US pharmaceutical giant Pfizer has received a shot in the arm with the company securing two Indian process patents related to its blockbuster drug Etanercept, marketed under the brand name Enbrel in countries like the US. Pfizer got the grant of patents, after successfully getting past the pre-grant oppositions filed by drug companies Mylan and Biocon. Enbrel is used to treat autoimmune diseases including rheumatic arthritis.
Pfizer Ireland Pharmaceuticals, part of Pfizer, had in 2007 filed two separate applications related to patent for Enbrel, one titled ‘Production of Polypeptides’ and another for the production of Tnfr-Ig Fusion Protein. According to sources close to Pfizer, the applications were for the process patents for Enbrel and were subsequently opposed by Mylan and Biocon.
After hearing the arguments of opposing pharma companies, Nilanjana Mukherjee, assistant controller of patents and designs, Delhi, dismissed the contentions put forth by both companies and granted the patents. Mylan had mainly sought the patent authority to refuse the application based on grounds including lack of novelty and obviousness.
Biocon argued that the ‘claimed inventions’ were non-patentable and there was lack of sufficient disclosure. Biocon charged that Pfizer was trying for effecting double patenting as an attempt to secure multiple patents relating to same invention. However, in detailed separate orders for each pre-grant opposition, the assistant controller dismissed all the objections raised by Mylan and Biocon.
On the issue of double patenting, the patent office said the scope covered by both patent applications were different. The inventions claimed in both the applications were patentably distinct and do not involve any issue of ever greening or double patenting. Pfizer has a co-marketing tie-up with Amgen to sell Enbrel, used for the treatment of rheumatoid arthritis, psoriatic arthritis and plaque psoriasis, in the US and Canada.
Enbrel is a soluble form of a tumor necrosis factor receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience. The drug was first approved in 1998 for moderate-to-severe rheumatoid arthritis, in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis and in 2002 to treat psoriatic arthritis.
Subsequently in 2003, it was approved for the treatment of patients with ankylosing spondylitis, and in 2004 to treat moderate-to-severe plaque psoriasis in adults.
Recently, Amgen announced that the US Food and Drug Administration (FDA) has approved the supplemental biologics licence application for the expanded use of Enbrel (Etanercept), making it the first and only systemic therapy to treat pediatric patients between the age of 4 and 17 with chronic moderate-to-severe plaque psoriasis.