Friday, March 28, 2014

Pharmaceutical patents - MDR-TB*

Copyright © Françoise Herrmann

* MDR-TB means Multiple-drug resistant tuberculosis. 


On March 24 2014, the world celebrated World TB Day, an international health campaign launched by WHO (the World Health Organization) designed both to raise awareness about tuberculosis, and to reach the estimated 3 million people worldwide who are infected each year, and left untreated [WHO (2)].


TB is second only to HIV as the greatest killer due to an infectious agent [WHO (1)]. Every year about 9 million people are infected, 1.8 million die, and only 6 million will get treatment. The highest incidence of new TB cases occurs in Asia and sub-Saharan Africa.


Tuberculosis is a deadly bacterial and highly infectious disease that spreads from person to person through air. It is primarily an infection of the lungs, but it can also infect other organs. TB is preventable, treatable and curable. The two most potent standard treatments for TB are isoniazid and rifampin [CDC].


Due to a combination of factors, including but not limited to: how long the same two standard drug treatments have existed; time-consuming and antiquated sputum smear microscopy testing; poor, interrupted or incomplete treatments, overcrowded prison systems, and very low socio-economic conditions, an MDR-TB (multiple drug resistant- TB) epidemic now exists in conjunction with non-resistant TB strains [PIP]. Resistance occurs when the disease no longer responds to either of the two standard treatments plus any fluoroquinolone treatments. The estimated number of persons suffering from MDR-TB in 2012 was 450,000 [WHO (2)]. And contrary to beliefs, TB is estimated to infect 1 million children each year, 30,000 of which are infected with MDR-TB [PIP].


Accordingly, and thanks to the dissemination and availability of such epidemiological data, patenting activity related to tuberculosis exists and includes: inventions for cost-effective; fast and alternative methods of diagnosis of both TB and MDR-TB; and inventions disclosing new formulations for the treatment of TB and MDR-TB, including child-friendly diagnostic tools and formulations, since children cannot be tested via the traditional (and century old) methods of  sputum smear microscopy when they are very small, and the injection treatment options are also not well tolerated.  


The following are examples of this patenting activity (excluding sample Russian, Ukrainian, China and Taiwan patents since only the titles and abstracts of these patents are translated):
US2013095489 - Process for detection of multidrug resistant tuberculosis using real-time PCR and high resolution melt analysis 
WO201313247 – Real tme PCR detection.of M.Tuberculosis, resistant/susceptible to rifampicin and/or isoniazid. 
WO2013180779 – Methods of using isoniazid for the diagnosis of lung infections 
WO2014014434 – Preparation for the treatment of tuberculosis 
US2013150415 – Rationally improved isoniazid and ethionamide derivatives 
WO2012103119 – Compositions of the administering rifalazil and other anti-tuberculosis agents in unit dosage form for oral administration 
WO 2012044140 - Anti-tuberculosis preparation in tablet form and process for preparing same
US2011207684 – New low side effect pharmaceutical composition containing isoniazid



The extent to which these patented discoveries are used to avert the spread of this hydra-headed epidemic and to reach their target populations -- in the most destitute areas of a globally connected world – is as much a question of public health policies as it is a political and economic issue of human rights and access to healthcare and health technologies.
 Thanks to the tireless efforts of dedicated organizations such as Partners in Health and Médecins sans frontiers / Doctors without borders, among many others, the prevention, treatment and ultimate eradication of TB, at the very least, continues to appear on the health technology agenda of pharmaceutical companies.



CDC -  Multi-drug resistant tuberculosis (MDR-TB)

PIP – Partners in Health

WHO (1) Tuberculosis – WHO Factsheet No. 104

WHO (2) World TB Day – Reach the 3 million

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