Teva v. Sandoz: Teva’s Opening Merits Brief

By Jason Rantanen

Teva recently filed its merits brief in Teva v. Sandoz (previous PatentlyO discussion here and here).  It’s main argument on the issue of claim construction is that claim construction involves making findings of fact and Rule 52(a)(6) of the Federal Rules of Civil Procedure states that “[f]indings of fact, whether based on oral or other evidence, must not be set aside unless clearly erroneous.”   In support of the first part of this argument, the brief points to determinations about the perspective offered by a person of ordinary skill in the art and the use of extrinsic evidence to resolve ambiguities; these, the brief argues, are inherently factual determinations for which deference should be given to the district court.

A key issue will be whether these types of judicial determinations are actually factual findings, or whether they are something else.  Certainly reviewing courts make determinations about some types of historical evidence all the time – one need only look at Justice Breyer’s discussion of legislative history and Congressional intent in Aereo for recent example – without invoking deference.  These determinations aren’t limited to “purposivists”: Justice Scalia’s originalist approach to interpreting legal statutes, for example, involves looking to how the text would have been understood at the time it was issued, something that can involve historical linguistic research.  Figuring out whether the “facts” involved in claim construction are akin to something like legislative history or the historical determinations involved in an originalist approach, or instead are the type of “facts” encompassed by Rule 52 is central to the invocation of that rule.  Much of Teva’s brief seeks to tackle this challenge, arguing that the facts involved in claim construction are exactly the kinds of facts that are encompassed by Rule 52.

Of these arguments, I found the most compelling to be the point that even as  determinations such as the knowledge of a person of ordinary skill in the art are factual and reviewed with deference in one context (such as obviousness and enablement), they are reviewed without deference in claim construction.  It will be interesting to see how Sandoz responds.

One important tension that the brief fails to resolve, however, is the key question of how deference on factfinding plays into decisions about claim construction.  If the ultimate determination of the meaning of claim terms remains one of law, does that basically invite an obviousness-like determination wherein certain subsidiary issues – such as the knowledge possessed by a PHOSITA and content of extrinsic evidence – are reviewed with deference, but the reviewing court makes the final determination, weighing each of the various pieces of information, without deference?  Or is it something else?

The brief does seem to indirectly offer a vision of how deference to factual findings should work, but it strikes me as leaving no place for the other side of the mongrel practice: the legal component.  The vision offered by the brief appears in Part IV., on pages 53-54, where Teva argues that the Federal Circuit erred by not granting deference to the district court on the “understanding of Figure 1, of SEC technology,
and of the prosecution history.”  In other words, Teva’s view of deference manifests as the lens through which the interpreter of the legal doctrine looks at not just the extrinsic evidence (the SEC technology), but also the patent document itself and the prosecution history.  If this is the correct approach to deference – that the reviewing court must give deference to the district court’s interpretation of the patent document and prosecution history – it is hard for me to see anything left that isn’t entitled to deference.  (Maybe the ordinary meaning of the claims themselves?  But that’s “the ordinary meaning to a person of skill in the art,” so that doesn’t work.).  This “lens” approach to deference seems to go too far, in my mind, and is fundamentally at odds with the way other factual findings and deference work in patent law doctrines such as nonobviousness and enablement.

The brief also challenges the various rationales for reviewing factual issues in claim construction de novo: “Markman requires it” argument, the interpretation of legal documents is a question of law argument, and the uniformity argument.  It also  argues that allowing de novo review of facts on appeal produces poorer decisions and is costly to the patent system, citing to the reversal rate data.  (Although this latter point seems to depend heavily on how deference is actually implemented – it would seem that the de novo review of certain subsidiary elements of claim construction, alone, would have only a very marginal effect on decision quality and litigation cost).

You can download a copy of the brief here: Teva’s Opening Brief

14 thoughts on “Teva v. Sandoz: Teva’s Opening Merits Brief

  1. 5

    RE: “it would seem that the de novo review of certain subsidiary elements of claim construction, alone, would have only a very marginal effect on decision quality and litigation cost).”
    Perhaps, although summary judgment for non-infringement after [or together with] a Markman hearing is by far the most likely basis for getting S.J. in patent cases. Thus, [other than for IPRs] usually the only way for a patent suit defendant to avoid being stuck between only a choice of settlement or costly full blown discovery and trial on ALL possible issues. If Teva increases the sustaining of D.C. Markman claim-narrowing decisions based on extrinsic expert evidence of claim term meanings to a person of ordinary skill in the art at the time of the application filing, might that not encourage more S.J.s for non-infringement? Especially now with patent owners more likely to be risking an ambiguity rejection for seeking overly broad claim interpretations?
    However, those D.C. judges who refuse to even conduct Markman’ s until the eve of trial effectively deny defendants any such faster and lower cost defense. The Fed. Cir. ought to be addressing that.

    1. 5.1

      Paul, if a patent owner has adverse ruling on claim construction, more often than not they will stipulate to noninfringement so that they might appeal immediately. Moreover, given the two recent Supreme Court cases on the ability of courts to award attorney’s fees for asserting untenable positions, Octane Fitness and Hallmark, I would think most patent attorneys would stipulate to infringement rather than trying to proceed.

      The complicating factor I see here is the new Supreme Court case, Nautilus, on indefiniteness which critically depends on what one of ordinary skill in the art will understand the claim term to mean. This is the same consideration one encounters in claim construction. Thus the findings of fact on the one, claim construction, should also be binding on the indefiniteness analysis. The problem I see however is that there is a constitutional right to a trial by jury with respect to disputed facts when validity is at issue.

      I would think that smart patent owners would seek a trial by jury on these disputed facts after Nautilus to the extent a defendant asserts invalidity based upon indefiniteness and where that finding depends upon the resolution of the disputed facts. This would prevent the court from resolving these disputed facts during claim construction.

      We live in interesting times.

      1. 5.1.1

        Re: “..if a patent owner has adverse ruling on claim construction, more often than not they will stipulate to non-infringement so that they might appeal immediately.”
        Yes, but of course that stipulation for non-infringement is only IF the D.C. Markman claim construction is upheld by the Fed. Cir. Doesn’t that desirably save time and money for all parties and the Court? [Also, as you note, reducing the risk of a much larger High-Octane attorney fee sanction if either sides proposed claim interpretation was objectively unreasonable.] But only IF the Markman is held early enough in the litigation.]
        Since Markmans already allow contested facts testimony about claim term interpretations, why would that now have to be deferred to a full blown trial on all other issues? Just to benefit patent owners hoping to force settlements more easily?


          Paul, what I think is that if a defendant has a strong case on its construction, and that construction if accepted will lead to a finding and noninfringement, they will pursue that construction rather than assert the patent is invalid as indefinite. They run the risk if they assert that the patent is invalid because the patent owner may now demand a jury trial on disputed issues of fact and the courts will probably grant it. As a practical result, I think defendants will be pursuing noninfringement as a sole and exclusive strategy rather than pursuing both invalidity and noninfringement.


            Considering how common decisions of non-infringement are, and how very rare decisions of claim ambiguity have ever been, that certainly seems likely, but I have no idea if asserting both will create the problem you are concerned with, or not.


              Paul, well, allegations of indefiniteness have become routine — almost like willful infringement and inequitable conduct used to be. These latter accusation are now rarely made. I think indefiniteness will also become rare — for the reason I stated.

  2. 4

    The interesting question for me is this: will more D.C. judges start separately labeling parts of their claim construction decisions as “findings of fact” to more clearly bring them under FRCP Rule 52(a)(6) and reduce their Fed. Cir. reversals, by assuming the likelihood of another Sup. Ct. reversal of the Fed. Cir. in Teva v. Sandoz? Will not D.C. prevailing party’s attorneys be requesting that?
    [However, if the Fed. Cir. determines that those D.C. findings of fact are clearly inconsistent with intrinsic evidence in the records of the specification and the application prosecution itself, I would think they will still get overruled on appeal even after Teva?]
    [Also, claim ambiguity is a separate and now much more important issue even though tied to claim construction.]

    1. 4.1

      [Also, claim ambiguity is a separate and now much more important issue even though tied to claim construction.]

      Just ask those biscuit folks.

  3. 3

    I was wondering whether anyone has claimed a right to jury trial on indefiniteness, either before or since Nautilus, and whether there is a court ruling on the issue.

  4. 2

    The original panel decision was by Moore, Rader and Benson by designation. The trial was to the court, it appears. The Judge below was Barbara S. Jones of the SDNY.

    The factual dispute involved a measure of molecular weight, of which there are three known measures. The patent was non specific about which was intended. The lower court heard expert testimony that the written description could be interpreted only one way and that a “peak” average molecular weight was what the patent described and claimed. In the prosecution of a patent, the prosecuting patent attorney made a remark about what measure of molecular weight was intended and what he said made no sense. In a still later prosecution, the examiner again raised the same issue, and this time the patent attorney responded that “peak” was intended.

    The lower court her testimony from experts and credited the testimony of the patent owner that one of ordinary skill in the art reading the specification prosecution history would know that “peak” was intended. The nonsensical statement of the patent attorney was so far from technically accurate that one of ordinary skill in the art would give it no weight.

    The Federal Circuit reversed, and essentially substituted its own judgment of the record for that of the district court. In doing so, the court relied heavily on the different positions the patent applicant took before the patent office on the critical issue.

    One comes away from a discussion of the facts that the Federal Circuit was wrong to reverse the district court. However, the case does show that if one does not clearly described in the specification what one means by a particular term, and if one is not careful about statements made during prosecution, one is probably going to have a severe problem in court with definiteness.

    1. 2.1

      The post should read to the effect that the nonsensical statement was made during the prosecution of a later, but related, patent application.

    2. 2.2

      I must say, that I had a case exactly like this once upon a time where we were accused of infringement of a patent where the point of novelty was the degree of roughness. The specification disclosed two measures of roughness, one average, the other peak. The industry recognized both as measurements of roughness. The peak measurement was about 10 times the average.

      What measurement was intended by the claims that generally prescribed “roughness factor” never came up during prosecution. But during prosecution, the patent applicant distinguished the prior art by the great disparity between the roughness claimed and the roughness disclosed by the prior art. The problem was that the prior art was in average roughness, such that the if the prior art roughness were reinterpreted as peak roughness, the claim roughness would be right in the midst of the prior art roughness.

      It was my opinion then, and it is now, that the patent claims in that patent were indefinite.

  5. 1

    Apart from any (other) slight against the Justices of the Supreme Court, I would not compare what they “get away with” in the writings of their opinions with what lower level judges can or in actuality do.

    Lower level judges tend to write with more care (as a [TYPICAL] rule), given that someone above them may be readily available to trounce their decision for a misstep.

Comments are closed.