United States: The § 271(e)(1) Safe Harbor Covers Generic Quality Control Batch Testing Even After FDA Approval

In Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., Nos. 12-1062, -1103, -1104 (Fed. Cir. Aug. 3, 2012), the Federal Circuit vacated the district court's grant of a preliminary injunction and remanded for further proceedings, holding that the district court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1).

Lovenox (enoxaparin), a drug that prevents blood clots, is marketed by Aventis Pharmaceuticals, Inc.  Enoxaparin is made up of a range of different molecules, because it is produced from heparin starting material that includes molecules that vary in the length of the component polysaccharide chains, and in the types and distribution of disaccharide units in the polysaccharide chains.  In light of this molecular diversity, the FDA, which has "broad discretion" regarding the information it considers for bioequivalence, "identified five . . . 'standards for identity,' that 'together provide sufficient information to conclude that generic enoxaparin has the 'same' active ingredient as Lovenox' . . . includ[ing], inter alia, '[e]quivalence in dissaccharide building blocks, fragment mapping, and sequence of oligosaccharide species.'"  Slip op. at 4 (second alteration in original) (citations omitted).

Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc., and Watson Pharma, Inc. (collectively "Amphastar") filed the first ANDA for a generic version of enoxaparin.  Momenta Pharmaceuticals, Inc. and Sandoz, Inc. (collectively "Momenta"), however, were the first to receive FDA approval and to market generic enoxaparin, earning quarterly revenues of $260 million.

Momenta is the assignee of U.S. Patent No. 7,575,886 ("the '886 patent"), which relates to methods for analyzing heterogeneous populations of sulfated polysaccharides, such as heparin and enoxaparin.  Two days after Amphastar received FDA approval for its generic enoxaparin, Momenta filed suit against Amphastar, alleging that Amphastar infringed the '886 patent by using the claimed method for quality control batch testing during its manufacture of generic enoxaparin.  The district court granted a preliminary injunction to prevent the generic entry of Amphastar's enoxaparin.  Amphastar then filed emergency motions for relief from the preliminary injunction, which the district court denied.  Amphastar appealed the preliminary injunction and denials for relief.

On appeal, Amphastar argued that its testing fell within the plain language of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e), and that the district court took an unduly restrictive view of the safe harbor.  Momenta argued that the safe harbor did not apply to Amphastar's testing because (1) the testing is a postapproval activity; and (2) the availability of other testing methods means the alleged use is not required by the FDA.

"Under a proper construction of 35 U.S.C. § 271(e)(1), the fact that Amphastar's testing is carried out to 'satisfy the FDA's requirements' means it falls within the scope of the safe harbor, even though the activity is carried out after approval."  Slip op. at 20.

The Court first found that § 271(e)(1) does not reference the portion of the Federal Food, Drug, and Cosmetic Act describing the ANDA requirements, and instead uses "broad language [that] unambiguously applies to submissions under any federal law, providing that the law 'regulates the manufacture, use, or sale of drugs.'"  Id. at 12.  The Court indicated that this interpretation is consistent with the rest of the statutory scheme and with the Supreme Court's decisions in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 666 (1990), and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).  The Court held that the information in question was "submitted to the FDA" for purposes of the statute, reasoning that FDA regulations require the batch testing records be available for authorized inspection.

The Court found that the submissions were "anything but 'routine'" as "they implicate Amphastar's very ability to continue its FDA approval for its ANDA and to continue manufacturing and marketing enoxaparin under its ANDA."  Slip op. at 19.  The Court declined adopting the pre-/postapproval distinction set forth by Momenta, "hold[ing] that post-approval studies that are 'reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs' fall within the scope of the § 271(e)(1) safe harbor."  Id. at 20.  "Under a proper construction of 35 U.S.C. § 271(e)(1), the fact that Amphastar's testing is carried out to 'satisfy the FDA's requirements' means it falls within the scope of the safe harbor, even though the activity is carried out after approval."  Id.

The Court also rejected Momenta's second argument that Amphastar's testing is not protected because there are FDA-endorsed noninfringing alternatives available.  The Court held that "[t]he safe harbor's protection is not limited to the dire situation where the patented invention is the only way to develop and submit the information."  Id. at 21.  "Instead, the safe harbor expressly allows the submitter the freedom to use an otherwise patented means to develop the necessary information demanded by the 'Federal law.'"  Id.

The Court rejected Momenta's reliance on the term "solely," stating that the word "modifies 'uses reasonably related to the development and submission of information,' but does not place any other restriction on when the patented invention may be used without infringing."  Id. at 21-22.  "As long as the use of the patented invention is done to generate information that will be submitted pursuant to a relevant federal law, that use falls within the safe harbor."  Id. at 22.

The Court held that, under the correct interpretation of § 271(e)(1), Momenta would be unlikely to succeed on the merits of its infringement claim.  The Court thus vacated the preliminary injunction and remanded with instructions that "the district court may want to consider whether Momenta's admission that Amphastar's use of the patented invention is to 'satisfy the FDA's requirements' makes this case amenable to [SJ] of non-infringement."  Id. at 25.

Chief Judge Rader dissented, stating that the majority's "expansion of the law circumvents the purpose of the law and ignores the binding precedent of Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011)," and that "this result will render worthless manufacturing test method patents."  Rader Dissent at 2-3.  In Judge Rader's view, the "extensive" legislative history showed that "§ 271(e)(1) applied only to limited situations, namely pre-approval experiments to obtain FDA approval . . . ."   Id. at 3.  Judge Rader stated that "§ 271(e)(1) won approval because it was limited in time, quantity, and type."  Id. at 8.  Judge Rader noted that he was present through the legislative process, and that "[t]he authors of this section . . . did not imagine that § 271(e)(1) would allow continuous, commercial infringing sales during any portion of the life of the patent."  Id. at 10.  Judge Rader noted that the majority's decision "rewrites the law to allow Amphastar to infringe Momenta's patent throughout the entire life of Momenta's patent and for the purpose of obtaining profits on commercial sales of a product that competes with the patentee."  Id. at 10-11.

Judge Rader stated that the Court had already decided the meaning of § 271(e)(1) in Classen, and disagreed with the majority's distinction that the activities in Classen were not FDA-mandated.  Judge Rader added that the Supreme Court's decisions in Eli Lilly and Merck "support the holding in Classen and do not support [the majority's] decision."  Id. at 18 (citing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 1047 (1990); Merck, 545 U.S. 193).

This article previously appeared in Last Month at the Federal Circuit, September, 2012.

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