Replies to post #101746 on Biotech Values

[zipjet]

The interesting part of the irreparable harm issue is that both SNY and Sandoz can reasonably claim they would be IH'ed. That is a wash, in my book. But there is also harm to the public and health care system in higher costs if the competition is stopped.

I did not see "unclean hands" [UC] argued against SNY. I would think that is available in an action for TRO/PI. And in this case the UC, namely the fraud upon the Patent Office*, has already been litigated and established through the CoA.

ij



* The fact was recited.

[mouton29]

Actually, the argument is not so long, here it is:

Sanofi Has Not Demonstrated Irreparable Injury

Sanofi asserts that it would suffer “substantial and irreparable” losses in the absence of
preliminary relief, Reply at 18, but does not even attempt to demonstrate that its financial harm
would cause it severe hardship or threaten its existence, as required by Wisconsin Gas Co. v.
FERC, 758 F.2d 669, 674 (D.C. Cir. 1985) and Gulf Oil Corp. v. Dep’t of Energy, 514 F. Supp.
1019, 1026 (D.D.C. 1981) and their progeny. Rather than attempt such a showing – which it
cannot make, given its substantial size and diverse product line9 – Sanofi argues that Wisconsin
Gas does not apply because FDA has sovereign immunity that precludes Sanofi from recovering
its losses from the government. Reply at 19-20. But, as set forth at length in the government’s
opening brief, even irrecoverable economic harm will not rise to the level of irreparable harm
unless it is so substantial as to cause extreme hardship to the plaintiff’s business or threaten its
existence.10

Sanofi cites cases suggesting that any loss that is irrecoverable due to sovereign immunity
is per se irreparable. Reply at 20-21. If that were the standard, however, it would eviscerate any

{footnotes]
9 As noted in the government’s opening brief, Sanofi is a global pharmaceutical giant
with annual worldwide revenue of approximately $40 billion. Its domestic sales of Lovenox
account for only a small portion of that revenue, and Sanofi has conceded that generic
competition in the United States would not have an appreciable long-term impact on the
company. See Br. at 40-42.
10 See, e.g., Gulf Oil Corp. v. Dep’t of Energy, 514 F. Supp. 1019, 1026 (D.D.C. 1981);
Sandoz, Inc. v. FDA, 439 F. Supp. 2d 26, 32 (D.D.C. 2006) (noting that “[t]o successfully
shoehorn potential economic loss into the irreparable harm requirement, a plaintiff must establish
that the economic harm is so severe as to ‘cause extreme hardship to the business’ or threaten its
very existence.”); Mylan Laboratories, Inc. v. Leavitt, 484 F. Supp. 2d 109, 123 (D.D.C. 2007);
Astellas Pharma. US, Inc. v. FDA, 642 F. Supp. 2d 10, 22 (D.D.C. 2009) (“it is well-settled that
economic loss alone will rarely constitute irreparable harm”); Hi-Tech Pharmacal Co., Inc. v.
FDA, 587 F. Supp. 2d 1, 11 (D.D.C. 2008) (“In this jurisdiction, harm that is ‘merely economic’
in character is not sufficiently grave under this standard.”); Coal. for Common Sense in Gov’t
Procurement v. United States, 576 F. Supp. 2d 162, 168-69 (D.D.C. 2008) (finding that “degree
of harm” asserted by coalition of pharmaceutical manufacturers did not approach “the level
required in this case (i.e. so severe as to cause extreme hardship to the business or threaten the
very existence of Coalition members”)); Apotex v. FDA, No. 06-0627, 2006 WL 1030151
(D.D.C. Apr. 19, 2006) at * 17 (where plaintiff did not establish that lost sales and market share
would cause “extreme hardship” to company, claim of harm fell “well short of the serious,
irretrievable damage to its business required to warrant a preliminary injunction”); Sociedad
Anonima Vina Santa Rita v. Dep’t of Treasury, 193 F. Supp. 2d 6, 14 (D.D.C. 2001) (“financial
harm alone cannot constitute irreparable injury unless it threatens the very existence of the
movant’s business”).
[end of footnotes]

requirement that the plaintiffs demonstrate anything other than a nominal degree of loss, and
would fly in the face of the requirement to demonstrate any meaningful “irreparable” harm. Nor
do those cases express the prevailing view in this circuit, as noted above. Indeed, the only
significance of sovereign immunity is that it means the plaintiff would not be able to recover its
financial losses. But, the weight of authority in this circuit holds that such irrecoverable losses
must nevertheless be of sufficient magnitude in comparison to the size of the business to cause a
severe impact or even threaten its existence. See, e.g., supra n.10. Further, as Coalition for
Common Sense makes clear, courts in this circuit have not hesitated to deny injunctive relief
where plaintiff did not meet the standard of irreparable harm, notwithstanding the court’s express
recognition that the losses were irrecoverable due to sovereign immunity. 576 F. Supp. 2d at 169
n.3.
In any event, the cases cited by Sanofi do not even purport to follow the “per se”
irreparable harm standard that they articulate. In Feinerman v. Bernardi, 558 F. Supp. 2d 36, 51
(D.D.C. 2008), the court stated that any loss of income from a loss that is irrecoverable due to
sovereign immunity is per se irreparable, citing a Second Circuit decision, U.S. v. New York, 708
F.2d 92, 93-94 (2d Cir. 1983). But the court’s own decision makes clear that it was not applying
a per se standard, but relied on the finding that the plaintiff’s claimed losses implicated forty
percent of its business. Feinerman, 558 F. Supp. 2d at 50-51. In Smoking Everywhere, Inc. v.
FDA, 680 F. Supp. 2d 62, 77 n. 19 (D.D.C. 2010), appeal pending sub nom, Sottera, Inc., et al. v.
FDA, et al., No. 10-5032 (D.C. Cir.), the court repeated this standard, citing Feinerman, and
found irreparable harm because plaintiff’s entire product line was at stake under FDA’s
regulatory decision. In Alf v. Donley, 666 F. Supp. 2d 60, 70 (D.D.C. 2009), although the court
similarly cited Feinerman’s “per se” irreparable harm standard, it failed to strictly apply that
standard because it evaluated the extent of the harm, the fact that plaintiff lost income (as
opposed to lost profits), and also considered other non-monetary factors. Thus, none of the cited
cases provide any justification to diverge from the prevailing line of cases requiring irreparable
injury to be, in fact, irreparable – a prerequisite that Sanofi wholly fails to meet.

III. The Balance of Harms and the Public Interest Weigh Against Preliminary
Injunctive Relief

For all of the reasons stated in FDA’s opposition brief, Sanofi has also failed to show that
any harm it may suffer in the absence of injunctive relief outweighs the potential harm to FDA
and the public. Br. at 44-45.