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ANDA Section VIII Label Carve-Outs Explained

ANDA Section VIII Label Carve-Outs Explained

One objective of the Hatch-Waxman Act was to help facilitate the approval and marketing of generic drugs while simultaneously guarding against patent infringement for the innovator product. Accordingly, the Hatch-Waxman Act requires ANDA applicants to make a certification regarding each of the patents listed in the Orange Book for the innovator product.  However, the Hatch-Waxman Act also permits ANDA applicants to avoid having to make patent certifications if the applicant does not pursue approval for the aspect of the innovator product that is covered by a listed patent. In this case, the ANDA applicant would make a Section VIII Statement.

Section 505(j)(2)(A)(viii) of the Food, Drug, and Cosmetic Act, aka the “Section VIII Statement,” protects generic drug companies from infringement lawsuits filed by innovator drug companies - as long as the ANDA applicant’s drug uses are not covered by the innovator patent(s).

But when should ANDA applicants submit Section VIII Statements? And what is the significance of the NDA holder’s use code?

A Quick Summary of ANDA Patent Certifications

Sponsors planning to market innovator drugs must submit a New Drug Application (NDA) containing extensive scientific evidence of the drug’s safety and effectiveness (for each indication), plus a list of any patents that claim the approved drug substance, drug product, or method of use.

Under the Hatch-Waxman Amendments, applicants for generic versions of brand name drugs can submit an Abbreviated New Drug Application (ANDA). The ANDA process is easier and quicker since it allows applicants to rely on the FDA’s previous findings of safety and effectiveness for the brand name drug. All the ANDA applicant has to show is that their generic version is bioequivalent to the listed drug.

With respect to any patents that are listed in the Orange Book for the brand name drug, ANDA applicants must submit a patent certification stating one of the following:

  1. That no patent information has been filed (Paragraph I Certification),
  2. That the relevant patent is expired (Paragraph II Certification),
  3. That the patent will expire on a certain date (Paragraph III Certification), or
  4. That the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug (Paragraph IV Certification).

If an applicant files a Paragraph I or II Certification, the patent in question (none in a Paragraph I Certification) won’t hinder ANDA approval.

For Paragraph III Certifications, the applicant must wait until the patent expires to seek final ANDA approval.

Applicants who want to seek ANDA approval before the patent expires can challenge the validity of the patent or try to prove that their product will not infringe on the patent by submitting a Paragraph IV Certification.

Once the ANDA applicant submits a Paragraph IV Certification, the NDA holder or patent owner will receive notice and can initiate a patent infringement action. As long as the patent holder initiates patent infringement litigation within 45 days of notice, the FDA must stay ANDA approval for 30 months from the notice date.  (This 30-month period may be shorter or longer depending on court proceedings).

After this 30-month period, the patent will no longer hinder final ANDA approval unless the court issues an injunction barring FDA approval. Also, if the patent owner does not bring suit within 45 days of the notice, the patent owner can still bring a- patent infringement action, however, the patent owner will not get the benefit of the 30-month stay.

When Do ANDA Applicants Use Section VIII Statements?

Besides the four patent certifications described above, there is another way an ANDA applicant can seek approval without having to address the listed patents – the “Section VIII Statement.”

If the relevant patent is listed only for a drug’s condition of use, the ANDA applicant can bypass Paragraph III or IV Certification and instead submit a Section VIII Statement acknowledging that the patent is listed and stating that it doesn’t claim the same condition of use that the ANDA applicant is seeking approval.

The ANDA applicant must then omit, or “carve out,” the protected use from its generic drug labeling information. Once the applicant makes the requisite labeling carve out, thereby creating a “skinny label,” the patent claiming the protected method of use will no longer hinder ANDA approval.

As long as the removing the label’s information would not make the generic drug less safe or effective and the use described in the Orange Book and the generic drug’s label don’t overlap, the FDA will accept the Section VIII Statement.

Although other ANDA applicants could be eligible for 180-day exclusivity with respect to the relevant patent, once a labeling carve out is completed, the 180-exclusivity will no longer hinder ANDA approval for the generic product with the “carved-out” labeling.

ANDA applicants cannot carve out conditions of use for products that aren’t protected by patent or exclusivity.

Significance of the Patent Use Code forSection VIII Label Carve Outs

When reviewing listed patents to determine whether a Section VIII Statement will be permitted, the FDA does not actually review the patents to determine whether the patent covers a particular condition of use that the ANDA applicant proposes to carve out. Instead, the FDA defers to the “use codes” listed by the NDA holder to determine what uses the listed patents cover.

The use code will determine whether the ANDA applicant must file a patent certification or whether a Section VIII statement would be appropriate.  Accordingly, the NDA holder must exercise care in crafting strategically useful use codes that comply with FDA regulations and guidance.

If the ANDA applicant believes the use code is too broad because the patent does not, in fact, cover the condition of use that the ANDA applicant seeks to carve out, under 21 U.S.C. § 355(b)(c), the ANDA applicant can file an action requiring the NDA holder to correct the use code.  This provision provides a remedy for the ANDA applicant to prevent overly broad use codes from delaying ANDA approvals.

The Section VIII Statement option is not perfect.  Once a product is approved with a “carve-out” or “skinny” label, the ANDA product can be prescribed by physicians and filed by pharmacists for the infringing use.  Nevertheless, the Section VIII Statement makes it possible for generic applicants to seek approval for a product that deletes or “carves out” label information related to a condition of use that is protected by a patent or other exclusivity.

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Gregory J. Glover MD JD is a patent attorney and non-practicing physician. A noted expert on developments and emerging conflicts in the pharmaceutical industry, Greg is an expert on regulatory IP issues.



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