of People living with HIV (VNP+), all partners of Make Medicines Affordable campaign, have all filed lawsuits in a bid to stop the monopolization of the drug in order to make it affordable and accessible.
In January 2022, the WHO recommended baricitinib for COVID-19, which is recommended for patients who doctors determine are moderately or critically ill. The WHO stated that the extent to which these medicines will save lives depends on how widely available and affordable they will be, but patent applications by pharmaceutical companies Incyte and Eli Lilly threaten the accessibility of the treatment.
On December 22, 2022, ITPC-MENA filed an invalidation lawsuit against the patent granted in Morocco (MA32219B1) of Incyte that protects baricitinib compound. It is the first time that opposition to a patent on a medication has been filed in the country.
“Until now, patents have been regarded with a sort of sanctity in Morocco and were never challenged even when they were illegitimate,” said Othmane Marrakchi, Advocacy Officer, ITPC-MENA, Morocco.
“A victory in this case will not only mean access to affordable generic baricitinib, but also, more importantly, the beginning of questioning low-quality patents and a debate on the necessity of reforming the patent examination and granting system,” Marrakchi said.
VNP+ filed an invalidation lawsuit on December 29, 2022, against Incyte patent #14607, granted in Vietnam, which also protects the baricitinib compound.
“We have used patent oppositions to challenge the patent examination system and advocate for the patent law’s amendment to ensure that the law will be used to protect the public interests, particularly access to affordable medicines,” said Dong Do Dang, the Chairperson of VNP+.
TNP+ filed a third-party observation on March 8, 2023, against Incyte’s pending patent application (TH0901000922) which aimed to secure a monopoly on baricitinib compound in Thailand. Baricitinib has not yet been given a patent in Thailand as it is under examination by the Thai patent office.
In Thailand, medical experts and health advocates lobbied the government to include Baricitinib in the country’s national COVID-19 treatment guidelines and the national essential drug list. As a result, hospitals could prescribe the drug to patients who did not have to pay for the treatment themselves, explained Chalermsak Kittitrakul, TNP+’s Project Manager for Access to Medicines.
“However, the original Baricitinib’s price is quite high,” said Kittitrakul. “To bring down the price, we need to encourage the competition of generic baricitinib in Thailand.”
Prior to its use as a COVID-19 drug, baricitinib was initially used to treat moderately to severely active rheumatoid arthritis. Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib (sold under the brand name Olumiant) in December 2009. On June 1, 2018, Lilly announced on their website that baricitinib had been approved by the FDA for the treatment of moderately to severely active rheumatoid arthritis.
While the estimated cost of manufacturing baricitinib is $2 per treatment course, the drug was priced significantly higher by Lilly at the height of the COVID pandemic. According to a Harvard report, Eli Lilly’s list price of $1,109.92 per 14-day treatment course of baricitinib 4mg is 555 times the cost-based estimated generic price.
Additionally, Lilly did not proceed with sharing the technology widely during the pandemic or announcing non-enforcement of its patents for the drug for the purposes of COVID-19 treatment. Instead, as the Delta variant was raging in India in the spring of 2021, the company started to give voluntary licensing to selected local manufacturers in India, effectively keeping Lilly’s monopoly amid a global pandemic.
On November 19, 2020, baricitinib was the first immunomodulatory treatment for COVID-19 to receive FDA approval. The agency approved it for treating COVID-19 among hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Several reports indicate that there were multiple clinical trials assessing the efficacy of baricitinib for COVID-19 that were partially publicly funded. These trials include a trial on the safety and efficacy of investigational therapeutics for the treatment of COVID-19 in hospitalised adults, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) which is an agency of the United States Department of Health and Human Services. In addition, a therapeutic study in pre-ICU patients admitted with COVID-19 which assessed the efficacy of baricitinib and ravulizumab as potential treatments was sponsored by the National Health Service (NHS) in the UK. These results, in part, led to the inclusion of baricitinib in WHO and US COVID-19 treatment guidelines.
