Filed on behalf of: Par Pharmaceutical, Inc. et al.
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`Entered: January 19, 2017
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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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`PAR PHARMACEUTICAL, INC., BRECKENRIDGE PHARMACEUTICAL,
`INC., AND ROXANE LABORATORIES, INC.
`Petitioners
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`v.
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`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-000841
`U.S. Patent No. 5,665,772
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`
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`PETITIONERS’ RESPONSE TO PATENT OWNER’S
`IDENTIFICATION OF PORTIONS
`OF PETITIONERS’ REPLY
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`
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`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
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`Entered: January 19, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PAR PHARMACEUTICAL, INC., BRECKENRIDGE PHARMACEUTICAL,
`INC., AND ROXANE LABORATORIES, INC.
`Petitioners
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`v.
`
`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-000841
`U.S. Patent No. 5,665,772
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S
`IDENTIFICATION OF PORTIONS
`OF PETITIONERS’ REPLY
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`
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`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`
`
`IPR2016-00084
`U.S. Patent No. 5,665,772
`Pursuant to the Board’s email of January 6, 2017, Petitioners submits a
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`responsive numbered list of citations to the record that provide support for where
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`the arguments objected to by Patent Owner were previously raised by Petitioner, or
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`citations to arguments by Patent Owner to which the objected-to portions are
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`responsive with a one-sentence description of the relevance.
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`1. Patent Owner: Page 3, line 20 – page 4, line 3, and page 4, lines 13-15.
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`Petitioners assert a new basis for selecting rapamycin as a lead compound
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`(“potency”) that could and should have been raised as part of their prima facie
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`case, but was not included in the Petition.
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`Petitioners’ response: Petitioners asserted in the petition that rapamycin’s
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`immunosuppressant potency is a basis for selecting it as a lead compound (Pet. 16-
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`17, 26-27, 41-42 (citing, e.g., Ex. 1003 ¶ 133)), and the reply responded to
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`arguments to the contrary in the patent owner response (POR 48-49).
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`2. Patent Owner: Page 4, lines 10-12 and 17-20 (see also page 1, lines 17-
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`20). Petitioners assert a new basis for selecting rapamycin as a lead compound
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`(“researchers regularly selected rapamycin”) that relies on evidence (exhibits cited
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`in Ex. 2093 ¶¶ 63-83) that could and should have been raised as part of their prima
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`facie case, but were not included in the Petition.
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`1
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Petitioners’ response: The petition asserted that researchers were regularly
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`selecting rapamycin as evidence that a POSA would have selected it as a lead
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`compound (Pet. 18, 26, 41 (citing, e.g., Ex. 1003 ¶¶ 89-100, 136)), and the reply
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`responded to arguments to the contrary in Patent Owner’s Response (POR 47-50)
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`by, e.g., pointing to additional examples provided by Novartis in its Ex. 2093
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`¶¶ 63-83.
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`3. Patent Owner: Page 6, lines 3-16. Petitioners rely on new evidence (Ex.
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`1034 at 116; Ex. 1118 ¶¶ 25-26) to assert that it was known in the art that
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`rapamycin’s solubility led to formulation problems, when this argument and
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`evidence could and should have been raised as part of their prima facie case, but
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`were not included in the Petition.
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`Petitioners’ response: The petition established that rapamycin’s poor
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`solubility led to formulation problems (Pet. 4, 17, 26-27, 41-42, citing, e.g., Ex.
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`1003 ¶¶ 75-76, 138-140 and Ex. 1005 (Morris)), and the reply and Ex. 1118 ¶¶ 25-
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`26 responded to arguments in POR 51-55 and Ex. 2092 ¶¶ 150-160; see also POR
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`29 (“Par’s case is premised on its assertion that rapamycin’s water solubility was
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`sufficiently problematic to limit pharmaceutical utility”); Ex. 1118 ¶¶ 25-26
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`(expressly responding to Ex. 2092); Novartis’s Motion to Exclude (“Mot. Excl.”)
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`2
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`5-7 (Ex. 1034), 8-10 (Ex. 1118 ¶¶ 25-26) (Paper 54); Petitioners’ Opposition
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`(“Opp. Mot. Excl.”) 5-7 (Ex. 1034), 7-9 (Ex. 1118 ¶¶ 25-26) (Paper 59).
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`4. Patent Owner: Page 6, lines 5-16. Petitioners rely on new evidence (Ex.
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`1034; Ex. 1118 ¶¶ 26, 32-35) to assert a motivation to chemically modify
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`rapamycin, when this evidence could and should have been raised as part of their
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`prima facie case, but was not included in the Petition.
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`Petitioners’ response: The petition established that rapamycin’s poor
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`solubility limited its use in drug formulations (Pet. 4, 17, 23-24, 26-27, 32-34 41-
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`42, citing, e.g., Ex. 1003 ¶¶ 75-76, 138-140 and Ex. 1005 (Morris)), and the reply
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`and Ex. 1118 ¶¶ 26, 32-35 responded to arguments at POR 51-55 and Ex. 2092
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`¶¶ 150-160; see also Item 3 (above); POR 29; Mot. Excl. 8-10; Opp. Mot. Excl. 5-
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`7, 7-9.
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`5. Patent Owner: Page 10, lines 10-12 and 14-17. To the extent Petitioners
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`are arguing that (i) Lemke (Ex. 1008) discusses internal entropy and/or (ii)
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`Yalkowsky (Ex. 1007) discusses polar groups and hydrophilicity, these arguments
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`could and should have been raised as part of their prima facie case, but were not
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`included in the Petition.
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`3
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Petitioners’ response: Petitioners are not alleging that Lemke discusses
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`internal entropy or that Yalkowsky discusses polar groups and hydrophilicity;
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`rather, Petitioners are alleging that “Lemke and Yalkowsky together taught that
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`adding flexible side chains (to increase internal entropy) containing polar groups
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`(to increase hydrophilicity) is likely to improve solubility” as stated at Reply 10
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`(citing Pet. 44-48 where this issue was raised); see also Reply 11 n.2 (including
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`citations); Mot. Excl. 9 (re: the cites to Ex. 1118 in this portion of Reply); Opp.
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`Mot. Excl. 8-9 (same).
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`6. Patent Owner: Page 12, line 1 – page 14, line 9, and page 15, line 13 –
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`page 16, line 1. Petitioners attempt to explain how Yalkowsky is relevant to the
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`instant case, including why everolimus qualifies as a long-chain derivative of
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`rapamycin with more than 6 atoms in the chain, when such arguments and
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`evidence could and should have been raised as part of their prima facie case, but
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`were not included in the Petition, and when Petitioners’ declarant, Dr. Jorgensen,
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`refused to answer questions at his August 9, 2016 deposition about the length of
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`everolimus’s side chain (see Novartis’s Patent Owner Response, Paper 27 at 22
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`and 22 n.4).
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`Petitioners’ response: The petition established why Yalkowsky is relevant
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`(Pet. 7, 23, 32-33, 44-48), the reply at 12-14 expressly responded to Novartis’s
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`4
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`arguments at POR 19-25 and Ex. 2092 ¶¶ 31, 99, 105-108 that Yalkowsky does not
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`apply, and the reply at 15-16 expressly responded to Novartis’s contentions at POR
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`17-19 that Yalkowsky is not analogous art or is limited in its applicability here; see
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`also Mot. Excl. 9 (re: the cites to Ex. 1118 in this portion of Reply); Opp. Mot.
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`Excl. 8-9.
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`7. Patent Owner: Page 16, lines 1-9. Petitioners attempt to explain the
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`relationship between ideal solubility and real systems, and rely on new evidence
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`(Ex. 1118 ¶¶ 13, 92-102 and exhibits cited therein including Ex. 1117), when such
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`arguments and evidence could and should have been raised as part of their prima
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`facie case, but were not included in the Petition.
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`Petitioners’ response: The petition established why Yalkowsky is relevant
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`(Pet. 7, 23, 32-33, 44-48), the reply expressly responded to Novartis’s arguments at
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`POR 17-19 (see Reply 15) regarding Yalkowsky and ideal solubility, Dr.
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`Jorgenson (Ex. 1118 ¶¶ 13, 92-102) expressly responded to Ex. 2092, and Ex. 1117
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`was submitted in response to POR 17-18; see also Mot. Excl. 5-8 (Ex. 1117), 9
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`(Ex. 1118); Opp. Mot. Excl. at 7 (Ex. 1117), 8-9 (Ex. 1118); POR 26 (arguing
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`Yalkowsky and ideal solubility).
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`5
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`8. Patent Owner: Pages 17-18, footnote 6. Petitioners rely on new evidence
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`(Ex. 1119 ¶¶ 32-36, 43, 101-106 and exhibits and evidence cited therein) and make
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`a new argument that everolimus’s antitumor activity would have been reasonably
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`expected as of October 1992, when this evidence and argument that could and
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`should have been raised as part of their prima facie case, but were not included in
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`the Petition.
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`Petitioners’ response: Petitioners’ theory of invalidity does not require a
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`reasonable expectation of achieving antitumor activity; this section responds to
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`Novartis’s arguments on this issue at POR 59-60; see also Mot. Excl. 10-12 (Ex.
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`1119); Opp. Mot. Excl. 9-11 (same).
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`9. Patent Owner: Page 19, lines 10-13. Petitioners assert a new basis to
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`assert that everolimus would have been expected to “retain[] immunosuppressant
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`activity” that relies on evidence (Ex. 1118 ¶¶103-108, and exhibits cited therein,
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`and exhibits cited in Ex. 2092 ¶ 63) that could and should have been raised as part
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`of their prima facie case, but was not included in the Petition.
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`Petitioners’ response: The petition established that a POSA would have
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`reasonably expected to retain immunosuppressant activity (Pet. 18, 19-23, 27-31,
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`34-35, 42-44), the reply expressly responded to arguments at POR 42-47 and Ex.
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`2093 ¶¶ 115-130, including using examples provided by Novartis in Ex. 2092 ¶ 63,
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`6
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`and Dr. Jorgensen (Ex. 1118 ¶¶103-108) expressly responded to Dr. Roush (Ex.
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`2093); see also Mot. Excl. 1-2, 8-10 (Ex. 1118); Opp. Mot. Excl. 9 (Ex. 1118).
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`Dated: January 19, 2017
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`Respectfully submitted,
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`/Daniel G. Brown/
`By:
`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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`/Matthew L. Fedowitz/
`By:
`Matthew L. Fedowitz
`(Reg. No. 61,386)
`Merchant & Gould P.C.
`1900 Duke Street, Ste. 600
`Alexandria, VA 22314
`703-684-2500; 703-684-2501 (Fax)
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`Counsel for Petitioner
`Breckenridge Pharmaceutical, Inc.
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`/Keith A. Zullow/
`By:
`Keith A. Zullow (Reg. No. 37,975)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`212-813-8846; 646-558-4226 (Fax)
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`Counsel for Petitioner
`Roxane Laboratories, Inc.
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`7
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 19th day of January,
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`2017, a true and correct copy of the foregoing PETITIONERS’ RESPONSE TO
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`PATENT OWNER’S
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`IDENTIFICATION OF
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`PORTIONS OF
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`PETITIONERS’ REPLY was served by electronic mail on Patent Owner’s lead
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`and backup counsel at the following email address:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Peter J. Waibel (Reg. No. 43,228)
`Christina Schwarz (pro hac vice)
`Charlotte Jacobsen (pro hac vice)
`Susanne L. Flanders (pro hac vice)
`Jared L. Stringham (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
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`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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