Another Claim Bites the Dust left by Teva v. Sandoz

iStock_000022074976_SmallAlthough the jury found the claims valid, and the Fed. Cir. affirmed, this decision, which found that the claims were not insolubly ambiguous, was revisited by the Fed. Cir. While there are pages on issue preclusion, in the end, the Fed. Cir. took the appeal and reversed its original position. Here there were four possible methods to measure the parameter “stretch hardening” of the claimed polymer, and the specification did not identify which one was used. Following Teva, in which three┬ámethods of measuring molecular weight led to the Supreme Court’s imposition of the “reasonable certainty” standard for determining if a claim satisfied s.112, the Fed. Cir. had little choice but to invalidate the claims that recited this parameter. I have always resisted the mantra that would require lots of definitions of claim elements, but the writing is on the wall, and this new “easy-to-use” mode of claim invalidation will only gain momentum.

Dow v Nova

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2 Responses to Another Claim Bites the Dust left by Teva v. Sandoz

  1. george liu says:

    Hi Warren,
    thanks for your sharing.
    It has been a challenge to extract additional information from inventors because they thought that all others should know that much as they do. In this case, I assume that the scientists from Dow would have assumed that their methods are well known; while it turned out it is not, should the patent attorney bear the blame?

  2. Paul Cole says:

    There is a close similarity between the role of an inventor as the author of an article or a thesis for a PhD examination and a patent attorney as a referee or one of the external examiners. The comment in George’s second sentence is a matter of daily experience, time and cost pressure exert a negative impact on the quality of the resulting specification and although it is possible to point to errors and omissions, hindsight is a wonderful thing.

    Molecular weight is a well-known trap. A polymer specified as a range of weight average molecular weights weight defines a different material from that defined by number average molecular weight, and in some instances there may be no overlap between the populations of material according to the two different statistical definitions. To say that Teva is unsurprising is an understatement.

    In the present case if you look at the Dow patent the situation is less clear-cut. The specification is lengthy, detailed and well-written. There is a lengthy and detailed definition of how the stretch parameter in question should be measured. The patent attorney is not a person fully skilled in the art, even if working in-house, and may not pick up a subtle but important omission of the present kind. The inventor himself or herself may not realize it.

    On the whole I dislike blame games. However, the omission flows from the disclosure of the author in the case of a thesis or journal article or the inventor in the case of an invention. In chemistry we are taught at school the importance of writing-up our experiments and the importance of doing so fully and accurately. It is a possibility, though less than a certainty, that if the experiments in the Dow patents had been recorded in exhaustive detail, what was done in the slope calculations would have been recorded and the ambiguity would have been resolved. Primary responsibility for adequacy of disclosure rests on the author or inventor, and whereas this is appreciates in the case of theses and articles, in the case of patents unfortunately it is not, often because the inventor leaves detail to the attorney who is the “hired help”.

    It should be emphasized that specification drafting is a team task. The input of the attorney is a vector of fixed length defined by the expected skill and knowledge of that attorney, whereas the input of the inventor is a vector of variable length and direction that determines eventual outcome. Persuading inventors that they need to make a sufficient and detailed disclosure of all that they have done is a difficult and often painful task, and as these cases point out important detail is all too easy to miss.

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