title: Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Population Health Program, Faculty of Medicine and Faculty of Law, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Reed F
authors.initials: RF
authors.lastname: Beall
authors.affiliation: Bruyère Research Institute, Ottawa, Ontario, Canada.
authors.forename: Jason W
authors.initials: JW
authors.lastname: Nickerson
authors.affiliation: Center for Global Health & Development, Department of Global Health, WHO Collaborating Center for Pharmaceutical Policy, Boston University School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Warren A
authors.initials: WA
authors.lastname: Kaplan
authors.affiliation: Population Health Program, Faculty of Medicine and Faculty of Law, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Amir
authors.initials: A
authors.lastname: Attaran
mesh_terms: D004864:Equipment and Supplies; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations