Pharmaceutical selection inventions: PTO and ANVISA 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 (Carlos Correia, Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, January 2007, p14).

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. All of the possible combinations of 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 selection inventions is the selection of parameters in a process. For example, a process uses a temperature range between 50ºC and 200ºC and a pressure range between 40 pascal (Pa) and 90Pa, 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 72Pa, 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 allows the grant of patents for selection inventions, and such inventions should be analysed using the same patentability criteria as other inventions (ie, novelty, inventive activity and industrial use).

Although Brazilian law makes no distinction in relation to this kind of invention, the patentability of selection inventions is increasingly debated. This discussion mainly involves questions related to public health and the economy, as many selection inventions relate to pharmaceutical patents.

Proposed changes
In March 2015 the Brazilian Patent and Trademark Office (PTO) put forward a proposal for public consultation on the patent application examination guidelines discussing certain conditions that should be considered when examining a selection invention, and providing guidance for the examiners in such cases.

The amendments include the presentation of concepts to characterise a selection and some examples to help to determine whether a selection is obvious. The PTO's opinion, reflected in these guidelines, is that a selection should represent an independent invention 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 shows this feature, the selection is not inventive.

The proposal reflects the importance of this issue to the PTO, as it indicates that Brazil is moving towards agreement with the opinion of various patent offices worldwide (eg, the European Patent Office, the US Patent and Trademark Office and the Japan Patent Office).

It is extremely difficult to create a new molecule, even with major investments in R&D and technology. As a result, many pharmaceutical companies are investing in incremental inventions in an attempt to develop innovation in the pharmaceutical sector. Therefore, selection inventions are a real alternative for the development of new drugs and pharmaceutical companies are keenly investigating the possibilities.

Pharmaceutical patents can be analysed through two prisms:

• innovation favours the creation of new drugs; and
• patent protection of drugs may make access to medicines difficult.

Selection inventions offer the possibility of a vast increase in the availability of new drugs to society in general; however, they may also be used as a strategy to extend the expiry of patents (known as 'evergreening').

As a selection invention protects a new and inventive invention that is different from the originating patent and meets all the legal requirements for granting a patent, it makes no sense to interpret this kind of patent as an extension of the protection period of the originating patent.

ANVISA versus PTO
In Brazil, patent examinations in the pharmaceutical area are also carried out by the National Health Surveillance Agency (ANVISA). Article 229-C of the Industrial Property Law (added by Provisional Decree 2.006/1999, which was later converted into Law 10.196/2001) provides that “the granting of patents for pharmaceutical products and processes will depend on the prior consent of the National Health Surveillance Agency - ANVISA”. Thus, ANVISA must approve the grant of a pharmaceutical patent before it can be examined by the PTO. ANVISA usually analyses applications that are thought to be of interest to the drug and pharmaceutical care policies of the public health service (SUS).

On October 16 2009 the Federal Public Attorney (PGF) established that the institutional prerogatives of the PTO and ANVISA were specific and proprietary, and should not be confused or 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 was the PTO's own and unique prerogative. Further, the PGF ruled that in the prior approval analysis ANVISA should act within the limits of its competence (ie, to prevent the production and sale of products and services that were potentially harmful to human health). The PGF's opinion was adopted by a number of public bodies, such as the federal regional courts of the first and second regions, the Public Prosecutor's Office and the Federal Courts of the Federal District. 

Despite this PGF ruling, ANVISA examines patent applications for patentability criteria when the patent in question is of interest to the SUS. Moreover, although the examination of patent applications is conducted under the same legal provision, ANVISA adopts different positions from those of the PTO. For example, ANVISA's existing policy is against the grant of selection inventions and inventions for second medical use.

As a result, a pharmaceutical selection invention that was included within the SUS's policies of interest would be unlikely to receive prior approval from ANVISA.

This difference of opinion between the PTO and ANVISA creates legal uncertainty for investors in pharmaceutical R&D and innovation. The holders of these patent applications are currently bringing legal appeals. To reduce this legal uncertainty, it is essential that ANVISA act within the limits of its competence when examining a patent application and cease carrying out patentability examinations, which are the prerogative of the PTO.

The PTO recently asked to intervene in a legal case involving the holder of a patent application and ANVISA. According to the PTO's opinion, ANVISA's 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. The PTO concluded that there was no legal backing for ANVISA to reject the prior approval of the application as no risk to health had been identified (for further details please see "PTO toughens its stance against ANVISA patent activity").

This active positioning by the PTO strengthens the PGF's ruling and increases the prospect that an examination carried out by ANVISA will be limited purely to its field of activity (ie, ANVISA will not evaluate the patentability requirements of a patent application).

Comment
The practice of innovation and the strategy of incremental innovation may have benefits in the pharmaceutical sector, provided that these are not used to extend the expiry of a patent, but rather employed to develop new products in such a way as to enable greater public access to drugs.