You called the America Invents Act the world's first patent law
specifically crafted for the 21st century, what did you mean by that?
We now live in an environment where there is much more collaborative
research that is not done solely within the confines of a single
organization. Part of the AIA was designed to optimize the way patent
laws work for those research teams, particularly those working in
research teams across entities.
If you look at the new grace period provisions in the patent law,
they're unlike provisions anywhere else in the world, and I consider
them to be optimally inventor friendly and collaboration friendly. The
new law will now look at an entire research collaboration – even one in
which the research entities working together span a private sector
company and a public sector company – as one team making patent filings.
Lilly, for example, does most of its research through teams within
Lilly, as well as by working with groups outside Lilly. The AIA will
expand the ability to file multiple patent applications, on inventions
by different inventors, some inventors being within Lilly and some
working as outside collaborators, without fear that the patent filings
of one team member can be used against the patent applications filed by
another member. These same patent filings – when they happened in Europe
as an example – often result in significant limitations on what patent
rights can be secured.
What do you think about the 'first to file' provisions?
The provisions relating to first-inventor-to-file are among the most
important in the new patent law. They will significantly improve the
operation of the US patent system.
The first inventor to file principle forms the core of a broader
simplification to our patent law relating to whether the invention
claimed in a patent filing is sufficiently different from what a patent
lawyer calls "prior art." The new law basically says that "prior art" is
now limited to work that had become available to the public before an
inventor sought a patent.
This requirement that inventions are tested for patentability based
solely on publicly accessible information assures transparency that
under the prior US law was sorely missing – secret information could be
dredged up, even years after a patent issued, to invalidate a patent on
the ground the invention wasn't really new or different enough to
warrant a patent. It was, in this respect, a crazy patent law.
In addition, before the legislative change, there were a number of
remedial actions to correct a defective patent that you couldn't take,
even one as simple as correcting an incorrectly named inventor. In this
and other respects, it was a hit-and-miss patent law – sometimes you
could and sometimes you couldn't. The new patent law is open more fully
to remedial measures. This includes a new supplemental examination
procedure that allows you to correct any mistakes or omissions that are
made in the original patenting process.
Lastly, subjective tests for invalidating a patent were removed,
including the so-called "best mode" requirement. When you add up this
coordinated set of reforms to the patent law, it basically underscores
the values of transparency, objectivity, predictability, and simplicity
that should lie at the heart of a modern, efficient and fair patent
Under the new 'first-to-file' regime, will Lilly need to change any internal processes?
Under our old patent system, the only people who actually received
patents 99.99% of the time were those who were first to file for the
patent on an invention. It was only in the rarest of circumstances that
anyone else could ever demonstrate under our old patent law that they
had the right to obtain a patent as the first to invent.
Every country outside of the US operates under the principle that
100% of the time the first inventor to file is entitled to patent. It
turns out that in a practical sense, the way you file patent
applications, the timing of patent application filings and the content
of patent application filings don't really change at all with this
change in law. Our new system basically has the great advantage of
aligning the fundamental legal concept of who is entitled to a patent
with the way that everybody has to make patent filings anyway.
That's interesting. It's a harmonization of sorts.
Precisely. There's a harmonization aspect to it because everyone else
outside the United States used the first-inventor-to-file principle as a
matter of law and we used that same principle, but only as a matter of
actual fact. I think the head of the patent office has said that an
inventor seeking a patent had one chance in 3 million of securing a
patent as the second inventor to file for a patent on an invention, that
is in the situation where another inventor had already sought a patent
for the invention – and he suggested that, rather than hold delaying a
patent filing hoping to garner a a patent by alleging you were the first
to invent, you'd be better served by buying lottery tickets as a hobby.
How do you see the new post grant proceedings playing out?
I can tell you that the intent of post grant review was to ensure
that they would work in the public interest. That requires the patent
owner to have a full and fair opportunity to defend its patent, and at
the same time, provide patent challengers a full and fair opportunity to
present whatever evidence there is to establish the invalidity of the
patent. Accomplishing both will require a careful titration.
So, how well the new post grant review procedure will work in the
public interest will depend on how that balance gets reflected in rules
that are now being drafted. I have some confidence that the USPTO is
going to strike the right balance. Part of this confidence that these
new procedures can be made to work comes from the fact that post grant
review will only apply to the new patents issued under the new law and
that new law greatly limits the issues that can be raised to invalidate a
patent – and, as I noted, there is a transparency and objectiveness
that was unknown under the old law.
The predictability and simplicity of the legal changes should save money, correct?
It helps the business model of everybody that uses the patent system
from the independent inventor to the university to the small business.
The last thing that anybody wants it to do is pay for the cost of
unpredictability and lack of certainty.
If you have a good patent, the new law helps make that patent more
valuable because its enforceability will be more certain. On the other
hand, if you have a weak patent, or it is unlikely to withstand
challenge, those patents can be weeded out much more efficiently with
the new post grant review procedure.
Again, there is nothing worse than investing in our business over a
long period of time based upon a patent right that is not going to
withstand challenge. So we at Lilly even look at the new provision in
the patent laws as making it easier to challenge a patent immediately
after it's issued as a positive development for the patent system as
Do you have any concerns or problems with the new legislation?
The overriding objective of the AIA was to create a law that was as
transparent as possible. In other words, public information determines
whether or not you are entitled to a valid patent. Next came the need
for objective standards in the law, so, inventors are not plagued with
uncertainty that exists because of factors that are subjective. As a
result, with the AIA, you have a highly predictable set of patentability
requirements and, at its core, a very simple patent system compared to
the old law. There are, without doubt, ways we can improve the new law,
but relative to the manner in which the AIA improved our old law, those
future improvements are likely to involve relatively minor changes.