Could patents interfere with the development of a cardiovascular polypill?

Abstract

BackgroundThe Wellcome Trust, the World Health Organization, and cardiologists have advocated for the idea of a “polypill” containing multiple cardiovascular drugs to be co-formulated into a single pill for over a decade. Some cardiologists have asserted that the drugs commonly considered for inclusion into such a polypill are older and therefore free of patent protection. We tested this assertion. This project was requested by the World Heart Federation (WHF).Methods, data and materialsTwo cardiologists from the WHF provided a list of 48 cardiovascular drugs for evaluation. We designated the United States and Canada as the base jurisdictions for this patent study. We linked patent data from these countries’ national medicine patent registers to patent information in over 96 other countries using Derwent and INPADOC via Thomson Innovation. We expanded our study beyond the aforementioned data linkage through a systematic search of the World Intellectual Property Organization’s PatentScope, which was based primarily upon the drugs’ active ingredient names.ResultsIn the United States and Canada, eight of the drugs were only available in the patent-protected, brand name formulation in one or both countries. Another 21 drugs had relevant patents, but generic equivalents were nevertheless available. Only 19 drugs (40 %) appeared entirely post-patent. Broadening the co-formulation searches globally, the overwhelming majority of drugs (40/48) were mentioned in patent applications for cardiovascular drug combinations.ConclusionThe assertion that most of these cardiovascular drugs are post-patent is accurate, but only in the sense that many of the original patents on these active ingredients have expired and that generic alternatives are usually available. The landscape of patents covering novel (co-) formulations is far more complex, however. Most research and development for cardiovascular combination medicines are likely to be undertaken by companies whose original patents on the active ingredient will soon expire or have recently expired. Cardiologists looking to accelerate polypill development may consider approaching such companies to partner.Electronic supplementary materialThe online version of this article (doi:10.1186/s12967-016-0997-3) contains supplementary material, which is available to authorized users.

Attributable Burden and Expenditure of Cardiovascular Diseases and Associated Risk Factors in Mexico and other Selected Mega-Countries

“…A lower-cost option is a polypill made from the combination of active substances that produce drug synergism. Its use and formulation with patent-free substances have been proposed as strategies to improve adherence and cost-effectiveness of treatment for CVD [110,111,112,113,114,115,116,117,118]. However, consistent evidence is needed to support generalized use.…”

Attributable burden and expenditure of cardiovascular diseases and associated risk factors in Mexico and other selected mega-countries

“…A lower-cost option is a polypill made from the combination of active substances that produce drug synergism. Its use and formulation with patent-free substances have been proposed as strategies to improve adherence and costeffectiveness of treatment for CVD [109][110][111][112][113][114][115][116][117]. However, consistent evidence is needed to support a generalized use.…”

Polypill: an affordable strategy for cardiovascular disease prevention in low–medium-income countries

“…Another barrier to the free implementation of the polypill are the patents for its components. A study in Canada and the United States assessed the availability of cardiovascular medication with free patents and found that only 40% of cardiovascular medications were totally patent free, 41 which could be a significant barrier for the worldwide marketing and distribution of the polypill. A potential solution to this issue is that the pharmaceutical companies who own the original patents bring the polypill to the market at an affordable price, or generic companies and government research agencies incentivize successful pricing models allowing its easy obtainment and implementation for adequate treatment.…”