Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc.

United States District Court, D. New Jersey

October 2, 2019

Bracco Diagnostics, Inc., Plaintiff,
v.
Maia Pharmaceuticals, Inc., et al., Defendants.

          MEMORANDUM AND ORDER

          PETER G. SHERIDAN, U.S.D.J.

         This matter comes before the Court on joint claim construction submitted by Plaintiff Bracco Diagnostics, Inc. ("Bracco") and Defendant Maia Pharmaceuticals, Inc. ("Maia") concerning United States Patent No. 6, 803, 046 (the "'046 Patent"). The '046 Patent is listed to market and sell the drug Kinevac® which is an injectable solution used for treating, preventing, and diagnosing gall bladder-related disorders. The parties dispute the meaning of three terms in the patent: (1) buffer; (2) surfactant/solubilizer; and (3) surfactant.

         Background

         Kinevac was originally introduced in 1976 as a lyophilized white powder for parenteral (by injection) administration. The active ingredient in Kinevac is sincalide, a peptide molecule composed of eight amino acids bound together. ('046 Patent at 1:9-16). The patent also claims five other ingredients: at least one stabilizer, a surfactant/solubilizer, a chelator, a bulking agent/tonicity adjuster, and a buffer. (Id. at 37:41-49).

         Kinevac currently has three uses approved by the FDA: (1) to stimulate gallbladder contraction; (2) to stimulate pancreatic secretion; and (3) to accelerate the transit of a barium meal through the small bowel. (See Declaration of Donald L. Rhoads ("Rhoads Decl."), Ex. 63, Labeling for Kinevac). Kinevac is a synthetic analog of a hormone produced by the human body known as CCK-8 (cholecystokinin). "CCK-8 acts on receptors within the gallbladder wall causing it to contract, cleaning out any remaining sludge or bile that may have accumulated within the gallbladder." ('046 Patent at 13:42-45). Kinevac "has a more rapid physiological effect on the gallbladder in terms of contraction and relaxation than the endogenous hormone (CCK-8)." (Id. at 13:49-51). Kinevac is "administered before and/or after diagnostic imaging ... to improve visualization and/or diagnosis of various disease states." (Id. at 13:55-58). "Typically, the gallbladder contracts within 15 minutes after sincalide [(Kinevac)] injection and the hepatobiliary imaging agent... is injected 30 minutes later." (Id. at 14:17-20). Once the gallbladder is emptied it "is better able to take up and accumulate imaging agent. . . which helps to reduce the number of false positive studies." (Id. at 14:20-23).

         As originally introduced, Kinevac suffered from some drawbacks. The '046 Patent identifies "potency variability" as one such drawback, which meant "a 20% overage of sincalide was required in previous sincalide formulations to compensate for the limitations of the bioassay." ('046 Patent at 1:27-40). The new invention "satisfie[d] the need for improved sincalide formulations by providing formulations that eliminate the need for a 20% overage of sincalide." (Id. at 1:43-45). "The sincalide formulations of the invention are also purer than prior art formulations, and have fewer degradants and more consistent potency." (Id. at 1:45-48).

         The '046 Patent sets forth 108 total claims, which are directed to sincalide formulations (claims 1-20 and 106); methods for making sincalide formulations (claims 21-39); kits containing sincalide formulations (claims 40-55 and 107-108); and methods for using sincalide formulations (claims 56-105). Claim 1 provides:

         A stabilized, physiologically acceptable formulation of sincalide comprising:

(a) an effective amount of sincalide,
(b) at least one stabilizer,
(c) a surfactant/solubilizer
(d) a chelator
(e) a bulking agent/tonicity adjuster, and
(f) a buffer.

('046 Patent at 37:41-49).

         In August 2017, Maia filed a new drug application with the FDA seeking approval to market a sincalide product. The FDA granted the product priority review and then approved it in February 2018. In a notice letter required under the statute, Maia notified Bracco of several reasons that Maia argued its product does not infringe the '046 Patent:

• Maia's product does not include either a buffer or a surfactant/solubilizer.
• The amino acids in Maia's product are not used as buffers and have no buffering capacity over the pH range of Maia's formulation. An excipient[1] generally only provides a buffering capability when the pH of the formulation is within 1 pH unit of the excipient's pKa.
• The amino acids in Maia's product provide no surfactant or solubilizing effect because they do not have a suitable hydrophobic tail, and are not surface active by themselves, and do not function as solubilizers.
• Maia's product does not contain either polysorbate 20 or dibasic potassium phosphate.

         Bracco filed this action pursuant to the Hatch-Waxman Act on December 15, 2017, claiming that Maia's proposed product infringes its claims in its '046 Patent. Maia challenges the validity of the asserted claims.

         For the purposes of this hearing, the definition of three terms is at issue: (1) buffer, (2) surfactant/solubilizer; (3) surfactant. The following proposed definitions are proposed:

Term

Bracco's Proposal

Maia's Proposal

Buffer

Excipients that “stabilize the pH” and “include, but are not limited to, phosphoric acid, phosphate (e.g. monobasic or dibasic sodium phosphate, monobasic or dibasic potassium phosphate, etc.), citric acid, citrate (e.g. sodium citrate, etc.), sulfosalicylate, acetic acid, acetate (e.g. potassium acetate, sodium acetate, etc.), methyl boronic acid, boronate, disodium succinate hexahydrate, amino acids, including amino acid salts (such as histidine, glycine, lysine, imidazole), lactic acid, lactate (e.g. sodium lactate, etc.), maleic acid, maleate, potassium chloride, benzoic acid, sodium benzoate, carbonic acid, carbonate (e.g. sodium carbonate, etc.), bicarbonate (e.g. sodium bicarbonate, etc.), boric acid, sodium borate, sodium chloride, succinic acid, succinate (e.g. sodium succinate), tartaric acid, tartrate (e.g. sodium tartrate, etc.), tris(hydroxymethyl) aminomethane, biological buffers (such as N-2- hydroxyethylpiperazine, N'-2- ethanesulfonic acid (HEPES), CHAPS and other ‘Good's' buffers), and the like.”

SOURCES: ‘046 Patent at 9:45-65, claims 3, 23, 41, 60, and 87, 9:65-10:9, Forrest Deci. at J 31-62; Exs. 15-39.

A compound that stabilizes the pH of a sincalide formulation.

SOURCES: ‘046 Patent at 9:44-47; Kilbanov DecI. at ¶ 92, 93, 95; Websters Ninth Collegiate Dictionary at 185 (1985); Webster's II New College Dictionary at 144 (1986); McGraw-Hill Dictionary of Scientific and Technical Terms at 278 (5th ed. 1994).

Surfactant/solubilizer

Excipients that “may reduce the interfacial tension or aid in solubilization” and “include, but are not limited to, pluronics (e.g., Lutrol F68, Lutrol F127), Poloxamers, SDS, Triton-l00, polysorbates such as TWEEN® 20 and TWEEN® 80, propylene glycol, PEG and similar compounds, Brij58 (polyoxyethylene 20 cetyl ether), cremophor EL, cetyl trimethylammonium bromide (CTAB), dimethylacetamide (DMA), NP-40 (Nonidet P 40), and N-methyl-2- pyrrolidone (Pharmasolve), glycine and other amino acids/amino acid salts and anionic surfactants containing alkyl, aryl or heterocyclic structures, and cyclodextrins.”

SOURCES: ‘046 Patent 11:26-12:14; Forrest Decl. ¶Â¶ 63-72.

A surfactant that is also a solubilizer.

A solubilizer is a compound that aids in solubilization, thus preventing or reducing sincalide denaturation and/or degradation caused by peptide aggregation, precipitation, surface adsorption, or agitation at air/liquid or liquid/solid interfaces in solution.

SOURCES: ‘046 Patent at 11:27-35, 11:51, claims 1, 6, 21, 26 Klibanov Decl. at ¶ 63, 64, 66-74.

Surfactant

Excipients that “may reduce the interfacial tension” and “include, but are not limited to, pluronics (e.g., Lutrol F68, Lutrol F 127), Poloxamers, SDS, Triton-100, polysorbates such as TWEEN® 20 and TWEEN® 80, propylene glycol, PEG and similar compounds, Brij58 (polyoxyethylene 20 cetyl ether), cremophor EL, Dictionary of Scientific and cetyl trimethylammonium Technical Terms. bromide (CTAB), dimethylacetamide (DMA), NP-40 (Nonidet P-40), and N-methyl-2-pyrrolidone (Pharmasolve), glycine and other amino acids/amino acid salts and anionic surfactants containing alkyl, aryl or heterocyclic structures, and cyclodextrins.”

SOURCES: ‘046 Patent at 9:49-65, 11:26-36, claims 44, 63, 90; Forrest Decl. at ¶Â¶ 74- 107.

A compound that reduces the tension of the air/liquid or liquid/solid interface.

SOURCES: ‘046 Patent at 11:29-34; Klibanov Decl. at ¶ 35-39, 43-48; Condensed Chemical Dictionary; Webster's Ninth Collegiate Dictionary; McGraw-Hill Dictionary of Scientific and Technical Terms.

         Markman Standard

         "It is a 'bedrock principle' of patent law that 'the claims of a patent define the invention to which the patentee is entitled the right to exclude.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). Claim construction determines the correct claim scope and is a determination exclusively for the court as a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The focus in construing disputed terms in claim language "is on the objective test of what one of ordinary skill in the art at the time of the invention would have understood the term to mean." Id. at 986.

         To determine the meaning of the claims, courts start by considering the intrinsic evidence. Phillips, 415 F.3d at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); BellAtl. Network Servs., Inc. v. Covad Comms. Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims themselves, the specification, and the prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at 861.

         The court "begin[s] [its] analysis with the claim language itself." Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1347 (Fed. Cir. 2004). The "claims 'must be read in view of the specification of which they are a part."' Phillips, 415 F.3d at 1315 (quoting Markman, 52 F.3d at 979). "[T]he specification 'is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.'" Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). This is true because a patentee may define his own terms, give a claim term a different meaning than the term would otherwise possess, or disclaim or disavow the claim scope. Id. at 1316. In these circumstances, the inventor's lexicography governs. Id. But, although "the specification often describes very specific embodiments of the invention," the Federal Circuit has "repeatedly warned against confining the claims to those embodiments." Phillips, 415 F.3d at 1323.

         Buffer

         The parties first disagree as to the definition of "buffer." Both claim their construction derives from the intrinsic evidence but also rely on some extrinsic evidence. As previously stated, Bracco urges the following definition:

Excipients that "stabilize the pH" and "include, but are not limited to, phosphoric acid, phosphate (e.g. monobasic or dibasic sodium phosphate, monobasic or dibasic potassium phosphate, etc.), citric acid, citrate (e.g. sodium citrate, etc.), subsalicylate, acetic acid, acetate (e.g. potassium acetate, sodium acetate, etc.), methyl boronic acid, boronate, disodium succinate hexahydrate, amino acids, including amino acid salts (such as histidine, glycine, lysine, imidazole), lactic acid, lactate (e.g. sodium lactate, etc.), maleic acid, maleate, potassium chloride, benzoic acid, sodium benzoate, carbonic acid, carbonate (e.g. sodium carbonate, etc.), bicarbonate (e.g. sodium bicarbonate, etc.), boric acid, sodium borate, sodium chloride, succinic acid, succinate (e.g. sodium succinate), tartaric acid, tartrate (e.g. sodium tartrate, etc.), tris(hydroxymethyl)-aminomethane, biological buffers (such as N-2-hydroxyethylpiperazine, N'-2- ethanesulfonic acid (HEPES), CHAPS and other 'Good's' buffers), and the like."

(See Brief of Bracco, ECF No. 50 at 11). Maia proposes a much shorter definition: "A compound that stabilizes the pH of a sincalide formulation." (See Brief of Maia, ECF No. 50 at 30).

         Accordingly, the parties generally agree that a buffer stabilizes pH. However, the critical difference is whether the phrase "of a sincalide formulation" should be included in the definition. Maia argues that buffer must be directed to sincalide formulations for two reasons: (1) the invention - as stated in the claims and specifications - is directed to sincalide formulations and (2) a compound, which may operate as a buffer in a formulation within a specific pH range, may not act ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.