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Dexcel Seeks to Intervene in Perrigo’s Tax Refund Suit

JAN. 27, 2020

Perrigo Co. et al. v. United States

DATED JAN. 27, 2020
DOCUMENT ATTRIBUTES
  • Case Name
    Perrigo Co. et al. v. United States
  • Court
    United States District Court for the Western District of Michigan
  • Docket
    No. 1:17-cv-00737
  • Subject Area/Tax Topics
  • Jurisdictions
  • Tax Analysts Document Number
    2020-3433
  • Tax Analysts Electronic Citation
    2020 TNTI 19-19
    2020 TNTF 19-41
    2020 TNTG 19-33

Perrigo Co. et al. v. United States

PERRIGO COMPANY AND SUBSIDIARIES,
Plaintiff,
v.
UNITED STATES OF AMERICA,
Defendant.

UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION

Hon. Robert J. Jonker

MEMORANDUM IN SUPPORT OF MOTION BY DEXCEL PHARMA TECHNOLOGIES LTD. TO INTERVENE UNDER FED. R. CIV. P. 24 FOR THE LIMITED PURPOSE OF PREVENTING PUBLIC DISCLOSURE OF ITS INFORMATION DESIGNATED AS “PROTECTED” OR “HIGHLY” PROTECTED UNDER THE AMENDED STIPULATED PROTECTIVE ORDER


TABLE OF CONTENTS

TABLE OF CONTENTS

INDEX OF EXHIBITS

INDEX OF AUTHORITIES

SHORT STATEMENT OF BASIS OF MOTION AND RELIEF REQUESTED

INTRODUCTION

RELEVANT BACKGROUND FACTS AND PROCEDURAL HISTORY

LAW AND ARGUMENT

I. MOTIONS TO INTERVENE PURSUANT TO FED. R. CIV. P. 24

II. THIS COURT SHOULD GRANT DEXCEL'S REQUEST TO INTERVENE PURSUANT TO FED. R. CIV. P. 24 

A. DEXCEL IS ENTITLED TO INTERVENE AS A MATTER OF RIGHT 

1. Dexcel's Motion is Timely

2. Dexcel Has A Sufficient Interest Which May Be Impaired by the Disposition of this Case

3. No Current Party Adequately Represents Dexcel's Interests 

B. IF DEXCEL IS NOT GRANTED INTERVENTION AS A MATTER OF RIGHT, IT IS ENTITLED TO PERMISSIVE INTERVENTION 

III. THE DEXCEL PRODUCT INFORMATION SOUGHT TO BE PROTECTED IS CONSIDERED BY THE COURTS AND FDA TO CONSTITUTE TRADE SECRET INFORMATION THAT IS TO BE PROTECTED FROM PUBLIC DISCLOSURE

IV. DEXCEL'S PROPOSED PROCEDURE TO LIMIT PUBLIC DISCLOSURE OF DEXCEL PROPRIETARY AND TRADE SECRET INFORMATION

V. REQUEST FOR HEARING AND ORAL ARGUMENT

CONCLUSION

INDEX OF EXHIBITS

EXHIBIT

A DOJ Letter dated November 1, 2019

B DOJ Letter dated January 21, 2020

C DOJ Letter dated January 13, 2020

INDEX OF AUTHORITIES

CASES

Bradley v. Milliken, 828 F.2d 1186 (6th Cir. 1987) 8, 9, 11, 12

Enteris Biopharma Inc. v. Clinical Pharmacology of Miami, 2015 WL 12085848 (S.D. Fla. Mar. 20, 2015)

Ford Dev. Corp., 2010 WL 3365927 (S.D. Ohio, Aug. 20, 2010)

Grubbs v. Norris, 870 F.2d 343 (6th Cir. 1989)

Grutter v. Bollinger, 188 F.3d 394 (6th Cir. 1999)

Jansen v. City of Cincinnati, 904 F.2d 336 (6th Cir. 1990)

Linton v. Comm'r of Health & Env't, 973 F.2d 1311 (6th Cir. 1992)

Makah Indian Tribe v. United States, 501 U.S. 1250 (1991)

Michigan State AFL-CIO v. Miller, 103 F.3d 1240 (6th Cir. 1997)

Nuesse v. Camp, 385 F.2d 694 (D.C. Cir. 1967)

Purnell v. Akron, 925 F.2d 941 (6th Cir. 1991)

The State of Ohio v. United States EPA, 313 F.R.D. 65 (S.D. Ohio 2016)

Trbovich v. UMW, 404 U.S. 528 (1972)

Triax Co. v. TRW, Inc., 724 F.2d 1224 (6th Cir. 1984)

United States v. Detroit, 712 F.3d 925 (6th Cir. 2013)

RULES

FED. R. CIV. P. 24

FED. R. CIV. P. 24(a)

FED. R. CIV. P. 24(a)(2)

FED. R. CIV. P. 24(b)

FED. R. CIV. P. 24(b)(1)

FED. R. CIV. P. 24(b)(1)(B)

FED. R. CIV. P. 24(b)(3)

FED. R. CIV. P. 30(b)(6)

REGULATIONS

21 C.F.R. 20.61(a)-(b)

21 C.F.R. 20.61(c).


SHORT STATEMENT OF BASIS OF MOTION AND RELIEF REQUESTED

Dexcel Pharma Technologies Ltd. (“Dexcel”) seeks intervention in this action as a matter of right under FED. R. CIV. P. 24(a)(2) or, alternatively, via permission under Rule 24(b)(1), for the limited purpose of preventing public disclosure of Dexcel proprietary and trade secret information as set forth in documents designated as “Protected” or “Highly Protected” under the Amended Stipulated Protective Order (ECF No. 71), and the information therein, in this action. Dexcel respectfully requests that the Court enter an Order setting forth a pretrial, trial and post-trial procedure to limit public disclosure of Dexcel proprietary and trade secret information.

INTRODUCTION

On November 1, 2019, Dexcel was advised by counsel for the United States (i.e., the Department of Justice, “DOJ”) that the DOJ intended to “flag certain protective order issues regarding the United States' use” of documents designated by Dexcel as “Protected” or “Highly Protected,” “and, potentially, the designated portions of Mr. Pollack's deposition testimony” during the pretrial conference then set for December 11, 2019, and now re-scheduled for February 13, 2020, the latter as part of a motion in limine. See Exhibit A at 3. In that same letter, the DOJ advised that a number of Dexcel documents constituting and relating to Dexcel's New Drug Application (“NDA”), produced to the DOJ by Dexcel's US agent, Lachman Associates (“Lachman”), and designated as “Protected” or “Highly Protected” by Dexcel, were included on the DOJ's Amended Exhibit List (see Exhibit A at 2) and also were cited as exhibits by DOJ expert witnesses in their reports, e.g., Dr. Korsmeyer. See Exhibit A at 5.

The parties have held several discussions, and exchanged correspondence and of these moving papers, in an effort to identify the information Dexcel seeks to protect from public disclosure, and a procedure to prevent the public disclosure of this information — not only by sealing documents — but to prevent disclosure should this Dexcel information be the subject of oral argument and witness testimony in open court, or incorporated in pretrial, trial and post-trial written submissions. As a result of these discussions, Perrigo concurs with Dexcel's Motion to Intervene and relief requested herein. DOJ concurs with limited intervention by Dexcel, if the need arises, for the purpose of preventing public disclosure of a limited set of documents reflecting Dexcel trade secret information, in accordance with procedures outlined on page 2 of the DOJ's correspondence of January 21, 2020 (Exhibit B).

However, Dexcel and DOJ remain unable to agree on how this information should be protected if disclosed during oral argument or witness testimony, in transcripts, or in any party's written submissions. Further, DOJ has advised that it may use other and as of yet unknown documents during its cross-examinations for purposes of impeachment — these unknown documents potentially containing Dexcel proprietary and trade secret information. Dexcel seeks to set a procedure that would enable Dexcel to prevent public disclosure of its proprietary and trade secret information if disclosed under each of the foregoing circumstances.1

Absent protection by this Court, Dexcel — a third party to this tax-related action — may suffer significant and irreparable harm. Dexcel's competitors that gain knowledge of proprietary and trade secret information relating to the formulation, manufacturing methods and properties associated with the Dexcel over-the-counter omeprazole product (“the Dexcel Product”) contained in certain “Protected” and “Highly Protected” documents, will be able to expedite efforts to develop generic versions of the Dexcel Product and related products, as well as closely-related products. The unfair advantage provided by disclosure of this information, which would inevitably lead to the introduction of additional competitive products into the marketplace, would irreparably and unjustly harm Dexcel's competitive position.

Precluding disclosure of the Dexcel formulation and manufacturing information is not contrary to the concept of an open proceeding in this tax-related case. Dexcel does not seek to preclude public access to financial or tax-related information or other broad categories of information or documents. However, Dexcel sees no basis for the public disclosure of specifically identifiable proprietary and trade secret information that appears to be only marginally relevant, if at all, to this case. In fact, Perrigo was not provided Dexcel formulation and manufacturing information at the time it entered into the marketing agreement with Dexcel in July 2005, nor has Dexcel at any time provided Perrigo with the New Drug Application (“NDA”) submitted to the U.S. Food & Drug Administration (“FDA”), which sought approval to market the Dexcel Product. It is therefore difficult to see the relevance in this case of this Dexcel proprietary information about which Perrigo was not aware, and therefore could not have relied on in its actions that are the subject of this tax-related case.

Relevance aside, there is no good reason to irreparably damage an unrelated third party's business interests by permitting public access to its proprietary and trade secret formulation and manufacturing information — access that would assuredly lead to increased competition for the third party's US market-leading product.

For the reasons set forth herein, Dexcel respectfully requests that this Court enter an appropriate order preventing the public disclosure of Dexcel proprietary and trade secret information.

RELEVANT BACKGROUND FACTS AND PROCEDURAL HISTORY

Dexcel first became aware of the potential disclosure of its proprietary and trade secret information after its US agent, Lachman Associates (“Lachman”), notified Dexcel that it received a subpoena from the DOJ for the production of documents relating to Dexcel's Product, as well as a related notice for a deposition under FED. R. CIV. P. 30(b)(6). The documents requested by the subpoena included, among others, Dexcel's “New Drug Application” (“NDA”), FDA correspondence concerning that NDA, and other information concerning the Dexcel Product. This information was maintained in confidence by Lachman pursuant to a contract entered into between Dexcel and Lachman, and was to be used by Lachman solely for purposes of pursuing FDA review, and hopefully FDA approval, of the Dexcel Product as described in the Dexcel NDA.

Prior to producing the documents required by the subpoena, Dexcel was provided the opportunity to review and designate certain documents as Protected or Highly Protected under the Amended Stipulated Protective Order entered in this action. (See, ECF No. 71). Dexcel did so, and later also reviewed and designated the Rule 30(b)(6) transcript of the Lachman deposition (given by Robert Pollack) as protected.

Dexcel had no other involvement in this action until November 1, 2019, when it received notice from the DOJ that the DOJ intended to discuss, at the pretrial conference (then scheduled for December 11, 2019)2, certain documents and information that had been designated by Dexcel as “Protected” or “Highly Protected” under the Amended Stipulated Protective Order. See Exhibit A. These documents and information include Dexcel proprietary and trade secret formulation, manufacturing, and other information concerning the product submitted to FDA by Dexcel (via its US agent, Lachman) in support of Dexcel's request for FDA approval of the Dexcel Product. Dexcel also became aware that a DOJ expert, Dr. Korsmeyer, prepared an expert report (the “Korsmeyer Report”) that relied on certain pages from the Dexcel NDA describing formulation and manufacturing information of the Dexcel Product.

After learning of DOJ's intended disclosure, Dexcel began a process of review and discussions with the DOJ and Perrigo counsel to assess the extent of the parties' intended disclosure of Dexcel proprietary information during the pretrial conference and at trial. As part of this process, counsel for Dexcel requested and received a copy of the Korsmeyer Report, and began to review its contents.Further discussions with the DOJ and Perrigo resulted in the identification of other experts that are expected to testify in this action, and which required review by Dexcel and its counsel to determine if any would rely on any Dexcel proprietary information.3

During this time, counsel for Dexcel moved forward in an effort to identify the universe of Dexcel documents and information that might potentially be publicly disclosed by either party, either in written submissions or in open court. While DOJ did identify a number of documents it was likely to use, DOJ also indicated that other as of yet unknown Dexcel documents (produced by Lachman) may be used at trial for purposes of impeachment. See Exhibit A at 5.These documents may include portions of the Dexcel NDA and FDA correspondence relating thereto.

After completing its review of the documents identified by DOJ, as well as expert reports submitted on behalf of Perrigo and the United States, Dexcel was able to significantly reduce the scope of the information Dexcel seeks to protect from public disclosure to the Dexcel Product formulation (ingredients, grades thereof and suppliers, with the exception of the API supplier, i.e., Cipla), methods for its manufacture, its NDA submission strategy and details of its bioequivalence studies. Dexcel does not seek to protect the active ingredient used in its formulation, nor its source (Cipla), as this information was made available in prior litigation.

Based on information made available to Dexcel by the parties, Dexcel has identified to DOJ the following documents referenced in the Korsmeyer Report, and which are also part of the Dexcel NDA, that contain the some of the foregoing Dexcel proprietary and trade secret information:

A. LACHMAN05693-5695, LACHMAN05697-5699, LACHMAN05702-5710.

B. LACHMAN05725, LACHMAN05734-5736, LACHMAN05738-5740, LACHMAN05743, LACHMAN05745-5752.

These documents (A. & B. above) form the Dexcel NDA (Chemistry Manufacturing and Controls section) disclose details on Dexcel's quantitative and/or qualitative formulation (ingredients, amounts, etc.), manufacturing process, and packaging materials (that support stability). These pages are part of two LACHMAN documents attached as exhibits to the Korsmeyer Report.

C. LACHMAN1324-1326

DOJ has agreed to redact the entirety of LACHMAN1324-1326 which discloses information on Dexcel's pharmacovigilance working methods.

Dexcel has also identified to DOJ information in the Korsmeyer Report (Common Exh. No. 5394, e.g., p. 6, second paragraph; page 8, regarding the equipment used by Dexcel for coating; page 10, last 3 sentences which cite to pages within A. & B. above; page 11, third and fourth sentences regarding manufacturing the Dexcel product; and page 12, 2nd and 3rd sentences in last partial paragraph that cite to certain pages within A. & B. above) that constitutes Dexcel proprietary and trade secret information, and which reference documents identified in A.,B. and C. above and/or information contained therein.

DOJ agrees that these Dexcel NDA documents, and the information therein, constitute Dexcel trade secret information, that the Korsmeyer Report cites to these documents, and that the Report itself discloses information that even DOJ agrees may arguably constitute trade secret information. See Exhibit B at 2 (wherein DOJ agrees that Dexcel ingredient and manufacturing information constitutes protectable subject matter); Exhibit C at 2 (wherein DOJ identifies portions of the Korsmeyer Report that “might, arguably” reveal Dexcel trade secret information.)

Discussions with the DOJ and Perrigo indicate that there continues to be a significant risk of disclosure of even this more limited set of Dexcel proprietary documents and information, as well as unknown documents that DOJ has advised it reserves the right to use for impeachment, at the pretrial conference (as well as at trial, in oral arguments and in written submissions). As the parties have been unable to agree on a particular procedure to protect that information from public disclosure, Dexcel has no option but to file the present Motion to Intervene to prevent public disclosure of its proprietary and trade secret information.

LAW AND ARGUMENT

I. MOTIONS TO INTERVENE PURSUANT TO FED. R. CIV. P. 24

Dexcel seeks intervention in this action under FED. R. CIV. P. 24(a)(2), or alternatively under Rule 24(b)(1)(B), for the limited purpose of protecting public disclosure of its proprietary information relating to the Dexcel Product. Rule 24 states in relevant part:

(a) Intervention of Right. On timely motion, the court must permit anyone to intervene who: . . . (2) claims an interest relating to the property or transaction that is the subject of the action and is so situated that disposing of the action may as a practical matter impair or impede the movant's ability to protect its interest, unless existing parties adequately represented that interest.

(b) Permissive Intervention. (1) On timely motion, the court may permit anyone to intervene who: . . . (B) has a claim or defense that shares with the main action a common question of law or fact.

“The Sixth Circuit has opted for a rather expansive notion of the interest sufficient to invoke intervention of right[,]” (Michigan State AFL-CIO v. Miller, 103 F.3d 1240, 1245 (6th Cir. 1997)), and that “interest is to be construed liberally.” Bradley v. Milliken, 828 F.2d 1186, 1192 (6th Cir. 1987). Further, Rule 24 need not be literally applied. See e.g., Nuesse v. Camp, 385 F.2d 694, 700 (D.C. Cir. 1967) (stating that the Rule is “obviously tailored to fit ordinary civil litigation, these provisions [of Rule 24] require other than literal application in atypical cases.”).

Dexcel's intervention will not in any manner restrict the ability of Perrigo or the DOJ to present the substance of their respective cases in the manner in which they desire — they will be able to use any of the documents on the exhibit list and present the testimony from any witness. Dexcel only seeks to prevent the public disclosure of proprietary and trade secret information concerning the formulation and manufacturing aspects of the Dexcel Product during the pretrial conference, as well as at trial, oral argument and in any written submissions.

II. THIS COURT SHOULD GRANT DEXCEL'S REQUEST TO INTERVENE PURSUANT TO FED. R. CIV. P. 24

A. DEXCEL IS ENTITLED TO INTERVENE AS A MATTER OF RIGHT

The Sixth Circuit has developed a four-factor test to determine whether a party should be granted intervention as of right. See Triax Co. v. TRW, Inc., 724 F.2d 1224, 1227 (6th Cir. 1984); see also Grubbs v. Norris, 870 F.2d 343, 345 (6th Cir. 1989). These rules are to be “construed broadly in favor of potential intervenors.” Michigan State AFL-CIO v. Miller, 103 F.3d 1240, 1246 (6th Cir. 1997); see also Makah Indian Tribe v. United States, 501 U.S. 1250 (1991).

Granting a motion for intervention of right is appropriate upon a showing that: (1) the application for intervention is timely; (2) the applicant has a substantial, legal interest in the subject matter of the pending litigation; (3) the applicant's ability to protect that interest is impaired; and (4) the present parties do not adequately represent the applicant's interest. Grubbs, 870 F.2d at 345.

1. Dexcel's Motion is Timely

The timeliness of a motion to intervene “should be evaluated in the context of all relevant circumstances.” Jansen v. City of Cincinnati, 904 F.2d 336, 340 (6th Cir. 1990) (citing Bradley v. Milliken, 828 F.2d 1186, 1191 (6th Cir. 1987)). The Sixth Circuit has outlined five factors to be considered when assessing the timeliness of a motion to intervene: (1) the stage of the proceeding; (2) the purpose of intervention; (3) the length of time between when the proposed intervenor knew or should have known of his interest and moved to intervene; (4) the prejudice to the original parties caused by the proposed intervenor's failure to promptly intervene after he knew or reasonably should have known of his interest; and (5) the existence of unusual circumstances militating in favor or against intervention. Jansen, supra (citing Grubbs, 870 F.2d at 345).

In this instance, Dexcel satisfies all five factors. As regarding timing “[t]he mere passage of time — even 30 years — is not particularly important” when considering timeliness; instead, the “proper focus is on the stage of the proceedings and the nature of the case.” United States v. Detroit, 712 F.3d 925, 931 (6th Cir. 2013). At present, no trial date is set, and Dexcel seeks intervention in advance of the pretrial conference so the Court and parties have sufficient time to consider Dexcel's motion and enter an appropriate remedy. Moreover, Dexcel did not delay in seeking to protect its rights. Rather, Dexcel raised the issues addressed herein with the parties as soon as Dexcel learned (via the November 1, 2019, letter from the DOJ's counsel) that the DOJ intended to disclose Dexcel's proprietary and trade secret information at the pretrial conference and trial. Dexcel made repeated attempts to resolve these concerns with the parties, and with DOJ in particular, without the need for adversarial pleadings.

2. Dexcel Has A Sufficient Interest Which May Be Impaired by the Disposition of this Case

The second and third requirements under Rule 24(a) are that Dexcel must have an interest in the litigation and that the disposition of this suit will impair those interests. “To satisfy [the impairment] element of the intervention test, a would-be intervenor must show only that impairment of its substantial legal interest is possible if intervention is denied. This burden is minimal.” Michigan State AFL-CIO, 103 F.3d at 1247.

The Sixth Circuit “has opted for a rather expansive notion of the interest sufficient to invoke intervention of right.” Id. at 1245. Dexcel is not required to show “that impairment will inevitably ensue from an unfavorable disposition; the would-be intervenors need only show that the disposition may impair or impede their ability to protect their interest.” Purnell v. Akron, 925 F.2d 941, 948 (6th Cir. 1991) (emphasis in original) (internal quotations and modifications omitted). Even so called “close cases should be resolved in favor of recognizing an interest under Rule 24(a).” Grutter v. Bollinger, 188 F.3d 394, 398 (6th Cir. 1999) (citing Michigan State AFL-CIO, 103 F.3d at 1245).

Dexcel has an interest in this action as its proprietary and trade secret Dexcel Product information (as advised by the parties to this action) may be publicly disclosed, according to the DOJ letter, at the pretrial conference and trial. Dexcel is thus facing a real and substantial risk associated with this public disclosure — which would result in irreparable harm to its business interests, in a court case in which Dexcel is not even a party.

In contrast, no prejudice would befall the DOJ or Perrigo by granting Dexcel's motion for intervention and appropriate relief. Dexcel notes that the prejudice inquiry is related to timeliness, as the “analysis must be limited to the prejudice caused by the untimeliness, not the intervention itself.” See Detroit, 712 F.3d at 933.

3. No Current Party Adequately Represents Dexcel's Interests

The fourth factor in the intervention analysis is whether the “present parties . . . adequately represent the applicant's interest.” Grubbs, 870 F.2d at 345. Dexcel need only prove that the “representation of [their] interest may be inadequate.” Trbovich v. UMW, 404 U.S. 528, 538, n.10 (1972); see also, Michigan State AFL-CIO, 103 F.3d at 1247 (citing Linton v. Comm'r of Health & Env't, 973 F.2d 1311 (6th Cir. 1992)).

Only when a proposed intervenor and an existing party share the same ultimate objective in the litigation do courts presume that the existing party adequately represents the intervenor's interests. Bradley, 828 F.2d at 1192. Even when there is a presumption of adequate representation, a proposed intervenor can overcome the presumption by showing “that there is a substantial doubt about whether the intervenor's interests are being adequately represented by an existing party.” The State of Ohio v. United States EPA, 313 F.R.D. 65, 69 (S.D. Ohio 2016), quoting Ford Dev. Corp., 2010 WL 3365927, at *4 (S.D. Ohio, Aug. 20, 2010) (citing Trbovich, 404 U.S. at 538 n. 10 (1972)).

Here, the DOJ has advised that it intends to raise protective order issues concerning “Protected” and “Highly Protected” documents at the pretrial conference. While the DOJ has made Dexcel aware of this potential disclosure, no party has offered to affirmatively seek the Court's assistance in preventing the public disclosure of the Dexcel proprietary information. Indeed, the DOJ's letter of November 1, 2019, informing the parties of the DOJ's intent to raise Dexcel Protected and Highly Protected information at the pre-trial conference, invited Dexcel to take action to protect its proprietary and trade secret interests. (See Exhibit A at 3, e.g., [Dexcel] may “take whatever steps [it] may deem appropriate to maintain the confidentiality of items that may be offered as evidence or otherwise discussed or utilized at trial, and, for that matter, during the pretrial conference.”) Thus, Dexcel is without adequate representation absent intervention.

B. IF DEXCEL IS NOT GRANTED INTERVENTION AS A MATTER OF RIGHT, IT IS ENTITLED TO PERMISSIVE INTERVENTION

Even if this Court determines that Dexcel is not permitted to intervene in this lawsuit as a matter of right, Dexcel should be granted permissive intervention pursuant to Federal Rule of Civil Procedure 24(b). This Rule provides for permissive intervention where a party timely files a motion and “has a claim or defense that shares with the main action a common question of law or fact.” FED. R. CIV. P. 24(b)(1)(B).

Intervention under Rule 24(b) is a “discretionary power” left to the judgment of the district court. Bradley, 828 F.2d at 1193. In exercising its broad discretion under this Rule, the Court must consider whether intervention will unduly delay or prejudice the adjudication of the original parties' rights. FED. R. CIV. P. 24(b)(3).

For the reasons outlined above, Dexcel has established its right to permissively intervene in this matter. Dexcel has filed this Motion before trial. Including Dexcel as an intervenor for the limited purpose described herein will not cause any delay or prejudice on the current parties. Furthermore, Dexcel will be directly and irrevocably impacted by any decision relating to its proprietary and trade secret information relating to the Dexcel Product. Disallowing intervention would prejudice its interests and rights.

The DOJ has included documents designated by Dexcel as “Protected” or “Highly Protected” on its Amended Exhibit List, and has indicated they may use additional Lachman documents reflecting Dexcel confidential information in written submissions or in open court, e.g., for impeachment or other unspecified purposes. See Exhibit A at 5. The only means to protect this proprietary Dexcel information is to permit Dexcel to intervene.

III. THE DEXCEL PRODUCT INFORMATION SOUGHT TO BE PROTECTED IS CONSIDERED BY THE COURTS AND FDA TO CONSTITUTE TRADE SECRET INFORMATION THAT IS TO BE PROTECTED FROM PUBLIC DISCLOSURE

The relief requested by Dexcel — protection of its formulation, manufacturing and other information (e.g., bioequivalence studies) relating to the Dexcel Product, all of which is set forth in Dexcel's NDA — is consistent with the treatment by the courts and FDA of information contained in an NDA, the latter which also contains formulation, manufacturing, methods for quality analysis, clinical study reports and clinical trial information.4 Courts have held that information such as production and manufacturing methods and processes, formulations, methods for quality analysis, clinical study reports and clinical trials are protectable trade secret information. See, e.g., Enteris Biopharma Inc. v. Clinical Pharmacology of Miami, 2015 WL 12085848, at *8–9 (S.D. Fla. Mar. 20, 2015).

FDA regulations are consistent in recognizing formulation and process information as trade secrets. The FDA regulations define a trade secret as “any commercially valuable plan, formula, process or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort.” “Commercial . . . information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.” See 21 C.F.R. 20.61(a)-(b).

FDA maintains data or information that falls within the definition of a trade secret or confidential commercial or financial information as confidential — this information is not available for public disclosure. See 21 C.F.R. 20.61(c).

It is therefore appropriate for this Court to preclude public disclosure of the Dexcel Product's formulation, method of manufacture and properties, including information set forth in the Dexcel NDA, that has been designated as “Protected” or “Highly Protected.”

IV. DEXCEL'S PROPOSED PROCEDURE TO LIMIT PUBLIC DISCLOSURE OF DEXCEL PROPRIETARY AND TRADE SECRET INFORMATION

As discussed above, Dexcel seeks to intervene in this action solely to prevent public disclosure of its proprietary and trade secret information, the release of which would cause significant commercial harm to Dexcel. Dexcel believes that reasonable procedures can be adopted for that purpose and which appropriately balance both Dexcel's commercial and proprietary rights with the need for an open, fair and public judicial process. Therefore, Dexcel proposes that the Court enter an Order setting forth the following procedures for purposes of pretrial, trial, and post-trial evidentiary submissions, written pleadings, and testimony in this action, along with any additional or different procedures this Court believes to be proper and just under the circumstances:

(a) the courtroom will be closed while Dexcel trade secret information is disclosed, whether via oral argument or witness testimony, with Dexcel counsel and/or a Dexcel representative permitted to attend trial and participate therein to the extend necessary to prevent public disclosure of this Dexcel information (the latter agreed to by DOJ, see Exhibit B, p. 2);

(b) exhibits and written submissions will be prepared and filed in both confidential and public versions (the public versions having Dexcel proprietary and trade secret information redacted), with the exhibits and submissions remaining confidential for no more than 10 days during which time Dexcel will be able to review and designate its proprietary and trade secret information appearing in those documents; and

(c) hearing and trial transcripts be prepared in both confidential and public version (the public versions having the Dexcel proprietary and trade secret information redacted), with the final transcripts remaining confidential for no more than 10 days during which time Dexcel will be able to review and designate its proprietary and trade secret information appearing therein.

The above are Dexcel's proposed procedures for protecting its proprietary and trade secret information from unnecessary and damaging public disclosure in this action. To the extent either Perrigo or the DOJ wish to propose alternative or different procedures, Dexcel remains amenable to any reasonable alternatives. Again, Dexcel's only purpose in intervening in this matter is to protect its proprietary and trade secret information from public disclosure.

V. REQUEST FOR HEARING AND ORAL ARGUMENT

Dexcel respectfully requests oral argument on its Motion to Intervene and that the Court set the matter for hearing, either at a date and time convenient to the Court and prior to February 13, 2020, or immediately preceding the pretrial conference pending for February 13, 2020.

CONCLUSION

Dexcel is not a party to this action. Despite going to great lengths to protect its proprietary and trade secret information, and through no fault of its own, Dexcel now finds itself in a position where its proprietary and trade secret information stands at risk of public disclosure. The Federal Rules of Civil Procedure envision a mechanism — i.e., intervention under FED. R. CIV. P. 24 — where third-parties such as Dexcel may seek relief from the Court to protect their property rights and interests. This is just such a circumstance requiring intervention under the Rule.

For the reasons discussed herein, Dexcel respectfully requests that this Court grant its Motion to Intervene under FED. R. CIV. P. 24 and, further, that this Court enter an Order setting forth a reasonable procedure to protect from public disclosure the proprietary and confidential information identified by Dexcel and marked as Protected or Highly Protected under the parties' First Amended Stipulated Protective Order.

Respectfully submitted,

RHOADES MCKEE

January 27, 2020

By: G. Will Furtado
Paul A. McCarthy (P47212)
G. Will Furtado (P77848)
55 Campau Avenue, NW, Suite 300
Grand Rapids, Michigan 49503
Telephone: (616) 235-3500
Facsimile: (616) 233-5269
mccarthy@rhoadesmckee.com
gwfurtado@rhoadesmckee.com

Robert F. Green
Christopher T. Griffith
GREEN, GRIFFITH & BORG-BREEN LLP
City Place, Suite 3900
676 North Michigan Avenue
Chicago, Illinois 60611
Telephone: (312) 883-8000
Facsimile: (312) 883-8001
rgreen@greengriffith.com
cgriffith@greengriffith.com

Counsel for Proposed Intervenor
Dexcel Pharma Technologies Ltd.

FOOTNOTES

1As explained herein, Dexcel has, after being provided with and analyzing expert reports served by the parties, further limited the documents and information for which Dexcel seeks protection from public disclosure.

2On December 6, 2019, the Pretrial Conference was adjourned to February 13, 2020. (ECF No. 269).

3As part of this process, Dexcel also learned, for the first time, that the entire deposition transcript of Robert Pollack (an employee of Lachman Associates), portions of which had been designated as “Protected” or “Highly Protected” by Dexcel, had been inadvertently filed on the public docket by Perrigo months earlier. As the transcript itself did not disclose any formulation and manufacturing trade secret information relating to the Dexcel Product (although it referenced “Protected” and “Highly Protected” documents), noting that the disclosure had occurred months prior, and desiring to limit the scope of its potential motion for protection, Dexcel chose not to pursue a remedy for the inadvertent disclosure of the Pollack deposition transcript.

4While FDA does make certain non-proprietary information in an NDA publicly available, the information sought to be protected by Dexcel via this motion is proprietary and not publicly available.

END FOOTNOTES

DOCUMENT ATTRIBUTES
  • Case Name
    Perrigo Co. et al. v. United States
  • Court
    United States District Court for the Western District of Michigan
  • Docket
    No. 1:17-cv-00737
  • Subject Area/Tax Topics
  • Jurisdictions
  • Tax Analysts Document Number
    2020-3433
  • Tax Analysts Electronic Citation
    2020 TNTI 19-19
    2020 TNTF 19-41
    2020 TNTG 19-33
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