Additional Grounds for Challenging Patents in Proposed Post Grant Review LegislationOn Wednesday, the House of Representatives formally introduced H.R. 1249, as previewed here last Friday. The bill includes some changes to the proposed post grant review and inter partes review proceedings.The two major changes being discussed in the House are: (1) The expansion of the Post Grant Review window to 12 months (S.23 previously provided 9 months); and (2) The reemergence of the SNQ standard as the threshold determination in the proposed inter partes review proceeding (S.23 previously proposed a likelihood of success standard). The Bio/Pharma community has been clear that the House’s adoption of the SNQ standard for inter partes review is not a welcomed change.Yet, the “additional grounds” subsection of postgrant review may prove much more troublesome for the bio/pharma community.Both the Senate and House bills prevent a post grant review proceeding form going forward unless the request demonstrates that “it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” (Sec. 324 subsection (a))Subsection (b) provides:(b) ADDITIONAL GROUNDS–The determination required under subsection (a) may also be satisfied by a showing that the petition raises a novel or unsettled legal question that is important to other patents or patent applications.Subsection (b) clearly addresses the concern that subsection (a) would, by virtue of the “more likely than not” outcome standard, prevent challenges on unproven theories. But, is subsection (b) necessary?  Is the USPTO the best venue for such novel legal challenges?  What kinds of “theories” would fall into this category anyway?It is hard to imagine too many novel or untested legal theories that are “important to other patents or patent applications” that would not in some way involve application of 35 U.S.C. § 101. Arguing against the patentability of gene sequencing, aspects of human cloning, genome mapping, and the like would seem to be the types of “novel or untested” legal theories having a wide ranging impact on other patents. Subsection (b) is nothing more than an invitation to take these battles to the USPTO.It seems to me that untested legal theories that have far reaching public policy implications are best left to the courts and legislators. The USPTO is best equipped to review issues of technology and prior art, not novel legal questions.Moreover, this legislation is a game changer with respect to the Board of Patent Appeals & Interferences (BPAI). The USPTO will have enough on their plate transitioning to a Patent Trial & Appeal Board to accommodate inter partes review, while simultaneously accommodating an entirely new procedure, post grant review. Encouraging the public to pursue novel and untested legal theories during this time of change seems more than a bit misguided. Clearly, the post grant aspects of the bill will be hotly debated in the coming weeks. Yet, not all aspects of the proposed post grant review mechanism are problematic for bio/pharma.  Interestingly, since the grounds of post grant review are based on the statutory defenses of 35 U.S.C. § 282, instead of patent reexamination’s “patents and printed publications,” obviousness-type double patenting is seemingly excluded from post grant review. The absence of this ground is a boon to the bio/pharma community. Many patent reexaminations that involve drug patents include such rejections with the hopes of limiting patent term.More on the various post grant options of the legislation next week.  

On Wednesday, the House of Representatives formally introduced H.R. 1249, as previewed here last Friday. The bill includes some changes to the proposed post grant review and inter partes review proceedings.

The two major changes being discussed in the House are: (1) The expansion of the Post Grant Review window to 12 months (S.23 previously provided 9 months); and (2) The reemergence of the SNQ standard as the threshold determination in the proposed inter partes review proceeding (S.23 previously proposed a likelihood of success standard). The rn-with-inter-partes-review-changes/”>Bio/Pharma community has been clear that the House’s adoption of the SNQ standard for inter partes review is not a welcomed change.

Yet, the “additional grounds” subsection of postgrant review may prove much more troublesome for the bio/pharma community.

Both the Senate and House bills prevent a post grant review proceeding form going forward unless the request demonstrates that “it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” (Sec. 324 subsection (a))

Subsection (b) provides:

(b) ADDITIONAL GROUNDS–The determination required under subsection (a) may also be satisfied by a showing that the petition raises a novel or unsettled legal question that is important to other patents or patent applications.

Subsection (b) clearly addresses the concern that subsection (a) would, by virtue of the “more likely than not” outcome standard, prevent challenges on unproven theories. 

But, is subsection (b) necessary?  Is the USPTO the best venue for such novel legal challenges?  What kinds of “theories” would fall into this category anyway?

It is hard to imagine too many novel or untested legal theories that are “important to other patents or patent applications” that would not in some way involve application of 35 U.S.C. § 101. Arguing against the patentability of gene sequencing, aspects of human cloning, genome mapping, and the like would seem to be the types of “novel or untested” legal theories having a wide ranging impact on other patents. Subsection (b) is nothing more than an invitation to take these battles to the USPTO.

It seems to me that untested legal theories that have far reaching public policy implications are best left to the courts and legislators. The USPTO is best equipped to review issues of technology and prior art, not novel legal questions.

Moreover, this legislation is a game changer with respect to the Board of Patent Appeals & Interferences (BPAI). The USPTO will have enough on their plate transitioning to a Patent Trial & Appeal Board to accommodate inter partes review, while simultaneously accommodating an entirely new procedure, post grant review. Encouraging the public to pursue novel and untested legal theories during this time of change seems more than a bit misguided. 

Clearly, the post grant aspects of the bill will be hotly debated in the coming weeks. 

Yet, not all aspects of the proposed post grant review mechanism are problematic for bio/pharma.  

Interestingly, since the grounds of post grant review are based on the statutory defenses of 35 U.S.C. § 282, instead of patent reexamination’s “patents and printed publications,” obviousness-type double patenting is seemingly excluded from post grant review. The absence of this ground is a boon to the bio/pharma community. Many patent reexaminations that involve drug patents include such rejections with the hopes of limiting patent term.

More on the various post grant options of the legislation next week.