NOVARTIS PHARMACEUTICALS CORPORATION, NOVARTIS CORPORATION, NOVARTIS AG, and NOVARTIS PHARMA AG, Plaintiffs,
ACTAVIS, INC. and ACTAVIS ELIZABETH LLC, Defendants.
CHRISTOPHER J. BURKE, Magistrate Judge.
In this Hatch-Waxman action filed by Plaintiffs Novartis Pharmaceuticals Corporation, Novartis Corporation, Novartis AG, and Novartis Pharma AG (collectively, "Novartis" or "Plaintiffs") against Defendants Actavis, Inc. and Actavis Elizabeth LLC (collectively, "Actavis" or "Defendants"), Novartis alleges infringement of U.S. Patent Nos. 6, 465, 504 (the "504 Patent") and 6, 596, 750 (the "'750 Patent") (collectively, the "patents-in-suit"). Pending before the Court is Novartis' letter motion to strike the supplemental expert report of Actavis' expert Kenneth N. Raymond, Ph.D. ("Motion"). (D.I. 157) For the following reasons, the Court DENIES the Motion.
A. Procedural Posture
On June 6, 2012, this case was referred to the Court by Judge Richard G. Andrews to hear and resolve all pretrial matters, up to and including case-dispositive motions. On June 18, 2012, the Court entered a Scheduling Order in the case. (D.I. 27) Fact discovery closed on August 1, 2013. A pre-trial conference is scheduled for January 10, 2014, and a bench trial is to begin on January 27, 2014.
The initial Scheduling Order contemplated three rounds of expert reports: (1) opening reports from the party who has the initial burden of proof; (2) rebuttal reports; and (3) reply reports limited in scope to "respond[ing] to secondary considerations raised by Plaintiffs' rebuttal expert reports[.]" (D.I. 27 at ¶ 3(h)(1)) The Scheduling Order also provided that "[n]o other expert reports will be permitted without either the consent of all parties or leave of the Court, " ( id. ), but a subsequent Court order (issued at the parties' joint request) did set a deadline for "[a]ll and final supplementation under [Fed. R. Civ. P.] 26(e), unless good cause shown upon a motion for leave, " (D.I. 96). Pursuant to multiple Court-ordered amendments to these expert-related deadlines (all also issued at the parties' joint request), opening expert reports were due on September 4, 2013; rebuttal reports were due on October 15, 2013, reply reports were due November 11, 2013, and final supplementation under Fed.R.Civ.P. 26(e) ("Rule 26(e)") was due on December 20, 2013. (D.I. 121; D.I. 150)
Actavis produced the opening report of its expert, Dr. Raymond, on September 4, 2013. (D.I. 157 at 1; D.I. 160, ex. C (hereinafter, "Raymond Report")) In response, Novartis produced the rebuttal report of its expert, Robert C. Hider, Ph.D., on October 15, 2013. (D.I. 160, ex. F (hereinafter "Hider Rebuttal")) Actavis subsequently produced two additional reports by Dr. Raymond. The first reply report, responding to portions of the Hider Rebuttal regarding secondary considerations of nonobviousness (also referred to as "objective considerations of nonobviousness"), was timely produced and is not at issue in this Motion. ( Id., ex. D (hereinafter "Raymond Reply")) At issue is the second of these reports, which is titled "Supplemental Expert Report" and purports to respond to other opinions set out in the Hider Rebuttal relating to the alleged validity of the patents-in-suit. ( Id., ex. E at ¶ 2 (hereinafter "Raymond Supplement")) Actavis served the Raymond Supplement on November 25, 2013. ( Id. at 24-25) Nine days later, on December 4, 2013, Novartis took the deposition of Dr. Raymond. (D.I. 157 at 1; D.I. 163, ex. 1 at 1)
On November 27, 2013, Novartis filed its letter-motion to strike the Raymond Supplement. (D.I. 157) The Court ordered expedited briefing on the Motion, and briefing was completed on December 13, 2013. (D.I. 167)
B. Content of the Expert Reports
As they are relevant to the issues described below, the Court will first summarize certain content of the Raymond Report, the Hider Rebuttal, and the Raymond Supplement.
1. Raymond Report
The Raymond Report, which spans 84 pages and 255 paragraphs, explains the bases for Dr. Raymond's main conclusions that: (1) the asserted claims of the patents-in-suit are not entitled to a priority date earlier than October 30, 2000, because the earlier patent applications to which Novartis claims priority for the patents-in-suit were not enabling; and (2) the asserted claims of the patents-in-suit are invalid as either anticipated or obvious over certain prior art. ( See Raymond Report at ¶¶ 1-3) The expert opinions at issue here relate to the first conclusion.
To give context to his opinion regarding the priority date of the patents-in-suit, Dr. Raymond explains that:
[U]nder 35 U.S.C. § 112, a patent's specification must adequately disclose to one of ordinary skill in the art how to make the claimed invention without undue experimentation, the so-called enablement requirement. Under 35 U.S.C. § 101, any patentable invention must also be useful, the so-called utility requirement. If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement. These requirements under 35 U.S.C. §§ 101 and 112 are analyzed from the perspective of a person of ordinary skill in the art as of the filing date of the alleged invention.
( Id. at ¶ 21) The patents-in-suit both claim priority to U.S. application No. 09/202, 769 (the "'769 Application"), filed on June 24, 1997, which claims foreign priority to Swiss application No. 1593/96 (the "Swiss Application"), filed June 25, 1996 (collectively, the "Priority Applications"). ( Id. at ¶ 82 (internal citations omitted)) The '750 Patent issued from a division of the application that issued as the '504 Patent. ( Id. (internal citation omitted)) On October 30, 2000, U.S. application No. 09/699, 765 (the "'765 Application") was filed as a continuation-in-part of the '769 Application. ( Id. at ¶ 110)
To support the alleged enablement of the Priority Applications, Novartis' Interrogatory Responses pointed to certain statements contained in their specifications. ( Id. at ¶¶ 173-77) However, Dr. Raymond concludes that the asserted claims of the patents-in-suit are not entitled to a priority date earlier than the filing date of the '765 Application. ( Id. at ¶¶ 1, 110, 165) According to Dr. Raymond, that application supplied vital information that was missing from the Priority Applications-data from in vivo animal tests conducted with the claimed compounds, which allegedly demonstrated the compounds' utility for the excretion of iron. ( Id. at ¶ 110)
The Raymond Report opines that because the Priority Applications lacked such data, a person of ordinary skill in the art reading the applications would not have understood that the claimed compounds had any utility as therapeutic iron chelation agents (and would only have gained such an understanding after the filing of the '765 Application, which supplied such data). ( Id. at ¶¶ 166-86) Dr. Raymond explains that "[i]n order to have a reasonable expectation that a compound would have  pharmacological activity [as an iron chelator useful for treating excess iron] in humans or animals... one of ordinary skill in the art would have to have been presented with adequate data showing in vivo activity in an appropriate animal model." ( Id. at ¶ 170; see also ¶ 186 (explaining that "a person of ordinary skill in the art would need to view data from appropriate in vivo tests to be reasonably convinced that a compound would work as an iron chelator in human or animal therapy")) Dr. Raymond opines that the absence of supporting data would prevent a person of ordinary skill in the art from drawing any conclusions about the claimed compounds, and instead that person would accept the statements "merely as a hypothesis or object of future research." ( Id. at ¶ 176; see also id. at ¶¶ 178-79 (explaining that such statements would not have indicated to the person of ordinary skill in the art that the claimed compounds and methods would work because they indicated that the in vivo animal experiments described could be performed, but were not actually performed))
Dr. Raymond elaborates that if such experiments had been performed, "a person of ordinary skill in the art would have expected to see data included" as "[t]hat was (and remains today) a central tenet of the scientific method." ( Id. at ¶ 179) That is, "[i]f one has actually undertaken an experiment, a scientist expects another scientist to provide sufficient information regarding the experimental protocol, the use of an appropriate control, and empirical results sufficient for one of ordinary skill to attempt to replicate the experiment(s) and the result(s)." ( Id. ) But according to Dr. Raymond, "[t]he bare statements in the [relevant applications] contain no supporting data, and therefore no measure of the degree of alleged iron chelation, statistical analysis, or controls." ( Id. at ¶ 180)
Dr. Raymond also argues that, contrary to Novartis' position in its Interrogatory Responses, an internal report ("Internal Report") containing in vivo data that applicants submitted to the PTO during prosecution of the '769 Application did not demonstrate utility of the claimed compounds. ( Id. at ¶¶ 187-94) For one thing, Dr. Raymond opines, the only date shown on the report is the date on which it was faxed, and thus the person of ordinary skill in the art would have no way of knowing when the data contained in the report was generated. ( Id. at ¶ 189) Second, the report did not contain, ...