Protecting innovation through patents is the lifeblood of the global pharmaceutical industry. Without patents the world and its expanding population would be deprived of new and, ultimately, affordable life-saving medicines.
Granting patents accelerates technological progress. This holds especially true for biomedicine where big and risky investments – between $1 and $1.5 billion per drug – are required to get a new medicine to market. Copying or producing an authorised medicine, however, costs a fraction of its development. But let’s not forget, it is the huge cost of R&D that innovation-driven pharma companies invest that enables cheaper and effective generic drugs to be made available in the end.
There is, of course, a high risk that research projects may fail but the rewards for a company that carries out successful R&D are, admittedly, equally high. Yet analysis shows that the returns on R&D have more than halved in five years – from ten percent in 2010 to just 4.2 percent in 2015. This notwithstanding, innovation-driven pharma companies are the largest funders of R&D into chronic and deadly diseases that ravage poorer countries.
Nevertheless, the high profitability of pharma companies has prompted an increasingly widespread (and often ill-informed) political debate on patents. This is not just because of mounting health costs but also the lack of access to life-saving medicines in developing countries. But this argument on the alleged high costs caused by patents falls short because most patents for essential medicines on the World Health Organization (WHO) list are expired and are available at generic medicine prices. Even so, patients in countries where they are most needed do not have access to generics. And the reasons for this are multiple, not least inadequate, poorly-funded healthcare systems.
Against this background, the initiative on patents of the World Intellectual Property Organisation (WIPO), the International Federation of Pharmaceutical Manufacturers’ Association (IFPMA) and now 21 of the world’s leading pharmaceutical companies is significant. On the side-lines of this year’s Assemblies of the Member States of WIPO the two organizations have signed a memorandum announcing Pat-INFORMED which aims to help procurement experts assess the patent status of medicines. As patent experts know, there are numerous patents which are not filed in every country and that have different expiry dates. For government officials working on medicines procurement, it can be unclear whether a medicine is still protected by a patent in a certain country or a cheaper generic is available. The Pat-INFORMED database administered by WIPO will enhance access to information in these areas.
This initiative is founded upon the research-based bio-pharmaceutical industry’s firm belief that a properly implemented patent system should not only work to sustainably incentivize innovation, but should also strive to make information about patented inventions available and accessible to the public. Sharing such information also helps to inform and educate, add to the body of scientific and technological knowledge, and promote the further advancement and improvement of technology. The database will seek to make it easier for national and international drug procurement agencies to access a basic body of patent information.
In a first step, 20 (now 21) pharma companies (Abbvie Inc, Astellas Pharma, Boehringer-Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai Co., Ltd, Eli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Ipsen, Johnson & Johnson, LEO Pharma, Merck KGaA, Merck Sharp & Dohme, Novartis, Novo Nordisk Inc, Pfizer Inc., Roche Group, Shionogi, Takeda Pharmaceutical Company, UCB) have committed under IFPMA’s lead to provide the database with all patent information on chemical modules for the treatment of cancer, Hepatitis C, cardiovascular diseases, AIDS, diabetes and respiratory diseases as well as other products that are on the WHO’s essential medicines list. More companies and product areas, including sophisticated vaccines, are expected to be added.
Some companies are already disclosing patent information, but there is no consistent approach. As other companies were planning on doing the same, it was decided that setting up a common platform would ensure a more consistent approach and best serve the needs of drug procurement agencies.
Following the announcement in early October, some of course, have argued that the initiative does not go far enough. That, for instance, it does not give information on patents that have been rejected or withdrawn, or those that have prompted objections. But such criticism is premature. This is an initiative in its first phase and has been designed as a global version of the tried and tested US Orange Book.
In addition to the database, participating companies will respond to enquiries from procurement agency’s bona fides and reasonable requests for additional patent information related to a product of interest.
And it has already won plaudits across the (non-pharma) world: “For WHO, I think every initiative that increases transparency on patents in relation to medicines is a good step forward. We spend a lot of time verifying patents on medicines, going to patent offices in countries or asking experts to find patent information for us. This database can help us save time and money. So, it is good for the WHO, procurement organizations and society as a whole”, says patent expert of the WHO, Peter Beyer. Likewise, Trevor Mundel, head of health at the Gates Foundation, calls Pat-INFORMED “an important step to reduce uncertainty and improve transparency in medicines procurement”.
And, as Hon Samuel Tembenu, Malawi’s minister of Justice and Constitutional Affairs, said at the launch: “Intellectual property rights and the patent system in particular lubricate the wheels of innovation, ensuring that pharmaceutical companies continue to invest in the development of much-needed newer and improved health technologies, medicines and vaccines.”
The principal purpose of the initiative is to facilitate requests from procurement agencies to obtain information that could enable them to form a preliminary view about whether they can lawfully obtain a generic product without infringing patents. Procurement agencies may not have the expertise, tools, or resources enabling them to make this assessment, and the Pat-INFORMED is primarily aimed at facilitating this process.
It will, at first, provide information on granted patents for small molecule products within oncology, hepatitis C, cardiovascular, HIV, diabetes, and respiratory therapy areas; and any products on the WHO Essential Medicines List that are not within these therapy areas. In addition, a facility for follow on enquiries will also provide a direct contact point for procurement agencies to seek additional clarification regarding the patent status of the products.
Any organization such as a generic company, other research-based biopharmaceutical companies, biotech firms, universities and research institutes willing to comply with the Pat-INFORMED Guiding Principles may and is welcome to join.