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Pharmacyclics LLC v. Acerta Pharma B.V.

United States District Court, D. Delaware

August 7, 2019

PHARMACYCLICS LLC, Plaintiff,
v.
ACERTA PHARMA B.V., ACERTA PHARMA LLC, and ASTRAZENECA PHARMACEUTICALS LP, Defendants. Claim Term Construction

          MEMORANDUM ORDER

         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 9, 079, 908 ("the '908 patent"), 9, 139, 591 ("the '591 patent"), and 9, 556, 182 ("the '182 patent") (collectively, "the asserted patents").[1] I have considered the parties' joint claim construction chart and brief. (D.I. 119, 140). I heard oral argument on May 8, 2019. (D.I. 171).

         A. BACKGROUND

         On November 3, 2017, Plaintiff filed suit against Defendants for infringement of the asserted patents. (D.I. 1). The asserted patents relate to small molecule compounds that bind to a protein known as Bruton's tyrosine kinase ("BTK"). (Id. ¶ 1). The compounds act to irreversibly inhibit BTK activity. (Id.). Plaintiff obtained FDA approval for a new drug, Imbruvica, that allegedly practices the asserted patents. (Id. ¶¶ 3-5). On October 31, 2017, Defendants obtained FDA approval for a different new drug, Calquence. (Id. ¶ 16). Plaintiff asserts that Calquence is a BTK inhibitor within the class of compounds claimed by the asserted patents.

         B. LEGAL 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) (citation omitted). '"[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources 'in light of the statutes and policies that inform patent law."' SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Of these sources, "the 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." Phillips, 415 F.3d at 1315.

         "[T]he words of a claim are generally given their ordinary and customary meaning. . . . [This is] the 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 1312-13. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321. "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314.

         When a court relies solely upon the intrinsic evidence-the patent claims, the specification, and the prosecution history-the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015). The court may also make factual findings based upon consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19. Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

         "A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'l Trade Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation omitted).

         C. CONSTRUCTION OF AGREED-UPON TERMS

         The Court adopts the following agreed-upon constructions.

Claim Term
Construction

"heterocycle"; "heterocyclic"

"Heteroaromatic and heteroalicyclic groups containing one to four heteroatoms each selected from 0, S and N, wherein each heterocyclic group has from 4 to 10 atoms in its ring system, and with the proviso that the ring of said group does not contain two adjacent 0 or S atoms. Herein, whenever the number of carbon atoms in a heterocycle is indicated (e.g., C1-C6 heterocycle), at least one other atom (the heteroatom) must be present in the ring. Designations such as 'C1-C6 heterocycle' refer only to the number of carbon atoms in the ring and do not refer to the total number of atoms in the ring. It is understood that the heterocylic ring can have additional heteroatoms in the ring. Designations such as '4-6 membered heterocycle' refer to the total number of atoms that are contained in the ring (i.e., a four, five, or six membered ring, in which at least one atom is a carbon atom, at least one atom is a heteroatom and the remaining two to four atoms are either carbon atoms or heteroatoms). In heterocycles that have two or more heteroatoms, those two or more heteroatoms can be the same or different from one another. Heterocycles can be optionally substituted. Binding to a heterocycle can be at a heteroatom or via a carbon atom. Non-aromatic heterocyclic groups include groups having only 4 atoms in their ring system, but aromatic heterocyclic groups must have at least 5 atoms in their ring system. The foregoing groups, as derived from the groups listed above, are optionally C-attached or N-attached where such is possible. Depending on the structure, a heterocycle group can be a monoradical or a diradical (i.e., a heterocyclene group)."

"lower heterocycloalkyl"

"A heterocycloalkyl having a maximum of 8 carbon atoms." [2]

         D. CONSTRUCTION OF DISPUTED TERMS

         The asserted patents provide express definitions for each of the disputed terms, which both parties adopt into their proposed constructions. The parties disagree, however, on what those definitions mean. Specifically, Defendants seek to add a sentence clarifying that each of the following four phrases "imposes no upper limit on the number of carbon atoms": (1) "optionally has 1 to 10 carbon atoms," (2) "include groups having from 3 to 10 ring atoms," (3) "can be formed by five, six, seven, eight, nine, or more than nine carbon atoms," and (4) "includes one or more ring heteroatoms." In addition, the parties dispute whether "substituted," as defined, imposes a limit on the number of substitutions that can be made.

         1. "alkyl"; "lower alkyl"

a. Plaintiff's Proposed Construction:
"An aliphatic hydrocarbon group. The alkyl moiety includes a 'saturated alkyl' group, which means that it does not contain any alkene or alkyne moieties. The alkyl moiety also includes an 'unsaturated alkyl' moiety, which means that it contains at least one alkene or alkyne moiety. An 'alkene' moiety refers to a group that has at least one carbon-carbon double bond, and an 'alkyne' moiety refers to a group that has at least one carbon-carbon triple bond. The alkyl moiety, whether saturated or unsaturated, includes branched, straight chain, or cyclic moieties. Depending on the structure, an alkyl group includes a monoradical or a diradical (i.e., an alkylene group), and if a 'lower alkyl" having 1 to 6 carbon atoms. As used herein, C1-Cx includes C1-C2, C1-C3 ... C1-Cx. The 'alkyl' moiety optionally has 1 to 10 carbon atoms (whenever it appears herein, a numerical range such as' 1 to 10' refers to each integer in the given range; e.g., '1 to 10 carbon atoms' means that the alkyl group is selected from a moiety having 1 carbon atom, 2 carbon atoms, 3 carbon atoms, etc., up to and including 10 carbon atoms, although the present definition also covers the occurrence of the term 'alkyl' where no numerical range is designated). The alkyl group of the compounds described herein may be designated as 'C1-C4 alkyl' or similar designations. Alkyl groups are optionally substituted or unsubstituted."
b. Defendants' Proposed Construction:
Identical to Plaintiffs proposed construction, except adding, "For clarity, the definition of alkyl imposes no upper limit on the number of carbon atoms."
c. Court's Construction:
"An aliphatic hydrocarbon group. The alkyl moiety includes a 'saturated alkyl' group, which means that it does not contain any alkene or alkyne moieties. The alkyl moiety also includes an 'unsaturated alkyl' moiety, which means that it contains at least one alkene or alkyne moiety. An 'alkene' moiety refers to a group that has at least one carbon-carbon double bond, and an 'alkyne' moiety refers to a group that has at least one carbon-carbon triple bond. The alkyl moiety, whether saturated or unsaturated, includes branched, straight chain, or cyclic moieties. Depending on the structure, an alkyl group includes a monoradical or a diradical (i.e., an alkylene group), and if a Tower alkyl" having 1 to 6 carbon atoms. As used herein, C1-Cx includes C1-C2, C1-C3 . .. C1-Cx. The 'alkyl' moiety optionally has 1 to 10 carbon atoms (whenever it appears herein, a numerical range such as' 1 to 10' refers to each integer in the given range; e.g.,' 1 to 10 carbon atoms' means that the alkyl group is selected from a moiety having 1 carbon atom, 2 carbon atoms, 3 carbon atoms, etc., up to and including 10 carbon atoms, although the present definition also covers the occurrence of the term 'alkyl' where no numerical range is designated). The alkyl group of the compounds described herein may be designated as 'C1-C4 alkyl' or similar designations. Alkyl groups are optionally substituted or unsubstituted. I do not understand this express definition to impose an upper limit of 10 on the number of carbon atoms."

         The specification defines "alkyl" as a moiety that "optionally has 1 to 10 carbon atoms." '908 patent at 27:63-28:15. The specification explains, "[A] numerical range such as' 1 to 10' refers to each integer in the given range; e.g., '1 to 10 carbon atoms' means that the alkyl group is selected from a moiety having 1 carbon atom, 2 carbon atoms, 3 carbon atoms, etc., up to and including 10 carbon atoms." Id. Therefore, the only dispute is over the meaning of "optionally." Plaintiff argues that "optionally has 1 to 10 carbon atoms" means a maximum of 10 carbon atoms. (D.I. 140 at 7). Defendants argue that "optionally" indicates that there is no upper limit on the number of carbon atoms. (Id. at 21).

         Defendants argue that Plaintiffs construction renders "optionally" superfluous. (Id. at 22-23). I agree. The specification expressly states that "1 to 10 carbon atoms" means any number of carbon atoms between 1 and 10, which is no different from Plaintiffs proposed construction of "optionally has 1 to 10 carbon atoms." In contrast, the specification defines "lower alkyl" as simply "having 1 to 6 carbons," which the parties agree creates an upper limit of 6 carbons. (Id. at 22). Therefore, construing "optionally has 1 to 10" to mean an upper limit of 10 would ignore the difference in wording between the definitions of "alkyl" and "lower alkyl." "A claim construction that gives meaning to all the terms of the claim is preferred over one that does not do so." Merck & Co., Inc. v. Teva Pharma. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005); Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., 2018 WL 389183, at *7 (D. Del. Jan. 12, 2018) (rejecting a proposed construction that rendered meaningless the difference in the way two limitations were written).

         Plaintiff argues that it is consistent with other parts of the specification to read out "optionally" from "optionally has 1 to 10." For example, the specification states, "Alkyl groups are optionally substituted or unsubstituted." '908 patent at 28:10-11. It is undisputed that a group can only be "substituted" or "unsubstituted." There is no third possibility. Therefore, there is no difference between stating "optionally substituted or unsubstituted" and simply "substituted or unsubstituted."

         I agree that the specification does not always use "optionally" in a way that is strictly necessary. That does not mean, however, that all uses of "optionally" are superfluous. The plain and ordinary meaning of "optionally" is non-limiting. See Optional, Merriam-Webster.com Dictionary (2019) ("involving an option: not compulsory"). Where "optionally" is followed by all possible choices, such as "optionally substituted or unsubstituted," it is superfluous. But where "optionally" is followed by a subset of possible choices, such as "optionally has 1 to 10 carbon atoms" or "optionally substituted, "[3] it has independent meaning. Both uses of "optionally" are non-limiting. In contrast, Plaintiff advocates for a construction that would read "optionally" as sometimes limiting and sometimes non-limiting. I do not think the record supports deviating from the plain and ordinary meaning of "optionally." Therefore, I adopt Defendants' proposed construction.[4]

         2. "alkenyl"; "cycloalkenyl"


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