Patents and patent filings

Broad patent protection is the foundation of all new pharmaceuticals and their commercial prospects. Patent activities are a fundamental and integrated part of Medivir’s early preclinical activities. At the close of 2008, Medivir had 89 patent families, including those filed by collaboration partners and that may generate royalties for ­Medivir. 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 20 of 89 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 US/EU ­patents, Medivir had 374 granted patents in force at year-end. Of the patent families that are in the early stages of the official examination process, 40 patent families are in the international stage, which applies in more than 130 countries worldwide; 15 of these “PCT” applications were filed in the year. The 26 patent families, for which priority applications were filed in 2008, i.e. the official global documentation that first presents a unique aspect of an innovation, are even earlier in the patent process.

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, 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. The projects where European extension is relevant (extended expiry in brackets) are: MIV-606 (2/2022), Lipsovir® (2/2021), MIV-210 (8/2023), MIV-150 (1/2024) and MIV-160 (3/2027).
  
• 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 will gain 10 years protection from generic ­pharmaceutical applications regardless of whether 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 soon, 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 is pending or has been validated.

Additional patent families

• With the exception of MIV-310 and some cancer projects, all Medivir’s patent families have 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 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.