Opinion
Civil Action No. 11-cv-5997 (DMC)(MF)
12-27-2012
NOVEN PHARMACEUTICALS., Plaintiff, v. WATSON LABORATORIES, INC., and WATSON PHARMACEUTICALS, INC., Defendants.
NOT FOR PUBLICATION
Hon.
OPINION
DENNIS M. CAVANAUGH. U.S.D.J.
This matter conies before the Court by request of Noven Pharmaceuticals ("Noven" or "Plaintiff") and Watson Laboratories, Inc., and Watson Pharmaceuticals, Inc., (collectively "Watson" or "Defendants") for a claim construction hearing, pursuant to Local Patent Rule 4.5. The parties sought the Court's interpretation of disputed terms in U.S. Patent No. 6, 210,705 (the '"705 patent") and U.S. Patent No. 6,348,211 (the '"211 patent") (collectively the "patents-in-suit"). A Markman hearing was held on December 6, 2012, at which all parties ably presented sophisticated and intelligent arguments. Having considered the parties' written and oral arguments, the Court has set forth its construction of the disputed terms.
I. BACKGROUND
The patents-in-suit are directed to the Daytrana® transdermal patch, which provides a topical application of the drug methylphenidate, for the treatment of attention deficit hyperactivity disorder ("ADHD"). Prior to Noven's patents, methylphenidate was available in the form of Ritalin® tablets. Noven, in its Opening Markman Brief, states a number of disadvantages of immediate release tablets that Noven's patch system helps to overcome, including: difficulty of some patients in complying with frequent dosing requirements, difficulty that some patients have in swallowing pills, the potential for drug abuse, and the stigma for children attending school to have to leave class to visit the school nurse to get the controlled medication.
Noven asserts that the patents-in-suit are based on the discovery that the use of adhesive polymers with no, or low levels of acid functional monomers would facilitate stability and delivery of the methylphenidate. Noven claims that these patents teach the use of polymers without or with minimal acid functional groups, thereby helping to stabilize the methylphenidate, and permit transport of methylphenidate across the skin in a substantially uniform manner for at least approximately 10 hours.
Watson denies Noven's allegations of infringement and seeks a declaration that the patents-in-suit are invalid and/or not infringed. Watson filed an Abbreviated New Drug Application ("ANDA") No. 200147, which seeks approval to market methylphenidate transdermal patches of certain doses. There are four claim terms for the Court to consider. These terms are: (1)"substantially zero order kinetics;" (2)"wherein the proportion of methylphenidate silicone adhesive:acrylic adhesive (wt % dry) is about 5-30:0-70:0-70, respectively;" (3) "wherein the adhesive includes an acrylic which is a nonfunctional or minimally functional polymer" and; (4) "wherein the composition comprises no more than about 5 wt % of acid functional monomers"/ "wherein acid functional monomers are present in an amount of no more than about 5 wt %" (similar issue for claims specifying "no more than about 1 wt %").
Prior to the Markman Hearing, Noven submitted a Markman Opening Brief ("Nov. Mark. Br.") on July 20, 2012. (EOF No. 54). Watson also submitted a Markman Opening Brief ("Wat. Mark. Br.") on July 20, 2012. (ECF No. 59). Noven submitted a Responsive Brief ("Nov. Resp. Br.") on September 20, 2012. (ECF No. 70). Watson also submitted its Responsive Brief ("Wat. Resp. Br.") on September 20, 2012. (ECF No. 69).
II. LEGAL STANDARD
Claim construction is a matter of law to be determined solely by the Court. Phillips v. AWH Corp., 415 F.3d 1303, 1.312 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006). Analysis of a patent infringement claim is a two-step process. Tate Access Floors, Inc. v. Interface Architectural Resources. Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002). A court must first construe the meaning and scope of the patent claims, Markman v. Westview Instruments. Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996), and then compare the claims as construed to the alleged infringing product. Tate. 279 F.3d at 1.365. At this stage, the Court will only engage in the first step.
To construe the terms of a patent, a Court should look first to the language of the claim itself. Vitronics Corp. v. Conceptronic. Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Terms within a claim "are generally given their ordinary and customary meaning." Id. "[T]he ordinary and customary meaning of a claim term 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 1313.
To determine how a person of ordinary skill in the art would understand a patent's claim language, a Court must first examine the intrinsic record-the patent itself, including the claims, the specification and the prosecution history. Vitronies, 90 F.3d at 1582 (citing Markman, 52 F.3d at 979). The specification "acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication." Id. Indeed, the Federal Circuit has explained that the specification is "usually . . . dispositive . . . [and is the] best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582) (internal quotations omitted). It is proper for a court to "rely heavily on the written description for guidance as to the meaning of the claims." Id. at 1317.
A patent's prosecution history is also a critical source of guidance, as it "provides evidence of how the [Patent Trademark Office] and the inventor understood the patent." Id. The prosecution history is the complete record of the proceedings before the PTO, and "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. The Federal Circuit has repeatedly emphasized the need to consult the prosecution history to "exclude any interpretation that was disclaimed during prosecution." See Rhodia Chimie v. PPG Indus., 402 F.3d 1371, 1384 (Fed. Cir. 2005) (recognizing that, in exchanges with the PTO, a patent applicant may disavow or disclaim certain claim coverage, thereby precluding any claim interpretation that would encompass the disavowed or disclaimed subject matter).
After consulting intrinsic evidence, a District Court may also examine extrinsic evidence—i.e., "all evidence external to the patent and prosecution history." Markman, 52 F.3d at 980; Phillips, 415 F,3d at 1317-18 (stating that the Federal Circuit "ha[s] authorized district courts to rely on extrinsic evidence"). Such evidence consists of testimony by the inventor or by experts, dictionaries, and treatises. Markman, 52 F.3d at 980. However, extrinsic evidence is generally "less significant than the intrinsic record in determining the legally operative meaning of claim language." C.R. Bard, Inc, v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (quotations omitted). Extrinsic evidence, when relied upon, must be considered in view of the specification and prosecution history. Phillips, 415 F.3d at 1320. ("[E]xtrinsic evidence may be useful to the court, but it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of intrinsic evidence.").
III. DISCUSSION
A. First Term: "substantially zero order kinetics"
Noven's Proposed Construction: Delivery of methylphenidate through the skin or mucosa at a rate which is approximately constant once steady state is attained
Watson's Proposed. Construction: Delivery of methylpendiate through the skin or mucosa at a rate which is approximately constant once steady state is attained. This approximately constant rate requires maintaining blood levels within 30% to 40% of the mean blood level of methylphenidate (as measured during the period of time extending from 3 to 10 hours after administration) during the entirety of the period extending from 3-10 hours after the administration of methylphenidate.
Noven argues that the patents-in-suit provide the following express definition for "substantially zero order":
The phrase, "substantially zero-order" as used herein means delivery of methylphenidate through the skin or mucosa at a rate which is approximately constant once steady state is attained.('705 patent, col. 7, ll. 56-59; '211 patent, col. 7, ll. 57-60.)
In Noven's view, this definition is clear and unambiguous and should be controlling. See Sinorgchem Co. v. ITC, 511 F.3d 1132, 1136-38 (Fed. Cir. 2007) ("[W]hen the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term."); Phillips, 415 F.3d at 1316 ("The inventor's lexicography governs ... the inventor's intention, as expressed in the specification, is regarded as dispositive.").
Noven further contends that Watson's proposed construction of the term adds to, and substantially changes, the inventors' specific definition by adding extraneous limitations from, the specification to the claim. Noven argues that Watson's additional language is contrary to logic and common sense. The language that Watson seeks to import comes from selected portions of the following sentence, which is also found in the specification of the patents-in-suit:
Typical variability contemplated within the scope of this meaning is about a 30% to about 40% difference from the mean in the blood levels of methylphenidate at steady state (3-10 hours after administration).('705 patent, col. 7, ll. 59-63).
According to Noven, the inclusion of the words "typical variability" plainly and expressly means the particular blood level variation mentioned is not necessary to the invention, does not always occur, and so is not part of the definition of zero order kinetics. (PL Mark. Br. 11). In support of this argument, Noven points the Court to Iscar Ltd. v. Sandvik AB, No. 99-1577, 2000 U.S. App. LEXIS 221.89 (Fed. Cir. Aug. 25, 2000), where the Federal Circuit found that the patentee's use of the term "typically" in noting that "grinding is 'typically' used in the fabrication of the [claimed] inserts" did not limit the claims to grinding, and the District Court had impermissibly read a limitation from the specification into the claim. Id. at * 11. See also, Aguayo v . Universal Instruments Corp., 356 F. Supp. 2d 699, 722 n.49 (S.D. Tex. 2005) (refusing to read a limitation into the claim from the specification because the "patentees prefaced both descriptions with the word 'typically' and did not use words of exclusion or restriction").
Watson argues that Noven explicitly provided a two sentence definition for the term "substantially zero order kinetics" In the specification, but that Noven is now ignoring the second sentence of the specification definition, which includes in it the requirement that certain blood levels are maintained. (Nov. Op. Br. 15). Watson maintains that its proposed construction correctly requires the specified blood levels. See, e.g., Sinorgchem Co. v. Int'l Trade Comm'n, 511 F.3d 1132, 1136-38 (Fed. Cir. 2007) (reversing a construction that was based on only the first portion of the express definition set forth in the specification). Watson further argues the importance of the second sentence in giving meaning to this term in dispute, pointing the Court to the portion of the second sentence "within the scope of this meaning," to show that Noven originally intended for a specific blood level variability. (Nov. Mark. Br. 16),
Additionally, Watson argues that the word "typically" does not nullify the second half of the specification's express definition. In support of this argument, Watson has a cited a number of cases where the Federal Circuit has construed claims as limited by the specification's description of "typical" features. See e.g., Emergency Fuel, LLC, v. Penzoil-Quaker State Co., 71 F. App'x 826, 829-30 (Fed. Cir. 2003); Leoutsakos v. Coll's Hosp. Pharmacy, Inc., 98 F. App'x 835, 838 (Fed. Cir. 2004).
Noven, in its Opposition Brief, disagrees with Watson's Interpretation of Sinorgchem. and argues that the case actually supports Noven. Noven points out that Watson's proposed definition does not incorporate the second sentence of the specification as it is was originally written. Rather, Watson's proposed definition changes the second sentence of the specification significantly. (Nov. Resp. Br. 2). In Watson's proposed definition, certain blood levels become "required" rather than "typically occurring." (Id.). The Court agrees that Noven has provided an. explicit one sentence definition for this term, and that definition ends the inquiry as to whether or not the term needs further interpretation.
Therefore, in light of the well-established rule that an express definition provided in the specification controls, the Court adopts the definition, of "substantially zero order kinetics" provided by Noven.
B. "wherein the proportion of methylphenidate:silicone adhesive: acrylic adhesive (wt % dry) is about 5-30:0-70:0-70, respectively"
Noven's Proposed Construction: Plain meaning/no construction necessary or, alternatively: "wherein the proportion of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) is 5-30:0-95:0-95, respectively"
Watson's Proposed Construction: Under this plain meaning, the dry weight percent ratio of methylphenidate silicone adhesive :acrylic adhesive is about 5-30:0-70:0-70. "About" allows for the additional margin appropriate for rounding decimals to whole.
The principal dispute between the parties is over the meaning of the word "about." The parties debate whether the presence of the word "about" allows for a strict, numerical range in the ratios that follow, or whether those ratios can be more broadly construed.
Noven contends that no construction for this term is necessary because this term should be given a broad scope, consistent with its ordinary and plain meaning. (PL Mark. Br. 14). In the alternative, Noven contends that the plain meaning includes at least the ranges 0-80% or 0-90% acrylic adhesive. (Id). Noven claims that Watson's proposed construction ignores the broadening term "about," and instead requires the range of acrylic adhesive to be within the exact numerical limits set out. Id. According to Noven, when "about" is used as part of a numerical range, "the use of the word 'about' avoids a strict numerical boundary to the specified parameter." (Nov. Mark. Br. 15). Thus, Noven would be able to produce its product in a ratio not listed in the specification. Noven feels that the Cohesive Techs, case is instructive on this issue;
When "about" is used as part of a numerical range, the "the use of the word 'about' avoids a strict numerical boundary to the specified parameter. Its range must be interpreted in its technologic and stylistic context. In determining how far beyond the claimed range the term about extends the claim, '[w]e must focus ... on the criticality of the [numerical limitation] to the invention.Cohesive Techs., 543 F.3d 1351, 1368 (Fed. Cir. 2009) (internal citations omitted).
In this ease, the critical feature of the invention, according to Noven, is the several limits on the amount of acid functional monomer used, which allow the use of adequate amounts of methylphenidate, and allow sustained, relatively constant delivery to the patient across the patient's skin in a practical transdermal delivery system. (See, e.g. '705 patent, Summary of the Invention).
Noven points the Court to examples in the specification, where the ranges of acrylic adhesive were 0-80% and 0-90%, as proof that "about 0-70%" contemplated embodiments of the product with greater amounts of acrylic adhesive than 70% composition. (See '705 patent, Examples 22-29). Examples 22-25, 27 and 29 all show compositions with 80% acrylic adhesive, while Examples 26 and 28 show compositions with 90% acrylic adhesive.
Conversely, Watson argues that its construction correctly gives this term its plain and ordinary meaning, namely that "0-70" means 0-70. (Wat. Mark. Br. 33). Watson's proposed AND A product has 21% methylphenidate and 79% acrylic adhesive and 0% silicone adhesive. Watson argues that Novell's current attempt to use "about" to expand the claimed range of acrylic adhesive from. 0-70% to 0-95% is impermissible, as it would result in over a 35% increase in breadth. See Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995) (rejecting construction of "about" that would have expanded claimed range 10%).
On the other hand, Watson's believes that its construction of the word "about" in the proportion limitation correctly allows for an additional margin appropriate for rounding decimals to whole numbers. For example about 70% would include 69.5%-70.4%, resulting in a range of 0-70.4%. Watson states that this construction of "about" is supported by the intrinsic record, which uses integers in 1% increments to refer to the percentages of each component of overall drug composition. (E.g., '211 patent, col. 8, ll. 26-col. 10 (Examples 1-29)). (See, e.g., TIP Sys., LLC v. Phillips & Brooks/Galdwin. Inc., 529 F.3d 1364, 1373 (Fed. Cir. 2008) ("[T]he mere fe.ce that there is an alternative embodiment disclosed in the...patent that is not encompassed by [the] district court's construction is supported by the intrinsic evidence.")).
The Court agrees with Watson, that the presence of the word "about" in this definition permits Noven with some ability to round decimals to whole numbers, but it does not allow the 0-70 range of acrylic adhesive present to be modified to include at least 0-80. If Noven had. wished to create versions of this product in proportions more expansive than those listed, in the specification, it could have done so at the time that the specification was drafted, to allow for a claim over a greater range. Therefore, the Court adopts Watson's construction of this term.
C. "wherein the adhesive includes an acrylic which is a nonfunctional or minimally functional polymer"
Novell's Proposed Construction: Plain meaning/no construction necessary or: The adhesive includes an acrylic polymer which has either no acid functional or hydroxy! functional monomers, or no more than about 5 wt % of acid functional or hydroxyl functional monomers by weight of the acrylic polymer.
Watson's Proposed Construction: The adhesive includes an acrylic polymer that has either no acid functional monomers or no more than about 5 wt % acid functional monomers by weight of the acrylic polymer.
The principal dispute between the parties is whether this claim term is restricted to only acid functional groups or whether it applies to both acid and hydroxyl functional groups.
Noven contends that no construction is necessary for this term, and that the plain meaning should apply. In the alternative, Noven contends that Watson's use of the word "acid" into the claim-twice-Ineorrectly construes the claim as restricting only acid functional groups. (Nov. Mark. Br. 20). Noven's position is that the specifications for both patents-in-suit refer to both acid functional groups and hydroxyl functional groups. (Id.). Thus, the claim language restricting "functional groups" generally must restrict both types of functional groups, acid and hydroxyl functional groups. Noven points to the following language in the specification:
In view of the foregoing, acrylic polymers that are non-functional. hydroxyl functional, or minimally acid functional are preferred. A "minimally acid functional acrylic" is defined as an acrylic polymer having no more than about 5 wt % of acid functional monomers, preferably no more than about 1 wt %, and more preferably no more than about 0.6 wt % of acid functional monomer, based on the weight of the acrylic polymer.('705 patent, col. 5, ll. 11-18) (Noven's emphasis added).
Noven argues that the claim, element at issue refers to functional groups generally, by specifying a "non-functional or minimally functional polymer," and therefore does not limit the minimally functional restrictions to acid functional groups only. (Id. at 21). Thus, the claim element limits both acid and hydroxyl functional groups.
Noven further argues that allowing Watson's construction to be used would require plainly different terms to mean the same thing, even though the patent claims use those terms differently. (Nov. Resp. Br. 14). As an example, Noven points out that claim 1 of the "705 patent refers to "no more than about 5 wt % of acid functional monomers," while claim 11 of that patent, which depends on claim 1, requires that "the adhesive includes an acrylic which is a nonfunctional or minimally functional polymer." Thus, according to Noven, when the inventors meant to say "acid," e.g., claim 1, they plainly could and did. (Nov. Resp. Br. 14).
Watson argues that the claimed "minimally functional polymer" acrylic adhesive should be construed in light of the specification's disclosure of acrylic adhesives that are minimally acid functional. (Wat. Mark. Br. 29). Watson claims that the portion of the specification of the patents-in-suit that is specific to the functional groups of the acrylic adhesive is at col. 5, ll. 11-18, which provides:
In view of the foregoing, acrylic polymers that are non-functional, hydroxyl functional or minimally acid functional are preferred. A "minimally acid functional acrylic " is defined as an acrylic polymer having no more than about 5 wt % of acid functional monomers, preferably no more than about 1 wt %, and more preferably no more than about 0.6 wt % of acid functional monomer, based on the weight of the acrylic polymer.('705 patent, col. 5, ll. 11-18)(Watson's emphasis added).
Thus, Watson argues, the specification explains that the acrylic polymer adhesive can be minimally acid functional. However, according to Watson, the specification does not describe an acrylic polymer that is "minimally functional," nor does the specification warn against functional groups other than acid functional groups.
The Court is persuaded by Noven's arguments that the term applies to both acid and hydroxyl functional groups. Watson's proposed definition simply ignores that the restriction provided in the express definition of the specification also apples to hydroxyl functional polymers. Therefore, the Court applies the definition of this term advanced by Noven.
D. "wherein the composition comprises no more than about 5 wt % acid
Noven's Proposed Construction: The composition in the flexible, finite system comprises no more than about 5 wt % of acid functional monomers by weight of the composition.
The composition in the flexible, finite system comprises no more than about 5 wt % of acid functional monomers by weight of the composition.
Watson's Proposed Construction: Wherein, for the monomers in the flexible, finite system, no more than about 5 wt % are acid functional.
Wherein, for the monomers in the flexible, finite system, no more than about 1 wt % are acid functional.
The parties disagree as to the meaning of "wt %" of acid functional monomers, specifically concerning what the weight of acid functional monomers is to be compared to. Noven's construction compares the weight of acid functional monomers to the total monomer content. Watson compares the weight of acid functional monomers to all the components of the system.
Noven argues that the claim elements refer to the "wt 5 of acid functional monomers," which refers directly to the total monomers. (Nov. Mark. Br. 23). Noven points the Court to the specification, which Noven claims includes a specific discussion of acid functional monomer in the context of acrylic polymers, and that the wt % reference is to the acrylic polymer, not the entire system of composition:
In view of the foregoing, acrylic polymers that are nonfunctional, hyrdoxyl functional, or minimally acid functional are preferred. A "minimally acid functional acrylic" is defined as an acrylic polymer having no more than about 5 wt % of acid functional monomers, preferably no more than about 1 wt %, and more preferably, no more than about 0.6 wt % of acid funtional monomer, based on the weight of the acrylic polymer.('705 patent, col 5, ll. 1-18) (Novell's emphasis added).
Thus, Noven claims that its construction is consistent with the claims and the patent specification.
Noven further claims that its construction is consistent with the prosecution in related patent application 10/024,513 ("the '513 application"). (Nov. Mark. Br. 23). In discussing claims which similarly require that "said composition comprises no more than 5 weight % of acid functional monomers" (Pe Deck, Ex. 10, '513 application, Sept. 25, 2003 Amendment and Reply at 4. WATSON-DAY0058699-58710 at WATSON-DAY0058702), the Examiner asserted that Noven had to show that the prior art fell outside the claims, namely:
"Applicant argues that Vickers does not disclose a composition that comprises no more than about 5 weight % of acid functional monomers. In the first instance, Applicant does not indicate the scope of the limitation "about." In the second instance, Applicant has not shown that the prior art composition does not comprise no more than about 5 weight % of acid functional monomers, i.e. Applicant must show that the adhesive in Example 1 (Vickers, Pgs. 15, 16) does not comprises [sic] no more than about 5 weight % of acid functional monomers."
Noven states that its patents are directed to the novel discovery that methylphenidate in a transdermal patch system undergoes degradation in the presence of, acid functional groups, and so the specification teaches the importance of using minimal amounts of such acid functional groups. As a result, Noven believes that it is entitled to claim it broadly.
Watson argues that the plain language of the claim requiring that "the composition comprises no more than about 5 wt % of acid functional monomers" and that "acid functional monomers are present in an amount of no more than about 5 wt %" reveals that the 5 wt % limitations refer to the percentage of acid functional monomers relative to, i.e., based on the weight of, the methylphenidate drug composition that resides in the claimed, flexible, finite system. (Wat. Mark. Br. 21).
Watson states that the claim language is clear that the 5 wt % limitations refer to the weight percentage of acid functional monomers by weight of the "composition." Id. at 22. Watson points the Court to claims 1 and 18, which provide:
1. A composition for topical administration of methylphenidate comprising methylphenidate in a flexible, finite system, wherein the methylphenidate is present in a therapeutically effective amount.... and wherein the composition comprises no more than about 5 wt % of acid functional monomers("705 patent, claims 1, 18).
18. A composition for topical application of methylphenidate comprising methylphenidate in a flexible, finite system, wherein the methylphenidate is present in an amount sufficient to permit a therapeutically effective dose . . . and wherein acid functional monomers are present in an amount of no more than about 5 wt %.
Thus, according to Watson, the claim language makes clear that the final wherein clause containing the 5 wt % limitations refers to the methylphenidate composition, within the flexible, finite system.
The Court agrees with Noven, that Noven's patent specifications teach the importance of using minimal amounts of acid functional groups, in order to prevent the degradation of methylphenidate. As a result, Noven should be entitled, here, to claim it broadly. Accordingly, the Court adopts the proposed construction set forth by Noven.
IV. CONCLUSION
The Court, in accordance with the discussion above, has construed the terms of the '705 and '211 Patents.
______________________
Dennis M. Cavanaugh, U.S.D.J.
Orig.: Clerk
cc: Hon. Mark Falk, U.S.M.J.
All Counsel of Record
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