The Zyprexa case is a timely reminder that in IP Strategy, a simple
rule of thumb, though useful, is almost always inadequate. Zyprexa
underscores the point that infringement and novelty are not flip sides of the
same coin.
A disclosure
can infringe a claim but not necessarily invalidate it for lack of novelty. (And, if the prior disclosure were a patent
claim, it can be infringed by the later patent, but not disclose sufficient
subject matter to invalidate the later patent claims for lack of
novelty.)
The degree
of disclosure as understood by the person of ordinary skill in the art is the
key.
On 26
December 2006, in a unanimous judgment in
a closely monitored Hatch-Waxman contest, the US Court of Appeals for the
Federal Circuit held that Eli
Lilly’s Zyprexa (Olanzapine) composition of matter (or active
pharmaceutical ingredient) patent (US
5,229,382),was not anticipated nor obvious in light of
prior disclosures of a class of molecules with optional substituents
which included Olanzapine.
Comment
The human brain
is particularly attracted to simple explanations and rules of thumb. Clearly they are very useful in many
circumstances. However, the Zyprexa case is a timely reminder that the simple
explanation is almost always inadequate.
One such
rule of thumb is that in patent law, infringement and novelty are flip sides
of the same coin. This is not a bad
rule of thumb and has arisen because very similar steps are used to determine
the construction and breadth of the claims and whether the prior art or
alleged infringement falls within their scope.
The Zyprexa case demonstrates that a particular disclosure can
infringe a claim but not necessarily invalidate it for lack of novelty. (And, if the prior disclosure were a patent
claim, it can be infringed by the later patent, but not disclose sufficient
subject matter to invalidate the later patent claims for lack of novelty.) How does this come about?
The two
tests part company when determining the actual content of the disclosure of
the prior art (or alleged infringement) in each case.
In Zyprexa, the prior art (the Chakrabarti
article) disclosed a class of molecules with optional substituents
which included Olanzapine. Consequently, to the extent that it included
Olanzapine, the Chakrabarti
article ‘infringed’ the US
‘382 patent claims.
Furthermore, if the Chakrabarti article had itself
been a patent claim, then it would clearly have encompassed the Olanzapine molecule which would thus have infringed the (Chakrabarti) claims.
However,
since the Chakrabarti article was prior art, to
invalidate the claim, it was required to provide a sufficient degree of
disclosure so that the skilled addressee would be in possession of the
invention (Olanzapine). It was held that this was not the case
since, if one were to try every combination disclosed by the molecular diagrams
in question, there would be millions of possible molecules and the Chakrabarti article favoured a class (halogenated)
which excluded Olanzapine.
Inherent
anticipation
Lilly’s
simple answer to the anticipation case was, of course, that nowhere in any of
the prior art citations was the Olanzapine
molecule described or depicted. This left
the appellants (Zenith Goldline – now Ivax, Teva,
and Dr Reddy’s)
to argue that the disclosure in the prior art inherently anticipated claims
to the Olanzapine molecule. The argument being that the skilled
addressee would be taught the Olanzapine molecule
on reading the prior art disclosure (even though it was not literally
present). The test for inherent
anticipation is slightly different in different jurisdictions, but basically
requires that the skilled addressee would inevitably read the disclosure as
teaching the required subject matter (ie 100% of
the time).
Here, the
CAFC held that the Chakrabarti article did not anticipate
the claim as it did not put the Olanzapine molecule
in the possession of the public and did not disclose each and every essential
feature of Olanzapine.
Why was
this case so closely monitored?
The Zyprexa Hatch-Waxman litigation is an example of generic
companies filing a paragraph IV certification against a composition of
matter patent. In essence, such
patents are supposed to provide the strongest protection for the innovator
product. If the Zyprexa
patent had been invalidated, it would encouraged generic companies to use
this strategy in the future and likely have a serious affect on the
monopolies (and share prices) held by innovator companies. (For this reason, in a 2005 research paper,
one analyst firm referred to the Zyprexa case as
the ‘Z Bomb’).
Other
grounds of appeal
The unanimous opinion was written by Judge Rader and also
dealt with obviousness, experimental use and inequitable conduct.
Links
Orange Book Blog commentary here.