I’ve complained in this blog about the previous Commissioner’s predilection for exceeding his authority. From a just-published decision of Deputy Commissioner Noah Shlomovitz (released today but dated March 30), we see that the ex-Commissioner isn’t the only person infected with this particular bug.
The decision concerns an opposition to Lilly Icos’ patent application no. 147642, which is a national phase application in Israel of WO 2001/008688. The corresponding U.S. and European patents are US 6,821,975 and EP 1200092; the U.S. patent is one of seven presently listed in the FDA’s Orange Book for Eli Lilly’s drug Cialis for the treatment of erectile dysfunction. The claims as originally allowed by the ILPTO correspond to those of the European patent.
After allowance in 2006, a pre-grant opposition was filed by Teva. Since the ILPTO does not make opposition files available electronically, I assume for the present discussion that the claims remained unchanged during the opposition.
According to the DC’s decision, after both sides submitted their written evidence-in-chief and hearings were held before the DC at which the sides cross-examined each other’s witnesses and experts, the opposition was withdrawn by agreement of the parties.
That should have been the end of the story…but if it was I wouldn’t be writing this blog post, would I?
The rub here is that §34 of the patent statute says that “If an opposition was filed per §30 and cancelled afterward, the Commissioner is allowed to not grant the patent, if as a result of the opposition material was shown to him according to which the patent application should not have been allowed a priori.” In this case, the DC invoked his power under §34 and determined that the application should not have been allowed a priori. And that’s where the problems with the decision begin.
First, Rule 74 says that if the Commissioner exercises his power under §34 of the statute, viz. after cancellation of the opposition he refuses to grant the patent because of material that came to light during the opposition proceedings, he must provide the patent applicant with a detailed explanation of his reasoning. Rule 74 then goes on to say that within 30 days of service of the Commissioner’s reasoned explanation for refusal under §34, the applicant may respond in writing to explain why the Commissioner should not exercise that power, and that if the applicant so responds, the Commissioner must grant the applicant the opportunity to present oral arguments.
The difficulty is that in this instance, rather than provide detailed reasons as required, the Deputy Commissioner stated that he would provide a more reasoned explanation for his decision at a later date. Now, if the DC had said that the 30-day clock would only begin to run upon service of that yet-to-be-delivered detailed explanation, he might be on ok grounds – although since in Israel there’s no mechanism to compensate patentees for time lost off the life of their patents due to oppositions, the DC probably should have either let the patent issue, or provided a detailed explanation of his reasoning. Or at least waited until the detailed reasons were written before informing the applicant that he was going to refuse the application under §34.
But not only did the DC fail to say that the patentee’s 30 days would run from service of the detailed explanation, he actually went so far as to say that the patentee’s time would run from March 30 and be shortened to April 16 – including any oral arguments to be made. Why? Because, it turns out, the DC is leaving office at the end of April, and since he’s the one who’s familiar with the case and presided over the cross-examination of the witnesses and experts, it would be inefficient to turn the case over to another hearing officer who is completely unfamiliar with the matter. (He didn’t mention that in addition the ILPTO will be closed from April 18 through the 25th and reopen on the 26th for Passover.)
Perhaps the DC thought that in doing this, he was being fair to the applicant. He’s correct that putting the matter before another hearing officer would slow things down tremendously, and result in the loss of the impressions of the witnesses that the DC formed during the hearings. But even if he is well-intended, that doesn’t give him the authority to derogate from the procedures and timelines set forth in the rules. Who is he to prejudice the applicant in that way, by foreshortening its time to respond?
If Mr. Shlomovitz felt so strongly that a patent shouldn’t be granted, he should have delayed his departure from his position for long enough to see the job through properly. Alternatively, if he was so intent on leaving office by the end of April, a more fair result would have been for him to have let the patent issue, without saying to anyone why he thought it shouldn’t. I say that because it’s not some amorphous public that would be adversely affected by the grant of an invalid patent, but rather the local competition, viz. the local generic drug companies. But those companies are adept at protecting their own interests and attacking patents they find problematic; Mr. Shlomovitz need not look out for them. Of those companies, only Teva thought it worthwhile to file a pre-grant opposition, and since Teva dismissed its opposition, Mr. Shlomovitz should have let the patent issue – if none the other generic drug companies care about this patent, why should the DC?
Moreover, in addition to pre-grant oppositions, Israel has post-grant cancellation proceedings, so if any of the generic drug companies other than Teva were to suddenly find an interest in this patent, they could avail themselves of that route. The materials from the opposition would be available to them, and the generic drug companies employ chemists and pharmacologists who understand the science involved. (Mr. Shlomovitz is neither a chemist nor a pharmacologist.)
The second gaffe on the part of the DC is that he said that per §159 of the statute, he would allow the opponent, Teva, to be involved in the proceedings pursuant to rule 74. §159 says that “The Commissioner shall exercise any power granted him by this statute after an opportunity has been given to any person who, in the Commissioner’s view, might be injured by his decision, to present his arguments before the Commissioner.” But Teva dismissed the opposition. That not only indicates that in Teva’s own view, it will not be injured by the grant of the patent. It means that Teva is now estopped from attacking the validity of the patent, whether in proceedings before the ILPTO or before the courts. The statute does not give the DC the authority to resurrect the legally dead.
Also, reading between the lines, one suspects that at this point in time Teva is as interested as Lilly in the patent being granted: given the late stage at which Teva withdrew the opposition - after the sides had brought witnesses to the Patent Office and conducted cross-examination - and that the withdrawal was by assent of both parties, it's a fair assumption that Teva and Lilly reached an agreement under which Teva received some sort of inducement not to pursue the opposition to the end - a convenant not to sue, or a reverse payment to keep a Teva version of the drug off the market, or something of that nature. So the guess here is that right now Teva would be perfectly happy for Lilly to have a patent to keep Teva's competitors at bay, and would be disappointed were the patent to be denied.
Mr. Shlomovitz would have done well to recall the recent incident in which a former minister was convicted of a crime but received no jail time. Unlike in the USA, in Israel the prosecution may appeal both a finding of not guilty as well as the sentence passed on the convicted. However, at the time the deadline for appeal came up, the prosecutors were on strike, and an appeal against the lenient sentence was not timely filed. When shortly afterward the prosecutors returned to work and asked for an extension to appeal, the courts said, too bad. The guilty ex-minister – whose last name, incidentally, can be scrambled to spell “Hayignov”, which in Hebrew means, appropriately enough, “he who shall steal” – is out free. If the country can suffer a crooked politician out walking free, surely it can suffer a patent that no one except the DC himself has objection to.
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Although Mr. Shlomovitz didn’t provide detailed reasons for his refusal, as required under Rule 74, he did say that his reasoning in brief was that the essence of the invention pertained to tadalafil, specifically the problem of its solubility; that the invention solved the problem by breaking the solid bulk tadalafil into very small particles, whereby increase the rate of dissolution to enable “rapid onset” of the effects of the drug; but that according to the material before him, it was obvious to any average professional (he didn’t say in what field) that decreasing particle size would increase the dissolution rate, and that even the prior art that Lilly Icos asserted taught away from the invention actually showed that decreasing particle size was always the first thing one would try in order to increase the rate of solubility.
Not having seen either the parties’ submissions, including the prior art relied upon, or the transcripts of the cross-examinations, and not having seen Mr. Shlomovitz’s still non-existent full reasoning, I won’t comment at this stage on the substance of his decision, save for one point: the brief explanation provided in the March 30 decision doesn’t relate to each claim separately, but only relates to the claims as a whole. But even if one accepts that decreasing particle size is the most obvious way to increase the dissolution rate, that might affect claims 1 and 5 (reproduced below), but how does that necessarily lead one to the specific Cmax and AUC recited in claim 8?
1.A free drug particulate of a compound having a formula
and pharmaceutically acceptable salts and solvates thereof in which the compound is present as solid particles not intimately embedded in a polymeric co-precipitate, wherein at least 90% of the particles have a particle size of less than about 40 microns.
5.A pharmaceutical composition comprising: (a) a free drug particulate of a compound having a formula
and pharmaceutically acceptable salts and solvates thereof in which the compound is present as solid particles not intimately embedded in a polymeric co-precipitate, wherein at least 90% of the particles have a particle size of less than about 40 microns; and (b) one or more pharmaceutically acceptable carriers, diluents or excipients.
8.A pharmaceutical composition comprising: (a) a free drug particulate of a compound having a formula
and pharmaceutically acceptable salts and solvates thereof, in which the compound is present as solid particles not intimately embedded in a polymeric co-precipitate; and (b) one or more pharmaceutically acceptable carriers, diluents or excipients, wherein the composition exhibits a Cmax of 180 to 280 micrograms/liter or an AUC of 2280 to 3560 microgram hour/liter, measured using a 10 miligram [sic] dose of the compound.