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Sunday, July 21, 2024 5:38:06 PM
Another company cannot use existing BIEL CLEARANCE(S) required to sell Class II Medical Devices by simply replicating the product.
Path of least resistance is for a prospective company to BUYOUT today if they want to have those FDA - Cleared products under their roof NOW and get a jump on 01 January 2025.
They could then file for patents on existing products as there is no replication of products involved, and therefore no “cancellation” of FDA Clearances…unlike there would be would be if they were an “outside” company replicating BIEL’s products. In effect, the buyer “BOUGHT” the Clearances.
I imagine they could even submit new application(s) for FDA clearances on future modifications they make using “former BIEL’s” products as a predicate.
Patents protect infringement for any company’s products and is the basis for legal recourse. New buyer needs that.
FDA Clearances are the ticket to sell product. Comes with buyout. A totally separate issue from patents.
Imo
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