July 6, 2011

Paragraph IV Certification Letters Subject to Public Disclosure New Jersey District Court Rules

by Michael W. Harkness

not confidential.bmpAttorneys involved in Hatch-Waxman work may want to take a good look at a recent decision from a District Court in the District of New Jersey. The unpublished decision, Nycomed US Inc. v. Tolmar, Inc. (D.N.J. 2011), involved a dispute over whether a Paragraph IV notice letter is a confidential document that should be protected from unrestricted disclosure under a related discovery confidentiality order. The New Jersey District Court deferred to FDA's previous statements in holding that Paragraph IV notice letters are to be considered public disclosures, and therefore available to anyone with access to the Internet. ANDA filers should now be aware that, at least in the District of New Jersey, information contained in a Paragraph IV notice letter can be made public, even if the information appears to be protected by an offer of confidential access.

The court in Nycomed noted that FDA had previously stated multiple times that Paragraph IV notice letters were to be considered public disclosures. In particular, the court considered FDA's statement from June, 2003 in the Federal Register addressing the question "Should all Paragraph IV Certifications Be Made Public . . . ?" to be especially persuasive:

We decline to amend the proposed rule to make public all paragraph IV certifications . . . . Under current practice, paragraph IV certifications are subject to public disclosure under the Freedom of Information Act (FOIA) and FDA's public disclosure regulations once the notice of the paragraph IV certification has been provided to the NDA holder and patent owner. Because the notice to the NDA holder or patent owner of the paragraph IV certification is considered a public disclosure after notice has been given, the certification is available under FOIA.

Furthermore, the court found FDA's January 7, 2010 letter ruling to also be persuasive, particularly the FDA's statement that the decision to file an ANDA "reflects a deliberate decision by an ANDA applicant to publicly disclose certain information about its ANDA so that it may be eligible for FDA approval of its generic drug product prior to the expiration of the relevant patent." In that letter ruling, the notice letter at issue expressly stated the information within was to be considered confidential, but that did little to convince FDA. Instead, FDA explained that the notice letter is "an integral part of a public process," and should therefore be available for the public to inspect.

Having decided that the information included in a Paragraph IV notice letter is subject to public disclosure, the court then ruled that notice letters cannot, as public documents, be subject to any discovery confidentiality order. In particular, the court held that "[b]ecause the Paragraph IV Notice Letter is not shielded from public view, it is not subject to the Discovery Confidentiality Order. The Detailed Statement, as part of the Paragraph IV Notice Letter, is a public disclosure."

For those unfamiliar with the statutory procedures surrounding the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, when a pharmaceutical company seeks to market a generic version of a drug previously approved by the FDA, the company is obligated to send notice to the drug's NDA holder and patent owners. This notice is known as a Paragraph IV Notice Letter, and must include "a detailed statement of the factual and legal basis of the opinion of the applicant that the [drug's] patent is invalid or will not be infringed," as stated by the Hatch-Waxman Amendments. A Notice Letter must also include an offer of confidential access, to allow the NDA holder and patent owners the opportunity to evaluate the ANDA's claims of patent invalidity or non-infringement.