1. USPTO Public Meeting July 20, 2010 Enhanced Examination Timing Control Initiative Hans Sauer, Biotechnology Industry Organization

2. Enhanced Prosecution Flexibilities Among BIO members: Among BIO members: Significant interest in more prosecution timing flexibility; Significant interest in more prosecution timing flexibility; Interest in additional time between filing and examination is often expressed, but not universal; Interest in additional time between filing and examination is often expressed, but not universal; Need for accelerated examination exists in selected cases; Need for accelerated examination exists in selected cases; High sensitivity to inequitable conduct issues High sensitivity to inequitable conduct issues BIO has endorsed a three-tier structure in principle. BIO has endorsed a three-tier structure in principle. BIO letter to President-elect Obama, Dec. 2008; available at: www.bio.org/ip/domestic/BIO.PTOReform.pdf BIO letter to President-elect Obama, Dec. 2008; available at: www.bio.org/ip/domestic/BIO.PTOReform.pdf BIO has previously commented on PPH and SHARE initiative BIO has previously commented on PPH and SHARE initiative Available at: www.bio.org/ip/letters/20091211.pdf Available at: www.bio.org/ip/letters/20091211.pdf

3. Comparison to Existing Flexibilities Fast-track examination: Fast-track examination: BIO members rarely use existing acceleration options; BIO members rarely use existing acceleration options; Lack of incentives, ineligibility (PPH), or inequitable conduct concerns and high cost (Accelerated Examination Program) cited; Lack of incentives, ineligibility (PPH), or inequitable conduct concerns and high cost (Accelerated Examination Program) cited; Deferral of examination: Deferral of examination: BIO members do not use the existing Suspension of Action provisions at 37 CFR 1.103 (“opt-in,” front-end fee, and loss of PTA cited) BIO members do not use the existing Suspension of Action provisions at 37 CFR 1.103 (“opt-in,” front-end fee, and loss of PTA cited) Track I of the current proposal eliminates many existing disincentives and appears to be a viable and flexible option for accelerated examination. Track I of the current proposal eliminates many existing disincentives and appears to be a viable and flexible option for accelerated examination. Track III of the current proposal eliminates some disincentives that prevent use of existing Rule 103 deferral, but suffers from some of the same problems. Track III of the current proposal eliminates some disincentives that prevent use of existing Rule 103 deferral, but suffers from some of the same problems.

4. Track III Additional time between filing and examination could Additional time between filing and examination could help better coordinate patent prosecution with product development in biotech and other “slow to market” technologies; help better coordinate patent prosecution with product development in biotech and other “slow to market” technologies; lead to additional abandoned applications (e.g. abandonment rates after no request for examination: JPO, about 35%; KIPO about 15-20%; IP Australia about 30%; GPTO about 40%). lead to additional abandoned applications (e.g. abandonment rates after no request for examination: JPO, about 35%; KIPO about 15-20%; IP Australia about 30%; GPTO about 40%). Proposed Track III is more likely to realize some of these benefits than existing Rule 103, but: Proposed Track III is more likely to realize some of these benefits than existing Rule 103, but: Concerns over Patent Term Adjustment offset; Concerns over Patent Term Adjustment offset; Does it really provide prosecution timing benefits over the use of the PCT system? Does it really provide prosecution timing benefits over the use of the PCT system?

5. “Aggregate Average Period” ?

6. Foreign-First Filed Cases The vast majority of international application families in the biomedical arts originate in the U.S. – predominantly via PCT The vast majority of international application families in the biomedical arts originate in the U.S. – predominantly via PCT U.S.Japan Biotech32,1397,094 Pharma43,3177,738 Med. Instruments57,90217,611 Telecom34,62739,479 Semiconductors20,43148,369 Optics18,01254,278 Foreign-filed patent families 2001-2005, by top 2 originator countries. Source: WIPO World Patent Rep. 2008 A simple question of reciprocity? (JP-First, PACE) A simple question of reciprocity? (JP-First, PACE) How are applications that claim foreign priority under the Paris Convention treated in JPO and EPO? How are applications that claim foreign priority under the Paris Convention treated in JPO and EPO?

7. Foreign-First Filed Cases (2) Examination cannot be triggered without filing foreign search report, Office Action, and “reply.” Examination cannot be triggered without filing foreign search report, Office Action, and “reply.” Certified translation? Certified translation? New liability concerns; New liability concerns; How to “reply” to formality objections, statutory subject matter, non-prior art related rejections; interaction with U.S. restriction practice? How to “reply” to formality objections, statutory subject matter, non-prior art related rejections; interaction with U.S. restriction practice? Sacrifice DOE? Sacrifice DOE? Who will decide if “reply” is responsive if the case is not yet on any examiner’s docket? Who will decide if “reply” is responsive if the case is not yet on any examiner’s docket? Would filing just the search report accomplish the same benefits? Would filing just the search report accomplish the same benefits?

8. Selected Open Questions Can an application claiming foreign priority ever be fast-tracked without waiting for foreign search and OA? Can an application claiming foreign priority ever be fast-tracked without waiting for foreign search and OA? E. g. ongoing infringement, other exigent circumstances. E. g. ongoing infringement, other exigent circumstances. Foreign applicants systematically disadvantaged compared to domestic applicants? Foreign applicants systematically disadvantaged compared to domestic applicants? Possible increase in U.S. first-filings, but domestic filing laws may compel applicants to file in foreign office first; Possible increase in U.S. first-filings, but domestic filing laws may compel applicants to file in foreign office first; Impact of foreign prosecution delays on U.S. patent term and patent term adjustment Impact of foreign prosecution delays on U.S. patent term and patent term adjustment Priority application filed in request-for-examination jurisdiction? Priority application filed in request-for-examination jurisdiction? Availability or non-availability of acceleration procedures in foreign office? Availability or non-availability of acceleration procedures in foreign office? Foreign examination backlogs Foreign examination backlogs Treatment of national stage PCT applications? Treatment of national stage PCT applications?

9. Hans Sauer Deputy General Counsel, BIO 1201 Maryland Avenue, S.W. Washington, D.C. 20024 U.S.A. Tel. (x1)-202-962-6695 Fax. (x1)-202-488-0650 hsauer@bio.org