LEONARD P. STARK, District Judge.
On April 3, 2017, in response to a Paragraph IV certification to U.S. Patent No. 6,992,218 from Defendant B. Braun Medical Inc. ("Defendant" or "Braun"), Plaintiffs Mallinckrodt IP Unlimited Company, Mallinckrodt Hospital Products Inc., and SCR Pharmatop (collectively, "Plaintiffs") sued Braun, alleging infringement of the '218 patent and U.S. Patent No. 9,399,012. On May 31, 2017, in response to a second Paragraph IV letter from Braun with a certification to the '012 patent, Plaintiffs Mallinckrodt IP Unlimited Company and Mallinckrodt Hospital Products Inc. (collectively, "Mallinckrodt") filed a second lawsuit, alleging infringement of the '012 patent and U.S. Patent No. 9,610,265 (collectively with the '012 and '218 patents, the "asserted patents"). The '218 patent is directed to the manufacture of aqueous formulations of acetaminophen products with a reduced oxygen content below 2 parts per million ("ppm") that are stable over a prolonged period. The '012 and '265 patents are directed to methods of treatment utilizing intravenous administration of acetaminophen at reduced doses.
Presently before the Court is the issue of claim construction. The parties submitted briefs (see C.A. No. D.I. 128, 129, 146, 147) and the Court held a claim construction hearing on May 18, (see Tr.).
The ultimate question of the proper construction of a patent is a question of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "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. A WH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.
"[T]he words of a claim are generally given their ordinary and customary meaning . . . [which 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 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent 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." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
While "the claims themselves provide substantial guidance as to the meaning of particular claim terms," the context of the surrounding words of the claim must also be considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment . . . [b ]ecause claim terms are normally used consistently throughout the patent . . . ." Id. (internal citation omitted).
It is likewise true that "[d]ifferences among claims can also be a useful guide . . . . For example, 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 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence," "consists of the complete record of the proceedings before the PTO [Patent and Trademark Office) and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[T)he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.
In some cases, "the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period." Teva, 135 S. Ct. at 841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90 F.3d at 1583).
Finally, "[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). 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) (quoting Modine Mfg. Co. v. U.S. Int'l Trade Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
The parties agree that an inert gas is a nonreactive gas, but dispute whether: (1) the gas must be nonreactive under "ordinary" conditions, as Defendant proposes, or under "particular" conditions, as Plaintiffs propose; and (2) steam is an inert gas in the context of the patent.
Plaintiffs contend the '218 patent and prosecution history provide no definition for inert gas, so they rely on a specialized technical dictionary, the International Union of Pure and Applied Chemistry ("IUPAC") Gold Book. (D.I. 128 at 5) The IUP AC defines "inert gas" as "[a] non-reactive gas under particular conditions." (Id. at 5-6) The term "particular conditions," Plaintiffs contend, adds clarity because a POSA "would readily understand that whether a gas is non-reactive depends on the
Defendant contends that the patent describes and claims "three uses of `inert gas': 1) inert gas is bubbled through the aqueous solution (which includes an oxidation sensitive active ingredient) to deoxygenate the solution; 2) inert gas is used to clear glass bottles of air before adding the aqueous solution; and 3) inert gas is used as a `topping gas which is heavier than air' to create an `inert gas atmosphere' in the bottle after the aqueous solution is added." (D.I. 129 at 5) According to Defendant, because steam is reactive "in several ways that are antithetical to the alleged invention's goal of avoiding degradation of acetaminophen," it should be excluded from the construction of inert gas. (D.I. 147 at 3)
The Court agrees with Plaintiffs that defining an inert gas in terms of "particular" conditions is accurate and provides clarity. As both parties recognize, the intrinsic record does not resolve this dispute. (See D.I. 128 at 5; D.I. 147 at 4) Looking to the extrinsic evidence, the technical dictionaries cited by Plaintiffs explain that examples of inert gases are "nitrogen at ordinary temperatures and the noble gases." (D.I. 128 Ex. 5 at 1; see also id. Ex 6 ("examples are the noble gases, and nitrogen at ordinary temperatures"); id. Ex 7 ("An inert gas is a gas which does not undergo chemical reactions under a set of given conditions. The noble gases and nitrogen often do not react with many substances.")) By calling out nitrogen separately from the noble gases, the dictionaries imply that different gases may have different reactivity levels at different conditions. Moreover, the Court is not persuaded a POSA would know what "ordinary conditions" are in this context.
With respect to the dispute about steam, the Court agrees with Plaintiffs that this is not an issue of claim construction but should instead be decided on a full record in the context of infringement. (See Tr. at 70-71 (Plaintiffs' counsel acknowledging that time to decide if steam is within scope of "inert gas" is when evidentiary record is complete); id. at 88-89 (Plaintiffs' counsel stating "whether steam is an inert gas in the scope of claim 1 is better for the infringement phase when you have a more wholesome record")) Defendant has not pointed to any clear and unmistakable disavowal of steam by the patentees.
Finally, the Court agrees with Defendant's proposed examples of inert gases. Contrary to Plaintiffs' suggestion, Defendant's construction does not limit the inert gases solely to one of the five identified gases. See, e.g., '218 patent at 2:39-40 ("an inert gas such as nitrogen, carbon dioxide or argon . . ."); see also D.I. 147 at 5 ("Braun's construction does not limit `inert gas' to the five disclosed gases — but allows for use of other gases that are inert . . . .").
The parties dispute whether "residual oxygen content" refers to the oxygen content remaining after deoxygenation, as Plaintiffs contend, or to the oxygen content that is maintained throughout the "prolonged period" of stability, as Defendant contends. The Court agrees with Defendant.
This term appears in claims 3, 4, 20, and 21 of the '218 patent, which are all dependent on claim 1. Independent claim 1 recites:
Representative dependent claim 4 recites:
As Defendant describes, "the goal/purpose of the alleged invention is to manufacture a
The patent contains no examples that expressly refer to the oxygen content of the aqueous solution during the prolonged period (e.g., 6-24 months). (See, e.g., '218 patent at 7:9-18, 8:3-17 (examples noting oxygen content at certain points in deoxygenation process, but never addressing oxygen content after process is done); see also Tr. at 28-29 (Plaintiffs' counsel acknowledging this point); id. at 75 (Defendant's counsel agreeing)) In the Court's view, the patent's silence on this point supports a finding that a POSA would understand, in the context of the entirety of the patent specification and the remainder of the intrinsic record (which now includes the history of the reexamination), that the "residual oxygen content" has to remain under 2 ppm for the entirety of the prolonged period. A POSA would expect that if the purpose of the patent could be achieved without maintaining the required deoxygenation level, that the patent or prosecution history would have given at least a hint of this reality (which they do not).
As just noted, this conclusion is supported by the evidence provided by the '218 patent inventor, Dr. Frarnçois Dietlin, who is also an expert for Plaintiffs. Dr. Dietlin explained in a declaration submitted during reexamination that the '218 patent resulted from accidental testing in which acetaminophen solutions that had been deoxygenated to an oxygen content of 2 ppm or greater
This Court as well as the Southern District of California have previously construed these terms. See Cadence Pharm., Inc. v. Paddock Labs. Inc., 886 F.Supp.2d 445, 459-60 (D. Del. 2012); Cadence Pharm., Inc. v. Agila Specialties Inc., 2016 WL 4524171, at *4 (D. Del. Aug. 29, 2016); Cadence Pharm., Inc. v. Fresenius Kabi USA, LLC, 2013 WL 12123854, at *9-15 (S.D. Cal. Dec. 2, 2013). Plaintiffs propose the Court adopt the prior constructions with only minor modifications. Defendant asks the Court to adjust the prior constructions to clarify that: (1) it is the
As discussed at the hearing, the parties agree that the "solution" proceeds through three stages during the claimed method: (1) an initial, pre-deoxygenation stage, (2) an extreme deoxygenation stage, during which the solution is deoxygenated until it reaches an oxygen content below 2 ppm, and (3) a post-deoxygenation stage, in which the solution is packaged and shelved and must remain stable for a prolonged period. (See Tr. at 22-24 (differentiating "mixing process" of "bubbling/vacuuming step" from "what happened once [the solution] got into the container" after bubbling/vacuuming step); id. at 44-45 (same)) The third stage — the stage involving what the Court will call the "final" aqueous solution — is the center of the parties' disputes here.
Defendant contends the purpose of the invention is to "manufacture a
Plaintiffs insist that the doctrine of claim differentiation forecloses including a requirement in claim 1 that the oxygen content of the solution in a closed container — i.e., the final aqueous solution — be below 2 ppm. (D.I. 128 at 17; Tr. at 20-21) Specifically, Plaintiffs assert that claim 11 of the '218 patent "has a different scope" than claim 1 because claim 11 does not merely address "the oxygen content of the solution while it is being prepared," but rather, goes to "the oxygen content in the closed containers." (Tr. at 24) Plaintiffs contend the PTO Examiner similarly understood this to be a key difference between claims 1 and 11 during reexamination, as the Examiner found claim 11 to require "the dissolved oxygen content [be] minimized and maintained at th[e] reduced level," while finding claim 1 to only involve the formulation itself and not maintaining the oxygen level. (Id. at 36-37; see also '218 Patent Reexamination Non-Final Office Action dated July 30, 2014, pp. 11-15)
However, as Plaintiffs concede, claim 11 contains various other differences from claim 1. (See Tr. at 39-41, 56-57) Hence, here, as may often be the case, claim differentiation is not dispositive. See Wenger Mfg., Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225, 1233 (Fed. Cir. 2001) ("Claim differentiation, while often argued to be controlling when it does not apply, is clearly applicable when there is a dispute over whether a limitation found in a dependent claim should be read into an independent claim, and that limitation is the only meaningful difference between the two claims."); SunRace, 336 F.3d at 1303 ("That presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim.").
The Court agrees with Defendant that it is the
Despite agreeing with Defendant on this point, the Court finds it unnecessary to adjust its prior construction (other than adding the agreed reference to 6 months). The term "aqueous solution" is used in the patent to refer to times throughout the deoxygenation process, so the term does not
Regarding the term "while preserving for a prolonged period," the parties agree that the Court's prior construction should be modified to clarify that the "prolonged period" must be greater than six (6) months. (D.I. 128 at 11 n.2; D.I. 129 at 11) Unlike the term "aqueous solution," this term only arises in claim 1, a claim that does not mention the "residual oxygen content." Therefore, the Court finds it necessary to clarify that the solution being "preserved for a prolonged period" is the final deoxygenated solution. As the patent specification teaches, "it is necessary to ensure that the solution,
However, as the claims specifically recite how preservation is accomplished and that the concentration must be below 2 ppm, the Court finds Defendant's recitation of "preserved by extreme deoxygenation to an oxygen concentration below 2 ppm" redundant. See '218 patent at cl. 1 ("A method for preparing an aqueous solution with an active nature susceptible to oxidation . . . while preserving for a prolonged period, comprising
Finally, regarding the term "deoxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2ppm," as the parties agree that bubbling "with at least one inert gas" is implicit in the Court's prior construction, the Court sees no reason to modify its construction here. In the context of this term, the solution is in a period of transition, and thus, the Court finds Defendant's added limitation improper. Accordingly, the Court will adopt its prior construction.
Plaintiffs contend the term "about" needs no construction and alternatively propose construing "about" as "approximately." (D.I. 128 at 18) Defendant counters that the patentee clearly and unambiguously disavowed claim scope and, therefore, the "about" terms need to be construed accordingly. (D.I. 147 at 13-14)
The Court agrees with Defendant. Plaintiffs offered no reason in their briefing or during the hearing as to why the Court should not adopt Defendant's constructions. In fact, Plaintiffs conceded that they narrowed the claim scope during prosecution, consistent with Defendant's proposals. (See Tr. at 93-94)
Defendant contends the claims' recitation of "`
The Court agrees with Plaintiffs. The Federal Circuit "has repeatedly emphasized that an indefinite article `a' or `an' in patent parlance carries the meaning of `one or more' in open-ended claims containing the transitional phrase `comprising.'" KCJ Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351, 1356 (Fed. Cir. 2000). Further, the '012 and '265 patent specifications state that "use of the singular includes the plural unless specifically stated otherwise." '012 patent at 3:63-67; '265 patent at 4:4-9. Moreover, dependent claim 12 of the '265 patent recites: "The method of claim 1, wherein the second pharmaceutical composition is administered as a single dose
The Court will construe the disputed terms as explained above. An appropriate Order follows.
The parties also identified indefiniteness disputes regarding certain claim language — "an active principle of phenolic nature susceptible to oxidation, which is paracetamol," appearing in all asserted claims, and "colorless," appearing in claim 24 of the '218 patent — but agreed that these issues need not be addressed in connection with the instant claim construction proceedings. (Id. at 1 n.1)
