Avid Bioservices Inc (CDMO)

[Bungler]

CP, permitted clinical use of a patented compound has nothing to do with whether or not it has been approved for marketing. It is expressly permitted by US Law. 35 USC 271(e) exempts all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs, from claims of patent infringement. So held the US Supreme Court in Merck KGaA v. Integra Lifesciences I, Ltd. 545 U.S. 193 (2005).

PD-1 is NOT FDA approved as was CTLA-4.

That means PPHM could not do any pre-clinical or clinical trial with PD-1 without the authorisation of the BP that owns it