In a follow-up on our earlier discussion regarding the Supreme Court’s broad scope of the research exemption to the Integra case, the question came up asking if a patented delivery formulation — say, a sustained release formulation as opposed to a therapeutic itself — would fall within the exemption from infringement under the Food and Drug Administration (“FDA”) Exemption.

This “safe harbor” under 35 U.S.C. ‘271(e)(1) states:

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 (emphasis added).

It’s very clear that the Supreme Court recently gave pharmaceutical companies broad latitude to study and experiment with compounds covered by other companies’ patents in its recent decision, Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372, No. 03-1237. The operative effect of the decision is that, in certain circumstances, drug companies can now conduct preclinical research (laboratory and animal testing) using patented compounds without risk of infringement.

The Supreme Court decided, unanimously, that such use in preclinical studies is protected as long as there is a reasonable basis to believe that the experiments will produce types of information relevant to an Investigational New Drug Application (“IND”) or New Drug Application (“NDA”) filed with the FDA.

But what if it is not the active agent that is subject to patent protection but a specific formulation or controlled release invention for use with the active agent?

Writing for a unanimous Court, Justice Scalia found that:

“As an initial matter, we think it apparent from the statutory text that §271(e)(1)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA.” (emphasis added).

The use of the term “patented inventions” seems to indicate that the Court very much intended for the §271(e)(1) exemption to apply to any patented technologies that are used in drug development as long as they are reasonably related to the development and submission of information under the FDCA. The Supreme Court therefore ruled that the exemption applies broadly to all the aspects of when researchers seek out new compounds having pharmaceutical safety and efficacy, and is not limited to situations in which a pharmaceutical candidate has already been identified and is being tested in order to obtain FDA approval.

That would seem to include patented methods of making compounds, patented formulations and any other patented technologies related to the drug including tableting systems, coating and encapsulation technologies and even the machinery for manufacturing the drug.

Relying heavily on the language of the statute, Justice Scalia states that “there is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.”

Critical to triggering the exemption is that experiments be “reasonably related” to FDA submissions; the parameters of this standard are set forth by the Supreme Court:

At least where a drug maker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information under…Federal law.’ 125 S. Ct. at 2382, No. 03-1237, slip op. at 13.

In view of the Merck decision, it appears that many preclinical studies using patented inventions will be exempt from infringement under § 271(e)(1). They may include:

Clinical and Preclinical studies of patented compounds that are appropriate for submission to the FDA;

Studies intended to generate pharmacological, toxicological, pharmacokinetic, and biological qualities of the drug in animals;

Studies intended to generate information regarding a risk-benefit assessment of the appropriateness of [a proposed clinical] trial; and

Safety related tests even if not compliant with FDA regulations.

Unfortunately, the Supreme Court explicitly declined to express a view about whether § 271(e)(1) exempts from infringement the use of research tool patents in furtherance of research for regulatory approval.

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  1. Hi,

    I read this article with interest and have a couple of questions which I’m wondering if you have an answer to:

    1. does the research exemption safe harbor extend beyond pre-clinical studies to clinical studies ? do the same terms apply for clinical studies ?

    2. does this safe harbor apply to biologics submitted via a BLA ? the article talks about INDs and NDAs submitted under the FDCA only. If it applies to biologics, how was Amgen able to sue TKT for infringement at the IND stage ?



  2. […] regulatory filings. And the language of the ruling makes it look like it’s intended to cover all sorts of patented technologies as […]