Selection Inventions – Inventive Step Requirement, other Patentability Criteria and Scope of Protection
Questionnaire published in AIPPI, 2009
Groups are asked to give a summary of the legal position as regards a patent for a purported selection invention in their jurisdiction in relation to the following:
1. Legal developments on selection inventions
What specific types of inventions are recognized under the concept of selection invention and are patentable in your jurisdiction?
In Romania the following types of inventions are recognized under the concept of selection inventions:
a) a particular case from a general disclosure which includes the particular case; or
b) a subfield selected from a field disclosed in a document in the state of the art,
c) an element or a limited number of elements selected from a known larger class.
According to the Romanian Patent law, Chapter II an invention having a subject matter of any technology field shall relate to a product, process or use.
Do you have any examples of selection inventions in a field other than chemical, pharmaceutical or material science fields?
No, we have not any examples of selection inventions in a field other than chemical, pharmaceutical or material science fields. Although a selection, within a process, of those technical parameters contained in a known range, which produces unexpected effects on the carrying out of the process or on the properties of the product obtained can relate to any
Groups are asked to discuss any issues that should be considered with respect to the novelty of selection inventions. For example, is merely carving a range out of a broad prior art disclosure sufficient to make a selection invention novel? Is a different advantage or use, or the same advantage with an unpredictable improvement required for a selection invention to be novel?
The Romanian patent law, in generally, has similar provisions as EPC. The claimed invention is new, if it refers to:
a) a particular case, and the document in the state of the art has in view a general disclosure which includes the particular case; or
b) a subfield selected from a field disclosed in a document in the state of the art, on condition that the subfield is narrow and it is not close to known values and has a different technical effect; or
c) an element or a limited number of elements selected from a known larger class.
Further, in the Implementing Regulation of the Romanian patent Law, it is said that according to a generic claim, an invention is not new if the document in the state of the art comprises a specific example and said claim relates to a general disclosure that also includes that specific example, and the technical equivalents of the features of the claimed invention shall not be taken into account when examining the novelty.
3. Inventive step or non-obviousness
Groups are asked to discuss the inventive step or non-obviousness requirements in their jurisdiction. The provisions of the Romanian patent law from the point of view of inventive step are the following:
– the inventive step of an invention shall be assessed in connection with the technical problem it solves and with the claimed invention taken as a whole, by comparing the same with the state of the art. The analysis of the inventive step shall be performed only for the claims fulfilling the novelty condition.
– an invention is deemed to involve an inventive step if it is particularly in one of the following situations:
a) a selection, within a process, of those technical parameters contained in a known range, which produce unexpected effects on the carrying out of the process or on the properties of he product obtained;
b) a selection within a very large group of compounds of known chemical combinations of those that have unexpected advantages;
The selection is not considered as non-obvious if a person skilled in the art, having access to the whole state of art, would find the solution based on his experience and daily routine.
If experimental data is used to back up the inventive step or non-obviousness requirement can it be submitted after initial patent filing?
Are there any prerequisites or limitations on the late submission of data?
Yes, the late submission of data should have to be done until such time as a decision is made.
4. Sufficiency and/or written description requirements
Groups are asked to discuss the sufficiency or written description requirements in their jurisdiction. There may be several aspects to this question: (1) the threshold for sufficiency; (2) the allowable timing for submission of experimental data; (3) the time frame within which sufficiency or written description requirements must be satisfied; and (4) the breadth of claim scope that can be supported by a limited number of examples of asserted or proven advantages. With respect to item (1), please discuss to what extent all members of the class selected by the patentee are required to possess the requisite advantage in your jurisdiction. Is there an absolute requirement that all of the selected class possess the relevant advantage, or is the patentee excused if one or two examples fall short? Also, with respect to item (4) above, if a new utility is asserted as a selection invention, would it suffice to claim a particular range or selection of components which have been found to be associated with such a new utility or would it be necessary to recite such a new utility in the claims?
(1) The threshold for sufficiency.
The invention shall be disclosed in the patent application in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. The specification of the patent application should contain sufficient technical information to allow a person skilled in the art to carry out the invention as claimed, without any inventive step, and if it allows the third parties to understand the contribution the claimed invention brings to the state of the art. The clear and complete disclosure of the invention has in view the patent application considered in whole, including the description, claims and drawings, as the case may be. The written description has to disclose how the patentee solved an objective problem and the special qualities and advantages of the selected compound in comparison with those of the multitude of components from which it was selected. The selected compound must be pointed out through its chemical name and structure. The patentee must indicate the general formula from those he selected the compound.
A skilled person having access to the whole state of the art, general knowledge in the technical field which the technical problem solved in the invention on the relevant date belongs to, has knowledge of the invention and all the documents cited in the patent may assess the sufficiency of disclosure. The Romanian group opinion is that all members of the class selected by the patentee have to possess the requisite advantage so that it is as far away from the prior art.
(2) The allowable timing for submission of experimental data. The advantages of selected compound and the experimental data for proving these advantages have to be included in description and have to be filed with the patent authority at the filing date of the patent application. It is possible to later submit experimental data that helps to distinguish the selection invention from prior art but, the latest, until a decision for granting the patent is made.
(3) The time frame within which sufficiency or written description requirements must be satisfied. The sufficiency or written description requirements must be satisfied at the regular filing date. The patentee may modify the description until a decision for grant is made but the changes do not extend beyond the disclosure of the invention of the patent application on the filing date.
(4) The breadth of claim scope that can be supported by a limited number of examples of asserted or proven advantages. If a new utility is asserted as a selection invention it is sufficient to claim the selected components which have been found to be associated with such a new utility in the claims. Usually a single example may suffice to cover the breadth of
claimed scope of protection if the person skilled can carry out the claimed invention.
If a certain advantage or superior results were the reasons for the grant of a patent on a selection invention, does such advantage or superior result have to be implicitly or explicitly utilized by a third party for an infringement to be established?
If the invention refers to a product the advantage or superior result does not have to be implicitly or explicitly utilized by a third party for an infringement to be established. If the invention is for a new use, the advantage or superior result utilized by a third party it is not consider an infringement if the alleged infringer use the product in a different way that the selection invention as it was claimed.
If a selection invention is claimed as a new use, what are the requirements to establish infringement? Would a manufacturer of a product that may be used for the new use infringe the patent? Does the intention of an alleged infringer play any role in the determination of infringement?
The implicit or explicit utilization in whole or in part of a selection invention granted for a new use, as it was claimed, is an infringement. The manufacturer of a product does not infringe the patent for new use if the product is not claimed as such in the patent. In case the competitor who manufactures the claimed selected compound supplies it with no instructions, it can be assumed from the circumstances that the product is likely to be used to infringe the patent. In this case, manufacturing the product may be considering contributory infringement. If the manufacturer of a product makes it at the order of a third party who intend to use for the claimed new use, the last one infringes the patent. The intention of an alleged infringer does not play any role in determination of the infringement. According to the Romanian Civil law only the infringement is punished. However, the intention may play a role in the assessment of the casual connection between the contributory action and the direct infringement.
Groups are asked to give a short commentary as to the policy that lies behind the law on selection inventions in their jurisdictions, and then to consider whether or not such policy considerations are still valid today as technology continues to advance.
In Romania the law which is applicable to selection inventions corresponds to the law and practice of the EPC. The last developments in different areas of technology show the increased occurrence of selection inventions from the state of art. The policy that lies behind the law on selection inventions is to encourage the applicants to file for such invention which stimulate the competition.
With Reference to the Examples
In example 1 would the prior disclosure of the compounds containing the generic class of radicals anticipate any claim to a specific compound having a particular radical, or group of specific compounds having a selection of particular radicals in your jurisdiction?
No, the prior disclosure of the compounds containing the generic class of radicals does not anticipate any claim to a specific compound having a particular radical if in the prior document this compound has not been disclosed explicitly (namely, formula, etc.).
In the analysis, does it matter how wide the prior disclosed generic class of compounds is – i.e. would the analysis be different if the prior disclosed generic class consisted of 1,000,000 possible compounds (very few of which were specifically disclosed) as opposed to merely, say, 10?
No, in analysis of novelty it does not matter how wide the prior disclosed generic class of compounds is. Which does matter is that compound be explicitly disclosed in the prior document by a specific example referring to the selected compound.
8. Inventive step or non-obviousness
In example 2 would any of the three possibilities constitute an inventive step over the prior art in your jurisdiction?
In Romania the third (iii) possibility constitutes an inventive step over the prior art.
Further, if, say, scenario (iii) does constitute an inventive step over the prior art, what scope of protection should the inventor be able to obtain? Should the inventor be able to obtain protection for the products per se (that happen to have this advantageous property), or should any patent protection available be limited to the use of the products for the advantageous property (as an adhesive) not possessed by, and not obvious over the prior art?
The inventor could obtain protection for the products per se because the compound has unpredictable advantageous property as adhesive. The inventor can also claim the new use as adhesive in the same patent.
9. Sufficiency and/or written description requirements
To what extent are all members of the class selected by the patentee required to possess the requisite advantage in your jurisdiction? Is there an absolute requirement that all of the selected class possess the relevant advantage, or is the patentee excused if one or two examples fall short?
There is no specific rule in the Romanian law. The Romanian group opinion is that an absolute requirement could be that all members of the class selected by the patentee have to possess the requisite advantage because this property has been the reason for accepting claim.
By reference to example 3 to what extent is evidence of the knowledge of the advantageous property of the selection, or intention of the infringer as to its supply, required to find infringement in your jurisdiction?
The knowledge of any advantageous property disclosed by the claimed selection is not required to find infringement. In Romania there is no provision for establishing infringement for of a use claim. Extending the provisions for establishing infringement for product or process or a product covered by process, we may say that the alleged infringer should use the product for the claimed scope or offer it for that scope. Any document which proves that the manufacturer knew the advantageous property of the selection could be evidence in assessing of the casual connection between the contributory action and the direct infringement.
Groups are asked to consider, in respect of example 1 / 2, whether it matters how much effort the inventor has invested in arriving at his selection in order to found a valid selection patent. The answer to this question is closely related to the policy considerations that underpin the grant of selection patents and the incentive / reward equation involved. The inventor may have expended considerable time and money in trawling through the whole host of possible compounds encompassed by the prior disclosed generic class, and the particular selection that he has made may constitute a leap-forward in the field. Surely the inventor should be rewarded for his efforts and obtain protection? On the other hand, it could be argued that such considerations may have been relevant in an age when the inventor’s efforts actually involved many man-years of careful and painstaking laboratory work, but are now increasingly irrelevant in an age of combinatorial synthesis when large varieties of different compounds can be manufactured in a fraction of the time. Are such considerations relevant?
Yes, the efforts of the inventor matter and he should be rewarded. In order to more completely understand the complexities of the development of a individual selected chemical compound, the inventor must provide in description the technical challenges and a brief history of the progress made in the area to arrive at the new selected compound. More specifically, the background information gives an overview of problems connected with the disadvantages of prior art and the methods of compounds development. The research and development of chemical compounds is extremely difficult, and there are a vastly greater number of failures than successes. Numerous problems had to be solved in the unpredictable and difficult area of drug design; including interaction with a number of unspecified other compounds of unknown structure to yield an individual compound for solve the objective problem raised. All of this is understood and appreciated by the skilled person.
12. Groups are asked to analyse what should be the harmonised standards for the patentability of selection inventions. In particular, the items discussed in 1-6 and the examples discussed in 7-10 above should be referred to.
The rules for examination selection inventions are different from jurisdiction to jurisdiction and a lot of contrary decisions have been taken by the patent authorities and courts referring to the same selection invention. In order to avoid such contrary decisions the Romanian group considers harmonizing the standards for the patentability of selection inventions with EPC.
13. Groups are also asked to recommend any issues for harmonisation not referred to in 11 above.