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Glycobiosciences, Inc. v. Innocutis Holdings, LLC

United States District Court, D. Columbia

November 25, 2015

INNOCUTIS HOLDINGS, LLC, et al., Defendants

          For GLYCOBIOSCIENCES, INC., Plaintiff, Counter Defendant (1:12-cv-01901-RDM): Jerold I. Schneider, LEAD ATTORNEY, SCHNEIDER ROTHMAN INTELLECTUAL PROPERTY LAW GROUP PLLC, Boca Raton, FL; Joseph Jude Zito, ZITO, TLP, Washington, DC.

         For INNOCUTIS HOLDINGS, LLC., DARA BIOSCIENCES, INC., Defendants, Counter Claimants (1:12-cv-01901-RDM): Leonard R. Svensson, LEAD ATTORNEY, PRO HAC VICE, BIRCH, STEWART, KOLASCH & BIRCH, LLP, Falls Church, VA; Quentin Rick Corrie, LEAD ATTORNEY, BIRCH STEWART KOLASCH & BIRCH, LLP, Falls Church, VA.

         For Glycobiosciences, Inc., Plaintiff (1:15cv592): Jerold I. Schneider, SCHNEIDER ROTHMAN INTELLECTUAL PROPERTY LAW GROUP PLLC, Boca Raton, FL.


         RANDOLPH D. MOSS, United States District Judge.

         Plaintiff Glycobiosciences, Inc. filed this patent infringement suit against Defendants Innocutis Holdings, LLC and Dara Biosciences, Inc., see Dkt. 1, alleging that Defendants indirectly or contributorily infringed U.S. Patent No. 6,387,407 (" the '407 patent" ) by importing, selling, or offering to sell Defendants' BIONECT product, see Dkt. 23 ¶ ¶ 18, 25, 32, 38.[1] Plaintiff subsequently filed a second infringement action asserting the '407 patent against Defendant Fidia Farmaceutici, S.p.A (" Fidia" ), the manufacturer of BIONECT. See No. 15-592, Dkt. 1. Given the overlap in the complaints, the Court consolidated the cases. See June 10, 2015, Minute Order.

          " A determination of [patent] infringement involves a two-step analysis. First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process." Omega Eng'g, Inc, v. Raytek Corp., 334 F.3d 1314, 1320 (Fed. Cir. 2003) (internal quotation marks omitted). The matter before the Court pertains to the first step of this analysis: claim construction. See Dkts. 48, 49, 62, 63, 70, 72. The parties have asked the Court to construe two disputed terms in claim 1 of the '407 patent: " nonionic polymer" and " weight average molecular weight from about 650,000 to about 800,000." See '407 patent, col.16:21-36 (emphases added).

         For the reasons given below, and upon consideration of the '407 patent, its prosecution history, the parties' briefs and expert declarations, and the argument and testimony at the June 10, 2015, claim construction hearing, the Court concludes as follows:

(1) " Nonionic polymer " means a polymer composed of macromolecules that do not contain ionic bonds, ions, or functional groups that would ionize in aqueous solution under conditions applicable to the production of pharmaceutical products.

(2) The use of the word " about " in the phrase " [w]eight average molecular weight from about 650,000 to about 800,000 " is not subject to a precise numerical definition. The meaning of the term, moreover, turns on both (a) consideration of fair notice to those skilled in the art regarding the scope of the claimed invention and (b) consideration of how variations in molecular weight affect the performance and characteristics of the claimed invention. Considering the first factor, the Court concludes that the word " about" cannot admit of variations even approaching the ± 10% figure that Plaintiff attributes to the term. The Court accordingly recognizes a maximum possible variation in the claimed range.

         The Court, however, reserves judgment as to whether the meaning of " about" can be affixed with greater precision based on the second factor. As explained below, the parties have yet to present the Court with sufficient evidence to permit it to assess how small variations in molecular weight might affect the functionality of the claimed invention. Thus, for present purposes, the Court merely concludes that any variation in molecular weight even approaching ± 10% plainly falls beyond the scope of claim 1. In the face of uncertainty regarding the effect of small changes in molecular weight on the performance and characteristics of the invention, Defendants' proposed range of variation of no more than ± 2% might have merit, while a somewhat wider range might be appropriate if Plaintiff can show that such a variation would have no functional affect on the invention.

         I. BACKGROUND

         The only patent presently asserted in this litigation is Plaintiff's '407 patent, which issued on May 14, 2002.[2] See Dkt. 23-1. That patent is directed to a topical-or " transdermal" -drug delivery process. See '407 patent, col. 1:10-15. As explained in the patent's specification, the claimed process involves the application of a water-based gel that may contain a therapeutic drug to the skin; the drug is released slowly over time as the gel penetrates the tissues beneath the skin's outer layer. See id. col. 1:10-15, col. 2:52-64; col. 3:29-46. The gel contains a blend of two polymer components: (1) " a negatively charged polymer material" called " hyaluronate sodium salt," and (2) an unspecified " nonionic polymer." Id. col. 16:26-31.

         The '407 patent's only independent claim, claim 1, recites:

A process for the use of a composition as a medical device, for drug delivery, the application of a diagnostic agent, or the prevention of post operative adhesions, said process comprises topically administering to a mammal an aqueous based gelled composition containing a polymer matrix composed of a negatively charged polymer material blended with a nonionic polymer ;

wherein the negatively charged polymer material is hyaluronate sodium salt; and

wherein the hyaluronate sodium salt has a weight average molecular weight from about 650,000 to about 800,000, a sulphated ash content below about 15%, a protein content below about 5%[,] and purity of at least 98%.

Id. col. 16:22-36 (emphases added). The parties ask the Court to resolve the meaning of two disputed claim terms: " nonionic polymer" and " weight average molecular weight from about 650,000 to about 800,000." Dkt. 61 at 1-2.

         To set the stage for the parties' dispute, it is necessary to review some basic chemistry. A " polymer" is " [a] macromolecule formed by the chemical union of five or more identical combining units called monomers." Hawley's Condensed Chemical Dictionary 1013 (15th ed. 2007) (" Hawley's Dictionary " ); see also Dkt. 42-1 at 3 (Kolbert (I) Decl. ¶ 10); Transcript of Claim Construction Hearing at 82-83 (" Markman Hearing" ). The monomers are connected together in long, bead-like chains that are often made up of thousands of monomers. See Hawley's Dictionary at 1013; see also Transcript of Technology Hearing (" Tech. Hearing" ) at 24. The physical characteristics of a polymer are often dependent on the length of these chains. Dkt. 42-1 at 3 (Kolbert Decl. (I) ¶ 10).

         Because the number of monomers in a polymer can vary, and this variation may affect the characteristics of the polymer, it can be important to specify its size, or " molecular weight." Dkt. 63-7 at 2 (Ex. F).[3] As with other polymers, " many of the biological functions of [hyaluronic acid] are dependent on molecular size," Dkt. 63-8 at 2 (Ex. G),[4] which explains why-as here-" the molecular weight of [hyaluronic acid] is a primary criterion in patents describing [hyaluronic acid] production," Dkt. 63-7 at 2 (Ex. F at 2759). Generally speaking, changes in the molecular weight of hyaluronic acid affect its viscosity-its ability to flow. Markman Hearing at 67.

         There are several ways to calculate molecular weight, see Dkt. 63-12 at 2-3 (Ex. K),[5] which is measured in Daltons-a unit of mass equal to one-twelfth " the mass of a free carbon 12 atom, at rest and in its ground state." Nat'l Institute of Standards & Tech., NIST Special Publ'n No. 330, The International System of Units (SI) 34 (Barry N. Taylor & Ambler Thompson eds., 2008).[6] The parties do not dispute, however, that " weight average molecular weight," measured in Daltons, is the relevant measure with respect to the construction of claim 1 of the '407 patent. See Dkt. 61 at 2. The " weight average molecular weight" of a polymer is calculated in a manner that accounts for variation in size between the individual molecules in a sample. See Dkt. 63-12 at 3 (Ex. K). It is a method of calculating the weight of a polymer " by taking all the different-sized molecules in the mix that makes up [the polymer] and calculating their average weight while giving heavier molecules a weight-related bonus when doing so." Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 836, 190 L.Ed.2d 719 (2015).

         Polymers, like other molecules, contain chemical bonds. The monomers in a polymer are linked together by " covalent" bonds, Markman Hearing at 81-82, that is, bonds in which electrons are shared between two atoms, Hawley's Dictionary at 342. Polymers may also contain " ionic" bonds, which are bonds created by " the force of attraction between oppositely charged" ions. Dkt. 63-3 at 6 (Ex. B).[7] An ion is " [a]n atom or radical that has lost or gained one or more electrons and has thus acquired an electric charge." Hawley's Dictionary at 697. In short, an atom that loses an electron has more protons than electrons, and accordingly becomes a positively charged ion, which is called a cation. Dkt. 63-3 at 6 (Ex. B at 11); see also T.R. Dickson, Introduction to Chemistry 254 (8th ed. 2000) (Dickson, Intro to Chemistry ). An atom that gains an electron has more electrons than protons, and thus becomes a negatively charged ion, which is called an anion. Dkt. 63-3 at 6 (Ex. B at 11); Dickson, Intro to Chemistry, at 254. An ionic bond occurs when one molecule transfers an electron to another molecule, forming oppositely charged ions that are attracted to each other. See Hawley's Dictionary at 697; Dkt. 63-3 at 6 (Ex. B at 11). By contrast, the bonded molecules in a covalent bond share, rather than transfer, electrons between them. See Hawley's Dictionary at 342. Covalent bonding occurs between molecules that are not ionized; they do not depend on the loss or gain of an electron to form a bond. See Dickson, Intro to Chemistry at 258-59. Rather, " [t]he result of [a covalent bond] is that both atoms attain a stable electronic configuration by mutual possession of electrons." Id. at 259.

         Hyaluronic acid, a polymer used to prepare the gel composition described in the '407 patent, is derived from " various tissue sources including umbilical cords, skin, vitreous humour, synovial fluid, tumors, haemolytic streptocci pigskin, rooster combs, and the walls of veins and arteries." '407 patent col. 4:33-35. It can also be " synthesized artificially and by recombinant technology." Id. col. 4:36-37. It is soluble in water and able to form a gel matrix to which drugs that are dissolved or disbursed in water may be added. Id. col. 4:23; id. col. 5:56-57.

         Of particular relevance here, the parties agree that " hyaluronate sodium salt" -the salt form of hyaluronic acid-contains ionic bonds. See Dkt. 70 at 9; Dkt. 72 at 11. The parties also agree that hyaluronic acid itself does not contain ionic bonds before it is in solution. See Dkt. 70 at 9; Dkt. 72 at 11; Markman Hearing at 39. Hyaluronic acid does, however, contain ionizable " carboxyl" or " -COOH" acid functional groups that consist of carbon, oxygen, and hydrogen atoms. Dkt. 70 at 8; Tech. Hearing at 27-29. As relevant here, when hyaluronic acid is placed into an aqueous solution containing sodium hydroxide, a process known as neutralization, the carboxyl groups lose hydrogen ions (protons), leaving oxygen atoms from the carboxyl group negatively charged. Tech. Hearing at 27-29; see also Michael Munowitz, Principles of Chemistry 284 (1st ed. 2000) (explaining carboxylic acid functional groups); Hawley's Dictionary at 1054 (defining " proton" ). The negatively charged oxygen ions then form ionic bonds with the positively charged sodium ions from the ionized sodium hydroxide, forming hyaluronate sodium salt (and water). Tech. Hearing at 27-29. To summarize, hyaluronic acid does not contain ionic bonds, but when placed in an aqueous solution, hyaluronic acid ionizes -it dissociates into ions that are then attracted to oppositely charged ions, resulting in ionic bonds. As relevant here, those bonds are formed with sodium cations, creating hyaluronate sodium salt.

         The '407 patent claims a process for the use of " an aqueous based gelled composition containing a polymer matrix composed of" hyaluronate sodium salt " blended with a nonionic polymer." Col. 16:25-31. The hyaluronate sodium salt, moreover, must have a weight average molecular weight of between " about 650,000 to about 800,000" Daltons. Id. col. 16:32-34.

         On February 20, 2015, the parties filed their opening claim construction briefs addressing the meaning of (1) " nonionic polymer" and (2) " a weight average molecular weight from about 650,000 to about 800,000." See Dkts. 48, 49. Pursuant to the Court's May 1, 2015, Minute Order, the parties subsequently filed a Joint Claim Construction Statement to identify the disputed terms and proposed constructions. See Dkt. 61. They then filed responsive claim construction briefs on May 20, 2015. See Dkts. 62, 63. On May 29, 2015, the parties presented a technology tutorial to the Court, and, on June 10, 2015, the Court held a claim construction-or " Markman " -hearing. At the hearing, Defendants offered the testimony of their expert, Dr. Jason Burdick. Plaintiff offered no expert testimony at the hearing.

         At the claim construction hearing, Plaintiff conceded that dependent claim 2 is indefinite because it does not contain any limitation that is narrower than independent claim 1. Markman Hearing at 24-25. At the hearing, Plaintiff also conceded that dependent claim 3 " may be redundant" and failed to identify any way in which the subject matter covered by that claim differs from the subject matter covered by independent claim 1. Markman Hearing at 24. The Court, accordingly, does not address claims 2 or 3 in this order. In addition, on the same day as the Markman hearing, the Court consolidated Plaintiff's infringement action against Innocutis Holdings, LLC and Dara Biosciences, Inc., No. 12-cv-1901, with its later-filed action against Fidia, No. 15-cv-0592. The parties agree that the Court's ruling on claim construction will bind Fidia, as well as the previously named Defendants. Dkt. 69 at 2 (Defendants); Markman Hearing at 25-26 (Plaintiff).

         After the hearing, Plaintiff filed a motion to strike portions of Defendants' claim construction submissions, or for alternative relief. See Dkt. 66. The Court denied the motion for failure to comply with Local Civil Rule 7(m) and directed the parties jointly to propose a schedule for the submission of reply briefs addressing any remaining claim construction disputes. See June 22, 2015, Minute Order; see also Dkt. 68 (Joint Stipulation); June 23, 2015, Minute Order. Plaintiff filed its reply on June 30, 3015, see Dkt. 70, and Defendants filed their reply on July 8, 2015, see Dkt. 72.

         The construction of the disputed terms of the claim, accordingly, is now ripe for decision.


          " '[T]he construction of a patent, including terms of art within its claim,' is not for a jury but 'exclusively' for 'the court' to determine . . . even where the construction of a term of art has 'evidentiary underpinnings.'" Teva, 135 S.Ct. at 835 (quoting Markman v. Westview Instruments, Inc., 517 U.S. 370, 372, 390, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996)). In this limited respect, the construction of a patent is " much the same task as the judge would [conduct] in construing other written instruments, such as deeds, contracts, or tariffs." Id. at 837. " [T]he ultimate issue of the proper construction of a claim should be treated as a question of law," but " subsidiary factfinding is sometimes necessary." Id. at 838.

          In construing a patent, the court considers both intrinsic and extrinsic evidence. The first category, intrinsic evidence, includes the claim language itself, the specification, and the prosecution history of the patent. " [T]he claims are 'of primary importance'" because they " 'ascertain precisely what it is that is patented.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (quoting Merrill v. Yeomans, 94 U.S. 568, 570, 24 L.Ed. 235, 1877 Dec. Comm'r Pat. 279 (1876)). When the court construes the language of a claim, words are given " the ordinary and customary meaning . . . that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1313. In turn, " the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent . . . ." Id. This context includes the patent specification, which is the statutorily required " written description of the invention, and of the manner and process of making and using it" in " full, clear, concise, and exact terms," such that " any person skilled in the art" could make and use the invention. 35 U.S.C. ยง 112(a). Other than the language of the claim itself, the specification " 'is the single best guide to the ...

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