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.