Teva prevails in Copaxone case, but was the case correctly decided?
the district court’s judgments of infringement and no
invalidity with respect to Group II claims, reverse its
judgment of no invalidity with respect to Group I claims,
The defendants argued that the claims were indefinite under 35 USC 112 P 2 because the
term "molecular weight" was ambiguous.
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).)
The group II claims survived because molecular weight was expressed differently than for group I. Within group II claims, the measure was a fraction of molecules falling within a certain molecular weight range.
There was separately an issue of lack of enablement of the ways to measure molecular weight.
Although the court rejected the appellants' arguments of nonenablement, it did appear that there were some issues with the calibrations. The CAFC cited Edwards v. Corevalue, 699 F.3d 1305 (CAFC 2012) , for the proposition that failure to enable a commercial embodiment does not constitute failure to enable.
Although not evident within the CAFC opinion, there is a relationship between the indefiniteness argument against group II claims and the enablement argument. If there were no molecular weight standards disclosed in the applications to unambiguously measure the exact molecular weights of the type recited in group II, then the group II claims are in fact insolubly ambiguous. Different standards will give different molecular weight values, and the skilled artisan could not determine the metes and bounds of group II claims. That is, 2kD and 20 kD are NOT precise points on a molecular weight axis, if the axis itself may move depending on what calibration is used to establish the axis. Although it is correct that methods to calibrate molecular weight scale were known, unless the precise calibrants are recited, the exact molecular weight scale is unknown.
The CAFC decision as to the group II claims would appear to be based on an incorrect scientific understanding, and ultimately legally incorrect.
As a small point, for legal precedent on obviousness, the Teva opinion cited Allergan v. Sandoz, (May 1, 2013) and not KSR. Separately, the Teva opinion might be in error in stating that asserting a preference for one range amounts to teaching away from a different range.
Note: “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Teaching an alternative or equivalent method, however, does not teach away from the use of a claimed method. See In re Dunn, 349 F.2d 433, 438 (CCPA 1965).
To teach away, prior art must “criticize, discredit, or otherwise discourage the solution claimed.” Mere disclosure of alternative embodiments is not a teaching away. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
“A reference may be said to teach away when a person of ordinary skill, upon reading
the reference, would be discouraged from following the path set out in the reference, or would be
led in a direction divergent from the path that was taken by the applicant.” A reference, however,
does not teach away if it “merely expresses a general preference for an alternative invention but does
not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.”