Tuesday, April 22, 2014

Why did the Supreme Court take Teva v. Sandoz?

The U.S. Supreme Court has decided to review the case of Teva v. Sandoz. The legal issue is "what deference" is given to fact-finding by the district court. The science issue concerns measurement of molecular weight. The drug in question is Copaxone.

Teva, which lost at the CAFC as to its patent 5,800,808 (and thus stands to lose months of patent protection), framed the issue to the US Supreme Court as

Whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires.

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

The question, as framed by Teva, gets at the enduring question of the CAFC's de novo review of claim construction of district courts. Under current law, the appellate court gives no deference to the district court on how a patent claim is construed. This approach has been questioned for years. But one wonders if the Teva v. Sandoz case is the right vehicle to resolve the question.

What was the "factual finding" at issue in the case?

The CAFC found "group I" claims, which recited "molecular weights" of 5 to 9 kilodaltons, to be ambiguous because these claims did not specify how to measure the molecular weights. The district court construed the claims to reflect the molecular weight measure Mp (peak average molecular weight). Viewed in this light, the CAFC merely observed the self-evident legal problem: the claim did not say "which measure" of molecular weight was intended. End of story.

That is, without going into any "facts," one observes that the claim itself does not specify "which" measure of molecular weight is to be be used. This ambiguity was specifically identified by the Examiner during prosecution of the '539 and '847 patents. One might have thought the Examiner would have required insertion into the respective claims of the specific molecular weight measure. However, the Examiner apparently accepted arguments without requiring an amendment to achieve clarity. For the '539 patent, Teva said it was peak average, but for the '847 patent it was weight average. The contradictory resolution is a self-evident problem.

The matter of "facts" in the case enters in with the testimony of Teva's expert, Dr. Grant. The gist of his argument seems to be that because only Mp can be read directly from a size exclusion curve, Mp must have been intended for the "group I" claims. One wonders "why" the ability to read a parameter directly from a graph is proof of "which parameter" was intended in a claim.

As to legal matter of "clear error," the clear-error standard “requires
us appellate judges to distinguish between the situation in
which we think that if we had been the trier of fact we would
have decided the case differently and the situation in
which we are firmly convinced that we would have done so.”); Carr v. Allis
on Gas Turbine Div., Gen. Motors Corp., 32 F.3d 1007,
1008 (7th Cir. 1994)

Arguably, the crediting of the reasoning of Dr. Grant by the district court could be deemed clear error, and the debate rendered moot. [same outcome under either standard]

One also wonders why the Supreme Court took this case to begin to address the "de novo" review issue. When the standard for obviousness under 35 USC 103 was reviewed in KSR v. Teleflex, a very simple fact pattern existed. In the Teva case, one has some esoteric "molecular weight" issues, and some seemingly contradictory facts, which renders this case murky.

From a chemistry point of view, one of ordinary skill in the art knows that there are different measures of molecular weight, which give different results, and without guidance as to "which to use", one would not know the scope of the claim.

See earlier IPBiz post Teva prevails in Copaxone case, but was the case correctly decided?




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