Is Information Contained in a Paragraph IV Certification Notice Letter Accompanied by an Offer of Confidential Access Subject to Public Disclosure? One District Court has an Answer

June 29, 2011

By Kurt R. Karst –      

A recent unpublished decision out of the U.S. District Court for the District of New Jersey presented an interesting public disclosure issue that we think will be of interest to the Hatch-Waxman community.  The case, like so many Hatch-Waxman cases, is complicated.  It involves an ANDA for a generic version of SOLARAZE (diclofenac sodium) Gel, Paragraph IV certifications to six Orange Book-listed patents, a subsequent Paragraph IV Notice Letter with a Detailed Statement, an Offer of Confidential Access (“OCA”), and a Discovery Confidentiality Order (“DCO”) previously entered in the patent infringement litigation.  We’ll spare you a recitation of all of the details of the case, but what’s important is the question the court addressed in its decision: whether the ANDA sponsor’s Paragraph IV Notice Letter, including the appended Detailed Statement, is a confidential document that should be protected from unrestricted disclosure under the DCO. 

Pursuant to the FDC Act (§ 505(j)(2)(B)), as amended by the Hatch-Waxman Amendments and the Medicare Modernization Act, and FDA’s implementing regulations (21 C.F.R. § 314.95), an ANDA sponsor whose application contains a Paragraph IV certification must send notice of such certification to the NDA holder and patent owner.  Such notice must:

(I) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and

(II) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.

In addition, FDC Act § 505(j)(5)(C) provides that a Paragraph IV notice letter may include an OCA to provide the NDA holder/patent owner confidential access to certain information from an ANDA “for the sole and limited purpose of evaluating possible infringement of the patent that is the subject of the [Paragraph IV certification] and for no other purpose.” An OCA must “contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information.”  Moreover, “[a]ny person provided an offer of confidential access . . . may not disclose information of no relevance to any issue of patent infringement to any person other than a person provided an [OCA].”

In the case before the New Jersey District Court, a dispute arose between the NDA holder/patent owner, on the one hand, and the ANDA sponsor, on the other hand, as to whether the ANDA sponsor’s Paragraph IV Notice Letter, which included an OCA,  should be subject to the restrictions of the DCO previously entered in the case.  The Court directed the parties to file a joint dispute letter setting forth their respective positions on the issue, and based on which the Court made its decision.  The NDA holder/patent owner argued that under controlling authority, all Paragraph IV Notice Letters are public disclosures and that the OCA is not applicable to a Paragraph IV Notice Letter.  The ANDA sponsor argued otherwise, saying that “Plaintiffs have provided no legitimate reason why the Paragraph IV Notice Letter and the OCA’s detailed statement should be exempt from the DCO’s confidentiality provisions entered by the Court.”

In reaching its decision, the Court first addressed “Whether the Detailed Statement is Part of the Paragraph IV Notice Letter, and Whether the OCA Applies to the Detailed Statement.”  On the first part of that issue, the Court said that the Paragraph IV Notice Letter cannot be separated from the Detailed Statement, as a “detailed statement that contains a ‘full and detailed explanation’ is a necessary part of a paragraph IV notice letter,” and that “[p]aginating the OCA and Detailed Statement consecutively does not eliminate the requirement that the Detailed Statement must be part of the Paragraph IV Notice Letter.”  With respect to the OCA’s applicability to a Detailed Statement, the Court commented that “an OCA pertains to access to an ANDA and not to a paragraph IV notice letter,” and that because “an OCA ‘accompanie[s]’ a paragraph IV letter notice, [it] is thus not a part of a notice letter itself or a notice letter’s detailed statement.”  Moreover, “viewing the OCA and the Detailed Statement as one and the same is inconsistent with the FDCA.”  After all, says the Court quoting from the joint dispute letter, “the confidential access provision ‘does not indicate that use of information provided in a paragraph IV notice letter or failure to object to the proposed terms of confidentiality contained in a paragraph IV notice letter constitutes acceptance of such terms.’”

Having decided that the ANDA sponsor’s Detailed Statement is part of the Paragraph IV Notice Letter and that the OCA does not govern them, the Court next addressed “Whether the Paragraph IV Notice Letter Is a Public Disclosure.”  In making its decision, the Court relied heavily on a January 7, 2010 FDA Letter Decision concerning whether certain Paragraph IV notice information included in a Citizen Petition docket (Docket No. FDA-2009-P-0423) – but in a patent infringement case not involving an OCA – is protected from disclosure by FDA.  In its Letter Decision, FDA explained that a Paragraph IV Notice Letter “is an integral part of a public process” and that “the statutory scheme contemplates that the paragraph IV notice letter is the first step in an inherently public process.”  The FDA also noted, however, that in that case, the Paragraph IV Notice Letter and the information in it was disclosed to a member of the public without the ANDA sponsor “taking advantage of the process specifically set forth in § 505(j)(5)(C)(i)(III) for disclosing sensitive information contained in its ANDA.”  Nevertheless, given FDA’s Letter Decision, the New Jersey District Court ruled that the information disclosed by the ANDA sponsor “in its Paragraph IV Notice Letter is now part of ‘an inherently public process’ and therefore constitutes a public disclosure.” 

Having completed the above two-step analysis, the Court ultimately ruled that “[b]ecause the Paragraph IV Notice Letter is not shielded from public view, it is not subject to the [DCO].  The Detailed Statement, as part of the Paragraph IV Notice Letter, is a public disclosure.  The [DCO] does not restrict access to or use of documents that are public,” and therefore, the DCO does not restrict use of the ANDA sponsor’s Paragraph IV Notice Letter.

So, what’s the take-away message for ANDA sponsors?  Be careful what information you disclose in a Paragraph IV Notice Letter and in the appended Detailed Statement, even if you include an OCA.  The disclosed information is not, according to one court, subject to an OCA and could be made available to the world with the click of a mouse.