The Rejection of the Bedaquiline Patent Opposition in Indonesia Raises the Risk of Difficulty in Accessing Optimal TB Therapy

The Indonesia AIDS Coalition (IAC) and Indonesia for Global Justice (IGJ) have filed a patent opposition for the Tuberculosis (TB) drug Bedaquiline with dispersible tablet formulations (hereinafter, in the context of this article, will be referred to as ‘Bedaquiline’). The patent opposition was filed to the Patent Appeal Commission, Directorate General of Intellectual Property (DGIP), Ministry of Law and Human Rights. The patent opposition was submitted in November 2022 and was rejected by a decision from the Judiciary Panel on November 9th, 2023.

IAC and IGJ, acting as the Claimants, went against Johnson & Johnson through their subsidiary Janssen, which had registered a patent for the TB drug in Indonesia. The Claimants are of the opinion that the registered patent is a secondary patent, or mere extension, and is not eligible for obtaining patent rights due to the lack of inventive steps.

IGJ’s Executive Director, Rahmat Maulana Sidik, said that this is the first time a Civil Society Organization (CSO) has filed a patent opposition, which must be brought to the attention of all relevant parties.

“We filed this patent opposition because it clearly does not meet the requirements for the granting of a patent and is only an attempt for patent extension. This is the first time that a CSO has filed a patent opposition, which hopefully will serve as a catalyst for further advocacy efforts.”

The Claimant’s attorney, Ranggalawe Suryasaladin, affirmed that the basis for IAC and IGJ’s patent opposition is the lack of inventive steps.

“In the patent opposition process, the evidence and witnesses that we have presented quite clearly show that the patent application for this drug does not contain inventive steps. This indicates that the basis for patent application, particularly in regard to the methods used to create the drug, is well-known or commonly done by researchers or subject-matter experts (persons skilled in the arts). Therefore, this is something that is clear or obvious, so it does not fulfill inventive steps as a requirement for obtaining a patent.”

The patent on Bedaquiline was supposed to expire in 2027 but was extended until 2036. Responding to this matter, IAC’s Executive Director, Aditya Wardhana, commented that so far, patents have been a real obstacle to the production of generic versions of essential medicines.

“Patent extensions hinder the production of generic drugs and raise their prices. The price of the patented version of Bedaquiline is set at USD 3,000 per patient per six months for developed countries and USD 900 per patient per six months for developing countries, meaning that even in developing countries, around USD 150 per patient is needed for one month of treatment. On the other hand, according to a study presented at the European AIDS Conference, based on estimated costs of active ingredients, excipients, formulation, packaging, and a reasonable profit margin, the actual price of Bedaquiline is approximately USD 8.8–16.4 per patient per month. Thus, it is obvious that Janssen’s price is significantly higher than the original price. Bedaquiline is an essential medicine for treating TB, which has reached more than 900,000 cases in Indonesia. We hope for no further extension of the patent protection period amidst this crisis. We, as civil society, encourage the Judiciary Panel to also consider the relationship between patents and public health interests, especially in relation to access to essential medicines, when making their decision,” added Aditya Wardhana.

This understanding became the basis for the Claimant’s conclusion in the patent opposition process for Bedaquiline, in which several points were conveyed. First, the Claimant is an interested third party because, referring to the relevant law, namely Law 20/2016 concerning Marks and Geographical Indications, interested parties include foundations, religious institutions, etc.; thus, interpretation can be made broadly and not only limited to owners of Intellectual Property Rights (IPR). As parties that fight for the public interest, CSOs are interested parties for filing patent oppositions and possess legal standing.

Second, the Claimant rejected the Defendant’s objection, which stated that the Claimant did not possess legal standing. Third, the Bedaquiline patent application does not contain inventive steps, so it is not eligible to obtain a patent based on Law 13/2016 concerning Patents. This is proven by prior arts documents that prove the obviousness of the use of excipients to quickly dissolve drugs. In other words, the steps for creating dispersible tablets are already known. Finally, Bedaquline’s patent application, which covers a new use of a known substance without any increase in efficacy, cannot be considered an invention and is merely a routine optimization.

The Judiciary Panel’s decision to reject the Bedaquiline patent opposition on the basis of IAC and IGJ’s legal standing as the Claimant is a blow to our advocacy efforts. Especially considering that Indonesia ranks second in the world for total TB cases in 2023, with a total of 969,000 cases and a death toll of 93,000 per year, or 11 persons per hour. Not to mention the number of cases of Multidrug-Resistant (MDR) TB, which is estimated to reach 28,000 of the total number

of cases, in which Bedaquiline is part of the first-line treatment regimen. On the other hand, referring to the attached document on the Bedaquiline National Public Procurement Agency page, the net pharmacy sales price per box is approximately USD 478.26 for 188 tablets. Or around USD 2.58 per tablet. This price is quite steep considering that data from Statistics Indonesia found that the average employee salary in Indonesia in 2023 is USD 202.77 per month, with a much lower rate for self-employed and casual workers.

In fact, Johnson & Johnson has committed to not enforcing the Bedaquiline patent status for the treatment of MDR TB in 134 low-and middle-income countries, including Indonesia. Therefore, the Judiciary Panel’s decision is disheartening, and as a community-based organization

that contributes to efforts to increase transparency, accountability, and community participation in national health programs in Indonesia, IAC is committed to continuing the fight for affordable access to essential medicines. Not only for HIV-AIDS, but also for TB, Hepatitis C, and various other diseases. This patent opposition is the first step, and IAC’s advocacy efforts will continue.

Copyright: Indonesia AIDS Coalition (IAC) and Indonesia for Global Justice (IGJ)