Merck v. Integra: Supreme Court Reverses, Broadens Statutory Experimental Use Safe Harbor

Merck v. Integra, 545 U. S. ___  (2005).

In a unanimous decision, the Supreme Court has set aside the Federal Circuit’s holding that narrowly interpreted the statutory safe harbor of §271(e)(1). Writing for the 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 in original).

This includes:

• 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.

The court recognized that “scientific testing is a process of trial and error.”  As such, 271(e)(1) must also protect research for which an IND is not ultimately filed.

Congress did not limit §271(e)(1).s safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a generic drug. Rather, it exempted from infringement all uses of patented compounds reasonably related to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs.

Patent Attorney Jason Rantanen points out that the court declined to address two big questions:

The common law experimental use exception and the effect of 271(e)(1) on "research tools."  The latter issue the Court explicitly declined to address, noting in a footnote that it was not expressing a view about whether 271(e)(1) exempts from infringement the use of "research tools" in the development of information for the regulatory process.

Of course, any future case involving research tools will cite Merck v. Integra as persuasive authority of the proposition that 271(e)(1) covers those as well.  Rather than settling the law, the Court appears to have created an unfortunate uncertainty regarding the value of patents covering research tools.

Case vacated and remanded to determine whether Integra can prove its case under the Court’s new interpretation of the law.

Links:

• File Attachment: Merck v. Integra.pdf (103 KB) (The opinion is only 15 pages and easy to read).
• Background