Janssen Biotech, Inc. ("Janssen") alleged that the Defendants Celltrion Healthcare Co. and Celltrion, Inc. (collectively, "Celltrion") and Hospira, Inc. ("Hospira"), infringed U.S. Patent No. 7,598,083 (the "'083 patent"), under the doctrine of equivalents, by producing a biosimilar infliximab drug (Remicade biosimilar). The '083 patent claims "a soluble composition, suitable for producing a final volume of cell culture media" with the following ingredients:
anhydrous CaCl2, 5-200 mg;
anhydrous MgCl2, 15-50 mg;
anhydrous MgSO4, 20-80 mg;
FeSO4.7H2O, 0.05-0.50 mg;
Fe(NO3)3.9H2O, 0.01-0.08 mg;
ZnSO4.7H2O, 0.40-1.20 mg;
ferric ammonium citrate, 0.04-200 mg;
KCl, 280-500 mg;
NaCl, 5000-7500 mg;
NaH2PO4.H2O, 30-100 mg;
Na2HPO4, 30-100 mg;
CuSO4.5H2O, 0.001-0.005 mg;
CoCl2.6H2O, 0.001-0.10 mg;
(NH4)6Mo7O24 4H2O, 0.001-0.005 mg;
MnSO4.H2O, 0.000070-0.0080 mg;
NiSO4.6H2O, 0.000025-0.0005 mg;
Na2SeO3, 0.004-0.07 mg;
Na2SiO3.9H2O, 0.02-0.4 mg;
SnCl2.2H2O, 0.000025-0.0005 mg;
NH4VO3, 0.0001-0.0025 mg;
D-Glucose, 500-8000 mg;
sodium pyruvate, 0.0-1000 mg;
sodium hypoxanthine, 0.0-20.0 mg;
glycine, 0.0-150 mg;
L-alanine, 0.0-150 mg;
L-arginine.HCl, 200-5000 mg;
L-asparagine.H2O, 40-250 mg;
L-aspartic acid, 20-1000 mg;
L-cysteine.HCl H2O, 25.0-250 mg;
L-cystine.2HCl, 15-150 mg;
L-glutamic acid, 0-1000 mg;
L-histidine.HCl.H2O, 100-500 mg;
L-isoleucine, 50-1000 mg;
L-leucine, 50-1000 mg;
L-lysine.HCl, 100-1000 mg;
L-methionine, 50-500 mg;
L-ornithine.HCl, 0-100 mg;
L-phenylalanine, 25-1000 mg;
L-proline, 0-1000 mg;
L-serine, 50-500 mg;
L-taurine, 0-1000 mg;
L-threonine, 50-600 mg;
L-tryptophan, 2-500 mg;
L-tyrosine.2Na.2H2O, 25-250 mg;
L-valine, 100-1000 mg;
d-biotin, 0.04-1.0 mg;
D-calcium pantothenate, 0.1-5.0 mg;
choline chloride, 1-100 mg;
folic acid, 1-10 mg;
i-Inositol, 10-1000 mg;
nicotinamide, 0.5-30 mg;
p-aminobenzoic acid, 0.1-20 mg;
riboflavin, 0.05-5.0 mg;
thiamine.HCl, 0.5-20 mg;
thymidine, 0-3.0 mg;
vitamin B12, 0.05-5.0 mg;
linoleic acid, 0.01-2.0 mg;
DL-α-lipoic acid, 0.03-1.0 mg;
pyridoxine.HCl, 0.5-30 mg;
putrescine.2HCl, 0.025-0.25 mg; and
ethanolamine.HCl, 2-100 mg.
The defendants moved for summary judgment of non-infringement on the grounds that Janssen's asserted scope of equivalents would ensnare the prior art. The ensnarement defense prevents the patentee from obtaining, under the doctrine of equivalents, coverage which he could not lawfully have obtained from the PTO by literal claims.
The court conducted a "hypothetical claim" analysis. The hypothetical claim analysis is a two-step process. First, the patentee must "construct a hypothetical claim that literally covers the accused device," which involves expanding the claim limitations to encompass the features of the
accused product. Second, "prior art introduced by the accused infringer is assessed to determine whether the patentee has carried its burden of persuading the court that the hypothetical claim is patentable over the prior art."
Celltrion did not assert that the hypothetical claims would have been anticipated, but only that they would have been obvious. In performing an obviousness analysis, the court refused to do a lead compound analysis: “The Federal Circuit's statement that ‘[a] lead compound analysis is not required in analyzing obviousness of a chemical compound when, in the inventing process, there was no lead compound’ does not mean that the lead compound analysis is required whenever evidence shows an inventor or POSA would begin development with a particular composition or product.”
The first prior art relied on by the defendants disclosed a medium with 50 of 52 ingredients required by the hypothetical claims, and for those 50 shared ingredients, the concentration ranges disclosed in the reference partially overlap with the concentration ranges in the hypothetical claims.
The two claimed ingredients missing from the first prior art reference that are required by the hypothetical media are ferric ammonium citrate ("FAC") and ammonium metavanadate. The five claimed ingredients missing from the second prior art reference were: FAC, ammonium metavanadate, manganese (II) sulfate monohydrate, sodium selenite, and tin(II) chloride dehydrate. With respect to the ingredients required by the hypothetical claims that are not disclosed in the references, it was undisputed that the media disclosed in these references contained alternative, previously-known ingredients that were known to provide the same active components as the claimed ingredients, For example, the first reference did not contain Ferric Ammonium Citrate, but had the alternatives ferric fructose and ferric citrate.
Furthermore, “For those 50 ingredients required in the hypothetical media that were previously disclosed in the first reference medium, all of the concentration ranges of the hypothetical claims overlap at least partially with the concentration ranges listed in the reference.”
Janssen argued that because the prior art discloses amounts of each ingredient that overlap only partially with the claimed concentration ranges, the non-overlapping portions constitute differences between the prior art and the hypothetical media that make the latter nonobvious. The court disagreed, stating that “the Federal Circuit has held in a series of cases that partially overlapping concentration ranges establish a prima facie case of obviousness.”
The court held that the "defendants are entitled to summary judgment of non-infringement of
the '083 patent because Janssen has not produced sufficient evidence to prove that the scope of equivalents would not ensnare the prior art."
1:17-cv-11008 Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al.
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