Blog January 17, 2023
Biosimilars 2022 Year in Review
Last week, Senator Orrin Hatch of Utah introduced the "Hatch-Waxman Integrity Act of 2018," which seeks "to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development." See Hatch Files Amendment to Restore Hatch-Waxman Balance, June 13, 2018. The proposed legislation would apply to both generic and biosimilar drug applicants.
The purpose of the proposed legislation aims "[t]o prevent the inter partes review [IPR] process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation." The proposed legislation "would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation, which affords certain advantages such as being able to rely on the drug innovator's safety and efficacy studies for FDA approval, and IPR, which is cheaper and faster than Hatch-Waxman litigation but does not provide the advantages of a streamlined generic approval process." Similar restrictions would be placed on biosimilar applicants seeking an abbreviated regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA).
In particular, the proposed amendment seeks to amend the Food, Drug and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) to prevent using IPR (or post-grant review (PGR)) challenges to circumvent the specific patent challenge processes for drugs and biologics created by Congress. The proposed legislation would require that New Drug Applications submitted under 505(b)(2) of the FD&C Act or Abbreviated New Drug Applications filed under 505(j) of the FD&C Act contain the following certification:
(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 ... 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 ....
This proposed certification does not appear to apply to patents outside those listed in the so-called "Orange Book." Therefore, it would seem that the generic manufacturer which chooses to pursue an abbreviated regulatory pathway under the Hatch-Waxman Act could still bring an IPR to challenge a non-Orange Book manufacturing, metabolite, or intermediate patent.
At the same time, the proposed certification appears to be relatively broad, requiring an applicant to certify it is not relying in part or in whole on any IPR or PGR decision even decisions obtained from proceedings instituted by unrelated parties.
For biosimilar applications, the legislation would modify Section 351(k) of the Public Health Service Act, requiring a biosimilar application to include:
with 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 ...
Currently, the BPCIA does not require the biosimilar applicant to address any patents in its application. Because FDA does not maintain a listing of patent exclusivities for biologics as it does in the Orange Book, it is not clear how a biosimilar applicant would be able to identify all patents that "[are], or that could be, included on a list of patents [that the reference sponsor might identify] under subsection 18 (l)(3)(A)(i)" in its application. A biosimilar manufacturer may therefore have to commit to refraining from challenging a biologic's portfolio in the PTAB, even without knowing the full scope of the patent portfolio.
Senator Hatch has stated that he "strongly support[s] IPR" but he does "not support its use in a way that upends or eviscerates Hatch-Waxman," of which he is a namesake. Hatch, who plans to retire at the end of the year, has stated the proposed legislation "will be a top priority for [him] during [his] remaining months in office." Id.
We will continue to monitor this proposed legislation and provide updates.
Authors:Jenny Shmuel, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
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