United States District Court, D. Delaware
SPECTRUM PHARMACEUTICALS, INC. and UNIVERSITY OF STRATHCLYDE, Plaintiffs,
INNOPHARMA, INC., MYLAN TEORANTA, MYLAN INSTITUTIONAL LLC, and MYLAN INSTITUTIONAL INC., Defendants.
REPORT AND RECOMMENDATION
CHRISTOPHER J. BURKE, Magistrate Judge.
In this action filed by Plaintiffs Spectrum Pharmaceuticals, Inc. ("Spectrum") and University of Strathclyde (collectively, "Plaintiffs") against Defendants InnoPharma, Inc. ("InnoPharma"), Mylan Teoranta, Mylan Institutional LLC and Mylan Institutional Inc. (the "Mylan Defendants" and, collectively with InnoPharma, "Defendants"), Plaintiffs allege infringement of U.S. Patent No. 6, 500, 829 (the "829 patent"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions as set forth below.
A. The Asserted Patent
Plaintiffs assert infringement of the '829 patent, a patent entitled "Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives[.]" (D.I. 1, ex. A (hereinafter, the "'829 patent" or "the patent")) The patent is based on U.S. Appl. No. 08/426, 458 and was issued on December 31, 2002. ( Id. ) At the time of its issue, the '829 patent was assigned to University of Strathclyde, who subsequently issued an exclusive license to Spectrum. (D.I. 100 at ¶ 13)
The present invention centers on 5-formyltetrahydrofolic acid, a chemical compound commonly known as leucovorin. ('829 patent, col. 1:28-29) According to the '829 patent, leucovorin has long been used to act as a "rescue agent" to help prevent the toxic side effects of methotrexate, a chemotherapy agent. ( Id., col. 1:19-29; D.I. 47 at 2) The leucovorin compound is composed of equal amounts of two diastereoisomers, referred to as the "(6S)" and "(6R)" diastereoisomers. (D.I. 47 at 2; D.I. 52 at 1) The '829 patent asserts, however, that a report from 1981 found that only the (6S) diastereoisomer - also known as levoleucovorin - is responsible for leucovorin's beneficial clinical effects. ('829 patent, col. 1:57-61; see also D.I. 52 at 2) Other reports suggested that the (6R) diastereoisomer might actually inhibit the beneficial effects of the (6S) diastereoisomer. ( Id., cols. 1:62-2:12) Accordingly, the present invention relates to the preparation of a substantially pure form of the desired (6S) diastereoisomer from leucovorin. ( Id., Abstract; id., Fig. 4; see also D.I. 52 at 3)
B. Procedural Posture
This case arises out of InnoPharma's submission of Abbreviated New Drug Application ("ANDA") No. 203576 to the United States Food and Drug Administration ("FDA"), which seeks to market levoleucovorin products that are generic forms of Fusilev®, Spectrum's pharmaceutical product. (D.I. 100 at ¶¶ 1, 19) Spectrum is the holder of approved New Drug Application No. 20-140, which covers Fusilev®. ( Id. at ¶ 14)
Plaintiffs filed suit against InnoPharma on March 2, 2012, alleging that InnoPharma's submission of ANDA No. 203576 infringes at least one claim of the '829 patent under 35 U.S.C. § 271(e)(2)(A). (D.I. 1 at ¶ 22) Plaintiffs now make infringement allegations against InnoPharma and the three Mylan Defendants (who are said to have entered into an agreement to market InnoPharma's products at issue, or to be affiliated with entities that have done so), pursuant to 35 U.S.C. § 271(a)-(c). (D.I. 100 at ¶¶ 7, 24, 28-31)
On May 23, 2012, this case was referred to the Court by Judge Richard G. Andrews to hear and resolve all pretrial matters, up to and including case-dispositive motions. The parties completed initial briefing on claim construction on June 28, 2013. (D.I. 74) This briefing was followed by a series of letters to the Court from the parties further addressing the disputed claim terms. (D.I. 80, 82, 83, 84) The Court held a Markman hearing on July 23, 2013. (July 23, 2013 Hearing Transcript, hereinafter "Tr.") Pursuant to the Court's request at that hearing, (Tr. at 5), the parties later filed a joint stipulation requesting that the Court adopt agreed-upon constructions of nine terms in the '829 patent that had earlier been the subject of disputes between them. (D.I. 85)
After the Markman hearing, Plaintiffs submitted a notice of subsequent authority, attaching a Claim Construction Order issued by the United States District Court for the District of Nevada, Spectrum Pharms., Inc. v. Sandoz Inc., No. 2:12-cv-000111-GMN-NJK, 2013 WL 6865692 (D. Nev. Dec. 31, 2013) (hereinafter, the "Nevada Order"), which construed terms of the '829 patent that are at issue in this case. (D.I. 109) Each side later submitted a letter to the Court addressing whether one of the constructions found in the Nevada Order should be adopted by this Court. (D.I. 110, 117) The Court then held a hearing on February 14, 2014, where it allowed the parties to make supplemental Markman presentations in light of the Nevada Order. (D.I. 164, ex. 3)
After a discovery dispute arose, ( see D.I. 141), the parties asked the Court to construe one additional term of the '829 patent, (D.I. 158). The parties submitted briefing on this additional term, and completed such briefing on May 12, 2014. (D.I. 172)
II. STANDARD OF REVIEW
It is well-understood that "[a] claim in a patent provides the metes and bounds of the right which the patent confers on the patentee to exclude others from making, using, or selling the protected invention." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). The proper construction of claim terms is a question of law for the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The Court should generally give claim terms their "ordinary and customary meaning[, ]'" which is "the meaning that the term[s] 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." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (citations omitted). However, when determining the ordinary meaning of claim terms, the Court should not extract and isolate those terms from the context of the patent, but rather should endeavor to reflect their "meaning to the ordinary artisan after reading the entire patent." Id. at 1321.
To that end, the Court should look first and foremost to the language of the claims, because "[i]t 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." Id. at 1312 (internal quotation marks and citations omitted). For example, the context in which a term is used in a claim may be "highly instructive." Id. at 1314. In addition, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable" in discerning the meaning of a particular claim term. Id. This is "[b]ecause claim terms are normally used consistently throughout the patent, [and so] the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Moreover, "[d]ifferences among claims can also be a useful guide, " as when "the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15.
In addition to the words of the claims, the Court should look to other intrinsic evidence. For example, the Court should analyze the patent specification, which "may reveal a special definition given to a claim term... that differs from the meaning [that term] would otherwise possess." Id. at 1316. In that case, "the inventor's lexicography governs." Id. Even if the specification does not contain a special definition of the term at issue, it "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. at 1315 (internal quotation marks and citation omitted). That said, however, the specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). In addition to the specification, a court should also consider the patent's prosecution history, if it is in evidence, because it "can often inform the meaning of the claim language by demonstrating how the inventor understood the invention[.]" Phillips, 415 F.3d at 1317 (citations omitted).
Extrinsic evidence, "including expert and inventor testimony, dictionaries, and learned treatises[, ]" can also "shed useful light on the relevant art." Id. (internal quotation marks and citations omitted). Dictionaries (especially technical dictionaries) may be useful in this process because they typically provide "the accepted meanings of terms used in various fields of science and technology[.]" Id. at 1318. However, the United States Court of Appeals for the Federal Circuit has cautioned that "heavy reliance on [a] dictionary divorced from the intrinsic evidence risks transforming the meaning of the claim term to the artisan into the meaning of the term in the abstract, out of its particular context, which is the specification." Id. at 1321. Overall, while extrinsic evidence may be useful, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language." Id. at 1317 (internal quotation marks and citations omitted); accord Markman, 52 F.3d at 981.
In utilizing these resources during claim construction, courts should keep in mind that "[t]he 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." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
A. Agreed Constructions
As noted above, the parties have reached agreement with respect to construction of nine claim terms in the '829 patent that were previously in dispute. ( See D.I. 85) The Court recommends that these now agreed-upon constructions be adopted, and includes the parties' agreed-upon constructions as part of the Court's recommended constructions (listed as constructions 1-9) at the conclusion of this Report and Recommendation. Research Found. of State Univ. of N.Y. v. Mylan Pharms., L.P., C.A. No. 09-184-JJF-LPS, 2010 WL 1911589, at *2 (D. Del. May 12, 2010).
B. Disputed Terms
1. The "mixture" and "percentage" claim terms
The first dispute concerns two sets of claim terms, those labeled by Defendants as the "mixture" and "percentage" claim terms. The "mixture" claim terms are: "the compound consists of a mixture of (6S) and (6R) diastereoisomers" (found in Claim 1); "the composition consists of a mixture of (6S) and (6R) diastereoisomers" (found in Claim 5); and "a mixture of: a (6S) diastereoisomer selected from the group consisting of (6S) leucovorin (5-formyl-(6S)-tetrahydrofolic acid) and pharmaceutically acceptable salts and esters of (6S) leucovorin and the (6R) diastereoisomer thereof" (found in Claim 10). (D.I. 47 at 5-6; D.I. 52, ex. A) The "percentage" claim terms are: "consists of at least 92% by weight of the (6S) diastereoisomer" (found in Claim 1); "which consists of greater than 95% by weight of the (6S) diastereoisomer" (found in Claim 2); "consists of at least about 92% by weight of the (6S) diastereoisomer" (found in Claim 5); "said mixture of (6S) and (6R) diastereoisomers consists of at least about 95% by weight of the (6S) diastereoisomer" (found in Claim 7); "said mixture of (6S) and (6R) diastereoisomers consists of at least about 92% by weight of the (6S) diastereoisomer" (found in Claim 10); and "said mixture of (6S) and (6R) diastereoisomers consists of at least about 95% by weight of the (6S) diastereoisomer" (found in Claim 12). (D.I. 47 at 11-12; D.I. 52, ex. A)
As noted above, the "mixture" and "percentage" terms are found in Claims 1, 2, 5, 7, 10 and 12 of the '829 patent, respectively. (D.I. 47 at 5-6, 11-12) Moreover, the two sets of terms are related to each other, in that the compositions referred to in the "mixture" terms in Claims 1, 5, and 10 are said to "consist of" what is further described in the "percentage" terms in Claims 1, 2, 5, 7, 10 and 12. Claim 1's language is representative (at least for purposes of the dispute here) of the way the terms are used in other of the patent's claims:
A pharmaceutical composition for therapeutic use which consists essentially of a therapeutically effective amount sufficient for the treatment of human beings for methotrexate rescue or folate deficiency, of a pharmaceutically acceptable compound which is a (6S) diastereoisomer selected from the group consisting of (6S) leucovorin (5-formyl-(6S)-tetrahydrofolic acid) and pharmaceutically acceptable salts and esters of (6S) leucovorin; wherein the compound consists of a mixture of (6S) and (6R) diastereoisomers and consists of at least 92% by weight of the (6S) ...