There has been a steady increase in disputes between Indian drug companies and the multinationals over the grant of patents in the country ever since the Indian Patent Act was amended in 2005. With this amendment, the grant of product patent was allowed by the government for the pharmaceutical products in the country after a gap of 35 years. The decision saw a rush of patent applications for various pharmaceutical products from most of the global pharmaceutical companies. As many of these applications were not for new molecules and were actually for modified versions of already marketed chemical entities, patent disputes amongst the companies grew much faster. Thus several patent dispute cases are already going in patent offices and in different courts in the country. The most recent case is the one between Abbott Biotechnology and the leading Indian company, Glenmark Pharmaceutical. The patent office, in its ruling early this month, has set aside its own order that granted a patent to Abbott’s Humira on a review petition by Glenmark. In fact, the patent office was directed by Delhi High Court to review its own decision of granting patent to Abbott while disposing of an appeal from Glenmark. The Indian company had alleged that its pre-grant opposition, filed in September 2008, was not considered by the controller of patents while granting the patent to Abbott in 2009. The patent office in its recent order stated that product is lacking in inventive step, the description of the invention is also insufficient and ambiguous and therefore granting of patent to Abbott stands withdrawn.
In the historic judgement of Supreme Court in April 2013, patent granted to Novartis by the patent office for its cancer drug, Glivec, was set aside on the ground that there was no new invention and no new substance used in the drug. The company fought a six-year battle for retaining its Glivec patent issued by the patent controller. In March 2012, the Patent Controller granted the first compulsory license to Natco for the Bayer's patented cancer drug, Nexaver, as it was highly priced and not easily accessible to patients. Bayer obtained the patent for the drug in March 2008. Bayer challenged the Patent Controller's decision to grant CL to Natco in IPAB. The appeal was rejected by IPAB on grounds that Bayer has not taken any steps in revising the marketing strategy and not cut the price of the product in three years. The Bayer has now approached the Madras High Court challenging IPAB's rejection. The Madras High Court may take several months if not years to decide on the case. There are no indications that patent disputes in India will subside in the coming years as many of the patents sought by the MNCs are not actually for new compounds. It is quite unfortunate that patents are being granted either because of oversight or on account of lack of proper scrutiny of undeserving cases. That calls for building up of a strong and efficient team of patent examiners in all patent offices to eliminate these avoidable litigations.