America-Israel Patent Law Blog

Lots of verbiage was spent in the run-up to the U.S. Supreme
Court’s Myriad Genetics decision last week, lots has already been spent
since the decision, and lots more will be spent in the coming weeks.  To call the decision “reasoned” or “logical”
is kind of like Vezzini’s use of the word “inconceivable” in the
Princess Bride. 

But my intent here isn’t to rant on the SCOTUS, although I
may do that in a separate post.  Rather,
one of the things that interests me is the potential impact of the Myriad
decision on patents in Israel, in two respects.

The first thing I wonder about is its impact on gene patents
generally.  Hitherto, Israel has
subscribed to the notion that isolated DNA is not a product of nature and is
therefore patent-eligible.  One wonders
to what extent, if any, the ILPTO or courts here will be influenced by the
SCOTUS decision, and if Israel will reverse course with respect to isolated
DNA.  

If the patent system here were to change tack, the mechanism
by which it would have to do so would need to be slightly different than that
enunciated so obfuscatorily by SCOTUS. 
That’s because there is no patent-eligibility bar to products of nature per
se (except for plants and animals, which are barred from patent eligibility
under section 7 on moral grounds). 
Rather, section 3 of the Israel statute, which defines patentable (and
by extension, patent-eligible) inventions, simply says “An invention, whether a
product or process in any technical field, which is new, useful, susceptible of
industrial use and inventive – is a patentable invention.”  Israel law thus generally denies patentability
to products of nature on lack of novelty grounds.   And asserting that isolated DNA already
exists in nature is something I don’t foresee the examining corps at the ILPTO
doing – as scientists they’re too sophisticated to be duped by PUBPAT-type
hand-waving into buying into that.

On a more immediate, practical level, I wonder about the
impact of this decision on already-granted gene patents in Israel that were
granted under the section 17(c) procedure, on the basis of a grant of a
corresponding patent in the USA.  17(c)
is a real work-saver for the ILPTO, since it allows one to piggyback the Israel
application on an allowed corresponding application in the USA, the EPO, the
JPO, and certain other jurisdictions. 
But what happens when that corresponding foreign patent is invalidated –
and not on substantive lack of novelty or obviousness grounds, but
patent-eligibility grounds?  The statute
is silent on that point.  It does include
sections 17(d) and 17(e), which place some limits on the use of 17(c), but only
in the context of still-pending applications:

17(d):    The Commissioner, as well as the Chief Examiner and his Deputy,
are at liberty not to accept the application [for which allowance under 17(c)
has been sought], if they determined on the basis of material at their disposal
or which was brought to their attention during the course of examination, that
the application does not fulfill the requirements detailed in subsection (c) [viz.
17(c)] or if there is another special reason not to accept the application.

17(e): If proceedings for the
cancellation of the corresponding foreign patent or opposing the grant of the
corresponding foreign patent are ongoing, the applicant shall notify the
Commissioner, no later than the date of the grant of the patent in Israel.

These sections are somewhat murky anyway – as I’ve mentioned
in earlier posts, what constitutes “special circumstances” in 17(d), and the effect
of reporting under 17(e) as well the penalty for non-reporting under 17(e), are
unclear – and prima facie they have no effect on issued patents.  17(e), for example, only imposes a
requirement to report proceedings against the corresponding foreign patent up
until the grant of the Israel patent, not after grant in Israel.  On the other hand, logic dictates that if the
corresponding patent on which a 17(c) request was granted was itself invalidated
on substantive grounds, at the very least the Israel court or the ILPTO during
cancellation proceedings would need to revisit the question of substantive patentability
of the Israel patent.

Regarding 17(d), it’s worth mentioning that the ILPTO’s
examination guidelines (last updated December 9, 2012) state that if the
corresponding foreign application is from a country that has a grace period –
e.g. the USA prior to the Asinine Inventorship Assault – then the Israel
examiner must look to see if the invention was published during the grace
period, since such publication would not have been cited abroad but is citable
in Israel; and if such publication took place, the Office applies 17(d) to
refuse the 17(c) request and raise a novelty and/or inventive step
rejection.  But no word on what might
constitute “another special reason” to refuse the 17(c) request.  Would withdrawal from issue by the USPTO following
the Myriad decision constitute such a “special reason”? 

As to 17(e), the statute doesn’t say what happens to the
Israel application if opposition or cancellation proceedings against the
foreign patent are reported, but the examination guidelines instruct examiners
to look for such proceedings (even though it is the applicant’s duty to report
such) and if such proceedings are found, to move the application from 17(c)
examination to regular examination and examine the application for novelty,
inventive step etc.    

The Myriad decision effectively means that all claims
in US patents to DNA sequences isolated from natural sources are invalid and
thus unenforceable.  But in the Israel
context, two things should be noted. 
First, those US claims were examined and found to be novel and
non-obvious.  If one is willing to accept
– as Israel law presently does – that isolated DNA, as opposed to cellular DNA,
is not found in nature, then under Israel law that isolated DNA needs to be
examined for novelty (did someone else isolate it first?) and inventive step,
which in the case of 17(c)-allowed Israel patents already occurred abroad.  So the effective invalidation of the US
patent upon which an isolated DNA claim in Israel was allowed should not impugn
the 17(c) allowance retroactively. 

Second, it should be stressed that the US claims
are effectively invalidated, but not formally invalidated.  As a formal matter, by statute those US claims
are still presumed valid until challenged. 
Following Myriad, we won’t be seeing attempts to enforce those
claims, because that would open the door to such challenges being made by
defendants, and such challenges are now trivial to make; but technically every
one of those claims is valid until a court points to a specific claim and says
it’s not valid because it’s directed to patent-ineligible subject matter.  In which case there’s even less basis for
asserting the claims in Israel should be shot down because of the Myriad
decision, since at present there are no isolated DNA claims granted under 17(c)
in Israel whose corresponding US claims have been invalidated per Myriad.