Selection invention in the pharmaceutical area: an overview of the BPTO and ANVISA’s legal opinions
A selection invention is one in which a single element or small segment within a broad known group is selected and claimed in an independent way, based on a particular feature that is not mentioned in the broader group.
The patents that use a Markush-type formula to claim a compound are one of the most common examples to illustrate a selection invention in the chemical/pharmaceutical area. A Markush-type formula has various radicals with vast possibilities of possible substituents that can be chosen. The combinations of all the possibilities of the radicals may lead to a large number of compounds, some of which are neither studied nor described in the patent application. A selection invention consists of the selection of specific substituents that bring about a different compound with surprising properties in relation to the broader compound from which the selection was made.
A more practical example to illustrate the selection inventions is the selection of parameters in a process. For example, a process uses a temperature range between 50 and 200ºC and a pressure range between 40 and 90 Pa and the yield from it is X. It was verified that the yield of the process had tripled using a temperature of 58ºC with a pressure of 72 Pa but such conditions were not tested or described in the prior art. This process with the selection of specific conditions and the provision of a superior result may also be used as an example for selection inventions.
Brazilian law has no impediment to granting patents for selection inventions and such inventions should be analyzed using the same patentability criteria of the other inventions, i.e. innovation, inventive activity and industrial use.
Although there is no distinction in Brazilian law in relation to this kind of invention, the patentability of the selection inventions is being increasingly more discussed. This discussion mainly involves questions related to public health and the economy as a large part of the selection inventions are related to pharmaceutical patents.
In March 2015, the Brazilian Patent and Trademark Office (PTO) put forward a proposal for public consultation on the guidelines for patent application exams that discusses some conditions that should be considered in the exam of a selection invention and provides some guidance for the examiners to follow in examining an invention of this kind.
The highlights among the main guidelines presented were the presentation of concepts to characterize a selection and the provision of some situations exemplifying them to determine whether the selection could be regarded as obvious or not. The PTO´s opinion, reflected in these guidelines, is that the selection should represent an independent invention and/or a new breakthrough and should not be a mere arbitrary selection in relation to the prior art. Moreover, if a specific member of the broadest group from which the selection originated already showed this feature, the selection would not have an inventive activity.
This document reflects the concern and importance with which the PTO should deal with this subject as it also indicates that Brazil is moving towards an agreement with the opinion of a number of patent offices worldwide, such as the EPO, USPTO and JPO.
It is extremely difficult to create a new molecule at this time, even with the high investments in research, development and technology. As a result, many pharmaceutical companies are investing in incremental inventions in an attempt to develop innovation in the pharmaceutical sector. The selection inventions, which are incremental inventions, are a real alternative for the development of new drugs and these companies have paid great attention to these possibilities.
The patent system in the pharmaceutical area can be analyzed through two prisms, i.e. the first is that the innovation favors the creation of new drugs and the second is that the patent protection of drugs may make access to the medicament difficult. The selection inventions offer the possibility of a very large increase in the availability to society as a whole of new drugs but, on the other hand, it may be used as a strategy to extend the expiry of the patent. These are the cases known as evergreening.
Considering that the selection inventions protect new inventions and inventive activities that are different from the originating patent and meet all the requirements for the granting of a patent established by law, it does not make sense to interpret this kind of patent as an extension of the period of protection of the originating patent.
In Brazil, the patent exams in the pharmaceutical area are also carried out by ANVISA (National Health Surveillance Agency). The granting of a pharmaceutical patent requires the prior approval of ANVISA for it to be then examined by the PTO. ANVISA usually analyzes the applications that are regarded as being of interest to the drug and pharmaceutical care policies of the public health service, known as the SUS
The Federal Public Attorney (PGF) established, on October 16, 2009, that the institutional prerogatives of the PTO and ANVISA were specific and proprietary and should not be confused or even overlap. The PGF concluded that it was not ANVISA´s prerogative when carrying out a prior approval exam to undertake an analysis based on the patentability criteria as this would be the PTO´s own and unique prerogative. Furthermore, the PGF ruled that ANVISA should, in the prior approval analysis, act within the limits of its competence, i.e. to prevent the production and sale of products and services that were potentially harmful to human health. The PGF´s opinion was also adopted by a number of public bodies, such as the Federal Regional Courts of the 1st and 2nd regions, the Public Prosecutor´s Office and the Federal Courts of the Federal District.
Despite this ruling established by the PGF, ANVISA carries out a patentability criteria exam on examining a patent application when the patent in question is of interest to the SUS. Moreover, although the exam of the patent applications is conducted under the same legal provision, the ANVISA adopts a different position from that of the PTO. ANVISA´s present policy is against granting selection inventions and for a second medical use, for example.
As a result, a selection invention in the pharmaceutical area that was included within the SUS´s policies of interest would be highly unlikely to receive the prior approval from ANVISA.
This difference of opinion between the PTO and ANVISA creates legal uncertainty for investors in research, development and innovation in the pharmaceutical area. The holders of these patent applications are currently having to make legal appeals to have some idea of what will happen to their cases. To reduce this legal uncertainty, it is essential that ANVISA acts within the limits of its competence when examining a patent application and not carry out any patentability exam which is the prerogative of the PTO.
The PTO recently asked to intervene in a legal case involving the holder of a patent application and ANVISA to express its opinion on the matter. According to the PTO´s opinion, the ANVISA technical opinions that denied the prior approval of the patent application in question should have been challenged as ANVISA identified no dangers to public health in its opinions. The PTO concluded that there was no legal backing for ANVISA to reject the prior approval of the application as no such risks to health had been identified.
This active positioning by the PTO in this legal case strengthens the ruling established by the PGF and increases the prospects that the exam carried out by ANVISA will be limited purely to its field of activity, i.e. ANVISA will not evaluate the patentability requirements of a patent application.
Therefore, we can conclude that the practice of innovation and strategy of incremental innovation may have benefits in the pharmaceutical sector, as long as they are not used to extend the expiry of a patent but employed to develop new products in such a way as to bring greater popular access to the drugs.