Hearing of the Senate Judiciary Committee - Executive Business Meeting

Hearing

On today's agenda is the bipartisan PATENT Act, which addresses the problem of abusive
patent litigation tactics. I've already spoken at length on the need for legislation to crack down
on these abuses, so I'm going to be brief in my remarks. Also, I want to complete the markup of
this bill today, so I hope my colleagues will cooperate and be succinct in their remarks and
debate.

Let me briefly talk about the managers' package. There are a number of provisions that we've
included in the bill, including non-controversial PTO requests, the Leahy/Grassley Patents for
Humanity legislation that improves this PTO program, and other technicals. One provision I
want to highlight in the managers' amendment clarifies that in the fee shifting provision, "undue
economic hardship to a named inventor or institution of higher education" is a factor that a judge
can consider when determining if "special circumstances" make a fee award unjust.

Another provision I want to mention is the new section 11 which deals with inter partes and post
grant review proceedings at the PTO. I worked with the Ranking Member, Senator Cornyn,
Senator Schumer, Senator Hatch, and a number of my other Committee colleagues on this
particular piece. This effort was in response to concerns that had been raised by certain industry
groups about what they saw as abuse of the administrative proceedings at the PTO. At the same
time, there were also other stakeholders that believed these proceedings have been very effective
at getting rid of weak patents.

This piece is the product of discussions with various industry stakeholders, including the life
sciences and tech groups. I think that many of us believe that the post grant proceedings at the
PTO are working quite well with respect to weeding out poor quality and improperly granted
patents. So it was our goal to address concerns, but not derail the very important function that
these proceedings have in knocking out weak claims and patents.

I hope that we've succeeded in making limited changes to the PTO processes to address these
concerns. I know not everyone is happy, but we really tried to strike the right balance of
addressing concerns but not disrupting the PTO proceedings.

I'd like to point out that, as this bill moves to the floor, there remain a few issues that need to be
resolved. As we indicated, the language we included in the managers' amendment that deals
with amending claims in the PTO proceedings is a placeholder because it remains the subject of
good faith negotiations. This has been a difficult nut to crack, but I understand that both sides
believe that we can reach a compromise that will work. Unfortunately we weren't able to reach
agreement before today's session, so the placeholder language stands, but I'm committed to
getting resolution on this piece as we move to the floor.

In addition, there is a proposal by the life sciences community concerning the applicability of the
PTO's post grant proceedings to patents that are subject to the Hatch-Waxman Act and Biologics
Price Competition and Innovation Act (BPCIA) processes. The Hatch-Waxman process has
been instrumental in facilitating the entry of low cost generic drugs in the market. Consumers
want access to cheaper drugs as soon as possible, so I've been a big supporter of this law. I'm
also supportive of incentivizing biosimilar market entry. When the America Invents Act was
considered, it's my understanding that there was no debate over whether or how IPR would
impact these important processes.

It's imperative for us to hear from all sides, get additional information and data, and consult with
the HELP Committee, which is the Committee of jurisdiction over the Hatch-Waxman Act and
Biologics Price Competition and Innovation Act (BPCIA) laws. This is a complex issue that
needs to be seriously and responsibly considered, including further review, discussion, and
vetting. My colleagues and I have already started getting views on this matter, and we continue
to review and conduct outreach.

I agree that we need to preserve incentives for generics to come to market, and I'm committed to
working on this issue as we move towards the floor.

Once again, I thank my colleagues for their hard work on this important bill.

Source