JUST OUT - Molecular weights at the Supreme Court - Teva v Sandoz
This moggy covered (here and here) the UK litigation of Generics (t/a Mylan) v Yeda/Teva, in which a patent that covered glatiramer acetate (copolymer 1 or copaxone) was held valid despite having a few issues, one of which was that the claims specified a particular molecular weight range, but did not specify what method was used to measure the molecular weight. This finding was upheld on appeal as reported by Jeremy here.
Well, today the Supreme Court of the USA has weighed in on the same matter in the case of Teva v Sandoz. The judgement is out here (pdf). Sandoz argued that the equivalent US claim that specified "a molecular weight of 5 to 9 kilodaltons" was fatally indefinite under §112.
In the US litigation, the District Court declined to hold the claim fatally indefinite as Sandoz urged, and was convinced by Teva's argument that the claim clearly meant the "peak average molecular weight", and not either of the two alternatives of "number average molecular weight" or "weight average molecular weight".
On appeal, the Federal Circuit held to the contrary and found the patent invalid for indefiniteness. In reaching this conclusion, the Federal Circuit reviewed de novo all aspects of the District Court’s claim construction, including the District Court’s determination of subsidiary facts. The issue before the Supreme Court was whether that was permissible, or whether the Federal Circuit had impermissibly set aside the District Court's findings of fact without the requisite finding of clear error on the part of the District Court (in violation of Federal Rule of Civil Procedure 52(a)(6), for what it is worth).
Justice Breyer gave the Opinion of the Court with which Roberts, Scalia, Kennedy, Ginsburg, Sotomayor and Kagan joined; Justice Thomas filed a dissenting opinion in which Alito joined. According the majority opinion the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit's decision was vacated and the case remanded.
In the dissenting view, the opinion was that the Federal Circuit had not overturned findings of fact, but had instead formed a different conclusion of law as to the claim construction. Therefore, there had been no breach of the Federal Rules of Civil Procedure.
So back to the Federal Circuit before we find out what happens to the case substantively!
Justice Breyer gave the Opinion of the Court with which Roberts, Scalia, Kennedy, Ginsburg, Sotomayor and Kagan joined; Justice Thomas filed a dissenting opinion in which Alito joined. According the majority opinion the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit's decision was vacated and the case remanded.
In the dissenting view, the opinion was that the Federal Circuit had not overturned findings of fact, but had instead formed a different conclusion of law as to the claim construction. Therefore, there had been no breach of the Federal Rules of Civil Procedure.
So back to the Federal Circuit before we find out what happens to the case substantively!
