D.P.S.PARMAR,TECHNICAL MEMBER - (1.) THIS appeal is made against the order of the Deputy Controller of Patents dated 13th August 2009 refusing the application No. 1563/DEL/2005 dated 16th June 2005 filed by Green Cross Holdings, a Korean Corporation, for the invention relating to Pharmaceutical preparation of recombinant factor VIII lyophilized without Albumin as a stabilizer'.
(2.) THE matter came up for hearing on 20/05/2014. We heard the arguments of learned counsel for the appellants Ms. Anuradha Salhotra. No one appeared for the Respondents. Facts of the case
(3.) IN the hearing notice, following objections were communicated by Respondent 2 : - "1. Claim -1 do not sufficiently define the invention with respect to the term pharmaceutical preparation as the claim defines constituents of stabilizer before lyophilisation rather than pharmaceutical preparation. 2. Claims 1 -9 fall within the scope of such clause (d) and (e) of section 3. 3. Subject matter of claims lack inventive step in view of cited documents (i) WO9910011 (ii) US5407671 (iii) US 4297344 and (iv) WO9322336." During the prosecution of the case, the appellants have restricted their claims to six claims. The finally amended claim 1 reads as under: - "A pharmaceutical preparation of recombinant factor VIII lyophilized with a stabilizer comprising arginine having a concentration of 6 to 100 mM, isoleucine having a concentration of 3.5 to 50mM and glutamic acid having a concentration of 10 to 100 mM, the stabilizer stabilizing the recombinant factor VIII, which is used as a therapeutic preparation of hemophilia." ;