Momenta Pharms., Inc. v. Amphastar Pharms., Inc.

January 03, 2012

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Momenta Pharms., Inc. v. Amphastar Pharms., Inc., Civ. No. 11-11681-NMG, 2011 U.S. Dist. LEXIS 125184 (D. Mass. Oct. 28, 2011) (Gorton, J.)

Drug Product and Patent(s)-in-Suit: Lovenox® (enoxaparin sodium); U.S. Patent Nos. 7,575,886 and 7,790,466.

Nature of the Case and Issue(s) Presented: The issues here centered on plaintiffs' request for a preliminary injunction.  Shortly after filing suit, plaintiffs moved for a temporary restraining order, limited expedited discovery, and a preliminary injunction barring the defendants from making, selling and offering for sale its generic product.  Defendants also moved for limited discovery.  After hearing argument, the Court entered a TRO enjoining defendants from the activities that allegedly infringe one or more of the patents-in-suit and ordered discovery (plaintiffs dropped their infringement claim for the ‘466 patent after reviewing this discovery).  On October 20, 2011, the Court held a hearing concerning plaintiffs' request for a preliminary injunction.

The Court applied the general preliminary injunction standard, which required a showing of the following: (i) a substantial likelihood of success on the merits; (ii) a significant risk of irreparable harm if the injunction is withheld; (iii) a favorable balance of hardships; and (iv) a fit (or lack of friction) between the injunction and the public interest.  After finding a likelihood of success on the merits and a showing of irreparable harm, the Court entered a preliminary injunction against defendants.

Why Momenta Prevailed:  (High probability of infringement and "conclusory" evidence of invalidity lead to entry of preliminary injunction).  Defendants relied on arguments of noninfringement and invalidity to support their "success on the merits" argument.  In particular, and based on a narrow interpretation of the claim term "separation method," defendants argued that they did not practice one step of the alleged method claims, namely, "using a separation method to determine the presence of a structural signature associated with the non-naturally occurring sugar associated with peak 9 of Fig. 1."  Defendants contended that the "separation method" only embodied the separation technique known as Capillary Electrophoresis (CE).  Plaintiffs, on the other hand, contended that a person of skill in the art would construe "separation method" to include CE as well as another technique known as High Pressure Liquid Chromatography (HPLC).  The Court agreed with plaintiffs' construction and, therefore, found a high probability that defendants infringed the ‘886 patent. 

The Court also rejected the defendants' invalidity argument.  The defendants relied only on prior art that was before the examiner.  And defendants also failed to offer expert testimony, rendering their evidence "conclusory."  The Court therefore found that the defendants did not sufficiently show that there was a substantial likelihood that the ‘886 patent was invalid.

Next, defendants argued that even if they were deemed to infringe the ‘886 patent, their allegedly infringing activity fell squarely within the safe harbor provision of the Hatch-Waxman Act, 35 U.S.C. § 271(e)(1), which excepts infringement where the activity is solely for the purpose of development and submission of information under a federal law that regulates the manufacture, use or sale of drugs.  The Court rejected this argument because the defendants continued their infringing activity after they received FDA approval.

Regarding the second prong of the preliminary injunction analysis, the Court found that plaintiffs would be irreparably harmed if the defendants were not enjoined.  The defendants had the burden of proof because the plaintiffs established the patent was valid and infringed (in a later opinion, the Court recognizes that this standard was inapplicable).  The Court found that plaintiffs submitted sufficient evidence regardless of this burden.  Specifically, the Court noted that "plaintiffs have submitted sufficient evidence to demonstrate that the marketing of defendants' product will cause them immediate and long-term irreparable harm. That harm would likely involve price erosion, lost market share, loss of market capitalization, reputational injury and threats to both the funding of ongoing research development and the hiring and retention of critical scientific talent."  Defendants contended that this harm could be quantified and thus was not irreparable.  But the Court noted, "[a]lthough some of plaintiffs' potential for harm is quantifiable, its allegations of price erosion, reputational injury and loss of goodwill likely are not.  Defendants have failed to rebut the presumption" to reject this argument and the Court found irreparable harm.

In analyzing the balance of hardships, the Court found for the plaintiffs because of the risk of irreparable harm.  It observed that the defendants would only be monetarily harmed, which could be mitigated through a substantial bond (which the Court later set as $100 million).  Because defendants were not at risk of being irreparably harmed while plaintiffs were, the Court concluded the hardships weighed in plaintiffs' favor.

Finally, the Court found that the public interest would not be harmed if the preliminary injunction were granted.  It found that the public's interest in lower drug costs did not outweigh plaintiffs' interest in protecting their patent rights.  Thus, since all four factors weighed for plaintiffs, the Court entered the requested preliminary injunction.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

Related Publications

November 23, 2021
Briefly: Five tips for presenting your appeal
Ryan Marth and Ryan MacDonald - Minnesota Lawyer
November 16, 2021
Fintiv Denials in Drug Cases
Steven C. Carlson
Third Quarter
ANDA Approvals
GENERICally Speaking Fall 2021
Third Quarter
ANDA Litigation Settlements
GENERICally Speaking Fall 2021
Third Quarter
Generic Launches
GENERICally Speaking Fall 2021
Back to Top