The Israeli Patent Office has published a draft of new guidelines for examination of patent applications. The Israeli Patent Office invites comments by the public to be submitted by February 9th 2019.
The new guidelines are mainly directed to examination of biologically or natural-sciences oriented Israeli patent applications.
The comments below cover selected topics of the proposed amendments that are the most interesting.
Patentable subject matter
Section 7.2 of the Israeli Patent Law excludes varieties and strains of animals and plants from patentable subject matter. The new guidelines clarify the following in relation to Section 7.2. The exclusion of such strains does not apply to microorganisms, even if they are strains/varieties of animals/plants. Claims directed to strains of animals/plants, even if they are not microorganisms (larger than 1 micron), are patentable as long as the strains themselves are not what is claimed.
- New use – Claims directed to a new or alternative pathway of a disease or an active ingredient can be formulated in the following form. A [known, specified] pharmaceutical composition defined by a mechanism of a treatment of a [known, specified] condition. Or this: A [known, specified pharmaceutical composition defined by a treatment of a [known, specified] disease defined by a [specified] mechanism thereof. However, discovery or resolution of a pathway in itself is not patentable. In order for the claim to be patentable the use of the composition for the condition must be novel. A new diagnosis method for a known condition, based on the discovered pathway, would be considered as patentable subject matter.
- New use claims where the use is novel in respect of the treated population Before examining whether the claim has novelty in respect of the treated population other aspects of the claim must be examined for their novelty:
- Is the composition known as effective for the defined [known] treatment
- Are all the components of the [known] composition known as such and in known relative levels in the defined composition
- Is the defined treatment novel
- Is there a novelty in the dosage/delivery of the [known] composition for the [known] treatment.
Only if all of these queries result in a negative then the novelty of specific population treatment is examined. The examiner should check whether the population is inherently included in prior art relating to the treatment of the condition with the composition, or explicitly mentioned there; and whether there is teaching away in the prior art.
In my opinion the guideline should be amended since the determination of whether there is teaching away belongs to examination of inventive step/obviousness. Therefore the test should be moved to the appropriate section.
At any rate, the teaching away may be general, such as treatment of pregnant women. Or specific to the claimed treatment with the claimed composition for the claimed population.
The Guidelines emphasize that demonstration of a surprising effect such as enhanced effect [relative to a more general population that includes the claimed sub-population] is insufficient. The very idea of treating the claimed population must be surprising. It seems to me that we are relating to a special type of selection patent in this case. However, the patentability bar is raised to a higher level than such patents and thus the requirement should be dropped in general or at least applied on a per-case basis [as the Patent Office have said to me, “we exercise common sense”].
The Guidelines include a great number of examples, most of which I consider to be completely trivial. However, Example 6 of this matter is particularly elucidative.
A composition for use in a method of treatment, [the treatment] comprising: Administering Lorcaserin hydrochloride to an individual, wherein said individual has moderate renal impairment, and the treatment is selected from a group consisting weight management, prevention of obesity or treatment of obesity.
Prior art relates to treatment of obesity without relating to the target population. Since the composition is known to [adversely] affect the renal functionality, a skilled in the art would not consider treating patients with renal impairment.
1. Pharmacokinetic properties
An important feature of the Israeli Patent Law is discussed under this section. A pharmaceutical composition may be claimed as characterised by pharmacokinetic properties, wherein the active ingredient and the excipients are already known in such composition for the treatment. Such pharmacokinetic properties may result from some unclaimed feature of the composition, such as size of particles of the active ingredient/excipients. In such situations Section 13b of the Law is employed. i.e. the claims , containing foundations of the invention, should be considered as containing all of the limitations of the specification. Note that the limitations may not all be mentioned in the claims. The examiner should alert the Applicant that this section of the Law was invoked. Note that omnibus claims are no longer allowed in Israel.
2. Combination claims: Synergism and other non-additive/subtractive effects
In order for there to be an unexpected effect such as synergism in the claimed subject matter there has to be at least a statement in the specification regarding the effect. Alternatively, it has to be taught therein. In cases where there are no examples that demonstrate the effect, the examiner may allow the Applicant to provide evidence during the examination. However the examiner will not accept or consider the data and arguments of unexpected effect if the effect could not have been gleaned from the filed application. The examiner will reject the application as not meeting the requirements of Section 13 of the Israeli Patent Law [lack of support/enablement].
3. “Standard” references
The guidelines include a new list of standard references that the examiners use for arguing against inventive step. They are mostly related to biological effects.
Support for claims
As said, the claims do not have to specify in detail all of the elements of the invention, but rather only the “foundations”. In such case, of course the specification must clearly and unequivocally define the structure. The Guidelines stipulate that in this case the claims should clearly define the result of employing the invention.
In my experience specifying the result in the claim/s helps to understand the invention. However, the same is also a potential part of the claim that might lead to rejections or objections. Defining the result in claims is not required by Law and in my opinion should not be mandatory.