IPR2017-00323
`Patent No. 6,943,166
`
`
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
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`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`ICOS CORPORATION
`Patent Owner.
`
`______________________
`
`
`
`IPR2017-00323
`Patent No. 6,943,166
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`______________________
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`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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`
`
`
`
`

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`IPR2017-00323
`Patent No. 6,943,166
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`Grounds Of Alleged Unpatentability ............................................................... 3
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`
`
`I.
`
`II.
`
`III. Background ...................................................................................................... 3
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`A.
`
`B.
`
`C.
`
`The Parties ............................................................................................. 3
`
`Overview of U.S. Patent 6,943,166 to Pullman .................................... 4
`
`Prosecution History ............................................................................... 6
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`IV. The Petition Fails to Prove That the SNDA Document Is Prior Art ............... 8
`
`A. No Evidence Supports the SNDA Being Publicly Available on the
`FDA’s Website on March 27, 1998 ....................................................10
`
`B.
`
`No Evidence Supports the SNDA Being Obtainable from the FDA on
`March 27, 1998 ....................................................................................15
`
`V.
`
`Person Of Ordinary Skill In The Art .............................................................19
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`VI. Claim Construction ........................................................................................22
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`VII. The Petition Fails To Establish A Reasonable Likelihood That Claims
`1-12 Are Obvious ..........................................................................................23
`
`A.
`
`B.
`
`C.
`
`Petitioner’s “Scal[ing]” Theory Is Baseless Hindsight .......................24
`
`Petitioner’s “Scal[ing]” Theory Points to a Maximum Dose Far Above
`the Claimed 20 mg Limit ....................................................................27
`
`The Prior Art Would Not Have Provided Any Motivation to Limit the
`Dose of Tadalafil to 20 mg Per Day ....................................................31
`
`VIII. Conclusion .....................................................................................................36
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`i
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`
`TABLE OF AUTHORITIES
`
`IPR2017-00323
`Patent No. 6,943,166
`
`Page(s)
`
`Federal Cases
`Abbott Laboratories v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) .......................................................................... 25
`
`Alza Corp. v. Mylan Lab.,
`464 F.3d 1286 (Fed. Cir. 2006) .......................................................................... 26
`
`Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,
`776 F.2d 281 (Fed. Cir. 1985) ............................................................................ 11
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) ............................................................................ 30
`
`Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331 (Fed. Cir. 2016) .................................................................... 14, 19
`
`Centricut, LLC v. ESAB Group, Inc.,
`390 F.3d 1361 (Fed. Cir. 2004) .......................................................................... 11
`
`CFMT, Inc. v. Yieldup Intern. Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) .................................................................... 31, 36
`
`Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc.,
`807 F.2d 955 (Fed. Cir. 1986) ............................................................................ 20
`
`In re Cronyn,
`890 F.2d 1158 (Fed. Cir. 1989) ............................................................................ 9
`
`Daiichi Sankyo Co. v. Apotex, Inc.,
`501 F.3d 1254 (Fed. Cir. 2007) .......................................................................... 22
`
`In re Grabiak,
`769 F.2d 729 (Fed. Cir. 1985) ............................................................................ 25
`
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ...................................................................... 12, 16
`
`
`
`ii
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`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) ...................................................................... 9, 13
`
`IPR2017-00323
`Patent No. 6,943,166
`
`In re Omeprazole Patent Litigation,
`536 F.3d 1361 (Fed. Cir. 2008) .......................................................................... 18
`
`In re Wilson,
`424 F.2d 1382 (C.C.P.A. 1970) .......................................................................... 28
`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 22
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .......................................................................... 28
`
`Ortho-McNeil Pharm., Inc. v. Mylan Lab., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 36
`
`P&G v. Teva Pharms. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009) ............................................................................ 25
`
`SRI Int’l, Inc. v. Internet Security Sys., Inc.,
`511 F.3d 1186 (Fed. Cir. 2008) .......................................................................... 14
`
`Patent Trial and Appeal Board Cases
`Actavis, Inc. v. Research Corp. Techs., Inc.,
`IPR2014-01126, Paper 22 (PTAB Jan. 9, 2015) ................................................ 19
`
`Cisco Sys., Inc. v. Constellation Techs. L.L.C.,
`IPR2014-01085, Paper 11 (PTAB Jan. 9, 2015) .................................................. 9
`
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics, Inc.,
`IPR2015-01076, Paper 33 (PTAB Oct. 19, 2015) .................................... 9, 11, 12
`
`Ford Motor Co. v. Versata Devp. Group, Inc.,
`IPR2016-01012, Paper 12 (PTAB Nov. 4, 2016) ............................................... 19
`
`Intelgenx Corp. v. ICOS Corp.,
`IPR2016-00678, Paper 13 (PTAB September 1, 2016) ............................... 22, 30
`
`LG Elecs., Inc. v. Advanced Micro Devices, Inc.,
`IPR2015-00329, Paper 13 (PTAB July 10, 2015) .............................................. 12
`iii
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`Microsoft Corp. v. Bradium Technologies LLC.,
`IPR2015-01435, Paper 15 (PTAB December 23, 2015) .................................... 14
`
`IPR2017-00323
`Patent No. 6,943,166
`
`ServiceNow, Inc. v. Hewlett-Packard Co.,
`IPR2015-00707, Paper 12 (PTAB Aug. 26, 2015) ............................................. 13
`
`Federal Statutes
`
`35 U.S.C. § 102 .......................................................................................... 2, 9, 13, 19
`
`35 U.S.C. § 311(b) ..................................................................................................... 8
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`35 U.S.C. § 314(a) ................................................................................................... 19
`
`Rules
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`Fed. R. Evid. 702 ............................................................................................... 11, 24
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`Fed. R. Evid. 801 ..................................................................................................... 13
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`Fed. R. Evid. 802 ..................................................................................................... 13
`
`Regulations
`
`21 C.F.R § 314.430 .......................................................................................... 1, 9, 16
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`21 C.F.R. § 314.430(b) ............................................................................................ 15
`
`21 C.F.R. § 314.430(e) ....................................................................................... 15, 16
`
`37 C.F.R. § 1.7 ........................................................................................................... 1
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`37 C.F. R. § 42.1(a) .................................................................................................... 1
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`37 C.F.R. § 42.104(b)(4) .......................................................................................... 29
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`37 C.F.R. § 42.107 ..................................................................................................... 1
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`37 C.F.R. § 42.107(b) ................................................................................................ 1
`
`
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`iv
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`I.
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`Introduction
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`IPR2017-00323
`Patent No. 6,943,166
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`Patent Owner submits this preliminary response under 37 C.F.R. § 42.107.
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`This response is being timely filed on March 13, 2017, three months after the
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`December 12, 2016 notice indicating that the petition was granted a filing date
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`(March 12, 2017, falling on a Sunday). (Ex. 2011; Paper No. 5); 37 C.F.R. §§ 1.7,
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`42.1(a), 42.107(b).
`
`Petitioner has challenged the patentability of claims 1-12 of U.S. Patent No.
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`6,943,166 (“the ’166 patent,” Ex. 1001), which covers the FDA-approved method
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`of using tadalafil (the active ingredient in Cialis®) to treat erectile dysfunction. (Ex.
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`1010 (Cialis® label) at 1.) Petitioner relies on a single ground of obviousness over
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`the combination of: Daugan ’675 (“Daugan,” Ex. 1007), the Sildenafil Citrate
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`(Viagra®) Approval Package for New Drug Application No. 20-895 (“Sildenafil
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`NDA” or “SNDA,” Ex. 1008), and FDA Guidelines (Ex. 1009). The Petition fails
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`to establish, however, a reasonable likelihood that any claim of the ’166 patent is
`
`unpatentable. As a threshold matter, Petitioner fails to establish that the SNDA is a
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`prior art printed publication. This deficiency is fatal. On the merits, the Petition
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`fails to establish the claimed 20 mg per day maximum dose of tadalafil, instead
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`relying on a theory that points to a much higher maximum.
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`No record evidence supports the public availability of the SNDA before the
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`April 30, 1999, priority date. While Petitioner cites to 21 C.F.R. § 314.430 to assert
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`that this document would be “immediately available” from the FDA on the day of
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`IPR2017-00323
`Patent No. 6,943,166
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`Viagra’s March 27, 1998, approval, nothing in the record establishes what
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`“immediately available” means, when the document was available on the FDA’s
`
`website, how one of ordinary skill would request or obtain the document from the
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`FDA, or whether it was actually available from the FDA as of the approval date. In
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`other words, nothing establishes that the SNDA was printed prior art as of March
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`27, 1998−or indeed as of any date. Moreover, FDA reports and operating protocols
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`contradict Petitioner’s assumed same day availability. Instead, FDA documents
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`show that because of the time required to review and redact NDA documents,
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`“immediately available” did not mean publically available—much less printed
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`prior art under § 102—on the day of drug approval. Because the Petition’s sole
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`ground relies on the SNDA but Petitioner’s assertions are insufficient to establish
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`its public availability, as a threshold matter the Petition cannot establish a
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`reasonable likelihood of prevailing on the merits.
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`Even if the Board reaches the merits, the outcome should be the same: the
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`Petition fails to establish a reasonable likelihood that any claim is unpatentable. In
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`a hindsight effort to derive the claim unit dose range of about 1 to about 20 mg,
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`Petitioner contends it would have been obvious to “scale” the 5 - 100 mg doses
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`tested for sildenafil to obtain 2.8 to 57 mg doses for tadalafil—some of which are
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`within the range of about 1 to about 20. However, Petitioner’s scaling theory
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`results in a maximum of at least 57 mg—more than two fold higher than the
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`IPR2017-00323
`Patent No. 6,943,166
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`claimed “maximum total dose of 20 mg per day.” The claim as a whole would,
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`therefore, not have been obvious. Institution should be denied for this additional
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`reason.
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`II. Grounds Of Alleged Unpatentability
`The Petition raises one ground for alleged obviousness:
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`Claims 1-12 are unpatentable as obvious over Daugan ’675 (Ex. 1007) in
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`view of the Sildenafil Citrate (Viagra®) Approval Package for New Drug
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`Application No. 20-895 (Ex. 1008) and FDA Guideline (Ex. 1009). (Pet. at 30.)
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`III. Background
`A. The Parties
`Patent Owner, ICOS Corporation, in partnership with Eli Lilly & Company
`
`(collectively “Lilly”), developed, manufactures, and markets Cialis®. (See, e.g., Ex.
`
`1020 at 1.) Based in Indianapolis, Indiana, Lilly is a worldwide leader in the
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`development of innovative medicines. (Ex. 2001 at 1.)
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`Petitioner, Mylan Pharmaceuticals, Inc. is a pharmaceutical company that
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`formulates, manufactures, packages, and markets generic drug products for
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`distribution throughout the United States. (Ex. 2002 at 1; see Ex. 2003 at 4.) Mylan
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`has submitted an Abbreviated New Drug Application to the U.S. Food and Drug
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`IPR2017-00323
`Patent No. 6,943,166
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`Administration (“FDA”) for approval to market a generic version of Lilly’s Cialis®
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`(tadalafil) tablets prior to the expiration of the ’166 patent. (Ex. 2010.)
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`B. Overview of U.S. Patent 6,943,166 to Pullman
`The ’166 patent teaches inventive methods of treating sexual dysfunction by
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`orally administering one or more unit dose containing about 1 to about 20 mg, up
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`to a maximum total dose of 20 mg per day, of tadalafil. (Ex. 1001 at 14:65-15:15.)
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`It is based on the inventors’ surprising discovery, supported by extensive human
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`clinical trials, that tadalafil administered in the claimed unit dose up to a maximum
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`total dose of 20 mg per day provides effective treatment for erectile dysfunction
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`(ED) with an unexpected combination of safety, tolerability, and efficacy. (Id. at
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`2:22-51.) For example, the claimed method provides efficacious treatment with a
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`reduced tendency to cause the side effects of facial flushing and vision
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`abnormalities caused by sildenafil, which were thought to be both indicative of
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`PDE5 inhibition efficacy and inherent to treatment therewith. (Id. at 2:22-32, 5:15-
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`24.)
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`
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`The ’166 patent has 12 claims; claim 1 is the sole independent claim.
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`1. A method of treating sexual dysfunction in a patient in
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`need thereof comprising orally administering one or more unit
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`dose containing about 1 to about 20 mg, up to a maximum total
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`IPR2017-00323
`Patent No. 6,943,166
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`dose of 20 mg per day, of a compound having the structure [of
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`tadalafil]:
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`
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`(Id. at 14:65-15:15.) The dependent claims recite further features, such as a unit
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`dose of about 20 mg in claim 12. (Id. at 15:18-16:20.)
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`The ’166 patent specification provides background information on tadalafil
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`and sildenafil, the latter of which was the only approved PDE5 inhibitor for
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`treating sexual dysfunction at the time of filing. (Id. at 1:28-2:55.) The
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`specification also describes extensive human clinical trials entailing administering
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`tadalafil doses up to 100 mg in ED patients. (Id. at 12:9-14:42.)
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`Example 6 describes a study where tadalafil was administered at a range of
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`doses “in both daily dosing and for on demand therapy.” (Id. at 12:36-40.) “Doses
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`from 5 to 20 mg of Compound (I) were efficacious and demonstrated less than 1%
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`[facial] flushing and no reports of vision abnormalities.” (Id. at 12:40-42.) It was
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`also found that “a 10 mg dose of Compound (I) was fully efficacious and
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`demonstrated minimal side effects.” (Id. at 12:42-44.)
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`5
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`As shown in the tables in Example 7, which combined the clinical data for
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`IPR2017-00323
`Patent No. 6,943,166
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`tadalafil at unit doses in the range of 0 mg to 100 mg, the inventors were able to
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`develop a dosing regimen having desirable efficacy with minimal side effects, such
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`as facial flushing and vision abnormalities seen with and expected from sildenafil.
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`(Id. at 12:54-14:55.) This is opposite to the expectation at the time of the invention
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`that the vasodilation effects like flushing were inherently associated with efficacy,
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`such that efficacy and flushing would be directly correlated in a test population.
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`(See id. at 13:57-14:55; see also id. at 1:58-65, 2:33-51.) The unexpected results
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`shown in the ’166 patent were specifically linked to lower doses of tadalafil in the
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`range of about 1 mg to about 20 mg, with a maximum dose of 20 mg per day, as
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`occurrences of side effects, including flushing, started to increase above 25 mg.
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`(Id. at 13:57-14:55.)
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`Prosecution History
`
`C.
`The Examiner relied on the U.S. national phase entry of Daugan ’675,
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`Daugan ’329, in initially rejecting all of the claims. (Ex. 1006 at 385; Ex. 2009.)
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`Specifically, like the Petitioner does here with Daugan ’675, the Examiner cited
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`Daugan ’329 as “disclos[ing] the instant compound and a method of using it to
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`treat sexual dysfunction,” as well as “oral administration and a dosage within the
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`recited range.” (Id.; see also id. at 311.)
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`6
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`In response, Applicant distinguished Daugan ’329 for two separate reasons:
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`IPR2017-00323
`Patent No. 6,943,166
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`it “fails to teach or suggest [1] an oral dosage form containing about 1 to about 20
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`mg of the claimed PDE5 inhibitor, or [2] its use in a method of treating sexual
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`dysfunction using a maximum total dose of about 20 mg per day. (Id. at 343
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`(emphasis added).) For example, specifically addressing the second limitation,
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`Applicant argued:
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`• “the ’329 patent does not teach or suggest a low maximum daily dose
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`for effective treatment of sexual dysfunction” (id. at 294, 325, 344);
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`• “[Daugan ’329] fails to teach or suggest . . . a maximum total dose of
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`about 20 mg per day” (id. at 324, 343);
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`• “The ’329 patent contains no disclosure that would lead a person
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`skilled in the art to consider using the presently claimed low unit dose
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`and maximum daily dose of Compound (I)” (id. at 326, 345); and
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`• “The ’329 patent . . . fails to teach or suggest the specific unit dosage,
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`maximum daily dosage, and the specific compound of the present
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`invention that provides such new and unexpected benefits” (id. at 294,
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`329).
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`Applicant further cited unexpected results from the unit dose range of the
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`claimed method, which surprisingly provides comparable efficacy to higher doses
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`but with no or low side effects. (Id. at 54-62, 293-301, 327-329, 346-355.) In this
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`regard, Applicant cited data in the specification showing that unit doses in the
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`IPR2017-00323
`Patent No. 6,943,166
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`range of 2 mg to 100 mg are efficacious, but there were unpleasant adverse events
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`above 25 mg. (Id. at 54, 293.) Applicant explained that the low dose range claimed
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`“has surprisingly low adverse side effects while still unexpectedly found to be
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`efficacious.” (Id. at 293.) This was surprising, as further explained, because
`
`although “decreasing a dose of drug often decreases side effects, it also often
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`decreases efficacy.” (Id. at 55 (emphasis added).) Therefore, the “observed
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`divergence of retained efficacy from decreased side effects in [the claimed]
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`substantially lower doses is unexpected.” (Id.) In support of these unexpected
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`results, Applicant submitted two declarations from Dr. Gregory Sides, who
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`testified that the “dramatic reduction in adverse events . . . coupled with an efficacy
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`[comparable to higher doses] across the claimed dose range is an unexpected
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`advance in the art.” (Id. at 58-62, 296-301.)
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`The Examiner found Applicant’s unexpected results persuasive, concluding
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`that the claimed low dose of tadalafil showed comparable efficacy to a higher dose
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`but “dramatically reduced” adverse side effects. (Id. at 35 (Notice of Allowance).)
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`IV. The Petition Fails to Prove That the SNDA Document Is Prior Art
`A Petitioner may only challenge the claims of a patent on the basis of “prior
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`art consisting of patents or printed publications.” 35 U.S.C. § 311(b). The burden is
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`therefore on the Petitioner to make a threshold showing in the Petition that a
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`8
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`reference is available as a prior art printed publication. Cisco Sys., Inc. v.
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`IPR2017-00323
`Patent No. 6,943,166
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`Constellation Techs. L.L.C., IPR2014-01085, Paper 11 at 8-9 (PTAB Jan. 9, 2015);
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`Coalition for Affordable Drugs IV LLC v. Pharmacyclics, Inc., IPR2015-01076,
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`Paper 33 at 5 (PTAB Oct. 19, 2015).
`
`To qualify as a prior art printed publication, a reference must have been
`
`publicly accessible before the critical date. In re Lister, 583 F.3d 1307, 1311-12
`
`(Fed. Cir. 2009). The key inquiry is whether the reference was “sufficiently
`
`accessible to the public interested in the art” before the critical date. In re Cronyn,
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`890 F.2d 1158, 1160 (Fed. Cir. 1989).
`
`Exhibit 1008 is described by Petitioner as the Approval Package for
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`Application No. 020895, Sildenafil Citrate, from the Center for Drug Evaluation
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`and Research (“Sildenafil NDA” or “SNDA”). (Pet. at 67; Ex. 1008 at 1.)
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`Petitioner asserts that the Sildenafil NDA “became publicly available on March 27,
`
`1998” and thus is prior art under 35 U.S.C. § 102(b) (pre-AIA). (Pet. at 12, 14.)
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`Petitioner asserts it is prior art because as of March 27, 1998 (1) it was accessible
`
`via the FDA’s website and (2) it was otherwise immediately available for the
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`public to request and obtain from the FDA under 21 C.F.R. § 314.430. (Pet. at 12-
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`14.) These assertions are unsupported. Petitioner cites no evidence establishing
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`whether, when, or how documents are published on the FDA’s website; no
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`evidence of what “immediately available” under 21 C.F.R § 314.430 means; and
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`no evidence establishing how one of ordinary skill would have requested or
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`IPR2017-00323
`Patent No. 6,943,166
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`obtained this document from the FDA.
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`A. No Evidence Supports the SNDA Being Publicly Available on the
`FDA’s Website on March 27, 1998
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`The Petition states that the data and information accessible to the public as
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`of March 27, 1998 for sildenafil was 500 pages of information from the “FDA’s
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`Clinical, Statistical and Biopharmacological Review of Viagra Clinical
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`Development,” which it asserts is the same as Exhibit 1008. (Pet. at 13.) It cites a
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`hyperlink to what it calls “Sildenafil NDA Access Data” (Ex. 1031), and contends
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`that the date on this hyperlink means that the “files were created on March 27,
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`1998.” (Pet. at 13.) However, Petitioner cites nothing other than the date on the
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`hyperlink—which does not itself establish anything about the public availability of
`
`the SNDA—to support that the public could, in fact, access the contents of Exhibit
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`1008 through the FDA’s website as of March 27, 1998, or that Exhibit 1008
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`represents what (if anything) was publicly available from the FDA as of that date.
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`First, Petitioner did not submit any declarations to establish either the
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`contents of the website on March 27, 1998 or the FDA’s website publishing
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`practices. Instead, its declarants, Dr. Issa (Ex. 1004) and Dr. Grass (Ex. 1002),
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`assume the SNDA is prior art using verbatim identical statements. Specifically,
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`without citing any evidence of public availability or personal knowledge, the Issa
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`10
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`and Grass declarations only state that Ex. 1008 indicates that sildenafil was
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`IPR2017-00323
`Patent No. 6,943,166
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`approved on March 27, 1998 and that each “understand[s]” it can be applied
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`against the ’166 patent. (Ex. 1004 at ¶ 41; Ex. 1002 at ¶ 62.) No weight can be
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`afforded to these conclusory statements, especially as they are not even established
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`to be within the declarants’ respective areas of alleged expertise. Ashland Oil, Inc.
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`v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (finding a
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`lack of objective support for expert opinion may render the testimony of little
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`probative value); Fed. R. Evid. 702 (requiring expert witnesses to be qualified by
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`“knowledge, skill, experience, training, or education”); Centricut, LLC v. ESAB
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`Group, Inc., 390 F.3d 1361, 1368 (Fed. Cir. 2004) (disregarding testimony of
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`inventor that had no foundation for offering reliable testimony and was found not
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`to be qualified under Fed. R. Evid. 702 as an expert on the issues before the Court);
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`see also, Coalition, IPR2015-01076 at 7 (giving little weight to the conclusory
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`testimony of Petitioner’s expert that a document from www.clinicaltrials.gov was
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`prior art).
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`Second, in lieu of declaration evidence, counsel for Petitioner asserts that the
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`statement “Date created: March 27, 1998” on Exhibit 1031 indicates that “the files
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`were created” on this date. (Pet. at 13; Ex. 1031.) This “Date created” language,
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`however, does not establish the public availability on March 27, 1998 of the
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`specific SNDA document pulled by Petitioner nearly two decades later from the
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`current version of the website. No record evidence establishes what “created”
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`IPR2017-00323
`Patent No. 6,943,166
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`means in the context of the FDA’s website or equates “created” with being made
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`publicly available, as Petitioner has assumed. Nor does any record evidence
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`establish what the FDA’s website publishing practices were once a document was
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`“created.” And no record evidence establishes what the website looked like on
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`March 27, 1998—if it existed at all—and if it looked anything like Exhibit 1031 or
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`whether it has been updated or otherwise revised in the subsequent nearly two
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`decades before it was accessed and printed as Exhibit 1031 for these proceedings.
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`Indeed, no record evidence establishes whether any content was created on this
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`date or rather just the URL for the website was created.
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`Third, even if the SNDA or website was created on the “Date created,” this
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`does not alone establish their public availability on March 27, 1998. See In re Hall,
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`781 F.2d 897, 899 (Fed. Cir. 1986) (requiring more than just the date the library
`
`received the thesis to prove public accessibility), see also Coalition, IPR2015-
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`01076 at 7-8 (finding that “updated” date on document did not prove publication
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`on that date absent information regarding website’s publishing practices or
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`evidence of what the date meant); see also LG Elecs., Inc. v. Advanced Micro
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`Devices, Inc., IPR2015-00329, Paper 13 at 13 (PTAB July 10, 2015) (holding that
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`date printed on face of reference did not establish that it was published on that
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`date). In addition, to the extent the Petitioner is relying on the “Date created” as
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`alleged fact, i.e., for the truth of the matter asserted, that would constitute
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`inadmissible hearsay. Fed. R. Evid. 801, 802; see ServiceNow, Inc. v. Hewlett-
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`Packard Co., IPR2015-00707, Paper 12 at 16 (PTAB Aug. 26, 2015).
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`Fourth, the Petition also fails to make the critical connection between the
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`public availability of Exhibit 1031, which is a page containing hyperlinks to
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`different parts of the FDA’s review of Viagra, and the availability of each of the
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`individual sections listed on Exhibit 1031 (e.g. “Chemistry Review”). (Ex. 1031);
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`see ServiceNow, IPR2015-00707 at 14 (Petitioner failed to connect the public
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`accessibility of a webpage for downloading references to the public accessibility of
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`the references themselves). Nothing establishes what hyperlinks existed on March
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`27, 1998, that the hyperlinks listed on Exhibit 1031 were in existence or active on
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`March 27, 1998, or that they linked to any sections that corresponded to the
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`contents of Exhibit 1008.
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`Finally, even if a website looking like Ex. 1031 was created and online as of
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`March 27, 1998, Petitioner also fails to explain whether or how one of ordinary
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`skill would have navigated the FDA website to find Ex. 1031, i.e., whether it was
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`sufficiently “public” within the meaning of 35 U.S.C. § 102. Importantly,
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`“[w]hether a reference is publicly accessible is determined on a case-by-case basis
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`based on the facts and circumstances surrounding the reference's disclosure to
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`members of the public.” In re Lister, 583 F.3d at 1311-12 (citations and quotations
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`omitted) (holding that an article was not publicly accessible based on registration
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`in the Copyright Office whose database could not be search by subject matter). The
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`Petition, for example, contains no information on whether the FDA categorized
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`drug information in 1998 (and if so how it was categorized (by trade name, active
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`ingredient, application number, etc.)), whether the website had a search capability
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`in 1998, or whether there were any “tools for customary and meaningful research”
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`in 1998. SRI Int’l, Inc. v. Internet Security Sys., Inc., 511 F.3d 1186, 1194-97 (Fed.
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`Cir. 2008) (finding no evidence that an interested person would have freely
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`navigated through the FTP cite’s directory structure to find the Live Traffic paper).
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`Petitioner has therefore failed to establish that the reference was sufficiently
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`accessible to the public. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1349-
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`50 (Fed. Cir. 2016) (holding reference was not publicly accessible because no
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`evidence was introduced showing that an interested person would be aware of the
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`web address of the reference or that an internet search would have located the
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`reference); see Microsoft Corp. v. Bradium Tech. LLC., IPR2015-01435, Paper 15
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`at 11 (PTAB December 23, 2015) (no evidence provided regarding how interested
`
`persons would have navigated the website to find the article at issue or whether the
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`website had any index or catalog that allowed searching).
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`Thus, Petitioner’s unsupported and conclusory assertions regarding the
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`public availability of the FDA website does not prove that Ex. 1008 was publically
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`available on March 27, 1998.
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`B. No Evidence Supports the SNDA Being Obtainable from the FDA
`on March 27, 1998
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`In the absence of evidence specific to the SNDA, Petitioner relies heavily on
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`the provisions of 21 C.F.R. § 314.430(e) to establish the “immediate availability”
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`of the SNDA. (Pet. at 12-14.) This provision, however, does not establish that the
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`documents corresponding to Exhibit 1008 would have been accessible to the
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`interested public as of March 27, 1998, or any other specific date.
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`Part (b) of Rule 314.430 states that information regarding a pending NDA is
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`confidential pending approval. 21 C.F.R. § 314.430(b). Part (e) of this rule further
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`states that after the FDA sends an approval letter to the applicant, certain
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`enumerated information in the application becomes “immediately available” for
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`public disclosure. 21 C.F.R. § 314.430(e). Petitioner asserts that the information
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`enumerated by section (e), including “summaries of the safety and effectiveness
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`data,” is the same as Exhibit 1008, and therefore Ex. 1008 was “immediately
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`available” as of the approval date of sildenafil, March 27, 1998. (Pet. at 12-14.)
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`The Petition cites no support for this assertion. Petitioner submits no expert
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`declaration or other evidence regarding what documents comprise the “safety and
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`effectiveness data” in 21 C.F.R. § 314.430(e) or much less that this information
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`necessarily corresponds to the document presented as Exhibit 1008, which includes
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`sections that on their face appear to not be “safety and effectiveness data,” such as
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`“Chemistry Reviews,” “Administrative Documents,” “Patent and Exclusivity
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`Information for Viagra,” and “Correspondence.” (Ex. 1008 at 258, 497, 508, 510.)
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`Petitioner also does not establish that “immediately available” means
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`documents are available to the public on the very day a drug is approved, as it
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`assumes without basis. In In re Hall, the Court relied on affidavits establishing the
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`library’s general practice as to indexing, cataloging, and shelving to establish the
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`public accessibility of a student thesis. 781 F.2d at 899. Here, however, Petitioner
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`does not submit any declaration, any standard operating procedure, any examples,
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`or any other evidence beyond the bare words of Rule 314.430, to establish the
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`public availability of the SNDA on the day of its approval, March 27, 1998.
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`Indeed, actual evidence of the FDA’s practices shows that “immediately”
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`has a much different meaning then Petitioner assumes. A 2003 report by the Office
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`of the Inspector General states that the FDA’s goal was to post within 6 weeks of
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`approval but that “[d]rug approvals are not promp