A new database has been launched with the principal purpose of providing easily accessible and understandable information about the patent status of a specific medicine in a particular country, by identifying key patents related to the medicine worldwide.
This database is meant to have all this information in a single place, and to complement other patent databases including commercial products, national patent offices and WIPO's PatentScope.
It is called Pat-INFORMED, or more fully, the Patent Information Initiative for Medicines.
Establishing the patent status of medicines can be a difficult task. The Orange Book has been providing the relevant information for many years but only contains US patent numbers. Pat-INFORMED aims to provide similar information on a worldwide basis.
It currently contains information on 160 products in six therapeutic areas plus additional products on the World Health Organization Essential Medicines List. There are over 14,000 patents from over 600 patent families at this time.
The six therapeutic areas are HIV/ AIDS, cardiovascular disease, diabetes, hepatitis C, oncology and respiratory conditions.
Pat-INFORMED is a collaboration between WIPO, IFPMA and 20 pharmaceutical companies, namely Abbvie, Astellas, Bristol-Myers Squibb, Daiichi-Sankyo, Eisai, Gilead Sciences, GSK, Ipsen, Johnson & Johnson, Leo Pharma, Lilly, Merck, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Shionogi, Takeda and UCB.
This is undoubtedly a valuable addition to the Orange Book but as a patent information professional with many years of searching pharmaceuticals notched on my belt, it is clear that Pat-INFORMED is not without its shortcomings.
It is limited to granted patents. Pending applications are not listed, for the reason that pending applications can be refused, amended or abandoned, where they may no longer be applicable to a pharmaceutical product. To be fair the Orange Book is the same. These databases are to start you off in the right direction, but patents are not listed if they are solely directed to metabolites, intermediates, packaging or methods of manufacture. The problem is there are many more patent applications, and granted patents for that matter, that will be relevant to the drug you are interested in, and these are not discoverable here.
Some shortcomings are listed in Pat-INFORMED's terms and conditions of use.
Any participant who lists patents or provides information or other services does so on a purely voluntary basis. This can be contrasted with the Orange Book, where providing patent information is mandatory. Pat-INFORMED is already limited to just twenty participants and their patents. Many drug names do not appear. Hopefully this picks up and we see more pharmaceutical companies adding information.
The next issue is twofold. The terms state that "Once fully populated, information in the database will be updated at least annually". Firstly, it points to the fact that the database is essentially incomplete, or a work in progress. There's no indication as to when it will be complete. Secondly, it won't be updated very often, which can lead to out of date information being relied upon. Commercial patent database providers and many national patent offices update their information daily, or at the very worst, weekly.
There are some challenges to searching for pharmaceuticals, and this database touches on one of those in particular. Pat-INFORMED relies on the International Nonproprietary Name (INN) or 'generic' name of the drug as the basis of the search. This is deliberate. It is relying upon participating pharmaceutical companies to provide patent information that might otherwise be undiscoverable by someone searching for an INN in PatentScope, for example.
Generic or brand names are not likely to appear in patent specifications early in the lifecycle of a particular drug, typically because the INN is approved some years after the first, or 'molecule' patent.
The language of the INNs and medical sector is different to the language of patents, which describe drugs in different ways or with different names.
It is therefore difficult to identify relevant patent applications filed before the INN is approved through a search using the common, generic name.
A variety of sources of information is required to bridge the information gap between the molecule patent of a pharmaceutical and the recommendation of its INN.
Some of the pieces of information are non patent, such as the chemical name, the manufacturer's code name and the drug type.
For example, the drug Brexpiprazole, approved in the United States in 2015, was originally filed as a patent application in 2006 and obtained its recommended INN in 2012, and is known by its chemical name (7-{4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one), its manufacturer's code (OPC-34712) and the drug type (antipsychotic/antischizophrenic).
Two of these pieces of information should be enough to identify the molecule patent as US7888362 as its chemical name appears in claim 7 and the drug type appears in the preamble. The third piece of information has been used in eleven patent families to identify the drug as being of interest, with some prior to the INN being proposed.
Other sources of information are relevant to a patent search. These include the IPC (International Patent Classification), or more recently, the CPC (Cooperative Patent Classification), and citation searching.
The patent classes that a drug such as Brexpiprazole is placed into are very straightforward. The compound class (C07D409) focuses on the benzothiophene ring and what is attached to it; the active ingredient class (A61K31) considers the piperazine ring as the primary ring; and the indications class (A61P25) relates to disorders of the nervous system and specifically mentions antipsychotics and schizophrenia. It is unlikely that a patent application relating to Brexpiprazole will not be placed in the correct patent class.
There are also other patent classes that may be of interest that relate to the pharmaceutical form or the inactive ingredients making up the form.
There are a number of searching techniques available that use these patent classes either alone, together or in combination with other pieces of information such as keywords and relevant parties (especially the manufacturer) that enable a searcher to locate relevant patent families filed between the filing date of the molecule patent and a time when the INN is in common use.
It is also worth remembering just because there is an INN, and it is in common use, that patent applicants will use it. There is no requirement to do so. For instance, use of the generic name 'Brexpiprazole' peaks in 2016, some four years after the INN was approved. Some advantage can be sought by not using the INN and instead referring to the chemical name, the manufacturer's code or sometimes "the compound of Formula I" in order to disguise the application to avoid early discovery of a competitor's intentions.
A further method of discovering patent applications filed before the INN is approved is citation searching. A patent application filed today may cite some related, earlier filed patents in the preamble, so while those earlier patents may not mention the INN, the later patents make the link.
Here's a line from the preamble of a patent application filed in 2016, clearly referencing an application that could not have mentioned the INN.
WO 2006/112464 A1 discloses brexpiprazole and its use for the treatment of schizophrenia...
Citations can not only be found in the preamble but also on the front page and in the search report.
Pat-INFORMED has the potential to reduce the amount of searching required when establishing the patent position around specific medicines. However, it should be regarded as a first step for the global health community and pharmaceutical procurement agencies, rather than a complete source of information, particularly given the consequences of missing a critical pharmaceutical patent.
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.
