Nycomed v. Tolmar: Paragraph IV Notice Letters Deemed Non-Confidential
Background of the Law
Paragraph IV notice letters are contemplated under the Hatch-Waxman Act, which formed a legislative compromise between producers of new and generic drugs. As part of the compromise, a pharmaceutical company can seek expedited FDA approval to sell a generic version of a drug (via an abbreviated new drug application, or ANDA), but in the process it must certify to the FDA the status of the previously approved drug’s patents. In a “Paragraph IV certification,” the applicant certifies that the relevant patents are invalid or will not be infringed by the generic drug to be approved. Applicants submitting a Paragraph IV certification must also provide notice of the certification to the holders of the patents and of the approved NDA. The “Paragraph IV notice letter” must set forth a detailed statement of the factual and legal basis for the invalidity or non-infringement opinion. To be able to seek declaratory relief, the generic drug applicant must additionally provide an offer of confidential access (“OCA”) to its ANDA.
When the Hatch-Waxman amendments were enacted, they raised public concerns that a paragraph IV notice letter's detailed statement “might compromise the applicant's trade secrets and adversely affect the applicant's ability to engage in litigation.” Nevertheless, the FDA declined to provide regulatory protection akin to the confidentiality afforded ANDAs, and later took the position that Paragraph IV notice letters were public disclosures. The FDA also declined to specify the type or amount of detail that a notice letter must include, noting that disputes regarding the sufficiency of a Paragraph IV notice letter would be left for the parties to resolve.
Background of the Case
In Nycomed, the plaintiffs (hereinafter, “Nycomed”) were the patent holder and the exclusive licensee and NDA holder for the approved drug Solaraze®. Defendant Tolmar, Inc. (“Tolmar”) filed an ANDA seeking approval for a generic version of the drug, along with a Paragraph IV certification, and sent a Paragraph IV notice letter to Nycomed. In an apparent effort to maintain the confidentiality of its detailed statement, Tolmar appended the statement to its OCA as one consecutively-paginated document, and incorporated the detailed statement by reference into the notice letter. The implicit suggestion was that the detailed statement was subject to the confidential access restrictions of the OCA.
Nycomed disagreed with the Paragraph IV notice letter, and in response, sued Tolmar for declaratory and injunctive relief, alleging infringement. Early in the proceedings, the court issued a discovery confidentiality order between the parties. Thereafter, the parties disputed whether Tolmar’s Paragraph IV notice letter was protected by the confidentiality order.
First, the court considered whether Tolmar’s detailed statement was part of the Paragraph IV notice letter, and whether the OCA applied to the detailed statement. The court held that because the detailed statement is a required part of a notice letter, it could not be separated from the notice letter. In that regard, the court noted that the notice letter incorporated the detailed statement by reference, and thus it was part of the letter. The court also held that Tolmar’s OCA did not apply to its detailed statement, because OCAs pertain only to access to ANDAs. In reaching that conclusion, the court noted that the statute references OCAs as “accompan[ying]” notice letters, and therefore they could not be part of the notice letters themselves. The court found Tolmar’s arguments to the contrary unpersuasive because the statutory scheme contemplated public disclosure of certain ANDA information in order to be eligible for FDA approval prior to the expiration of the original patent.
Second, the court weighed whether Tolmar’s Paragraph IV notice was a public disclosure. Tolmar did not dispute the adverse FDA opinions, but argued they were distinguishable. The court disagreed, finding the FDA opinions persuasive and on point. Further, the court found that public disclosure was consistent with the statutory scheme. In holding that Paragraph IV notice letters are public disclosures, the court stressed that the decision of whether and what to disclose rests “squarely in the hands of the ANDA applicant.” The court suggested that the applicant could release just enough ANDA information to provide sufficient notice, and then disclose the ANDA under the protective terms of an OCA.
Third, and lastly, the court decided whether the Paragraph IV notice letter was subject to the discovery confidentiality order. Because the order did not restrict access to public documents, the court held Tolmar’s notice letter was not protected.
The court’s opinion in Nycomed solidified the earlier FDA opinions that Paragraph IV notice letters are non-confidential, public documents. More interestingly, the opinion makes clear that a detailed statement cannot be separately protectable under an OCA. This puts the Paragraph IV applicant in the precarious position of enjoying confidentiality with respect to its ANDA, but being forced to disclose publicly sufficient details to support invalidity or non-infringement arguments in its Paragraph IV notice letter. The apparent solution to this problem, and the one suggested by the court in Nycomed, is to disclose the bare minimum information necessary to provide the NDA and patent holders with sufficient notice. An interesting question for the future may be whether and to what extent notice is sufficient if, instead of disclosing details from the ANDA, the applicant merely cites to the relevant portions of the ANDA in the Paragraph IV notice letter, which the NDA and patent holders may view subject to the restrictions of the OCA.
 Nycomed US Inc. v. Tolmar, Inc., Civ. No. 10-2635, 2011 U.S. Dist. LEXIS 47409 at *22 (D.N.J. Apr. 28, 2011) (Shwartz, Mag. J.) (not for publication).