Australia: Generic Pharmaceutical Patent Searching - Getting Information You Need

As a provider of comprehensive patent intelligence to generic pharmaceutical companies in over 35 countries, GenericsWeb frequently fields questions about how we identify and select relevant patents for inclusion in our Pipeline Patent Intelligence. This article is not intended to explain exactly how we conduct our searches, but to summarise the various options and dispel any myths. In doing so, I will first discuss the importance of defining the scope of the search and then contrast the various techniques that are commonly used.

Firstly, as with any patent search, we need to define the scope of the search to be undertaken. Various search parameters are shown in table 1, which should always be used prior to forming a search strategy.

Because patent searching is a non-exhaustive task (it is not possible to physically cite every published patent), and one that should be undertaken by professionally trained searchers, a trade off always occurs between the one or more of the first five parameters and the budget.

In considering a search trade-off, a good piece of advice is to consider the costs of not identifying the patent information that you specifically seek. This will help determine both the budget and where you can afford to cut corners on your search strategy.

For generic pharmaceutical developments, the costs of not identifying the required patent information can be significant due to the following potential outcomes:

• Executives spending time filtering through numerous irrelevant patents.

• Patenting a possible invention that has been prior disclosed and therefore lacks novelty.

• Increased production cost-base to avoid technology claimed in a patent that has expired, lapsed or been withdrawn.

• Changing the development mid-way due to later identification of constraining patents.

• Failure to out-license products in export territories due to later discovery that the processes and or products would be infringe patents.

• Infringing patents on products that are heavily protected by the innovator and/or generic competitors, resulting in possible product withdrawal and/or litigation.

The costs may also be implicit, in terms of low customer perception of your company’s ability to develop non-infringing generics and resulting reduction in shareholder value.

There are therefore very few areas where the patent search for generic pharmaceuticals can be compromised in the trade-off process. Patent information needs to be comprehensive, given the subject matter and geographical scope, but contain only relevant patents. It also needs to contain patents and applications of all statuses from a large date range and be kept up to date. So, given that you need all of this and that you have a limited budget, the question of how to go about finding this information arises (keeping the information up to date will be discussed in a future article).

In preparing a search strategy, the first stage is to select the type of data sources. The sources selected should primarily be able to accommodate the scope of the search, but should also match the skills of the searcher. True patent searching is considered a skill, requiring a combination of knowledge drawn from information science, foreign languages, patent procedures and a technical background.

Broadly speaking, there are two alternative types of patent data available to a searcher, raw data and indexed data. These will be explored in more detail below.

We define Raw Data as being that published directly by the patent offices. This includes such fields as applicant, abstract, patent classification code and, nowadays, the full text of the description and claims¹ .

Raw data can be searched using a variety of database interfaces, some of them are free to access, such as the EPO’s Esp@cenet, but offer limited searching functionality. In order to construct the complex search queries required and manage the large numbers of patents to be reviewed for pharmaceutical patent searching, more professional databases are required such as Minesoft’s PatBase.

The principle of searching raw patent data is that the searcher refines the available data down to a set of patents that contains all of those that are likely to fall within the subject matter scope (comprehensiveness) using a combination of the available fields. This set of patents contains a significant amount of ‘noise’, which is inevitable in building a comprehensive strategy. This set of data is then filtered manually using the inclusion policy to identify the relevant patent information (relevance).

Preparation of indexed data involves the ‘provider’ taking a set of raw patent data has been reviewed (manually, by computer or by a combination of the two) and assigned one or more ‘labels’ according to a defined index. In the case of pharmaceutical patents, the index may be a chemical abstract number or an INN. The principle of identifying patents using indexed information is that the user retrieves it in a standardised fashion, with reference to the relevant indexes. Due to the higher costs of indexed patent information, it does not lend itself to searching using the same methods as for raw data, therefore the level of relevance and comprehensiveness is reliant on the indexation of the information by the provider.

Speaking as a professional patent searcher, it is my opinion that a patent searcher who uses indexed data as their only data source is not conducting a true patent search, they are simply retrieving the results of another person’s analysis or, at worst, that of a computer. This is not to say that this would be an inappropriate method, on condition that the provider who carried out the indexation used the same the parameters (as outlined in table 1) as are appropriate for your specific search requirements. Failure to ask the right questions of the data provider in regard to indexation could result in patent information that is totally unsuitable for your requirements. For example some indexation has only been undertaken on a particular date range of patent publications, and others only on pre-selected sub set of raw patent data – this could lead to inherent limitations on the resulting indexed data.

In contrast, the options for searching raw data are almost unlimited, resulting in the ability to customise the search to meet the specific search parameters. However, searching of raw patent without applying the correct methodology and understanding the content and limitations of the data is unlikely to provide appropriate results. To emphasise this point, GenericsWeb conducted some analysis of a commonly heard example of searching for generic pharmaceutical patents by typing the drug INN as a keyword into full-text, raw patent databases. The results were astounding in that, on average, this method showed that only 62% of patents were identified for a particular pharmaceutical product when compared with the patents identified using GenericsWeb’s comprehensive searching techniques. Furthermore, of the data retrieved by such methods, 94% of publications did not relate to subject matter considered to be relevant to development of a generic pharmaceutical, based on the GenericsWeb inclusion policy. Such patent searching results not only give false confidence, but also cost the searchers’ organisation a significant amount of time in filtering through irrelevant data, meeting neither of the previously outlined key criteria for searching generic pharmaceutical patents.

So, given the above discussion, how is one supposed to meet all of the criteria of the generic pharmaceutical patent search and stay within the budget? This is where one should consider the offerings of third party providers who specialise in researching this information in a comprehensive manner, but benefit from economies of scale thus making it affordable to use.

For example, a company who uses patent searchers having expertise working within the generic pharmaceutical industry will better understand exactly what is important a customer who needs the information for that purpose and will better meet their patent information needs. Outsourcing such services is a viable option for generics companies of all sizes to remain flexible and in control of increasingly complex developments. However, it is essential in selecting a service provider that they adopt the same search parameters that meet your requirements and deliver the information in a manner which makes sense to the end user.

After reading this article, you may feel that you should not start a development with the same patent information as that purchased by your competitors, but I would suggest asking yourself whether you should really be starting with less.

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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances