FAQs Patent Questions

Question:When is a patent extension application submitted and where is it submitted?

Answer:
Application for patent extension must be filed within 60 days of FDA approval of the drug product even if the product cannot be commercially marketed at that time.

Question:How do I obtain the status of a patent?

Answer:
The Patent Application Information Retrieval (PAIR) system permits third parties to obtain information about applications that have been published pursuant to 35 U.S.C. 122(b) and issued patents, such as the status of maintenance fee payments and whether or not a reissue application or reexamination request has been filed. PAIR can be accessed on the United States Patent and Trademark Office (USPTO) web site at http://portal.uspto.gov/external/portal/pair.

Question:The requirements for filing a substitute specification is stated under the 37 CFR 1.125

Answer:
When applicants file a substitute specification, the following are required under 37 CFR 1.125: (1) a statement that the substitute specification includes no new matter; (2) a marked-up version of the specification with markings to show all the changes relative to the immediate prior version; and (3) a clean version of the substitute specification.

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