Martin Shimer Reviews Patents and Exclusivity

In a CDER Conversation piece entitled Patents and Exclusivities for Generic Drugs, Captain Martin Shimer, Deputy Direction, Division of Legal and Program Support, Office of Generic Drugs (OGD), briefly outlines various issues with patents, patent certifications and describes that various types of exclusivity that must be dealt with.

Patents are pretty straight forward, with the Orange Book listing the patents that ANDA applicants must address in their submissions with wither a paragraph I, II, III or IV certification.  Patents offer certain periods of protection from competition unless the patents are found to be invalid, not infringed by the generic product or are unenforceable.   We all know about the requirements for patents certifications and the impact that the specific certification may have on when the Agency may approve an ANDA, with the paragraph IV patent challenge the most contentious.  Shimer indicated that about 40% of all ANDAs received contain a paragraph IV patent challenge.  This is certainly an interesting statistic which I am not sure I had ever really seen before.

The article goes on to discuss the various types of exclusivity protection that are available to either the innovator or in the case of 180-day exclusivity the first to file a paragraph IV certification.  The list along with their explanation appears below:

  • Five-Year New Chemical Entity. This exclusivity applies to a brand-name drug that contains a new chemical entity (NCE), which is a drug substance that contains an active ingredient or moiety(ies) never previously approved by the FDA. This exclusivity generally blocks the submission of any ANDA that contain the same active moiety for five years.
  • Three-Year New Clinical Studies. This exclusivity attaches to a brand-name drug approved for a new use for a previously approved drug product. Applications for such new uses must be supported by information from new clinical investigations essential to approval of the new use, and conducted or sponsored by the applicant.  Such new uses could include changes in strength, dosage form, route of administration, or indication.
  • Orphan Drug. Certain drugs designated for the treatment of a rare disease or condition (e.g., one affecting fewer than 200,000 people in the United States each year) are eligible for orphan-drug exclusivity upon approval. This exclusivity prevents approval of any other application (brand-name or generic) for the same drug for the same orphan-protected use during a seven-year period.
  • This type of exclusivity is granted to a brand-name drug for which pediatric clinical studies have been conducted in response to a written request for such studies from the agency. Generally, pediatric exclusivity attaches to existing patents or exclusivities associated with the product line for the brand-name drug for six months.
  • The “Generating Antibiotic Incentives Now” (GAIN) exclusivity generally provides for an additional five years of exclusivity added to certain other exclusivity periods for a drug product that has been granted a “Qualified Infectious Disease Product” designation by FDA.
  • 180-Day. This type of exclusivity may be granted to the first generic applicant(s) to submit a substantially complete ANDA that contains a challenge to a patent listed in the Orange Book. The generic drug applicant found to be eligible for this exclusivity has an exclusive right to market the generic drug for 180 days.  Only ANDAs are eligible for this exclusivity.

Every once in a while, it pays to review these protections and the article does just that as well as providing a list of helpful Q&As.  The full text of the article can be found here.