Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Reckitt Benckiser Pharmaceuticals, Inc. v. Watson Laboratories, Inc.

United States District Court, D. Delaware

December 12, 2014

RECKITT BENCKISER PHARMACEUTICALS, INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC Plaintiffs,
v.
WATSON LABORATORIES, INC., Defendants. RECKITT BENCKISER PHARMACEUTICALS, INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC Plaintiffs,
v.
PAR PHARMACEUTICAL, INC., and INTELGENX TECHNOLOGIES CORP. Defendants.

Daniel A. Ladow (argued), Esq., Troutman Sanders LLP, New York, NY; James M. Bollinger, Esq., Troutman Sanders LLP, New York, NY; Timothy P. Heaton, Esq., Troutman Sanders LLP, New York, NY; J. Magnus Essunger, Esq., Troutman Sanders LLP, New York, NY; Timothy C. Bickham, Esq. (argued), Steptoe & Johnson LLP, Washington, DC; James F. Hibey, Esq., Steptoe & Johnson LLP, Washington, DC; Houda Morad, Esq., Steptoe & Johnson LLP, Washington, DC; Mary W. Bourke, Esq. (argued), Womble Carlyle Sandridge & Rice, LLP, Wilmington, DE; Daniel Attaway, Esq., Womble Carlyle Sandridge & Rice, LLP, Wilmington, DE; attorneys for plaintiffs.

Daniel G. Brown (argued), Esq., Latham & Watkins LLP, New York, NY; Emily C. Melvin, Esq., Latham & Watkins LLP, Chicago IL; David P. Dalke (argued), Esq., Winston & Strawn LLP, Los Angeles, CA; Peter Perkowski, Winston & Strawn LLP, Los Angeles, CA; Steven J. Fineman (argued), Esq., Richards, Layton & Finger, P.A.; John C. Phillips, Jr., Esq., Phillips, Goldman & Spence, P.A., Wilmington, DE; attorneys for defendants.

MEMORANDUM OPINION

RICHARD G. ANDREWS, District Judge.

Before this Court is the issue of claim construction of disputed terms found in three U.S. Patents, 8, 017, 150 ("the '150 patent"), 8, 475, 832 ("the '832 patent"), and 8, 603, 514 ("the '514 patent").

I. BACKGROUND

Plaintiffs assert that Defendants' ANDAs infringe the '150 patent, the '832 patent, and the '514 patent. (D.I. 106). The Court has considered the parties' claim construction briefing (D.I. 106, 107, 108) and held a Markman hearing on December 3, 2014.

II. LEGAL STANDARD

"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. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources in light of the statutes and policies that inform patent law.'" SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324). When construing patent claims, a matter of law, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Of these sources, "the 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." Phillips, 415 F.3d at 1315 (internal quotations and citations omitted).

Furthermore, "the 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, 415 F.3d at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314 (internal citations omitted).

A court may consider extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises, " in order to assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art and how the invention works. Id. at 1317-19 (internal quotation marks and citations omitted). However, extrinsic evidence is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

Moreover, "[a] claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." 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) (internal quotation marks and citation omitted).

III. CONSTRUCTION OF DISPUTED TERMS

A. The '150 Patent

Claim 1 of the '150 patent is representative:

A mucosally-adhesive water-soluble film product comprising:
an analgesic opiate pharmaceutical active; and
at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer;
wherein:
the water-soluble polymer component comprises greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer;
the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range 100, 000 to 300, 000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range 600, 000 to 900, 000; and
the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component.

(150 patent, claim 1).

1. "the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range of 100, 000 to 300, 000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range of 600, 000 to 900, 000; and the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component" (claims 1, 10)

a. Plaintiffs' proposed construction: The plain and ordinary meaning is a polyethylene oxide component comprising polyethylene oxide within the molecular weight range of 600, 000 to 900, 000 Daltons and at least about 60% polyethylene oxide within the molecular weight range of 100, 000 to 300, 000 Daltons.

b. Defendants' proposed construction: The polyethylene oxide comprises (i) one or more polyethylene oxides having a lower average molecular weight, calculated from the molecular weights of all the chains in the sample, in the range of 100, 000 to 300, 000; and (ii) one or more polyethylene oxides having a higher average molecular weight, calculated from the molecular weights of all the chains in the sample, in the range of 600, 000 to 900, 000, and (iii) the polyethylene oxide having the lower average molecular weight comprises about 60% or more by weight but less than 100% by weight in the polymer component. Alternatively, the term "molecular weight" is indefinite.

c. Court's construction: The polyethylene oxide comprises (i) one or more polyethylene oxides having a lower average molecular weight in the range of 100, 000 to 300, 000; and (ii) one or more polyethylene oxides having a higher average molecular weight in the range of 600, 000 to 900, 000, and (iii) the polyethylene oxide having the lower average molecular weight comprises about 60% or more by weight in the polymer component.

Plaintiffs argue that "molecular weight" in this term should be actual molecular weight or "the sum of the atomic weights of all the atoms in a molecule." (D.I. 106 at p.8). Defendants argue that molecular weight must be an average, but that a person of ordinary skill in the art "would also understand that there are multiple methods of calculating the average value (with results varying depending on the method used), such that it is necessary to specify which type of molecular weight is applicable to a given polymer sample." ( Id. at p.29) (emphasis in original). According to Defendants, therefore, because the patent does not provide guidance for calculating molecular weight of the PEOs, the term molecular weight should be indefinite. ( Id. ).

The Court finds that "molecular weight" means "average molecular weight, " not actual molecular weight. When the patent describes examples of films that include the blend of different weight polymers in Table 22 of the patent, it lists percentages of PEOs of different weights such as 100, 000, 200, 000, 300, 000, and 900, 000. (150 patent, 50:7-34). When explaining properties of these different resulting films, the patent refers to the particular weights listed in Table 22 as "higher molecular weight PEOs" and "lower molecular weight PEOs." ( See, e.g., '150 patent, 51:29-38). Defendants' expert points to the examiner in the' 150 prosecution history citing a brochure from Union Carbide that describes the average molecular weight of certain polymer samples using viscosity average. (D.I. 107-5 at 15-16). At the hearing, Defendants noted that common commercial polymers have single molecular weights, which a person of ordinary skill in the art would understand to be an average weight. (D.I. 147 at 39). Defendants, at the hearing, explained that a person skilled in the art would look at Table 22 of the patent and understand those molecular weight PEOs as the type made by commercial companies, described with average weights. (D.I. 147 at 48). The Court agrees. Molecular weight in the patent, therefore, must mean average molecular weight.

Both sides cite to Teva Pharmaceuticals USA, Inc. v. Sandoz Inc., 723 F.3d 1363 (Fed. Cir. 2013) to support their position, but Teva cuts against Plaintiffs' position. Plaintiffs argue that the current claim is nearly identical to the "Group II" claims in Teva, where the court found that molecular weight referred to precise points on a distribution curve, or what the Plaintiffs call actual molecular weight. (D.I. 106 at p.9). A representative claim from Group II in Teva reads: "Co-polymer-1 having over 75% of its mole fraction within the molecular weight range from about 2 kDa to about 20 kDa..." Teva, 723 F.3d at 1367. Plaintiffs force a comparison to the Group II claims, arguing that claim 1 of the '150 patent recites 60% of the lower molecular weight PEOs falling within the molecular weight boundary of 100, 000 to 300, 000. (D.I. 106 at p.11). Claim 1, however, describes lower molecular weight PEOs within a certain weight range and higher molecular weight PEOs within a certain range; the lower molecular weight PEOs then make up at least 60% of the polymer component, which also includes hydrophilic cellulosic polymer. Claim 1 does not say that 60% of the low molecular weight PEOs fall within a 100, 000 to 300, 000 boundary. Instead, the 60% refers to the composition of the lower weight PEOs in the final polymer component, which in addition to the two PEOs, also includes hydrophilic cellulosic polymer. In short, Teva does not support Plaintiffs' position on using actual molecular weight.

Even though Teva found that another set of claims with "molecular weight" construed as "average molecular weight" were indefinite because there are several different approaches to calculating average molecular weight, I believe that any indefiniteness arguments about "average molecular weight" are for another day. Defendants argue that a person skilled in the art would not know which measure of average weight to use because there is no guidance from the patent or prosecution history, and therefore "molecular weight" is indefinite. (D.I. 106 at p.34). Defendants' expert, however, points to prosecution history of the patent ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.