So that anyone isn’t fooled by some of the talk on Twitter that some CVM’s patents will be expiring soon…to be clear…the patents are not worth much. Patents only offer limited protection for the holder, but it doesn't matter for CVM.
Multikine is not a drug and therefore it doesn’t need this type of intellectual protection. It is a complex biologic which makes it nearly impossible to duplicate. In fact, if someone claimed they did duplicate Multikine, FDA would require them to go through a P3 trial.
6. What are the criteria for determining whether a patent for a human drug product is eligible for patent extension?FDA.org
The term of a patent which claims a human drug product, a method of using the product or a method of manufacturing the product will be extended from the original expiration date if it satisfies six conditions.
First, the applicant must show that the patent has not expired.
Second, the applicant must establish that the patent has not previously been extended.
Third, the patent owner or its agent must submit an application for patent term restoration that includes details about the patent and the activities undertaken to secure FDA approval.
Fourth, the applicant must establish the product was subject to a regulatory review period before its commercial marketing or use.
Fifth, the applicant must show that the product either represents the first permitted commercial marketing or use of the product after such regulatory review period or, in the case of a product manufactured under a process patent that primarily uses recombinant deoxribonucleic acid (DNA) technology, represents the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent.
Finally, the applicant must submit the application for patent term restoration to PTO within 60 days of FDA approval of the commercial marketing application.
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