Term Extension for Medical Patents
The maximum term extension for Medical Patents (and the invention claimed in a Medical Patent that was the subject of regulatory review) is five years from the original expiration date.
The regulatory body for this type of exemption is generally the Food and Drug Administration.
However, not all Medical Patents receive the benefit of the maximum term extension.
What Type of Medical Patents Receive Maximum Term Extensions?
35 U.S.C. §156, in part, reads:
(g) For purposes of this section, the term “regulatory review period” has the following meanings:
(1) (A) In the case of a product which is a new drug, antibiotic drug, or human biological product, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a new drug, antibiotic drug, or human biological product is the sum of …
(i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 2 became effective for the approved product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507,2 and
(ii) the period beginning on the date the application was initially submitted for the approved product under section 351, subsection (b) of section 505, or section 507 2 and ending on the date such application was approved under such section.
(3) (A) In the case of a product which is a medical device, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a medical device is the sum of—
(i) the period beginning on the date a clinical investigation on humans involving the device was begun and ending on the date an application was initially submitted with respect to the device under section 515, and
(ii) the period beginning on the date an application was initially submitted with respect to the device under section 515 and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of product development protocol was initially submitted under section 515(f)(5) and ending on the date the protocol was declared completed under section 515(f)(6).
(6) A period determined under any of the preceding paragraphs is subject to the following limitations:
(A) If the patent involved was issued after the date of the enactment of this section, the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years.
Conclusion
New drugs, antibiotic drugs or human biological products and Class III medical devices subject to FDA approval can be granted a five-year term extension from the original expiration date of the Patent.
Medical devices approved under the 510K process are not eligible for any term extension of the Patent.
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