Bedaquiline

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    In News

    • Recently, the Indian Patent Office rejected Johnson & Johnson’s attempt to extend its monopoly on manufacturing Bedaquiline  in India.

    About

    • Bedaquiline is an oral  medication used to treat active tuberculosis. it is particularly used to treat multi-drug-resistant tuberculosis (MDR-TB) 
    • It has a unique mechanism of action, targeting the adenosine triphosphate (ATP) synthase enzyme of the TB mycobacteria.

    J&J Patent

    • Bedaquiline is central to WHO ­recommended TB treatment regimens for which Johnson and Johnson holds patent .
    •  J&J  filed with the Indian patent office for evergreening of its patent on fumarate salt (a formulation salt of Bedaquiline), This  was challenged by TB survivors Nandita Venkatesan and Phumeza Tisile.
    • Evergreening is a strategy to extend the life of patents about to expire in order to retain revenues from them  by making multiple claims in its applications for patent extensions.
    • Indian Patent Office has rejected Johnson & Johnson’s attempt to extend its monopoly stating that the invention claimed was obvious and does not involve any inventive step, and is therefore non-patentable under Section 3(d) of the Patents Act.

    India’s Patent Office

    • The Patents Act, 1970 is the legislation that  governs patents in India. It first came into force in 1972.
    • The Patents Act has been  amended in 1999, 2002, 2005, 2006 respectively. The Patent Act was amended  in 2005 to include product patents were extended to all fields of technology like food, drugs, chemicals and microorganisms. The Rules under Patent Act were also amended in 2012, 2013, 2014.
    • The Office of the Controller General of Patents, Designs and Trade Marks or CGPDTM is the body responsible for the Indian Patent Act.
    • The Patent Office has its headquarters in Calcutta and has branches in New Delhi, Chennai and Mumbai.
    • The Controller General supervises the Act’s administration and also offers advice to the government on related matters.

    Challenges of the Indian Patent Regime: 

    • Complex system : Indian patent Regime is burdened with long waiting times for patents,unclear instructions regarding what can be patented reporting requirements, and data safety..
    • Compatibility: One of the main points of contention between India and the U.S. has been Article 3(d) of the Indian Patent Act.
      • Section 3 deals with what does not qualify as an invention under the Act.
      • Section 3(d) in particular excludes the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.
      • Section 3(d) prevents what is known as “evergreening” of patents.  
    • Judicial delays: The 2015 Commercial Courts Act offered an opportunity to reduce  delays and increase expertise but only a limited number of courts have benefited under the Act.
      • Jurisdictional challenges are reducing the courts’ effectiveness and courts are also suffering due to inadequate resources and training. 
    • Intellectual Property Appellate Board (IPAB): the overall scrapping of IPAB, which efficiently had been dealing with proceedings involving complex IPR issues, may create a void in the appellate resolution of cases leading to their shift to Commercial or High Courts thereby increasing pendency of cases.

    Way forward/ Suggestions:

    • A world compatible IP regime is necessary for innovation.India can utilise The Doha Declaration on the TRIPS Agreement and Public Health to ensure that India does not sacrifice   public utility for compatibility.

    MultiDrug Resistant TB

    • Mycobacterium tuberculosis,the bacteria that cause tuberculosis (TB) can develop resistance to the antimicrobial drugs used to cure the disease. 
    • Multidrug-resistant TB (MDR-TB) is TB that does not respond to at least isoniazid  and rifampicin, the 2 most powerful anti-TB drugs. 
    • Most people with TB are cured by a strictly followed, 6-month drug regimen that is provided to patients with support and supervision.
    •  Inappropriate or incorrect use of antimicrobial drugs, or use of ineffective formulations of drugs (such as use of single drugs, poor quality medicines or bad storage conditions), and premature treatment interruption can cause drug resistance, which can then be transmitted, especially in crowded settings such as prisons and hospitals. 
    • Extensively drug-resistant TB, XDR-TB, is a rare type of multidrug-resistant tuberculosis (MDR TB) that is resistant to isoniazid and rifampin, plus any fluoroquinolone and at least one of three injectable second-line drugs (i.e., amikacin, kanamycin, or capreomycin). It has been reported in 1117 countries worldwide. 

    Source:TH