Third World Network Information Service
TWN Info Service on Health and Intellectual Property
28 February 2025
Third World Network
Health: In significant move, Thailand rejects patent on vital Hepatitis C drug
Published in SUNS #10171 dated 27 February 2025
Penang, 26 Feb (Kanaga Raja) — In what is being hailed as a major victory for civil society organizations (CSOs) campaigning for expanded access to lifesaving medicines, Thailand’s Department of Intellectual Property has rejected a patent application on a drug combination essential for the treatment of chronic Hepatitis C, following a pre-grant opposition.
This major win comes after years of campaigning by the AIDS Access Foundation (AAF) and the Thai Network of People Living with HIV/AIDS (TNP+).
In a post on its website on 24 February, the Make Medicines Affordable (MMA) campaign, which is led by the International Treatment Preparedness Coalition (ITPC) and partners, reported that the Department of Intellectual Property in Thailand has accepted the pre-grant opposition against a patent application on sofosbuvir/ledipasvir (SOF/LED) made in July 2024.
The drug sofosbuvir in combination with ledipasvir has been recommended for treatment of genotypes 1, 4, 5 and 6 of chronic Hepatitis C.
MMA said that pharmaceutical giant Gilead Sciences initially filed sixteen patent applications in relation to sofosbuvir.
Subsequently, Gilead decided to discontinue eight patent applications, while the other eight patent applications were in the pipeline for patent examination, MMA added.
(Filing multiple patent applications is a common strategy of pharmaceutical companies to block generic competition. In the absence of opposition and weak examination by patent offices, 20-year patent monopolies are often granted for each application. Pre-grant opposition in Thailand and India has resulted in the withdrawal of applications showing that these were weak or unsubstantiated claims in the first place.)
As a result, MMA said AAF and TNP+ filed six patent oppositions, two of which were third-party observations, and four as pre-grant oppositions.
The opposition against Gilead’s patent application for the sofosbuvir/ledipasvir combination was initially filed in Thailand on 3 April 2018, MMA noted.
In its post, MMA has quoted Chalermsak Kittitrakul, a researcher and social activist who is also the Project Manager for TNP+, as saying: “This is one example of an evergreening patent because SOF/LED is a medicine that is available already.”
“Everyone knows about the drugs SOF and LED – this combination just puts them both in one tablet. There is no inventive step,” Kittitrakul added.
According to MMA, of the four pre-grant oppositions, three were rejected and one, which pertains to the SOF/ LED combination, was accepted by the Thai patent office.
It said TNP+ has filed appeals over the three rejected oppositions, while Gilead is appealing the decision of the Thai patent office on the SOF/LED combination.
MMA pointed out that patients with Hepatitis C in Thailand had been able to access the SOF/LED treatment at no charge since 2018.
When a newer and more-effective treatment for chronic Hepatitis C was introduced and included in the National Essential Drug List, the SOF/LED regimen was then replaced by sofosbuvir/velpatasvir (SOF/VEL) in 2022, it said.
Providing some background on the use of sofosbuvir in Thailand, MMA said that in 2017, Thailand was included in Gilead’s voluntary license (VL) for sofosbuvir, allowing the import of generic versions.
However, MMA said that this did not immediately resolve the issue of high prices for the drug.
In 2018, SOF and the combination of SOF/LED were introduced in Thailand and included in the universal health coverage scheme’s benefit package.
MMA said Thailand imported two generic versions from India, which led to a significant price reduction, from Gilead’s price of US$1,100 per bottle for SOF to US$110 per bottle for the generic version.
In 2021, Thailand revised and simplified its standard of care for HCV (Hepatitis C virus) to standard treatment of the pan-genotypic regimen of SOF and velpatasvir (VEL) supplied by generics manufacturers, it pointed out.
In January 2021, three years after the World Health Organization recommendation and years of campaigning and advocacy work by TNP+ and the AIDS Access Foundation led to sofosbuvir/velpatasvir (SOF/VEL) being added to the country’s National List of Essential Medicines.
However, MMA said barriers remain, including restrictive eligibility criteria and the need for specialist care, which delay treatment and allow illnesses to worsen.
Although the VL allows Thailand to import generic versions of SOF/VEL from a licensee in India, it costs about US$750 per treatment course, it added.
A local state-enterprise manufacturer could produce and supply generic versions of SOF/VEL in 2022 at the price of US$400 per treatment course, said MMA.
“The price for SOF/VEL remains unacceptably high because only one licensee filed for and obtained approval to market their product in Thailand and the local production requires the raw materials at high price from India,” MMA pointed out in its post.
According to experts, generic versions of SOF/VEL could be profitably mass-produced for US$86 per 12-week treatment course, it said.
MMA quoted Kittitrakul from TNP+ as saying: “There is a misuse and abuse of the [patent] system – instead of protecting and promoting innovation and access to lifesaving medicines, the system is protecting the multi-national drug companies’ benefits.”
IMBALANCE IN PATENT SYSTEM REMAINS
While the recent success of the opposition to SOF/LED has marked a major milestone in the fight to keep medicines affordable and accessible, Kittitrakul said that there is much work to be done, including efforts to keep the patent system in Thailand in balance vis-a-vis safeguarding the public interest versus protecting the rights of patent holders through the Department of Intellectual Property (DIP), which manages intellectual property rights in the country.
“We want to make our patent system better and prevent it from granting this type of [evergreening] patent applications in their system. The DIP should consider that these types of patent applications should be rejected immediately in the examination process,” Kittitrakul said, according to the MMA post.
Kittitrakul explained that TNP+ is committed to ensuring that pharmaceutical companies do not use “evergreening” as a tactic to monopolize the drug market and prevent access to life-saving and essential treatments for those who need them the most.
“To win this game, we have to make sure we have proper laws that see health before trade benefits,” said Kittitrakul.
According to MMA, Kittitrakul noted that Thailand is negotiating free trade agreements (FTAs) with developed countries that demand Thailand amend its intellectual property laws, including its patent law, allowing for longer and broader patent protection, accepting the “ever-greening” of patents, and delaying competition with the generic drug industry.
The multinational pharmaceutical corporations have been pushing this agenda through the free trade agreements, Kittitrakul pointed out.
In addition to these advocacy efforts, MMA said that TNP+ is also focused on raising awareness about Hepatitis C within Thailand, particularly on informing individuals that it is a treatable and curable disease and that Thai patients can now get laboratory tests and treatment at no cost under the national health security schemes. +
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