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Interview: Robert Armitage, Eli Lilly

The American Invents Act could have a big effect on the life sciences industry. Kevin Matha spoke with Robert A Armitage, senior vice president and general counsel at Eli Lilly, about the new legislative package

You called the America Invents Act (AIA) 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 organisation. Part of the AIA was designed to optimise 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 really improve the operation of the US patent system.

The first-inventor-to-file principle forms the core of a broader simplification in 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 system.

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.

Although 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 works through the rules. 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.

Should the predictability and simplicity of the legal changes save money?

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 whole.

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.


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