The Biden administration says it will support lifting patent protections

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16. They are related

in terms of actually "following the process exactly" with whatever that gets synthesized actually being what it is supposed to be when synthesized. Any slight deviation (pH of buffers, medium temps, centrifuge speeds/timing, etc), might result in a near-identical but slightly different entity (that itself also might have been patented, but was not explicitly approved for manufacture in the agreement). And thus if further protocols were not followed for batch/lot testing of that, no one would be the wiser, and the efficacy might be altered.