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Leo Pharma A/S v. Actavis Laboratories UT, Inc.

United States District Court, D. Delaware

February 12, 2018

LEO PHARMA A/S, LEO LABORATORIES LIMITED, AND LEO PHARMA, INC., Plaintiffs,
v.
ACTAVIS LABORATORIES UT, INC., AND ACTAVIS, INC., Defendants. LEO PHARMA A/S, LEO LABORATORIES LIMITED, AND LEO PHARMA, INC., Plaintiffs,
v.
PERRIGO UK FINCO LIMITED PARTNERSHIP AND PERRIGO COMPANY, Defendants.

          MEMORANDUM OPINION

          SHERRY R.FALLON UNITED STATES MAGISTRATE JUDGE.

         I. INTRODUCTION

         Presently before the court in this patent infringement action is the motion for issuance of a letter of request, filed by defendants Actavis Laboratories UT, Inc. ("Actavis"), Perrigo UK Finco Limited Partnership and Perrigo Company ("Perrigo") (collectively, "defendants"), requesting international judicial assistance to take document and deposition discovery from third party MedPharm Ltd. ("MedPharm"), pursuant to Federal Rule of Civil Procedure 28 and the Hague Convention on the Taking of Evidence Abroad in Civil or Commercial Matters (the "Hague Convention"). (D.I. 182)[1] Plaintiffs LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc. (collectively, "LEO" or "plaintiffs") oppose the motion. (D.I. 191) For the following reasons, defendants' motion for the issuance of a letter of request (D.I. 182) is granted.

         II. BACKGROUND

         This action arises out of the submission of Abbreviated New Drug Application | ("AND A") Nos. 208807 and 209086 (together, "the Actavis AND As"), and ANDA Nos. 209018 and 209019 (together, "the Perrigo AND As"), which were filed by defendants with the U.S. Food and Drug Administration ("FDA") seeking approval to market generic versions of LEO's Picato® pharmaceutical products. (C.A. No. 16-333-JFB-SRF, D.I. 73 at ¶ 1; C.A. No. 16-430-JFB-SRF, D.I. 99 at ¶ 1) The Picato® products are gels containing ingenol mebutate as the active pharmaceutical ingredient ("API") at dosage strengths of 0.015% and 0.05%. (C.A. No. 16-333-JFB-SRF, D.I. 73 at ¶ 1) LEO Pharma is the holder of New Drug Application ("NDA") No. 202833 for ingenol mebutate gel at concentrations of 0.015% and 0.05%, which was approved by the FDA on January 23, 2012. (Id. at ¶ 13) LEO's Picato® products are approved for the topical treatment of actinic keratosis. (Id. at ¶ 16)

         LEO filed Civil Action No. 16-333-JFB-SRF on May 6, 2016, and brought Civil Action No. 16-430-JFB-SRF on June 10, 2016, alleging that defendants infringed the patents-in-suit by filing their respective ANDA applications with the FDA. (C.A. No. 16-333-JFB-SRF, D.I. 1; C.A. No. 16-430-JFB-SRF, D.I. 1) The first amended complaint in Civil Action No. 16-430-JFB-SRF, brought against Perrigo, alleges infringement of twelve patents: U.S. Patent Nos. 6, 787, 161 ("the '161 patent), 6, 844, 013 ("the '013 patent"), 7, 410, 656 ("the '656 patent"), 8, 278, 292 ("the '292 patent"), 8, 372, 827 ("the '827 patent"), 8, 372, 828 ("the '828 patent"), 8, 377, 919 ("the '919 patent"), 8, 536, 163 ("the '163 patent"), 8, 716, 271 ("the '271 patent"), 8, 735, 375 ("the '375 patent"), 9, 416, 084 ("the '084 patent"), and 9, 676, 698 ("the '698 patent") (collectively, the "patents-in-suit"). (D.I. 99 at ¶ 13) The second amended complaint in Civil Action No. 16-333-JFB-SRF, brought against Actavis, alleges infringement of the '656 patent, the '292 patent, the '827 patent, the '828 patent, the '919 patent, the '163 patent, the '271 patent, the '375 patent, the '698 patent, and the '084 patent, but omits the '161 patent and the '013 patent. (D.I. 73 at ¶ 8) LEO is the owner of, and has the right to enforce, the patents-in-suit. (Id. at ¶ 21) The patents-in-suit fall into three groups: (1) the Aylward Patents, (2) the Brown Patents, and (3) the Process Patents.

         The Aylward Patents[2] are a group of related patents sharing a common specification and having one named inventor, James Harrison Aylward. The Aylward Patents are directed to methods of treating various cancerous conditions using certain ingenane compounds, including ingenol mebutate. ('656 patent, Abstract; col. 34:23-24) Dr. Aylward isolated compounds from certain species of Euphorbia, a genus of flowering plants used for traditional medicinal remedies, and discovered that angeloyl-substituted ingenanes could selectively kill cancer cells. (Id. at 4:62-5:1; 6:8-38) The claims of the '161 and '013 patents are directed to treating cancerous conditions with specific compounds obtained from the sap of Euphorbia species. ('161 patent, col. 31:22-32:35; '013 patent, col. 32:8-60) The claims of the '656 patent are more generally directed to isolated compounds. ('656 patent, col. 34:13-34)

         The Brown Patents[3] share a common specification and name as inventors Marc Barry Brown, Michael Edwards Crothers, and Tahir Nazir. The Brown Patents are directed to topical skin cancer treatments. Specifically, the Brown Patents claim pharmaceutically acceptable formulations of ingenol-3-angelate combined with pharmaceutical solvents and excipients to achieve a stable form. ('292 patent, col. 1:60-67)

         The '084 patent and the '698 patent, identified as the "Process Patents, " cover methods of producing ingenol mebutate. (D.I. 73 at ¶ 20) The Process Patents are both entitled, "Method of Producing Ingenol-3-Angelate, " they share a common specification and common inventors, [4] and both claim priority to Provisional Application No. 61/366, 018, which was filed in 2010. (D.I. 106, Exs. 6-7) The '698 patent is a continuation of the '084 patent. (Id., Ex. 7)

         In the summer of 2017, defendants served individual, third-party subpoenas on three named inventors of the Brown Patents: Marc Brown, Michael Crothers, and Tahir Nazir. (D.I. 182, Ex. B) Dr. Brown is a co-founder and Chief Scientific Officer of MedPharm, an English corporate entity which contracted with LEO's predecessor, Peplin Operations Pty Ltd, in developing the ingenol mebutate product marketed as Picato®. (Id., Ex. D at 2) Drs. Crothers and Nazir are former MedPharm employees. (D.I. 191, Ex. 1 at 47-48) Drs. Brown, Crothers, and Nazir agreed to voluntarily appear for depositions in response to the subpoenas, and produced a few documents in response to the subpoenas. Counsel for the inventors indicated that the majority of documents responsive to the subpoenas were in the possession of the inventors' former or current employers. (D.I. 182, Ex. B)

         In November 2017, prior to the depositions of the three inventors, defendants informed LEO of their intent to seek discovery directly from MedPharm pursuant to the Hague Convention. During Dr. Brown's deposition on November 15, 2017, he testified that MedPharm had transferred relevant documents to LEO several years ago, prompting LEO to renew its search for documents and produce documents found in an offsite storage facility on November 20, 2017. (D.I. 182, Ex. D at 11-14; D.I. 191, Ex. 1 at 14-16, 65-66) Dr. Brown also testified that MedPharm no longer employs any other person connected to the patents-in-suit. (D.I. 191, Ex. 1 at 48, 136-37) LEO opposes defendants' efforts to obtain discovery from MedPharm in England, alleging that the request is untimely, unduly burdensome, and cumulative of discovery already produced. (D.I. 182, Ex. F)

         III. LEGAL STANDARD

         The Hague Convention "prescribes certain procedures by which a judicial authority in one contracting nation may request evidence located in another nation." In re Automotive Refinishing Paint Antitrust Litig., 358 F.3d 288, 299 (3d Cir. 2004). The Hague Convention is not mandatory and "serves as an alternative or 'permissive' route to the Federal Rules of Civil Procedure for the taking of evidence abroad from litigants and third parties alike." Tulip Computers Int'l B. V. v. Dell Computer Corp., 254 F.Supp.2d 469, 472 (D. Del. 2003) (citing Societe Rationale Industrielle Aerospatiale v. U.S. Dist. Ct., D. Iowa, 482 U.S. 522, 538 (1987)).

         In this district,

"[a] party which seeks the application of the Hague [Evidence] Convention procedures rather than the Federal Rules [of Civil Procedure] bears the burden of persuading the trial court[] of the necessity of proceeding pursuant to the Hague Evidence Convention. That burden is not great, however, since the Convention procedures are available whenever they will facilitate the gathering of evidence by the means authorized in the Convention."

Pronova BioPharma Norge AS v. Teva Pharms. USA, Inc., 708 F.Supp.2d 450, 452-53 (D. Del. 2010) (alterations in original) (quoting Tulip Computers Int'l, 254 F.Supp.2d at 474). "When discovery is sought from a non-party in a foreign jurisdiction, application of the Hague [Evidence] Convention, which encompasses principles of international comity, is virtually compulsory." Tulip Computers Int'l, 254 F.Supp.2d at 474 (alteration in original) (internal citation and quotation marks omitted).

         In determining whether to utilize the Convention procedures, district courts are instructed to consider: (1) the particular facts of the case; (2) the sovereign interests involved; and (3) the likelihood that resort to the Hague Convention will prove effective. Societe Nationale, 482 U.S. at 544; see also In re Automotive Re finishing Paint Antitrust Litig., 358 F.3d at 301. Additional factors relevant to the court's decision include: "considerations of comity, [5] the relative interests of the parties including the interest in avoiding abusive discovery, [6] and the ease and efficiency of alternative formats for discovery." Tulip Computers Int'l, 254 F.Supp.2d at 474 (citation and quotation marks omitted).

         A letter of request, or "letter rogatory, " from a United States judicial authority to the competent authority in a foreign state is one of three available methods of taking evidence under the Convention. See Id. at 472 (citation omitted).[7] A letter rogatory "is the request by a domestic court to a foreign court to take evidence from a certain witness." Ethypharm S.A. France v. Abbott Labs., 748 F.Supp.2d 354, 358 (D. Del. 2010) (citation and quotation marks omitted). "Upon receipt of a Letter of Request, which must provide specific information regarding the lawsuit and the information sought to be discovered, the signatory state 'shall [then] apply the appropriate measure of compulsion' as is customary 'for the execution of orders issued by the authorities of its own country.'"[8] Pronova BioPharma, 708 F.Supp.2d at 452 (alteration in original) (quoting Tulip Computers Int'l, 254 F.Supp.2d at 472).

         "The person to whom the discovery requests in a Letter of Request are directed has the right to 'refuse to give evidence' to the extent that the person has a privilege under the law of the State of execution or the State of origin." Tulip Computers Int'l, 254 F.Supp.2d at 472 (citing Hague Evidence Convention, Art. 11); see also Pronova BioPharma, 708 F.Supp.2d at 454.

         The Third Circuit has explained that "the term[s] of [Fed. R. Civ. P. 28(b)] appear to give trial courts limited discretion to deny applications for the issuance of a [letter rogatory]." In re Complaint of Bankers Trust Co., 752 F.2d 874, 890 (3d Cir. 1984). The Third Circuit reasoned:

Prior to the 1963 amendment, Rule 28(b) said: "A commission or letters rogatory shall be issued only when necessary or convenient, on application and notice, and on such terms and with such directions as are just and appropriate." The amendment deleted the words "only when necessary or convenient" from the sentence. Although the Advisory Committee Note does not explain this change, it seems clear that the discretion trial courts formerly had in deciding whether to issue a commission or letters rogatory has been circumscribed.

Id. (citing Fed.R.Civ.P. 28(b)). The Third Circuit further explained that, "[a]lthough we do not dispute that it may be proper to refuse the issuance of... letters rogatory, there are cases in which courts have indicated that there must be some 'good reason' justifying the denial of this particular type of judicial assistance." Id. (citations omitted); see also Ethypharm S.A. France, 748 F.Supp.2d at 358 ("Courts have found 'that some good reason must be shown by the opposing party for a court to deny an application for a letter rogatory.'" (citing DBMS Consultants Ltd. v. Computer Assocs. Int'l, Inc., 131 F.R.D. 367, 369 (D. Mass. 1990))).

         "In entertaining a request of letter pursuant to the Hague Convention, '[t]he exact line between reasonableness and unreasonableness in each case must be drawn by the trial court, based on its knowledge of the case and of the claims and interests of the parties and the governments whose statutes and policies they invoke.'"[9] Purdue Pharma Products L.P. v. Par Pharm., Inc., C.A. No. 07-255-JJF, 2008 WL 3926158, at *1 (D. Del. Aug. 26, 2008) (quoting Societe Nationale, 482 U.S. at 546); see also Abbott Labs. v. Teva Pharm. USA, Inc., C.A. No. 02-1512-KAJ, 2004 WL 1622427, at *3 (D. Del. July 15, 2004) (same). Furthermore, "[o]n an application for the issuance of a letter rogatory seeking a deposition in a foreign country, the Court will not ordinarily weigh the evidence to be elicited by deposition and will not determine whether the witness will be able to give the anticipated testimony." AstraZeneca v. Ranbaxy Pharm., Inc., 2008 WL 314627, at *2 (D.N.J. Jan. 29, 2008) (internal citations and quotation marks omitted).

         IV. DISCUSSION

         A. Production of Documents

         Defendants seek document discovery from MedPharm pursuant to the Hague Convention regarding "the work performed at MedPharm by Marc Brown, Michael Crowthers [sic], and Tahir Nazir in developing pharmaceutically-acceptable, topical formulations of ingenol mebutate [which] resulted in the subject matter of the Brown Patents." (D.I. 182, Ex. A at 13) According to defendants, LEO's belated production of relevant documents following the deposition testimony of Dr. Brown illustrates the necessity of obtaining documents directly from MedPharm to ensure that LEO's production "constitutes the entirety of what MedPharm ostensibly provided to LEO." (D.I. 182 at ¶ 9) MedPharm is a non-party to this action, located in the foreign jurisdiction of England. (Id.) Consequently, defendants maintain that application of the Hague Convention procedures is appropriate. (Id.) In response, LEO opposes the breadth and cumulative nature of the discovery sought pursuant to defendants' motion, noting that the relevant documents formerly in MedPharm's possession have been produced by LEO. (D.I. 191 at ¶¶ 10-11)

         In the present case, defendants have met their burden of establishing the necessity of proceeding pursuant to the Hague Convention. As this court has previously recognized, the moving party's burden is "not great, " because "the Convention procedures are available whenever they will facilitate the gathering of evidence by the means authorized in the Convention." Pronova BioPharma,708 F.Supp.2d 450, 452-53 (internal citation ...


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