Guest post by Corey Salsberg, Vice President, Global Head IP Affairs, Novartis
The patent system depends on information to achieve its goal of promoting progress. Published information defines the prior art. Patents must disclose sufficient information to describe an invention and enable others to practice it. And applications containing this information are published after 18 months, even if no patent issues. Comparing patents to other intellectual property rights that also promote innovation—trade secrets, most notably—the system’s role in disseminating information is one of its most distinguishing features.
But “information is not knowledge,” as Einstein (and Frank Zappa) said. Information isn’t anything if it isn’t accessible. And it isn’t much use if those who can access it lack the ability or means to organize, process, and apply it to their work.
In the field of biopharmaceuticals, patent information is important to a wide variety of stakeholders. Innovators use it to assess the state of the art, to secure freedom-to-operate, to seek out opportunities for in- or out-licensing, to identify partners for collaboration, or to learn from, improve, or advance the field of medicine. Generics use it to plan product development, to design-around patents, craft strategies for patent challenges, and to help inform when and where they can proceed with generic product launches. Both of these groups generally have access to patent lawyers and other professionals, and to private services that can “landscape” patents better than Bierstadt or Frederic Church. But when it comes to something as important as patented medicines, there are other stakeholders that lack these resources, but who nevertheless would benefit from effective access to basic patent information. These include health authorities, multilaterals, and a variety of NGOs engaged in the procurement of medicines, who need access to patent information to inform their decisions about how, when, where and from whom to obtain life-saving products for their constituents. To be sure, granted patents, pending applications (at 18 months), and the information they contain are all public materials that are widely available through national patent offices, international organizations, and public search engines like Google Patents. But accessing this information and processing it in a way that connects it to medicines can be challenging, burdensome, or for some even daunting.
To help take up this challenge, over the last couple of years the research-based pharmaceutical industry has been hard at work developing an industry-based platform that aims to make it easier for global drug procurement agencies to access a basic body of patent information that connects issued patents to marketed medicines. Now under the joint sponsorship of the World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the platform, known as the Patent Information Initiative for Medicines, or “Pat-INFORMED,” is a voluntary endeavor comprised of a public database of patent information, and a platform for facilitating communication between procurement agencies and patent owners. The database portion of Pat-INFORMED, hosted by WIPO, is modelled on the US “Orange Book,” and will provide the public with a searchable online gateway that, on a global basis, correlates granted patents to a company’s marketed medicines. Information for the database will be supplied directly by participating companies like Novartis, and will be updated on a periodic basis. Meanwhile, the communication platform will provide a channel for follow-on inquiries, to make it easier for procurement agencies to seek more detailed public patent information about a particular medicine.
To date, twenty leading global research-based biopharmaceutical companies, including founders Novartis, GSK, Pfizer and Merck KGaA, have committed to participate, and we anticipate more. The initiative was formally announced last week at the WIPO General Assembly in Geneva, and is expected to be operational by mid-2018, with an initial wave of data for all small molecule medicines in the areas of oncology; hepatitis C, cardiovascular, HIV, diabetes, and respiratory disease, as well as any other products on the World Health Organization’s Essential Medicines List. In a second phase, Pat-INFORMED will expand to all therapeutic areas and explore the inclusion of complex therapeutics.
As a founding member, we at Novartis view Pat-INFORMED as a great illustration of what can be accomplished when the private sector and multilateral organizations work together to improve the status quo and craft solutions to society’s challenges.
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- Further information from IFPMA and WIPO: Pat-INFORMED backgrounder.
- The Press Release from WIPO includes further information.