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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`ARGENTUM PHARMACEUTICALS LLC
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`Petitioner
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`v.
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`CIPLA LIMITED
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`Patent Owner
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`_____________________
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`Case No. IPR2017-00807
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`U.S. Patent No. 8,168,620
`_____________________
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`CIPLA LIMITED’S REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Cipla Limited’s Motion for Rehearing
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`Table of Contents
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`I.
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`Introduction ......................................................................................................... 2
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`II. Legal Standard .................................................................................................... 3
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`III. Argument ............................................................................................................. 4
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`A. The Board misapprehended or overlooked the importance of the proper
`claim constructions of “nasal spray” and “suitable for nasal
`administration.” ............................................................................................... 4
`B. The Board misapprehended or overlooked that Argentum’s prior art
`references do not teach a “nasal spray” that is “suitable for nasal
`administration.” ............................................................................................... 6
`1. The Board overlooked that Segal is even more deficient than the
`closer prior art (Cramer) which Cipla overcame. ........................................ 7
`2. The Board misapprehended or overlooked that Ground 2 is deficient
`because Argentum’s alleged art is missing key claim limitations:
`“nasal spray” and “suitable for nasal administration.” ................................ 8
`3. Ground 3 also fails because it relies upon deficient Ground 2. .................10
`IV. Once the Board’s claim construction oversight/misapprehension is
`cured, it is appropriate to grant rehearing and deny institution on
`Grounds 2 and 3. ...............................................................................................12
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`V. Conclusion......................................................................................................... 14
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`Cipla Limited’s Motion for Rehearing
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`I.
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`Introduction
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`Patent Owner Cipla Limited requests rehearing under 37 C.F.R. § 42.71(d)
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`of the Board’s Decision on Institution (“Decision,” Paper 11). The Board correctly
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`denied institution of Ground 1, finding the challenged claims novel over Segal. But
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`the Board wrongly instituted trial on the obviousness grounds (Grounds 2 and 3).
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`At least two statements in the Decision evince that, in doing so, the Board
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`misapprehended or overlooked key evidence and arguments in Cipla’s Preliminary
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`Response that warranted denial of trial on Grounds 2 and 3. These statements are:
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`(1) the Board’s conclusion that “no claim terms require express interpretation for
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`purposes of this Decision;” and (2) the Board’s conclusion that “Patent Owner
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`does not identify any particular claim limitation as not disclosed in the prior art.”
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`(Paper 11, 7, 16.)
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`The first statement shows that the Board misapprehended or overlooked the
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`importance of construing the terms “nasal spray” and “suitable for nasal
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`administration.” As Cipla explained in its preliminary response, even under the
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`“broadest reasonable interpretation” standard, the terms “nasal spray” and “suitable
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`for nasal administration” must be construed to mean “pharmaceutical formulations
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`that are tolerable to patients, homogeneous, and can be suitably deposited onto the
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`nasal mucosa.” (See Paper 7, 9.)
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`This construction is important because the preliminary response then
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`Cipla Limited’s Motion for Rehearing
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`demonstrates that none of the combinations of cited art teach a person of ordinary
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`skill in the art how to make the claimed fixed-dose combination “nasal spray” or
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`formulation “suitable for nasal administration” with a reasonable expectation of
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`success. This is because the Petition fails to show how Segal (even in combination
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`with Hettche, Phillipps, and/or the Flonase® Label) teaches the composition that
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`would provide for the claimed fixed-dose combination “nasal spray” formulation
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`that is “suitable for nasal administration.” (Paper 7, 12-16, 24-25, 41-42.) None of
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`Hettche, Phillipps, nor the Flonase® Label describe formulations with two active
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`ingredients, and Segal does not teach how to successfully make a combination
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`formulation suitable for nasal administration.
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`Because the Board misapprehended or overlooked the relevance of Cipla’s
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`proposed claim construction to demonstrating this threshold failure in Argentum’s
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`Petition, the Board should grant Cipla’s motion for rehearing and reverse its
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`decision to institute trial on Grounds 2 and 3.
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`II. Legal Standard
`“A party dissatisfied with a decision may file a request for rehearing,
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`without prior authorization from the Board.” 37 C.F.R. § 42.71(d). The “burden of
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`showing a decision should be modified lies with the party challenging the
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`decision,” and the request “must specifically identify all matters the party believes
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`the Board misapprehended or overlooked, and the place where each matter was
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`Cipla Limited’s Motion for Rehearing
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`previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a
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`decision on petition, the Board will review the decision for abuse of discretion. 37
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`C.F.R. § 42.71(c).
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`Cipla’s request satisfies 37 C.F.R. § 42.71(d) and demonstrates that the
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`Board abused its discretion by overlooking Cipla’s proposed claim construction
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`and evidence in Cipla’s preliminary response that demonstrates how the Petition
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`failed to show that the cited art taught critical claim elements—“nasal spray” and
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`“suitable for nasal administration.”
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`III. Argument
`A. The Board misapprehended or overlooked the importance of the
`proper claim constructions of “nasal spray” and “suitable for
`nasal administration.”
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`In its Decision, the Board determined that “no claim term requires express
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`interpretation for purposes of this Decision.” (Paper 11, 7.) In doing so, the Board
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`misapprehended or overlooked that a key dispute between the parties is whether
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`the combination of cited references in Grounds 2 and 3 disclose a “nasal spray”
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`that is “suitable for nasal administration.” This is important because these elements
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`appear in every challenged claim, yet they are not found in the art.
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`As Cipla explained in its preliminary response, the broadest reasonable
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`interpretation of “nasal spray” or a formulation “suitable for nasal administration”
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`is “pharmaceutical formulations that are tolerable to patients, that are
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`Cipla Limited’s Motion for Rehearing
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`homogeneous, and that can be suitably deposited onto the nasal mucosa.” (Paper 7,
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`9.) This interpretation arises from the ’620 patent specification (EX1001, 1:37-53
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`3:36-39) and amendments and arguments made during prosecution of the ’620
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`patent. (Paper 7, 10-11.) For example, during prosecution, the ’620 patent’s
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`application was rejected over Example III in Cramer. In response to that rejection,
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`Cipla scientists prepared and tested a formulation by following the teaching of
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`Cramer Example III. The testing revealed that Cramer’s disclosed formulation had:
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`“(1) unacceptable osmolality, which would irritate patients; (2) unacceptable spray
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`quality, which would not have suitably deposited onto the nasal mucosa; and (3)
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`unacceptable settling, which would have adversely effected homogeneity of the
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`formulation.” (Id. (citing EX1002, 286-87, 220-21).) Cipla consequently
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`distinguished its claimed inventions from Cramer by (1) amending several claims
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`to recite “said pharmaceutical formulation is in a dosage form suitable for nasal
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`administration,” and (2) emphasizing the limitation “nasal spray,” as it appeared in
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`all other claims. (Id.) That is, the prosecution history shows that the inventors did
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`not claim just any formulation—they claimed only “pharmaceutical formulations
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`that are tolerable to patients, that are homogeneous, and that can be suitably
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`deposited onto the nasal mucosa.” (Paper 7, 9-11.)
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`These amendments and arguments made during prosecution and their effect
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`on claim construction of the ’620 patent claims should not be overlooked here.
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`Cipla Limited’s Motion for Rehearing
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`Indeed, the Federal Circuit has mandated that the Board “should [] consult the
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`patent’s prosecution history in proceedings in which the patent has been brought
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`back to the agency for a second review” to see if a given construction would be
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`“legally incorrect.” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed.
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`Cir. 2015); D’Agostino, 844 F.3d at 948. (Paper 11, 10.)
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`Had the Board adopted the proper claim construction, which Cipla proffered,
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`the Board would not have instituted trial. Rather, the Board would have found that
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`none of Argentum’s prior art references or arguments disclose a “nasal spray”
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`formulation that is “suitable for nasal administration,” as discussed in detail in
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`III.B., below.
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`B.
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`The Board misapprehended or overlooked that Argentum’s prior
`art references do not teach a “nasal spray” that is “suitable for
`nasal administration.”
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`The Board’s conclusion that “no claim terms require express interpretation,”
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`(Paper 11, 7), suggests that the Board misapprehended or overlooked Cipla’s
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`arguments that the art fails to give any reason to a person of ordinary skill in the art
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`to modify the cited art to arrive at the claimed “nasal spray” and formulation
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`“suitable for nasal administration” with a reasonable expectation of success. (Paper
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`7, 41-42.) This is underscored by the Board’s assertion that “Patent Owner does
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`not identify any particular claim limitation as not disclosed in the prior art.” (Paper
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`11, 16.) To the contrary, Cipla showed in its preliminary response that the claim
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`Cipla Limited’s Motion for Rehearing
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`elements “nasal spray” and formulation “suitable for nasal administration,” as
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`properly construed, are not taught in the art.
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`1.
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`The Board overlooked that Segal is even more deficient than
`the closer prior art (Cramer) which Cipla overcame.
`In finding that Cipla did not identify any particular claim limitation that was
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`not disclosed in the prior art, the Board overlooked Cipla’s evidence that Cramer
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`and Segal share the same teachings relevant to these proceedings, (Paper 7, 12-16),
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`and that Segal is even more deficient, as confirmed by the testimony of
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`Argentum’s experts, Dr. Schleimer and Dr. Donovan.
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`Attempting to avoid the irreparable deficiencies in Cramer’s disclosure
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`established during prosecution and confirmed in district court litigation, Argentum
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`instead relies on the more general teachings from the Segal reference to anchor its
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`obviousness Grounds 2 and 3. But not only does Segal fail to cure Cramer’s
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`shortcomings, it exacerbates them. There can be no dispute that Segal’s disclosure
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`is a “less specific” version of Cramer’s teachings. That is how Argentum’s expert,
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`Dr. Schleimer, described the two references during his testimony in district court.
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`(Paper 7, 12 (quoting CIP2019, 65:17-20).) That description is accurate: Segal
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`discloses more than 800 million hypothetical drug combinations, as the Board
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`found, (Paper 11, 13.), and contains no formulation examples or other description
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`of ingredients or concentrations. (See CIP2007, ¶29; see generally EX1012.)
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`In contrast to Segal, Cramer—which Cipla overcame during prosecution by
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`Cipla Limited’s Motion for Rehearing
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`clarifying or inserting the “nasal spray” and “suitable for nasal administration”
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`claim elements—does provide specific example formulations and other
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`descriptions of ingredients and concentrations. Dr. Govindarajan, upon whose
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`testing Argentum’s expert Dr. Donovan relied in the district court, attempted to
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`recreate Cramer Example III. But his attempted formulations exhibited the same
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`shortcomings that Cipla had shown during prosecution. (Paper 7, 42 (citing
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`CIP2007, ¶¶42-47; CIP2030, 31, 39.)
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`If Cramer’s specific disclosure does not teach a POSA how to make a “nasal
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`spray” that is “suitable for nasal administration,” then Segal surely cannot. (Paper
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`7, 12-16, 40, 41-42.) Indeed, Argentum’s Petition shows no basis to assume it
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`could.
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`2.
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`The Board misapprehended or overlooked that Ground 2 is
`deficient because Argentum’s alleged art is missing key claim
`limitations: “nasal spray” and “suitable for nasal
`administration.”
`As the Board correctly recognized, Segal does not anticipate the ’620 patent
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`claims. (Paper 11, 10-14.) Consequently, a person of ordinary skill in the art must
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`modify Segal in order to stand any chance of arriving at the claimed formulations.
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`But Cipla’s preliminary response highlights how a person of ordinary skill in the
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`art would have had no reasonable expectation that the POSA could successfully
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`modify Segal to arrive at a “nasal spray” formulation “suitable for nasal
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`administration.” In fact, as Cipla explained in its Preliminary Response, testing by
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`Cipla Limited’s Motion for Rehearing
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`Dr. Govindarajan that Dr. Donovan relied on in the district court showed that even
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`modifications of Cramer (and thus, Segal) that might be considered routine in the
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`art, still did not yield the claim elements. Both Dr. Govindarajan’s efforts and
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`additional testing conducted by Cipla (including varying the viscosities of the
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`HPMC thickening agent, varying the micronization of triamcinolone, applying
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`heat, and applying high-speed mixing steps) all showed that various so-called
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`“routine” modifications failed to cure the deficiencies that Cipla exposed during
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`prosecution. (Paper 7, 42 (citing CIP2007, ¶¶48-50, CIP2030, 27; CIP2105, 4-6;
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`CIP2110, 4-7, CIP2040, 4; CIP2029, 3; EX1002, 285-86; CIP2030, 30-31, 33, 36,
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`37).) These failed results underscore that parameters necessary for a “nasal spray”
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`that is “suitable for nasal administration” within the meaning of the claims are
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`interrelated, such that modifying the formulation to address one problem will have
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`adverse consequences for other parameters. And the scant formulation guidance in
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`Segal would not have taught a person of ordinary skill in the art how to modify a
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`combination of azelastine and fluticasone to make it suitable for nasal
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`administration with any reasonable expectation of success. (Paper 7, 38-42).
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`The Board concluded that Cipla’s preliminary response creates “disputed
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`issues of fact” as to whether a person of ordinary skill in the art would have had a
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`reasonable expectation of success. (Paper 11, 20.) There is no such dispute: in
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`district court, both Argentum’s and Cipla’s experts provided testing of numerous
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`Cipla Limited’s Motion for Rehearing
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`changes to Cramer’s formulation and the process for making the same (each of
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`which would fall within the scope of Segal’s unspecific teachings). (Paper 7, 42.)
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`The results of these formulation tests cannot be disputed, and each test was
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`unsuccessful. The repeated failures do not give rise to any expectation of success,
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`reasonable or otherwise. (Id., 41-42.) For Argentum’s expert to testify otherwise
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`does not create a dispute of fact where the testing she previously relied upon
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`proves that there is no dispute. See Brand Management, Inc. v. Menard, Inc., 135
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`F.3d 776, *9 (Fed. Cir. 1998) (rejecting a later declaration that contradicted a
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`witness’s earlier deposition testimony).
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`Ground 3 also fails because it relies upon deficient Ground 2.
`3.
`The Board’s decision to institute Ground 3 also overlooks the importance of
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`the correct construction of the limitations, “nasal spray” and “suitable for nasal
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`administration.” As with Ground 2, there can be no dispute that the same
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`limitations above are missing from Ground 3. But Cipla highlighted additional
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`shortcomings in Ground 3 that the Board would have found persuasive had it not
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`overlooked the correct claim construction.
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`Specifically, the Board found that “Patent Owner’s contention that the
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`Petition fails to articulate a motivation to combine Hettche, Phillipps and Segal
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`with the Flonase® Label is an issue for trial,” and that “Patent Owner’s arguments
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`and evidence” regarding teaching away and the additional excipients “raise a
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`Cipla Limited’s Motion for Rehearing
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`disputed issue of fact that is best resolved on a complete record.” (Paper 11, 21-
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`22.)
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`First, Cipla explained that the use of either CMC or MCC was inconsistent
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`with the homogeneity requirement of the correctly construed claims. CMC and
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`MCC—both thickening agents intended to keep the fluticasone suspended—were
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`expected to precipitate out of solution in the presence of cationic drugs. (Paper 7,
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`44-45.) Azelastine hydrochloride is cationic. (Id., 45.) Thus, by using CMC or
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`MCC in a formulation with azelastine, a POSA would not expect fluticasone to
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`stay properly suspended, which in turn yields a non-homogeneous formulation.
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`(Id.) The Board’s finding that this is a disputed issue is an abuse of discretion: the
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`pre-invention art unambiguously established this expectation, and post-invention
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`testing by Meda Pharmaceuticals confirmed the expectation. (Id., 45-46.)
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`Second, Cipla explained that Segal itself teaches that Argentum’s proposed
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`combination is inconsistent with the tolerability requirement of the correctly
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`construed claims. Segal teaches that “[p]reservative-free compositions are
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`preferred due to reduced sensitivity and increased patient acceptance.” (Paper 7, 47
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`(quoting EX1012, 6:15-19).) There can be no dispute that this is what Segal
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`teaches. And the parties also do not dispute that a POSA would have known that
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`Astelin® is the commercial embodiment of Hettche. (Compare Paper 7, 47, with
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`Paper 2, 12 (“[Hettche], issued in 1982, is the patent that covers Astelin®.”).) Both
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`Cipla Limited’s Motion for Rehearing
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`drugs—Astelin® and Flonase®—contain two preservatives: BKC and EDTA in
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`Astelin® and BKC and phenyl ethyl alcohol in Flonase®. (Paper 7, 47 (citing
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`EX1008, 2; EX1010, 1).) Putting them together, as Argentum proposes in Ground
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`3, yields three preservatives and increased concentration in the formulation. (Paper
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`7, 47.) But Segal teaches away from that very result, particularly in a situation
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`where, as here, the formulation must be tolerable to patients. In finding that Cipla’s
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`arguments “raise a disputed issue of fact,” the Board overlooked that there is no
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`dispute of fact: Segal teaches not to increase preservative content, but that is
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`precisely what Argentum’s purported combination achieves. (See Paper 2, 44-45
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`(listing EDTA, BKC, and phenylethyl alcohol as preservatives).)
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`In short, the Board’s misapprehension of the correct construction of terms
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`“nasal spray” and “suitable for nasal administration” compounded its
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`misapprehension of the arguments presented in Ground 3. The undisputed facts are
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`sufficient to show that Ground 3 should not have been instituted.
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`IV. Once the Board’s claim construction oversight/misapprehension is
`cured, it is appropriate to grant rehearing and deny institution on
`Grounds 2 and 3.
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`The Board’s precedent establishes that rehearing is particularly appropriate
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`in situations where it either arrived at an incorrect claim construction and the
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`correct construction would change the outcome of its original decision. See, e.g.,
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`WesternGeco LLC v. PGS Geophysical AS, IPR2015-00313, Paper 45 (Feb. 3,
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`Cipla Limited’s Motion for Rehearing
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`2017) (granting rehearing and reversing original opinion when corrected claim
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`construction changed the import of prior art); AVX Corp. v. Greatbatch, Ltd.,
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`IPR2015-00710, Paper 13 (Jan. 13, 2016) (same).
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`Cipla showed that the broadest reasonable interpretation of the claim terms
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`“nasal spray” and “suitable for nasal administration” is “pharmaceutical
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`formulations that are tolerable to patients, that are homogeneous, and that can be
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`suitably deposited onto the nasal mucosa.” (Paper 7, 9-11.) Cipla also established
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`that these claim elements are absent from Argentum’s cited prior art. (See supra.)
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`Accordingly, the Board should grant Cipla’s request for rehearing, construe these
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`claim terms, and reverse its decision to institute because Argentum’s Petition failed
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`to show that either element was known in the prior art.
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`Cipla Limited’s Motion for Rehearing
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`V. Conclusion
`The Board misapprehended or overlooked various critical (and indisputable)
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`facts raised in Cipla’s Preliminary Response that warrant denial of institution of
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`Argentum’s Grounds 2 and 3. Argentum’s arguments alleging that Segal taught a
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`“nasal spray” formulation that is “suitable for nasal administration,” within the
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`proper meaning of these terms, is at odds with its own experts’ prior testimony.
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`Cipla, therefore, respectfully requests that the Board grant rehearing and deny
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`institution on Grounds 2 and 3.
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` Respectfully Submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`__________________________
`
` Dennies Varughese
` Lead Attorney for Patent Owner
` Registration No. 61,868
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`
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`Date: September 5, 2017
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`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 772-8501
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`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
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`The undersigned hereby certifies that the above-captioned “Cipla Limited’s
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`Motion for Rehearing Pursuant to 37 C.F.R. § 42.71(d)” was served in its entirety
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`on September 5, 2017, upon the following parties via email:
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`Michael R. Houston: mhouston@foley.com
`Joseph P. Meara: jmeara@foley.com
`James P. McParland: jmcparland@foley.com
`ARG-dymista@foley.com
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`FOLEY & LARDNER LLP
`321 North Clark Street
`Suite 2800
`Chicago, IL 60654
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`__________________________
`Dennies Varughese
`
`
`Date: September 5, 2017
`Lead Attorney for Patent Owner
`1100 New York Avenue, N.W.
`Registration No. 61,868
`Washington, D.C. 20005-3934
`(202) 371-2600
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