Proposed Amendment to Hatch-Waxman Act May Prohibit Use of Post-Grant Procedures

U.S. Senator Orrin Hatch, co-author of the Hatch-Waxman Act, recently proposed an amendment to the Act that would prevent generic drug companies from using any AIA post-grant procedure (IPR or PGR) on an Orange Book patent identified in their PIV certifications.  The proposed amendment would require that the patent certification required under 21 USC § 355(j)(2)(A)(vii) include a certification that:

(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 under chapter 31, or 32, respectively, of title 35, United States Code; and

(II)     In making the certification required under clause (vii) [which sets forth the requirement to make certifications with respect to Orange Book patents under Paras. (I) to (IV)], 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 under chapter 31 or chapter 32, respectively, of title 35, United States Code.

A similar amendment is proposed to the statute controlling the approval of biosimilars.

According to subsection (I), the ANDA applicant certifies that it, or a party in privity with it, has not, and will not, file a petition to institute an IPR or PGR.

Under subsection (II), the ANDA applicant would be required to confirm that it is not relying on any IPR or PGR decision made by the PTAB.  Thus, it appears that an ANDA applicant would not be permitted to rely on an IPR ruling that a patent is invalid in its certification, even though that IPR was brought by a third party having no relation to the applicant.

When introducing this amendment, Sen. Hatch noted that the Hatch-Waxman Act included “carefully calibrated requirements effecting timing, market exclusivity, and FDA approval.”  The IPR, on the other hand “is a much blunter instrument than Hatch-Waxman and which contains none of the important industry-specific balancing features that come into play in Hatch-Waxman litigation.”

It is hard to see how this proposal embodies such balancing.  Without the threat of an IPR, brand companies will be motivated to list and litigate patents of dubious validity, which will raise costs for generic companies and may further delay their entry into the market. Senator Hatch did not identify any reason why IPRs should be of diminished value and significance to the pharmaceutical industry relative to all other industries.

We will keep you up to date with this proposed amendment as it works its way through the legislative process.