`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioners,
`
`v.
`
`UCB PHARMA GMBH,
`Patent Owner.
`
`Case IPR2016-005101
`Patent 6,858,650 B1
`
`
`
`
`PATENT OWNER’S REPLY TO OPPOSITION TO MOTION
`TO EXCLUDE EVIDENCE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Petitioners Alembic Pharmaceuticals Limited from IPR2016-01596, Torrent
`Pharmaceuticals Limited from IPR2016-01636, and Amerigen Pharmaceuticals
`Limited from IPR2016-01665 have been joined as Petitioners to this proceeding.
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`UCB Pharma GmbH (“UCB” or “Patent Owner”) submits this reply in
`
`support of its motion to exclude evidence of Mylan Pharmaceuticals Inc. and
`
`Mylan Laboratories Limited (“Petitioner”) pursuant to 37 C.F.R. §§ 42.64(c),
`
`42.23 and the Scheduling Order entered in this proceeding.
`
`I.
`
`PETITIONER’S COMMERCIAL SUCCESS EVIDENCE (EXHIBIT
`NOS. 1033-1034, 1036-1049) SHOULD BE EXCLUDED
`
`A.
`
`
`Petitioner Identifies No Precedent Supporting Its Introduction of
`Commercial Success Evidence
`
`An affirmative showing of commercial success may suggest long felt need,
`
`as in ATD Corp. v. Lydall, Inc., 159 F.3d 534, 546 (Fed. Cir. 1998), cited by
`
`Petitioner. This does not lead to Petitioner’s proposed legal proposition – that a
`
`patent challenger can introduce evidence of a product’s purported market share and
`
`marketing spend to somehow disprove medical evidence of therapeutic need. In
`
`fact, Petitioner cites no case in which a patent challenger was allowed to introduce
`
`commercial success evidence when the patent owner had not first introduced
`
`evidence of commercial success.
`
`Petitioner cites Santarus, Inc. v. Par Pharm., Inc., 720 F. Supp. 2d 427 (D.
`
`Del. 2010) for the proposition that commercial success is relevant to the long felt
`
`need inquiry. Petitioner’s Response (Paper 39) at 2. The Santarus court, after
`
`considering the evidence of long felt need (unrelated to sales), held there was no
`
`need “for advancements on the existing prior art,” but rather, if anything, only a
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`need for recognition of the “commercial potential of what already existed in the
`
`prior art.” Santarus, 720 F. Supp. 2d at 455. The court continued, in dicta cited by
`
`Petitioner, that “even this commercial and marketing ‘need’ has not proven to be
`
`substantial, since [ ] sales continue to be dwarfed…” Id. Although Petitioner’s
`
`Opposition would suggest otherwise, the Santarus court’s findings on long felt
`
`need did not turn on commercial success evidence, which was of record only
`
`because patent owner had advanced it as a separate indicium of non-obviousness.
`
`The additional authority cited by Petitioner does not help its argument either.
`
`Unlike UCB, the patent owner in In re Cyclobenzaprine Hydrochloride Extended-
`
`Release Capsule Patent Litigation, 794 F. Supp. 2d 517 (D. Del. 2011) “did not
`
`present expert testimony on [long felt need], instead relying on the commercial
`
`success of the immediate release [version of the compound] to show that an ER
`
`version was needed.” Id. at 538. Here, UCB has offered no commercial success
`
`evidence, but has offered expert testimony from a chemist, Dr. Chyall (Ex. 2024),
`
`and a urologist, Dr. MacDiarmid (Ex. 2023), to demonstrate long felt need. The
`
`Cyclobenzaprine court found commercial success evidence “insufficient to show
`
`long felt need,” which, if anything, suggests that long felt need and commercial
`
`success are not as closely linked as Petitioner argues. Id. The court in Vanda
`
`Pharmaceuticals Inc. v. Roxane Laboratories, Inc., 13-cv-1973-GMS, 2016 WL
`
`4490701 (D. Del. Aug. 25, 2016) does not consider commercial success in
`
`
`
`
`2
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`assessing long-felt need, but rather identifies increased valuation of a product
`
`(prior to launch) as an indicator of long-felt need. Id. at *10. Finally, Petitioner’s
`
`quote from Chisum explains “the nexus between commercial success and
`
`nonobviousness,” not the “connection between commercial success and long-felt
`
`need,” as Petitioner claims. Chisum§5.05[2][a].
`
`Petitioner argues that Exhibits 1039 and 1049 “provide useful background
`
`regarding the knowledge of one of ordinary skill in the art,” (Paper 39 at 5-6), but
`
`they do no such thing. Exhibits 1039 and 1049 present OAB market share and a
`
`consumer price index, and the Petition does not explain their relevance. In short,
`
`Petitioner’s authority is silent on the issue it seeks to advance: that a patent
`
`challenger can introduce commercial evidence, such as market share and marketing
`
`spend, when the Patent Owner has not raised the issue of commercial success.
`
` Commercial Success Evidence Is Not Relevant to the Nexus Between the B.
`
`
`Claimed Invention and Long Felt Need
`
`Petitioner argues that its commercial evidence, particularly the testimony of
`
`its economist, DeForest McDuff (Ex. 1033), support its contention that there is no
`
`“nexus” between long felt need and the merits of the claimed invention. Paper 39
`
`at 4-5. Petitioner’s economist is not qualified to respond to the testimony of
`
`UCB’s expert chemist or urologist regarding nexus between long felt need and the
`
`benefits of the claimed invention. Paper 20 at 64-65.
`
`
`
`
`3
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`Moreover, the cases cited by Petitioner finding a lack of nexus involve
`
`entirely different facts and are uninformative. See Paper 39 at 5; Ethicon Endo-
`
`Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1035 (Fed. Cir. 2016) (need for
`
`staples of different heights rather than claimed surgical device); Merck Sharpe &
`
`Dohme B.V. v. Warner Chilcott Co., 13-cv-2088-GMS, 2016 WL 4497054, at *14
`
`(D. Del. Aug. 26, 2016) (no need for the alleged inventive aspect of the claimed
`
`vaginal drug delivery system); Mark Sharp & Dohme Corp. v. Hospira Inc., 14-cv-
`
`915-RGA, 2016 WL 5872620, at *11 (D. Del. July 10, 2016) (need for the
`
`chemical compound, not the claimed formulation). As in Hospira, the need that
`
`existed prior to the introduction of Toviaz® was for the chemical compound
`
`fesoterodine. Petitioner’s cited cases, including Hospira, are inapposite because
`
`they involved patent claims to related formulations or devices. The patents-at-
`
`issue here claim the source of the need, i.e., the chemical compound.
`
`II.
`
`EXHIBIT NOS. 1050-1072 SHOULD BE EXPUNGED
`
`Petitioner agrees that “it would have been proper to wait” to submit its
`
`supplemental evidence. Paper 39 at 9. Petitioner is mistaken that UCB should
`
`have objected to its improperly filed supplemental evidence when it was filed. Id.
`
`at 8. The Board has advised that “there is only one round of supplemental
`
`evidence filed in response to objections,” and “no objection should be made to
`
`supplemental evidence to trigger another round of supplemental evidence.” Pier 1
`
`
`
`
`4
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`Imports (U.S.), Inc. v. Cosmo Lighting Inc., IPR2016-00296 (P.T.A.B. June 30,
`
`2016) (Paper 12) at 2; Google Inc. v. Patrick Zuili, CBM2016-00021 (P.T.A.B.
`
`June 30, 2016) (Paper 13) at 2.
`
`Respectfully submitted,
`
`WHITE & CASE LLP
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke, Reg. No. 37,409
`joelke@whitecase.com
`James S. Trainor, Jr., Reg. No. 52,297
`jtrainor@whitecase.com
`Robert E. Counihan, Reg. No. 61,382
`rcounihan@whitecase.com
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8200
`Attorneys for UCB Pharma GmbH
`
`
`5
`
`
`
`
`
`
`
`Date: March 29, 2017
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Reply to Opposition to Motion to Exclude Evidence Pursuant to 37
`
`C.F.R. § 42.64(c) was served on March 29, 2017, by filing this document through
`
`the Patent Trial and Appeal Board End to End system as well as delivering a copy
`
`via electronic mail upon the following attorneys of record for the Petitioners:
`
`Mitchell G. Stockwell, Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`D. Clay Holloway, Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Alyson L. Wooten, Reg. No. 58,045
`awooten@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE Suite 2800
`Atlanta, Georgia 30309
`(404) 815-6500
`
`
`
`William Hare, Reg. No. 44,739
`bill@miplaw.com
`Gabriela Materassi, Reg. No. 47,774
`materassi@miplaw.com
`Renita S. Rathinam, Reg. No. 53,502
`rathinam@miplaw.com
`MCNEELY, HARE & WAR LLP
`5335 Wisconsin Ave., NW
`Suite 440
`Washington, DC 20015
`(202) 640-1801
`
`
`6
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`
`Neal Seth, Reg. No. 67,075
`nseth@wileyrein.com
`Lawrence Sung, Reg. No. 38,330
`lsung@wileyrein.com
`WILEY REIN LLP
`1776 K Street NW
`Washington, DC 20006
`(202) 719-7000
`
`Manish Mehta, Reg. No. 64, 570
`mmehta@sheppardmulllin.com
`Laura Burson, Reg. No. 40,929
`lburson@sheppardmullin.com
`SHEPPARD MULLIN
`Three First National Plaza
`70 West Madison Street, 48th Floor
`Chicago, Illinois 60602
`(312) 499-6300
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke
`Reg. No. 37,409
`Phone: (212) 819-8936
`
`
`Date: March 29, 2017
`
`
`
`
`
`7
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
