Replies to post #128033 on Biotech Values

[mouton29]

Submission by Amphastar. I have put lines in for page breaks and added "fn" before two footnotes for clarity but otherwise this just a cut and paste from the pacer document, as converted by OCR software.

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DEFENDANTS' REDACTED EXPARTE SUBMISSION IN CONNECTION WITH
THE ADOPTION OF THE TEMPORARY RESTRAINING ORDER
Pursuant to the Court's direction, Defendants Amphastar Phannaceuticals, Inc.
("Amphastar"), Intemational Medication Systems, Ltd. ("IMS"), and Watson Pharmaceuticals,
Inc. ("Watson") (collectively, "Defendants") respectfully provide the Court with this ex parte
submission in connection with the adoption ofthe temporary restraining order.!
The Court Did Not Make the Findings Required for Issuance ora Temporary Restraining
Order
The Supreme Court has held that preliminary injunctive relief should not issue absent
four factors: "A plaintiff seeking a preliminary injunction must establish that he is likely to
succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary
relief, that the balance of equities tips in his favor, and that an injunction is in the public
interest." Winter v. Natural Res. De! Council. inc., 555 U.S. 7, 20 (2008) (emphasis added); see
also Holmes Prods. v. Catalina Lighting, Inc., 67 F. Supp. 2d 10, 11·12 (D. Mass. 1999) (Gorton,
J.) (same). It is also well settled that "[t]he standard used by a district court considering a request

fnI Defendants intend to file publicly a redacted version of this submission, so that
Plaintiffs may review the non-confidential portions of the document.

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for a temporary restraining order is the same standard used for determining whether to issue a
preliminary injunction," Quincy Cab/csyslcms, Inc. v. Sully's Em; IIIC., 640 F. Supp. 1159, 1160
(D. Mass. 1986).
Federal Rule of Civil Procedure 52(a) requires the Coul1 to make findings of fact to
suppol1 the granting of preliminary relief. See. e.g., Conai,. Group. Inc. v. AulomalikApparateMoschillellbou
GmbH, 944 F.2d 862, 866 (Fed. Cir. 1991) (citation omitted). "These findings
must be 'sufficiently comprehensive and pertinent to the issue to form a basis for the decision.'''
Id. (quoting Oakley, Inc. v. Int'/ Ti·opic-Ca/. Inc., 923 F.2d 167, 168 (Fed. Cir. 1991). The
Federal Circuit has held that, without such findings, the circuit court "cannot conduct a
meaningful review and the injunction must be vacated." Id. (citation omitted).
At today's hearing on Plaintiffs' motion for a temporary restraining order, the Court
expressly stated that it was making no finding on likelihood ofsuccess on the merits.
Accordingly, Defcndants respectfully suggest that the Court's order has issued in error.
Issuance of a Bond for Harm to Amphastar

- REDACTED -

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- REDACTED -

Objections to Scope of Proposed Temporary Restraining Order

Although the Court indicated its intent to issue a temporary restraining order, and
Plaintiffs have submitted a proposcd order, Defendants respectfully request that any such order
be limited to the claims Plaintiffs actually allege have been infringed. Enjoining Defendants
from selling any enoxaparin product does not conform to the patent claims Plaintiffs have
asserted before this Court.

Plaintiffs' patent infringement claims are expressly limited to analytical testing methods
for enoxaparin. See Cmplt.; PIs.' Mem. at Exhs. A, a.2 Those claims relate to testing, not to the
manufacture of enoxaparin. Accordingly, a temporary restraining order going beyond enjoining
the use of the tests claimed in the Momenta patents is inappropriate in this case. See, e.g., Bayer
AG v. flousey Pharms., Inc., 340 F.3d 1367, 1377-78 (Fed. Cir. 2003) (granting motion to
dismiss and holding that a patent claiming research processes is not infringed by the manufacture
of a product). The proposed order submitted by Plaintiffs is thereforc ovcrbroad.

fn2 Plaintiffs allege infringement of claims I and 8 of the '466 patent and claims 6, IS, and
53 ofthe '886. Claim I of the '466 patent provides "A method for analyzing an enoxaparin
preparation, comprising..... Claim 8 of the 446 patent provides "A method of processing an
enoxaparin preparation, comprising..... Claim 6 of the '886 patent provides "A method for
analyzing an enoxaparin sample " Claim 15 orthe "886 patent provides "A method for
analyzing an enoxaparin sample " Claim 53 of the "886 patent provides "A method for
analyzing an enoxaparin sample "

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Dated: October 7, 2011
Anthony T. Pierce (admitted pro hac vice)
[e-mail]
Mark Mansour (admitted pro hac vice)
[e-mail]
Jonathan P. Robell (admitted pro hac vice)
[e-mail]
AKIN GUMP S1l\AUSS HAUER & Fan LLP
1333 New Hampshire Avenue NW
Washington, DC 20036
Telephonc: 202.887.4000
Facsimile: 202.887.4288
Respectfully submitted,
lsi Steven M. Bauer
Stcven M. Bauer (BBO No. 542531)
[e-mail]
PROSKAUER ROSE LLP
One lntcrnatianal Place
Boston. MA 02110
Telephone: [phone]
Facsimile: 617.526.9899
Jan P. Weir (admitted pro hac vice)
[e-mail]
STRADLING VacCA CARLSON &RAlffH
660 Newport Center Drive, Suite 1600
Ncwport Beach, CA 92660
Telephone: [phone]
Facsimile: 949.725.4100
Counsel/or Defendants Amphas/ar Pharmaceuticals. inc., International Medication Systems.
Lid., and Watson Pharmaceuticals, Inc.

[I have omitted the Certificate of Service]