Sunstein Kann Murphy & Timbers LLP: Generic Drugmakers Gain Safe Harbor Protection For Compliance Activities That Occur After FDA Approval

By Isabelle Blundell, a member of our Life Sciences Practice Group

Ever since the Hatch-Waxman Act became law in 1984, generic-drug manufacturers have had increasing success in lowering barriers to entry in the marketplace.  The Act created a streamlined process, the Abbreviated New Drug Application (ANDA), for manufacturers who seek approval for generic versions of proprietary drugs.

The patent law, for its part, provides these manufacturers with protection--a safe harbor--from claims of infringement that might otherwise arise from activities intended to show the equivalence of the generic drug to the brand-name drug.  This protection has typically been thought to be confined to the period before FDA approval is obtained.

Remarkably, the Federal Circuit has now extended safe harbor protection to certain post-approval activities.

In Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, the court held that all uses of the patented invention, even those conducted after FDA approval of the generic drug, benefit from the exemption from infringement claims so long as use of the invention is, in the language of the safe harbor provision, "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs..." 35 U.S.C. 271(e)(1).

Interestingly, both Momenta and Amphastar are generic manufacturers. Momenta was the first to get approval of a generic version of Lovenox® (enoxaparin), a low molecular weight version of heparin, that helps prevent the formation of blood clots.

The FDA requires rigorous ongoing testing to identify the composition of each manufactured batch of a drug before its launch on the market. Unlike common pharmaceutical drugs which have a defined structure and formula (and can thus be identified with long-established methods), heparin is a mixture of biopolymer chains that have variability in both structure and formula.

For generic drugs, identifying the composition of each batch is a necessary step to showing equivalency to the branded drug.

After Momenta gained market approval for its generic version of enoxaparin, Amphasar did the same. Momenta had developed and patented a method for identifying the composition of the batches. This method became the only listed method in the FDA-sanctioned US Pharmacopoiea Convention.

Even though other valid methods are available, Amphastar used the FDA-sanctioned method--patented by Momenta--for identifying its batches during manufacturing.  In an attempt to stop Amphastar, and keep a second generic version of heparin off the market, Momenta sued, complaining that, in complying with FDA requirements for testing its enoxaparin product, Amphastar infringed its patent.

A split panel of the Federal Circuit construed the safe harbor provision to protect Amphastar's post-marketing activities as reasonably related to the development and submission of information pursuant to a federal law regulating the manufacture, use, or sale of a drug, even though the information is not submitted to the FDA, but merely kept available as proof of compliance in the event of FDA inspection.  Thus, the testing results are needed to comply with the terms of the FDA's approval of Amphastar's ANDA, the court ruled.

The Supreme Court's decision in Merck v. Integra (2005) lends support to this broad interpretation. The high court found that pre-marketing activities conducted to develop information intended to be submitted to the FDA, but which was ultimately not submitted, were within the ambit of the safe harbor provision.  The key factor in Merck was the interpretation of "reasonably related": so long as the information is of the kind that would be submitted to the FDA, activities performed to gather that information fall under the exemption.

Taking account of Amphastar's activities, the Federal Circuit held that all that is required is that the "accused infringer 'has a reasonable basis for believing' that the use of the patented invention might yield information that 'would be appropriate to include in a submission to the FDA."

In Merck, the Supreme Court had no occasion to opine whether using testing-method patents in the pharmaceutical industry fell within the exemption. The Federal Circuit, however, had no qualms about concluding that such use is in fact protected by the safe harbor.  Since the most profitable use of such patents is in monitoring the quality of the manufactured drug, this decision renders testing-method patents virtually worthless.

© 2005-2012 Sunstein Kann Murphy & Timbers LLP, All Rights Reserved.

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