Federal Trade Commission v. Bisaro

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

FEDERAL TRADE COMMISSION,

Petitioner,

v. Misc. Action No. 10–289 (CKK) (AK)
PAUL M. BISARO,

Respondent.

MEMORANDUM OPINION
(December 2, 2010)

Petitioner, the Federal Trade Commission, has filed this action for the purpose of

obtaining an order compelling Respondent Paul Bisaro to comply in full with a subpoena ad

testificandum issued to him on July 22, 2009 in aid of a law enforcement investigation being

conducted by the Federal Trade Commission (“FTC”). This Court referred the matter to

Magistrate Judge Alan Kay, who issued a Report & Recommendation recommending that the

FTC’s petition be granted. See Report & Recommendation (“R&R”) (Aug. 17, 2010), Docket

No. [35]. Respondent timely objected to Magistrate Judge Kay’s Report & Recommendation,

and the parties have fully briefed Respondent’s objections. Pursuant to Local Civil Rule 72.3(c),

this Court makes a de novo determination regarding Respondent’s objections. For the reasons

explained below, the Court shall overrule Respondent’s objections to the Report &

Recommendation and GRANT the FTC’s [3] Petition for an Order Enforcing Administrative

Subpoena Ad Testificandum.

I. BACKGROUND

Respondent Paul Bisaro is the President and CEO of Watson Pharmaceuticals, Inc.
(“Watson”), a company engaged in the development and distribution of generic pharmaceuticals.

This dispute arises from the FTC’s attempts to investigate and stop so-called “reverse payment”

settlements between brand-name pharmaceutical companies and their generic counterparts.

“Reverse payment” settlements are the result of patent infringement litigation between brand-

name pharmaceuticals and generic companies who seek to enter the market with a generic

versions of brand-name drugs prior to the expiration of their patent terms pursuant to the Drug

Price Competition and Patent Term Restoration Act of 1984, also known as the “Hatch-Waxman

Act,” Pub. L. No. 98-417, 98 Stat. 1585 (1984).

The Hatch-Waxman Act enables generic drugmakers to obtain expedited approval for

generic drugs and challenge the validity of brand-name drug patents by submitting an

Abbreviated New Drug Application (“ANDA”) with the Food & Drug Administration. See 21

U.S.C. § 355(j). As part of the ANDA, the applicant must submit a so-called “Paragraph IV”

certification attesting that brand-name patent on which the generic drug is based is either invalid

or will not be infringed by the generic drug. See id. § 355(j)(2)(A)(vii)(IV). The ANDA is

approved immediately unless, within 45 days, the brand-name patent holder files an infringement

lawsuit against the applicant, in which case approval is delayed for a period of 30 months (unless

the patent expires or the patent litigation is resolved sooner). Id. § 355(j)(5)(B)(iii). The first

generic drugmaker who files a successful ANDA receives a 180-day period of marketing

exclusivity for the drug. Id. § 355(j)(5)(B)(iv). A “reverse payment” settlement occurs when the

brand-name drugmaker pays the generic drugmaker to delay its entry into the market, effectively

extending the monopoly period for the brand-name drug. The FTC believes that such payments

are “unfair methods of competition” in violation of Section 5 of the Federal Trade Commission

2
Act, 15 U.S.C. § 45. However, most federal courts examining the issue have determined that

such agreements are not unlawful so long they do not expand the scope or duration of the

monopoly granted by the patent. See, e.g., In re Ciproflaxin Hydrochloride Antitrust Litig., 544

F.3d 1323, 1333 (Fed. Cir. 2008), cert. denied, 129 S. Ct. 2828 (2009).

A. The FTC’s Modafinil Investigation

In 2006, the FTC began an investigation into settlement agreements reached between

Cephalon, Inc. (“Cephalon”) and five generic drugmakers, including Watson, relating to generic

versions of modafinil, a narcolepsy drug that Cephalon sells under the brand-name Provigil. See

Pet. Ex. 2 (Resolution Authorizing Use of Compulsory Process in a Nonpublic Investigation, File

No. 0610182 (Aug. 30, 2006)). These generic companies had filed ANDAs challenging

Cephalon’s patent for Provigil (the ’546 patent), and the four companies other than Watson had

all filed on the same day before Watson, making them potentially eligible for first-filer marketing

exclusivity. See Pet. Ex. 1 (Decl. of James Rhilinger, Esq.) ¶ 6. Cephalon sued all of the generic

companies for patent infringement, ultimately settling these suits in 2005 and 2006. Id. ¶ 7.

Cephalon reached a settlement with Watson and its development partner, Carlsbad Technology,

Inc. (“Carlsbad”), on August 6, 2006 (the “2006 Settlement Agreement”). Id. ¶ 7. Under the

terms of these agreements, Watson and the other companies agreed not to market generic

Provigil until 2012. Id. The FTC filed a lawsuit against Cephalon on February 13, 2008,

alleging that its agreement with the four “first filers” was unlawfully anticompetitive. See FTC v.

Cephalon, Inc., Civil Action No. 2:08-cv-02141-MSG (E.D. Pa. filed Feb. 13, 2008).

On December 19, 2007, Cephalon listed a new patent for Provigil (the ’346 patent), and

Watson and Carlsbad filed a supplemental ANDA and Paragraph IV certification as to the newly

3
listed patent on the same day. See Resp’t’s Opp’n, Decl. of Steven C. Sunshine (“Sunshine

Decl.”) ¶¶ 14-15.

B. The FTC Reopens Its Investigation

Although the listing of a new patent by Cephalon was a matter of public record, the FTC

staff who had conducted the modafinil investigation did not learn of it until January 2009. See

FTC’s Interrog. Resp. at 3. When the FTC learned that Watson had filed a supplemental ANDA

and Paragraph IV certification with respect to the new patent, the FTC realized that it was

possible that Watson could have first-filer marketing exclusivity and potentially block other

companies from entering the market for generic modafinil. See id. at 3-4. The FTC had

discussions with FDA staff in January and February 2009 regarding the implications of the ’346

patent and how Watson’s potential first-filer status might affect the market for generic modafinil.

Id. at 4-5.

As part of its investigation, the FTC also contacted Apotex, Inc. (“Apotex”), a

pharmaceutical company that had filed an ANDA for modafinil and was selling generic

modafinil in Canada. See FTC’s Interrog. Resp. at 7. From February 2 through March 3, 2009,

FTC staff had approximately four conversations with Apotex’s Vice President, who is a

published expert in the field of generic drug patent and FDA law. Id. at 7-8. The discussions

focused on the following issues: (1) Cephalon’s listing of the ’346 patent; (2) whether Apotex

had submitted to the FDA an amended ANDA containing a Paragraph IV certification as to the

’346 patent; (3) Apotex’s analysis of whether any first filer(s) eligible for marketing exclusivity

on the later-listed ’346 patent would block Apotex’s ability to launch generic Provigil; (4) what it

would take Apotex to launch a generic version of Provigil in the United States, assuming it was

4
interested in doing so; and (5) how a generic company could know the date on which a brand-

name patent holder would list a later-issued patent with the FDA so that it could try to become a

first-filer by submitting an amended ANDA on the same day. See id. at 9.

Beginning on March 2, 2009, Markus H. Meier and Saralisa Brau, Assistant Director and

Deputy Assistant Director in the FTC’s Health Care Division of the FTC, respectively, contacted

counsel for Watson, Steven C. Sunshine, to discuss the FTC’s modafinil investigation. See

FTC’s Interrog. Resp. at 9. According to Mr. Sunshine, Mr. Meier suggested that Watson should

consider relinquishing any first-filer exclusivity rights associated with its supplemental ANDA

for the ’346 patent, and he posited several hypothetical scenarios under which Watson could

profit from relinquishment. Sunshine Decl. ¶ 16. The FTC believed at this time that

relinquishment could be a more profitable option for Watson than waiting to launch its generic

modafinil product under the terms of the 2006 Settlement Agreement. See Decl. of Saralisa C.

Brau (“Brau Decl.”) ¶ 7. According to Mr. Sunshine, Mr. Meier telephoned him on March 13,

2009 and reiterated that Watson should consider relinquishing its marketing exclusivity and

stated that failure to relinquish would likely cause the FTC “Front Office” to reopen the

modafinil investigation. Sunshine Decl. ¶ 17. Mr. Meier also told Mr. Sunshine that he was in

contact with a third-party generic company and inquired whether Watson would be open to

communicating with them. Id. ¶ 18. Mr. Sunshine indicated that Watson would be interested

and identified Watson’s General Counsel, David Buchen, as the appropriate contact person.

FTC’s Interrog. Resp. at 9. The FTC then contacted Apotex’s Vice President to inform him of

Watson’s interest and gave him Mr. Buchen’s contact information. Id. at 10. Apotex

subsequently contacted Watson to discuss a possible agreement whereby Watson would

5
relinquish its exclusivity to bring generic modafinil to market. Sunshine Decl. ¶ 18.

The FTC claims that it did not “broker a deal” between Watson and Apotex and that it

played no further role in the discussions between the two companies. See FTC’s Interrog. Resp.

at 10. However, the FTC did periodically follow up with Apotex to inquire about the status of

the discussions with Watson. Id. On May 6, 2009, Apotex told the FTC that discussions with

Watson had stalled and that Watson did not appear to be interested in pursuing a deal. Id.; Brau

Decl. ¶ 10. The FTC became concerned that the reason Watson was not pursuing a potentially

profitable business deal was because its 2006 Settlement Agreement with Cephalon restricted

Watson’s right to relinquish, and FTC believes that such an agreement would be unlawful. See

Brau Decl. ¶¶ 5-7, 11. On May 19, 2009, the FTC issued civil investigative demands (“CID”) to

Watson and Carlsbad and a subpoena ad testificandum to David Buchen. Sunshine Decl. ¶ 19.

The CIDs sought to determine, inter alia, whether Watson is a party to any agreement that limits

its ability to relinquish any marketing exclusivity rights it may have with respect to generic

Provigil. Brau Decl. ¶ 12; Pet. Ex. 4(F) (CID issued to Watson on May 19, 2009). Watson

provided responses to the CID, and David Buchen appeared before the FTC in an investigational

hearing held on June 25, 2009.

The FTC issued a subpoena ad testificandum to Respondent on May 22, 2009, but it later

withdrew that subpoena and issued a new one on July 22, 2009. See Pet. Ex. 3 (Subpoena Ad

Testificandum issued to Paul Bisaro on July 22, 2009). Respondent filed a petition to quash the

subpoena, and on April 2, 2010, the FTC issued an order denying the petition and ordering

Respondent to appear for an investigational hearing on April 15, 2010. See Pet. Ex. 7 (FTC

Order of April 2, 2010). On April 27, 2010, the FTC filed with this Court its Petition for an

6
Order Enforcing Administrative Subpoena Ad Testificandum. On May 22, 2010, Respondent

filed his opposition to the Petition, along with a motion to compel discovery from the FTC

regarding the purpose for issuing the subpoena. See Docket Nos. [13], [16]. This Court

subsequently referred the Petition to Magistrate Judge Alan Kay for a report and

recommendation.

C. Magistrate Judge Kay’s Report & Recommendation

Before he could address the merits of the FTC’s Petition, Magistrate Judge Kay had to

resolve Respondent’s motion to compel the FTC to produce discovery relating to its purpose for

issuing the subpoena. On July 13, 2010, Magistrate Judge Kay issued a [31] Memorandum

Order granting-in-part and denying-in-part the motion to compel, rejecting Respondent’s request

to depose Mr. Meier but compelling the FTC to answer Respondent’s First Set of Interrogatories.

Magistrate Judge Kay acknowledged that discovery in a subpoena enforcement proceeding is

only warranted in extraordinary circumstances, but he determined that based on the facts in the

record, Respondent had made a colorable claim that the FTC exceeded its authority by using its

investigative power to pressure Watson into a business deal that the FTC considers desirable.

See [31] Mem. Order at 7-9. Following this discovery, both parties supplemented the record.

On August 17, 2010, Magistrate Judge Kay issued his Report & Recommendation based

on the supplemented record. Magistrate Judge Kay found that the information the FTC seeks

from Respondent is relevant and not unreasonably duplicative of what it already possesses.

Magistrate Judge Kay also concluded that Respondent’s status as the CEO and President of

Watson does not immunize him from being deposed. Furthermore, he found that although

Respondent had previously made a colorable showing that the FTC had acted outside its

7
authority, the supplemented record did not establish that the FTC had conducted its investigation

for an improper purpose, issued the subpoena to harass Respondent, or shared confidential

information about Watson with unauthorized parties. Accordingly, Magistrate Judge Kay

recommended that this Court grant the FTC’s Petition.

On August 31, 2010, Respondent filed his Objections to the Report & Recommendation,

presenting three arguments as to why the Petition should be denied: (1) an agency cannot

establish a prima facie case for enforcement of a subpoena when the only information the agency

seeks is already within its possession; (2) a court may not enforce an administrative subpoena

that is issued for the improper purpose of pressuring a company to relinquish statutory rights just

because there is a facially proper purpose for the subpoena; and (3) enforcement of the subpoena

would amount to an abuse of process because (a) the subpoena was issued to pressure Watson to

relinquish its rights in order to partner with Apotex to bring generic modafinil to market and (b)

the FTC improperly shared confidential information relating to Watson with third parties to

further its attempt to broker a business deal beyond its statutory mission. The FTC filed a

memorandum in response, and Respondent filed a reply.

II. LEGAL STANDARD

Like many federal agencies, the Federal Trade Commission has authority to issue

subpoenas to compel the testimony of witnesses in the course of an investigation. See 15 U.S.C.

§ 49 (“[T]he Commission shall have power to require by subpoena the attendance and testimony

of witnesses and the production of all such documentary evidence relating to any matter under

investigation.”). “It is well established that a district court must enforce a federal agency’s

investigative subpoena if the information sought is reasonably relevant—or, put differently, not

8
plainly incompetent or irrelevant to any lawful purpose of the [agency]—and not unduly

burdensome to produce.” FTC v. Invention Submission Corp., 965 F.2d 1086, 1089 (D.C. Cir.

1992) (internal citations and quotation marks omitted). An agency’s own appraisal of relevancy

must be accepted so long as it is not “obviously wrong.” Id. at 1089; see also FTC v. Texaco,

Inc., 555 F.2d 862, 874 (D.C. Cir 1977) (en banc) (“[T]he relevance of the agency’s subpoena

requests may be measured only against the general purposes of its investigation.”).

The Supreme Court has found the FTC’s investigatory function to be comparable to that

of the grand jury, which “can investigate merely on suspicion that the law is being violated, or

even just because it wants assurance that it is not.” United States v. Morton Salt Co., 338 U.S.

632, 642 (1950); see also FTC v. Carter, 636 F.2d 781, 786 (D.C. Cir. 1980) (“[T]he

Commission is not limited by ‘forecasts of probable result of the investigation,’ nor is the district

court ‘free to speculate about the possible charges that might be included in a future complaint.’”

(quoting FTC v. Texaco, 555 F.2d at 874-76)). A district court may “impose reasonable

conditions and restrictions with respect to the production of the subpoenaed material if the

demand is unduly burdensome.” Texaco, 555 F.2d at 881. However, “[b]roadness alone is not

sufficient justification to refuse enforcement of a subpoena.” Id. at 882. “[C]ourts have refused

to modify investigative subpoenas unless compliance threatens to unduly disrupt or seriously

hinder normal operations of a business.” Id. at 881.

The Supreme Court has recognized, however, that when administrative agencies seek the

aid of the courts in enforcing investigative powers, courts should not permit their process to be

abused. In United States v. Powell, 379 U.S. 59 (1964), a case involving an administrative

summons issued by the Internal Revenue Service, the Court explained that “[s]uch an abuse

9
would take place if the summons had been issued for an improper purpose, such as to harass the

taxpayer or put pressure on him to settle a collateral dispute, or for any other purpose reflecting

on the good faith of the particular investigation.” 379 U.S. at 58. The Court explained that the

burden of showing an abuse of process is on the party challenging the agency’s process. Id. The

Powell Court analogized the IRS’s authority to that of the FTC, and the federal courts have

recognized that the “improper purpose” defense applies to investigatory subpoenas issued by

other federal agencies. See, e.g., Fed. Election Comm’n v. Comm. to Elect Lyndon La Rouche,

613 F.2d 849, 862 (D.C. Cir. 1979) (reciting the standard with respect to subpoenas issued by the

Federal Election Commission).

Respondent argues that Powell requires an agency to establish “that the information

sought is not already within [its] possession.” Powell, 379 U.S. at 57-58. However, this

requirement is best understood as originating from § 7605(b) of the Internal Revenue Code,

which explicitly protects a taxpayer from being subjected to “unnecessary examination or

investigations.” See 26 U.S.C. § 7605(b). Therefore, it is doubtful that Powell puts the burden

of proof on any agency other than the IRS to establish that the information sought is not already

within its possession. Nevertheless, if it is clear that the agency already possesses the

information it seeks, the Court may find the agency is abusing its process by acting in bad faith or

with an improper purpose.

III. DISCUSSION

Respondent objects to both the legal standard applied by Magistrate Judge Kay and his

conclusion that the FTC issued the subpoena for a proper purpose. Specifically, Respondent

argues that (1) there is no basis for enforcing the subpoena because the FTC already has the

10
information it seeks in its possession; (2) the FTC may not enforce a subpoena that is issued for

an improper purpose even if there is also some other legitimate purpose for the subpoena; and (3)

the enforcement of the subpoena would be an abuse of process because the record clearly shows

that the FTC did not issue the subpoena for a valid purpose and that the FTC improperly shared

confidential information about Watson to further an improper purpose. The Court shall address

these arguments below, beginning with its contention that the FTC already possesses the

information it seeks to obtain through its subpoena.

A. The FTC’s Knowledge Regarding Watson’s Agreements About Exclusivity

Respondent argues that the subpoena should not be enforced because the FTC already has

a definitive answer from Watson regarding its agreements with Cephalon about its right to

relinquish any exclusivity rights it may have. The FTC disputes this, claiming that the answers

given by Watson and Mr. Buchen are inconsistent and incomplete.

The Court need not wade through the parties’ discovery exchanges in detail because the

FTC is not required to prove that Respondent possesses some unique personal knowledge in

order to subpoena his testimony. As the Supreme Court explained in Morton Salt Co., the FTC’s

investigatory power is analogous to that of the grand jury, and it may take steps to inform itself as

to whether there is a probable violation of the law. See 338 U.S. at 642-43. As the CEO and

President of Watson, Respondent is in a position likely to possess relevant information, and the

FTC may properly seek his testimony to determine what he knows and what he does not.

Moreover, there is evidence in the record suggesting that Respondent does have personal

knowledge about information relevant to the FTC’s investigation. The record demonstrates that

Respondent was involved in conversations with Mr. Buchen regarding a possible deal with

11
Apotex. See Pet’r’s Reply, Suppl. Ex. 5 (Investigational Hr’g Tr.) at 37. Therefore, it is

plausible that Respondent possesses information relevant to the relinquishment issue that is the

subject of the investigation. If this were a civil action, the FTC would clearly have authority to

depose Respondent in order to determine whether or not he knows anything about this issue. The

scope of the FTC’s investigative powers is no less broad than the scope of discovery permissible

under the Federal Rules of Civil Procedure. Cf. Okla. Press Publ’g Co. v. Walling, 327 U.S. 186,

216 & n.55 (1946) (comparing a federal agency’s investigative function to that of the federal

courts in issuing discovery orders).

Nevertheless, Respondent argues that “the only information that the [FTC] itself claims it

needs is indisputably already within the agency’s possession.” Resp’t’s Objections at 1. The

record, however, is not so crystal clear. The FTC is seeking to determine whether Watson chose

not to partner with Apotex because it has a potentially unlawful agreement with Cephalon. In

Watson’s response to the FTC’s CID, Watson identified the 2006 Settlement Agreement as an

agreement that “may relate” to Watson’s ability to relinquish exclusivity, but it failed to identify,

as requested by the FTC, “[t]he portion(s) of the agreement that prohibit or limit Watson or

Carlsbad’s ability to relinquish.” See Resp’t’s Opp’n, Ex. R (Watson’s Responses to May 22,

2009 CID) at 5. In response to the FTC’s follow-up inquiry, Watson supplemented its response

by asserting that the 2006 Settlement Agreement speaks for itself and chiding the FTC for failing

to investigate the scope of the agreement sooner. See Pet’r’s Reply, Suppl. Pet. Ex. 4 (June 17,

2009 response letter to FTC) at 2. When Mr. Buchen testified before the FTC, he declined (on

advice of legal counsel) to answer questions regarding whether the 2006 Settlement Agreement

restricts in any way Watson’s right to relinquish. See Pet’r’s Reply, Suppl. Pet. Ex. 5

12
(Investigational Hr’g Tr.) at 50-51. Mr. Buchen also testified that there were non-privileged

bases for not pursuing an agreement with Apotex—reasons that had not been disclosed in

response to the FTC’s earlier inquiries. See id. at 33-36. Although Mr. Buchen has now

provided the FTC with a less equivocal declaration stating that the 2006 Settlement Agreement

does not restrict Watson’s right to relinquish, see Resp’t’s Suppl. Br., Decl. of David A. Buchen,

the FTC is not required to rely on this declaration as conclusive proof on this issue. The Court

agrees with Magistrate Judge Kay that it must defer to the FTC’s judgment as to whether further

testimony from Respondent will aid its investigation. See R&R at 10 (“To the extent that the

FTC still believes that Mr. Bisaro may have information relevant to its investigation and not

already in the FTC’s possession, it is proper for it to take Mr. Bisaro’s testimony.”).

It is true that courts may modify a subpoena in cases where the request is “unduly

burdensome.” See Texaco, 555 F.2d at 882 (“We emphasize that the question is whether the

demand is unduly burdensome or unreasonably broad.”). However, the Court is not persuaded

that the burden on Respondent in this case is undue. Respondent has argued that the Court

should apply the “apex” doctrine to preclude the deposition of a high-ranking official unless the

requesting party can demonstrate he has personal knowledge of relevant information that cannot

be obtained through other means. See Resp’t’s Objections at 26 n.6 (citing Thomas v. IBM, 48

F.3d 478, 483 (10th Cir. 1995)). Magistrate Judge Kay correctly noted that this doctrine has very

limited application and that Respondent has failed to identify any cases in which it was applied in

an administrative investigation. See R&R at 10. Moreover, Respondent has failed to

demonstrate that compliance with the subpoena—which merely requires him to testify at a

hearing or deposition before the FTC in Washington, D.C.—would be burdensome at all, let

13
alone unduly so. Therefore, the Court overrules Respondent’s objection and adopts Magistrate

Judge Kay’s conclusion that the FTC may subpoena Respondent to testify despite the fact that

Mr. Buchen has already provided a direct answer to the FTC’s central question.

B. The Improper Purpose Defense

Respondent argues that Magistrate Judge Kay both applied the wrong legal standard and

wrongly discounted evidence that the FTC issued the subpoena for an improper purpose.

Because this Court must review the record de novo, the Court shall not parse the Report &

Recommendation to determine the extent to which the alleged errors are legal or factual in

nature. Rather, the Court shall discuss the facts in the record and make an independent legal

conclusion as to whether the FTC issued the subpoena for an improper purpose.

The FTC contends that the subpoena was issued as part of a legitimate investigation into

whether the 2006 Settlement Agreement contained any anticompetitive provisions restricting

Watson’s ability to relinquish its exclusivity rights. Respondent disputes this, arguing that the

real purpose behind the subpoena (and the investigation as a whole) was to coerce Watson to

relinquish its exclusivity rights and partner with Apotex to bring generic modafinil to market.1

Based on Mr. Meier’s statements to Mr. Sunshine on the telephone on March 13, 2009, the Court

can certainly understand why Respondent believes this to be the case, and Magistrate Judge Kay

agreed that the initial record was sufficient to warrant the extraordinary step of allowing limited

discovery into the FTC’s basis for the investigation. However, the evidence that has been

produced by the FTC as a result of that discovery demonstrates that the subpoena was not issued

1
The Court assumes without deciding that the FTC has no legitimate authority to use its
investigatory power for such a purpose.

14
for the reason that Respondent believes.

The declarations and verified interrogatory answers submitted by FTC officials clearly

indicate that the FTC reopened its modafinil investigation in January 2009 once it learned of

Watson’s supplemental ANDA for the ’346 patent—not in response to Watson’s subsequent

reluctance to enter into an agreement with Apotex. Therefore, the fact that the FTC allegedly

threatened to “reopen” its investigation during a March 2009 telephone call does not show that

the FTC’s investigation was motivated by an improper purpose. Respondent attempts to cast

doubt on the agency’s declarations by pointing out that the FTC never communicated its

concerns about the 2006 Settlement Agreement with Watson until it raised the prospect of a

reopened investigation in March 2009. However, “until evidence appears to the contrary,

agencies are entitled to a presumption of regularity and good faith.” FTC v. Owens-Corning

Fiberglas Corp., 626 F.2d 966, 975 (D.C. Cir. 1980). There is no basis in the record for

disbelieving the FTC’s explanation that it reopened its modafinil investigation in January 2009,

before it began talking to Apotex and Watson.

Respondent also points to the fact that the FTC had communications with Apotex prior to

contacting Watson about a potential business deal in which the FTC and Apotex discussed, inter

alia, what it would take Apotex to launch a generic version of Provigil in the United States. See

FTC’s Interrog. Resp. at 9. However, the FTC has explained that the purpose of this discussion

was to help the investigatory staff understand the regulatory significance of the ’346 patent and

how it might affect the market for generic modafinil. See id. at 8. Respondent argues that the

record shows that the FTC conceived of the potential deal with Apotex and acted as an

intermediary to bring the parties together. However, while the FTC facilitated contact between

15
the two companies, the FTC credibly explains that it did so as a part of its investigative process

to determine whether Watson was open to the possibility of relinquishing its exclusivity rights,

which the FTC believed was in its economic interest. The FTC disavows any intent to broker a

deal, and the record does not clearly show that the FTC took any actions to coerce either party to

enter into such an agreement. Respondent relies heavily on the FTC’s concession that the

modafinil investigation continued as a result of Watson’s failure to reach an agreement with

Apotex. However, this is hardly surprising, as the purpose of the FTC’s investigation was to

determine whether Watson had any agreement affecting its exclusivity rights. If Watson had

made a deal with Apotex to bring generic Provigil to market in the United States, the FTC’s

investigation naturally would have terminated because it would know that Watson did not have

any such anticompetitive agreement. Therefore, this fact does not support a finding that the

subpoena was issued for an improper purpose.

Respondent also argues that the FTC must have issued the subpoena for an improper

purpose because it was issued after Watson had already explained to the FTC that its Settlement

Agreement with Cephalon did not preclude Watson from relinquishing its exclusivity rights and

after Mr. Buchen testified that there were legitimate business reasons for not pursuing a deal with

Apotex. However, as explained in the previous section, Watson’s responses to the FTC’s initial

inquiries were somewhat evasive and inconsistent, and the FTC reasonably determined that

further investigation was necessary to determine the veracity of Watson’s position. Respondent

also relies on the fact that the FTC was continuing to communicate with Apotex about the status

of a deal with Watson as late as July 15, 2009, the week before the subpoena was issued.

However, the timing of that communication is not circumspect in light of the ongoing status of

16
the FTC’s investigation. Respondent points to an email from Apotex’s Vice President indicating

that the FTC said it was investigating Watson because it refused to talk to Apotex. See Resp’t’s

Opp’n, Ex. H (July 15, 2009 email from S. Upadhye). However, that email merely reflects

Apotex’s understanding that the FTC was trying to determine why Watson was not interested in a

potentially profitable business deal—a legitimate subject of investigation given the FTC’s

concerns about the scope of the 2006 Settlement Agreement.

Lastly, Respondent argues that his clear lack of personal knowledge regarding the

Settlement confirms that the FTC issued the subpoena for an improper purpose. As the Court

explained above, there is evidence in the record suggesting that Respondent does have personal

knowledge about the reasons that Watson chose not to pursue a deal with Apotext, and the FTC

is entitled to depose Respondent in order to determine precisely what he knows rather than rely

on the statements of others.

The record shows, at best, that an FTC official made an inappropriate comment in the

context of a lawful investigation that suggested that the purpose of the FTC’s investigation was

to coerce Watson to enter into an agreement with Apotex. In fact, Watson may have felt that it

was under pressure from the FTC to reach some agreement with Apotex. However, the Court’s

inquiry is focused on purpose rather than effect, and the record as a whole does not support the

conclusion that the FTC initiated the investigation or issued the subpoena for an improper

purpose. Even if the Court could conclude that Mr. Meier had an improper purpose in making

his comments on the telephone to Watson’s counsel, that alone would not establish an abuse of

process with respect to the subpoena, which was issued several months later. See Carter, 636

F.2d at 789 (“[E]ven if an improper purpose by an agency or member of the staff is shown,

17
enforcement of the subpoena is called for so long as proper purposes exist as well.”).

Respondent attempts to buttress his improper purpose argument by claiming that the

record shows that the FTC improperly disclosed confidential information about Watson’s first-

filer status to Apotex in the course of its investigation. However, the Court agrees with

Magistrate Judge Kay’s conclusion that “there is nothing beyond slight inferences and strong

accusations to show that the FTC divulged confidential information.” R&R at 12. Respondent

relies primarily on two facts in the record to support its claim: (1) the FTC used hypothetical

scenarios in the course of its investigation causing inferences to be drawn by the recipients; and

(2) an email from Apotex’s Vice President suggests that the FTC confirmed to Apotex that

Watson was “mum about deal making,” a fact that Respondent claims could only have been

learned through its confidential investigation of Watson.

With respect to the use of hypothetical scenarios, Respondent points to the FTC’s

admission that FTC staff posited hypothetical scenarios to Watson “to determine if Watson could

profit from relinquishment of any modafinil marketing exclusivity for which it might be eligible,

including scenarios where Watson relinquished any such exclusivity to potential new entrants

into the market.” See FTC’s Interrog. Resp. at 9. Respondent argues that because the FTC posed

hypothetical questions suggesting that Watson had marketing exclusivity and then put it contact

with Apotex for a potentially profitable deal, the only logical inference that could be drawn was

that Watson had marketing exclusivity. However, FTC officials have explicitly denied that they

disclosed any confidential information in the course of the investigation. See FTC’s Interrog.

Resp. at 5, 11; Decl. of Richard Feinstein ¶¶ 14. As a practical matter, the Court understands that

18
although the FTC’s investigation is nonpublic, the agency cannot solicit information from market

participants in a vacuum; hypothetical questions are an investigatory tool that agencies utilize to

get answers to questions without explicitly disclosing underlying facts, which may be

confidential. See Decl. of Richard Feinstein ¶¶ 6-9 (describing the FTC’s use of hypothetical

questions). The fact that Watson could draw the correct inference from the nature of the FTC’s

questioning does not establish that the FTC improperly disclosed confidential information.

Respondent also argues that an email in the record from Apotex’s Vice President dated

July 15, 2009, “leads to the inescapable inference that the FTC was discussing with Apotex

information obtained from Watson in its supposedly nonpublic investigation.” See Objections at

37; Resp’t’s Opp’n, Ex. H (July 15, 2009 email from S. Upadhye). However, the language in the

email is not so clear. The pertinent language reads, “In my call with FTC enforcement this

morning, I indicated and he confirmed that Watson is just mum about deal making. The reason

for silence truly evades us and FTC.” Resp’t’s Opp’n, Ex. H. It is unclear exactly what

inference should be drawn from this statement; it is plausible that the FTC merely told Apotex

that Watson had not informed it of any deal and that the FTC does not know why it would not

pursue one. Such a statement would not necessarily disclose the existence of an investigation.

Respondent makes much of the fact that Mr. Buchen had already informed the FTC of Watson’s

reasons for discontinuing discussions with Apotex, see Resp’t’s Reply in Supp. of Obj. at 16, but

that would seem only to confirm that the FTC did not share information learned during its

investigation with Apotex.

Ultimately, the record as a whole does not establish that the FTC disclosed confidential

information relating to Watson in the course of its investigation. The evidence relied on by

19
Respondent is inconclusive and directly rebutted by sworn declarations by agency officials.

Accordingly, the Court finds that the FTC did not issue the subpoena ad testificandum to

Respondent for an improper purpose, and it would not be an abuse of process to issue an order

enforcing the subpoena.

IV. CONCLUSION

Having reviewed the record as a whole de novo, the Court finds that the subpoena ad

testificandum issued to Respondent by Petitioner Federal Trade Commission is relevant to a valid

investigation, not unreasonably duplicative, and not issued for an improper purpose. Therefore,

the Court overrules Respondent’s Objections and adopts Magistrate Judge Kay’s [35] Report &

Recommendation insofar as it is not inconsistent with this Memorandum Opinion. The Court

shall GRANT the FTC’s [3] Petition for an Order Enforcing Administrative Subpoena Ad

Testificandum and issue an order enforcing the subpoena. An appropriate Order accompanies

this Memorandum Opinion.

/s/
COLLEEN KOLLAR-KOTELLY
United States District Judge

20