#2 provides a comparative view of the patent side of the case, discussing
both whether the Canadian approach to utility is valid, and whether Lilly’s
secondary use patents were valid in the first place.
Norman Siebrasse – Professor, University of New Brunswick
dives into the new USPTO guidelines and provides commentary on how there is
diversity between countries when it comes to secondary use and novelty requirements.
Gunpowder, for example, would not be patentable under the new guidelines in the
U.S. because it uses naturally occurring substances. He believes that the U.S.
Supreme Court has taken the wrong approach with some of its cases when it
considered whether certain types of inventions should be patented (e.g. Myriad Genetics). He reminds us that
patent laws are national, but innovation occurs on an international scale, so
it is important to look to other countries’ rules to determine what is optimal.
|A video of Norman Siebrasse's presentation is unavailable due to technical difficulties. You can find the slides from Norman's presentation here.
Richard Gold – Professor, McGill University
“There is an implied premise (in fact I think
it’s pretty expressed) that there is something called a promise doctrine in
Canadian law, and in fact you will never find such a promise doctrine. No court
has ever called this a promise doctrine. Promise is just another way to say,
what is the utility that a patentee asserted?”
gives us a different perspective on how patent law should be implemented. He
finds no reason to have Canada change their current approach, as there is no
international requirement or standard regarding how utility should be assessed
in patent law. He states that very few cases have actually been decided using what
became known as the “promise doctrine,” in contrast to Lilly’s claims. When it
has been assessed, the court is looking at whether there is a logical,
empirical basis for the prediction, even if there have been no clinical trials.
He also states that Canada’s utility standard is actually a lower standard than
the U.S. standard. Regardless, he reminds us that the Supreme Court of Canada
has yet to hear a case on the “promise doctrine.”
John Covert – Partner, Sterne Kessler Goldstein & Fox
“Rush to filing – how long can we hold off until
we file that patent application? How much time can we wait for the generation
of additional data to put into our application to support the utility? There
are situations where there is a rush to filing, and the application goes in,
and there is a question about how much data is there.”
provides a view from a patent prosecution standpoint, and speaks about the
importance of the timing of filing a patent application. He gives insight into the
differences between U.S. and international utility standards, and how whether
you have a first or second generation product affects your timing of filing.
There is the real possibility of filing too early, causing your patent to be
invalidated later, while waiting too long invites others to file before you. He
finds that the U.S. patent system is set up to reward innovation first, with actual
proof of utility to come later, while in places like Japan, the idea must already
be taken to completion.
Jonathan Stainsby – Partner, Aitken Klee
“When I deposed one of the inventors, he told me
that prior to the filing, he couldn’t have told anyone with his hand on his
heart it had any of the advantages, any of the side effect benefits, that Lilly
asserted in the patent. And the basis of the data that Lilly had at the time of
the filing, expert evidence at the trial said the predictive value of that data
was nil. So Lilly didn’t know what the properties of the compound were, nor
could they have predicted them. So if that’s not a speculative claim, I don’t
know what is.”
closes the talk with a strong assertion – the “promise doctrine” is a complete
fiction fabricated by Lilly. The sound prediction test is what the court
actually looked to for assessing utility. He rebuts Lilly’s fear of
subjectivity in judge’s interpretations of patents by reminding us that this is
what judges do all the time with contracts, treaties, and other documents. He
states that the olanzapine patent was a selection patent, so they had to make
statements that it had advantages beyond the original patent, and the
predictive value of their evidence was nil. He indulges, “if that’s not a
speculative claim, I don’t know what is.” Atomoxetine was similar. Canada’s
sound prediction test, according to Jonathan, is actually in favor of
patentees, since they just have to predict what their invention will do. But
they have to tell the world the factual basis for their prediction, and Lilly
did not do that.
Question: The irony in the case is that this came from
litigation in which the counterpart to Lilly is probably using the drug for the
use that Lilly predicted. Lilly predicted it right, and they are being
criticized for not having a reasonable basis for the prediction. Isn’t there a
neither case was it necessary to say the drug didn’t work. Lilly just didn’t
meet its side of the patent bargain with atomoxetine. They didn’t state the
basis that they used for the prediction; they never referenced their 7-week,
double-blind, crossover study that was ongoing at the time the patent was
filed. With olanzapine, it was one of
many, many compounds, and Lilly stated that it was better than the genus
compound, but had no factual basis for the prediction, and their prediction was
actually not true.