Working Guidelines by Jochen E. BÜHLING, Reporter General Dariusz SZLEPER and Thierry CALAME, Deputy Reporters General Nicolai LINDGREEN, Nicola DAGG and Shoichi OKUYAMA Assistants to the Reporter General Question Q209 Selection Inventions the Inventive Step Requirement, other Patentability Criteria and Scope of Protection Introduction 1. A selection patent is a patent granted for making an inventive selection from a field that is already known. Selection inventions may involve the selection of individual elements, subsets, or sub-ranges, which have not been explicitly disclosed previously, within a larger known set or range. 2. Selection patents have traditionally been seen in the chemical and pharmaceutical industries. For example, a selection patent may involve a claim to a particular group of compounds having certain advantageous properties, where that group is selected from a prior-disclosed wide class of compounds, where that advantageous property is not possessed by the prior-disclosed wide class of compounds. Also, in the field of alloys, within a broadly defined class of alloys, a specific range of compositions may give rise to a special property due to a previously unknown mechanism such as newly discovered phase transition. Such a range, if it is new, can form a selection invention. Finally, selection inventions can also be found in engineering and manufacturing processes, where a special selection in a process of particular operating conditions (e.g. temperature and pressure) within a known range produces unexpected effects in the operation of the process or the properties of the resulting product. Selection inventions may also be found in other technological areas, such as biotechnology, material science and telecommunications. 3. Further, a new use may be considered to fall under the concept of selection invention or at least to relate to this concept. Typically, a new use may be found for a known chemical compound or material. It can be claimed as a "use" or a method or as a product intended for such new use. 4. To be patentable an invention needs to be new, non-obvious or inventive, sufficiently disclosed, and, of lesser importance to the current question, enabled. A selection patent is no different. Selection patents can cause difficulties, however, both in terms of their patentability and their enforceability. It has been suggested, in some jurisdictions, that selection patents constitute a special case to "normal" rules on patentability. 5. As regards validity, a difficulty with selection patents may arise on how the patentee chooses to craft his selection, both when attempting to define the selection from the wider class (that had previously been disclosed) and when attempting to define the inventive feature of the selection. Of course, the same principles of patentability still apply, but there 1
may be difficulties in applying these principles when the prior-disclosed group and the selection are similar in terms of how they are named or defined. 6. As regards infringement, the difficulty that arises is the same as that which arises with patents claiming new uses for old products 1, such as "Use of Product X as [new use]" (where product X had been known for many years for an old use. The difficult issue (which is yet to be tackled by the courts in many countries) is whether evidence of the intention of the infringer is required to arrive at a finding of infringement of such a claim. Previous work of AIPPI 7. AIPPI studied "Protection of groups of chemical substances and selection inventions" under Q81. This study resulted in an interesting Summary Report and a very short resolution stating essentially that the question of selection inventions should continue to be studied. Q84 entitled "Selection inventions" was subsequently established, but no working guidelines and no group reports were published. Novelty 8. The founding principle upon which the novelty of a selection invention rests is that a general disclosure is not to be regarded as a specific disclosure of everything embraced by the general disclosure, thereby permitting claims to protect further discoveries within (or selected from) the prior general disclosure. Of course, much depends upon the way in which the patentee has crafted his claim. The issue is best considered by reference to an example. Example 1 Say a prior art document discloses a chemical compound characterised by a specified structure including a substituent group designated "R". This substituent "R" is defined so as to embrace a generic class of broadly-defined functional groups such as all alkyl or aryl radicals, either unsubstituted or substituted by a halogen and/or a hydroxyl group, although for practical reasons only a very small number of specific examples are given. The (later) alleged invention consists of the selection of a particular radical or particular group of radicals from amongst the generic class, where the selected radical or group of radicals were not specifically disclosed in the prior-art document. The resulting compounds are described as having a new, advantageous property, say as adhesives, not possessed by the prior art examples. 9. While it may also relate to the question of inventive step or non-obviousness, merely finding a new range or combination may not be considered to give rise to novelty. A different property or advantage, or a similar advantage of unpredictable extent may be required if an invention is to qualify as a novel selection invention. Non-obviousness or Inventive Step 10. The law on inventive step will vary from jurisdiction to jurisdiction. Although we are beginning to see a shift in the approaches taken by the courts around the world as to what is or what is not obvious (most notably in the KSR decision in the USA), differences remain. 1 Such claims will be familiar to European patent practitioners as MOBIL claims, following the EPO case MOBIL/Friction reducing additive [1990] OJ EPO 93 or, in the pharmaceutical sector, as medical use claims. 2
11. As regards selection patents, once it has been established that novelty arises in the particular selection that the inventor has made, a patent for that selection will only be valid if the selection is non-obvious or inventive. 12. Since a selection invention, when a patent is granted on it, cuts out a certain scope of monopoly from the public domain accorded with the prior art, it may be justifiable to require more data to support the purported inventive step, for example a higher level of criticality associated with the inventive level of the selection invention or superior results in comparison with what was known prior to the invention. Example 2 In the selection that the inventor has made in example 1, i.e. specific compound having a particular radical, or group of specific compounds having a selection of particular radicals, the resulting compounds may be: (i) neither described as having nor shown to possess any advantageous properties (as adhesives) not possessed by the specific prior art examples; (ii) described as possessing advantageous properties compared with the compounds specifically referred to in the prior art, but these properties are ones which the person skilled in the art would expect such compounds to possess, so that he is likely to be led to make this selection; or (iii) described as having advantageous (adhesive) properties but there are no indications which would lead the person skilled in the art to this particular selection as opposed to any other members of the generic class in order to achieve the advantageous (adhesive) properties. Sufficiency or Written Description Requirements 13. The new, inventive selection must also be sufficiently disclosed so that the skilled addressee of the patent is able to put the invention disclosed in the patent into effect. The invention will necessarily be required to be disclosed across the full breadth of the monopoly claimed. Again, much depends on exactly how the patentee has defined his selection. 14. So as to ensure the grant of a valid patent, the patentee will want to strike a careful balance between inventive step (by defining the advantage possessed by the selection so that it is as far away from the prior art as possible) and sufficiency (so that all the members of the claimed selection possess that advantage). 15. It can also be an issue at what timing experimental data supporting a selection invention should be submitted to a patent granting authority. Because selection itself is the key to any selection invention, the identification of prior art and data supporting the selection may have to be included in the originally filed specification. Alternatively, it may be possible to later submit experimental data that helps to distinguish the selection invention from prior art by providing evidence of new advantages or superior results during prosecution before the patent granting authority. It may also be possible that experimental data proving the existence of inventive step or non-obviousness may be dealt with differently from that supporting the breadth of a patent claim. 3
Infringement 16. As alluded to above, a difficult issue that arises with claims to products having a particular advantageous property is the extent to which evidence of the advantageous property is required for a finding of infringement. The advantageous property is often found by use of the product, and the selection patent may be drafted either as: (i) a product claim, (which exploits the selection's advantageous property); or (ii) a use claim, claiming the use of the selection for a new use (again which exploits the selection's advantageous property). This is best illustrated by our example above: Example 3 In the selection that our inventor has made, the claim extends to the use of a particular compound arising from a selection as an adhesive (where the adhesive nature of the compound is the advantageous property not possessed by the prior disclosed generic class of compounds). A competitor manufactures the claimed compound and supplies it with no instructions as to its use. Questions General 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: Q1 Legal developments on selection inventions What specific types of inventions are recognized under the concept of selection invention and are patentable in your jurisdiction? Do you have any examples of selection inventions in a field other than chemical, pharmaceutical or material science fields? To be patentable, inventions in Brazil must attend the general patentability requirements of novelty, inventive activity and industrial applicability and not fall into the specific legal prohibitions of articles 10 (defining matter not considered to be invention) and 18 (specific exclusions of patentability) of Law 9279/96. Selection patents are not listed in either article 10 or 18 and are thus subjected to the general patentability requirements. We are aware of a Court Action raised before the District Court of Rio de Janeiro, under number 2004.51.534476-1, author being Ishiara Sangyo Kaisha LTD, against the Brazilian Patent Office, asking to invalidate the administrative act that rejected the patent application. The Court Action is still pending. There are several selection patents that have been issued by the Brazilian Patent Office (BPO). Currently, there are no guidelines in force regarding examination procedures for this kind of inventions. The BPO has announced that this topic, amongst others, will be subjected to public hearings in order to evaluate parameters to take into account for soon to be implemented guidelines. Hence, the fate of these inventions in our country is undeterminable since it will depend on the opinion of the Examiner appointed for a particular case. 4
Although it is more frequent to talk about selection patents when dealing with the chemicalpharmaceutical area, to some extent, the concept of selection might be envisaged as applicable to any technical field. Q2 Novelty 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? Any specific feature not disclosed in the prior art, even if within a generic definition, should be considered to be novel. Any issues regarding different advantages or uses, or the same advantage with an unpredictable improvement, are to be discussed regarding inventive step. Q3 Inventive step or non-obviousness Groups are asked to discuss the inventive step or non-obviousness requirements in their jurisdiction. 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? Inventive step is present whenever, for a person skilled in the art, an invention is seen as not deriving in an evident or usual manner from the state of the art. The claimed subject-matter in the selection patent must not be directly inferred by someone skilled in the art from the teachings of the prior art. According to our practice and law, it is not possible to add subject-matter to an already filed application; the application as filed must contain enough data (including experimental data) to back up the scope of what is claimed. Experimental data can be offered to the Examiner as further explanatory arguments that will support the inventiveness, however such data cannot be inserted into the pending specification as such. Q4 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? 5
Regarding the threshold for sufficiency (item 1 above) our law does not bring specific definitions. However, in practice, the Examiners have been demanding full disclosure in the specification in support not only of the description of the radicals but also of the advantageous properties of the particular selection as opposed to any other members of the generic class. As already commented upon replying to the above Question 3, the application as filed must contain enough data (including experimental data) to back up the scope of what is claimed. Experimental data can be offered to the Examiner as further explanatory arguments that will support the inventiveness, however such data cannot be inserted into the pending specification as such. The claimed subject-matter must be fully backed up by the initial disclosure, not being possible to add supporting examples at a later prosecution stage. According to our practice, it is not necessary to mention the utility in the claim. However, the specification must clearly define the unexpected results obtained with the inventive matter. Q5 Infringement 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 utilised by a third party for an infringement to be established? 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? We are not aware of any Court Action involving possible infringement of selection patents. In principle, in order to rule for the existence of infringement, infringement of the elements of at least one independent claim of the patent in question must occur. The doctrine of equivalents is also applicable in our jurisdiction. Independently of the fact that the selection invention is based on a new use, we would dare to say (not having any known to us Court Action on the matter) that in order to infringe a given selection patent the infringer would have to explicitly use the object of the invention. To characterize infringement of the new use selection patent it is necessary to use it intentionally for the same purpose. Therefore, the manufacturer of a product will not infringe a new use selection invention unless he practices or contributes to the practice of the invention for that particular purpose. Q6 Policy 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. 6
Our Law is silent concerning selection patents and, as explained above on Q1, therefore patents should be issued for inventions attending the general patentability requirements and not falling into the prohibitions of articles 10and 18 of Law9279/96. However, in more recent years, we have been observing an ever increasing stricter interpretation on behalf of the BPO as to the concepts of inventive step and sufficiency of description, paralleling the Governmental policies clearly favorable to the generic industries. The examination of inventions within the pharmaceutical art has been further and specifically made more complex by having the Brazilian FDA conducting examination on the merits of patent applications independently of that already made by the BPO; The Brazilian FDA s examination standards are more restrictive than those already applied by the BPO. The current policy applied by FDA is not to allow selection patents or second medical use patents. With Reference to the Examples Q7 Novelty 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? 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? According to the BPO's practice, if the specific compound is not described in itself within the prior disclosure, novelty would have been preserved. Q8 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? 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? Regarding example 2, the possibility that would constitute an inventive step over the prior art would be that as defined in scenario (iii). The protection afforded would cover the product per se. The enforceability of this product claim would depend on the interpretation of the judge on a case by case basis. We stress once more that we do not have case law decision to base our comments on. Q9 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 7
selected class possess the relevant advantage, or is the patentee excused if one or two examples fall short? There must be full support in the disclosure for the claims of the patent. Q10 Infringement 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? We are not aware of any Court actions pending or Case Law in our country dealing with possible infringement of selection patents. To characterize infringement of the new use selection patent it is necessary to use it intentionally for the same purpose. Therefore, the manufacturer of a product will not infringe a new use selection invention unless he practices or contributes to the practice of the invention for that particular purpose. Q11 Policy 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? The Brazilian group considers such considerations relevant and the effort, time consumed, investment made into the development of the selection invention should all be taken into consideration upon evaluating its patentability. However, what really determines the validity the selection patent is the new effect brought about by the invention. Harmonisation Q12 Groups are asked to analyse what should be the harmonised standards for the patentability of selection inventions. In particular, the items discussed in Q1-Q6 and the examples discussed in Q7-Q10 above should be referred to. Q13 Groups are also asked to recommend any issues for harmonisation not referred to in Q11 above. Q13 Groups are asked to outline any other potential issues that merit discussion within AIPPI as regards selection inventions. 8
Note: It will be helpful and appreciated if the Groups follow the order of the questions in their Reports and use the questions and numbers for each answer. 9
Q209- AIPPI SUMMARY Brazilian IP Law does not have any statutory bar against the patentability of selection inventions and the BR patents that have been already issued, for covering such inventions in different technical fields, were allowed as complying with the general requirements of novelty, inventive activity and industrial applicability, after being submitted to the same substantive examination guidelines applied to non-selection inventions. Although the concepts of absolute novelty, inventive activity and industrial applicability are those applied to inventions other than selection inventions, the selection inventive matter needs to have all its possible particular embodiments clearly and fully disclosed in the specification. The specification, as originally filed, should contain also all the data (including experimental data) necessary and sufficient to clearly define the non-expected and superior results obtained from the selection inventive matter. To be infringed, a selection patent must have the invention, or an equivalent technical solution, as defined in at least one independent claim, exploited by a nonauthorized third party. In the case of a selection invention based on a new use of a certain product, the manufacturer of the product will not infringe the selection patent unless he uses or contributes to the use of the product by a non-authorized third party. Since BR IP Law 9279/96 is silent concerning selection inventions, patents are issued for such inventions which comply with the general patentability requirements and which do not fall within the prohibitions of articles 10 (defining matter not considered to be an invention) and 18 (specific exclusions of patentability). However, all patents referring to the pharmaceutical field are submitted to a second examination on the merits by the Brazilian FDA (ANVISA), after having received the allowance from the Patent Office. The examination standards applied by said BR Agency, particularly regarding inventive activity, are more restrictive than those applied by the Brazilian Patent Office. Further, the current policy applied by the Brazilian FDA is not to allow selection patents or second medical use patents. --- La loi brésilienne n a pas aucune interdiction contre la brévetabilité des inventions de séléction et les brevets brésiliens déjà octroyés qui couvrent ces inventions en différents domaines techniques, ont été autorisés si obéissant les caractères de
nouveauté, activité inventive et application industrielle, après avoir observé les mêmes orientations substatives d examen appliqués aux inventions en générale. Quoique les caractères de nouveauté absolue, activité inventive et application industrielle soient ces appliqués a tous les inventions, les inventions de sélections doivent avoir tous ces particularités claires et totalement ouvertes dans les espécifications. L espécification, comme originellement déposée, doit aussi contenir toute information (inclus des informations experimentales) nécéssaires et suffisantes pour définir clairement les résultats non-espérés et supérieurs obténus de la sélection inventive. Pour être enfreindre, un brévet de séléction doit avoir une invention, ou une solution technique equivalente, comme défini au moins dans une des revendications, exploités par un tiers non-autorisé. Dans le cas d une invention de selection fondée dans un nouvel usage d un certain produit, le producteur n enfreindre le brevet de sélection a moins qu il utilise ou contribu pour l utilisation du produit par un tiers non-autorisé. Considérant le silence de la loi brésilienne de propriété industrielle par rapport aux inventions de sélection, les brévets pour ces inventions sont octroyés si accomplis les conditions générales de brévetabilité et si elles ne retombent dans les prohibitions de l article 10 de la Loi de Propriété Industrielle (ce qui ne constitue une invention) et l article 18 (exclusions espécifiques de brévetabilité). Néamoins, tous les brévets pharmaceutiques sont submis a un second examen de fond fait par l Agence de Vigilance Sanitaire Brésilienne (ANVISA), après avoir reçu l autorisation de l INPI. Les standards d éxamen de l Agence, particulièrement en relation à l activité inventive, est plus strict que celui de l INPI. En plus, la politique actuelle appliqué par l ANVISA c est de ne pas autoriser les brevets de selections et de second usage medicales.