Saturday, October 18, 2014

More Teva v. Sandoz: what factual issue?

The underlying legal issue in Teva v. Sandoz is "how" one of ordinary skill in the art would have construed the term molecular weight when said term was not defined in the specification. The Teva expert rendered an opinion, which was directed to this legal issue. Should that opinion of an expert directed to the determinative legal issue be considered a factual issue?

A commenter on PatentlyO cites to a PatentDocs post from July 29, 2013 for the text

The Appellants challenged the lower court’s determination that “molecular weight” could be defined, because one of skill in the art would not understand which measurement (Mp, Mw, Mn, or something else) should be used. The specification of the patents-in-suit was silent as to which measurement was appropriate, other than to describe the use of SEC (which can be used to obtain all three values). Statements made in the prosecution history compounded the problem. In response to an indefiniteness rejection in one of the patents, the patentees said that “[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that ‘average molecular weight’ refers to the molecular weight at the peak of the molecular weight distribution curve,” or Mp. However, in response to an identical rejection in an earlier related application, the patentees said that “”[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight,” or Mw.

Teva argued that one skilled in the art would have understood that average molecular weight could only be Mp. Teva asserted that use of SEC without more suggests Mp because determining Mn and Mw required additional calculations. The Court appeared skeptical of this argument, because SEC can be used to calculate all three values. Teva also downplayed the prosecution history by explaining that a skilled artisan would recognize that the statement in the earlier application was false — because “kilodalton units” does not imply weight average. Teva appears to have alleged that the second statement rectified the earlier misstatement. However, there is no indication that the patentees in the later application retracted the earlier statement. Therefore, the Court was left with two contradictory statements that could not be rectified. As such, the claims in Group I were held to be indefinite.

From an IPBiz post, July 27, 2013:

As to the group I claims, Teva had a problem because of arguments made in file histories. For one application, Teva argued molecular weight was Mp (peak average) but for another Mw (weight average). As the CAFC observed, Teva's two definitions cannot be reconciled. There was also an inconsistency within a figure as between the graph itself and the legend for the figure.
[The CAFC stated the peak average molecular weight Mp is the molecular weight of the most abundant molecule in the sample, so that it is not an "average" molecular weight." The CAFC also noted that Mn is the total mass of all molecules divided by the number of molecules, but did not give a definition for Mw. For completeness, Mw is the sum of the (square of molecular weight X number with that molecular weight) divided by sum of (molecular weight X number with that molecular weight).)

From IPBiz post, Why did the Supreme Court take Teva v. Sandoz? , April 22, 2014:

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]


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