[Ip-health] Fwd: Pfizer gets process patents for Enbrel despite Mylan & Biocon opposition

Susan Isiko Strba susan.isiko.strba at bluewin.ch
Thu Nov 10 01:33:40 PST 2016

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.


With Best Regards
Dr. Gargi Chakrabarti
Associate Professor
Coordinator, IPR Chair
National Law University

More information about the Ip-health mailing list