Federal Circuit Expands Hatch-Waxman Safe Harbor to Include Post-approval Commercial Manufacturing

Practical Law Legal Update 5-520-7818 (Approx. 4 pages)

Federal Circuit Expands Hatch-Waxman Safe Harbor to Include Post-approval Commercial Manufacturing

by PLC Intellectual Property & Technology

Key Litigated Issue

The key litigated issue in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. was whether the safe harbor provision of the Hatch-Waxman Act, 35 U.S.C. § 271(e)(1), allows a second generic drug manufacturer to use the patented method of a first generic drug manufacturer where the second generic drug manufacturer maintains its manufacturing records for proof that the product it produces with the method complies with FDA requirements, even though the FDA has already approved the generic drug and does not, in most cases, inspect the maintained records.

Background

This case involves the generic version of Lovenox (enoxaparin), which prevents blood clots. Momenta Pharmaeuticals, Inc. (Momenta) received FDA approval to market enoxaparin more than one year before Amphastar Pharmaceuticals, Inc. (Amphastar).

Momenta owns US Patent 7,575,886 ('886 patent), which describes and claims a method for analyzing an enoxaparin sample. Momenta sued Amphastar for infringement of the '886 patent because Momenta alleged that Amphastar used the claimed method of analyzing an enoxaparin sample in its commercial process for manufacturing batches of enoxaparin sodium. The district court granted Momenta's motion for a preliminary injunction based on its conclusion that Amphastar infringed Momenta's patent. Amphastar appealed.

Outcome

Majority Opinion

In its August 3, 2012 decision, the Federal Circuit vacated the preliminary injunction and remanded the matter to the district court for further proceedings.

The Federal Circuit's decision in this case turned on its interpretation of the Hatch-Waxman safe harbor provision, which reads:

"It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … 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 or veterinary biological products."

(35 U.S.C. § 271(e)(1).)

The majority read this statute broadly to apply to:

Submissions under any federal law, if the law regulates the manufacture, use or sale of drugs.
Any use of a patented invention if the use is reasonably related to the development and submission of information under that federal law.

The majority also found no basis to limit the safe harbor to either:

The phase of the research in which it is developed.
The particular submission in which it could be included.

Therefore, the majority concluded that if the accused infringer has a reasonable basis for believing that the use of the patented invention might provide information that would be appropriate to include in an FDA submission, that use is reasonably related to the development and submission of information under federal law and is subject to the safe harbor. The court found that both pre- and post-approval uses fall within the scope of the safe harbor.

Because Amphastar maintains its manufacturing records for proof that the product it manufactures with the patented method complies with FDA requirements, the majority determined that Amphastar's accused activities were exempt from patent infringement. This is the case even though the FDA does not in most cases inspect records of this kind.

Dissent

Chief Judge Rader dissented from the majority opinion and argued that the safe harbor is a limited exception to patent infringement. Chief Judge Rader reviewed the legislative history of the safe harbor provision and noted that:

The purpose of the statute was to overrule Roche Products, Inc. v. Bolar Pharmaceutical Co. and establish an infringement exception for certain experimentation.
The statute won approval because it:
- was limited to pre-marketing approval activities; and
- would have a limited impact on the patentee's exclusivity during the patent term.

Chief Judge Rader also expressed his concern that the majority's decision:

Would allow almost all activities by pharmaceutical companies to constitute a submission under the statute because the FDA can inspect the records of any drug manufacturer and seller.
Conflicts with the Federal Circuit's decision in Classen Immunotherapies, Inc. v. Biogen IDEC, which limited the safe harbor provisions to pre-approval activities.
Would render drug manufacturing method patents worthless.
Could create a disequilibrium in the Hatch-Waxman statute because the patent owner would not get a patent term extension even though its competitors would be allowed to infringe during the patent term.

Practical Implications

This decision is noteworthy because it expands the Hatch-Waxman safe harbor provision to exempt from patent infringement certain commercial activities of a generic drug manufacturer after FDA approval of the generic drug. However, it is likely that the patent owner will seek en banc review by the Federal Circuit and possibly petition the Supreme Court if en banc review is denied.

Update: On June 24, 2013, the US Supreme Court denied Momenta’s petition for a writ of certiorari.

Federal Circuit Expands Hatch-Waxman Safe Harbor to Include Post-approval Commercial Manufacturing | Practical Law