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Tuesday, 20 January 2015

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!


Anonymous said...

A welcome decision I think. The Federal Circuit will now need to give more deference to District Court findings on claim construction. That is good for predictability. There may be more use of 'extrinsic evidence', e.g. experts, in District Court proceedings to make it less likely that the Federal Circuit carries out a de novo review of claim construction.

MaxDrei said...

Can you tell us what got into the Federal Circuit, to reverse the DC on the "average molecular weight" point. After all, the DC came to the same conclusion as Mr Justice Arnold did, in 466 careful paragraphs. In England, the issue wasn't even appealed, was it?

Anonymous said...

Anonymous @13:08,

A slight - but not minor - correction:

The Federal Circuit will now need to give more deference to District Court findings on extrinsic factual findings.

There remains a HUGE difference between extrinsic factual findings, the legal notion of just how those findings impact a case, and the STILL very much de novo review of the legal end game of claim construction.

As is beginning to be recognized across the blogosphere, that "it's good to be more predictable" comes at a higher cost - and provides a lower benefit (can you say dueling experts?) than what the first blush would indicate.

You still need to get to court to get to that extrinsic "certainty," and you can be sure that both sides will be vying for that leverage (thus, costs are sure to rise).

Anonymous said...

The dissenting opinion seems to see construction as entirely legal (without a 'factual' component). I'm not sure whether it's a good thing or bad thing that the Supreme Court judges cannot agree on what the components of construction are and therefore what level of deference is important.

Anonymous said...

MaxDrei I think the Federal Circuit just got used to doing de novo reviews because it's a specialist court that probably knows better. It's normally easier to throw something away and start again than to patch up a bad job. However unfortunately appeal systems don't work like that and now they're going to have to give District Courts more respect.

Darren Smyth said...

MaxDrei - you are indeed correct that in the UK the molecular weight point was not appealed. I had actually forgotten that, and so it is certainly ironic that it is the point keeping multiple layers of appeal and remittal going in the USA. Thanks for pointing it out.

Anonymous said...

Anonymous @ 14:52,

Hmmm, your post has me thinking - does multiple views in a legally binding opinion by a court signify a fatal level of lack of predictability?

Well, of course not.

Those views expressed in a dissent, no matter how "appealing" they may be to certain ideologies [pun intended], are LOSING views. By not garnering enough votes of consensus, they are informative of what the Court - as a whole - does NOT hold.

I am sure that they have some possible future value, signifying whose views may one day become ascendant (given a possible shift in Court composition), but for the here and now, only the majority position has the weight of law, and those views articulated, but not agreed upon by the majority, are indicative of non-law views.

Anonymous said...

I think there are 2 types of patent judgments at the Supreme Court: those that create new law and those that correct the Federal Circuit's actions. This falls into the latter category, bringing the Federal Circuit back into line on an issue where it overstepped the mark. The Federal Circuit needs to play its part within the system it is part of, being more cautionary in its actions. It may be filled with superstars but they still need to adhere to their court's role instead of creating issues that need to be sorted out.

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