Amphastar Pharm., Inc. v. Momenta Pharm., Inc., Civil Action No. 16–10112–NMG

• Decision Date: 01 June 2018
• Docket Number: Civil Action No. 16–10112–NMG
• Citation: 313 F.Supp.3d 366
• Parties: AMPHASTAR PHARMACEUTICALS, INC. and International Medication Systems, Ltd., Plaintiffs, v. MOMENTA PHARMACEUTICALS, INC. and Sandoz Inc., Defendants.
• Court: U.S. District Court — District of Massachusetts

313 F.Supp.3d 366

AMPHASTAR PHARMACEUTICALS, INC. and International Medication Systems, Ltd., Plaintiffs,

v.MOMENTA PHARMACEUTICALS, INC. and Sandoz Inc., Defendants.

Civil Action No. 16–10112–NMG

United States District Court, D. Massachusetts.

Signed June 1, 2018

Alan D. Rose, Sr., Rose, Meredith Wilson Doty, Michael L. Chinitz, Chinitz & Rose, Boston, MA, Chul Pak, Pro Hac Vice, Jeffrey C. Bank, Pro Hac Vice, Wilson Sonsini Goodrich and Rosati PC, New York, NY, Seth C. Silber, Pro Hac Vice, Wilson Sonsini Goodrich and Rosati LLP, Washington, DC, for Plaintiffs.

Julia Jill Bredrup, Michael J. Proctor, Caldwell Leslie and Proctor PC, Kimberly Kisabeth Chemerinsky, Alston and Bird LLP, Los Angeles, CA, Michael L. Keeley, Pro Hac Vice, Bradley D. Justus, Pro Hac Vice, Daniel K. Oakes, Pro Hac Vice, Richard B. Dagen, Pro Hac Vice, Axinn, Veltrop & Harkrider, LLP, Thomas P. Steindler, McDermott Will & Emery LLP, Washington, DC, Daniel C. Winston, Pro Hac Vice, Diane Seol, Pro Hac Vice, Diane Seol, Pro Hac Vice, Greta A. Fails, Irene Oberman Khagi, Robert M. Buchanan, Jr. Pro Hac Vice, Robert S. Frank, Jr., Pro Hac Vice, Sophie F. Wang, Pro Hac Vice, Choate, Hall & Stewart, Joshua N. Ruby, Brendan T. St. Amant, T. Christopher Donnelly, Donnelly, Conroy & Gelhaar, LLP, Melissa Nott Davis, White and Williams LLP, Boston, MA, Jason T. Murata, Pro Hac Vice, Jeremy C. Lowe, Pro Hac Vice, Thomas G. Rohback, Pro Hac Vice, Axinn, Veltrop & Harkrider LLP, Hartford, CT, Varnitha Siva, Pro Hac Vice, Xianxiao Liu, Pro Hac Vice, Axinn, Veltrop & Harkrider LLP, New York, NY, D. Andrew Hatchett, Matthew D. Kent, Pro Hac Vice, Michael P. Kenny, Pro Hac Vice, Teresa T. Bonder, Pro Hac Vice, Alston & Bird LLP, Atlanta, GA, for Defendants.

MEMORANDUM & ORDER

GORTON, J.

This is an antitrust case in which plaintiffs Amphastar Pharmaceuticals, Inc. ("Amphastar Pharmaceuticals") and International Medication Systems, Ltd. ("IMS")(collectively, "Amphastar" or "plaintiffs") allege that defendants Momenta Pharmaceuticals, Inc. ("Momenta Pharmaceuticals") and Sandoz Inc. ("Sandoz")(collectively, "Momenta" or "defendants") restricted trade and prevented competition in the manufacture and sales of the generic drug enoxaparin

.

Pending before the Court is Momenta's motion for certification of an interlocutory appeal (Docket No. 159). For the following reasons, that motion will be denied.

I. Procedural Background

This case has followed a long and protracted road to this point. This action was filed in the Central District of California in September, 2015. In December, 2015, Momenta filed a motion to dismiss and a separate motion to transfer the case to the District of Massachusetts based upon "substantial overlap" of issues, claims, witnesses and evidence between the instant case and the prior patent action in this Court. The District Court for the Central District of California allowed the motion to transfer and the case was assigned to this session in January, 2016. Amphastar filed a writ of mandamus to the Ninth Circuit Court of Appeals ("the Ninth Circuit") to revoke the transfer on personal jurisdiction grounds and the Ninth Circuit denied that petition in May, 2016.

In July, 2016, this Court allowed Momenta's motion to dismiss on the grounds that Amphastar's claims were precluded by the Noerr–Pennington doctrine. Amphastar appealed that order to the First Circuit Court of Appeals ("the First Circuit") which reversed the order and remanded the case, directing this Court to consider defendants' alternative arguments for dismissal. In March, 2018, after careful consideration of those arguments, this Court denied defendants' motion to dismiss.

In April, 2018, defendants filed the pending motion for certification of an interlocutory appeal, seeking a (second) review by the First Circuit of this Court's disposition of their motion.

II. Motion for Certification of an Interlocutory Appeal

A. Legal Standard

District courts may certify an otherwise non-appealable order for interlocutory review by the Court of Appeals if the order 1) involves a controlling question of law 2) as to which there are grounds for a substantial difference of opinion and 3) an immediate appeal would materially advance the ultimate termination of the litigation. 28 U.S.C. § 1292(b) ; Caraballo–Seda v. Municipality of Hormigueros, 395 F.3d 7, 9 (1st Cir. 2005). The First Circuit has emphasized that interlocutory certification "should be used sparingly and only in exceptional circumstances". Caraballo–Seda, 395 F.3d at 9. Generally, the First Circuit will not certify interlocutory appeals from a denial of a motion dismiss. Id. Interlocutory appeals may be necessary, however, "in long-drawn-out cases, such as antitrust and conspiracy cases." Milbert v. Bison Lab., 260 F.2d 431, 433 (3d Cir. 1958) (citing House Report No. 1667, 85 Cong. 2d Sess., pp. 1, 2).

B. Application

Momenta contends that interlocutory review is appropriate here to resolve two controlling questions of law. Momenta submits that the First Circuit has not yet considered (1) whether antitrust liability in the standard-setting context requires that the alleged misconduct cause the standard-setting organization to eliminate alternative technologies and (2) whether antitrust plaintiffs must allege that the standard-setting organization would not have adopted the patented technology but for the defendant's misrepresentation.

Amphastar disputes whether there is a difference of opinion on a controlling question of law. It asserts that the allegations in the complaint are consistent with well-established precedent that deception before a standard-setting organization which leads to the exclusion of competitors can form the basis for antitrust liability. Amphastar emphasizes that (1) the question of whether or not the adoption of the 207 Method by the United States Pharmacopeial Convention ("USP") represented a mandatory method is a factual dispute not appropriate for resolution at the motion to dismiss stage and (2) Momenta's second proposed question on causation is also fact-intensive because it depends on the existence of alternative technologies in the marketplace.

Certification of an interlocutory appeal from a denial of a motion to dismiss is disfavored in the First Circuit. Caraballo–Seda, 395 F.3d at 9 (citing In re Heddendorf, 263 F.2d 887, 889 (1st Cir. 1959) (noting a general preference...