SHIRE DEVELOPMENT, LLC, Shire Pharmaceutical Development, Inc., Cosmo Technologies Limited, Giuliani International Limited, NKA Nogra Pharma Limited, Plaintiffs-Appellees v. WATSON PHARMACEUTICALS, INC., NKA Actavis, Inc., Watson Laboratories, Inc.—Florida, NKA Actavis Laboratories FL, Inc., Watson Pharma, Inc., NKA Actavis Pharma, Inc., Watson Laboratories, Inc., Defendants-Appellants
2016-1785
United States Court of Appeals, Federal Circuit.
February 10, 2017
848 F.3d 981
First, in its analysis of whether Smith has established the GDOC‘s grooming policy substantially burdens his religious exercise, Holt requires the district court to consider the choice that the grooming policy imposes on Smith: either to engage in conduct that violates his sincerely held religious beliefs, or to face disciplinary action. Second, Holt demands a more particularized, less deferential analysis as to those issues for which the GDOC bears the burden, namely, whether the grooming policy is the least restrictive means of furthering compelling governmental interests. Specifically, Holt calls for an individualized, context-specific inquiry that requires the GDOC to demonstrate that application of the grooming policy to Smith furthers its compelling interests. It requires the GDOC to consider the “marginal interest in enforcing” the grooming policy in Smith‘s case.
IV. CONCLUSION
The district court in this case did not have the benefit of Holt v. Hobbs, 574 U.S. 352 (2015) when it considered Owens’ motion for summary judgment, and this case lacks the evidentiary record that supported affirmance in Knight II. Because Smith‘s case was never analyzed in a manner consistent with Holt v. Hobbs with respect to substantial burden, compelling interests, or least restrictive means—and because the GDOC has revised its grooming policy since the district court rendered its decision, the district court‘s order granting Owens’ motion for summary judgment is vacated, and the case is remanded for further consideration. On remand, the district court is instructed to analyze Smith‘s RLUIPA claim as it relates to the GDOC‘s revised grooming policy in a manner consistent with Holt v. Hobbs.
VACATED AND REMANDED.
STEVEN ARTHUR MADDOX, Maddox Edwards, PLLC, Washington, DC, argued for defendants-appellants. Also represented by JEREMY J. EDWARDS, KAVEH SABA.
Before PROST, Chief Judge, TARANTO and HUGHES, Circuit Judges.
HUGHES, Circuit Judge.
Plaintiffs (collectively, Shire) sued Defendants (collectively, Watson) for infringing claims 1 and 3 of U.S. Patent No. 6,773,720 by filing Abbreviated New Drug Application No. 203817 with the Food and Drug Administration seeking to market a generic version of Shire‘s mesalamine drug, LIALDA®. Because Watson‘s ANDA Product does not satisfy the Markush group requirements in claim 1(b), we reverse and remand with instructions to enter judgment of non-infringement.
A
The ‘720 patent is directed to a controlled-release oral pharmaceutical composition of mesalamine (also known as mesalazine or 5-amino-salicylic acid) used to treat certain inflammatory bowel diseases. Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359, 1361 (Fed. Cir. 2015) (2015 Decision). That composition includes the mesalamine active ingredient; an inner, lipophilic matrix; an outer, hydrophilic matrix; and other optional excipients. ‘720 patent col. 2 ll. 36-44.
When a matrix is hydrophilic, it “has an affinity for water” and therefore “readily dissolves in” it. 2015 Decision, 787 F.3d at 1362 n.1; see Shire Dev. LLC v. Watson Pharm., Inc., No. 12-60862-CIV, 2016 WL 1258885, at *6 (S.D. Fla. Mar. 28, 2016) (2016 Trial Decision) (noting the parties’ stipulated-to definition of “hydrophilic” as “having an affinity to water“). Conversely, when a matrix is lipophilic, it “has an affinity for lipids” and therefore “resists dissolving in water.” 2015 Decision, 787 F.3d at 1362 n.1; see id. at 1365 (noting the parties’ stipulated-to definition of “lipophilic” as “poor affinity towards aqueous fluids“).
Shire asserts claims 1 and 3 of the ‘720 patent. In relevant part, claim 1 reads:
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 triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90° C., and wherein the active ingredient is dispersed both in said [sic] 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....
‘720 patent col. 6 ll. 7-30 (emphases added). Dependent claim 3 limits the composition to “the form of tablets, capsules, [or] mintablets [sic].” Id. col. 6 ll. 34-35.
B
In 2013, following a bench trial, the district court rejected Watson‘s invalidity arguments that the ‘720 patent lacked written description and enablement, and held that Watson infringed claims 1 and 3. Shire Dev. LLC v. Watson Pharm., Inc., No. 12-60862-CIV, 2013 WL 1912208, at *16 (S.D. Fla. May 9, 2013) (2013 Trial Decision).
On appeal, and again after remand from the Supreme Court, we held that the ‘720 patent matrices are “defined by mutually exclusive spatial characteristics—one inner, one outer—and mutually exclusive compositional characteristics—one hydrophilic, one lipophilic.” 2015 Decision, 787 F.3d at 1366, remanded by — U.S. —, 135 S.Ct. 1174, 191 L.Ed.2d 130 (2015), granting cert. to and vacating 746 F.3d 1326 (Fed. Cir. 2014). Thus we concluded that a “matrix—not just an excipient within the matrix“—must exhibit the appropriate characteristic. Id. at 1365 (emphasis omitted). We further explained that the matrix compositions are “limited by the
Summarizing the operation of the Markush groups in the ‘720 patent, we determined that “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.
On remand, the district court concluded that Watson‘s ANDA Product satisfied the “inner lipophilic matrix” and “outer hydrophilic matrix” limitations. See 2016 Trial Decision, 2016 WL 1258885, at *4, *15. The court also determined that Watson‘s ANDA Product satisfied the Markush limitations because the excipients falling outside the respective Markush groups were “unrelated” to the invention since they did not drive the water-affinity property of their respective matrices. Id. at *15. Watson appeals the district court‘s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” and its findings of infringement. We have jurisdiction under
II
“Following a bench trial, we review a district court‘s conclusions of law de novo and its findings of fact for clear error.” Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1303 (Fed. Cir. 2015).
“A Markush claim is a particular kind of patent claim that lists alternative species or elements that can be selected as part of the claimed invention.” Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1357 (Fed. Cir. 2016). This typically appears in the form: “a member selected from the group consisting of A, B, and C.” 2015 Decision, 787 F.3d at 1363 n.3 (quoting Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1372 (Fed. Cir. 2005)).
Here, claim 1‘s (a) and (b) limitations use the phrase “consisting of,” or “consists of,” to characterize the matrix, and “consisting of” to define the groups, which “creates a very strong presumption that that claim element is ‘closed’ and therefore ‘exclude[s] any elements, steps, or ingredients not specified in the claim.‘” Multilayer Stretch Cling Film Holdings, 831 F.3d at 1358 (quoting AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1245 (Fed. Cir. 2001)). Overcoming this presumption requires “the specification and prosecution history” to “unmistakably manifest an alternative meaning,” such as when the patentee acts as its own lexicographer. Id. at 1359; see Conoco, Inc. v. Energy & Envtl. Int‘l, L.C., 460 F.3d 1349, 1359 n.4 (Fed. Cir. 2006).
Though the “consisting of” presumption is very strong, we permit the rare exception for “aspects unrelated to the invention.” Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331 (Fed. Cir. 2004). In Norian, we considered whether adding a spatula to a calcium phosphate chemical kit designed to repair teeth and bones took the accused product outside the scope of the asserted patent. Id. at 1324, 1331-32. The claim at issue contemplated only aspects of the chemicals themselves:
8. A kit for preparing a calcium phosphate mineral, said kit consisting of:
at least one calcium source and at least one phosphoric acid source free of uncombined water as dry ingredients; and
a solution consisting of water and a sodium phosphate, where the concen-
tration of said sodium phosphate in said water ranges from 0.01 to 2.0 M and said solution has a pH in the range of about 6 to 11.
Id. at 1324-25. We concluded that “[i]nfringement is not avoided by the presence of a spatula, for the spatula has no interac-tion with the chemicals, and is irrelevant to the invention.” Id. at 1332.
Here, Watson‘s ANDA Product does not facially satisfy the claim 1(b) Markush limitation. The Watson ANDA Product‘s extragranular space—which the district court recognized is the outer hydrophilic matrix—contains the following excipient composition and properties:
| Excipient | Amount (mg) | Property |
|---|---|---|
| SSG | <34 (unknown) | Hydrophilic |
| Magnesium stearate | <7 (unknown) | Lipophilic |
| Colloidal silicon dioxide | 4 |
Watson‘s Opening Br. at 16, see J.A. 2162, 2209.1 As the district court concluded, “[m]agnesium stearate, an excipient not within the claim 1(b) Markush group, is present within the extragranular space.” 2016 Trial Decision, 2016 WL 1258885, at *15. So the claim 1(b) limitation is literally violated.
Nonetheless, the district court found that Watson infringed because the component outside of the Markush group—i.e., the lipophilic magnesium stearate in the hydrophilic outer matrix—is unrelated to the invention. Therefore, the district court held that the lipophilic component in the outer hydrophilic matrix fell within the exception announced in Norian. Id. at *14-15. We disagree with the district court‘s interpretation of Norian and what constitutes a component unrelated to the invention.
The putative invention of the ‘720 patent is a multi-matrix system that relies on the hydrophilic and lipophilic characteristics of the matrices to release mesalamine in the colon “in a sustained and uniform manner.” 2015 Decision, 787 F.3d at 1362. When the outer, hydrophilic matrix interacts with a person‘s digestive fluids, the matrix creates a swollen barrier preventing aqueous solution from reaching the inner, lipophilic matrix. See ‘720 patent col. 2 ll. 60-64. This delay permits the product to proceed through the digestive system until the water breaks apart the outer matrix, releasing the lipophilic granules. See id. col. 3 l. 57-col. 4 l. 5.
Here, the district court concluded that the “magnesium stearate in the extragranular space is overwhelmed by the hydrophilic properties of the sodium starch glycolate in the extragranular space” and credited expert testimony that the hydrophilic “sodium starch glycolate is more potent than the mag stearate” when “outside” the granules. 2016 Trial Decision, 2016 WL 1258885, at *15 (emphases added) (internal quotation marks omitted). The district court thereby found that the magnesium stearate exerted lipophilic influence in the outer matrix, and that finding is well supported: Shire‘s expert acknowledged that “the magnesium stearate
Shire argues, and the district court held, that the magnesium stearate in Watson‘s product—which Watson includes as a lubricant rather than for its lipophilic properties—is unrelated to the invention because it is not sufficiently lipophilic to render the outer matrix lipophilic. But Norian did not restrict “related” components to only those that advance or are intended to advance a Markush group‘s allegedly inventive elements. And we decline to impose such a requirement, which would in effect equate the scope of a Markush group‘s “consisting of” language with either “comprising” or “consisting essentially of” language. See CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“‘[C]omprising’ ... is inclusive or open-ended and does not exclude additional, unrecited elements or method steps....” (quoting Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1327-28 (Fed. Cir. 1999))); AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1239 (Fed. Cir. 2003) (“The phrase ‘consisting essentially of ... permit[s] inclusion of components not listed in the claim, provided that they do not ‘materially affect the basic and novel properties of the invention.‘” (quoting PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998))).
Shire also argues that we must interpret claim 1(b) to cover products with magnesium stearate in the extragranular space because the ‘720 patent examples disclose magnesium stearate in the outer matrix. Assuming that Shire is correct about the content of the examples, we still find that Shire has not “overcome the exceptionally strong presumption” that Markush groups are closed. Multilayer Stretch Cling Film Holdings, 831 F.3d at 1359 (holding that a patent specification‘s listing of components not listed in a Markush group was insufficient to overcome the presumption created by “consisting of” claim language). Shire does not challenge the district court‘s construction of “consisting of,” and neither the ‘720 patent specification nor the prosecution history reflect intent to adopt a meaning of “consisting of” other than the well-established, limited definition. Thus, we apply the plain claim language.2
Accordingly, we conclude that Watson‘s ANDA Product does not satisfy the claim 1(b) Markush limitation, and, by extension, does not satisfy dependent claim 3. See Ferring B.V. v. Watson Labs., Inc.-Florida, 764 F.3d 1401, 1411 (Fed. Cir. 2014)
REVERSED AND REMANDED.