Supreme Court Gets Another Petition On Hatch-Waxman Safe Harbor Dispute

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By Tony Dutra  


A petition for a writ of certiorari filed on Feb. 21 will give the Supreme Court an opportunity to rethink from the other party's perspective its Jan. 14 denial of review of a case featuring one side of a debate on the extent of the Hatch-Waxman Act's safe harbor provision on patent infringement (Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., U.S., No. 12-1033, review sought 2/21/2013).

The safe harbor applies to non-sales activities of a generic drug maker. There is no debate that 35 U.S.C. §271(e)(1) extends the safe harbor to activities required by the Food and Drug Administration before it approves marketing of the generic drug. However, two decisions by the U.S. Court of Appeals for the Federal Circuit were arguably in conflict about extending safe harbor protection to other activities, particularly to those that might occur after FDA approval.

After receiving advice from the Solicitor General, the high court denied a cert petition appealing the decision that limited safe harbor protection to the pre-approval stage. GlaxoSmithKline v. Classen Immunotherapies Inc., No. 11-1078 (U.S., review denied Jan. 14, 2013) (06 PTD, 1/9/13).

In the Momenta case, on the other hand, the appeals court held that the generic drug maker may, post-approval, continue to infringe a follow-on method patent so long as performing the method satisfies FDA requirements. Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 686 F.3d 1348, 103 U.S.P.Q.2d 1800 (Fed. Cir. 2012) (151 PTD, 8/7/12).

The drug underlying the controversy in the instant case is the blood-thinning injectable Lovenox (enoxaparin sodium injection), with composition patents owned by Aventis Pharmaceuticals Inc. Momenta Pharmaceuticals Inc.'s patent (U.S. Patent No. 7,575,886) at issue here is on methods of analyzing and monitoring particular therapeutic heparin products such as Lovenox.

Generic maker Amphastar Pharmaceuticals Inc. survived a lawsuit by Aventis. Aventis Pharma S.A. v. Amphastar Pharmaceuticals Inc., 525 F.3d 1334, 87 U.S.P.Q.2d 1110 (Fed. Cir. 2008) (98 PTD, 5/21/08). But it then faced Momenta's challenge on infringing the method patent.

In a split decision, the Federal Circuit majority said, “Congress could not have been clearer in its choice of words: as long as the use of the patented invention is solely for uses 'reasonably related' to developing and submitting information pursuant to 'a Federal law' regulating the manufacture, use, or sale of drugs, it is not 'an act of infringement.' ”

In its recommendation that the Supreme Court deny review in Classen, the government contented that the Federal Circuit majority in Momenta “cabin[ed] the adverse impact” of the Classen decision.

The high court made no mention of the solicitor general's advice in denying review, so there was little doubt Momenta would argue that a controversy still exists and needs to be resolved. Indeed, its cert petition gave considerable attention to the solicitor general's brief in Classen, essentially arguing that Federal Circuit failed in both cases.

“These two interpretations of Section 271(e)(1) are irreconcilable, and yet both are fundamentally wrong,” according to the brief. “Both Classen and the ruling below give the wrong scope to the safe harbor provision and together they leave its meaning in an intolerable state of uncertainty.”

The question presented in the Momenta cert petition is:  

Whether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”  




Deanne E. Maynard of Morrison & Foerster, Washington, D.C., represents Momenta.

Amphastar's response is due March 25. At the Federal Circuit, Amphastar was represented by Patricia A. Millett of Akin Gump Strauss Hauer & Feld, Washington, D.C.

Two Other Cert Petitions Filed

Two other new petitions for certiorari were recently filed with the Supreme Court:

• In Alcon Research Ltd. v. Apotex Inc. ( U.S., No. 12-984, review sought 2/8/13). The petition appeals the Federal Circuit's invalidation of some of the claims of the patent underlying the eye disease drug Patanol. Alcon Research Ltd. v. Apotex Inc., 687 F.3d 1362, 103 U.S.P.Q.2d 1737 (Fed. Cir. 2012) (154 PTD, 8/10/12). Specifically, the petition asks whether it was appropriate under 35 U.S.C. §112(d) for the Federal Circuit to eliminate a claim limitation--“therapeutically effective amount”--in an independent claim based on concentration ranges specified in dependent claims.

• In Andrews Arts & Sciences Law L.L.C. v. SnoWizard Inc, ( U.S., No. 12-974, review sought 2/11/13). The petition asks whether a Louisiana state court properly declined to exercise subject matter jurisdiction over a defamation and unfair practice collateral lawsuit that was brought against an attorney who published an article on his firm's website about an opponent in a patent dispute that was being litigated in federal court. Andrews Arts & Sciences Law L.L.C. v. SnoWizard Inc. (La. Ct. App., 7/31/12).




Text of the Momenta petition is available at


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