LEONARD P. STARK, District Judge.
On July 24, 2013, Plaintiffs Eisai Co., Ltd., Eisai Inc. (collectively, "Eisai"), and Novartis Pharma AG ("Novartis") (collectively, "Plaintiffs") filed suit against Glenmark Pharmaceuticals, Ltd., Glenmark Generics Limited, and Glenmark Generics Inc. USA (collectively, "Glenmark") (C.A. No. 13-1279-LPS D.I. 1); Hetero Labs Ltd. and Hetero USA Inc. (collectively, "Hetero") (C.A. No. 13-1280-LPS D.I. 1); Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, "Lupin") (C.A. No. 13-1281-LPS D.I. 1); Mylan Pharmaceuticals Inc. ("Mylan") (C.A. No. 13-1282-LPS D.I. 1); and Roxane Laboratories, Inc. ("Roxane") (C.A. No. 13-1284-LPS D.I. 1), alleging infringement of U.S. Patent Nos. 6,740,669 ("the `669 patent"), 7,750,028 ("the `028 patent"), and 8,076,362 ("the `362 patent") (collectively, "the patents-in-suit"). Defendants are alleged to infringe the patents-in-suit pursuant to 35 U.S.C. § 271(e)(2) by having filed their respective Abbreviated New Drug Applications ("ANDA") seeking approval to market a generic version of Eisai's anti-epileptic drug product Banzel®. The patents-in-suit relate to crystal modification A of the compound 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide, which is the active ingredient in Banzel®, and its use as a pharmaceutical product.
Pending before the Court is the issue of claim construction of various disputed terms of the patents-in-suit. The parties completed briefing on claim construction on November 14, 2014. (C.A. No. 13-1279-LPS D.I. 90, 97, 118, 120
On June 8, 1998, Novartis filed PCT Application No. PCT/EP98/03427 ("the `427 application"). The national stage entry of the `427 application was U.S. Serial No. 09/125,329 ("the `329 application"), which ultimately issued on May 25, 2004 as the `669 patent. The `329 application was filed with independent claims directed to crystal modification A of the compound 1-(2,6-difluorobenzyl)-1 H-1,2,3-triazole-4-carboxamide (hereinafter, "rufinamide") characterized by peaks determined by the patterns from different experimental techniques (e.g., X-Ray Powder Diffraction ("XRPD"), Fourier-Transform Infrared Spectroscopy ("FT-IR"), Fourier-Transform Raman Spectroscopy ("FT-Raman"), and Differential Scanning Calorimetry ("DSC")). (See D.I. 79 ("JCCC") Exs. R, S, T)
On June 1, 2000, the examiner rejected all pending claims (claims 1-25) on four separate bases.
In response to the § 102 prior art rejections, applicants stated:
(JCCC Ex. G (Sept. 1, 2000 Amendment) at 5) (emphasis added) Similarly, with regard to the § 103 obviousness rejection, the applicants stated that "no more than a cursory review of the Meier references reveals the fact that they are silent with regard to even a hint of a recognition that the specific compound alluded to above can exist in different crystalline forms, let alone contains any suggestion that different crystalline forms could or should be made or how any of the crystalline forms can be obtained." (Id. at 6)
In an effort to overcome the§ 112 indefiniteness rejection, the applicants either amended or canceled and replaced claims 1-9, 11-14, 16-21, 23, and 24 to recite either "crystal modification" or "crystal modification A." (Id. at 1-2) For example, amended claim 1 began: "Crystal modification A of the compound ...." (Id. Ex. J (Appendix of April 19, 2001 Appeal Brief) at A-1 (reciting claims as last amended, canceled, and replaced before Final Office Action)) On October 13, 2000, the rejections were maintained in the Final Office Action. (See id. Ex. H) In a response to the examiner's comment under§ 112 that Claims 1-9, 13, 14, 16-21, 26, 28, 30, and 31 are substantial duplicates, the applicants stated: "Claim 1 is intended to claim a specific crystalline form of the compound 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide, viz., crystal modification A, and characterizes said crystalline form with sufficient particularity. As to the other crystalline form, viz., crystal modification A', it is
After the Final Office Action rejected all pending claims, applicants filed an appeal with the USPTO Board of Patent Appeals and Interferences ("the Board"). Applicants re-stated their prior arguments for§ 103 and obviousness-type double patenting. (See id. Ex. J (April 19, 2001 Appeal Brief) at 5-7) As for the § 102 and § 112 rejections, they were eventually withdrawn by the examiner. (See id. Ex. K (Examiner's Answer) at 3)
The Board reversed the examiner's rejections with regard to both remaining grounds. In terms of the § 103 obviousness rejection, the Board held that after "[h]aving carefully reviewed each Meier reference and the discussion of polymorphism in each Muenzel [sic] reference, we disagree that the cited prior art would have led a person having ordinary skill to the specific crystal modifications A and A' recited in the claims on appeal." (Id. Ex. V (Nov. 17, 2003 Board Decision) at 6)
On January 11, 2006, Novartis filed U.S. Serial No. 11/329,945 ("the `945 application"), which is a continuation of the `329 application and ultimately issued on July 6, 2010 as the `028 patent. The `945 application included claims directed to methods of treating epilepsy using crystal modification A of rufinamide characterized by characteristic XRPD values.
On November 13, 2007, the examiner rejected all pending claims under § 102(b) as being anticipated by Meier II supplemented "with Palhagen et al." and under § 103 as unpatentable "over Palhagen et al. and Meier II in view of Rowland and Tozer, and Tasso et al." (JCCC Ex. X (Nov. 7, 2007 Office Action) at 2) In response to the § 102(b) rejection, the applicant stated:
(Id. Ex. Y (Feb. 19, 2008 Amendment and Reply) at 7) (emphasis added) With regard to the reference to "page 2" in the specification, the disclosure states: "The novel crystal modification A of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide melts at 242° C (239-245° C)." (See id. Ex. EE (U.S. Serial No. 10/294,408) at 2 (continuation of `329 application containing common specification for all three patents-in-suit); see also `028 patent at 2:8-9)
On April 26, 2010, Novartis filed U.S. Serial No. 12/767,003 ("the `003 application"), which is a continuation of the `329 application and ultimately issued on December 13, 2011 as the `362 patent. The `003 application was filed with independent claims directed to a solid dosage/tablet containing crystal modification A of rufinamide.
The ultimate question of the proper construction of a patent is a question of law. 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. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction." Phillips, 415 F.3d 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 also must 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 "[d]ifferences 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." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), aff'd, 481 F.3d 1371 (Fed. Cir. 2007).
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), 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, "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 ordinary 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 claimed invention, reliance on 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 GmbHv. Int'l Trade Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007).
In the alternative: "a crystal modification of the compound 1-(2,6-difluorobenzyl)-1H -1,2,3-triazole-4-carboxamide (as opposed to a method of use or a method of manufacturing), referenced as `A,' and having the characteristics specifically set forth in each respective claim or the claim from which it depends"
In the alternative: "a polymorphic crystal modification that can be distinguished from other crystal modifications"
Alternatively, the claim is indefinite.
As an initial matter, the parties dispute whether the preamble is limiting.
The Court construes the term "crystal modification A" to mean: "a crystal modification of the compound 1-(2,6-difluorobenzyl)-1 H-1,2,3-triazole-4 -carboxamide, referenced as `A,' and having the characteristics specifically set forth in each respective claim or the claim from which it depends" — which is an amended version of Plaintiffs' alternative proposed construction. This construction reflects the preamble's limitation that "crystal modification A" claims a specific crystal modification of the compound, while refraining from reading in limitations recited elsewhere in the body of claim 1 or only in one of the dependent claims.
The Court rejects Roxane's position that the preamble imposes a limitation that "crystal modification A" must be characterized by characteristic lines at interplanar spacings specifically recited in the `669 patent specification at column 2, lines 23-26. The purported prosecution history disclaimer cited by Roxane distinguishes the Meier reference on the basis that it is "devoid of any mention that the compound ... can exist in different crystalline forms, let alone the specific crystalline forms to which the instant claims are limited." (Id. Ex. G at 5) The applicant then stated: "Moreover, the instantly claimed crystalline forms are characterized by characteristic lines at interplanar spacings as determined by means of an X-ray powder pattern." Thus, the applicant sought to overcome the § 102(b) rejection by explaining that the Meier reference fails to disclose even
Likewise, the Court rejects Roxane's position that the preamble includes the limitation that crystal modification A "must melt at 242° C." Roxane endeavors to read a statement made by the applicant during the prosecution of the `028 patent, years after the `669 patent had already issued, back into the preamble of claim 1 of the `669 patent. More specifically, Roxane contends that because the applicants expressly stated during the `028 patent's prosecution that the claimed modification A is "defined on page 2 of the specification as `melting at 242° C'" (id. Ex. Y at 7), the patentee's statements to the examiner apply equally to the earlier `669 patent, as the `669 patent's specification also has the same "melting at 242° C" phrase on page 2.
Roxane's argument fails for several reasons. First, the phrase Roxane references as appearing in the specifications of both the `669 and `028 patents actually reads in full: "crystal modification A of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide
Separately, Hetero contends that its construction must be adopted to avoid rendering the term indefinite in claims 10 and 11. (See D.I. 90 at 17) (arguing Plaintiffs' construction makes claims 10 and 11, which claim modification A as characterized by "bands at 3412 cm
As for manifesting those physical defects, the specification and claim 8 — the only other claim that mentions crystal modification A' — disclose and claim one possible way of detecting them. More precisely, during XRPD analysis, a characteristic measurement can be used to identify modification A': "smaller" spacings between certain pairs of lines at particular interplanar spacings in comparison to those found for modification A generally. (Id. at 6:28-31; id. at claim 8 (A' is "characterized by line spacings, smaller compared to modification A, between the pairs of lines at interplanar spacings 3.68 Å and 3.64 Å, 3.51 Å and 3.48 Å and 3.19 Å and 3.15 Å")) Other measurements resulting from other analysis may not necessarily manifest the physical difference. Hetero insists that FT-IR spectrum measurements in claims 10 and 11 must allow a person of ordinary skill to distinguish between A and A'. However, Hetero has not pointed to any proof in the intrinsic record — or proffered extrinsic evidence — that confirms that these defects must be evident in measurements taken using FT-IR spectrum analysis involved in these claims. Hetero has failed to prove indefiniteness.
In short, crystal modification A' is a subtype of modification A. Claims 10 and 11 do not require this subtype to be identified, but rather claim the broader category (crystal modification A), as detected using bands in the FT-IR spectrum. Claims 7, 12-16, 20, and 21 make clear A' can be identified from within the more general A population because A' has physical defects in the lattice, and claim 8 claims one particular method (XRPD) whose measurements will manifest that physical difference if examined as specified in the claim. Hence, in light of the intrinsic evidence, the Court concludes that its adopted construction for "crystal modification A" informs a person of ordinary skill with "reasonable certainty" about the difference between crystal modification A and crystal modification A' across the asserted claims. Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2124, 189 L. Ed. 2d 37 (2014) (holding "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention").
As an initial matter, Plaintiffs and Defendants Hetero and Roxane dispute whether (i) the plain meaning of the term "characterized by" accounts for experimental error and (ii) whether the term requires every single recited d-value to be present in every experimental run.
With regard to the first dispute, the claims and specification are silent on the matter of measurement error. However, the experts who have opined on the issue for both Plaintiffs and Defendants agree that XRPD — which the claims themselves state is used to determine "characteristic lines at [with] interplanar spacings (d values)" — was universally known at the pertinent time to be subject to measurement error. (See D.I. 97 (Declaration of Allan S. Myerson) ("Myerson Decl.") at ¶ 41; Declaration of Arnold L. Rheingold ("Rheingold Decl.") at ¶¶ 29-31 (minuscule unit of measurement for "d values" (Angstroms) introduces measurement error); see also id. Ex. C (U.S. Pharmacopeia (1995)) at 1844 ("20 values should typically be reproducible to ±0.10 or 0.20 degrees")) It follows that a person of ordinary skill's understanding of the term XRPD would include the expected error associated with the measurement being used. See Takeda Pharm. Co. v. Handa Pharm., LLC, 2012 WL 1243109, at *12 (N.D. Cal. Apr. 11, 2012) (concluding in light of expert deposition that "person skilled in the art would not have required any discussion of the experimental error associated with XRPD diffraction, either in the specification or in the claims, to understand that the references to `characteristic peaks at interplanar spacings (d)' allowed for such experimental error").
As for the second issue, the plain and ordinary meaning of "characterized by" does not require all of the recited d-values to be present in every experimental run (i.e., an exact one-to-one match). Rather, as the broad claim language (drafted by the applicants and approved by the PTO) sets out, the claim limitation is satisfied as long as the crystal form can be "characterized by" — that is,
The remaining dispute among the parties concerns whether a certain measurement, "relative intensities," is necessary to characterize the claimed crystal modifications. With regard to Roxane's proposed construction, the plain language of the claims does not require inclusion of "relative intensities," and Roxane has failed to demonstrate that the prosecution history evidences a clear and unambiguous disavowal of claim scope such that the issued claims' reference to "XRPD" necessarily requires relative intensity values. (See JCCC Ex. G, (September 1, 2000 Office Action Response) at 5 (no discussion of relative intensities); id. Ex. I at 2; id. Ex. J at 4-5) Therefore, having rejected the proposed limitations Hetero and Roxane would have the Court read into the claim language, and because Lupin, Mylan, and Glenmark largely view their construction as concordant with Plaintiffs proposal (see Tr. at 69-70),
Defendant Hetero's Proposed Construction: "with the following absorptions in the FT-IR spectrum (KBr pellet-transmission method) 3412 cm
Court's Construction: "identifiable by reference to a FT-IR spectrum (KBr pellet-transmission method) that includes bands at 3412 cm
The proposed constructions for terms characterizing the claimed crystal modification on the basis of (i) absorptions/bands in the FT-IR spectrum, (ii) absorptions/bands in the FT-Raman spectrum,
Defendant Roxane contends that the term "sodium carboxymethylcellulose" is limited to versions of the compound that are not cross-linked. "Sodium carboxymethylcellulose" appears only once in the specification as a "Core material" in "Formulation I." (See `362 patent at 8:33-59) (Example 1) Nothing in the patent or the prosecution history expressly or implicitly limits that material to sodium carboxymethylcellulose that is "not cross-linked." Furthermore, Roxane relies on expert testimony that unpersuasively characterizes the relevant entry in the Handbook of Pharmaceutical Excipients (see D.I. 93 (Declaration of Kinam Park) ("Park Decl.") at ¶ 22), and is at odds with testimony proffered by formulation expert Professor Gregory Amidon, to the effect that a person of ordinary skill would have understood from the single reference to sodium carboxymethylcellulose in Table 1 of the specification that the compound was to be used as a disintegrant, which could employ both the cross-linked or non-cross-linked forms. (D.I. 120 Ex. 5 (Declaration of Gregory Amidon) ("Amidon Decl.") at ¶ 23)
In order to remain faithful to the definitional statement expressly provided by the patentee in the specification, the Court rejects both parties' constructions and construes the term to mean "purity of greater than 95% based on modification A or A'." ('669 patent at 6:32-36) ("The invention relates to the essentially pure form of the modification A or A' of [rufinamide]. The term `essentially pure form' means purity of >95%, in particular >98%, primarily >99%, based on the modification A or A'.")
The Court construes the disputed terms as explained above. An appropriate Order follows.