1. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. Chemical Patent Practice: US and ROW Jim Sales Barnes & Thornburg LLP Indianapolis, Indiana

2. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. Major Differences First to file vs. First to invent Best Mode Disclosure Duty of Disclosure Inventorship

3. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. I) Judicially Created Obviousness-Type Double Patenting (Sun Pharmaceuticals Industries, LTD., v. Eli Lilly and Company (“Gemzar” case)) Does this CAFC Decision Create a New kind of “Art”? What does this mean for ROW practitioners?

4. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. First Application Series 1) US Application 473,883 Filed March 10, 1983. 2) US CIP of #1 Filed December 4, 1984. 3) US Divisional of #2 filed February 28, 1989, issued as US4,808,614: expired May 15, 2010. Second Application series 1) US Application 677,783 Filed December 4, 1984. 3) Through series of related applications, issued as US5,464,826: original expiry November 7, 2012. Facts of Gemzar Case

5. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. II) Application of KSR: Structural Similarity and Obviousness (Daiicho Sankyo v. Matrix & Mylan (“Sankyo” case)) Graham v. John Deere – this is the starting point for all obviousness evaluations in the US KSR v. Teleflex – Teaching, motivation, or suggestion (TSM) test is not sole approach to obviousness evaluations, and motivation need not be explicit in the art

6. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. Structural Similarity and Obviousness To establish a prima facie case of obviousness for a chemical compound based on structural similarity, one must - use the Graham v. John Deere factual findings - provide proof that a medicinal chemist of ordinary skill would have been motivated to select a prior art compound as a lead compound, and - provide proof that a medicinal chemist of ordinary skill would have been motivated to modify the prior art compound to result in the claimed compound - not employ hindsight bias - not rely on mere structural similarity, but consider knowledge in the art of the functional properties and limitations of the prior art compounds (“potent and promising activity in the prior art trumps mere structural relationships”)

7. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. Structural Similarity and Obviousness ( cont. ) The CAFC affirmed the District Court Decision that - the asserted prior art compounds would not have been selected as lead compounds - even if selected, there was no motivation (and actually a teaching away) to modify the prior art compounds to result in the claimed compound

8. © 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced, disseminated or disclosed without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP. Structural Similarity and Obviousness ( cont. ) What would have happened in the EPO? The asserted prior art compounds would most probably have been the closest prior art, as there were only two modifications to the prior art compound to result in the claimed compound and the same technical features (utility) are present Use of the problem/solution approach would most probably have resulted in the same decision, as least one of the changes is suggested (aliphatic v. hydrophilic) and the teaching away (use of medoxomil as prodrug) should result in a finding of inventive step over the asserted prior art compounds.