[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
Coordinator, IPR Chair
National Law University
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