Orange You Glad You Used the Right Form?

Listing patent information in the Orange Book is one of the most important things you can do as an innovator sponsor to ensure that your property rights are respected.  And, of course, it’s statutorily required.  So that makes the new guidance FDA just issued on how to list your patents in the Orange Book—or rather how to properly fill out Forms 3542a and 3542—pretty important.  It’s not groundbreaking stuff if you’re familiar with the forms, but the submission is complicated when you’re not experienced with it.  This guidance serves to simplify it.

With the familiar Question and Answer format, the 3542 guidance begins by outlining the statutory requirement to submit drug product, drug substance, and method-of-use patent information both as part of an NDA or supplement and after approval.   Form 3542a should be used for applications in progress while Form 3542 is used for approved applications and can be submitted no later than 30 days after approval unless the patent issues after approval.  If a patent issues after approval of the NDA, the sponsor must submit a Form 3542 no later than 30 days after patent issuance.

If FDA identifies errors in a timely filed Form 3542, the NDA sponsor has 15 days from FDA notice to remedy the issues.  And if a sponsor is changing the description to an approved use code, the sponsor must submit Form 3542 within 30 days of the corresponding change to product labeling or within 30 days of a decision by the court or PTO that alters the construction of the patent’s method-of-use claim.

The guidance further reminds sponsors that the correct form must be used and filed within the 30-day window, with one issued patent per form.  The forms must be filed through the Electronic Submission Gateway and should not be sent any other way.  Nor should copies of patents be submitted.

There is little in the way of substantive advice in the new guidance, but it does highlight several recurring deficiencies that sponsors should watch out for:

• Failure to identify any applicable U.S. agent for either the patent owner or NDA holder;
• Failure to describe and clearly explain all changes made by the NDA holder to a use code listed for its drug product in the Orange Book.
• Failure to identify the specific subsections of the approved product labeling that describe the approved method of use claimed by the patent submitted.
• Failure to ensure the use code description matches the corresponding use code description in the Orange Book where the sponsor intends to use a use code identical to one already published in the Orange Book.

Remember that only listable patents can be included (drug substance, drug product, and method-of-use patents) and that FDA has strict timing rules for 3542 submissions.

Again, this guidance isn’t novel, but it is important because it gives sponsors a roadmap for timely and accurate Orange Book submissions.  Just don’t forget to use the correct form!