A few weeks ago I posted about the Commissioner of Patents getting very publicly raked over the coals by a legislator for having unilaterally decided a few years earlier to cease paper publication of the Patents Journal by the Government Press Office (GPO), as required by statute, and to instead only publish the Journal on the ILPTO’s website, all the while continuing to collect the publication fees set by law. The incident occurred in the context of a committee hearing in the Knesset in which the topic of discussion was a statutory amendment that would enshrine the practice prospectively and ex post facto give legal force to the online publication that had already taken place. Although the committee decided to put off further discussion until later, I noted at that time that (a) the failure to engage in paper publication cast a cloud over the validity of several thousand patents, but (b) for that very reason the Knesset would enact the proposed legislation to retroactively fix the situation.
Perhaps unsurprisingly, it only took a few days for some cash-hungry lawyers and some potential plaintiffs to find each other and to file suit against the Commissioner, seeking to have the suit declared a class action. After all, a single thousand-shekel publication fee paid by an individual applicant is hardly worth fighting over, but if several million shekels in official fees paid by thousands of applicants are at stake, a win would be a windfall for the lawyers, and the plaintiffs might even see a few shekels themselves. The reasoning evinced in the complaint is seriously flawed, but that’s the topic for a later post.
In the interim, the ILPTO got the message: on October 31, 2010, it published Patent Journals Nos. 2/2010, 3/2010 and 4/2010, but this time it made sure to have the GPO simultaneously print a copy of each Journal, so that there was simultaneously publication online AND in “Reshumot”, the official state publication organ. No doubt about it, these three Patents Journals are definitely kosher.
Today’s post focuses on some of the many patents the status of which is presently in question, and which are in need of a legislative fix.
Exhibit A is a group of patents belonging to IBM. The four patents in question, IL 151545, IL 153888, IL 157506, and IL 159655 all lapsed in 2007-2008 for failure to pay maintenance fees. When IBM discovered the oversight, it filed requests to reinstate the patents, in August and October 2009. Notice of the requests to reinstate were published in the Patents Journal online on the ILPTO website, but paper copies weren’t published. In the absence of opposition, all four patents were reinstated. Or were they? The statute requires that notices of requests to reinstate be published in “Reshumot” by the GPO. Since formally such publication never took place, it can be argued that technically these four patents still haven’t been reinstated and are therefore presently unenforceable.
Actually, in this particular case, it gets even better: it’s not clear that any of the four patents were actually granted. The original publication per §26 of the statute of notices that the applications had been allowed by the ILPTO also took place on the ILPTO’s website, without a corresponding paper publication in “Reshumot”. Since publication in Reshumot is a sine qua non of the patent grant process, it can be argued that technically these patents are still merely applications awaiting publication in Reshumot. If that’s the case, then IBM should probably ask for a refund of the fees it paid to reinstate the “patents”…
Of course, at worst for IBM, the ILPTO could now publish a paper version of the Patents Journal that would list these four patents. While that would represent several years lost from the life of the patents, the patents would still be in force. As will presently be explained, that option isn’t available for our next exhibit.
Exhibit B is IL 95691. This patent covers tiotropium bromide monohydrate. That’s the active ingredient in Boehringer Ingelheim’s product Spiriva®, a drug for treating chronic obstructive pulmonary disease. Spiriva had worldwide sales of over 2 billion Euros in 2009. 
The patent was filed on September 14, 1990, but the drug wasn’t approved by the local health authorities until 2004, making the patent eligible for a patent term extension (PTE). Boehringer timely applied for a PTE, and in March 2010 the ILPTO published notice of intent to grant the extension; the PTE was ostensibly granted several months later in the absence of any opposition thereto.
But here too, the publication of the notice of intent to grant the PTE occurred only on the ILPTO website, not in the GPO-published, cellulose-based “Reshumot”. Technically, then, the Commissioner wasn’t authorized to grant the PTE, the “granted” PTE is a nullity, notice of the intent to grant still awaits paper publication in “Reshumot”, and only thereafter can the Commissioner grant the PTE.
Now we come to the real problem: without a valid PTE, this patent expired in September 2010. And under the current statute, the Commissioner is neither empowered to grant interim PTEs prior to expiration of the patent (in contrast to the situation in the USA), nor is he authorized to grant a PTE after the expiration of the patent. In other words, without amendment of the statute to retroactively give legal force to the online publication, this patent is dead. I don’t know what the local market for Spiriva is, but if it’s doing 2B Euros annually it has to be worth at least a few million here in Israel.
Exhibit C is IL 95572. This patent covers etanercept, a version of the alpha- and beta-receptors of tumor necrosis that is the active ingredient in Immunex’s (Amgen’s) Enbrel®. Enbrel, which is indicated for various types of arthritis, had sales of nearly 3.5 billion dollars in 2009. Enbrel was approved by the Israel Ministry of Health in 2000. Unfortunately for Immunex/Amgen, although the patent application was filed in 1990, the ILPTO didn’t allow the application until 2008, at which point it was published in the Patents Journal. Online. Without a paper publication in “Reshumot”. So again, technically, the grant of this patent is a nullity, and Immunex needs to await paper publication before it can get its patent. The only problem with that is that the 20-year term for this “patent” ended in April 2010. Moreover, this “patent” was eligible for a PTE, and ostensibly received such a PTE, but again, the notice of intent to grant the PTE was only published online, not in “Reshumot”. So, as in the case of Spiriva, the patent for the API for Enbrel is no longer in force, the Commissioner can’t grant a PTE, and the only hope for getting patent protection at this point is for a retroactively effective amendment to the statute. The good news for Immunex/Amgen is that since this is a biologic drug rather than a traditional small molecule, it may be a while before generic competition is in a position to receive Israel Health Ministry approval.
It’s unclear to me why the Knesset committee chose to stall action on this amendment last month. If, as it seems it may be, the committee chairman, David Rotem, is either trying to capriciously flex his legislative muscle or simply nursing a bruised ego, the present situation is reminiscent of a Laurel & Hardy film. I stand by my prediction that the Knesset will enact the necessary amendment to fix this problem. The Commissioner’s motives in this case were the right ones: online publication is a faster and far more efficient way to disseminate the notices that hitherto have been published in “Reshumot”. True, he should have lobbied the Knesset to make the change first, or at least seen to it that at least one paper copy of the Journal would be published by the time the Journal went online. Nevertheless, the fact that he didn’t get the statute changed first is no excuse for committee chairman to keep the necessary amendment holed up in committee. Such failure to act would be folly. Ultimately, no one has been harmed by the online-only publication. To the contrary: the filing of oppositions to patent applications has continued apace, indicating that the notice function of publication is being met. Israel patents continue to be indexed in international patent databases, such as the EPO’s Inpadoc and Derwent’s WPI. It’s inconceivable that the thousands of patent applicants stand to lose their patents because of Knesset inaction.