UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner
`_____________________
`
`CASE IPR2013-00371
`Patent 8,394,405
`_____________________
`
`PETITIONER'S REPLY
`TO PATENT OWNER'S RESPONSE TO PETITION
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner
`_____________________
`
`CASE IPR2013-00371
`Patent 8,394,405
`_____________________
`
`PETITIONER'S REPLY
`TO PATENT OWNER'S RESPONSE TO PETITION
`
`
`
`
`
`
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`SUPERNUS HAS NOT REBUTTED AMNEAL'S SHOWING OF
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`Galderma — A Real Party In Interest — Adopted Petitioner's
`
`A Skilled Artisan Would Have Combined the Teachings of the
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`Supernus's Attempts to Invoke the CREATE Act Must Also
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`OBVIOUSNESS ............................................................................................. 1
`A. Ashley '932 Teaches IR/DR Formulations of Doxycycline .................. 1
`B.
`View of the Disclosure of the Ashley '854 Application ....................... 2
`C.
`Prior Art at Issue .................................................................................... 3
`The Art as a Whole Does Not "Teach Away" ....................................... 6
`D.
`E.
`The Claimed IR/DR Ratios Are Not Critical ........................................ 8
`Objective Indicia Do Not Support Patentability ................................... 8
`F.
`FAIL ..............................................................................................................12
`A. Ashley '932 Properly Incorporated the '854 Application ....................12
`B.
`Supernus Fails to Antedate the Ashley References ............................13
`C.
`Fail .......................................................................................................15
`III. CONCLUSION ............................................................................................15
`
`SUPERNUS' ATTEMPTS TO SIDESTEP THE PRIOR ART
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`I.
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`II.
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`Petitioner Amneal Pharmaceuticals LLC ("Amneal") submits this Reply to
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`Patent Owner Supernus Pharmaceuticals, Inc.'s ("Supernus") Response to the
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`Petition filed by Amneal concerning claims 1-13 and 17-20 of U.S. Patent No.
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`8,394,405 ("the '405 patent"). As set forth in detail below, Supernus has failed to
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`rebut Amneal's showing that the foregoing claims of the '405 patent would have
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`been obvious in view of (1) International Publication No. WO 02/080932 ("Ashley
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`'932")[ Ex. 1002] (incorporating by reference U.S. Provisional Patent Application
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`No. 60/281,854 ("Ashley '854") [Ex. 1003]) combined with (2) U.S. Patent No.
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`5,348,748 ("Sheth") [Ex. 1005].
`
`I.
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`
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`SUPERNUS HAS NOT REBUTTED AMNEAL'S SHOWING OF
`OBVIOUSNESS
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`A. Ashley '932 Teaches IR/DR Formulations of Doxycycline
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` The Petition demonstrated that Ashley '932 teaches an IR/DR formulation.
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`Paper 1 at 10-14. Ashley '932, by its incorporation of the Ashley '854, teaches
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`formulations comprising "a controlled release agent selected from the group
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`consisting of an instantaneous release agent, a sustained-release agent, a delayed-
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`release agent, and combinations thereof." Ex. 1003 at 5:24-26. The Board cited this
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`language in holding that Ashley '854 discloses an IR/DR-only formulation (among
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`others). Paper 11 at 8.
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`Supernus and its expert, Dr. Edward Rudnic, insist that Ashley '854 requires
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`a sustained-release agent in all embodiments. Paper 40 at 11-13. During his
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`deposition, Dr. Rudnic criticized the Board's "very narrow interpretation" of the
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`Ashley '854 reference based on its recitation of an IR/DR only formulation as one
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`of seven possible combinations; but then Dr. Rudnic inexplicably insisted that the
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`Ashley reference does not disclose an IR/DR combination. Ex. 1052 at 102:10-22;
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`97:23-99:3. When pressed to explain his rationale, Dr. Rudnic repeatedly asserted
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`that the "central theme" or "central focus" is a substantially constant rate of release.
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`Id. at 79:7-81:15.
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`But that is not the law. It is well settled that "[a] reference may be read for
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`all that it teaches, including uses beyond its primary purpose" and not just its
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`"central focus" or "central theme" as Supernus and Dr. Rudnic insist. In re Mouttet,
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`686 F.3d 1322, 1331 (Fed. Cir. 2012). As the Board previously noted, "[t]hat
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`Ashley '854 devotes more attention to formulations including sustained-release
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`agents than to others is irrelevant." Paper 11 at 12.
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`Dr. Rudnic also emphasizes the absence of working examples of
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`formulations in Ashley '854. See, e.g., Ex. 2016 at ¶ 127. But the law does not
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`require working examples; prior art "is relevant for all it contains." In re Heck, 699
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`F.2d 1331, 1332-33 (Fed. Cir. 1983).
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`B. Galderma — A Real Party In Interest — Adopted Petitioner's
`View of the Disclosure of the Ashley '854 Application
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`Supernus' insistence that Ashley '854 must always include an SR component
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`
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`is directly refuted by statements made by Galderma—a real party in interest in this
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`proceeding—during prosecution of U.S. Application No. 10/474,240 (which
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`claims priority to Ashley '854 and has a nearly identical specification). During the
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`'240 application's prosecution, Galderma argued that the very language cited by the
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`Petitioner and Board, i.e. "a controlled release agent… consisting of an
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`instantaneous release agent, sustained-release agent, a delayed-release agent and
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`combinations thereof" supported a claim for an IR/DR only dosage form. Ex. 1020
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`at 3-4, citing Ex. 1092 at 9-10. Indeed, it insisted that the Ashley invention
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`"cannot include a prolonged release agent." Id. at 4 (emphasis in original).
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`As a real party in interest, Galderma's representations concerning Ashley
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`'854's disclosure are relevant evidence of the prior art and a POSA's understanding
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`thereof. See Abbott Labs. v Andrx Pharm., Inc., 452 F.3d 1331,1341 (Fed. Cir.
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`2006). Dr. Rudnic testified that he did not consider this Galderma admission in
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`forming his opinions. Ex. 1052 at 77:12-15. Supernus now argues to the Board that
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`Ashley '854 must include a sustained release agent in any combination; but the real
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`party in interest, Galderma, argued the exact opposite to the Patent Office.
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`C. A Skilled Artisan Would Have Combined the Teachings of the
`Prior Art at Issue
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`As the Board correctly noted, "Amneal relies on Sheth merely for its
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`
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`disclosure concerning the ratio of immediate release pellets to delayed release
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`pellets." Paper 11 at 12. As an initial matter, Supernus has not rebutted—and
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`cannot rebut—the disclosure in Sheth that includes the claimed ratios of 70:30 to
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`80:20 of IR/DR formulations. Dr. Rudnic criticizes the combination of Ashley '932
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`and Sheth on the basis that such a combination would not "necessarily be
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`successful." Ex. 2016, ¶¶ 56, 58. But obviousness requires only a reasonable
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`expectation of success, not certainty or necessary success. Pfizer, Inc. v. Apotex,
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`Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Dr. Rudnic admitted that he did not
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`know if the "necessarily successful" standard he relied on in his declaration was
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`the correct standard for obviousness. Ex. 2016, ¶56, 58; Ex. 1052, 47:12-16.
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`Supernus argues that a POSA would not combine Ashley and Sheth because
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`Ashley teaches low plasma levels of doxycycline and Sheth teaches antimicrobial
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`levels of minocycline. Paper 40 at 25-26. As set forth in the Petition (at 21-26),
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`however, a POSA would have looked to a reference such as Sheth if a POSA
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`needed further guidance regarding IR/DR ratios to develop a formulation achieving
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`the plasma concentrations taught by Ashley '932. In its Decision (at 12), the Board
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`accepted Petitioner's argument, "that the otherwise close relatedness of these two
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`drugs [i.e. doxycycline and minocycline] in structure and function makes
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`information about formulation of one relevant to formulation of the other."
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`Doxycycline and minocycline are closely-related in terms of chemical
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`structure, pharmacokinetics, and therapeutic properties as Dr. Glenn Van Buskirk,
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`Amneal's pharmaceutical formulation expert, explains in his declaration. Ex. 1022,
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`¶180. While some differences exist, they are not so great that a POSA would
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`ignore minocycline art as guidance on doxycycline. Ex. 1066, ¶¶ 56-58.
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`In fact, Ashley '932 itself expressly states that doxycycline and minocycline
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`are useful for treating rosacea, providing another reason for a POSA to combine
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`Ashley with Sheth. Ex. 1002 at 7:24-25. And Sheth is concerned with achieving a
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`once-daily administration of minocycline, a further reason to combine Sheth with
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`Ashley. Moreover, Dr. Rudnic's own patent, which published as US 2002/0136766
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`A1 prior to the '405 patent filing date, teaches tetracycline IR/DR formulations that
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`would be suitable for both doxycycline and minocycline. Accordingly, the Board
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`should give little weight to his testimony that minocycline formulations are
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`irrelevant. Compare Ex. 2016, ¶ 138-42 with Ex. 1089, Ex. 1032, claims 1 & 2,
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`and Ex. 1052 at 143:21-25.
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`Armed with what was known about the absorption properties of
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`doxycycline, a POSA would have at least a reasonable expectation of success that
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`an IR/DR formulation would be a successful strategy to achieve once-daily dosing
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`of doxycycline. See Ex. 1066, ¶ 68; Ex. 2016, ¶ 50. This expectation is supported
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`by the teachings of Sheth, which showed that an IR/DR combination is useful for
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`once-daily dosing of minocycline which, like doxycycline, was known to be
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`absorbed in the upper gastrointestinal tract. Ex. 1066, ¶¶ 51, 68. And it is further
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`supported by the knowledge in the art that both IR and DR doxycycline products
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`were in use. Id., ¶ 75; Ex. 1068, 95:2. Whether a POSA would be aware that
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`doxycycline may have lower absorption below the duodenum is of no moment
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`because a POSA would know that doxycycline is absorbed in the duodenum, and
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`could therefore reasonably expect to formulate successful IR/DR dosages. Ex.
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`1066, ¶¶ 51, 68.
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`Supernus suggests that it would require too much trial and error for a POSA
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`to achieve a successful doxycycline formulation based on Ashley '932 and Sheth.
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`Paper 40 at 37-40. But preparing prototype formulations and conducting routine
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`testing to evaluate those formulations would be well within the skill and ability of
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`a POSA. Ex. 1022, ¶¶ 171, 178; Ex. 1066 at Table 3 at 14.
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`
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`D. The Art as a Whole Does Not "Teach Away"
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`Supernus argues that Ashley '932 and Sheth "teach away" from the IR/DR
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`formulations claimed by the '405 patent. Paper 40 at 21-23. For art to "teach
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`away," it must "criticize, discredit, or otherwise discourage the solution claimed."
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`In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). But there are no teachings in
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`any of the art of record that remotely criticize, discredit, or discourage IR/DR
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`formulations. The mere fact that Ashley '932 identifies another embodiment as
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`preferred is not a "clear discouragement." Santarus, Inc. v. Par Pharm., Inc., 694
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`F.3d 1344, 1356 (Fed. Cir. 2012). Moreover, Dr. Rudnic offered no evidence that
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`the art as a whole teaches away; indeed his own prior art patent application recited
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`the use of IR/DR formulations to deliver doxycycline. Ex. 1089. Dr. Rudnic's
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`"teaching away" allegations are, ironically, contradicted by his own prior art.
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`As set forth in the Petition (at 21-23), Sheth discloses a formulation with two
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`pulses: an IR pulse provided by an initial loading portion and a DR pulse provided
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`by a secondary loading portion. Sheth teaches that the "second pulse provides a
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`delayed release and a controlled release of [drug], preferably in the duodenum."
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`Ex. 1005, 7:34-36 (emphasis added). The second pulse has a "rapid and
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`substantially complete release" in a buffer "having a pH of from about 4.5 to 6.5"
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`Id., 8:40-47.
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`Dr. Rudnic conceded that there would be a "lag" associated with the initial
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`release of drug from the Sheth secondary loading component. Ex. 1052 at 247:20-
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`248:5. But he disputes that this is delayed release because it releases "a small
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`amount of drug in the stomach" before a complete release "in the human upper
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`intestinal tract and particularly in the duodenum." Ex. 1005, 7:14-21. This attempt
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`to mischaracterize Sheth's express language reciting a delayed release portion as a
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`"modified release or a short sustained release" system also fails. Ex. 2016, ¶ 177.
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`Nowhere do the Sheth inventors describe their embodiments using this
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`terminology. Ex. 1066, ¶¶ 39-40.
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`Even if Supernus' unduly narrow construction of delayed release is credited,
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`the combination of Ashley '932 and Sheth still teaches a delayed release portion.
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`Indeed, Supernus admits that "delayed-release agents" are disclosed by Ashley
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`'854. See Paper 40 at 13. Consequently, there is no dispute that the art of record
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`discloses DR dosage forms. Ex. 1022, ¶ 223.
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`E.
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`The Claimed IR/DR Ratios Are Not Critical
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`Supernus offers no argument that the 70:30-80:20 IR/DR ratios claimed in
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`the '405 patent are critical to achieving therapeutic blood levels. Paper 40, at 40-41.
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`Indeed, it offers no evidence that the prior art taught away from the claimed ratios,
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`no evidence that the claimed ratios achieve new or unexpected benefits and, as
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`explained below, no evidence of any other objective indicia that might warrant
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`finding the claims nonobvious. See Galderma Labs., L.P. v. Tolmar, Inc. 737 F.3d
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`731, 737 (Fed. Cir. 2013). This absence of criticality is confirmed by the fact that
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`related U.S. Patent No. 8.206,740 claims an even broader range (99:1 – 70:30) to
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`achieve the same steady-state levels between 0.1 µg/ml and 1.0 µg/ml. Ex. 1001,
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`claim 3. And the '405 patent states these blood levels can even "be accomplished
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`with a single daily dose of an immediate release formulation." Ex. 1007 at 4:4-7.
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`F. Objective Indicia Do Not Support Patentability
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`
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`Supernus' objective indicia arguments lack merit and fail to support a
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`conclusion of nonobviousness. Ex. 1066, Section X; Ex. 1056; Ex. 1071.
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`There was no long-felt need. A showing of a long felt need requires that the
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`need must have been a persistent one that was recognized by a POSA. In re
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`Gershon, 372 F.2d 535, 539 (CCPA 1967). Supernus argues that a long-felt need
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`existed for a once-daily oral formulation of doxycycline to treat rosacea, without
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`the undesired antibiotic side effects. Paper 40 at 43. But absent from the record is
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`evidence "of an articulated identified problem and evidence of efforts to solve that
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`problem." Texas Instr. Inc. v. U.S. Intern. Trade Com'n, 988 F.2d 1165, 1178 (Fed.
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`Cir. 1993) (emphasis added). There is also no evidence of a persistent need
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`recognized by a POSA. Gershon, 372 F.2d at 539.
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`Supernus offers only the unsupported testimony of a dermatologist, Dr. Guy
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`Webster, who admitted that he knew of no literature discussing a long-felt need for
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`the claimed invention. Ex. 1054 at 113:2-11. An expert's bare assertion is not
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`probative of a long-felt need. Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d
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`1324, 1333 (Fed. Cir. 2009). Dr. Webster alleged a "need" for a once-daily version
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`of Periostat®, due to alleged patient compliance problems with twice-daily dosing.
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`Ex. 2018, ¶ 26. But the record contains no documented evidence of such alleged
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`problems or even a reliable head-to-head comparison of compliance rates. Ex.
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`1054, 84:25-85:17.
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`Dr. Elaine Gilmore, a practicing dermatologist who filed a declaration in
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`support of Amneal's reply, explains that from a clinical perspective there is no
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`evidence of a long-felt need for a once-daily oral rosacea treatment that avoided
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`side effects associated with higher antibiotic doses. Ex. 1056, ¶¶ 25-30. Dr.
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`Gilmore further explains that, contrary to Dr. Webster's assertions, there is no
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`reliable evidence that the claimed invention's side-effect profile is an improvement
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`over 50 mg or 100 mg of doxycycline administered once-daily. Id., ¶¶ 27-29. She
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`also explains that there is no evidence that twice-daily dosing created compliance
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`concerns with patients, or that once-daily dosing achieves a better therapeutic
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`outcome in rosacea patients. Id., ¶¶ 44-51. Dr. Webster further admitted that his
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`opinions are unsupported by any controlled studies. Ex. 1054, 55:17-23, 76:11-21.
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`There is no evidence of "failure of others." Supernus argues that a single
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`biostudy of the "Faulding formulations" demonstrates a "failure of others." But that
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`study showed at least one formulation could achieve steady-state blood levels
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`within the range claimed by the '405 patent using once-daily dosing. Ex. 1066, ¶
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`78-80. And Supernus' arguments regarding Faulding's bioavailability levels are
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`irrelevant because the '405 patent claims do not require any particular level of
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`bioavailability. Ex. 1001, claims. Moreover, the fact that Galderma/CollaGenex
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`apparently elected not to pursue the Faulding formulation is of little probative
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`value where there is no direct evidence of why Galderma/CollaGenex made that
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`decision. See DyStar v. C.H. Patrick Co., 464 F.3d 1356, 1371-72 (Fed. Cir. 2006).
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`There is no commercial success. Supernus and its declarant, Dr.
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`Grabowski, have shown only that a commercial embodiment of the claimed
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`invention might enjoy healthy sales. But Supernus has not shown a nexus between
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`the allegedly novel elements of the challenged claims and any marketplace
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`performance. See Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir.
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`2006). Instead, the record confirms that Oracea® sales are driven by commercial
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`factors as explained by Mr. Philip Green, an expert on economic issues involving
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`intellectual property. Ex. 1071, ¶¶ 54-75.
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`Mr. Green explains that the only arguably distinguishing features of
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`Oracea®, the commercial embodiment of the claimed invention, that are
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`potentially probative of commercial success are its once-daily dosing regimen and
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`its 30:10 (IR/DR ) ratio. Id., ¶¶ 28-31, 36-40. But there is no evidence that these
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`claimed features drive sales. Id., ¶ 41-49. In fact, Dr. Grabowski repeatedly
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`insisted that all of Oracea®'s features drive sales. Ex. 1055 at 86:8-14, 87:10-88:2,
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`93:8-18, 93:19-94:8. And Dr. Grabowski repeatedly emphasized Oracea®'s status
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`as the only FDA-approved oral treatment for rosacea. Ex. 1071, ¶¶ 50-53. But any
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`success due to such an "unclaimed feature" is irrelevant. Ormco Corp., 463 F.3d at
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`1312. Moreover, it is well-settled that "if the feature that creates the commercial
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`success was known in the prior art, the success is not pertinent." Id.; see also Tokai
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`Corp v. Easton Enter., Inc., 632 F.3d 1358, 1369-70 (Fed. Cir. 2011). Dr.
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`Grabowski did not consider the prior art. Ex. 1071, ¶¶ 32, 39-40, 47. As Dr.
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`Grabowski did not properly analyze commercial success in this case, his opinions
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`should be disregarded.
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`Supernus fails to establish copying. Supernus asserts that copying supports
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`the nonobviousness of the '405 patent claims (see Paper 40 at 47), but "copying
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`requires evidence of efforts to replicate a specific product." Wyers, 616 F.3d at
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`1246. Supernus only relies on Dr. Rudnic's observation that various generic
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`companies filed ANDAs seeking to market bioequivalent versions of Oracea. Upon
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`cross-examination, Dr. Rudnic admitted that he relied only an excerpt from one
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`page of the Amneal Paragraph IV Notice Letter (Ex. 2053) to speculate that
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`Amneal's product meets all the limitations of all the '405 patent claims. Apart from
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`Amneal's recitation of the word "bioequivalent," Dr. Rudnic could point to no
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`other evidence of alleged "copying." Ex. 1052 at 326:11-14. Thus, there is no
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`factual evidence of copying. Moreover, as the Federal Circuit has repeatedly held,
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`"evidence of copying in the ANDA context is not probative of nonobviousness
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`because a showing of bioequivalence is required for FDA approval." Bayer
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`Healthcare Pharm., Inc. v. Watson Pharm., Inc., 713 F.3d 1369, 1377.
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`II.
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`SUPERNUS' ATTEMPTS TO SIDESTEP THE PRIOR ART FAIL
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`A. Ashley '932 Properly Incorporated the '854 Application
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`Ashley '932 identifies the '854 application with sufficient particularity, as
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`viewed from the vantage point of a POSA, to incorporate it by reference in its
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`entirety. Ex. 1002, 15:26-30; Ex. 1049, ¶¶ 22, 28-31; Ex. 1066, ¶¶ 13,107-08.
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`Supernus' contrary arguments must fail, as Supernus' declarant Stephen Kunin
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`admittedly cannot offer the views of a POSA or speak to this question of law. Ex.
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`1051 at 31:12-32:3; Hollmer v. Harari, 681 F.3d 1351 (Fed. Cir. 2012); See
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`Advanced Display Sys., Inc. v. Kent State Univ., 212 F. 3d 1272, 1283 (Fed. Cir.
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`2000) (holding that "[w]hether and to what extent material has been incorporated
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`by reference into a host document is a question of law" to be determined using "the
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`standard of one reasonably skilled in the art.") And a simple keyword search using
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`the application's title unambiguously leads to a single application having the
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`referenced April 5, 2001 filing date, as explained by Amneal's declarant Mr. John
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`Doll. Ex. 1049, ¶¶ 29-40; Ex. 1066, ¶¶ 107-108. Thus, Ashley '854 is deemed as
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`matter of law part of the Ashley '932 disclosure published on October 17, 2002. Id.
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`Supernus attempts to distract from this straightforward legal question by
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`offering irrelevant speculation as to how quickly a member of the public could
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`have actually obtained a copy of Ashley '854. Paper 40 at 54-55. But the prior art
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`date of a reference cannot turn on the speed at which the PTO's administrative
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`machinery might move. Ex. 1049, ¶¶ 42-48. And, in any event, an interested POSA
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`could have actually obtained a copy of the '854 application long before the April 7,
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`2003 asserted priority date of the '405 patent. Id., ¶¶ 49-57.
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`B.
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`Supernus Fails to Antedate the Ashley References
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`Even if the Board accepted all of Supernus' statements in its attempt to
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`antedate Ashley '932, their argument still fails. First, Supernus does not assert that
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`the inventors made an embodiment of the claimed invention and demonstrated that
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`it works for its intended purpose, as required for an actual reduction to practice.
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`Instead, Supernus argues that "the inventors of the Chang '405 patent expressly
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`contemplated conducting 'in silico modeling . . . .'" Paper 40 at 56-57. But
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`contemplating in silico modeling is not an ARTP of the claimed invention. Second,
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`Supernus failed to offer any inventor testimony or explain why such evidence is
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`not provided. Borror v. Herz, 666 F.2d 569, 573 (CCPA 1981). Third, the sole
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`proffered witness on this issue, Dr. Jones Bryan, is a non-inventor who lacks
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`personal knowledge of an ARTP and relies on hearsay in documents he did not
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`prepare. Ex. 1053 at 62:9-25. Fourth, Dr. Bryan admitted that the in vivo study he
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`relied on did not use an IR/DR formulation nor disclose steady-state blood level
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`values for any formulation. Id. at 124:19-24; 126:1-7. So, Supernus cannot show
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`that it had an ARTP of the claimed invention, and it cannot even show that it
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`invented as much as Ashley '932 teaches, as Ashley '932 teaches steady state blood
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`levels and IR/DR formulations. Ex. 1002, 11:1-3; Ex. 1003 at 5:24-26.
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`Moreover, Supernus offers no credible evidence of conception and diligence,
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`as Dr. Bryan had no personal knowledge of the facts and events. And he did not
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`explain the many substantial gaps in activity during the critical period. Ex. 1053 at
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`62:9-64:20 & 72:24-73:5; see e.g. Ex. 2147 at 2, ll. 70-71 (more than a month of
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`inactivity); see Bosies v. Benedict, 27 F.3d 539, 542 (Fed. Cir. 1994); In re
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`McIntosh, 230 F.2d 615, 619 (CCPA 1956). Supernus has not met its burden of
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`
`persuasion that the Ashley references are antedated.
`
`C.
`
`Supernus's Attempts to Invoke the CREATE Act Must Also Fail
`
` Even if Supernus properly substantiated its CREATE Act claim, Supernus'
`
`attempt to invoke the CREATE Act here should be rejected. Under 35 U.S.C.
`
`§255, Supernus' Certificate of Correction cannot be used to amend the
`
`specification, because such an amendment would raise issues that necessitate
`
`further re-examination. For example, if the CREATE Act is used to disqualify
`
`subject matter as prior art, the '405 patent should be assessed for obviousness-type
`
`double patenting over patents arising from Ashley '932, e.g., USPNs 7,211,267;
`
`7,232,572; and 8,603,506. Supernus' CREATE Act claim must fail.
`
`III. CONCLUSION
`
`
`Nothing Supernus argued should alter the Board's initial views regarding
`
`unpatentability. Amneal has demonstrated by at least a preponderance of the
`
`evidence that claims 1-13 and 17-20 would have been obvious.
`
`
`
`
`
`RESPECTFULLY SUBMITTED,
`
`
`
`
`
`Date: May 23, 2014
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
` /Eldora L. Ellison/
` Eldora L. Ellison, Ph.D.
` Attorney for Petitioner
` Registration No. 39,967
`
`- 15 -
`
`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`
`
`
`The undersigned hereby certifies that a copy of the foregoing "Petitioner's
`Reply to Patent Owner's Response to Petition" was served in its entirety on May
`23, 2014, via email upon the following counsel of record for the Patent Owner:
`
`smaebius@foley.com
`Stephen B. Maebius
`stalapatra@foley.com
`Sunit Talapatra
`
`abaluch@foley.com
`Andrew S. Baluch
`Gerald J. Flattmann, Jr. geraldflattmann@paulhastings.com
`Gregory Morris
`
`gregorymorris@paulhastings.com
`Evan Diamond
`
`evandiamond@paulhastings.com
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`
`
`
`
`
` /Eldora L. Ellison/
` Eldora L. Ellison, Ph.D.
`Date: May 23, 2014
` Lead Attorney for Petitioner
`
`
`
`
`
`1100 New York Avenue, N.W. Registration No. 39,967
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`- 16 -
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