`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S REQUEST FOR
`REHEARING OF THE DECISION TO INSTITUTE TRIAL
`
`
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`TABLE OF CONTENTS
`
`
`
`
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II.
`
`LEGAL STANDARDS ................................................................................... 2
`
`III. ARGUMENT ................................................................................................... 4
`
`A.
`
`The Petition Does Not “Acknowledge” that the Final “Wherein”
`Clause Should Be Given Patentable Weight ......................................... 4
`
`1.
`
`2.
`
`Ground 1: The present record provides evidence that the final
`“wherein” clause is obvious over Plachetka in view of Graham
`and Goldstein. ............................................................................. 5
`
`Ground 2: The present record provides support that the final
`“wherein” clause is an inherent result of Plachetka. .................10
`
`B.
`
`The Fact that the Examiner Added the Final “Wherein” Clause During
`Prosecution Does Not Entitle It to Patentable Weight ........................12
`
`IV. CONCLUSION ..............................................................................................13
`
`
`
`
`
`i
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`Achates Reference Publ’g, Inc. v. Apple Inc.,
`803 F.3d 652 (Fed. Cir. 2015) ....................................................................... 1, 2, 3
`
`In re Pearson,
`494 F.2d 1399 (CCPA 1974) ...............................................................................10
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ............................................................................10
`
`In re Spada,
`911 F.2d 705 (Fed. Cir. 1990) ..............................................................................10
`
`In re Zierden,
`411 F.2d 1325 (CCPA 1969) ...............................................................................11
`
`Minton v. National Ass’n of Securities Dealers, Inc.,
`336 F.3d 1373 (Fed. Cir. 2003) ............................................................................11
`
`Par Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ............................................................................11
`
`Redline Detection, LLC v. Star Envirotech, Inc.,
`811 F.3d 435 (Fed. Cir. 2015) ................................................................................ 3
`
`Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n.,
`988 F.2d 1165 (Fed. Cir. 1993) ............................................................................11
`
`Statutes
`
`35 U.S.C. § 314(a) .................................................................................................2, 3
`
`Regulations
`
`37 C.F.R. § 42.104(4) ................................................................................................ 5
`
`37 C.F.R. § 42.120 ..................................................................................................... 2
`
`ii
`
`
`
`
`37 C.F.R. § 42.71(c) ................................................................................................... 3
`
`37 C.F.R. § 42.71(d) ..............................................................................................3, 4
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`iii
`
`
`
`
`
`As authorized by the Board by email on March 10, 2016, Petitioner files this
`
`Opposition to Patent Owner’s Request for Rehearing of the Decision to Institute
`
`IPR2015-01718
`Patent 8,945,621
`
`Trial filed on March 4, 2016 (Paper 19).
`
`I.
`
`INTRODUCTION
`
`There are two distinct phases of an IPR proceeding—an institution phase
`
`and a merits phase. See Achates Reference Publ’g, Inc. v. Apple Inc., 803 F.3d
`
`652, 654–55 (Fed. Cir. 2015). Patent Owner’s Request for Rehearing is an attempt
`
`to short-circuit this two-part process and skip the merits phase of this proceeding.
`
`During the first phase of this proceeding, the Board considered the
`
`information presented in the Petition and the Preliminary Response and found that
`
`the “Petition establishes a reasonable likelihood” that claims 1–16 of the ’621
`
`patent are unpatentable on both Grounds 1 and 2 of the Petition. Decision at 21.
`
`The Board also raised the issue of whether the final “wherein” clause of the
`
`independent claims should be entitled to patentable weight. Decision at 15, 20.
`
`The second phase of this proceeding will conclude with the Board making a
`
`final determination—on the merits—as to the patentability of each claim. See
`
`Decision at 21 (“[W]e have not made a final determination with respect to the
`
`patentability of any claim.”). Patent Owner’s Request for Rehearing urges the
`
`Board to bypass the merits phase and to prematurely conclude that the claims are
`
`1
`
`
`
`
`directed to patentable subject matter at this stage of the proceeding. Request for
`
`IPR2015-01718
`Patent 8,945,621
`
`Rehearing at 11.
`
`Patent Owner makes its Request for Rehearing without identifying any
`
`matters “misapprehended” or “overlooked” by the Board. Patent Owner’s request
`
`for relief, instead, is based on its disagreement with the Board’s interpretation of
`
`the claims. Specifically, Patent Owner’s request for relief is based on the Board’s
`
`“misinterpretation” of the final “wherein” clause of independent claims 1, 8, 15,
`
`and 16. Request for Rehearing at 4. This is not the purpose of a proper request for
`
`rehearing. Patent Owner will have a full opportunity to address its disagreements
`
`with the Board’s interpretation of the claims during the merits phase of this
`
`proceeding, particularly when it files its Patent Owner Response pursuant to
`
`37 C.F.R. § 42.120.
`
`At this stage, the Board’s preliminary interpretation of the final “wherein”
`
`clause of the independent claims is supported by the record. Patent Owner has not
`
`met its burden of showing that the Board abused its discretion or that the
`
`Institution Decision should be modified in any way. As such, Patent Owner’s
`
`Request for Rehearing should be denied.
`
`II. LEGAL STANDARDS
`
`The Board has authority, under 35 U.S.C. § 314(a), to decide whether there
`
`are sufficient grounds to institute an IPR proceeding. Achates, 803 F.3d at 654–55.
`
`2
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`Based on the petition and any response, the Board decides whether there are
`
`sufficient grounds to institute a proceeding, i.e., whether there is a “reasonable
`
`likelihood” that the petition will prevail. See id.; 35 U.S.C. § 314(a).
`
`A party dissatisfied with a decision to institute an IPR proceeding may file a
`
`request for rehearing. 37 C.F.R. § 42.71(d). “The burden of showing a decision
`
`should be modified lies with the party challenging the decision.” Id. A request for
`
`rehearing “must specifically identify all matters the party believes the Board
`
`misapprehended or overlooked, and the place where each matter was previously
`
`addressed . . . .” Id.
`
`The applicable standard for a request for rehearing of an institution decision
`
`is abuse of discretion. 37 C.F.R. § 42.71(c). The Federal Circuit has held that “[a]n
`
`abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or
`
`fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly
`
`erroneous fact findings; or (4) involves a record that contains no evidence on
`
`which the Board could rationally base its decision.” Redline Detection, LLC v. Star
`
`Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). Patent Owner, however, has
`
`not established any abuse of discretion by this Board.
`
`3
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`III. ARGUMENT
`
`Although Patent Owner’s Request for Rehearing recites the proper legal
`
`standard of review,1 it fails to specifically identify any “matters . . .
`
`misapprehended or overlooked” by the Board. 37 C.F.R. § 42.71(d). Rather,
`
`Patent Owner’s request for relief is based on its disagreement with the Board’s
`
`interpretation of the claims. See Request for Rehearing at 4 (“The Patent Owner
`
`requests reconsideration of both grounds of the Decision to institute on claims 1-16
`
`. . . because the Decision misinterprets the final “wherein” clauses of independent
`
`claims 1, 8, 15, and 16.”). In support of its argument that the Board
`
`“misinterpreted” the final “wherein” clause of the independent claims, Patent
`
`Owner makes two fundamentally flawed points, discussed in detail below.
`
`A. The Petition Does Not “Acknowledge” that the Final “Wherein”
`Clause Should Be Given Patentable Weight
`
`Patent Owner asserts that the Petition and Preliminary Response
`
`“acknowledge” that the final “wherein” clause should be afforded patentable
`
`weight. Request for Rehearing at 5–6. This assertion mischaracterizes the
`
`Petition. Indeed, the Petition and supporting expert declaration show the
`
`
`1 Request for Rehearing at 3.
`
`4
`
`
`
`
`opposite—i.e., that the final “wherein” clause is obvious and should not be entitled
`
`IPR2015-01718
`Patent 8,945,621
`
`to any patentable weight.
`
`The fact that Petitioner and its expert declarant specifically addressed the
`
`final “wherein” clause in the Petition and in the supporting expert declaration is not
`
`an “acknowledgment” that this clause is entitled to patentable weight. The Petition
`
`included a section, in both Grounds 1 and 2, devoted to the “final wherein clause,”
`
`as it did for each and every other element of the challenged claims. Petitioner used
`
`this format to comply with the PTAB’s rules and regulations. See, e.g., 37 C.F.R.
`
`§ 42.104(4) (“The petition must specify where each element of the claim is found
`
`in the prior art patents or printed publications relied upon.”).
`
`The format of the Petition is far from an admission that the final “wherein”
`
`clause should be afforded patentable weight. On the contrary, the Petition and
`
`supporting expert declaration provide evidence and legal support showing that the
`
`final “wherein” clause is obvious and should not be entitled to any patentable
`
`weight in both Grounds 1 and 2 of the Petition.
`
`1. Ground 1: The present record provides evidence that the
`final “wherein” clause is obvious over Plachetka in view of
`Graham and Goldstein.
`
`Ground 1 of the Petition asserts that the final “wherein” clause of the
`
`independent claims is disclosed by Plachetka in view of Graham and Goldstein:
`
`5
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`Specifically, Graham and Goldstein disclose that 6.25% of patients
`
`taking a combination of 15 mg of lansoprazole and an NSAID with
`
`LDA have gastric ulcers, while 23% of patients taking a combination
`
`of 15 mg of lansoprazole and an NSAID without LDA have gastric
`
`ulcers. ([Ex. 1003, Shargel Decl.], ¶ 83.) Similarly, Graham and
`
`Goldstein disclose that 0% of patients taking a combination of 30 mg
`
`of lansoprazole and an NSAID with LDA have gastric ulcers, while
`
`17% of patients taking a combination of 30 mg of lansoprazole and an
`
`NSAID without LDA have gastric ulcers. (Id.)
`
`Petition at 17–18. Quoting this same passage of the Petition and similar language
`
`in the Shargel Declaration, the Board—siding with Patent Owner—concluded that:
`
`Neither Petitioner nor Dr. Shargel identifies the basis for these
`
`purported results, much less the basis for the conclusion that an
`
`ordinary artisan “would have understood that a combination of
`
`lansoprazole and naproxen was more effective at reducing the
`
`incidence of the NSAID-associated ulcers in patients taking LDA than
`
`in patients not taking LDA.
`
`Decision at 15 (citing Petition at 18; Ex. 1003, Shargel Decl., ¶ 83).
`
`The Board’s conclusion is understandable in light of Patent Owner’s
`
`misleading Preliminary Response, which states: “while the Petition cites to a
`
`declaration from Dr. Leon Shargel, the declaration merely recites, word-for-word,
`
`the Petition and provides no independent analysis.” Prelim. Resp. at 18. This
`
`statement simply is not true. The Shargel Declaration, which includes 123 pages
`
`6
`
`
`
`
`of detailed claim charts in the appendices, does not recite the Petition “word-for-
`
`IPR2015-01718
`Patent 8,945,621
`
`word.”
`
`Indeed, Dr. Shargel’s full analysis—the basis for the conclusion that Graham
`
`and Goldstein render the final “wherein” clause obvious—is located in Appendix B
`
`to the Shargel Declaration,2 which discusses the Graham and Goldstein results in
`
`depth and provides in relevant part:
`
`Graham shows that, for the total study population of patients who
`
`were long-term users of NSAIDS, 49% of the patients in the placebo
`
`group had GUs (51% free), 21% of the patients in the lansoprazole 15
`
`mg group had GUs (79% free of GUs), and 17% of the patients in the
`
`lansoprazole 30 mg group had GUs (83% free of GUs). Goldstein
`
`shows that, for the total study population of patients who were long
`
`term users of NSAIDS and on LDA, 65% of the patients in the
`
`placebo group had GUs (35% free of GUs), 6.25% of the patients in
`
`the lansoprazole 15 mg group had GUs (93.75% free of GUs), and 0%
`
`of the patients in the lansoprazole 30 mg group had GUs (100% free
`
`of GUs).
`
`
`2 Ex. 1003, Shargel Decl., ¶ 55 (“I agree with and incorporate the claim chart for
`
`this ground, which is attached hereto as Appendix B . . . .”).
`
`7
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`Ex. 1003, Shargel Decl., Appendix B at 12. Dr. Shargel also provides, in
`
`Appendix B, that a POSA would have been able to use simple math to determine
`
`the number of patients in the study who were not on LDA:
`
`A POSA would have understood Graham and Goldstein to disclose
`
`the number of patients not on LDA to be 111 for those in the placebo
`
`group, 120 for those in the lansoprazole 15 mg group, and 125 for
`
`those in the lansoprazole 30 mg group. Thus, a POSA would have
`
`understood Graham and Goldstein to disclose the percentage of
`
`patients not on LDA with GUs to be 46% for the placebo group, 23%
`
`for the lansoprazole 15 mg group, and 18% for the lansoprazole 30
`
`mg group.
`
`Id. at 13. Dr. Shargel further provides that “a POSA would have arrived at the
`
`following table,” summarizing the simple math:
`
`
`
`8
`
`
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`Id. at 13–14. Finally, Dr. Shargel ties the numbers in the table to the arguments
`
`
`
`made in the Petition:
`
`Graham and Goldstein show that, in the lansoprazole 15 mg group,
`
`those taking LDA had a less chance (6.25% versus 23%) of gastric
`
`ulcers compared to those not on LDA. Similarly, in the lansoprazole
`
`30 mg group, those taking LDA had a less chance (0% versus 18%) of
`
`gastric ulcers compared to those not on LDA. Thus, a POSA would
`
`have understood Graham and Goldstein to disclose this limitation
`
`given the structural, functional, and other similarities between
`
`Graham’s and Goldstein’s lansoprazole and Plachetka’s
`
`esomeprazole.
`
`Id. at 14.
`
`Although it is true that Petitioner did not quote Dr. Shargel’s full analysis of
`
`the Graham and Goldstein results in the body of the Petition due to page-limit
`
`constraints, the basis for Petitioner’s conclusion that Graham and Goldstein render
`
`the final “wherein” clause obvious is included in the present record. This evidence
`
`will be amplified during the merits phase of this proceeding to establish that the
`
`final “wherein” clause should not be afforded any patentable weight.
`
`9
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`2. Ground 2: The present record provides support that the
`final “wherein” clause is an inherent result of Plachetka.
`
`Ground 2 of the Petition asserts that the final “wherein” clause is inherently
`
`present in the disclosure of the ’621 Patent itself and in Plachetka, which both
`
`disclose PN400, an existing composition for which the ’621 Patent purports to
`
`claim a new use. As discussed in the Petition, the ’621 Patent plainly discloses
`
`“PN400 (a combination therapy of 500 mg of enterically coated naproxen and 20
`
`mg of esomeprazole).” Petition at 38 (citing Ex. 1001, ’621 Patent, col. 12 l. 63–
`
`col. 13 l. 5). The Petition also discusses that “Plachetka discloses a composition
`
`comprising 500 mg of enterically coated naproxen and 20 mg of esomeprazole.”
`
`Petition at 37 (citing Ex. 1004, Plachetka, col. 3 ll. 39-59, col. 8 ll. 35-37, and col.
`
`7 ll. 7-18).
`
`It is well settled that the recitation of a new intended use for an existing
`
`composition, such as PN400, does not make a claim to that existing composition
`
`patentable. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citing In re
`
`Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“The discovery of a new property or
`
`use of a previously known composition, even when that property and use are
`
`unobvious from prior art, cannot impart patentability to claims to the known
`
`composition.”); In re Pearson, 494 F.2d 1399, 1403 (CCPA 1974) (intended use of
`
`an old composition does not render a composition claim patentable); In re Zierden,
`
`10
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`411 F.2d 1325, 1328 (CCPA 1969) (“[M]ere statement of a new use for an
`
`otherwise old or obvious composition cannot render a claim to the composition
`
`patentable.”).
`
`The Petition provides a recent Federal Circuit decision that extends this
`
`well-settled law to method claims: “the application of an old process to a new and
`
`analogous purpose does not involve invention, even if the new result had not
`
`before been contemplated.” Petition at 39 (quoting Par Pharm., Inc. v. TWI
`
`Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014)). The Petition further provides
`
`that “inherency may supply a missing claim limitation in an obviousness analysis.”
`
`Id. (quoting Par Pharm., 773 F.3d at 1194–95).
`
`This is essentially the same argument that the Board makes in pointing out
`
`that “[a] ‘whereby’ clause that merely states the result of the limitations in the
`
`claim adds nothing to the patentability or substance of the claim.” Decision at 15–
`
`16 (citing Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n., 988 F.2d 1165,
`
`1172 (Fed. Cir. 1993); Minton v. National Ass’n of Securities Dealers, Inc., 336
`
`F.3d 1373, 1381 (Fed. Cir. 2003)). The Board notes that this “underlying issue” is
`
`“not yet addressed on this record.” Decision at 15, 20. This issue will be
`
`addressed fully during the merits phase of this proceeding to establish that the final
`
`“wherein” clause should not be afforded any patentable weight.
`
`11
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`B.
`
`The Fact that the Examiner Added the Final “Wherein” Clause
`During Prosecution Does Not Entitle It to Patentable Weight
`
`Patent Owner further asserts that the final “wherein” clause is necessarily
`
`limiting—and is entitled to patentable weight—because it was added by the
`
`Examiner as a condition of allowance. Request for Rehearing at 8–10. Patent
`
`Owner essentially argues that the Board should not question the Examiner’s
`
`finding that the final “wherein” clause limits the claim scope to an unexpected
`
`result. Id. at 10.
`
`This assertion makes the false assumption that an Examiner can never make
`
`a mistake, which is not consistent with the PTAB’s record of finding hundreds of
`
`issued patent claims to be directed to unpatentable subject matter. According to
`
`the PTAB’s most recent statistics, in 719 of the 828 IPR trials that have reached a
`
`final written decision, at least one challenged claim was found to be unpatentable.3
`
`Thus, the Board has disagreed with an Examiner’s determination of patentability in
`
`87% of IPR trials that have reached a final written decision.4
`
`
`3 See Patent Trial and Appeal Board Statistics, 2/29/2016, available at
`
`http://www.uspto.gov/sites/default/files/documents/2016-2-29%20PTAB.pdf.
`
`4 See id.
`
`12
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`Moreover, in this case, the Examiner made the amendment, adding the final
`
`“wherein” clause, without considering material prior art. Patent Owner admits in
`
`its Preliminary Response that the Examiner added the final “wherein” clause, and
`
`allowed the claims, without considering Graham and Goldstein. See Prelim. Resp.
`
`at 11 (“[T]he Graham and Goldstein references relied upon in Ground 1 were not
`
`submitted to the Office during prosecution of the ’621 patent.”). For this reason,
`
`the Examiner’s reasons for allowance should be given less weight.
`
`Regardless, the Board considered the fact that the Examiner added the final
`
`“wherein” clause during prosecution in an attempt to limit the claim scope to the
`
`unexpected result. Thus, the Board did not “misapprehend” or “overlook” this
`
`information. Decision at 19–20. Considering this information, and the record as it
`
`presently stands, the Board found a “reasonable likelihood” that claims 1–16 of the
`
`’621 patent are unpatentable on both Grounds 1 and 2 of the Petition. Id. at 20–21.
`
`IV. CONCLUSION
`
`Patent Owner has not met its burden of showing that the Institution Decision
`
`should be modified. As such, Patent Owner’s Request for Rehearing should be
`
`denied.
`
`
`
`
`
`13
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`Date: March 24, 2016
`
`Respectfully submitted,
`
`
`
`
`
`/Jerry C. Harris, Jr./
`Jerry C. Harris, Jr. (Reg. No. 66,822)
`Amy E. LaValle (Reg. No. 51,092)
`WICK PHILLIPS GOULD & MARTIN, LLP
`3131 McKinney Avenue, Suite 100
`Dallas, TX 75204
`(214) 692-6200 (phone)
`(214) 692-6255 (fax)
`jerry.harris@wickphillips.com
`amy.lavalle@wickphillips.com
`
`Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
`
`
`
`
`
`
`
`
`
`14
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on March 24, 2016 a
`
`copy of the foregoing PETITIONER’S OPPOSITION TO PATENT OWNER’S
`
`REQUEST FOR REHEARING OF THE DECISION TO INSTITUTE TRIAL was
`
`provided via email to the following counsel of record for Patent Owner:
`
`Counsel for Horizon Pharma USA, Inc.
`Back-Up Counsel
`Lead Counsel
`Dennis Bennett
`Lauren L. Stevens, Ph.D.
`GLOBAL PATENT GROUP, LLC
`GLOBAL PATENT GROUP, LLC
`1005 N. Warson Road, Suite 404
`1005 N. Warson Road, Suite 404
`St. Louis, MO 63132
`St. Louis, MO 63132
`Tel: (314) 812-8018
`Tel: (650) 387-3813
`Fax: (314) 685-2300
`Fax: (314) 685-2300
`dennisbennett@globalpatentgroup.com
`lstevens@globalpatentgroup.com
`Back-Up Counsel
`Back-Up Counsel
`Thomas A. Blinka, Ph.D.
`Ricardo Rodriguez
`COOLEY LLP
`COOLEY LLP
`1299 Pennsylvania Avenue, NW
`3175 Hanover Street
`Suite 700
`Palo Alto, CA 94304-1130
`Washington, DC 20004-2400
`Tel: (650) 843-5046
`Tel: (202) 842-7800
`Fax: (650) 843-7400
`Fax: (202) 842-7899
`rr@cooley.com
`tblinka@cooley.com
`zIPR2015-01718@cooley.com
`Counsel for Pozen Inc.
`Back-Up Counsel
`Margaret J. Sampson, Ph.D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd., Suite 1500
`Austin, TX 78701-4078
`Tel: (512) 322-2552
`Fax: (512) 322-3652
`margaret.sampson@bakerbotts.com
`
`Lead Counsel
`Stephen M. Hash, Ph.D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd., Suite 1500
`Austin, TX 78701-4078
`Tel: (512) 322-2587
`Fax: (512) 322-3687
`stephen.hash@bakerbotts.com
`PozenVimovoBB@bakerbotts.com
`
`15
`
`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`
`
`
`
`/Amy E. LaValle/
`Back-Up Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
`
`
`Back-Up Counsel
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`98 San Jacinto Blvd., Suite 1500
`Austin, TX 78701-4078
`Tel: (512) 322-2624
`Fax: (512) 322-3652
`Jeff.Gritton@bakerbotts.com
`
`
`
`Date: March 24, 2016
`
`
`
`16