MNTA will rely more on trade secretes and less on patents from here on. Moreover, it’s reasonable to assume that the FDA will be less revealing of the methods used by ANDA applicants in light of the CAFC ruling in the Amphastar case.
In the FoB arena, relatively little IP has been patented by FoB’s aspirants. Under the 351(k) regulatory pathway, an FoB applicant must disclose IP to the branded-drug company, but not to competing FoB players.
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