Our partners and attorneys are highly qualified and highly experienced to advise you in all areas of Intellectual Property law. We advise start-ups, SMEs, and multinational corporations and ensure that your inventions, brands and designs are expertly protected.
Hospira are interested in selling the breast cancer drug trastuzumab, marketed by Genentech under the trade name Herceptin®. Trastuzumab is a monoclonal antibody that targets the HER2 receptor (a protein on the surface of a cell that affects the cell’s growth) and is approved for use in the treatment of HER2+ breast cancer (i.e. breast cancer in which the breast cancer cells have a high number of HER2 receptors causing the cells to divide and grow quickly). Genentech’s SPC for its basic t rastuzumab patent is due to expire in July 2014, but Genentech had additional patent protection for t rastuzumab in the form of EP 1210115, which relates to do sage regimes, and EP 1 308 455, which relates to a composition of trastuzumab with low levels of impurities. Hospira brought a revocation action against both EP 1210115 and EP 1 308 455. The following discussion focusses on EP 1210115. EP 1210115 claimed an initial dose of 8 mg/kg of body weight and a plurality of subsequent doses of 6 mg/kg of body weight; the doses being administered every three weeks, summarised as 8 + 6 q3w. Hospira asserted that this claim was invalid for obviousness and/or lack of sufficiency.
Download the PDF and read the whole article.
Category: Latest Insights | Author: Marianne Privett | Published: | Read more