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Mallinckrodt IP Unlimited Co. v. B. Braun Medical Inc.

United States District Court, D. Delaware

June 5, 2018


          Thomas C. Grimm, Jeremy A. Tigan, Stephen J. Kraftschik, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE Kenneth G. Schuler, Marc N. Zubick, Sarah W. Wang, LATHAM & WATKINS LLP, Chicago, IL Daniel G. Brown, Michelle Ernst, LATHAM & WATKINS LLP, New York, NY Attorneys for Plaintiffs Mallinckrodt IP Unlimited Company and Mallinckrodt Hospital Products Inc.

          Thomas C. Grimm, Jeremy A. Tigan, Stephen J. Kraftschik, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE Charles A. Weiss, Merri C. Moken, HOLLAND & KNIGHT LLP, New York, NY Attorneys for Plaintiff SCR Pharmatop

          Benjamin J. Schladweiler, GREENBERG TRAURIG, LLP, Wilmington, DE Richard C. Pettus, Scott J. Bomstein, GREENBERG TRAURIG, New York, NY Attorneys for Defendant B. Braun Medical Inc.



         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, 2018 (see Tr.).[1]


         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. AWHCorp., 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 "[differences 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), affd, 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)).


         A. The '218 Patent

         1."inert gas"[3]

         Plaintiffs No construction is necessary beyond plain and ordinary meaning, which is "a nonreactive gas under particular conditions"

         Defendant A gas that is "inert, " i.e., nonreactive under ordinary conditions (e.g., argon, carbon dioxide, neon, nitrogen, xenon - but does not include steam)

         Court "a nonreactive gas under particular conditions (e.g., argon, carbon dioxide, neon, nitrogen, xenon)"

         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 IUPAC 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 particular conditions to which it is subjected; i.e., specific gases may or may not be non-reactive under various conditions." (D.I. 146 at 3) Plaintiffs also contend that Defendant's proposal improperly narrows the claims by "adding the litigation-driven negative limitation that claimed 'inert gas' excludes steam." (D.I. 128 at 6; see also D.I. 146 at 4)

         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.[4]

         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.[5]

         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....").

         2."residual oxygen content"[6]

         Plaintiffs No construction is necessary beyond plain and ordinary meaning, which is "remaining oxygen content"

         Defendant The oxygen content of the aqueous solution for the "prolonged period" of stability

         Court The oxygen content of the aqueous solution for the "prolonged period" of stability

         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:

1. A method for preparing an aqueous solution with an active nature susceptible to oxidation, which is paracetamol, while preserving for a prolonged period, comprising deoxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2 ppm, and optionally the aforementioned aqueous solution with an active principle is topped with an inert gas atmosphere heavier than air and placed in a closed container in which the prevailing pressure is 65, 000 Pa maximum, and the oxygen content of the aqueous solution is below 2 ppm, and optionally the deoxygenation of the solution is completed by addition of an antioxidant.

         Representative dependent claim 4 recites:

4. The method for preparing a formulation of claim 1 wherein the residual oxygen content in the aqueous solution is equal to 0.5 ppm or below.

         As Defendant describes, "the goal/purpose of the alleged invention is to manufacture a final acetaminophen solution with below 2 ppm of oxygen using extreme deoxygenation and to maintain that oxygen level below 2 ppm for the claimed prolonged period in order to achieve the required preservation/stability." (D.I. 129 at 7; see also '218 patent at 2:56-60 ("[O]xygen shows a very great facility to dissolve in water, making it necessary to ensure that the solution, once deoxygenated, does not subsequently come into contact with atmospheric air, otherwise the advantage of having previously eliminated the oxygen will be lost."'') (emphasis added); id. at 3:66-4:14 ("The object of the invention is specifically a method for producing aqueous formulations . . ., which are stable over a long period of time, . . ., characterized in that they are obtained by submitting them to extreme deoxygenation either by bubbling of an inert gas, or by placing under vacuum, then protecting them from possible resorption of oxygen during the course of production . . . .") (emphasis added))

         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. Francois 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 and were exposed to oxygen during sterilization were contaminated, while solutions that had an oxygen content of below 2 ppm and were not contaminated with oxygen during sterilization achieved the desired stability of greater than 6 months. (See D.I. 128 Ex. 13 at 13-14; see also Id. at 16 (Dr. Dietlin stating, "at least 5 of our competitors have not only copied our formulation, but also our process of maintaining oxygen below 2 ppm. They must, otherwise prolonged stability is impossible., y) (emphasis added); id. (Dr. Dietlin concluding, "through the extreme deoxygenation process, we were able to realize our goal as we developed a commercial, IV acetaminophen solution . . . which has an oxygen content of below 2 ppm and is stable for at least 2 years"))[7]

         3. Previously ...

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