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ETANERCEPT APPLICATIONS GRANTED BY THE
IPO undesirable factors and/or lactate.
In a significant victory for the drug major Pfizer, The main culture conditions according to claim 1
Inc. the Delhi Patent Office allowed two of its are:
applications (2315/DELNP/2007 (IN 2315) (a) The following media characteristics:
and 2317/DELNP/2007 (IN 2317)) covering their
commercial method for production of Etanercept. (i) cumulative amino acid amount per unit
Each of the applications were opposed in pre- volume of greater than 70mM;
grant oppositions filed by Biocon Ltd. and Mylan
Laboratories Ltd. (ii) molar cumulative glutamine to
cumulative asparagine ratio of less than
The first application, i.e., Indian patent application 2;
no. 2315/DELNP/2007 is directed to the production
of polypeptides, in a large-scale production cell (iii) a molar cumulative glutamine to
culture comprising the steps of: cumulative total amino acid ratio of less
than 0.2;
providing a cell culture comprising; mammalian cells that
contain a gene encoding a polypeptide of interest, which (iv) a molar cumulative inorganic ion to
gene is expressed under condition of cell culture; and cumulative total amino acid ratio
a medium containing glutamine, having a cumulative between 0.4 to 1;
amino acid amount per unit volume greater than 70 mM,
a molar cumulative glutamine to cumulative asparagine (v) a combined cumulative amount of
ratio of less than 2, and wherein the cumulative total glutamine and asparagine per unit
amount of histidine, isoleucine, leucine, methionine, volume of greater than 16 mM or a
phenylalanine, tryptophan, tyrosine, and proline per unit combination thereof; and
volume in said medium is greater than 25 mM;
maintaining said culture in an initial growth phase (b) maintaining the cell culture in an initial growth
under a first set of culture conditions for a first period phase for a first period of time to allow the cells
of time sufficient to allow said cells to reproduce to a to reproduce to a viable cell density between
viable cell density within a range of 20%-80% of the about 20% to 80% of the maximal possible
maximal possible viable cell density if said culture were viable cell density under the first set of culture
maintained under the first set of culture conditions; conditions; shifting at least at least one of the
changing at least one of the culture conditions, so that a culture conditions to a second set of culture
second set of culture conditions is applied; conditions and maintaining the said culture
maintaining said culture for a second period of time for a period of time under the second set of
under the second set of conditions and for a second conditions so that the polypeptide accumulates
period of time so that the polypeptide accumulates in in the said culture.
the cell culture.
Some of the key findings of the order of the
The second application, allowed by the Controller. Controller are as follows:-
i.e., Indian patent application no. 2317/DELNP/2007, 1. Novelty: There is neither an unambiguous,
relates to an improved process for large scale
production of TNFR-Ig that allows high level of clear and direct disclosure of the claims nor
protein production and lessens the accumulation of are all the features claimed present in the same
order in any prior art document. Therefore,
the claims cannot be held to lack novelty.
2. Inventive step: The Controller considered the
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