More on the Proposed ANDA / 505(b)(2) Rule

As we continue our march through the 371 page document, as something piques our interest we will provide you with a bit of a summary along with some background.  Here are today’s tidbits!

Amended Patent Certifications

The Proposed Rule clarifies the FDA expectation as to when an amended patent certification must be made.  Currently, a new patent certification is required to add a new condition of use or new indication or to add a new strength of the product.  The FDA is now proposing to codify the requirements to also require a new patent certification with an amendment for anything other than a minor formulation change or to change the crystalline or polymorphic form of the drug.

Once a court decision is rendered declaring a patent invalid or not infringed or upon voluntary withdrawal of the patent by the NDA holder, historically, the FDA has maintained the patent listing in the Orange Book to protect the 180-day exclusivity of the first-to-file against that patent.  The FDA is now codifying that process.

Cite to Pharmaceutically Equivalent Product

“The proposed regulations will require a 505(b)(2) applicant to identify a pharmaceutically equivalent product if one is already approved, as the listed drug and follow the regulatory requirements including appropriate patent certifications and exclusivity statements.  FDA is proposing this to ensure that a 505(b)(2) applicant does not circumvent the patent certification obligations if the proposed product was not eligible as an ANDA.”  This is somewhat different from the “selection of the closest pharmaceutical equivalent” argument that FDA has made in some instances in the past and is perhaps being proposed to make a distinction between the argument FDA made recently in the colchicine case, where they did not require reliance on the most similar product for another 505(b)(2) application for a product which was a different dosage form.

Receipt of Patent Notice and Trigger of 30-month Stay

FDA is clarifying that the date of the 30-month stay will begin on the “latter of the date of receipt of notice of paragraph IV certification by the any owner of the patent or by the NDA holder who is an exclusive licensee” of the patent.   FDA is codifying what is their current practice to assure that each patent holder or NDA applicant received its full statutory 30-month stay.  This applies when the patent holder may be different from the NDA holder and where notice (which is required to be sent to each) may be delayed to one party.  So the 30-month stay does not start until the date of the latest receipt of the notice by all impacted parties.

That’s it for today.  Stay tuned for more on this Proposed Rule.