Categories: Claim Construction Date: May 23, 2014 Title: Shire Development, LLC v. Watson Pharma., Inc.: Overly Broad Interpretation Strays from the Claim Language
|Title||Shire Development, LLC v. Watson Pharma., Inc., No. 2013-1409 (Fed. Cir. March 28, 2014).|
| [Did the district court err by construing] “'lipophilic matrix' [as] a matrix that includes at least one lipophilic excipient[?]” |
Shire Development, LLC at *9-10 (text added, internal citation removed).
| In construing the matrix terms, the district court rejected Watson’s position that the inner matrix and outer matrix must be “separate and distinct.” |
Id. at *10 (text added).
| [Lipophilic] is an adjective that modifies matrix. [...] Thus, the matrix [itself] must exhibit the [...] lipophilic characteristic. |
Id. at *10 (text added, internal citation removed).
| A court must identify “[t]he construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention.” [, therefore, a proper interpretation is that the inner and outer matrices must be “separate and distinct” such that they retain their claimed properties and are consistent with their respective group limitations]|
Id. at *14 (text added).
|Procedural History||[Shire owns] U.S. Patent No. 6,773,720, .... [...] Shire sued [Watson] for infringement of the ’720 patent. After construing certain relevant claim language, the district court found that Watson’s product infringed the ’720 patent. |
Shire Development, LLC at *2 (text added).
|Legal Reasoning (Rader, Prost, Hughes)|
|Legal Standard||When construing asserted claims, claim terms are given “their ordinary and accustomed meaning as understood by one of ordinary skill in the art.” [...] Intrinsic evidence, such as “the specification, . . . may shed contextual light” on the ordinary and customary meaning of a claim term. [...] “The construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention will be, in the end, the correct construction. [...] In addition to the specification, this court looks to the prosecution history. For example, “where the patentee has unequivocally disavowed a certain meaning to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the ordinary meaning of the claim congruent with the scope of the surrender.” |
Shire Development, LLC at *8-9 (text added, internal citations removed).
|The '720 Patent||The ’720 patent [...] concerns controlled-release oral pharmaceutical compositions for treating inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis. [...] The active ingredient in these compositions is [mesalamine]. [...] [M]esalamine must pass through the stomach and small intestine without being absorbed into the bloodstream. [...] And, it must be administered throughout the entire length of the colon so that the mesalamine contacts all affected tissues. [...] The ’720 patent teaches an inner lipophilic [resists disolving in water] matrix and an outer hydrophilic [readily disolves in water] matrix to address the limitations of the prior art systems. According to the ’720 patent, the combination of a lipophilic and hydrophilic matrix in an inner-outer matrix system, respectively, is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. |
Id. at *2-3 (text added, internal citations and footnote removed).
|Representative Claim||1. Controlled-release oral pharmaceutical compositions containing as an active ingredient 5-amino-salicylic acid, comprising:|
a) an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerid[e]s, waxes, ceramides, and cholesterol derivatives with melting points below 90° C., and wherein the active ingredient is dispersed both in said the lipophilic matrix and in the hydrophilic matrix;
b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums;
c) optionally other excipients;
wherein the active ingredient is present in an amount of 80 to 95% by weight of the total composition, and wherein the active ingredient is dispersed both in the lilophilic matrix and in the hydrophilic matrix.
Id. at *4.
| The Matrix Must Exhibit the Lipophilic Characteristic|
|Focus is on the Properties of the Matrix Itself|
[T]he district court erred by construing “‘lipophilic matrix’ [as] a matrix that includes at least one lipophilic excipient.” [...] That construction erroneously focuses on the lipophilic properties of an excipient in the matrix, rather than the properties of the matrix itself. Looking first to the language of the claims, “lipophilic” is an adjective that modifies matrix. The parties stipulated that “lipophilic” means “poor affinity towards aqueous fluids.” [...] Thus, the matrix—not just an excipient within the matrix—must exhibit the stipulated-to lipophilic characteristic. [...] [For example, the] Background of the Invention explains that a lipophilic matrix is one “in which the main component of the matrix structure” exhibits certain lipophilic properties. [...] And, the specification teaches that a lipophilic matrix “generally entail[s] non-linear, but esponential [sic] release of the active ingredient.” [...] Thus, a “lipophilic matrix” is more than just a matrix with at least one lipophilic excipient—the matrix itself must exhibit lipophilic characteristics.
| The Inner Matrix and the Outer Matrix Must be "Separate and Distinct"|
|No Unambiguous Disavowal in the Prosecution History||During prosecution, Shire carefully characterized the prior art as not having separate matrices but never actually stated that the claimed invention does have separate matrices. See, [for example] “While the [prior art] publications might teach the advantageous results of using a lipophilic matrix, the publications fail to disclose or suggest a composition comprising a combination of two separate matrices.” [...] Although the prosecution history statements do not rise to the level of unmistakable disavowal, they do inform the claim construction. |
Shire Development, LLC at *11 (text added, internal citation removed).
|The Claims Require the Matrices to be Separate||Moreover, the logical reading of the claim requires separation between the matrices because the matrices are defined by mutually exclusive spatial characteristics—one inner, one outer—and mutually exclusive compositional characteristics—one hydrophilic, one lipophilic. According to the ordinary and customary meanings of these characteristics, one matrix cannot be both inner and outer in relation to a second matrix. Nor can one matrix be both hydrophilic and lipophilic. Thus, considering matrix is properly construed as “a macroscopically homogenous structure in all its volume,” the construction of “inner lipophilic matrix” requires the inner volume to be separate from the outer volume. |
Id. at *12.
|Lack of Overlap Between Markush Groups Supports Separate Matrices||The compositions of the inner volume and outer volume, i.e., inner matrix and outer matrix, respectively, are further limited by the Markush groups. [...] The lack of overlap of the components of the two Markush groups supports the requirement that the volumes be separate. Accordingly, the correct construction requires that the inner volume contain substances from the group described for the inner lipophilic matrix (which are all lipophilic substances), and that the outer volume separately contain substances from the group described for the outer hydrophilic matrix (which are all hydrophilic). |
Id. at *13 (text added).
|The Specification Teaches Separate Matrices||The specification explains that a lipophilic matrix “opposes some resistance to the penetration of the solvent due to the poor affinity towards aqueous fluids.” [...] Thus, the matrix that is deemed the “lipophilic” matrix cannot have hydrophilic properties. But, a matrix comprised of only one lipophilic substance and several hydrophilic substances—and thus capable of exhibiting hydrophilic properties—would meet the district court’s construction of “lipophilic matrix.” Such a result contradicts the customary and ordinary meaning of “lipophilic” and “hydrophilic.” |
Id. at *13 (text added, internal citation removed).
|District Court's Construction Incorrectly Allows for A Single Mixed Matrix||[U]nder the district court’s construction, a single mixed matrix with both hydrophilic and lipophilic components—such as the one disclosed in the [prior art] reference, which the applicants described as “mixing together hydrophilic and lipophilic substances into a single matrix”—could contain both an “inner lipophilic matrix” and an “outer hydrophilic matrix.” [...] The claims, however, require two matrices with a defined spatial relationship. |
Id. at *14 (text added).
|Unresolved Question Does not Compel Claim Construction that Departs from Customary and Ordinary Meaning||Shire argues that the intrinsic evidence does not describe any particular degree of separation and thus, such a construction would create ambiguity. Shire’s argument misses the point. A court must identify “[t]he construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention.” [...] Whether or not a composition infringes when there is a trace of hydrophilic molecules in the inner volume because of the mixing step inherent in the manufacturing process, for example, is a question for the fact finder. That this question may need to be resolved does not compel a claim construction that departs from the customary and ordinary meaning of the claims, i.e., that the matrices must be “separate” such that they retain their claimed properties and are consistent with their respective Markush group limitations. |
Id. at *14 (text added).
|We conclude that the district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broaden the ordinary meaning of the terms. Accordingly, we reverse the district court’s claim constructions of “inner lipophilic matrix” and “outer hydrophilic matrix,” and subsequent finding of infringement, and remand for further proceedings consistent with this opinion. |
Shire Development, LLC at *2.