America-Israel Patent Law

Is the Israel PTO Trying To Usurp the Knesset (Legislature) And The Courts?

Some years ago, the Israel PTO started publishing a set of “Examination Guidelines” (“EGs”). These are like the USPTO’s Manual of Patent Examination Practice (MPEP), but the modern State of Israel being younger than the USA, and Israel having a smaller population and therefore fewer patents and less case law than the USA, the ILPTO’s EGs in total run much shorter than the MPEP.

Like the MPEP, the EGs are supposed to reflect actual case law, but like the MPEP, they often reflect the Office’s preferences, unsupported by caselaw. Also like the MPEP, the ILPTO revises the EGs from time to time.

Last month the Office announced a three-hour roundtable meeting on June 23 (since postponed because of the butt-kicking that Israel and the USA gave Iran; a new date has not yet been announced) to discuss possible changes to two sections of the EGs, paragraph 6.11 of Annex F concerning the novelty of method of use claims that recite a specific patient population, and Annex T concerning antibodies. The Office did not specify topics under consideration for the latter section, but it did put forth three possibilities for the former section. 

Specifically, paragraph 6.11 of Annex F presently reads (translation taken from the ILPTO; the actual text is in Hebrew):

6.11. Claims directed to a pharmaceutical composition for a certain target population

Examination of a claim directed to a composition for a therapeutic use defining a certain population, for example:

A pharmaceutical composition for use in treating cancer in a subject with a cancer having a mutation in EGFR (SEQ ID NO: 1), wherein the mutation is substitution of a methionine for a threonine at position 790; and wherein the pharmaceutical composition comprises an irreversible epidermal growth factor receptor (EGFR) inhibitor.

The following must be accounted for during examination:

1. 1. Is the composition recognized for the claimed indication?
   2. Is there a difference in one of the composition's components or its relative part in the composition?
   3. Is there a difference in the claimed dosage regimen or mode of administration?

The claim would be lacking novelty only where the answer to question (a) is yes and to questions (b) and (c) is no, and the claimed target population is either explicitly disclosed in the prior art or included in the population of the prior art, and there is no teaching-away prior art excluding the claimed target population from that of the prior art. This is due to the fact that the knowledge on treating the claimed target population is part of the prior art regarding the broad population that includes also the target population. In other words, the use of the pharmaceutical composition is known for treating every subject belonging to the broad population, whether or not belonging to the claimed target population.

• • A teaching-away prior art may be general with respect to the claimed target population, such as pregnant women, patients with liver failure, patients with kidney failure, etc. On the other hand, teaching-away prior art may be specific to the claimed target population, such as patients suffering from G6P deficiency (G6PD) treated with a sulfonamide-based antibiotic that results in hemolysis.
  • Presenting or exemplifying a surprising effect, such as increased efficiency in the target population, is insufficient to qualify for novelty. In other words, it is rather required that the very possibility of treating said target population would be surprising in order for the claimed invention to be deemed novel.

In some cases, the prior art relates to a specific population while the claimed invention relates to a broader population (including said specific population) or a different specific population. In such cases, the claimed invention would be deemed novel only where there is no overlap between the population of the prior art and that of the claimed invention. Where the prior art relates to a specific population, the latter must be excluded from the claim to meet the requirements of Section 4 of the Law. Examples for claims regarding a pharmaceutical composition for the treatment of a specific target population are presented in Appendix 6.2.

The first thing one notes about this section is that it cites NO authority in support what it says. That in and of itself is a red flag.

The second thing that one notices (or that I noticed, anyway) is that this section is not consistent with Israel practice with regard to novelty in the situation of genus/sub-genus in claims on chemical compounds. In that situation, it’s well-established that (a) if the prior art discloses a genus of compounds, (b) the applicant claims a sub-genus of that genus, and (c) no member of the sub-genus is explicitly disclosed in the prior art, then (1) the sub-genus is regarded as novel, (2) the sub-genus is presumed to be obvious over the genus, and the applicant must present evidence of some unexpected advantage over the genus as a whole, e.g. greater efficacy, lower toxicity, greater stability in storage, easier to process into tablets, etc. 

Section 6.11, however, says that with regard to compositions for treating a particular patient population, we assume that the sub-population recited in the claim was included in the earlier, wider population disclosed in the prior art, and therefore even if there’s some unexpected benefit in treating the subpopulation, the claim lacks novelty. 

Seems to me that (a) consistency in considering novelty is warranted, (b) there’s no harm in applying the same standard for novelty used for chemical compounds per se to methods of treatment when the difference over the prior art is only in the patient population, and in subjecting such method of treatment claims to the same inventive step requirements as required for claims on sub-genera of compounds per se, and (c) by looking for ways to deny patentability to methods of treating sub-populations, the ILPTO would discourage research into sub-populations for treatment.

The ILPTO says it’s considering three possibilities with regard to paragraph 6.11 of Annex F: (a) revising the section to say that if the claim includes a step of diagnosing or identifying the subpopulation, it will be regarded as novel, (b) leaving the section as-is, or (c) deleting the section.  Clearly, in my mind, the last option is the one that needs to be chosen.

But what I can’t wrap my head around is, How on earth is this something for the ILPTO to decide, let alone for public discussion at the ILPTO?  Novelty is in the statute. That’s something the legislature decides. If there’s a question of interpretation, the matter can go to the courts, or the legislature can revise the statute. But what business is it of the ILPTO to establish policy with regard to what’s novel and what’s not? Either the statute means X or it doesn’t. The ILPTO doesn’t have the privilege of saying, “We want to interpret the statute as meaning X because that will implement the public policy that we prefer.” It’s not the ILPTO’s prerogative to decide policy.

You Can’t Make This Stuff Up, Installment Number I’ve Lost Count

I wrote in April and May about the Israel PTO’s update to its patent electronic filing system, in particular about how there were many glitches in the system, even as the Office claimed everything was hunky dory.

This post is about two ongoing problems with the electronic filing system: the lack of a filing acknowledgement showing what was submitted; and the fascistic design of the system, that presumes to anticipate every possible scenario and thus limit a filer’s options accordingly.

When the Israel PTO introduced electronic filing for patent applications in December 2015 as an optional filing means, they didn’t include a mechanism to provide the filer with confirmation of what had been filed.  As the deadline forcing practitioners to use the electronic system approached in June 2016, apparently at the urging of one of the more senior practitioners, the ILPTO started sending the filer an email containing the files submitted. Not ideal, but better than nothing.

But since the ILPTO first forced us to file new patent applications via the “new” electronic system in September 2023, the “new” system has never provided a filing receipt showing what you filed.

Now, theoretically, one can see what one filed after it’s been submitted. That’s because what happens when one files a new application, or a response, via the new system is that the system opens what I’ll call a “basket”. As soon as the “basket” is opened, a tracking number is assigned to this basket, and the date on which the “basket” was opened is recorded.  One then uploads to the “basket” the files one wishes to submit, and then clicks “submit”.  There’s a lag between when one clicks “submit” and when the system actually “accepts” the submission, to use the Hebrew term (what I’ll call “processes” a submission), but once the “basket” has been submitted, one can enter the basket in the EFS and see the documents that were submitted.  However, there are two problems here.

First, the system only provides information about two dates: the date on which the basket was created, and the date on which the basket was last updated. There’s no listing of the date and time on which a particular basket was processed into the system, and no email or other documentation is ever sent to the filer confirming the time of submission and what was submitted. And although the basket creation date can’t be changed, at least not by the end user, any time one goes into the basket to look at the documents contained therein – even after the basket has been processed into the system – the “basket last updated” status gets changed to the date on which one accessed the already-processed basket. I call it the Heisenberg feature of the system: you can’t prove both what you filed and the date on which it was processed into the system, because by entering the “basket” to see what’s contained therein, the system changes the “last updated” status.

In principle, once a document has been processed into the system, it’s visible in the ILPTO’s database (which is separate from the filing system). But the ILPTO has the capability to remove files from the database. So there really is no way to prove what one filed. And not all submissions show up in the database. For example, when one pays certain fees via the new system, there’s nothing in the database to reflect that something was paid.  Indeed, whereas in the “old” system, an extension of time, for example, always needed to be accompanied by some accompanying letter (e.g. an OA response or just an extension request), filings done under the “new” system have no such requirement, so no document appears in the database.

With the USPTO’s EFS, and even now with the USPTO’s PatentCrapper, which in many ways is a downgrade from its predecessor EFS, you can immediately download a filing acknowledgement that lists exactly the documents you submitted.  Moreover, those documents appear in the list with a hash function value, so that if you ever need to prove what it was you filed, you can do so. Why can’t the Israel PTO’s electronic patent filing system do the same?

The ”old” ILPTO electronic filing system is still available for certain actions. And because that system provides users with a filing confirmation, I continue to use that system for anything I can. Admittedly, that filing confirmation is itself flawed: the system emails back to the filer all the files that were submitted, except each one is shown as being about 2 kilobytes larger than the file that was actually submitted.  Still, it’s possible to retain those emails, or if one doesn’t wish to do that, to print out each email and the list of attached files, so that one can prove what was submitted.

This brings me to the limited choices that both the “old” system, but especially the “new system” provide to users.

When filing a response, or a request for extension, or a fee, the “old” system asks you to input the application number, and then to choose an action from a list of actions. In some cases, it says “Nyeah nyeah nyeah, you can’t do that action in this file!” The “new” system is even more draconian: you input the application or patent number, and the system proactively gives you a list of possible actions. In neither system is there the possibility of filing a “miscellaneous paper”.

This, of course, leads to problems if the system calculates things incorrectly.  For example, in neither the “old” system or the “new” system is “supplemental OA response” one of the choices. Another example: in the “new” system, if you want to submit something and an extension fee is due, the system calculates the amount it thinks is due and won’t let the filer submit until that fee is paid. I discussed previously a case in which the system told me I had 30 days to file a response even though a response had already been filed, and another case I had in which no fee was due but the system thought one was due and therefore wouldn’t let me submit.  In the latter case, without the option to file a “miscellaneous paper” for which the system wouldn’t calculate a fee, it took some work to get the issue resolved.

But those examples are nothing compared what happened to a colleague recently. He was asked by a pro se applicant to file a divisional application of an application in which the applicant/inventor was listed as the address for service. But the system wouldn’t let the practitioner file the divisional, because this colleague wasn’t listed as the address for service in the parent case – “You can’t file a divisional because you don’t have power of attorney in the parent case” was what the system told him.

The problem here is there’s nothing in the statute that says a divisional can only be filed by a party that has POA in the parent case. Moreover, for initial filing, Paris Convention filings, or PCT national phase filings, the office allows practitioners to file without a POA, and then gives the applicant time to provide a POA.  That POA need not necessarily appoint the practitioner who submitted the application.

In this case, because of the glitch, the inventor called the person in charge of the filing system, who is not a lawyer nor, as far as I know, a patent practitioner, and when the inventor found he was having trouble explaining the issue, he patched the practitioner into the call so that the practitioner could explain the problem. At which point the non-lawyer non-patent practitioner ILPTO person said, “I can’t talk to you about this, you don’t have power of attorney”.

You can’t make this stuff up.

What’s really surprising about that incident, and the fascistic nature of the ILPTO’s electronic filing system in general, is that the aforementioned person in charge grew up in what was then a communist country. You’d think such a person would understand that central planning, i.e. trying to anticipate every possible scenario, and then trying to limit people’s choices on that basis, is not a winning formula.

Earth to Israel Patent Office: your patent electronic filing system leaves much to be desired. If you had asked for input from us users before you launched it, it wouldn’t be deficient. And now that you’ve launched this deficient system, you need to learn from WIPO, which is fantastic in responding to user input about ways to improve the already-good ePCT system.