Patents and patent filings

Securing patent protection in the early preclinical research phase is the foundation of all new pharma­ceutical projects and the company’s future commercial prospects. Patent activities are an important and ­integrated part of work at Medivir during product development, and when the product is on the market. At the close of 2010, Medivir had 73 patent families, including those filed by collaboration partners.

A patent family is the collection of national or regional patents and patent applications that cover a single invention or group of related inventions. In 30 of these 73 families, the official examination process has progressed to the point that at least one US or EU patent has been granted. Including these approved US/EU patents, Medivir had 424 granted patents in force at year-end.


Normal expiry
  • Since 1995, almost all countries specify a patent life of 20 years from the international application date.
  • Older US patents have a life of 17 years from grant, which could lead to substantially different lives in different countries. An example is MIV-310, where Medivir’s US patent claiming the use of alovudine in the treatment of HIV is due to expire in March 2019, almost ten years after the expiry of the remaining patents in this patent family.
  • In Europe, it is possible to secure up to five year’s extension of pharmaceutical through what are termed “Supplementary Protection Certificate” papers. This supplementary protection is granted if the European marketing authorization was granted more than 5 years after the patent filing date. Of Medivir’s projects, such extensions would apply to MIV-606 (2/2022), MIV-210 (8/2023) and TMC 435 (7/2028, assuming launch in 2013), extended expiry stated in brackets. For Xerclear/Xerese, Medivir currently has currently been granted five years supplementary protection certificates in Sweden, Denmark and Portugal. In other countries where both patents and marketing authorizations have already been granted, including Germany and France, the formal application documentation has been filed and applications are under consideration by the patent offices in these countries. Thus the expiry date for patent protection on Xerclear/Xerese, including supplementary protection, is 2/2021.
  • Many countries have an additional form of market exclusivity for pharma­ceuticals, called “data exclusivity”. This prevents generic pharmaceutical applications “ANDA” being approved based on an original product for a defined number of years, namely 10 years in Europe, 2.5 - 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 may secure 10 years’ protection from generic pharmaceutical applications notwithstanding that the European patent has expired.
Country codes
  • AU Australia, BR Brazil, 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 At present, a European patent can cover all countries in the EU and a number of other European countries such as Switzerland, Iceland, ­Croatia, Turkey, and Norway. Medivir always validates granted European patents, at least in the key pharmaceutical markets of Germany, the UK, France, Italy, Spain, Switzerland and Sweden. The figure in this column is the total number of European countries where the patent has been validated or is pending.
Additional patent families
  • Wherever possible, Medivir ensures that its patent applications include product claims (also known as “composition of matter”) and therapeutic method claims. Product claims are preferred in pharmaceutical contexts as they give control over product pricing, notwithstanding that further uses for a product may be discovered in the future.
  • Medivir practices patent portfolio management and files subsequent applications for enhancements conducted 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.