Eli Lilly and Company v. Medtronic, Inc.

PETITIONER: Eli Lilly and Company
RESPONDENT: Medtronic, Inc.
LOCATION: United States District Court for the Eastern District of Pennsylvania

DOCKET NO.: 89-243
DECIDED BY: Rehnquist Court (1988-1990)
LOWER COURT: United States Court of Appeals for the Federal Circuit

CITATION: 496 US 661 (1990)
ARGUED: Feb 26, 1990
DECIDED: Jun 18, 1990
GRANTED: Oct 10, 1989

ADVOCATES:
Arthur R. Miller - on behalf of the Respondent
Timothy J. Malloy - on behalf of the Petitioner

Facts of the case

In 1983, the predecessor-in-interest to Eli Lilly & Co. sued Medtronic, Inc. for patent infringement to enjoin Medtronic’s research and marketing of an implantable cardiac defibrillator, a device used to treat heart problems. Medtronic argued that the information was used to develop and submit new information under the Food, Drug, and Cosmetic Act (FDCA), and therefore it was exempt from the statutes governing patent infringement. The district court held that there was no such exemption and issued a permanent injunction. The U.S. Court of Appeals for the Federal Circuit reversed and held that Medtronic’s actions could not be considered patent infringement if they were reasonably related to obtaining approval under the FDCA.

Question

Are activities that would normally constitute patent infringement excused if they are used to develop and submit information to the Food and Drug Administration to obtain marketing approval for a medical device?

Media for Eli Lilly and Company v. Medtronic, Inc.

Audio Transcription for Oral Argument - February 26, 1990 in Eli Lilly and Company v. Medtronic, Inc.

William H. Rehnquist:

We'll hear argument now in Number 89-243, Eli Lilly and Company v. Medtronic, Inc.--

Timothy J. Malloy:

Thank you, Mr. Chief Justice, and may it please the Court:

We are here on certiorari to the United States Court of Appeals for the Federal Circuit.

This suit was filed in 1983 to stop Medtronic from infringement of two basic patents related to a medical device known as an automatic implantable defibrillator.

Medtronic defended in part in the court below arguing that its infringing activities were exempt from the patent infringement laws based on a 1984 statute.

The question before this court is the interpretation of that statute, which is 35 U.S.C. Section 271(e)(1).

That statute provides that it shall not be an act of infringement to manufacture, use or sell a patented invention solely for uses reasonably related to the development and submission of information under a Federal law regulating drugs.

I submit that there is only one proper interpretation of that statute.

It applies to drugs only, and has no application whatever to other nondrug products regulated under the Food, Drug and Cosmetic Act, namely, medical devices, color additives and food additives.

The statute refers on its face only to drugs.

The statutory definition of drugs in the FDA Act excludes specifically devices.

A century of FDA legislation has treated drugs differently from devices from 1906 until the present.

Now, Medtronic argues that the phrase "Federal law regulating drugs"... and it takes that phrase out of context... Medtronic, the respondent, argues that the phrase "Federal law regulating drugs" equals and means the entire Food, Drug and Cosmetic Act and even the nondrug products.

Byron R. White:

Well, the court though so too, didn't it?

Timothy J. Malloy:

No, Your Honor.

The court, I suggest... well, the court of appeals did not analyze what the phrase Federal law regulating drugs meant.

What the court did was go to one piece of the legislative history dealing with their analysis of what the Roche Bolar decision had done and look at that.

And, in fact, the court decision when it goes to the words of the statute simply leads off by saying we conclude that this statute covers any patented invention so long as it's for the limited purposes enumerated.

But it never discusses how... what the meaning of the remaining phrase is and how does that fit into the statute.

And I suggest one of the errors of the court of appeals' opinion which Medtronic has failed to support is that it doesn't deal with the specific language of the statute.

Byron R. White:

Mr. Malloy, am I right the critical language of the statute is,

"a Federal law which regulates the manufacture, use or sale of drugs? "

Timothy J. Malloy:

No, Your Honor.

I would suggest that the critical language starts with after

"solely for use as reasonably related to. "

and then we focus,

"the development and submission of information under a Federal law regulating drugs. "

Byron R. White:

No, under... well, but is the last language... I... I just want to make sure I have the last part of the language correct.

Timothy J. Malloy:

Oh, absolutely.

Byron R. White:

"Which regulates the manufacture, use or sale of drugs. "