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Quest Diagnostics Investments LLC v. Laboratory Corporation of America Holdings

United States District Court, D. Delaware

January 14, 2020

QUEST DIAGNOSTICS INVESTMENTS LLC, Plaintiff,
v.
LABORATORY CORPORATION OF AMERICA HOLDINGS, ESOTERIX, INC. and ENDOCRINE SCIENCES, INC., Defendants.

          MEMORANDUM ORDER

          THE HONORABLE MARYELLEN NOREIKA UNITED-STATES DISTRICT JUDGE.

         IT IS HEREBY ORDERED that the claim terms of U.S. Patent Nos. 7, 972, 867 (“the '867 Patent”), 7, 972, 868 (“the '868 Patent”), 8, 101, 427 (“the '427 Patent”) and 8, 409, 862 (“the '862 Patent”) with agreed-upon constructions are construed as follows (see D.I. 81 at 5-6):

1. “generating a protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 [said vitamin D metabolite]” means “adding a proton and removing a water molecule from said 25-hydroxyvitamin D2 [said vitamin D metabolite] to generate a precursor ion” ('867 Patent)
2. “derivatizing” means “reacting two molecules to form a new molecule” ('868 Patent)
3. “derivatizing the dihydroxyvitamin D m metabolites from said sample with 4'-carboxyphenyl-TAD” means “reacting the dihydroxyvitamin D metabolites from said sample with 4'-carboxyphenyl-TAD to form a new molecule” ('868 Patent)
4. no construction necessary for “detecting the amount” ('427 and '862 Patents)
5. no construction necessary for “detecting the presence or amount” ('867 Patent)
6. no construction necessary for “determining the presence or amount” ('867 Patent)

         Further, as announced at the hearing on January 7, 2020, IT IS HEREBY ORDERED that the disputed claim terms of the '862, '867 and '427 Patents are construed as follows:

1. “capable of detecting testosterone at concentrations of less than 10 ng/dL [or 5 ng/dL or 1 ng/dL] in the sample” shall be given its plain and ordinary meaning, which is “the method is able to detect testosterone at concentrations below 10 ng/dL [or 5 ng/dL or 1 ng/dL] in the sample” ('862 Patent, claims 1, 8, 9, 15, 23 & 24)
2. “ionizing” shall be given its plain and ordinary meaning, which is “altering a molecule such that it has a net electric charge” ('862 Patent, claims 1, 10-12, 15 & 18-20)
3. “testosterone ions” shall be given its plain and ordinary meaning, which is “one or more testosterone molecules that have been altered to have a net electric charge or one or more fragments thereof with a net electric charge” ('862 Patent, claims 1, 12, 15 & 20)
4. “purifying testosterone” shall be given its plain and ordinary meaning, which is “enriching the amount of testosterone relative to one or more other components of the sample” ('862 Patent, claims 1 & 15)
5. no construction is necessary for “relating the detected ions to the presence or amount of said 25-hydroxyvitamin D2 in said sample” ('867 Patent, claim 21)[1]
6. no construction is necessary for “relating the detected ions to the amount of said vitamin D metabolite in said sample” ('427 Patent, claim 1)[2]

         The parties briefed the issues (see D.I. 81) and submitted an appendix containing both intrinsic and extrinsic evidence, including expert declarations (see D.I. 87, 88 & 89; see also D.I. 72, 73 & 75). Both sides also provided a tutorial describing the relevant technology. (See D.I. 80 & 83). The Court carefully reviewed all submissions in connection with the parties' contentions regarding the disputed claim terms, heard oral argument (see D.I. 96) and applied the following legal standards in reaching its decision:

         I. LEGAL STANDARD

         A. Claim Construction

         “[T]he ultimate question of the proper construction of the patent [is] a question of law, ” although subsidiary fact-finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015). “[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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc) (internal citations and quotation marks omitted). Although “the claims themselves provide substantial guidance as to the meaning of particular claim terms, ” the context of the surrounding words of the claim also must be considered. Id. at 1314. “[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 . . . [as] 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). 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. “Even when the specification describes only a single embodiment, [however, ] 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) (internal quotation marks omitted) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)).

         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) (en banc), 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, courts “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. 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.” Phillips, 415 F.3d at 1318. 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, although 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 ...


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