English to Russian Law/Patents Law: Patents, Trademarks, Copyright

In particular, Petitioner asserts that Edwards inherently discloses treating RA with rituximab "in a human patient who experiences an inadequate response to a TNFα-inhibitor," an element required by each of the challenged claims.

"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). "Inherency ... may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient."

Patent Owner asserts that Petitioner's inherency position is insufficient, as it is based upon probabilities. Prelim. Resp. 31-32. We agree. It is well established that "inherency does not follow even from a very high likelihood that a prior art method will result in the claimed invention." In re Montgomery, 677 F.3d 1375, 1384 (Fed. Cir. 2012), citing Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed.Cir.1995) (holding that even though the defendant's experts reproduced a prior art method "thirteen times and each time they made [the claimed] crystals," the patentee's chemists twice produced different crystals from the same method, thus precluding inherency).

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Dr. Boers provided testimony based upon a belief that "patients who experience 'an inadequate response' [to a TNFα-inhibitor] are not limited to patients who have actually been treated with a TNFα-inhibitor." Ex. 1002 ¶ 27. Dr. Boers explains that "many patients inherently have an inadequate response to TNFα-inhibitor" and that such a response is innate to one's physiology.

В последнем случае, как я понял, речь идет о том, что многие по своей природе дадут ненадлежащий ответ, даже если не проходили такое лечение. То есть посчитать всех, у кого наблюдался такой ответ, не будет правильным, нужно учитывать вероятность, что среди остальной выборки есть еще такие же пациенты.

Слово одно и то же, но смысл в первом случае для меня не очень понятен.