Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 1 of 13 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK JDS THERAPEUTICS, LLC; NUTRITION 21, LLC, Plaintiffs, -v- PFIZER INC.; WYETH LLC; WYETH CONSUMER HEALTHCARE, LTD.; WYETH CONSUMER HEALTHCARE LLC, 12 Civ. 9002 (JSR) MEMORANDUM ORDER Defendants. JED S. RAKOFF, U.S.D.J. Plaintiffs JDS Therapeutics, LLC and Nutrition 21, LLC (collectively "JDS") bring this case asserting claims of patent infringement, misappropriation of trade secrets, breach of contract, and unjust enrichment against defendants Pfizer Inc., WyethLLC, Wyeth Consumer Healthcare, Ltd., and Wyeth Consumer Healthcare LLC (collectively, "Pfizer"). JDS's patent infringement claims involve United States Patents numbered 5,948,772 ("'772 patent"), 6,136,317 ("'317 patent"), 6,143,301 ("'301 patent"), 6,251,889 ("'889 patent"), and 6,471,998 ("'998 patent"), as well as Reissued Patent No. RE39,480 ("Re '480 patent"). On April 12, 2013, after full briefing, the Court conducted a hearing to aid its construction of terms that appear in the patents-in-suit. See Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). On May 21, 2013, the Court resolved the parties' disputes
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 2 of 13 regarding the meanings of the terms. This Memorandum Order reaffirms and explains the reasons for the constructions in the May 21 Order. Claim construction is a matter of law, exclusively within the province of the Court. Id. at 384-91. In Phillips v. AWH Corp., an en banc Federal Circuit elaborated the principles that govern claim construction. 415 F.3d 1303 (Fed. Cir. 2005) (en banc). " [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 quotation marks omitted). By way of further elaboration, the Federal Circuit has focused courts' attention on "the importance of intrinsic evidence," which consists of the claims, specification, and prosecution history. Id. at 1317. "A claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to... distinctly claim... as his invention." Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004) (internal quotation marks and alterations omitted). Accordingly, "one of the cardinal sins of patent law [is] reading a limitation from the written description [contained in the specification] into the claims." Phillips, 415 F.3d at 1320. Moreover, "the person of ordinary skill in the art is deemed to read 2
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 3 of 13 the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Id. at 1313. At the same time, however, the Federal Circuit has also stated that "the best source for understanding a technical term is the specification from which it arose, informed, as needed, by the prosecution history." Id. at 1315 (internal quotation marks and alterations omitted). The prosecution history can frequently "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. at 1317. In the instant case, however, the parties agree that, with the exception of the Re '480 patent, there is no significant prosecution history to aid the Court' s construction. See, e.g., Defendants' Opening Claim Construction Brief ("Def.. Cl. Br."), Mar. 8, 2013, at 6. Finally, courts may look to extrinsic evidence to define claim terms, 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 (internal quotation marks omitted). However, extrinsic evidence may not be used "to contradict claim meaning that is unambiguous in light of the intrinsic evidence." Id. at 1324. 3
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 4 of 13 With these claim construction principles in mind, the Court now turns to explaining its construction of the disputed claim terms. First, in its May 21 Order, the Court concluded that the chemical terms "chromic tripicolinate," "picolinic acid," and "nicotinic acid" require no construction. Pfizer proposes construing all three chemical terms so that each is represented by a formal chemical name, its symbol, and a graphical representation. However, the Court agrees with JDS that such a construction injects "highly-technical chemical formulas, which, even if precise," substitute scientific jargon that would be meaningless to a jury. Plaintiffs' Opening Claim Construction Brief ("Pl. Cl. Br."), at 9. It needs to be noted, in that respect, that a court construing the terms of a patent has to keep one eye cocked on the putative jury that may ultimately decide the parties' basic dispute, for a claim construction that is incomprehensible to a jury may be, in the end, of little use. See generally Jed S. Rakoff, Down with Patentese, 21 Fordham Intell. Prop. Media & Ent. L.J. 839 (2011). Additionally, the Court finds that JDS's proposed constructions of "chromic tripicolinate" and "nicotinic acid" impermissibly broaden the claims to include other, discrete substances. Next, the Court construes "essential metals" as "metals that are necessary for the performance of vital biological functions in a body." The parties disagree about two main issues whether more 4
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 5 of 13 than one metal is required by the use of the plural form in the patent, and whether the Court should add a parenthetical reference to "minerals" in its construction. The Court believes that in construing the term "essential metals" by itself, it is sufficient to use the term "metals" as it appears in the claim language, although, as discussed more fully below, the Court does adopt a more specific requirement of plurality in certain contexts. Also, the Court excludes the parenthetical reference to minerals because Pfizer correctly notes that the term "minerals" is broader than "metals." Defendants' Responsive Claim Construction Brief ("Def. Cl. Resp."), Mar. 22, 2013, at 13. Finally, JDS fails to provide any compelling reason to include the phrase "necessary to maintain good health" in the construction. Turning to the claims within the '772 family of patents, 1 the Court first explains why it does not import limitations relating to effectiveness from various claims' preambles. While, in principle, preambles can limit claims, see Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999), the Court will not use a gloss on various preambles to narrow claim language that has a clear and plain meaning. The Court agrees with JDS that the plain meaning of the preambles to claims in the '772 family of patents is "clear on [its] face, and [that] a person having ordinary skill in the art 1 The parties agree that five of the six patents-in-suit heavily overlap: The '317, '301, '889, and '998 patents all claim priority to U. S. Patent Application 09/144,026, which ultimately issued as the '772 patent. The Court refers to these patents collectively as the "'772 family of patents." 5
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 6 of 13 readily knows that the claimed methods and compositions are not subject to such rigorous tests of medical efficacy. " Pl. Cl. Br., at 14. Furthermore, other dependent claims in the '772 family of patents actually use the word "effective," thus giving rise to a presumption that the independent claims do not contain such a limitation. Plaintiffs' Opposing Claim Construction Brief ("Pl. Cl. Resp."), Mar. 22, 2013, at 5-6 (citing Phillips v. AWH Corp., 415 F.3d 1303, 1314-15 (Fed. Cir. 2005) (en banc)). Turning to the specific claim phrases, the Court affirms its construction that the term "A composition for supplementing dietary chromium and facilitating absorption of essential metals" means "A composition for supplementing dietary chromium and facilitating absorption of two or more metals necessary for the performance of vital biological functions in a body." First, in deciding whether "essential metals" means "two or more" essential metals, the Court applies the rule of thumb that "the plural form of a claim term should generally be defined simply as 'two or more' of the term's singular form." In re Fenofibrate Patent Litig., No. 11 MDL 2241, 2011 U.S. Dist. =CIS 95061, at *9 (S.D.N.Y. Aug. 23, 2011). Moreover, claims 1 and 9 of the '889 patent expressly refer to "one or more essential metals," thus showing that the patentees knew how to claim "one or more" when they wanted to do so. See '889 patent, claims 1 & 9. Finally, the Court finds that the phrases "supplementing dietary chromium" and 6
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 7 of 13 "facilitating absorption" require no clarification or alternate formulation. Next, the Court reaffirms that "A method for supplementing dietary chromium in an individual" requires no construction. See Harris Corp. v. IXYS Corp., 114 F.3d 1149, 1152 (Fed. Cir. 1997). The Court construes the term "A method for reducing hyperglycemia and stabilizing serum glucose levels in an individual in need thereof" as "A method for reducing elevated blood sugar and decreasing blood sugar fluctuations in an individual with a perceived need to reduce elevated blood sugar and to decrease blood sugar fluctuations." The Court agrees with JDS that it is inappropriate to import limitations from one embodiment in the specification into more general claim language. See Phillips, 415 F.3d at 1323. The Court also finds that Pfizer's multiple attempts to limit the asserted patents to treatment of diabetes by importing language from the '623, '624, and '156 patents and by using the prior litigation and prosecution history of those patents are inappropriate, particularly because the patents are not asserted in this case and are only incorporated by reference into the background section of the '772 family of patents to describe the prior art. Finally, to avoid confusion and to be precise, the Court substitutes the complete description of the goals of the method when construing the phrase "in need thereof." 7
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 8 of 13 Next, the Court finds that the term "said effective amount" means "the dosage amount of chromium." While the term lacks an antecedent basis, this does not automatically mean that the claim is indefinite. In circumstances such as this one, in which "the scope of a claim would be reasonably ascertainable by those skilled in the art,... the claim is not indefinite." Energizer Holdings, Inc. v. Int'l Trade Commin, 435 F.3d 1366, 1370-71 (Fed. Cir. 2006) (internal quotation marks omitted). In addition, the Court affirms its construction of the term "an effective daily hyperglycemia-reducing amount" as "a daily amount that is sufficient to reduce elevated blood sugar." The principal dispute regarding construction of this phrase is that Pfizer would add that the hyperglycemia that the invention reduces is "associated with diabetes." Pfizer admits that its reasoning for reading "associated with diabetes" into the claim is "[t]he same reasoning [as it offers] for the term 'reducing hyperglycemia.'" Def. Cl. Br., at 21. Therefore, for the same reasons described earlier in the context of the claim phrase "reducing hyperglycemia," the Court does not include the phrase "associated with diabetes" in its construction. In addition, the Court believes that the phrase "daily amount that is sufficient" captures the claim requirement that the amount be "effective," contrary to Pfizer's concerns. 8
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 9 of 13 For reasons already outlined when explaining its construction of other claim terms, the Court also affirms that the term "A method for facilitating absorption of one or more essential metals by an individual in need thereof" means "A method for facilitating absorption of one or more metals that are necessary for the performance of vital biological functions in a body by an individual with a perceived need for one or more such metals." Next, the term "A method for supplementing dietary chromium in an individual in need of enhanced dietary chromium" means "A method for providing additional chromium in an individual with a perceived need for additional dietary chromium." The parties' disputes with respect to this phrase in the '998 patent are the same as their disputes discussed earlier regarding the inclusion of "effectiveness," "specific perceived need," "chromium-deficient diet," and "associated with diabetes," and the Court' s reasoning on those disputes applies with equal force here. With respect to the remaining terms in this claim, the Court adopts the constructions on which the parties agree. Also for reasons discussed earlier in the context of other claim terms, the Court reaffirms that "A method for reducing hyperglycemia and stabilizing serum glucose levels in an individual in need of reduced and/or stabilized blood sugar" means "A method for reducing elevated blood sugar and decreasing blood sugar fluctuations 9
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 10 of 13 in an individual with a perceived need to reduce and/or stabilize blood sugar." Construction of the Re '480 patent's claims differs because of the patent's different prosecution history. In its request to reissue the '066 patent, the named applicant which the Court labels "JDS" for descriptive ease intended "to add a claim that [did] not require both a reduction in hyperglycemia and the stabilization of the serum glucose level in an individual... [and] to add claims that exclude [d] compositions having other active blood glucose serum ingredients." Declaration of Michael S. Heesters in Support of Defendants' Opening Claim Construction Brief, Mar. 8, 2013, Ex. C (U.S. Prosecution History for U.S. Patent No. RE39,480), at N21 Pfizer 8. While prosecuting the reissuance, JDS argued that the term "greater than additive effect" meant "an effect greater than one would expect from simply combining two ingredients." Id. at N21 Pfizer 223. After JDS s request was initially rejected based on the written description requirement, JDS commented: The Abstract of the instant application discloses "[a] method for treating Type II diabetes by administering... a combination of chromic tripicolinate and biotin" (emphasis supplied). Applicant submits that it is well-recognized that the primary focus of therapy for Type II diabetes is the reduction of hyperglycemia. As such, Applicant's teaching of the administration of chromium tripicolinate and biotin to reduce the requirement for insulin (which reduces hyperglycemia by increasing glucose uptake) makes clear that the 1 0
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 11 of 13 Applicant contemplated use of the present method for reducing hyperglycemia. Id. at N21 Pfizer 221-22. JDS also met an indefiniteness rejection by noting that it "would be addressed by amending Claims 11 and 12 so that the preamble provides antecedent basis for the phrase 'reducing blood glucose levels,'" and that "[a]s amended, the recitation of 'reducing blood glucose levels' in the preamble of Claims 11 and 12 now provides antecedent basis for the phrase 'reducing blood glucose levels' in the body of the claims." Id. at N21 Pfizer 339-40. Largely as a result of this prosecution history, the Court construes the term "A method for reducing hyperglycemia and stabilizing the level of serum glucose comprising administering to an individual in need thereof" in the '480 patent as "A method for reducing the elevated blood sugar associated with diabetes and decreasing blood sugar fluctuations comprising administering to an individual having a perceived need for such treatment." The preamble to claim 1 for the patent should be construed to associate "diabetes" with "hyperglycemia" and to use the word "treatment" in the construction of "need thereof." However, for the reasons discussed in the context of the '772 family of patents, the Court does not call the need "specific" or require that the method be "effective." Moreover, in the '480 patent, the term "wherein the amounts of chromic tripicolinate and biotin are selected together to provide 11
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 12 of 13 a greater than additive effect" means "wherein the amounts of chromium picolinate and biotin are selected together to provide a combined effect that is greater than the sum of the individual effects if administered separately." Also, the term "wherein the amounts of chromic tripicolinate and biotin are selected together to provide a synergistic effect in reducing blood glucose levels" means "wherein the amounts of chromium picolinate and biotin are selected to provide a combined effect that is greater than the sum of the individual effects if administered separately." The Court agrees with JDS that there is no need to construe "selected," and even if there were, the introduction of an "intentional choice" into the claim is based on at best weak extrinsic evidence. The Court, however, does agree with Pfizer that "provide a synergistic effect" and "greater than additive effect" should be construed similarly as "a combined effect that is greater than the sum of the individual effects if administered separately." Finally, for reasons outlined earlier in the context of other claims, the Court reaffirms that the term "A method of reducing blood glucose levels comprising administering to an individual in need thereof" in the '480 patent means "A method of reducing blood glucose levels comprising administering to an individual with a perceived need to reduce blood glucose levels." 12
Case 1:12-cv-09002-JSR Document 129 Filed 12/02/13 Page 13 of 13 For the aforementioned reasons, the Court hereby reaffirms the constructions in its May 21 Order. SO ORDERED. Dated: New York, New York November AT 2013 13