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Rats were sacrificed at 5 min, 30 min, and 60 min after medication and the brain tissue was rapidly harvested by dissection and snap-frozen in liquid nitrogen

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Applied that way, the court accepted objective same effect (¶74, resting heavily on Afqlir’s biosimilar approval status) but denied the second question: the skilled person, even with full knowledge of Afqlir’s composition, had no “begründete Erwartung” that swapping to a histidine buffer combined with removing the dissociated tonicity salt would preserve stability, given how differently the two buffers behave ionically at the relevant pH (¶75)