Patent Law

The following is excerpted from a September 29, 2008 GenericsWeb press release:

A recent case heard in the Federal Court of Australia illustrates the need for comprehensive, accurate and regularly updated patent information to ensure that the planned launch of a generic pharmaceutical product is not delayed.

In Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1283, the applicant was unsuccessful in seeking, among other things, an order setting aside the Commissioner?s decision to extend the term of the AU565856 patent. The patent in question describes and discloses a class of compounds having an anti-viral therapeutic effect and is the basis for the registration of the commercial product Gemzar (Gemcitabine hydrochloride).  In one of the key aspects of the case the applicant was unaware of the existence of this Australian patent, and thus its subsequent extension, until August 2007 ? more than 7 years after the grant of extension of term.  The applicant had relied on information provided by a third part supplier of its generic drug product based in Austria to determine the possible launch date of the product. This failure to obtain comprehensive and accurate patent information in a timely manner, before making the commercial decision to register and market a generic product, led directly to the Court's dismissal of the proceedings.

Read the full press release here.