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The dispute emerged after Abbott filed a patent application for a formulation of human antibodies for treating TNFAlpha associated disorder, which was granted by the patent office on June 8, 2009. While Glenmark Pharmaceuticals filed a pre-grant opposition on September 4, 2008, it was not brought to the notice of the controller before the patent granted.
Later, in July 2009, when Glenmark pointed this out through a letter, and the then controller treated the patent letter as cancelled with immediate effect through a letter on October 30, 2009.
Abbott Pharma approached the Delhi High Court against the controllers order, on which the Court stayed the cancellation of the patent at first. In an order on September 9, 2010, the Court ordered that the pre grant opposition of Glenmark Pharma should be treated as the petition under section 77(f) of the Patents Act seeking review of decision of the Controller to grant patent to Abbott Pharma and set aside the previous order of cancellation of patent. The Court also observed that there will be no bar of limitation for entertaining for such review petition.
The Senior Joint Controller of Patents and Designs, K S Kardam, who reviewed the issuance of patent following the court order, observed, "....I firmly conclude that the impugned invention as disclosed in the specification and claimed in the claims is obvious to person skilled in the art and hence lacking in inventive step. I am also of the opinion that the description of the impugned invention is also insufficient and ambiguous as described in the specification."
"In view of the above circumstances and considering the order of the Honorable High Court of Delhi dated September 9, 2010, I hereby set aside the order of grant of patent dated June 8, 2009 in respect of patent application number No. 526/DELNP/2005 under section 77 of the Patents Act, 1970 and consequently the serial number of the patent No 234555 is hereby treated as void," added the order dated December 31, 2014.
In the pre-grant opposition filed by the opponents on 4th September, 2008, Glenmark argued that the patent sould not be granted on grounds including that it is not patentable under section 3(e) of the Act, lack of novelty, prior claiming, lack of inventive step which is not an invention or not patentable under the provisions of the Act, insufficient description and failure to disclose the foreign information required under section 8 of the Patents Act.
Abbott refuted all these grounds dealing with each of the objections and argued that its invention is patentable.
Humira, which has trade name adalimumab, is a TNF (tumor necrosis factor) inhibiting antiinflammatory drug, the first fully human monoclonal antibody drug approved by the US Food and Drug Administration, according to reports.
According to the financial results announced by AbbVie Inc, which is the research-based pharma company formed by Abbot Pharma, during the nine months ended September 30, 2014, the global sales of Humira was $9.18 billion, out of the total sales of $14.5 billion posted during the period for the company. Of this, around $4.6 billion of Humira sales comes from the US while the rest is from the international market, with an overall growth rate of over 20%.
