May 2019

The House of Representatives passed a bill on May 8, 2019, that effectively would require delisting Orange Book patents found invalid by the Patent Trial and Appeal Board (“PTAB”) or a district court. The House passed the bill unanimously. Its stated purpose, according to the bill’s author: “This legislation will increase access to lower cost generic drugs and bolster competition in the marketplace to drive down prescription drug costs by making technical changes to the Orange Book and listing process.” This bill is one of a number of bills introduced in this Congress dealing with various aspects of the Hatch-Waxman Act.

Introduced as H.R. 1503 and titled the Orange Book Transparency Act of 2019, among other things, the Act would require approved New Drug Application (“NDA”) holders to notify the FDA within 14 days of a PTAB or court decision “from which no appeal has been taken or can be taken that a patent for [an Orange Book-listed] drug is invalid.” The FDA then would remove the invalidated patent from the Orange Book “promptly,” but not prior to the expiration of any 180-day exclusivity applicable for an ANDA filer whose paragraph IV certification was based on invalidity of the patent found to be invalid. 

The proposed requirement to delist patents found invalid by the PTAB is new. Under current regulations, an NDA holder “is required to promptly notify FDA” for removal of an Orange Book-listed patent, for example, “if there has been a judicial finding of invalidity for a listed patent, from which no appeal has been or can be taken.” 21 C.F.R. § 314.53(f)(2)(i).  

In addition to H.R. 1503, the House also passed H.R. 1520, titled the Purple Book Continuity Act of 2019, which according to its sponsor Representative Anna G. Eshoo (D-CA) “would codify publication of the patents of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book, specify that the Purple Book should be published electronically on FDA’s website and updated routinely and direct FDA to consider the types of patents that should be listed in the Purple Book.” Press Release, Pallone & Eshoo on House Passage of Bills Increasing the Accuracy & Transparency of FDA’s Prescription Drug Databases, May 8, 2019. 

After the House passed the bill, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Eshoo released a joint statement stating, “Ensuring these databases [the Orange Book and the Purple Book] are up-to-date will help prevent patent listing errors that delay more affordable alternative medications from coming to market sooner. Research has shown that one of the most effective ways to reduce prices at the pharmacy counter is to ensure generics come to market promptly after patent and exclusivity periods end.” Id.

The bill was received in the Senate on May 9, 2019, and referred to the Committee on Health, Education, Labor and Pensions.

For more information about the status of this pending legislation and how it may affect business opportunities for generic pharmaceutical companies, please contact the authors or a member of our Hatch-Waxman Litigation and Opinion Practice Group.