Third World Network Information Service

TWN Info Service on Health and Intellectual Property Rights
3 October 2023
Third World Network


Health: Under pressure J&J announces non-enforcement of Bedaquiline patents in low and middle income countries

Geneva, 2 October (K M Gopakumar) – Pharmaceutical giant Johnson and Johnson (J&J) announced the non-enforcement of its “evergreening” patents on the tuberculosis (TB) medicine bedaquiline in 134 low- and middle- income countries.

The announcement came after mounting global pressure on the company against its practice of extending market monopoly using multiple patents even after the expiry of the original patent on the bedaquiline chemical molecule.

Bedaquiline is a designated essential medicine under the WHO’s Model List of Essential Medicines for the treatment of drug resistant TB. In 2020, the civil society mobilisation against  the high prices of bedaquiline forced  J&J to reduce the price to USD 1.50 per day. Similarly, in India TB survivors approached the Bombay High Court seeking a government use licence for the generic production of bedaquiline and delmanid for the enhancement of treatment access.

The first patent on the bedaquiline molecule expired in July 2023. However, the generic availability was threatened by evergreening patent applications pending in many countries including in high TB burden countries like South Africa. The announcement is now expected to pave the way for the generic availability in 134 low- and middle-income countries. However, the announcement of J&J does not provide any such list. A footnote in the announcement states: “The list of low- and middle-income countries is available upon request.”

[Evergreening is a term used to refer to the practice of obtaining multiple secondary patents on the same medicine (small changes or other parts such as polymers) to extend the statutory monopoly when the primary patent on the molecule has expired, for the purposes of preventing generic competition.]

The J&J announcement states: “The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of SIRTURO® without a concern that the Company will enforce its bedaquiline patents, provided the generic versions of SIRTURO® produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low- and middle-income countries”.

According to observers two important developments might be behind the decision of J&J. First, the rejection of an evergreening patent application on bedaquiline in India through a pre-grant opposition. Secondly, the initiation of the investigation on the high prices of J&J’s TB drug by the Competition Commission of South Africa.

In India, there were two pre-grant oppositions filed. First, by the Maharashtra Network of Positive People, a network of people living with HIV/AIDS in 2013 and the second by two TB Survivors, Nandita Venkatesan and Phumeza Tisile,  in 2019. The Patent Office concluded the process and announced its decision on 23rd March 2023. Since the original patent was expiring in July 2023 the rejection of the evergreening patents paved the way for generic entry of bedaquiline in India.

This rejection of patents in India triggered the demand for the dropping of such evergreening patents on bedaquiline globally to facilitate the access to drug resistant TB treatment. In a statement dated 18th  July, the day of expiry of the primary patent in India, MSF Access Campaign called “for the US pharmaceutical corporation to publicly announce it will not enforce any ‘secondary’ patents for the drug in any country with a high burden of TB and withdraw and abandon all pending secondary patent applications for this critical drug everywhere. MSF also called for a commitment from J&J to not take any legal action against any generic manufacturer that exports generic versions of bedaquiline to or from TB high-burden countries where secondary patents on the drug exist. The corporation should make this announcement public by the UN TB Summit taking place in New York this September (2023).”

According to the MSF statement, non-enforcement of evergreening patents would avoid 4 years of delay in the introduction of generic versions and benefit the majority of high burden countries. It states: “J&J holds secondary patents in at least 34 of the 49 countries with a high burden of TB, TB-HIV and/or DR-TB (drug resistant TB), for which bedaquiline is an essential part of treatment regimens. Several of these countries are in the EECA (Eastern Europe and Central Asia) region”.

The initiation of investigation by the South African competition authority came up amidst a report of the renewed contract with J&J for the procurement of bedaquiline at a high price of 5,500 rand while other countries procuring from the Stop TB Partnership’s Global Drug Facility pay only 2,444 rand. This investigation would have forced J&J to reveal much information to the competition authority. The J&J announcement is viewed as an attempt to pre-empt such an investigation.

(The Stop TB Partnership is a public-private initiative where J&J is a member.)

Prior to the non-enforcement announcement J&J announced a licensing deal with Stop TB Partnership. The announcement states: “to tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect”.

MSF’s statement date 18th July termed the deal as a partial solution. This is because “the Stop TB Partnership/Global Drug Facility (GDF) … deal with J&J to increase access to affordable generic versions of bedaquiline offers only a partial solution to the access problem, because the deal excludes many countries that have a high burden of people living with TB, primarily in EECA countries.

Ahead of the United Nations General Assembly High Level Meeting on TB that took place on 22nd September 2023, Stop TB Partnership announced the drop of the price of bedaquiline of up to 55% thereby bringing down the cost of the medicine for a 6-month course to USD 130.

While welcoming the price reduction the MSF Access Campaign reiterated their demand of non-enforcement of bedaquiline patents. In the statement “MSF calls on J&J not to enforce any ‘secondary’ patents for Bedaquiline in any country with a high burden of TB, and to withdraw and abandon all pending secondary patent applications for this critical drug everywhere”.

National TB Treatment programms of Belarus(11th July) and Ukraine (21st September) wrote to the CEO of J&J to commit to the non-enforcement of secondary patents on bedaquline.

On 23rd September in an open letter to J&J CEO, the Executive Director of Unitaid, Dr Philippe Duneton, demanded the following:  First, “remove all secondary patents or provide comprehensive licenses to generic manufacturers”, and secondly, “to make the lower GDF price available globally to all countries with a high burden of TB, including those currently excluded from the GDF agreement or not procuring through GDF” .

The Unitaid letter also stated that: “we express our disappointment that Johnson & Johnson, as the primary patentholder of bedaquiline for over 20 years, ignored the public health community’s calls to secure comprehensive and fair access to bedaquiline, acting only when generic competition became inevitable and even then, not going far enough. Today Johnson & Johnson continues to enforce secondary patents in many of the countries with the highest burden of DR-TB, hindering generic manufacturer competition and impeding broader access to this critical medicine. The recent lower J&J price for bedaquiline is accessible only for countries eligible or willing to procure through GDF and therefore represents a partial, short-term solution. Upcoming tenders and further competition from multiple generic manufacturers are expected to lead to lower prices in some countries in the near future, once again leaving countries where secondary patents remain in force with unequal access”.

MSF Access Campaign welcomed the J&J announcement of non-enforcement of secondary patents  on bedaquiline and hoped that “This decision means additional drugmakers will be allowed to make more affordable generic versions of the drug for people in low- and middle-income countries all over the world”.

Fatima Hassan, Director of Health Justice Initiative in South Africa stated: “The HJI welcomes the announcement by J&J which was in fact long overdue. This is an important day for TB activism and we remember all patients who suffered and died, enduring long treatment and side effects. We salute communities and civil society groups involved in this battle to ensure access to this drug for all patients, for more than a decade.

“However, we also look forward to the continuation of the investigation of the South African Competition Commission, as they will be reviewing the historical conduct of J&J related to this drug’s pricing and its patenting strategy (EVERGREENING) which also resulted in the denial or high price of bedaquiline affecting access for thousands of patients living with drug resistant TB.

“We now call on all pharmaceutical companies with secondary patents on TB drugs to follow J&J and drop their secondary patents now. We will continue our work to shine a spotlight on patent evergreening, it has no place in public health.”+

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