BASF Pharma (Callanish) Limited develops and manufactures concentrated omega-3 fatty acids. The Company manufactures fatty acids in concentrated liquid and powder form for the pharmaceutical industry for use as active ingredients in licensed products and for investigational products.
In India, the Pharmaceutical business of BASF Pharma (Callanish) Limited is focused on Multi-step separation process, Multi-step separation process, Simulated moving bed chromatographic separation process, SMB process for producing highly pure EPA from fish oil.
BASF Pharma (Callanish) Limited filed patent application numbered 5690/DELNP/2015 that is titled MULTI -STEP SEPARATION PROCESS. This Patent Application has been granted as as Patent number 317312.
The invention covers Chemical compound. The present invention provides a chromatographic separation process for recovering a polyunsaturated fatty acid (PUFA) product from a feed mixture, which comprises: purifying the feed mixture in a first chromatographic separation step using as eluent a mixture of water and a first organic solvent, to obtain an intermediate product; and purifying the intermediate product in a second chromatographic separation step using as eluent a mixture of water and a second organic solvent, to obtain the PUFA product, wherein the second organic solvent is different from the first organic solvent and has a polarity index which differs from the polarity index of the first organic solvent by between 0.1 and 2.0, wherein the PUFA product is other than alpha-linolenic acid (ALA), gamma-linolenic acid (GLA), linoleic acid, an ALA mono- di- or triglyceride, a GLA mono- di- or triglyceride, a linoleic acid mono, di- or triglyceride, an ALA C1 -C4 alkyl ester, a GLA C1 -C4 alkyl ester or a linoleic acid C1 -C4 or a mixture thereof.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that Claims 1 to 19 fall u/s 3(d) of the Patents (Amended) Act, 2005 as the said claims defines the mere use of a known process.
As a response to the said objection, the applicant submitted that the process claimed in the present invention is not known. In particular, none of the prior art teaches a two-step chromatographic separation process for recovering a (non-C18) PUFA product, wherein each step utilises an aqueous organic solvent, but the organic solvent used in the second step has a polarity index which differs from that of the organic solvent used in the first step by between 0.1 and 2.0.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
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