USPTO Public Meeting on Reexam Reform Claire Vasios June 1, 2011 COPYRIGHT © 2011 ALKERMES, INC.

® Explanation of how the SNQ is "new“, applies to every claim limitation, and is non-cumulative [A1, A2, A3]

COPYRIGHT © 2011 ALKERMES, INC. ® The basic problem – in biotech: oReexamination proceeding casts “cloud” over patent that complicates: - Licensing, sale, and enforceability of the patent; - Partnering, investment, access to capital. oBIO members almost universally identify high grant rate of requests (>90%) as problematic; - PTO not effectively operating as gatekeeper – results in de-facto burden shifting from requester to patentee, with PTO acting mainly as conduit; - Drives criticism and backlash against the system oIt is important that: - SNQ determination be meaningful; - Proceeding be focused on the best art; - Speed be balanced against fairness

COPYRIGHT © 2011 ALKERMES, INC. ® Concern: Requirement for Designation of SNQs as new and as non-cumulative by the Requester  Encourages USPTO to take a more passive role in reviewing a request by adopting Requester’s allegations at the outset  Unlikely to have a meaningful gatekeeper effect – any increase in the rate of rejected requests will likely be on formal grounds, not the merits  The existence of multiple references that relate to one SNQ, particularly ones that were not considered in other examinations, is an important consideration, and provides additional perspective with respect to the state of the art. The fact that a claimed element is found in multiple references should not be obscured by combining them into a single SNQ.  Effect of designating SNQs in same request as “cumulative” is unclear – are cumulative SNQs automatically adopted? If so, does the designation create the right incentives?

COPYRIGHT © 2011 ALKERMES, INC. ® Proposed solutions in order to balance the responsibilities of the Requester and the USPTO oFor Requester: Provide incentives to narrow the legal issues, such as: - Limiting number of primary references unless good cause shown; - Impose fee for SNQs that are presented in excess of a certain number oFor USPTO: Require an independent assessment of the cited art and the Requester’s arguments, before finding that an SNQ has been raised, rather than relying on the Requester’s representation of the SNQ