UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC., and AKORN INC.,
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`
`AMICUS CURIAE BRIEF OF JAMES R. MAJOR, D.PHIL.
`IN SUPPORT OF PETITIONERS’ OPPOSITION TO
`ST. REGIS MOHAWK TRIBE’S MOTION TO DISMISS
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC., and AKORN INC.,
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`
`AMICUS CURIAE BRIEF OF JAMES R. MAJOR, D.PHIL.
`IN SUPPORT OF PETITIONERS’ OPPOSITION TO
`ST. REGIS MOHAWK TRIBE’S MOTION TO DISMISS
`
`
`
`
`
`
`
`
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES .................................................................................... ii
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`ARGUMENT ............................................................................................................. 1
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`I)
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`II)
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`The Express Rights that the Tribe Retains Are Illusory ....................... 1
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`The Right of the Tribe to Enforce the Licensed Patents in
`
`Infringement Suits Unrelated to a Generic Equivalent Is
`
`Nugatory ................................................................................................ 3
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`III) The Rights that the Tribe Do Retain Are Insufficient to Support
`
`a Holding that the Tribe Retains All Substantial Rights in the
`
`Licensed Patents .................................................................................... 6
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`CONCLUSION .......................................................................................................... 7
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`i
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`CASES
`
`TABLE OF AUTHORITIES
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`Apple Inc. v. Motorola, Inc., 757 F.3d 1286 (Fed. Cir. 2014) ................................... 4
`
`eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006) ........................................ 5
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`STATUTES
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`35 U.S.C. § 283 .......................................................................................................... 4
`
`35 U.S.C. § 284 .......................................................................................................... 4
`
`TREATISE
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`7 DONALD S. CHISUM, CHISUM ON PATENTS § 20.07[3][a] (2011) ........................ 4-5
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`ii
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`Amicus Curiae James R. Major, D.Phil. (“Amicus”) hereby submits this
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`brief in support of Petitioners’ Opposition to St. Regis Mohawk Tribe’s Motion to
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`Dismiss (Paper 87) to Corrected Patent Owner’s Motion to Dismiss for Lack of
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`Jurisdiction Based on Tribal Sovereign Immunity (Paper 81) (the “Motion”).
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`Amicus takes no position as to the applicability, if any, of tribal sovereign
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`immunity in inter partes review proceedings and is submitting this brief to provide
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`arguments that may assist the Board in deciding the Motion. The arguments herein
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`do not necessarily reflect the views of: (i) Major IP Law PLLC or its clients; (ii)
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`Lucas & Mercanti, LLP or its clients; or (iii) any associations of which Amicus is a
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`member. Amicus has no direct financial or controlling interests in any of the
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`parties to the above-identified proceedings.
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`ARGUMENT
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`I)
`
`The Express Rights that the Tribe Retains Are Illusory
`
`Under the Patent License Agreement between Saint Regis Mohawk Tribe
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`and Allergan, Inc. Dated as of September 8, 2017 (the “Agreement”), Saint Regis
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`Mohawk Tribe (the “Tribe”) “retains all rights under the Licensed Patents not
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`expressly granted hereunder . . . .” Agreement (Ex. 2087) ¶ 2.4. The
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`expressly-retained rights “includ[e] the right to use and practice the Licensed
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`Patents for research, scholarly use, teaching, education, patient care incidental to
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`the foregoing, sponsored research for itself and in collaborations with
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`1
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`
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`Non-Commercial Organizations (‘Non-Commercial Uses’) . . . .” Id.
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`At first blush, the Tribe has apparently retained the right to practice, for
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`example, the method of claim 1 of U.S. Patent No. 8,633,162 B2 (the “’162
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`Patent”) in caring for patients incidental to a research study. See ’162 Patent cl. 1
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`(“A method of treating dry eye disease . . . comprising topically administering to
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`the eye of a human in need thereof an emulsion . . . .”) and Agreement, Schedule
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`1.32(a) (lising the ’162 Patent as a “Licensed Patent[].”). However, if taken at its
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`word, the Tribe already had the right to practice the Licensed Patents. This is
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`because, as the Tribe urges, the Tribe has “inherent sovereign immunity.” Paper
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`81, 8. Even when Allergan, Inc. (“Allergan”) was the assignee of the Licensed
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`Patents, the Tribe could, if taken at its word, assert sovereign immunity to defeat
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`any suit of Allergan’s alleging infringement of the Licensed Patents.
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`Of course, the patent laws do not exist in a vacuum and there may be other
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`laws and regulations that prevent the Tribe from practicing the Licensed Patents.
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`Allergan assigned to the Tribe all rights in the Licensed Patents by way of a Patent
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`Assignment Agreement dated September 8, 2017. Ex. 2086. However, Allergan
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`could not exempt the Tribe from any law or regulation at least on the principle of
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`nemo dat quod non habet: a party cannot give what it does not have.
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`Because the Tribe already had the express rights that the Tribe purportedly
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`“retained” in the Agreement, the express rights that the Tribe retains are illusory.
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`2
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`II) The Right of the Tribe to Enforce the Licensed Patents in Infringement
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`Suits Unrelated to a Generic Equivalent Is Nugatory
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`“With regard to any Infringement that does not relate to a Generic
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`Equivalent, as between the Parties, [the Tribe] shall have the first right, but not the
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`obligation, to control and prosecute any past, present or future Infringement with
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`respect to the Licensed Patents . . . .” Agreement ¶ 5.2.3. Therefore, “the Tribe
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`has the first right to enforce the [Licensed Patents] for all infringement unrelated to
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`generic equivalents of Restasis®.” Patent Owner’s Reply to Opp’n to Mot. to
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`Dismiss for Lack of Jurisdiction Based on Tribal Sovereign Immunity (Paper 93),
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`2. While these rights appear important, they are nominal on closer inspection.
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`While the Tribe purportedly retains some rights under the Agreement, the
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`Tribe has agreed “not [to] directly or indirectly develop, market or license any
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`Competing Product or engage in or license activities that would and/or are
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`intended to result in a Competing Product.” Agreement ¶ 2.4. A “‘Competing
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`Product’ means any Generic Equivalent or any product other than a Licensed
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`Product that is developed or approved by the FDA for any indication that includes
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`or is the same as any indication for which any Licensed Product is approved by the
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`FDA.” Agreement ¶ 1.10 (emphasis in original omitted). Written slightly
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`differently, a Competing Product “means any Generic Equivalent or any product
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`other than a Licensed Product that is developed or approved by the FDA for any
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`3
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`indication that includes or is the same as any indication for which any Licensed
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`Product is approved by the FDA.” An example of one such Competing Product
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`would be a compounded, non-FDA-approved product for an indication for which
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`the FDA has approved a Licensed Product such as Restasis® (cyclosporine
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`ophthalmic emulsion). See Paper 93, 2. However, the Tribe has agreed to refrain
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`from activities that would result in such a product. And this would doom any
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`possible suit against the producer of a Competing Product.
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`Remedies for infringement of a patent include injunctions, lost profits, or
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`damages no less than a reasonable royalty. See 35 U.S.C. §§ 283-84 (2012).
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`However, the Tribe could not successfully seek any of these remedies.
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`Lost profits would be unavailable because the Tribe has agreed to refrain
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`from activities that would result in a Competing Product. Additionally, the
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`reasonable royalty would be zero. “[I]t seems unlikely that a willing licensor and
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`willing licensee would agree to a zero royalty payment in a hypothetical
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`negotiation, where both infringement and validity are assumed.” Apple Inc. v.
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`Motorola, Inc., 757 F.3d 1286, 1328 (Fed. Cir. 2014). However, this is one such
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`case. Shorn of any ability to license activities that would result in a Competing
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`Product, the Tribe would not be a “licensor” in the hypothetical negotiation and no
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`rational licensee would seek a license when none was available. See Apple, 757
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`F.3d at 1330 (citing 7 DONALD S. CHISUM, CHISUM ON PATENTS § 20.07[3][a]
`
`
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`4
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`
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`
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`(2011) (“The premise of the reasonable royalty measure is that a holder of a valid
`
`and infringed patent has inherently suffered legal damage at least to the extent of a
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`lost license royalty opportunity.”) (emphasis added)).
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`To obtain a permanent injunction:
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`A plaintiff must demonstrate: (1) that it has suffered an
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`irreparable injury; (2) that remedies available at law, such as monetary
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`damages, are inadequate to compensate for that injury; (3) that,
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`considering the balance of hardships between the plaintiff and
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`defendant, a remedy in equity is warranted; and (4) that the public
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`interest would not be disserved by a permanent injunction.
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`eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006). However, the Tribe
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`would have suffered no injury in equity because the eBay Court rejected the
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`proposition that infringement of a valid patent was injury per se. eBay, 547 U.S. at
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`393-94. The Tribe would have also suffered no monetary damages as described
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`above, and the balance of the hardships would certainly favor an alleged infringer
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`for the same reasons. Finally, the public interest would certainly not be served by
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`enjoining the alleged infringer without good reason.
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`In sum, any infringement suit that the Tribe has the first right to bring would
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`fail. Therefore, the right of the Tribe to enforce the Licensed Patents in
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`infringement suits unrelated to a Generic Equivalent is nugatory.
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`
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`5
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`
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`III) The Rights that the Tribe Do Retain Are Insufficient to Support a
`
`Holding that the Tribe Retains All Substantial Rights in the Licensed
`
`Patents
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`Despite the arguments above, the Tribe does retain some rights, such as the
`
`right to enforce the Licensed Patents in connection with Generic Equivalents if
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`Allergan does not do so. Agreement ¶ 5.2.2. However, that right is contingent. In
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`any event, there would be no remedy in light of the Tribe’s agreement to refrain
`
`from activities that would result in a Competing Product. See infra § II. Another
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`right is to provide written consent to Allergan before Allergan can settle an
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`infringement suit related to a Generic Equivalent. Agreement ¶ 5.2.2. But that
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`consent is all but meaningless, given that the Tribe would receive no financial
`
`benefit from any such settlement. See Agreement ¶¶ 4.1 and 4.2 (providing for
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`payments of flat fees). Merely holding title to the Licensed Patents and having a
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`mixture of other, inconsequential rights is insufficient to support a holding that the
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`Tribe retains all substantial rights in the Licensed Patents.
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`6
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`CONCLUSION
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`Because the Agreement has stripped the Tribe of any meaningful rights in
`
`the Licensed Patents, the Board should hold that Allergan is the true owner of the
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`Licensed Patents and deny the Motion.
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`Respectfully submitted,
`
`/jrm65087/
`James R. Major
`Registration No. 65,087
`
`
`
`
`
`Date: December 1, 2017
`
`
`
`Major IP Law PLLC
`c/o 30 Broad Street, 21st Floor
`New York, NY 10004
`Tel:
`(804) 317-1028
`E-mail: jmajor@majoriplaw.com
`
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`7
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(3)(4) and 42.205(b), the undersigned certifies
`that on December 1, 2017, a complete entire copy of the Amicus Curiae Brief of
`James R. Major, D.Phil. in Support of Petitioners’ Opposition to St. Regis Mohawk
`Tribe’s Motion to Dismiss was provided, via electronic service, to the persons
`named below at their address of record, viz:
`
`Attorneys for Mylan Pharmaceuticals, Inc.
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`Wendy L. Devine
`WILSON SONSINI GOODRICH & ROSATI
`One Market Street, Spear Tower Floor 33
`San Francisco, CA 94105-1126
`wdevine@wsgr.com
`
`Douglas H. Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`dcarsten@wsgr.com
`
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`
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`8
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`Brandon M. White
`Crystal Canterbury
`Charles G. Curtis, Jr.
`Jennifer MacLean
`Benjamin S. Sharp
`Shannon M. Bloodworth
`PERKINS COIE LLP
`700 13th Street NW
`Washington DC 20005
`bmwhite@perkinscoie.com
`ccanterbury@perkinscoie.com
`ccurtis@perkinscoie.com
`jmaclean@perkinscoie.com
`bsharp@perkinscoie.com
`sbloodworth@perkinscoie.com
`
`Eric D. Miller
`PERKINS COIE LLP
`1201 Third Avenue, Suite 4900
`Seattle, WA 98101-3099
`emiller@perkinscoie.com
`
`Attorneys for Akorn Inc.
`
`Michael R. Dzwonczyk
`Azy S. Kokabi
`Travis B. Ribar
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave., NW, Suite 800
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`tribar@sughrue.com
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`9
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`Attorneys for Teva Pharmaceuticals USA, Inc.
`
`Gary J. Speier
`Mark D. Schuman
`CARLSON, CASPERS,VANDENBURGH, LINDQUIST &SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`IPRCyclosporine@carlsoncaspers.com
`
`Attorneys for Saint Regis Mohawk Tribe
`
`Alfonso G. Chan
`SHORE CHAN DEPUMPO LLP
`901 Main Street, Suite 3300
`Dallas, Texas 75202
`(214) 593-9110
`achan@shorechan.com
`mshore@shorechan.com
`cevans@shorechan.com
`
`Marsha Schmidt Attorney at Law
`14928 Perrywood Drive
`Burtonsville, MD 20866
`(301) 949-5176
`marsha@mkschmidtlaw.com
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`10
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`Attorneys for Allergan, Inc.
`
`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Jonathan Singer
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
`
`
`
`Major IP Law PLLC
`c/o 30 Broad Street, 21st Floor
`New York, NY 10004
`Tel:
`(804) 317-1028
`E-mail: jmajor@majoriplaw.com
`
`/jrm65087/
`James R. Major
`Registration No. 65,087
`
`
`
`
`
`11
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`
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