Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

PETITIONER:Teva Pharmaceuticals USA, Inc.
RESPONDENT:Sandoz, Inc., et al.
LOCATION: Teva Pharmaceuticals USA Headquarters

DOCKET NO.: 13-854
DECIDED BY: Roberts Court (2010-2016)
LOWER COURT: United States Court of Appeals for the Federal Circuit

CITATION: 574 US (2015)
GRANTED: Mar 31, 2014
ARGUED: Oct 15, 2014
DECIDED: Jan 20, 2015

Carter G. Phillips – for the respondent
Ginger D. Anders – Assistant to the Solicitor General, Department of Justice, for the United States as amicus curiae
William M. Jay – for the petitioner

Facts of the case

Sandoz, Inc., (Sandoz) and Mylan Pharmaceuticals, Inc. (Mylan) submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) to produce and market generic versions of Copaxone, a drug used to treat Multiple Sclerosis. Teva Pharmaceuticals USA, Inc., the manufacturer of the original drug, sued Sandoz and Mylan and used two different types of claims that are based on different ways to use molecular weight to distinguish between polymer samples. The district court did not distinguish between the different methods of using molecular weight and held that the claims were not indefinite as Sandoz and Mylan argued. After a bench trial, the district court held that the Sandoz and Mylan products infringed on Teva’s patent.

The U.S. Court of Appeals for the Federal Circuit held that the district court did not error in holding that the patents were infringed, but that some of the claims had not been effectively shown to be definite.


Can a district court’s finding of fact in the construction of a patent claim be reviewedde novo, as though for the first time, which the U.S. Court of Appeals for the Federal Circuit requires and did in this case?

Media for Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

Audio Transcription for Oral Argument – October 15, 2014 in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

Audio Transcription for Opinion Announcement – January 20, 2015 in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

John G. Roberts, Jr.:

Justice Breyer has a opinion this morning in case 13-854 Teva Pharmaceuticals USA, Inc. v. Sandoz.

Stephen G. Breyer:

This is a patent case and it is quite typical of many patent cases which is why we took it and I will show you what they are like.

Teva obtained a patent or a drug called Copaxone, which is used to treat Multiple Sclerosis, and it sued Sandoz who is also here as respondent for infringement, and Sandoz turned around and sued Teva saying your patent is no good and the court – they are all in district court to begin with and the Judge says why, and he said, well, it is too indefinite.

There are terms that are too indefinite and ambiguous, what term?

Well particularly Sandoz points to a statement in their claim which says this active ingredient in the drug has a molecular weight of 5 to 9 kilodaltons.

So that term molecular weight is ambiguous and indefinite.

And Teva says it is?

He says, Yes.

It might mean any of three different things.

It could mean when you have a sample of this drug that you measure the molecular weight by looking at the sample and you look at the weight of whatever molecule is the most prevalent or it could mean you add up the weight of all the molecules and divide by the number of molecules that is called the average.

Or it could mean the same thing you just did but when you do it, you get certain kinds of molecules more weight and it does not tell us which of those three it is so it is indefinite.

Well, at this point what happened on this issue is what often happens, experts come in in both sides and they submit reports and they testify.

And they were quite a few, and among other things they introduced was a graph, and the graph says Sandoz that proves were right or at least does not prove that Teva is right.

And Teva according to the District Judge eventually is right about the graph and the other things so they win, it then goes to the Court of Appeals for the Federal Circuit and the Court of Appeals for the Federal Circuit says we review this de novo, and we think in respect of that graph the District Judge made the wrong factual finding.

Now we have got to the legal issue.

The legal issue is, should the Court of Appeals as they often do review this de novo or should when they review this factual matter about the significance of this graph and what those curves meant which is a factual matter, though it is an expert factual matter.

Should they have deferred to the District Court, and we think they should have deferred, in this case and other similar cases.

Now our basic reason for thinking that is Rule 52(a).

It says that what District Courts are supposed to do is they are supposed to do in factual matters overturn the factual determination of a District Court only if it is clearly erroneous.

So that gives deference or weight for the District Court, and that is what we say they should do here because it was a factual matter.

And that is true in whole lot of other cases where the same problem has arisen there, and we have various reasons for that.

For one thing we think that that is what the rule says and we could not find a good reason not to follow the rule.

And for another thing we think this is not really that much like a statute where sometimes will courts — appellate courts will look into the underlying factual things, it is more like a deed or a contract or will or a certain kind of instrument, a legal instrument where judges are given weight in their fact findings by the appellate court when they are trying to interpret it, and there are other reasons, and if you read the opinion you will find the other reasons.

If you read both opinions you will find lot of interest here in particular if you are interested in molecular weight, kilodaltons and such matters.

But it is — our ultimate conclusion is yes, give weight to the District Court.

Justice Thomas has filed the dissenting opinion which Justice Alito joins.