Justices Side With Teva on MS Drug Patent

WASHINGTON (CN) - Teva Pharmaceuticals won another shot from the Supreme Court on Tuesday to fight generic versions of its patented multiple sclerosis drug.

The dispute stems from infringement claims that Teva, Yeda Research and Development, and other affiliates lobbed against Sandoz, Mylan and five other companies over the $4.3 billion-a-year multiple sclerosis drug Copaxone (glatiramer acetate).

Though a federal judge in Manhattan found that the defendants had infringed various claims of nine Teva patents-in-suit, the Federal Circuit gave the drugmakers some relief last year in finding a group of claims invalid for indefiniteness.

Teva's invalidated patent was set to expire on Sept. 1, 2015, but the Federal Circuit's ruling let the generic drugmakers enter the market last year.

The Supreme Court refused to stay that mandate but it vacated the Federal Circuit's ruling 7-2 on Tuesday after finding that the lower court reviewed the appeal under the wrong standard.

Writing for the majority, Justice Stephen Breyer cited an example from the District Court's analysis of a patent term that illustrates how "the Federal Circuit wrongly reviewed the District Court's factual finding de novo," rather than for clear error.

"The District Court's finding about this matter was a factual finding - about how a skilled artisan would understand the way in which a curve created from chromatogram data reflects molecular weights," Breyer wrote. "Based on that factual finding, the District Court 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).

The Federal Circuit accepted the defendants' argument, however, after it "recognized that the peak of the curve did not match the 7.7 kilodaltons listed in the legend of figure 1."

Breyer said "it did not accept Teva'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," the decision continues. "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.

Justice Samuel Alito joined the dissent by Justice Clarence Thomas, which says that the Federal Circuit applied the correct standard since claim construction does not involve findings of fact.

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