United States District Court, D. Delaware
EISAI CO., LTD., EISAI INC., and NOVARTIS PHARMA AG, Plaintiffs,
GLENMARK PHARMACEUTICALS, LTD. et al., Defendants.
Jack B. Blumenfeld, Maryellen Noreika, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE, Bruce M. Wexler, Joseph M. O'Malley, Jr., Young J. Park, Gregory A. Morris, PAUL HASTINGS LLP, New York, NY Attorneys for Plaintiffs Eisai Co. Ltd. and Eisai Inc.
Jack B. Blumenfeld, Maryellen Noreika, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE, Nicholas N. Kallas, Christina Schwarz, FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY, Attorneys for Plaintiff Novartis Pharma AG
Adam W. Poff, Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE, James Galbraith, Michael K. Levy, Karen Shen, KENYON & KENYON LLP New York, NY Huiya Wu, GOODWIN PROCTER LLP, New York, NY Attorneys for Defendants Glenmark Pharmaceuticals, Ltd., Glenmark Generics Ltd., and Glenmark Generics Inc. USA.
Steven J. Fineman, Katharine C. Lester, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE, Kenneth G. Schuler, Emily C. Melvin, Matthew C. Darch, LATHAM & WATKINS LLP, Chicago, IL, Roger J. Chin, LATHAM & WATKINS LLP, San Francisco, CA Jennifer Koh, LATHAM & WATKINS LLP, San Diego, CA Michelle Ma, LATHAM & WATKINS LLP, Menlo Park, CA Attorneys for Defendant Roxane Laboratories, Inc.
John C. Phillips, Jr., Megan C. Haney, PHILLIPS, GOLDMAN & SPENCE, P.A., Wilmington, DE, Carol Pitzel Cruz, KNOBBE, MARTENS, OLSON & BEAR, LLP, Seattle, WA William R. Zimmerman, Andrea L. Cheek, KNOBBE, MARTENS, OLSON & BEAR, LLP, Washington, DC, Sheila N. Swaroop, KNOBBE, MARTENS, OLSON & BEAR, LLP, Irvine, CA Nathanael R. Luman, KNOBBE, MARTENS, OLSON & BEAR, LLP, San Diego, CA Attorneys for Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc.
Richard L. Horwitz, David E. Moore, Bindu A. Palapura, POTTER ANDERSON & CORROON LLP, Wilmington, DE, T.O. Kong, WILSON SONSINI GOODRICH & ROSATI, San Francisco, CA Joshua A. Mack, Elham F. Steiner, Katherine Van Gunst, WILSON SONSINI GOODRICH & ROSATI, San Diego, CA, S. Brei Gussack, WILSON SONSINI GOODRICH & ROSATI, Washington, DC Attorneys for Defendant Mylan Pharmaceuticals Inc.
Dominick T. Gattuso, PROCTOR HEYMAN LLP, Wilmington, DE, Chad A. Landmon, Edward M. Mathias, Thomas K. Hedemann, AXINN, VELTROP & HARKRIDER LLP, Hartford, CT, Dan Feng Mei, AXINN, VELTROP & HARKRIDER LLP, New York, NY Attorneys for Defendants Hetero USA Inc. and Hetero Labs Ltd.
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) The parties also submitted technology tutorials (D.I. 87, 89) and provided expert reports (D.I. 92-96, 97 Ex. 1, 120 Ex. 5). The Court held a Markman hearing on December 8, 2014. ( See D.I. 139) (Transcript) ("Tr.")
I. PROSECUTION HISTORY
A. 669 Patent
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.(JCCC Ex. F) (May 30, 2000 Office Action) First, the examiner rejected the pending claims under§ 102(a), (b), (e), and/or (f) as anticipated by European Patent No. 199, 262 ("Meier I") and U.S. Patent No. 4, 789, 680 ("Meier II"), which disclosed "the crystal form of the instant compound obtained by recrystallization from ethanol" and therefore gave rise to anticipation under the "Petering doctrine" and related genus case law. ( Id. at 3) Second, the claims were rejected under§ 103(a) as obvious in light of the combined teachings of Meier I and Meier II, which "teach the crystal forms of the instant known compound" (although not the "the lines with interplanar spacings of the X-ray powder pattern of said form") in view of two articles written by K. Munzel ("Munzel I" and "Munzel II"), which "teach that compounds exist as polymorphs and retain pharmaceutical activity." ( Id. at 4) Third, all claims were also rejected under§ 112, ¶ 2 as indefinite, as the examiner found (among other things) that "modification" in claims 1-9, 11-14, 16-21, 23, and 24 was indefinite "since a modification refers not only to crystal forms but also to undefined possible modifications of the chemical structure." ( Id. at 5) The examiner also stated that Claim 1 "fails to clearly claim what is intended by applicants" with regard to crystal modifications A and A'." ( Id. at 6) ("How can modification A" be identical to modification A'? Claim 1 does not permit any defects in modification A.' Yet the dependent claims recite that modification A has defects.") Finally, all claims were also rejected for obviousness-type double patenting. ( See id. at 6-7)
In response to the § 102 prior art rejections, applicants stated:
Although Applicants agree with the propositions set forth in the case law relied upon by the Examiner, it is Applicants' belief that they are inapplicable to the present fact situation. Quite simply, the Meier I and Meier II references are devoid of any mention that the compound 1-(2, 6-difluorobenzyl)-1 H-1, 2, 3-triazole-4-carboxamide can exist in different crystalline forms, let alone the specific crystalline forms to which the instant claims are limited. Moreover, the instantly claimed crystalline forms are characterized by characteristic lines at interplanar spacings as determined by means of an X-ray powder pattern. Accordingly, neither the teachings of Meier I nor the teachings of Meier II anticipate any of the instant claims since each and every element of the instantly claimed invention is not disclosed by either the Meier I or Meier II references....
(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 identical to crystal modification A, save for smaller line spacings as detected by X-ray analysis." ( Id. Ex. I at 6) (emphasis in original)
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)
2. 028 Patent
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:
Applicant respectfully submits that, contrary to the Examiner's statement, Meier does not teach each and every element of Applicant's claims. More specifically, Meier, at col 20, example 35, discloses 1-(2, 6-difluorobenzyl)-1H-1, 2, 3-triazole-4-carboxamide with a melting point of 237-240° C. This does not anticipate Applicant's claimed invention because it does not disclose crystal modification form A or form A'.
Applicant claims 1-(2, 6-difluorobenzyl)-1-H-1, 2, 3-triazole-4-carboxamide - form A - which is not taught by Meier. Moreover, crystal modification A is a significant limitation because crystal modification A is defined on page 2 of the specification as "melting at 242° C", which is outside of the range taught by Meier. Furthermore, Applicant teaches "a therapeutically effective amount of crystal modification A..."which is nowhere disclosed or discussed in Meier.
( 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)
3. 362 Patent
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 ...