Merck KGaA v. Integra Lifesciences I, Ltd.

PETITIONER: Merck KGaA
RESPONDENT: Integra Lifesciences I, Ltd., et al.
LOCATION: Meramec River

DOCKET NO.: 03-1237
DECIDED BY: Rehnquist Court (1986-2005)
LOWER COURT: United States Court of Appeals for the Federal Circuit

CITATION: 543 US 1041 (2005)
GRANTED: Jan 07, 2005
ARGUED: Apr 20, 2005
DECIDED: Jun 13, 2005

ADVOCATES:
Daryl Joseffer - argued the cause for Petitioner
E. Joshua Rosenkranz - argued the cause for Petitioner
Mauricio A. Flores - argued the cause for Respondents

Facts of the case

Integra Lifesciences sued Merck for supplying an Integra patented compound to other drug companies for use in preclinical research. In response, Merck claimed its actions were allowed under the federal law that said it was not an act of patent infringement to use or import a patented invention into the United States, if the invention was used only in ways related to the development and submission of information under a federal drug law (such as the law governing submission of data to the FDA). The district court ruled against Merck and awarded Integra damages. The Federal Circuit affirmed the judgment but ordered a modification of damages.

Question

Did federal law allow the use of patented inventions in preclinical research, the results of which were not ultimately included in a submission to the FDA?

Media for Merck KGaA v. Integra Lifesciences I, Ltd.

Audio Transcription for Oral Argument - April 20, 2005 in Merck KGaA v. Integra Lifesciences I, Ltd.

Audio Transcription for Opinion Announcement - June 13, 2005 in Merck KGaA v. Integra Lifesciences I, Ltd.

William H. Rehnquist:

The opinion of the Court in Merck KGaA versus Integra Lifesciences will be announced by Justice Scalia.

Antonin Scalia:

This case is here on writ of certiorari to the Court of Appeals for the Federal Circuit.

Beginning in the early 1990s and continuing into 1998, petitioner, Merck, supplied RGD peptides developed in its labs in Germany to the Scripts Research Institute in San Diego for use in research on angiogenesis, the process by which new blood vessels grow from those already existing.

Angiogenesis plays an important role in many diseases including the growth of cancerous tumors and rheumatoid arthritis.

From 1994 to 1998, scientists at Scripts performed research on variations of petitioner’s peptides to determine which was the most suitable as a candidate for testing on humans.

The research ultimately settled on a particular peptide in 1997 and a year later, the National Cancer Institute submitted an investigatory new drug application, an IND, to the Food and Drug Administration seeking permission to test that peptide on humans in clinical trials.

In July 1996 in the midst of research at Scripts, respondent, Integra Lifesciences, sued petitioner alleging that its provision of the RGD peptides to Scripts infringed Integra Lifesciences’ patents.

Petitioner answered that respondent’s patents did not cover its peptides and that its use was in any case exempted from infringement by 35 U.S.C. Section 271(e)(1) which provides that “it shall not be an active infringement to use 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 use of drugs.”

A jury disagreed with petitioner on both issues and awarded damages of $15 million.

Petitioner appealed each determination.

A panel of the Federal Circuit unanimously affirmed the District Court’s determination that petitioner infringed respondent’s patents but divided on the question whether petitioner was entitled to judgment as a matter of law under Section 217(e)(1).

The panel majority concluded that it was not.

We granted certiorari to review the construction of 271(e)(1) on which this conclusion rested.

Finding that the Court of Appeals adapted an unduly narrow interpretation of 271(e)(1)’s exemption, we vacate its judgment and remand for further proceedings.

Though not exact in every respect, 271(e)(1)’s plain language provides wide scope for the use of patented drugs in activities related to the federal regulatory process.

First, we think it apparent from 271(e)(q)’s text that its exemption from infringement extends to all uses of all patented inventions that are reasonably related to the development of any information under the FDCA, the Federal Food Drug and Cosmetics Act.

Contrary to what some portions of the Court of Appeals’ opinion seem to suggest, this necessarily includes information developed in pre-clinical studies for submission in an IND application and is not limited to safety related information.

A review of FDA regulations makes clear that the FDA is interested in more that just safety.

At this stage, it is also interested in information relating to a drug’s efficacy, pharmacology, and pharmacokinetics as well.

Second, we do not think that Section 271(e)(1) is limited to either experimentation on drugs that are ultimately the subject of an FDA submission or use of patented compounds in experiments that are ultimately actually submitted to the FDA.

To limit the exemption in this fashion, as the Court of Appeals did, would disregard the reality that even at late stages in the development of a new drug, scientific testing is a process of trial and error.

In the vast majority of cases, neither the drug maker nor its scientists have any way of knowing whether an initially promising candidate will prove successful over a battery of experiments.

That is the reason they conduct the experiments.

Thus, to construe 271(e)(1) as the Court of Appeals did, not to protect research conducted on patented compounds for which an IND is not ultimately filed is affectively to limit assurance of exemption to the activities necessary to seek approval of a generic drug.

One can know what the outset that a particular compound will be the subject of an eventual application to the FDA, only if the active ingredient in the drug being tested is identical to that in a drug that has already been approved.

The text of the exemption extends well beyond generic drug applications, however, and we decline to adapt the construction of the reasonable relation requirement that would produce such a limitation.

For similar reasons, we think that the exemption includes use of patented compounds in experiments.

The results of which are not included in a submission to the FDA.

In sum, 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 as 271(e)(1) requires.”