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Showing contexts for: maltodextrin in Vifor (International) Limited & Anr. vs Msn Laboratories Pvt Ltd & Anr. on 7 February, 2024Matching Fragments
9. The learned Judge had also observed that since iron carbohydrate complexes were already known, the invention forming part of IN'536 resided in the specified process alone. This is evident from the following observations as appearing in paragraph 71 of the impugned decision:
―71. As rightly contended by the Defendants, there is an admission by Vifor that use of iron carbohydrate complexes is known and a water-soluble iron (III) hydroxide sucrose complex is a frequently and successfully used preparation. It is stated that the problem to be solved by the present invention is to provide an iron preparation which is especially to be applied parenterally and can be easily sterilized as the known parenterally applicable preparations on the basis of sucrose and dextran were only stable at temperatures up to 100oC, which made sterilization difficult. It is categorically asseverated in the complete specification that present invention is a process for producing iron carbohydrate complexes wherein one or more ‗maltodextrins' are oxidized in an aqueous solution at an alkaline ‗pH' using ‗aqueous hypochlorite solution' and further [2014] EWHC 3857 (Pat) 970 F.2d 834 566 F.3d 1282 that when one maltodextrin is applied, the DE value is between 5 and 20 and when mixture of several maltodextrin is applied, the DE value of the mixture lies between 5 and 20 and the DE value of each individual maltodextrin contained in the mixture lies between 2 and 40. Given the admission of Vifor in the complete specification that iron carbohydrate complexes were already known, the only prima facie conclusion that this Court can reach is that the purported invention resides in preparing iron carbohydrate complexes with maltodextrin as the starting material and/or the step of oxidation using the specified oxidizing agent i.e. aqueous hypochlorite solution. In fact, what Vifor overlooks in making the submission that the process is inconsequential, is that the characteristic properties that it claims in FCM, distinguished from the prior art, are a direct result of the process used by Vifor, an admission that it makes during the prosecution of the patent application and is glaringly evident in the complete specification. Therefore, the scope of Claim 1 of IN'536 is limited to a product obtained through a specific process feature identified therein and cannot cover any and all processes that may be used by a third party to produce FCM and it is thus held that Claim 1 is a product-by-process claim and not a pure product claim."
18. In order to appreciate the submissions which were addressed in this respect, we also reproduce the claims as appearing on the record hereinbelow:
―WE CLAIM
1. Water soluble iron carbohydrate complexes obtainable from an aqueous solution of iron (111) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40, wherein the obtained iron complexes have an average molecular weight of 80 kDa to 400 kDa.
33. We were informed that the appellants had placed voluminous technical literature before the learned Single Judge and which had established that maltodextrins could have a DE value upto 96. It was submitted that Claim 1 of the suit patent itself had spoken of maltodextrins of upto a DE value of 40 being possible. It was in the aforesaid backdrop that Mr. Kaul contended that the learned Judge has clearly erred in proceeding on the premise that maltodextrins with a DE value range of 2-20 was an essential facet of the process of manufacturing FCM. The findings in this respect were additionally assailed on the basis of the U.S. Markman Hearing order in which maltodextrins were accepted as being unbound by a DE value limitation. The relevant extracts of the aforesaid order are reproduced hereinbelow:
Parent Patents Divisional Patents
IN 221536 EP 1554315 US7612109 EP227820 US201403711 US20160215071
Water soluble Water soluble A water Water An iron An iron
iron iron soluble iron soluble Carboxypolym Carboxypolymaltose
carbohydrate carbohydrate carbohydrate iron(III)- altose complex complex of formula:
complexes complex complex carbohydr of formula:
obtainable having a having a ate
from an weight weight complexes
[FeOx(OH)y(H2O)x
aqueous average average on the
[Fe0x(OH)y(H ]n[
solution of iron molecular molecular basis of
20)zin[{c
III salt and an weight (Mw) weight (Mw) the
6H1005).(c6H {C6H10O5)(C6H12
aqueous of 80 kDa to of 80,000 to oxidation
1207) } ilk O
solution of the 400 kDa 400,000, products
wherein the
oxidation obtainable comprising of 7)}]Ik
values for
product of one from an the reaction maltodexti
USPTO
or more aqueous product of: ns, variables x, y, Wherein the values
maltrodextrins solution of wherein z, n, m, 1 and k for variables x, y, z,
using an iron (III) salts (a) an the iron are such that n, m, 1 and k are
aqueous and an aqueous (III) said iron such that said iron
hypochlorite aqueous solution of an carbohydr carboxypolym
solution at a solution of iron (III) salt ate altose Carboxypolymaltose
pH-value the oxidation and complexes complex has complex has an
within the product of have a an averageaverage molecular
(b) an weight in the range
alkaline range one or more weight molecular
aqueous of from 80 kDa to
where when maltodextrins average weight in the
solution of about 400 kDa and
one using an molecular range of from
the oxidation an iron content in the
maltodextrin is aqueous weight about
product of range of from about
applied its hypochlorite Mw of 80
dextrose solution at a KDa to 80 kDa to 24 to about 32% by
(i) at least
equivalent lies pH-value 400 kDa. about 400 kDa weight.
one
between 5 and within the and an iron
maltodextrin
20 and when a alkaline content in the
and
mixture of range, where, range of from
several when one (ii) an about 24 to
maltodextrins maltodextrin aqueous about 32%
is applied the is applied, its hypochlorite
by weight.
mixture lies dextrose solution at an
between 5 and equivalent alkaline pH,
20 and the lies between wherein,
dextrose 5 and 20, and when one
equivalent of when a maltodextrin
each individual mixture of is present, the
maltodextrin several maltodextrin
contained in maltodextrins has a
the mixture is applied, the dextrose
lies between 2 dextrose equivalent of
and 40 wherein equivalent of between 5
the obtained the mixture and 20, and
iron complexes lies between wherein,
have an 5 and 20 and
average the dextrose When a
molecular equivalent of mixture of
weight of 80 each more than
kDa to 400 individual one
kDa. maltodextrin maltodextrin
contained in is present, the
the mixture dextrose
lies between equivalent of
2 and 40. each
individual
maltodextrin
is between 2
and 40, and
the dextrose
equivalent of
the mixture is
between 5
and 20.