It takes many years to develop a drug, and in the course of that development researchers may find that the molecules they are working with have new properties, attributes, and applications that also may be patentable. This means that many patents may be associated with any one drug or medicine. Differentiating between key patents that relate to a specific formulation of a drug and more peripheral patents covering niche applications can be difficult, particularly for a non-patent specialist, such as someone procuring drugs for an aid agency.
The challenge of searching for drug patents is compounded by the fact that neither generic nor brand names for drugs are likely to appear in patents. Drug patents are most likely to be filed and granted early in the development of the product, long before the active ingredient of the formulation receives a generic name (i.e., an International Nonproprietary Name (INN)), or a registered trademark or brand name. The inevitable gap between terminology used to describe a drug in a patent and the name by which the product becomes generally known can create challenges for assessing the patent status of a medicine.
A few countries have overcome this information gap by publishing databases, such as the United States’ “Orange Book,” which lists the patents that are relevant to each drug, according to the standard name for each medicine. The Orange Book also indicates when patents and other exclusivities expire. However, the Orange Book provides information only for the United States, and most countries do not provide such straightforward and simple references.
Determining the patent status of medicines made easy with Pat-INFORMED
The World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), together with 20 participating global pharmaceutical companies, are teaming up to respond to this gap in information by effectively globalizing the concept of the Orange Book.
Under an initiative known as the Patent Information Initiative for Medicines (Pat-INFORMED), which was rolled out in September 2018, WIPO, IFPMA and its partners are providing information – specifically, patent numbers and application and grant dates – for approved medicines in jurisdictions around the world.
Pat-INFORMED links patent information worldwide with standard product names for important medicines. The database provides a clear, easy-to-use interface, where entering a product’s INN produces a concise list of patents, including the name of the company that owns the patents and the countries in which they have...