USPTO Public MeetingUSPTO Public MeetingJuly 20, 2010July 20, 2010

Enhanced Examination Enhanced Examination Timing Control InitiativeTiming Control Initiative

Hans Sauer,Hans Sauer,

Biotechnology Industry Biotechnology Industry OrganizationOrganization

Enhanced Prosecution Enhanced Prosecution FlexibilitiesFlexibilities

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 Interest in additional time between filing and examination is

often expressed, but not universal;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 issuesHigh 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: BIO letter to President-elect Obama, Dec. 2008; available at:

www.bio.org/ip/domestic/BIO.PTOReform.pdf www.bio.org/ip/domestic/BIO.PTOReform.pdf BIO has previously commented on PPH and SHARE BIO has previously commented on PPH and SHARE

initiativeinitiative Available at: www.bio.org/ip/letters/20091211.pdfAvailable at: www.bio.org/ip/letters/20091211.pdf

Comparison to Existing Comparison to Existing FlexibilitiesFlexibilities

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 Lack of incentives, ineligibility (PPH), or inequitable conduct

concerns and high cost (Accelerated Examination Program) concerns and high cost (Accelerated Examination Program) cited;cited;

Deferral of examination:Deferral of examination: BIO members do not use the existing Suspension of Action BIO members do not use the existing Suspension of Action

provisions at 37 CFR 1.103 (“opt-in,” front-end fee, and loss of provisions at 37 CFR 1.103 (“opt-in,” front-end fee, and loss of PTA cited)PTA cited)

Track I of the current proposal eliminates many Track I of the current proposal eliminates many existing disincentives and appears to be a viable and existing disincentives and appears to be a viable and flexible option for accelerated examination.flexible option for accelerated examination.

Track III of the current proposal eliminates some Track III of the current proposal eliminates some disincentives that prevent use of existing Rule 103 disincentives that prevent use of existing Rule 103 deferral, but suffers from some of the same problems.deferral, but suffers from some of the same problems.

Track IIITrack III

Additional time between filing and examination couldAdditional time between filing and examination could help better coordinate patent prosecution with product help better coordinate patent prosecution with product

development in biotech and other “slow to market” development in biotech and other “slow to market” technologies;technologies;

lead to additional abandoned applications (e.g. abandonment lead to additional abandoned applications (e.g. abandonment rates after no request for examination: JPO, about 35%; KIPO rates after no request for examination: JPO, about 35%; KIPO about 15-20%; IP Australia about 30%; GPTO about 40%).about 15-20%; IP Australia about 30%; GPTO about 40%).

Proposed Track III is more likely to realize some of Proposed Track III is more likely to realize some of these benefits than existing Rule 103, but: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 Does it really provide prosecution timing benefits over the

use of the PCT system?use of the PCT system?

““Aggregate Average Period”Aggregate Average Period”

??

Foreign-First Filed CasesForeign-First Filed Cases

The vast majority of international application families The vast majority of international application families in the biomedical arts originate in the U.S. – in the biomedical arts originate in the U.S. – predominantly via PCTpredominantly via PCT

U.S.U.S. JapanJapan

BiotechBiotech 32,13932,139 7,0947,094

PharmaPharma 43,31743,317 7,7387,738

Med. InstrumentsMed. Instruments 57,90257,902 17,61117,611

TelecomTelecom 34,62734,627 39,47939,479

SemiconductorsSemiconductors20,43120,431 48,36948,369

OpticsOptics 18,01218,012 54,27854,278Foreign-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 How are applications that claim foreign priority under the

Paris Convention treated in JPO and EPO?Paris Convention treated in JPO and EPO?

Foreign-First Filed Cases (2)Foreign-First Filed Cases (2)

Examination cannot be triggered without filing Examination cannot be triggered without filing foreign search report, Office Action, and “reply.”foreign search report, Office Action, and “reply.”

Certified translation?Certified translation? New liability concerns;New liability concerns; How to “reply” to formality How to “reply” to formality

objections, statutory subject objections, statutory subject matter, non-prior art related matter, non-prior art related rejections; interaction with rejections; interaction with U.S. restriction practice?U.S. restriction practice?

Sacrifice DOE?Sacrifice DOE? Who will decide if “reply” is Who will decide if “reply” is

responsive if the case is not responsive if the case is not yet on any examiner’s yet on any examiner’s docket?docket?

Would filing just the search Would filing just the search report accomplish the same report accomplish the same benefits?benefits?

Selected Open QuestionsSelected Open Questions

Can an application claiming foreign priority ever be Can an application claiming foreign priority ever be fast-tracked without waiting for foreign search and OA?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 Foreign applicants systematically disadvantaged compared to

domestic applicants?domestic applicants? Possible increase in U.S. first-filings, but domestic filing Possible increase in U.S. first-filings, but domestic filing

laws may compel applicants to file in foreign office first;laws may compel applicants to file in foreign office first; Impact of foreign prosecution delays on U.S. patent Impact of foreign prosecution delays on U.S. patent

term and patent term adjustmentterm and patent term adjustment Priority application filed in request-for-examination Priority application filed in request-for-examination

jurisdiction?jurisdiction? Availability or non-availability of acceleration procedures in Availability or non-availability of acceleration procedures in

foreign office?foreign office? Foreign examination backlogsForeign examination backlogs

Treatment of national stage PCT applications?Treatment of national stage PCT applications?

Hans SauerDeputy General Counsel,

BIO1201 Maryland Avenue,

S.W.Washington, D.C. 20024

U.S.A.

Tel. (x1)-202-962-6695Fax. (x1)-202-488-0650

hsauer@bio.org