Trastuzumab – UK

Trastuzumab – UK

On July 27, 2016, The Court of Appeal (UK) has confirmed that two Genentech patents concerning lyophilised formulations of trastuzumab (the active ingredient in Herceptin) are invalid for obviousness. It also confirmed that a finding of obviousness does not require, in every case, that the skilled person “would” have arrived at the claimed invention without inventive effort.

This is an appeal from the decision of Birss J dated 21 November 2014 in an action by Hospira UK Limited (“Hospira”) for revocation of two patents, European patents (UK) Nos. 1 516 628 and 2 275 119. The judge held both patents invalid on the ground of lack of inventive step and added matter. Genentech Inc. (“Genentech”), whose patents these are, appealed to the court.

At first instance, Birss J concluded that the differences between the claimed invention and the prior art (“Carter”) “were the result of nothing more than the application of routine screening techniques to common general knowledge excipients” by the motivated skilled team.

During appeal Floyd LJ noted that the judge was well placed to form an impression of the degree of interest in trastuzumab by the time it was known that phase II clinical trials were under way and it was open to him, upon the evidence, to reach the conclusions that he had reached as to the skilled person’s motivation to start developing a lyophilised formulation. Thus it was obvious to develop the lyophilised formulation and hence patents are invalid.

Leave a Reply

Leave a Reply

Your email address will not be published.

Disclaimer
All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2022 Pharma IP Circle. All Rights Reserved