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Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.

United States District Court, D. Massachusetts

May 9, 2016



Nathaniel M. Gorton United States District Judge.

This is a patent infringement case in which plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively, “Momenta” or “plaintiffs”) claim that defendants Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Actavis, Inc. and Watson Pharma, Inc. (collectively, “Amphastar” or “defendants”) infringed their patent during the course of defendants’ manufacture and sale of generic enoxaparin products.

The instant dispute concerns the amount of attorney’s fees and costs that Amphastar is to pay Momenta in connection with the imposition of sanctions ordered by a magistrate judge and confirmed by a district judge pursuant to Fed.R.Civ.P. 37(b)(2)(C). Pending before the Court is Momenta’s submission of attorney’s fees and costs (“the fee submission”). For the following reasons, the Court will award Momenta $343, 863 in fees and $8, 522 in costs.[1]

I. Background

A. Facts and procedural history

In July, 2010, after receiving approval from the United States Food and Drug Administration (“the FDA”), Momenta began to market the first generic version of Lovenox (otherwise known as enoxaparin) in the United States. Enoxaparin is an anticoagulant used to prevent blood clots. Momenta is the assignee of the ’886 patent, issued in August, 2009, which is directed at a set of manufacturing control processes that ensure that each batch of generic enoxaparin includes the individual sugar chains characteristic of Lovenox.

Amphastar received FDA approval to market its generic enoxaparin product in September, 2011. Momenta initiated this action two days later by filing a complaint alleging that Amphastar infringed the ‘886 patent by manufacturing generic enoxaparin for commercial sale using its patented methods.

In October, 2011, this Court allowed Momenta’s motion for injunctive relief by enjoining Amphastar from advertising, offering for sale or selling allegedly infringing enoxaparin products. That decision included the preliminary finding that the safe harbor provision in 35 U.S.C. § 271(e)(1) did not protect Amphastar’s infringing activities because it used the patented process to test products after it had already obtained FDA approval, such that the use was not “reasonably related to the development and submission of information” to the FDA.

The Federal Circuit vacated the grant of the preliminary injunction in August, 2012 and found that this Court applied “an unduly narrow interpretation” of the safe harbor provision. Momenta Pharm., Inc. v. Amphastar Pharm, Inc., 686 F.3d 1348, 1349 (Fed. Cir. 2012)(“Momenta I”). It explained that Amphastar’s post-approval use of the patented process to run quality control tests on its products fell within the scope of the safe harbor provision because its use generated information for records that Amphastar needed for continued FDA approval. Id. at 1357-61. It clarified that:

[T]he submissions are not routine submissions to the FDA, but instead are submissions that are required to maintain FDA approval . . . Amphastar is required by the FDA to use this test in order to ensure its enoxaparin is not adulterated. This testing, which generates information for submission pursuant to the Food, Drug, and Cosmetic Act, therefore falls squarely within the scope of the safe harbor.

Id. at 1358, 1361 (internal citations and quotation marks omitted).

Shortly thereafter, this Court stayed the case pending the completion of appellate proceedings and denied all outstanding motions without prejudice. The Federal Circuit denied Momenta’s petition for a hearing en banc in November, 2012.

This Court removed the stay in January, 2013 and Amphastar moved for summary judgment. In March, 2013, the Court allowed Momenta to re-file a motion to compel the production of testing documents and a motion for sanctions, both of which had been denied without prejudice at the time of the stay.

The United States Supreme Court denied Momenta’s petition for certiorari in June, 2013. Shortly thereafter this Court entered summary judgment in Amphastar’s favor, finding that its activities fell under the safe harbor provision and therefore did not infringe. The Court entered final judgment on Momenta’s infringement claims in January, 2014.

In November, 2015, the Federal Circuit vacated the grant of summary judgment with respect to that finding. Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610, 613 (Fed. Cir. 2015).[2] The Federal Circuit held that Amphastar’s post-approval use of the patented process to test its generic enoxaparin products was, in fact, a “routine” step in a commercial production process and thus not “reasonably related to the development and submission of information” to the FDA. Id. at 620. In doing so, it found that:

With the benefit of additional briefing in the current appeals, which reflects the full district court record developed by all parties after the preliminary injunction phase, we conclude Amphastar's submissions are appropriately characterized as “routine.”

Id. It also concluded that:

Although Momenta I held that post-approval studies can fall within the § 271(e)(1) safe harbor, 686 F.3d at 1359, whether such uses are reasonably related to a § 271(e)(1) submission requires more critical analysis in the post-approval context. The conclusion in Momenta I that Amphastar's commercial use of Momenta's patented method falls within the safe harbor of § 271(e)(1) would result in manifest injustice.

Id. at 621 (internal quotation marks omitted).

The Federal Circuit denied Amphastar’s petition for a hearing en banc in February, 2016. Amphastar informed the Court that it would file a petition for certiorari with the Supreme Court on or before May 17, 2016.

In March, 2016, the parties informed this Court of an outstanding issue in connection with a prior imposition of sanctions by the magistrate judge upon defendants for violating certain discovery-related orders.

B. The instant dispute

In December, 2013, Magistrate Judge Robert B. Collings imposed sanctions upon Amphastar after finding that it disobeyed his June 12, 2012 order (“the June 12th order”) and June 27, 2012 order (“the June 27th order”) by failing to produce 1) documents concerning its testing of certain batches of generic enoxaparin products, 2) unredacted copies of documents previously produced in redacted form and 3) a complete copy of all amendments to any Abbreviated New Drug Application (“ANDA”) filed by any defendant. He concluded that sanctions were warranted under Rule 37(b)(2)(C) and directed Momenta to submit

affidavits and other documents supporting the amounts which they claim as expenses, including reasonable attorney’s fees, caused by Amphastar’s violation of the Court’s June 12th and June 27th Orders (including the preparation and prosecution of the [re-filed motion for sanctions]) . . . .

Amphastar filed objections to the imposition of sanctions which this Court overruled in January, 2014.

Momenta filed a fee submission in December, 2013 which sought 1) $735, 209 in fees for work caused by Amphastar’s violations of the June, 2012 orders, 2) $70, 205 in fees for the preparation of the fee submission and 3) $8, 522 in costs caused by those violations. Momenta later informed the Court in footnote 2 of its reply memorandum that there were “two minor errors in the[] Fee Submission” which reduced the requested award by $6, 000.

Momenta now seeks $799, 414 in fees and $8, 522 in costs, figures which Amphastar fervently contests.

II. Attorney’s fees and costs

A. Legal standard

Rule 37 provides that a court

must order the disobedient party, the attorney advising that party, or both to pay the reasonable expenses, including attorney's fees, caused by the failure [to obey a discovery order or produce a person for examination], unless the failure was substantially justified or other circumstances make an award of expenses unjust.

Fed. R. Civ. P. 37(b)(2)(C). The party seeking fees and costs has the burden of showing that the expenses claimed are reasonable and traceable to the failures of the disobedient party. Ins. Recovery Grp., Inc. v. Connolly, 95 F.Supp. 3d 73, 78-79 (D. Mass. 2015). A court can reduce the award requested to the extent that “the documentation of hours is inadequate.” Hensley v. Eckerhart, 461 U.S. 424, 433 (1983).

A court has extremely broad discretion to determine the reasonable fees and costs to award to the entitled party. Lipsett v. Blanco, 975 F.2d 934, 937 (1st Cir. 1992). Under the lodestar method for calculating a reasonable fee, the court will first multiply the number of hours reasonably expended on the litigation by the reasonable hourly rate. Hensley, 461 U.S. at 433. The court may reduce the number of hours in order to eliminate time that was “unreasonably, unnecessarily, or inefficiently devoted to the case.” Torres-Rivera v. O’Neill-Cancel, 524 F.3d 331, 336 (1st Cir. 2008).

Although the lodestar figure represents the “presumptively reasonable fee”, Lipsett, 975 F.2d at 937(citing Blum v. Stenson, 465 U.S. 886, 897 (1984)), the court may further reduce the lodestar based upon factors such as 1) the time and labor required, 2) the novelty or complexity of the issues, 3) the skill required, 4) the preclusion of other employment by the attorneys, 5) the customary fee, 6) the fixed or contingent nature of the fee, 7) the time limitations imposed by the client or circumstances, 8) the damages involved and results obtained, 9) attorney experience, reputation and ability, 10) the desirability of the case, 11) the nature and length of the client relationship and 12) the size of awards in similar cases. Coutin v. ...

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