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The problem with drug patents: can a new global approach help?

12 Nov 2018

Many countries do not have the equivalent to the US’s Orange book, and as a result health official are waste time establishing whether drug patents have been taken out on medicines. As a solution, leading biopharmaceutical companies, the UN’s World Intellectual Property Organization (WIPO) and the IFPMA have worked together to develop Pat-INFORMED, an innovative global gateway.

The problem with drug patents: can a new global approach help?
he recently established Patent Information Initiative for Medicines (Pat-INFORMED) aims to make it easier for international drug procurement agencies to access a library of clear and understandable patent information

Throughout the last decade, new treatments for HIV, hepatitis C, cancer and many other diseases have transformed the lives of patients. It takes many years of complex endeavour to develop new drugs and often these novel products have molecules, properties and attributes that deserve extensive drug patents.

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) director general Thomas Cueni explains: “Basically, all of the therapeutic progress that has been made comes out of the labs of private industry. Without tools such as patents that provide innovators with a safe R&D environment, we would not have been able to witness these achievements.”

However, while patents may be an essential tool to support the innovation process, on the downside the patent system can be bewildering to the uninitiated.

“Although information on patents is already in the public domain,” says Cueni, “its technical nature, or the fact that it is presented differently according to national varying requirements, prevents people from understanding what they are about. Furthermore, resources that directly link patents to medicines are more limited, either in select countries – such as the US Orange Book – or through private databases.”

For years, pharmaceutical companies have been thinking about how to overcome this challenge; many have been disclosing patent information for decades, but there has been no consistent approach for doing so. By way of a solution, the recently established Patent Information Initiative for Medicines (Pat-INFORMED) aims to make it easier for international drug procurement agencies to access a library of clear and understandable patent information.

To ensure a consistent approach, this new global gateway is a collaborative venture between 20 research-led biopharmaceutical companies, the UN World Intellectual Property Organization (WIPO) and the IFPMA.

Pat-INFORMED: how the new global gateway took shape

In setting up a common global platform, Cueni was keen that it best serve the needs of those who work with the information on a daily basis, such as procurement agencies. “When designing the database, ‘user-friendly’ was our operating word,” he says.

“And I want to be clear that Pat-INFORMED is not a solution looking for a problem, but a solution to a real problem. In setting up the database, we have consulted with a number of stakeholders and have taken note of their needs. The difficulty of finding reliable patent information and getting in contact with the right person in the company is the most common feedback we have gotten.”

So far, Pat-INFORMED features patent information for small molecule drugs within oncology, hepatitis C, cardiovascular, HIV, diabetes, and respiratory therapy areas, as well as any products on the WHO Essential Medicines List that are not within these therapy areas. It houses more than 14,000 individual patents for 600 patent families, and 179 international non-proprietary names (INNs).

It has been no easy undertaking, admits Cueni: “This has proven to be a heavy lift for everyone involved. Although the information is publicly available, putting it together in a unique format and making sure it follows the Orange Book standards has been a considerable task.”

Positive feedback

While the database is free and available to all, the main purpose of Pat-INFORMED is to help government health agencies and NGOs responsible for procuring medicines to assess the patent status of medicines, as it discloses the patents relating to the active ingredient. The platform includes a channel for procurement agencies to get in touch with the patent holders, so they can speak directly to experts in the relevant company.

“Those who have tested the platform gave us positive reactions,” says Cueni. “They welcomed that the database allowed searches by medicine and by country. Most have said that Pat-INFORMED will speed up the overall procurement process, ultimately benefiting patients. For instance, we heard Wesley Kreft from i+solutions, a Netherlands-based NGO that is specialised in medicines procurement for developing countries, say that Pat-INFORMED has the potential to reduce the procurement process by 30%.”

Frost & Sullivan vice president of global life sciences Nitin Naik echoes this positive feedback:  “This new initiative is a boon for global health procurement or innovation agencies such as WHO, Bill & Melinda Gates Foundation and R&D staff in developing countries.”

He believes these agencies will benefit from access to information on small molecule patents, as the generic products manufactured subsequent to patent expiries are difficult to track before being included on supplier lists.

“Similarly, innovation agencies can use Pat-INFORMED to evaluate project funding on innovative therapies vs generics,” he explains. “Researchers in developing markets do not have easy access to private databases that monitor granted patents. This initiative will help researchers to judiciously use R&D funding on projects. They can now better understand the claims structure and use this information to design better products and at same time avoid direct infringement on granted patents.”

Future developments

Pat-INFORMED is still in its infancy, but what does the future hold for the global gateway?

“I am convinced we will see more partnerships that harness the expertise of the public and private sector to achieve better health outcomes,” says Cueni. “I am confident that, over time, more companies will sign up to the initiative and that we will manage to extend the platform to all therapeutic areas and explore the inclusion of complex therapeutics such as biologics.”

Naik believes that as the healthcare industry transitions towards personalised and value-based care, regenerative medicine will play an increasingly important role.

“Approvals of cell therapy products is expected to ramp in during next ten years,” he says. “Moreover, the success of these therapies offers promising opportunities for previously untreated diseases areas. Impending patent cliff on small molecules and heavy consolidation amongst generic drug manufacturers has set up the stage for R&D investments in specialty generics.”

Naik suggests these forces will require manufacturers to closely examine their commercial business models, and Pat-INFORMED will bring in transparency to both manufacturers and procurement agencies.

“The agencies will be better equipped to maintain a complex balance while making decisions around funnelling down cost-effective generics into health systems and providing equitable access to innovative therapies,” he comments. “It can be a powerful engine to spur the industry to refocus on the important question of serving the best interests of patients and not just maximising investments from drug development.”