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:
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- Is the composition recognized for the claimed indication?
- Is there a difference in one of the composition's components or its relative part in the composition?
- 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.
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- 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.