On 10 December, Schering Corporation’s (now Merck) patent on an asthma inhaler has been revoked.
In 2004, Schering Corporation filed an application (402/CHENP/2004) in India claiming a product patent on an aerosol suspension formulation containing two active drugs mometasone furoate and formoterol fumarate. These drugs are used to treat respiratory disorders such as asthma. In most cases doctors usually prescribe Aerosols/ inhalers containing these drugs to patients who have COPD/asthma.
The grant of the patent was published in the Patent Office Journal on 4th March 2011 (IN 246328). Cipla, an Indian generic company that produces COPD/asthma medicines particularly inhalers, filed a post grant opposition under Section 25(2) of the Indian Patent Act. As a result, the patent has been revoked (10/12/2012) on the ground that the combination therapy of mometasone furoate and formoterol fumarate in a pharmaceutical composition is known. The decision also states that there is no inventive step in the selection of non-CFCs for the preparation of the aerosol suspension formulation. There is no inventive concept on selecting HFA 227 and/or HFA 134a from known non-CFCs. The elimination of CFCs from the process of preparing the aerosol suspension formulation of two pharmaceutically active ingredients i.e. mometasone furoate and formoterol fumarate lacks inventive step.
The decision is available on the India Patent office site and can be accessed here . This decision also provides quite a lot of information on the kind of secondary patents (GB, US, PCT) that companies like Novartis, Astrazeneca, Glaxo have been filing on combinations of COPD/asthma drugs and their different compositions and formulations in inhalers(aerosols).
Don't trade our lives away 