Tuesday, January 20, 2015

Teva wins at Supreme Court by 7-2 vote

Reuters noted of the case

 In a 7-2 vote, the justices sent the case back to the U.S. Court of Appeals for the Federal Circuit for further review saying it had not used the correct approach in analyzing whether the patent, due to expire in September 2015, was valid. The appeals court had thrown out the patent in 2013.


Justices Thomas and Alito dissented.

The  punch line of the dissent is in the last paragraph:  Although it relied on expert testimony to understand  the science underlying petitioners'  claims, the District Court made no findings of fact as that term is used in Rule 52(a)(6).

The opinion by Teva's expert is, as a factual matter, clearly erroneous.

The comments by the majority in Section III are of interest.

The Supreme Court vacated the judgment of the CAFC.

From Section III:

 We can illustrate our holding by considering an instancein which Teva, with the support of the Solicitor General, argues that the Federal Circuit wrongly reviewed the District Court’s factual finding de novo. See Brief for Petitioners 54–56; Brief for United States as Amicus Curiae 31–32. Recall that Teva’s patent claim specifies anactive ingredient with a “molecular weight of about 5 to 9kilodaltons.” Recall Sandoz’s basic argument, namely thatthe term “molecular weight” is indefinite or ambiguous.The term might refer to the weight of the most numerousmolecule, it might refer to weight as calculated by the average weight of all molecules, or it might refer to weight as calculated by an average in which heavier moleculescount for more. The claim, Sandoz argues, does not tell uswhich way we should calculate weight. See Part I, supra.To illustrate, imagine we have a sample of copolymer-1
(the active ingredient) made up of 10 molecules: 4 weigh 6 kilodaltons each, 3 weigh 8 kilodaltons each, and 3 weigh9 kilodaltons each. Using the first method of calculation,the “molecular weight” would be 6 kilodaltons, the weight of the most prevalent molecule. Using the second method,the molecular weight would be 7.5 (total weight, 75, di- vided by the number of molecules, 10). Using the thirdmethod, the molecular weight would be more than 8, depend-
ing upon how much extra weight we gave to the heavier molecules.
Teva argued in the District Court that the term “molecular weight” in the patent meant molecular weight calculated in the first way (the weight of the most prevalentmolecule, or peak average molecular weight). Sandoz, however, argued that figure 1 of the patent showed that Teva could not be right. 810 F. Supp. 2d, at 590. (Wehave set forth figure 1 in the Appendix, infra). That figure, said Sandoz, helped to show that the patent term did not refer to the first method of calculation. Figure 1 showshow the weights of a sample’s molecules were distributedin three different samples. The curves indicate the number of molecules of each weight that were present in each of the three. For example, the figure’s legend says that the first sample’s “molecular weight” is 7.7. According toTeva, that should mean that molecules weighing 7.7 kilodaltons were the most prevalent molecules in the sample.But, look at the curve, said Sandoz. It shows that the most prevalent molecule weighed, not 7.7 kilodaltons, but slightly less than 7.7 (about 6.8) kilodaltons. See App.138a–139a. After all, the peak of the first molecular weight distribution curve (the solid curve in the figure) is
not at precisely 7.7 kilodaltons, but at a point just before
7.7. Thus, argued Sandoz, the figure shows that the patent claim term “molecular weight” did not mean molecular weight calculated by the first method. It must mean something else. It is indefinite. 810 F. Supp. 2d, at 590.
The District Court did not accept Sandoz’s argument.Teva’s expert testified that a skilled artisan would understand that converting data from a chromatogram to molecular weight distribution curves like those in figure 1would cause the peak on each curve to shift slightly; thiscould explain the difference between the value indicatedby the peak of the curve (about 6.8) and the value in the figure’s legend (7.7). App. 138a–139a. Sandoz’s expert
testified that no such shift would occur. App. 375a–376a.The District Court credited Teva’s expert’s account, thereby rejecting Sandoz’s expert’s explanation. 810 F. Supp. 2d, at 589; Brief for Respondents 61. The District Court’s finding about this matter was a factual finding—about how a skilled artisan would understand the way in whicha curve created from chromatogram data reflects molecular weights. Based on that factual finding, the DistrictCourt reached the legal conclusion that figure 1 did not undermine Teva’s argument that molecular weight referred to the first method of calculation (peak average molecular weight). 810 F. Supp. 2d, at 590–591.
When the Federal Circuit reviewed the District Court’s decision, it recognized that the peak of the curve did notmatch the 7.7 kilodaltons listed in the legend of figure 1. 723 F. 3d, at 1369. But the Federal Circuit did not acceptTeva’s expert’s explanation as to how a skilled artisan would expect the peaks of the curves to shift. And it failed to accept that explanation without finding that the District Court’s contrary determination was “clearly erroneous.” See ibid. The Federal Circuit should have accepted the District Court’s finding unless it was “clearly erroneous.” Our holding today makes clear that, in failing to do so, the Federal Circuit was wrong.


See previous IPBiz posts



with text:

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.



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