Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development,” (ii) “prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design,” and (iii) “ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications.” Press Release dated June 14, 2018. Specifically, the proposed legislation would amend certain sections of the Food, Drug, and Cosmetic Act that provide the current framework for generic pharmaceutical and biosimilar product approvals.

Under the current framework, an entity filing an Abbreviated New Drug Application (ANDA) requesting FDA approval for a generic product must certify one of the following for each patent listed in the Orange Book: (i) there is currently no patent information listed in the Orange Book; (ii) the patent has expired; (iii) the generic product will not enter the market until after the expiration of the patent; and (iv) the patent is invalid and/or not infringed.

The proposed revisions under the HWIA also require that any Paragraph (iii), Paragraph (iv), or Section viii statements (where the label carves out a patented method of treatment) are also accompanied by the following additional certifications:

(i) neither the applicant nor any party in privity with the applicant has filed, or will file, a petition to institute inter partes review or post-grant review of that patent …. and (ii) in making the certification required under subparagraph (A), the applicant is not relying in whole or in part on any decision issued by the Patent Trial and Appeal Board in an inter partes review or post-grant review ….

Likewise, a biosimilar application must also certify that

[W]ith respect to any patent that is, or that could be, included on a list of patents under subsection 18 (l)(3)(A)(i), … a certification that neither the applicant nor any party in privity with the applicant has filed, or will file, a petition to institute inter partes review or post grant review of that patent ….

This is a substantial departure from the current biosimilar approval pathway, as the Biologics Price Competition and Innovation Act does not require a biosimilar applicant to make any patent certifications in the application. The particular phrasing in the HWIA as currently proposed may present a substantial challenge to biosimilar applicants, in part due to the difficulties in identifying “any patent that is, or that could be, included on a list of patents under subsection 18 (l)(3)(A)(i).”

As noted in the excerpts above, the HWIA would limit ANDA and biosimilar applicants, who rely on safety and efficacy data of the reference drug product, to resolving patent disputes in federal district court, not in a USPTO proceeding. Under the current regulatory scheme, ANDA filers may challenge, in a Patent Office proceeding, patents that are asserted against the ANDA filer in district court litigation (though many courts will stay litigation pending the outcome of the Patent Office proceeding). Indeed, Sen. Hatch notes that the HWIA would require that a “generic manufacturer wishing to challenge a brand-name drug patent to choose between [district court] litigation, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval” and Patent Office proceedings, which are less expensive and faster than district court litigation. Press Release dated June 14, 2018. Thus, litigation in federal court would become the sole pathway forward for generic manufacturers, while preserving Patent Office trials where, according to Sen. Hatch, “other interests come into play.”

The HWIA, if passed into law, will present a difficult choice to a follow-on manufacturer: obtain their own safety at efficacy data (at great expense), or certify that they will not challenge the asserted patents in a Patent Office trial.

Written by: Caleb A. Bates, Ph.D. and Agnes Juang, Ph.D.