Correction: Author's Reply

Correction: Author's Repl

Map of DHS and MICS Surveys

<div><p>The map shows the number of DHS and MICS surveys by country, 1990–2005, according to completed reports made available to the public in June 2005. These reports are top-level summaries of the underlying micro-level survey data. Note, however, that UNICEF has not publicly disclosed micro-level data for 13 countries (Afghanistan, Algeria, Botswana, Cambodia, Cuba, Georgia, India, the Maldives, Somalia, Syria, Tunisia, Ukraine, and Federal Republic of Yugoslavia), making independent verification of those reports impossible (see <a href="http://www.childinfo.org" target="_blank">http://www.childinfo.org</a>; <a href="http://www.measuredhs.com/" target="_blank">http://www.measuredhs.com/</a>).</p> <p>(Illustration: Bang Wong, www.clearscience.info)</p></div

Components of a proposed international no-fault compensation program for vaccine injuries in developing countries.

<p>Components of a proposed international no-fault compensation program for vaccine injuries in developing countries.</p

Grams of morphine per capita versus gross national income.

<p>Based on 2011 INCB morphine annual estimates <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001153#pmed.1001153-International5" target="_blank">[14]</a> and World Bank data on population and gross national income <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001153#pmed.1001153-World2" target="_blank">[16]</a>–<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001153#pmed.1001153-World4" target="_blank">[18]</a>. Countries excluded because of incomplete data: American Samoa, Anquilla, Aruba, Ascension Island, Bermuda, British Virgin Islands, Cayman Islands, Channel Islands, Christmas Island, Cocos (Keeling) Islands, Cook Islands, Curacao, Equatorial Guinea, Falkland Islands, French Polynesia, Faeroe Islands, Gibraltar, Greenland, Guam, Isle of Man, Kuwait, Korea Dem. Rep., Kosovo, Liechtenstein, Mayotte, Monaco, Montserrat, Myanmar, Nauru, Netherlands Antilles, New Caledonia, Norfolk Island, Northern Mariana Islands, Puerto Rico, Qatar, San Marino, Saint Helena, Sint Maarten (Dutch Part), Somalia, South Sudan, St. Martin (French part), Tristan de Cunha, Turks and Caicos Islands, United Arab Emirates, Virgin Islands (US), Wallis and Fatuna Islands, West Bank and Gaza.</p

Additional file 1. of In which developing countries are patents on essential medicines being filed?

Methodological supplement. (DOCX 215 kb

Testing results by region of manufactureⁱⁱⁱ

iii.<p>Manufacturer information not available for 3 tested sampless</p

Testing results by formulation and country purchased for TLC and dissolutionⁱ,ⁱⁱ

i.<p>Percentages are supported by (total that failed either dissolution or TLC/total treatments tested)</p>ii.<p>Co-packaged ACTs are listed as individual monotherapies</p

Drug/device combination products compared by patent type (device or medicament) and last patent expiration.

<p>Drug/device combination products compared by patent type (device or medicament) and last patent expiration.</p

Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

<div><p>Background</p><p>Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market.</p><p>Materials and Methods</p><p>We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents.</p><p>Results</p><p>Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years).</p><p>Conclusion</p><p>Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.</p></div

Frequency of patent protection extensions via device patenting amongst the 49 combination products.

<p>Frequency of patent protection extensions via device patenting amongst the 49 combination products.</p