[A big thanks to Swaraj for his inputs on the post.]
The Indian Patent Office (IPO) is set to hear objections against Gilead Sciences’ patent claims for Lenacapavir, an HIV drug. This situation highlights the ongoing struggle between patent protections and access to essential medicines. Pre-grant oppositions (PGOs) are crucial in India’s patent system, allowing challenges to patents before they’re granted. The outcome could significantly affect the availability of affordable HIV treatments, emphasising the need to balance innovation with public health. This is a critical moment for ensuring that access to life-saving medications is prioritised over corporate profits, and this post intends to do the same.
The History of Lenacapavir and The Tale of Generic HIV Drugs in India
Lenacapavir is a more recent advancement in HIV treatment, approved by the U.S. FDA in December 2022 and holds promise not only for treatment but also for prevention through its twice-yearly injections. It is a prescription drug for treating HIV in adults, available in tablet and injectable forms, and is used in combination with other HIV medicines, currently licensed for treatment, not prevention, due to its high prices. However, clinical trials in South Africa and Uganda have shown it can protect young women entirely from HIV, offering a beacon of hope in the prevention of AIDS. Moreover, moving from daily Truvada to just two injections a year with Lenacapavir makes treatment much simpler for patients (shown in Gilead’s research and claims here and here). This shift really helps with adherence and makes managing their health a lot easier.
For decades, HIV infections have remained a pressing global issue, with 1.3 million new cases annually—one every 24 seconds. Low- and middle-income countries (LMICs) bear the brunt, accounting for 95% of these infections. In this context, affordable generic HIV medicines are lifelines, especially in India, which plays a crucial role in producing them. India is a major producer of generic antiretroviral (ARV) drugs for HIV/AIDS, including Tenvir, Viraday, Isentress, Biktarvy, Trustiva, Teevir, Vonavir, and Triumeq tablets.
However, when it comes to Lenacapavir, Gilead Sciences’ pricing strategy poses some significant questions. Media reports provide that in high-income countries (HICs), the annual cost is a staggering $42,250, while it is reported that Indian manufacturers could produce it for just $100 per person per year. The looming threat is the pending patent applications by Gilead in India. If granted, the PGO filers believe that it could potentially block generic production of this life-saving drug, if they do not otherwise decide to license the manufacturing. The decisions of the IPO will ultimately determine whether a very promising step towards ending AIDS can become a reality or remain an elusive goal for millions.
A Look at the Pre-Grant Oppositions
Gilead has multiple patent applications for Lenacapavir in India, including those seeking patents on its choline and sodium salts. Below is a table summarising the major patent application statuses for Lenacapavir by Gilead Sciences Inc. and the oppositions raised against these applications.
Sankalp Rehabilitation Trust is the main entity placing these PGOs. In their media interviews, they indicated that their main intention for these PGOs is that granting these patents, which would last until August 2038, could hinder access to affordable generic versions of Lenacapavir, and lead to “evergreening.”. However, without conducting a Section 3(d) analysis, it is difficult to comment on that reasoning as of now. The second reason they mention is that the Indian Patents Act does not grant monopolies on old science, like salt forms of Lenacapavir, that do not contribute significantly to the technological pool. Such monopolies can limit the entry of generic manufacturers and impede access to affordable medicines from India. Moreover, it is not like the First Examination Reports (FERs) of these applications released by the IPO don’t call out exactly these issues with the patent applications. The FERs for all five applications detail issues on the accounts of novelty, inventiveness, non-patentability and sufficiency of disclosure as raised in the GPOs.
Side note: A special shoutout to the Patents Opposition Database— a database of all the oppositions, including those made against the Lenacapavir patent (here). Interestingly, all oppositions against Lenacapavir have been made in LMICs (Argentina, India, South Africa, Thailand, and Vietnam).
People Over Patents for the IPO?
At the 25th International AIDS Conference in Munich, experts revealed a concerning truth about Lenacapavir, a potential breakthrough in HIV prevention. They estimated that a generic version could be produced for as little as $40 a year, assuming a user base of 10 million people. Yet, Gilead, the company behind the drug, claims it’s too early to set a price, citing the need for more clinical trial data. Seems like the future of HIV eradication largely hinges on the pharmaceutical giant’s decision to issue voluntary licences (VLs), and if so, then the specific terms of those VLs.
For instance, in 2011, Médecins Sans Frontières (MSF) reported that Gilead’s agreement to license several HIV/AIDS drugs to the Medicines Patent Pool could improve patient access to medicines, but notably excluded Brazil, China, and Russia, which have large populations living with HIV. This pattern continued with Gilead’s secret voluntary license for remdesivir during the COVID-19 pandemic, which also excluded Brazil and many South American countries, as well as China and Russia. MSF’s research (pdf) shows other examples of licensing exclusions, like:
- AbbVie’s 2019 MPP license for glecaprevir/pibrentasvir
- Gilead’s 2015 license for hepatitis C medicines
- AbbVie’s 2014 MPP license for lopinavir/ritonavir and ritonavir
- ViiV’s 2016 MPP license for dolutegravir
Inclusive licensing terms are crucial for all countries, especially as the WHO aims to eliminate HIV by 2030. To realistically achieve this goal, it’s vital that VLs facilitate access to effective treatments across diverse jurisdictions, especially LMICs.
This situation echoes India’s long-standing battle against pharmaceutical giants. Back in 1991, Yusuf Hamied, a key figure in Indian pharma, challenged the high prices of AIDS drugs like AZT, which cost around $10-15,000 annually in the U.S. He successfully brought that price down to just $1 a day by manufacturing generics. Now, public health groups in countries like Argentina, Thailand, and Vietnam are filing patent challenges against Gilead’s Lenacapavir as part of the “Make Medicines Affordable” campaign.
Indian manufacturers are reportedly ready to produce Lenacapavir generics, having developed the necessary active pharmaceutical ingredient. However, if Gilead’s patents are granted, access to affordable versions could be severely restricted, affecting countless lives. The IPO has a history of prioritising public health, as seen when it rejected a patent (pdf) for the salt form of Bedaquiline, an essential drug for drug-resistant tuberculosis, in 2023.
The PGO system in Indian patent law allows anyone to contest a patent before it’s granted, ensuring that only genuine innovations make it through. This process has been crucial in preventing unwarranted patents and fostering competition for affordable medicines. As noted by Priyam Cherian and Roshan John here, instances like these remind us how important the Pre Grant Opposition system is. They further highlighted how after the rejection of the patent for Bedaquiline, reports indicate that at least two Indian manufacturers were set to release generic versions as the primary patent expires in July 2023.
By taking a stance similar to Bedaquiline with Lenacapavir, India could safeguard access to affordable HIV treatments, ensuring that millions aren’t held hostage to corporate profit motives. The ongoing fight against pharmaceutical monopolies is essential for advancing public health, and the combined efforts of activists, manufacturers, and the IPO will play a critical role in shaping a fairer landscape for essential medicines.
A quick side note: The IPO website was pretty spotty at the end of September/beginning of October. It took me two days of trying and a couple of requests to others before I could access the patent application documents! It’s definitely inconvenient when resources as essential as these become difficult to access, especially when you need them quickly!