Sorry for the confusing language. My only point about patents was that I have never known FDA to question patents, GMP approved facilities - yes, sufficient demonstrated capacity - yes, but, patents - no. They are not as common in mfg as you may think, though they are much more common in biologic mfg, though declining as the base technologies become accepted standards. You can mfg with or without patents, as long as someone else does not own the patent, and, that is possible and maybe a question the agency asks but I have just never heard of it asked.
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