Proposed Patent Reexamination Pilot Program Touted as Pro-Business

In Monday’s Federal Register, a pilot program entitled Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System was introduced (here). The notice requests comments from the public on a newly proposed enhancement to ex parte patent reexamination that would allow certain Patent Holders to advance to the head of the USPTO line. The Patent Holders qualifying for this enhanced treatment would be those “demonstrating humanitarian practices with patented technologies.”

The notice primarily presents 12 questions proposed to the public, seeking guidance on a test that would properly identify a humanitarian practice stemming from a subject patent. Specifically, comment is sought on weighting and filtering factors that would best define the “humanitarian use” and  “humanitarian research” definitions that would entitle a patent to consideration under the pilot program.

The proposal appears modeled after an FDA program that provides “vouchers” to such patent holders for advancing them to the front of that agencies review line. The PTO proposes a similar system in which the ex parte reexamination of such patents would be completed (excluding periods spent by the Patent Owner to respond) within 6 months.

The USPTO is to be applauded for their efforts to address real world business realities, yet, in this instance, I am left wondering if this proposed program can meet its stated goals.

This program, practically speaking, appears limited to bio/pharma patents. Many such patents relate to products having well known names, such as Plavix. In such cases, evidence of non-obviousness is compelling. With the relative specificity of the claims of bio/pharma patents, the best third party defenses are not available in reexamination for original claims (i.e., enablement). Coupling these factors with the more favorable statistics for upholding claims in ex parte reexamination, challenging such patents in this manner is rarely advisable.

I acknowledge that the 12 questions of the notice are posed for comment/debate, and are not final requirements. Still, if these questions are exemplary of the analysis that would be required, a patent eligible for a voucher would arguably be awarded a de facto finding of secondary considerations of non-obviousness. Such a decision, prior to reexamination, may color the remainder of the proceeding to the benefit of the Patent Holder. (e.g., see questions 5 and 8).

In modeling the program on the FDA system, the USPTO is considering making the voucher transferable on the open market (question 2). I can already hear the independent inventors howling about big business being given special access, and gov’t services being sold to the highest bidder.

To me question 12 has nailed the true issue.  Isn’t this program more suited to initial application review, like the Green Tech Pilot Program rolled out earlier this year? The vast majority of patents subject to patent reexamination are important, in most cases subject to concurrent litigation. It seems to me that speeding up reexamination for all is a better pro-business goal than carving out exceptions for extra special dispatch.

As I will be involved in drafting comments for the American Bar Association on this proposal, I would welcome any commentary, especially from the bio/pharma community.