Replies to post #38699 on PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

Nice link!

[frosr6]

No de facto for PMCB! Pmcb's (Ciab) is NOT in FDA human trials so no time is being lost that would qualify them for the statute at 35 U.S.C. § 156(g)(3)(B) patent extension. Therefore the Hatch-Waxman Act you provided is not relevant.

Furthermore CIAB would be cassified as a class III requiring PMA not 510(k).

From the FDA
"If the device is a high risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury) and has been found to be not substantially equivalent (NSE) to a Class I, II, or III device, then the device must have an approved PMA before marketing in the U.S.


Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the class III device."

Under the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review period” is composed of a “testing phase” and a “review phase.” For a medical device subject to an approved Premarket Approval Application (“PMA”), the Patent Term Extension (“PTE”) statute at 35 U.S.C. § 156(g)(3)(B) states that the “testing phase” begins on “the date a clinical investigation on humans involving the device was begun and [ends] on the date [a PMA] was initially submitted with respect to the device.” The “review phase” is the period between PMA submission and approval. A patent term may be extended for a period of time that is the sum of one-half of the time in the “testing phase,” plus all the time in the “review phase.” The “regulatory review period” must be reduced by any time that the applicant “did not act with due diligence.” The total (calculated) regulatory review period may not exceed 5 years, and the extended patent term may not exceed 14 years after the date of PMA approval. FDA’s regulations implementing the PTE statute are located at 21 C.F.R. Part 60.


http://www.fda.gov/MedicalDevices/default.htm

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/03/pto-sidesteps-p.html