Battle of Lovenox Generics Brought to Supreme Court

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By Tony Dutra

May 19 — Generic drug makers asked the U.S. Supreme Court May 17 to reverse a decision limiting their “safe harbor” under the Hatch-Waxman Act.

The safe harbor is typically used by generic firms that perform some acts, prior to market introduction, that would infringe a brand drug maker's patent. Brand and generic makers have been battling over its limits for the past eight years, resulting in a split U.S. Court of Appeals for the Federal Circuit on the topic, particularly as related to activities after approval by the Food and Drug Administration.

But this case has a couple of twists, including that all the combatants are generic firms making the no-longer-patented anticoagulant Lovenox (enoxaparin sodium injection). Amphastar Pharmaceuticals Inc., International Medication Systems Ltd. and Actavis Inc., formerly Watson Pharmaceuticals Inc., are accusing Momenta Pharmaceuticals Inc. of “hijacking” the only approved test for showing bioequivalence by getting a process patent on it.

Bioequivalence must be shown to the FDA on an ongoing basis, well after FDA approval and market introduction.

The three firms'petition cites the growing number of Hatch-Waxman cases involving biosimilar generics, which will have similar testing requirements, as a reason for the court to define the breadth of the safe harbor now.

Source Material:

Cert. Petition:No. 15-1402 (May 17, 2016)

Panel decision:809 F.3d 610 (Fed. Cir. Nov. 10, 2015)

U.S. Patent:No. No. 7,575,886

Post-Approval Yes, ‘Routine' Reporting No

The petitioners charge the Federal Circuit with continually trying to read limits into the safe harbor that aren't in the statute.

Early on, the Federal Circuit was conflicted on whether the safe harbor covered any activities conducted after FDA approval. In fact, the court has now ruled twice on this case; its first ruling appeased the government's concerns, which appeased the Supreme Court's concerns.

In 2012, Judges Kimberly A. Moore and Timothy B. Dyk were in the majority when the court said that activities occurring after FDA approval were covered by the safe harbor. Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348, 103 U.S.P.Q.2d 1800 (Fed. Cir. 2012) (151 PTD, 8/7/12).

Faced with a related petition in another case, the high court asked for the views of the government. But the Office of the Solicitor General recommended against review then, saying that the Momenta decision had resolved the court's internal conflict properly (06 PTD, 1/9/13).

The case came back to the Federal Circuit, leading to the decision at issue here. Moore switched sides, joining Judge Evan J. Wallach's opinion in favor of Momenta, with Dyk in dissent.

The court held that Section 271(e)(1) does not apply to information that may be “routinely reported” to the FDA after marketing approval. Momenta Pharms., Inc. v. Teva Pharms. USA Inc., 809 F.3d 610, 116 U.S.P.Q.2d 1961 (Fed. Cir. 2015)(218 PTD, 11/12/15).

Amphastar contends that the word “routine” is nowhere in the statutory text and is against the intent of the Hatch-Waxman Act. Legislation intended to bring generic drugs to market is circumvented if Momenta can “monopolize the generic market for a drug,” the petition said.

The alleged infringers are unlikely to find support from the government this time around, though. The U.S. attorney general weighed in with an amicus brief in this second appeal, and its brief was arguably the genesis for the court's use of the word “routine.”

Side Issues Not in Question Presented

Two other points may affect the Supreme Court's decision on whether to grant review.

The Federal Circuit also held that Teva Pharmaceuticals USA Inc. could take advantage of the safe harbor by importing generic enoxaparin; because its testing was not performed in the U.S., it could not infringe a U.S. patent. That appears to favor overseas manufacture of generic drugs.

Second, the test requirement here is set by the United States Pharmacopeia (USP) Convention, a kind of standards-setting body. The petitioners contend that Momenta participated in the committee that selected the test and “never disclosed to USP its then-pending patent application.”

Pratik A. Shah of Akin Gump Strauss Hauer & Feld LLP, Washington, filed the petition. A response is due June 17. Morrison & Foerster LLP, Washington, represented Momenta before the Federal Circuit.

To contact the reporter on this story: Tony Dutra in Washington at

To contact the editor responsible for this story: Mike Wilczek in Washington at

For More Information

Text of petition at

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