FDA should require more detailed patent declarations for listing in the "Orange Book," a Generic Pharmaceutical Association proposal states.

The strengthened requirements would place "the burden of establishing Orange Book eligibility" on the NDA holder, GPhA's proposal says.

The declarations should detail "(1) the approved drug or method of use that the patent claims, (2) the basis on which the Orange Book proponent could sue for infringement of that patent, and (3) the connection between the approved product or method of use that forms the basis for Orange Book listing and these patent infringement claims," GPhA said.

The proposal was presented to FDA's recent moot court on Waxman/Hatch drug patent issues. FDA Chief Counsel Daniel Troy hosted the moot court Jan. 30 to hear brandname and generic drug industry arguments about the agency's interpretation of the Hatch-Waxman Act (¹ Also see "FDA Waxman/Hatch “Moot Court” Will Examine Brand/Generic Legal Positions" - Pink Sheet, 21 January, 2002., p. 3).

Under the current declaration process, an NDA holder "need only declare, without explanation or detail, that its patent 'covers' an approved drug and therefore meets Hatch/Waxman criteria for Orange Book listing," GPhA said.

GPhA's proposed changes, which would require FDA to amend its regulations, would require the NDA holder to certify that the "information is submitted under penalty of perjury."

Patent declarations should require NDA holders to specify the name of the patent owner, the patent number, expiration date and "for each patent, identify each claim that meets statutory requirements," the proposal says.

Declarations should include "a statement of the basis for concluding why each claim meets statutory requirements" and identify "the type of claim," such as whether a claim relates to the composition of matter or a method of use, GPhA said.

The NDA holder should also be required to disclose "the earliest effective U.S. filing date(s) to which each claim of the patent is entitled," GPhA said. The association recommended that declarations be made publicly available at the time of listing.

FDA could use the declaration to review whether a patent deserves to be listed in the Orange Book, GPhA said. The agency would need to undertake only "a limited substantive review" and would not have to undertake a full review of the patent, GPhA said.

GPhA expects that "the requirement of a detailed and substantive declaration, combined with a strong anti-perjury provision, would serve to deter wrongdoing and would force brandname companies to consider carefully whether a given patent" should be listed in the Orange Book.

The declaration would also aid FDA in determining whether a particular patent could be categorized as a "product-by-process" patent. "Listing of a product-by-process patent, like the listing of a process patent, runs against the Hatch-Waxman Act's goal of using Orange Book listing as an incentive for companies to develop new products, not new processes," GPhA said.

While the validity of such patents is not an issue, "the relevant question is whether they should be listed in the Orange Book, leading potentially to a 30-month stay," GPhA said.

The Pharmaceutical Research & Manufacturers of America, in a "white paper" submitted to the moot court, cited court decisions in support of its claim that FDA's role in listing patents in the Orange Book is ministerial.

Despite the generic industry's claim that FDA should play a role in reviewing patent information, the "courts have ruled, however, that FDA has no role in this process, asserting that FDA has no 'statutory franchise' to review proposed patent listings," PhRMA said.

"If the statute directed that 'FDA shall publish information on any patent that claims the drug' or words to that effect, it might properly be construed as obligating FDA to assess whether the patent met the standard."

However, PhRMA said, the statute "does not take that approach, and directs FDA simply to publish whatever is submitted."

In addition, PhRMA argued that FDA should list product-by-process patents. "There is no basis for any FDA refusal to list product-by-process patents, as some generic companies have urged," the white paper says. "Product-by-process patents plainly claim the drug...and FDA has no authority to refuse their listing," PhRMA said.

PhRMA cited the agency's refusal to list patents for the tablet form of Pfizer's Procardia (nifedipine), as an example of FDA's "pro-generic" interpretation of the listing criteria.

Pfizer sold only the capsule version, but wanted to list patents related to the capsule and tablet formulations because of concerns that generic companies might market a tablet formulation through the suitability petition process, the white paper says. However, FDA refused to list Pfizer's tablet patent.

"FDA's restrictive interpretation of the patent listing provisions is in no way compelled by the statutory language and cannot be reconciled with its purpose," PhRMA said.

Even with FDA's "restrictive" interpretation of the statute, PhRMA noted two areas where "room is available to list some patents that do not apply to the approved product."

The white paper identifies polymorphs and hydrates as one area where "FDA generally considers all variations to be the same."

In a May 2001 citizen petition seeking clarification of FDA's Orange Book patent-listing policy, the Federal Trade Commission contended that "a patent may not be listed even when the claimed unapproved compound differs only in its water of hydration from an approved component." The hydrates may be considered the same for the purposes of ANDA submission, FTC said (² Also see "FTC Asks FDA To Clarify "Orange Book" Listing Criteria In Citizen Petition" - Pink Sheet, 28 May, 2001., p. 33).

PhRMA maintained that if various crystalline forms are considered "interchangeable by FDA," then "it hardly makes sense to allow a generic applicant to avoid the pre-approval litigation process by selecting a form other than that used in the innovator's product."

Another area where "room is available" to list patents is when a patent "covers a form of the drug substance that is used in the production of a drug but is not present in the final product," PhRMA said, because "FDA regulations define a drug as including its components, whether or not the component is present in the finished product."

“Orange Book” Patent Listing Declarations Need More Detail – GPhA

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