`
`Post Grant Review No. PGR 2016-00008
`Patent No. 9,173,942
`Petitioner’s Request for Partial Rehearing Regarding
`Decision Denying Institution of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners
`
`v.
`
`HELSINN HEALTHCARE S.A. and ROCHE PALO ALTO LLC,
`Patent Owners.
`
`
`U.S. Patent No. 9,173,942 to Giorgio Calderari et al.
`Issue Date: November 3, 2015
`Title: LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`____________________________
`
`Post Grant Review No. PGR2016-00008
`__________________________________________________________________
`
`PETITIONERS’ REQUEST FOR PARTIAL REHEARING REGARDING
`DECISION DENYING INSTITUTION OF POST GRANT REVIEW
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .................................................................................... ii
`
`I.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT .............................. 1
`
`II.
`
`ARGUMENT ................................................................................................... 3
`
`Page
`
`A. The Board Improperly Limited Cooper Cameron To The
`Facts Of Gentry Gallery ........................................................................... 3
`
`B. The “Entirety Of The Specification” Makes Clear That
`Stability Is An Essential Element Of The Invention ................................ 6
`
`1. The Portions Of The Specification Quoted By The
`Board, And The Portions The Board Overlooked, Make
`This Clear ........................................................................................... 6
`
`2. A Person Of Ordinary Skill Would Not Understand
`The ’942 Inventors To Have Invented Unstable
`Formulations ...................................................................................... 7
`
`C. The Patent Owner’s Arguments Also Support Petitioner’s
`Position ..................................................................................................... 9
`
`D. There Must Be Written Description Support For The Full
`Scope Of The Claims ................................................................................ 9
`
`E. Reciting Selected Ingredients Is Not Sufficient To Justify
`The Failure To Require Stability In The Claims ....................................10
`
`F. Recent Precedent Further Supports Institution Of Post
`Grant Review ..........................................................................................11
`
`III. CONCLUSION ..............................................................................................12
`
`
`
`
`
`i
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`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`
`Abbvie Deutschland GmbH & Co. v. Janssen Biotech Inc.,
`759 F.3d 1285 (Fed. Cir. 2014) ............................................................................ 9
`
`Arnold P’ship v. Dudas,
`362 F.3d 1338 (Fed. Cir. 2004) ............................................................................ 3
`
`Bamberg v. Dalvey,
`815 F.3d 793 (Fed. Cir. 2016) ...................................................................... 11, 12
`
`Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .................................................................... 3, 4, 5
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ........................................................................ 3, 4
`
`ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) ............................................................................ 7
`
`PIN/NIP, Inc. v. Platte Chem. Co.,
`304 F.3d 1235 (Fed. Cir. 2002) (Petition 27-28) .................................................. 4
`
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005) ............................................................................ 3
`
`Univ. of Rochester v. G.D. Searle & Co.,
`358 F.3d 916 (Fed. Cir. 2004) ........................................................................ 9, 10
`
`STATUTES, RULES & OTHER AUTHORITIES
`
`35 U.S.C. § 112(a) ........................................................................................... 1, 5, 13
`
`37 C.F.R. § 42.71(c) ............................................................................................... 1, 2
`
`37 C.F.R. § 42.71(d) .................................................................................................. 1
`
`37 C.F.R. § 42.71(d)(2) .............................................................................................. 1
`
`
`
`ii
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`I.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT
`
`Pursuant to 37 C.F.R. § 42.71(c) and (d), Petitioner respectfully requests
`
`rehearing with regard to only Part C of the Board’s August 17, 2016 Decision
`
`denying institution of post grant review (“Decision”), appearing at pages 10-13
`
`thereof and addressing written description under 35 U.S.C. § 112(a). This request
`
`is timely filed within 30 days of the entry of the Board’s Decision, as set forth in
`
`37 C.F.R. § 42.71(d)(2).
`
`Petitioner respectfully submits that the Board misapplied the law, as set forth
`
`at pages 24-30 of the Petition, requiring that the “entirety of the specification” be
`
`used to determine whether, to one skilled in the art, the invention described in the
`
`specification is of a much narrower scope than that later claimed in U.S. Patent
`
`No. 9,173,942 (“the ’942 Patent”).
`
`In fact, the Board is believed to have overlooked the vast majority of the
`
`specification of the ’942 Patent which demonstrates that the “entirety of the
`
`specification” is directed to palonosetron formulations having enhanced stability,
`
`as set forth at pages 10-14 of the Petition, whereas the claims omit any requirement
`
`of stability. Even the portions of the specification the Board cited at pages 3-5 of
`
`the Decision support Petitioner’s position. Collectively, all of these portions
`
`
`
`
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`demonstrate the narrow invention of stable palonosetron formulations described in
`
`the specification as a whole, which is in stark contrast to the claims.
`
`The Board also misapprehended the Patent Owner’s argument discussed at
`
`page 10 of the Decision, which actually confirms Petitioner’s contention that
`
`increased stability was and is the central purpose of the ’942 Patent as a whole.
`
`Still further, the Board is believed to have overlooked the Declaration of
`
`Dr. Christopher A. Fausel (Exh. 1038 (cited in the Petition at 25, 27, 30)), which
`
`provided the only direct evidence in this record as to how a person of ordinary skill
`
`would have viewed the entirety of the specification: the specification limits the
`
`proper scope of the claims to stable formulations.
`
`Petitioner also respectfully submits that the Board overlooked the Patent
`
`Owner’s numerous prior patents having the same specification as the ’942 Patent,
`
`discussed at pages 16-18 of the Petition. Those prior patents contradict the Board’s
`
`conclusion (Decision 12) that recitation of certain selected ingredients and
`
`concentrations in the ’942 claims make it unnecessary for the ’942 claims to recite
`
`stability.
`
`Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a
`
`panel will review the decision for an abuse of discretion.” An abuse of discretion
`
`2
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`may be found if a decision is based on an erroneous interpretation of law, if a
`
`factual finding is not supported by substantial evidence, or if the decision
`
`represents an unreasonable judgment in weighing relevant factors. Star Fruits
`
`S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v.
`
`Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). Petitioner respectfully submits that
`
`this standard is met by this request, for the reasons which follow.
`
`II. ARGUMENT
`A. The Board Improperly Limited Cooper
`Cameron To The Facts Of Gentry Gallery
`
`The Petition cited and quoted Cooper Cameron Corp. v. Kvaerner Oilfield
`
`Products, Inc., 291 F.3d 1317 (Fed. Cir. 2002), for the proposition that: “[A] broad
`
`claim is invalid when the entirety of the specification clearly indicates that the
`
`invention is of a much narrower scope.” Id. at 1323. However, in its Decision
`
`declining to institute a trial, the Board deemed Cooper Cameron inapplicable
`
`because the Court in Cooper Cameron had issued the foregoing holding in the
`
`context of discussing an earlier decision, Gentry Gallery, Inc. v. Berkline Corp.,
`
`134 F.3d 1473 (Fed. Cir. 1998), which dealt with the location of a structural
`
`element; namely, certain controls for a recliner.
`
`3
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`But nothing in Cooper Cameron suggested that the “entirety of the
`
`specification” principle stated by the Federal Circuit was in any way limited to the
`
`facts of Gentry Gallery. In Gentry Gallery, the claims at issue encompassed
`
`recliners without requiring that the controls be on the console, while the “entirety
`
`of the specification” made clear that this location was essential. Here, the “entirety
`
`of the specification” makes clear that the invention was stable formulations, yet the
`
`’942 claims have no such limitation.
`
`The principle enunciated in Cooper Cameron has also been applied by the
`
`Federal Circuit in contexts other than Gentry Gallery. For example, in PIN/NIP,
`
`Inc. v. Platte Chemical Co., 304 F.3d 1235 (Fed. Cir. 2002) (Petition 27-28), the
`
`Federal Circuit relied on Cooper Cameron’s “entirety of the specification” holding.
`
`PIN/NIP involved an invalidity finding as to a claim that was so broad as to
`
`encompass sequential application of two chemicals, where the specification made
`
`clear that the invention was of a narrower scope, i.e., applying the two chemicals
`
`simultaneously in a mixture ____ a requirement that was omitted from the claims at
`
`issue. Id. at 1247-48. PIN/NIP is directly applicable here where the alleged
`
`invention ____ the very reason for the patent ____ was to overcome a stability problem
`
`with palonosetron that was asserted to exist by the ’942 inventors (see col.2
`
`4
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`ll.44-58); and yet the issued ’942 claims would embrace palonosetron formulations
`
`which are less stable than in the admitted prior art, or are stable for just a few
`
`hours.
`
`The Board concluded that Cooper Cameron was “not relevant here, where
`
`the specification describes formulations comprising the same ingredients, in the
`
`same amounts and concentrations, required by
`
`the challenged claims.”
`
`(Decision 12.) Respectfully, while the Board considered the limitations that are
`
`found in the claims, the Board overlooked limitations that are not found in the
`
`claims, but must be; namely, limitations requiring at least some measure of
`
`stability, which is shown to be essential by the “entirety of the specification.”
`
`Taken to its logical extreme, the Patent Owner could delete still further
`
`limitations of the ’942 claims, and the same rationale for validity could be
`
`advanced, so long as there is some correspondence between at least some
`
`ingredient, amount, or concentration in such claims, and some portion of the
`
`specification. If a patentee were permitted to do so, there could virtually never be a
`
`violation of the written description requirement of § 112(a), no matter how
`
`narrowly the “entirety of the specification” described the invention, and no matter
`
`how broad the claims ____ stripped of numerous limitations in prior patents (see
`
`5
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
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`Exhs. 1010-12, 1014, 1026-27) and made even broader with the transition term
`
`“comprising” ____ might be.
`
`B.
`
`The “Entirety Of The Specification” Makes Clear
`That Stability Is An Essential Element Of The Invention
`1.
`
`The Portions Of The Specification Quoted By The Board,
`And The Portions The Board Overlooked, Make This Clear
`
`In its Decision (at 3-5), the Board quoted several excerpts from the
`
`specification, including portions appearing at 4:58-5:6; 5:16-30; 5:40-46; 6:4-18;
`
`and 7:40-43. (Decision 4-5.) Each and every one of them, however, proves
`
`Petitioner’s point, in that each one makes reference to a “pharmaceutically stable
`
`solution,” or “increase the stability,” or even “greatest stability.”
`
`Only one portion of
`
`the specification quoted by
`
`the Board does
`
`not ____ specifically and in and of itself ____ mention stability; namely, the four-line
`
`excerpt at 5:12-15 quoted at page 4 of the Decision, which mentions palonosetron
`
`at a concentration of 0.05 mg/mL. But this single sentence does not suggest the
`
`invention was not stability, and cannot and does not negate the countless references
`
`to stability that permeate the entire specification. Moreover, the specification
`
`expressly
`
`links concentration
`
`to stability, explaining,
`
`in Example 2,
`
`that
`
`palonosetron concentration is a “critical” factor in chemical stability “with the
`
`6
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`greatest stability seen at the lowest concentrations.” (’942 at 7:40-43 (emphasis
`
`added).)
`
`The Board also appears to have overlooked numerous additional portions of
`
`the specification discussed at pages 10-14 of the Petition. These include the
`
`abstract, the background, the objects of the invention, and the summary of the
`
`invention, as well as additional portions of the detailed description. Taken together
`
`with the portions quoted by the Board, it is clear that stability is stressed
`
`throughout the entirety of the ’942 Patent specification ____ but never mentioned in
`
`the claims.
`
`2.
`
`A Person Of Ordinary Skill Would Not Understand The
`’942 Inventors To Have Invented Unstable Formulations
`
`Viewing the entirety of the specification ____ the portions the Board
`
`considered and the portions it overlooked ____ the conclusion is inescapable: given
`
`the full ’942 disclosure, “a person of ordinary skill would not understand the
`
`inventor[s] of the [’942 Patent] to have invented” palonosetron formulations that
`
`are unstable. See ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1378
`
`(Fed. Cir. 2009) (quoted in the Petition at 28-29, but overlooked by the Board).
`
`Indeed, the entirety of the specification makes clear that the lack of stability was
`
`7
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`the problem in the prior art which the inventors sought to solve. And yet such
`
`unstable formulations would infringe these claims.
`
`The only evidence in this record expressly directed to how a person of
`
`ordinary skill in the art (“POSA”) would read the ’942 Specification was the
`
`Declaration of Dr. Christopher A. Fausel (Exh. 1038 (cited in the Petition (at 25,
`
`27, 30)), but apparently overlooked by the Board. After carefully identifying the
`
`credentials of a POSA (Exh. 1038 ¶ 13), and discussing the constant emphasis on
`
`stability in the ’942 specification (id. ¶¶ 14-20), Dr. Fausel concluded:
`
`
`
`I read the specification of the ’942 Patent as I believe a POSA would read
`
`it and I understand that its disclosure and clear objective is for shelf-stable
`
`formulations of palonosetron. I believe that a POSA reading the specification
`
`of the ’942 Patent with its repetitive references to shelf-stability of
`
`palonosetron formulations would not read it as discussing or even hinting at a
`
`non-storage stable palonosetron formulation.
`
`(Id. ¶ 23.)1
`
`
`1The Patent Owner’s primary criticism of Dr. Fausel’s declaration was that
`
`Dr. Fausel did not disclose any “underlying facts” to support his opinion (Prelim.
`
`Resp. 30-31). This criticism could only be leveled by ignoring paragraphs 13-20 of
`
`the Fausel declaration.
`
`8
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`C. The Patent Owner’s Arguments
`Also Support Petitioner’s Position
`
`In its Decision, the Board also commented on arguments presented by the
`
`Patent Owner. At page 11 of the Decision, the Board pointed out that the Patent
`
`Owner had argued that the specification discloses that it is possible to increase the
`
`stability of a palonosetron formulation by adjusting the formula’s pH and/or
`
`excipient concentrations.
`
`But this, too, proves Petitioner’s point: it is all about stability.
`
`D. There Must Be Written Description
`Support For The Full Scope Of The Claims
`
`The Board cited University of Rochester v. G.D. Searle & Co., 358 F.3d 916
`
`(Fed. Cir. 2004), for the proposition that the written description requirement is
`
`satisfied when the specification “set[s] forth enough detail to allow a person of
`
`ordinary skill in the art to understand what is claimed and to recognize that the
`
`inventor invented what is claimed.” Id. at 928. That statement is not a full
`
`summary of written description jurisprudence, and does not address the central
`
`point of Petitioner’s contention of invalidity. As further explained in Abbvie
`
`Deutschland GmbH & Co. v. Janssen Biotech Inc., 759 F.3d 1285 (Fed. Cir. 2014),
`
`to comply with the written description requirement, an inventor must demonstrate
`
`that he or she has truly invented the full scope of the claimed invention. Id. at 1300
`
`9
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`(emphasis added). By stripping its claims of any requirement for stability (not to
`
`mention other ingredients that are described in the specification as being essential
`
`for stability), the Patent Owner has broadened the scope of its claims to the point
`
`that it bears little if any resemblance to the “entirety of the specification.”
`
`E. Reciting Selected Ingredients Is Not Sufficient To
`Justify The Failure To Require Stability In The Claims
`
`In its Decision, the Board also disagreed with Petitioner’s reliance on
`
`University of Rochester for the notion that the written description requirement
`
`polices against “overreach” by patentees. The Board stated that the specification of
`
`the ’942 Patent describes formulations comprising the same ingredients, in the
`
`same amounts, and concentrations, as required by the challenged claims “and
`
`moreover, describes them as optimal or preferred for stability.” (Decision 13.)
`
`But while the specification does recite a formulation that is “optimal” for
`
`stability, the ’942 claims recite only a few of the several parameters which are said
`
`to contribute such optimal stability. Nowhere does the specification provide any
`
`assurance to a POSA that the vast universe of formulations encompassed by these
`
`“comprising” claims (which could include additional ingredients mentioned
`
`nowhere in the specification) would be stable. And none of this establishes
`
`inherent stability across the entire spectrum of formulations claimed.
`
`10
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`The Board appears to have overlooked pages 16-18 of the Petition, which
`
`document how Patent Owner obtained at least six prior patents, with the same
`
`specification as the ’942 Patent, but in each instance, chose to recite in the claims
`
`that the invention was at least a pharmaceutically stable formulation and ____ in
`
`some instances ____ recited stability for specific periods of 18 or 24 months. The
`
`Patent Owner itself plainly believed that all of these prior patents ____ with narrower
`
`claims ____ nonetheless required a recitation of stability.2
`
`F. Recent Precedent Further
`Supports Institution Of Post Grant Review
`
`A month after the present Petition was filed, the precedential decision was
`
`issued in Bamberg v. Dalvey, 815 F.3d 793 (Fed. Cir. 2016). In Bamberg, the court
`
`
`2In allowing the ’942 Patent, the Examiner (who had allowed most if not all of the
`
`earlier patents) focused entirely on prior art in noting that “these applications have
`
`been examined and interviewed on many occasions and the arguments have been
`
`found persuasive.” (Exh. 1033, at 8.) There is no indication that the Patent Owner
`
`ever
`
`flagged
`
`for
`
`the Examiner
`
`the
`
`fact
`
`that ____ unlike all
`
`the prior
`
`applications ____ the ’942 Patent had omitted any requirement of stability or many of
`
`the ingredients claimed previously and described as improving stability, or that the
`
`Examiner considered the issue sua sponte.
`
`11
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`held that a specification does not reflect possession of an embodiment which it
`
`criticizes as undesired. Id. at 798.
`
`The ’942 specification denigrates the formulation disclosed in the prior art
`
`Berger et al. U.S. Patent No. 5,202,333 as having “a shelf stability of less than the
`
`1-2 year time period required by health authorities in various countries.” (’942
`
`at 1:56-2:11; see also 2:44-55 (reciting increased stability as object of the
`
`invention).)
`
`Clearly, by denigrating formulations that are stable for less than one or two
`
`years, the ’942 Specification does not show possession of an invention that
`
`encompasses palonosetron formulations that are less stable or not stable at all.
`
`Thus, claims that include no requirement of stability cannot stand.
`
`III. CONCLUSION
`
`For all of the foregoing reasons, Petitioner respectfully submits that with
`
`regard to the written description aspect of the subject Petition, the Board has
`
`misapprehended and/or overlooked important facts and binding legal principles
`
`which ____ when properly analyzed ____ should have led the Board to conclude that at
`
`least one claim of the ’942 Patent is more likely than not invalid for failure to
`
`
`
`
`
`12
`
`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`comply with the written description requirement of 35 U.S.C. § 112(a).
`
`Accordingly, post grant review should be instituted on that basis.
`
`
`
`Dated: September 15, 2016
`
`
`
`
`
`By:
`
`/Michael H. Teschner/
`Michael H. Teschner
`Registration No. 32,862
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4678217_1.docx
`
`
`
`
`13
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`

`

`Post Grant Review No. PGR2016-00008
`Patent No. 9,173,942
`Petitioner’s Request For Partial Rehearing Regarding
`Decision Denying Institution Of Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies
`
`that a copy of
`
`the
`
`foregoing
`
`PETITIONERS’ REQUEST FOR PARTIAL REHEARING REGARDING
`
`DECISION DENYING INSTITUTION OF POST GRANT REVIEW, and all
`
`other papers filed therewith, was served on September 15, 2016, as follows.
`
`VIA FEDEX
`Troutman Sanders LLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`Tel: 404.885.3000
`
`
`
`Joseph M. O’Malley, Jr.
`Paul Hastings LLP
`75 East 55th Street
`New York, NY 10022
`Tel: 212.318.6000
`
`
`Mark E. Waddell
`Loeb & Loeb LLP
`345 Park Avenue
`New York, NY 10154
`Tel: 212.407.4000
`
`
`
`Riccardo Braglia
`Group Chief Executive Officer
`Helsinn Healthcare SA
`Via Pan Scairol, 9
`CH-6912 Lugano-Pazzallo
`Switzerland
`Tel: +41 (0) 91 985.21.21
`
`William Mann
`CEO US Business Pharma
`Helsinn Therapeutics (U.S.), Inc.
`170 Wood Avenue South, 5th Floor
`Iselin, NJ 08830
`Tel: 732.603-2800
`
`David Austin, President &
`Chief Executive Officer
`Roche Palo Alto LLC
`1 DNA Way
`South San Francisco, CA 94080
`Tel: 650.855.5050
`
`Dated: September 15, 2016
`
`
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`
`
`By: /Michael H. Teschner/
`Michael H. Teschner
`Registration No. 32,862
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`4678217_1.docx
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