FAQs Patent Questions

Question:Amendment documents that changes an existing claim must include a complete listing of all claims presented

Answer:
Any amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented.

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.

Question:What is the difference between patents and exclusivity?

Answer:
Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

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