Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if enacted, will require brand pharmaceutical companies to submit more information about their innovator products.

Potential Changes to Orange Book Listing Requirements for Non-Biologics Drugs

As part of its current obligations, an innovator product manufacturer must submit to the FDA the patent number and expiration date of any patents that claim the drug or a method of using the drug. The FDA then performs the ministerial function of listing the information in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book. The Hatch-Waxman Act permits generic manufacturers to file a counterclaim to delist a patent that they believe is improperly listed. Over the years, FDA has issued technical regulations expanding on the requirements, which under statute, are relatively sparse. However, there has been some uncertainty regarding what patents must be listed—especially in the case of drug products with innovative delivery systems.

The Orange Book Transparency Act of 2020, H.R. 1503, seeks to codify certain existing regulations and bring some certainty to the process. First, the Orange Book Act provides greater clarity on the types of patents a brand company must list. Currently, the relevant statutes require submission of patent information for “any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug” that could be asserted based on the manufacture, use, or sale of the drug. The Orange Book Act would alter that language to require submission of patent information for patents that claim the drug substance (active ingredient), the drug product (formulation or composition), or a method of use that is included in the application (i.e., a method of use that corresponds with an approved indication/use code). All other patents—e.g., patents that cover off-label use—must not be listed.

Second, the FDA would be responsible for “specify[ing] any exclusivity period that is applicable,” including the 180-day exclusivity period for first-to-file applicants.

Finally, the Orange Book Act codifies certain existing agency requirements. Under current FDA regulations, brand manufacturers are required to promptly request delisting if they determine that a patent no longer qualifies or its relevant claims are invalidated, and within 14 days if court-ordered. The Orange Book Act would codify the duty on brand manufacturers to remove listed patents within 14 days—rather than “promptly”—when any claim of a listed patent “has been cancelled or invalidated pursuant to a final decision” by the Patent Trial & Appeal Board or a court once it is unappealable. This quick turnaround time of communicating to the public which patents have been found invalid will be key to giving generics an advantage in developing generic products and patents covering branded drug products invalid. The Orange Book Act includes a 30-day period for a brand manufacturer to list a patent after issuance; this requirement mirrors already existing FDA regulations.

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