Big Pharma using patent evergreening to monopolize vaccines

COVID Vaccine Donation Graphic

Penang, 20 Dec (Kanaga Raja) — Pharmaceutical companies took advantage of the COVID-19 pandemic by filing multiple patents on the same technology, also known as “evergreening”, thus ensuring maximum profits and monopolies on life-saving vaccines and drugs, the Make Medicines Affordable Campaign has said.

In a news release issued on 18 December, the Make Medicines Affordable (MMA) Campaign, which is led by the International Treatment Preparedness Coalition (ITPC), highlighted the findings of a study by a team of four independent researchers as well as two experts on access to medicines from the MMA Campaign.

The study, titled “Unveiling Patenting Strategies of Therapeutics and Vaccines: Evergreening in the Context of COVID-19 Pandemic,” was published in Frontiers, a leading science journal, and its lead researchers are Maria Lorena Bacigalupo, Maria Florencia Pignataro, Carolinne Thays Scopel, and Gabriela Costa Chaves.

According to the MMA news release, the study found that pharmaceutical companies and academic institutions filed a total of 73 patent applications through the Patent Cooperation Treaty (PCT) system to maintain their monopolies on selected drugs and vaccines, even during and after the COVID-19 pandemic.

“Of those, 29 patent applications were for antiviral drugs, three applications were for a biologic product, and 41 applications were for vaccines,” it said.

The MMA news release cited the study’s lead researchers Lorena Bacigalupo, Florencia Pignataro, and Thays Scopel as saying in a joint statement: “Our study shows that multiple patent applications get more complex when it comes to vaccines. This highlights the importance of taking a public health approach in patent examination.”

According to the study published in Frontiers, in the pharmaceutical sector, “evergreening” is considered a range of practices applied to extend monopoly protection on existing products.

Filing several patent applications related to the same active pharmaceutical ingredient (API) is one of the most common manifestations of “evergreening”, said the authors.

The study noted that the “evergreening” approach pursued has already been found in other diseases, with the risk of monopoly extension and also bringing legal uncertainty due to the lack of transparency of newer patent applications covering specific medical indications.

Therefore, efforts to address “evergreening” should be pursued by countries, including the adoption of a public health approach to the patent examination of those technologies to prevent the granting of undeserved patents, said the authors.

The authors further said that from an access perspective, “the patent protection of essential medicines has created a monopoly situation that allows companies to charge high prices, as seen over the past nearly three decades for the antiretrovirals for HIV infection and lately for direct acting-antivirals for hepatitis C and other disease areas.”

“The evergreening strategy worsens the patent-related access challenges by not only extending the term of the market monopoly situation, but also increasing legal uncertainty for procurement processes, due to the different status of those applications and the chilling effect (of even non-blocking secondary patents), preventing efforts to import or engage in local production for affordable alternatives (generics or biosimilars),” they added.

The MMA news release cited the authors as stating: “Governments, communities, and civil society organizations have witnessed the impacts of evergreening over the last 25 years, as it has led to continued inaccessibility of medicines and other treatments, which were sold at astronomically high prices in some cases”.

According to the news release, the study also highlighted that new patent applications were filed for known drugs to treat COVID-19.

It said that remdesivir, molnupiravir, and sarilumab were re-purposed and approved to treat COVID-19 during the pandemic, adding that the companies pursued new patent applications for this medical indication.

“There were 12, six, and three PCT applications filed, respectively. These applications were made between 2007 and 2022 with the last application for each drug expected to subsequently expire after 33, 27, and 34 years of monopoly if filed and granted in countries,” the MMA news release said.

Highlighting this issue, the study said there was renewed attention to re-purposing drugs during the COVID-19 pandemic.

It explained that drug re-purposing can be defined as “researching new indications for already approved drugs or advancing previously studied but unapproved drugs”.

“Remdesivir, favipiravir and sarilumab are therapeutics resulting from this approach. It has been adopted based on the assumption, among others, that the development process can be shortened, cheaper, and with lower risk in comparison with traditional approaches.”

However, pharmaceutical companies are also known for de-prioritizing or abandoning promising drug candidates during the R&D process, and intellectual property was identified as the second main barrier to drug re-purposing, said the study.

For example, the study said “intense patent filings on a compound prevent other institutions from exploring R&D activities on such compounds, unless they get a license with the patent holder, which can be time-consuming and difficult to negotiate.”

“It is common practice for drug developers to patent a variety of compounds during a drug development project, protecting not only the final candidate but many if not all of the “semi-finalist” compounds.”

Therefore, “this approach allows companies to protect their shelved compounds and prevent competitors from working on similar promising drug candidates,” the authors emphasized.

“This is reflected in the three antivirals analyzed, wherein initial patent applications focused on Markush type of claims and subsequent applications targeted specific compounds,” they added.

LESSONS FROM COVID-19 PANDEMIC

In their study, the authors also highlighted several lessons from the COVID-19 pandemic “regarding the effects of monopoly on access inequity to health technologies.”

They said that one lesson from the COVID-19 pandemic is that the monopoly situation not only affects prices but also the supply in a health emergency.

For instance, the study said in 2020, after being the first therapeutic to get emergency use authorization by the US FDA, almost all of the world’s supply of remdesivir was procured by the US government, which shows that high-income countries (HIC) prioritized their national interests.

“Additionally, the country paid US$2,340 per five-day treatment, while the estimated cost of manufacturing was US$0.93 per day,” said the authors.

According to the study, a second lesson from the COVID-19 pandemic is a new challenge to the way the current intellectual property system operates: the time period from when a patent application is first filed in the country of origin, published at the international level through the PCT system, until it gets to national level might take up to 30 months from the priority date.

It said as some technologies were developed and got market authorization for COVID-19 in a short period of time, from the time while the international patent application was not published, there was a gap of information about the full picture of the patent landscape and whether a patent application would enter in the national phase in a country or not.

For example, the study said while remdesivir got the Emergency Use Authorization in the United States in May 2020 and later the approval in October of the same year, the publication of the first PCT application involving the method of treatment for SARS-CoV-2 was only nearly one year later, on October 2021.

“PCT applications covering all the aspects of the COVID-19 mRNA vaccines were only made public in 2021, while the vaccines were approved in some countries at the end of 2020,” it added.

As the present analysis shows, the number of patent applications increased after the pandemic period. Therefore, the full picture of the patent landscape not being entirely and timely public in a country may limit the space for and delay the use of TRIPS public health safeguards to promote access, said the study.

The study said that the third lesson from the COVID-19 pandemic is that expanding manufacturing capacity for regional supply is critical to prepare for future pandemics and there are several challenges in doing so, including IP barriers, such as patents and trade secrets.

The authors added that the increased patent filing related to vaccines adds a key layer of complexity and legal uncertainty for governments and manufacturers in low- and middle-income countries (LMIC) to pursue efforts of local production.

The MMA news release cited Othman Mellouk, Access to Diagnostics and Medicines Lead at ITPC, as saying: “This research aligns with the Make Medicines Affordable campaign, because it contributes to bringing transparency to one of abusive pharmaceutical patenting strategies, and works to address the complex issues that affect access, in order to translate science into concrete actions regarding patent barriers on health technologies.”

(The full study can be accessed at: https://www.frontiersin.org/articles/10.3389/fmed.2023.1287542/full)