Patents
At the close of 2006 Medivir had close to 70 patent families, including those filed with Tibotec within the framework of the HCV partnership. A patent family is the collection of national or regional patents and patent applications which cover a single invention or group of related inventions. In 28 of these families, the official examination process has progressed to the point that at least one US or EU patent has been granted. Including these approved USA/EU patents, Medivir had 472 granted patents in force at year end. Of the patent families that are in the early stages of the official examination process, 22 patent families are in the international stage which worldwide applies in more than 130 countries. 18 of these "PCT" applications were filed during the year. The 15 patent families, for which priority applications were filed in 2006, i.e. the official documentation that present the initial unique aspect of an innovation, are even earlier in the patent process.

    Normal expery:

  • Since 1995 almost all countries specify a patent life of 20 years from the international application date.
  • Older US patents had a life of 17 years from grant which could lead to substantially different life in different countries. An example is MIV-310, which has an exceptionally long patent life in the world's biggest pharmaceutical market, the US.
  • Europe additionally allows up to five year's extension of pharmaceutical patents where the European marketing authorization was granted more than 5 years from the patent application date. As at 31 December 2005, Medivir was entitled to the following European extensions MIV-606 (2/2022), ME-609 (2/2021), MIV-210 (12/2022) and MIV-150 (1/2020).
  • Many countries have an additional form of market exclusivity for pharmaceuticals, called "data exclusivity". This prevents generic drug applications "ANDA" being approved based on an original product for a defined number of years, namely 10 years in Europe, 5 years in the US and 6 years in China. This exclusivity is independent of patents and as it is based on the launch date, the exclusivity may extend longer than the patent life. For example in Europe, MIV-310 will gain 10 years protection from generic drug applications even after the European patent expires.

    Country codes

  • AU Australia, CA Canada, CN China/Hong Kong, IL Israel, IN India, KR South Korea, JP Japan, MX Mexico, MY Malaysia, RU Russia, TH Thailand, TW Taiwan, US USA, ZA South Africa. WO is an international (PCT) patent application
  • EU-15 Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden. Switzerland, although not in the EU, is covered by EU-15 patents.
  • EU-25 The number of countries in the enlarged EU, but including Switzerland, covered by Medivir patents.

    Additional patent families

  • With the exception of MIV-310 all Medivir patent families have product claims (also known as "composition of matter") and therapeutical method claims. Product claims are preferred in pharmaceutical contexts as it gives control over product pricing, notwithstanding that further uses for a product may be discovered in the future.
  • Medivir practices patent portfolio management and files successive generations of patents to in-house and CRO developments such as formulations, synthesis methods and synergistic combinations. Although such patent families can seldom totally prevent generic competition after the basic product patent has expired, they do serve a role in ensuring continued royalty income from Medivir's partners even after the introduction of generic competition. This extended royalty period is indicated in this column.

Last Modified: 05/09/2008