Generic Drugs and Branded Drugs - Details about the FDA Process

Drugs Manufacturers are required by the Food and Drug Administration (FDA) to submit details of the scope of their patents when they submit a New Drug Application (NDA). The details, along with the patent number and expiration date of each patent are published in “Orange Book”. The details, among other things, correspond to information about the drug’s components, clinical data and the intended uses for which the drug will be marketed. This information is called “use codes”. After the submission, FDA may approve the NDA for multiple “methods of use”. The “methods of use” roughly translates into treatment of different conditions or treatment of the same condition in different manners. Thus, the patentee has rights either on the drug compound itself or on a specific method of using the drug.

After an NDA has been approved, a generic company can consult the details of Orange Book and subsequently file an Abbreviated New Drug Application (ANDA), put simply, an application for manufacturing the generic version of the patented drug. The company filing the ANDA needs to show to the FDA that the generic drug will not infringe the patentee’s patent. The FDA evaluates the ANDA application to assess whether the proposed drug would infringe the patent on the basis of the information present in the Orange Book. A unique aspect about the entire cycle is that the FDA does not validate the information (use codes) entered in the orange book and “assumes” the information to be accurate. Thus, the use codes become the deciding factor in the approval or denial of the ANDA application.

In situations where no patents exist in the orange book and where the relevant patents will expire before the ANDA application is approved by the FDA, there is not much cause for concern. In situations where patents exist and are active, the generic company has two options. The first option is to file a “Section viii” statement and the second option is to file a “Paragraph iv” certification. Under the first option, the generic company markets the drug for one or more “methods of use” not covered in the patentee’s patent. This option differentiates the generic company’s intended method of use from the patentee’s (brand company) method of use and allows the generic company to manufacture and market the generic only under the “method of use” approved by the FDA. Under the second option, the generic company, by filing “Paragraph iv” certification, states that a listed patent in the orange book will not be infringed or is invalid. “Paragraph iv” certification provides more options to the generic company as it does not have to differentiate its method of use from the brand company’s method of use and allows the generic to market the drug for all uses. A peculiar thing about “Paragraph iv” filing is that under the statutes, “Paragraph iv” filing is considered as an act of infringement and the patentee has the right to drag the generic to the court of law. The approval of the ANDA in such cases is stalled for 30 months or until the court decides on the validity or infringement of the patent.