Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website?
Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top selling prescription brand-name drugs, sponsors of innovator drug products and generic manufacturers need to know the ins and outs of patents and exclusivity.
A patent is a property right issued by the United States Patent and Trademark Office (USPTO) to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time, in exchange for public disclosure of the invention when the patent is granted. Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. A company may apply for a patent from the USPTO anywhere along the development lifeline of a drug and can encompass a wide range of claims. However, many other factors can affect the duration of a patent.
Patent information is required to be submitted with original new drug applications (NDAs) and supplements on FDA Form 3542a prior to approval. Post-approval, patent information should be submitted on FDA Form 3542. The information from FDA Form 3542 is published in the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). For patents issued after approval of the NDA, the applicant holder has 30 days in which to file the patent to have it considered as a timely filed patent. Patents may still be submitted beyond the 30 day timeframe but the patent is not considered a timely filed patent.
FDA will not publish the patent information on unapproved applications or on patents beyond the scope of the Food Drug & Cosmetic Act (i.e., process or manufacturing patents) in the Orange Book.
The patents that FDA regards as covered by the statutory provisions for submission of patent information are:
- patents that claim the active ingredient(s);
- drug product patents which include formulation/ composition patents;
- use patents for a particular approved indication or method of using the product & certain other patents as detailed on FDA Form 3542.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition.
Exclusivity is granted upon approval of a drug product if the statutory requirements are met. The length of time that FDA grants new drug exclusivity depends on the type of exclusivity. Note that exclusivity is not added to the patent life.
Read also: Drug Master File in Pharmaceutical Industry
Resource Person: Chakrapani K V C