Certification in the Request for Contract, or by requisition attached to this document, indicates that funds are available for this acquisition, or If funding is notpresently avail~ble but is anticipated, no award will be made until such funding is obtained.

An award will be made only if, during negotiations, it is shown that the anticipated cost to the Government will 'be fair and reasonable.

For the reasons explained in the attachment, the following officials consider this acquisition appropriate for negotiation with the contractor indicated above,using other than full and open competition, and do so recommend, conc~r, or approve. "

By their signatures below, the Project Officer and the Contracting Officer also certify that, to the best of their knowledge and belief, the justification isaccurate and complete.

Recommend'Concur Approve TItle Typed Name

./ Project Officer Regina Gaither

, p.roject Officer's Immediate J PIY Su ervisor ason ummer

./ Contracting Officer Foteni T. Tiffany

. ./ Branch/Section Chief Foteni T. Tiffany

.{ Director, Office of Acquisitions All son Y. Stokes

IC Director (optionsl)'

./ Director, DAPE, DAMP, OA Sherley M. Mizzell

.{ Director, QAMP, OA, HCA Diane J. Frasier

Senior Scientific Advisor forD D Extramural Research, OER,'NIH; Comp!'!tition Advocatefor R&DExecutive Director, Office of 'D 171 Intramural Research, NJH;

L£J Competition Advocate for Richard G. Wyatt, M.D.Non-R&DDeputy Assistant Secretaryfor A uisition M mt. Be Poll

( Sherle M. MIzzell 6100/6CO1NIH 1757-1 (Rev. 1/07)

\

Justification forOther than Full and Open Competition (JOFOC)

off

Justification for Other Than Full and Open Competition

Select the cost range applicable and read down the chart to find which officials are to recommend, concur, or approve.

* The Justification documentation shall conform to guidance in FAR part 13for acquisitions at or below the simplified acquisition threshold ($100,000). For acquisitions above thesimplified acquisition threshold, the Justification documentation shall conform to guidance in FAR Part 6and HHSAR 306.303.

The contracting officer has the authority to sign JOFOCs up to $550,000 (FAR 6.304(a)(1)). However,each Director, Office of Acquisitions, may determine to retain some or all of this dollar approval authorityat his/her level. .

NOTE: An authorized substitute may sign "for" the specified signatory in the event ofthe latter's absence,if authority has been appropriately delegated in writing.

Following the concurrence. approval, or other action by the R&D Competition Advocate or the 88Competition Advocate, as appropriate, all JOFOCs come back to OAMP, which (1) returns them to the IC or(2) forwards them to the-DA8AMP for review and approval. DA8AMPactions are sent back through theDirector, OAMP, NIH, who returns them to originating ICs.

NIH-1757-1 (Rev. 1/07) Back

!) lljWIi,d; ,; 'i~

Signature Levels

JUSTIFICATION FOR 0'

Background Information and Description of AcquisitionPart I.

1. Pro2ram Office

Regina GaitherProj ect Officer/ Management AnalystDivision of Administrative Management,(OTT)/NIH6011 Executive Boulevard, Suite 325Rockville, MD 20852

2. Title: Patent Le~al Services(Contract num~ers expfred on .fune 13. 2007)(Current purchase orders from June 14. 2007 - Julv 25. 2.QQ1l

3. Puruose/Brief History

a. Pursuant to the Federal Technology Transfer Act (FTTA) of 1986, the NIH hasa significant program in patenting and licensing inventions with commercialpotential. The Office of Technology Transfer (OTT) is responsible for thetechnology transfer program for the NIH and the Food and Drug Administration

III!(I~I!

~ ;' t

THER THAN FULLNARRATIVE

AND OPEN COMPETITION -

Office of Technology Transfer

JOFOC NarrativePatent Legal Services

(FDA). From time to time, OTT will also administer technologies for otherFederal agencies. An important part of the Act is obtaining and maintainingpatent prosecution for the inventions of NIH and FDA employees. The OTTalso pursues patent protection in a number of foreign countries under the termsof the Patent Cooperation Treaty (PCT). These PCT filings generally designateJapan, Canada, Australia, and the. European Patent Office.

The project with which therelated services to the OTT.1,300 cases and it is expectedapplications each year.

b.

thatThe inventions claimed

generally fall into three categories: biology, chemIstrymechanical/ electrical! software.

This requirement is to provide critical serviCes to support the mission of the NIHOffice of Technology Transfer (OTT). The purpose of the project is to providepatent-related services including patent searches, patent prosecution, infringementand interference services and licensing consultation to the NIH IOTT.. Thecontractor(s) serve as the representative(s) of the U.S. Government in pursuingthe mission of the OTT, which is to protect U.S. Government intellectualproperty. Under the contracts which expired 011 June 13,2007, over 14,185 taskorders were issued in total since the effective date ofthe contracts on June 14,

. 2002. Several hundr.ed task orders are issued monthly under these contracts

which include new work or existing work associated with a family of cases thatare already active. During the period 04/01/06 - 09/30/06 approximately 1,551Task Orders were issued in total under fourteen contracts. During the period1 % 1/06 - 03/28/07 roughly 1,556 Task Orders were issued. It is certain that thisvolume of work will continue during the period ofperfomiance requested underthis JOFOC (July 26,2007 through January 25,2008).

Purchase orders with a ceiling of $1 OOK each were awarded to thirteen currentcontractors to cover the period Jtme 14,2007 through July 25,2007. HellerEhrman LLP did not receive a purchase order since the firm disbanded. TheJOFOC to provide 12 bridge acquisitions from 7/26/2007 - 01/25/2008 willprevent a lapse in service during negotitation and award of multiple contractsunder RFP# 263-2006-P(GM)-0247 for Patent Legal Services. Perkins Coie LLP

. is not included in the JOFOC since the finn declined to prov~de service toNIH/OTT after expiration of the current ptirchase orders onJuly 25,:2007. .

d.'. ,.'.....

{I ) See attached for full estimate. The estima~ed;q~antities ~e based on' .": '.. ,:historiqa~, data which includes the transfer offi1~s ft."o])l He,lIer ~hnnan .

c,.: :.;. .;; ,(263-Q2D-0028) and Perkins Coie (263-02-D;~OQ54)tp t!1er~mail1ing .

, current-contractors. As stated above, HeHer Ehrman disbanded and' ".. P~rkinsC()ie declined future work with Nlli/OTT. ;'., . .'. ,

c.

~

d. Government's Independent Cost Estimate

.'. .

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JOFOC is directly associated is providing patentThe active patent prosecution docket is in excess of

the OTT will seek to file 200-300 patentin the NIH/FDA portfolio

. ,and

~~~~~

lJOFOC NanativePatent Legal Services

(2) Work is issued by intemal BP A (Record of Call) and funding for the TaskOrders is provided by the applicable Institute/Center (IC). Funding is

. available through the ICs and has been anticipated based on the current

solicitation (RFP# 263-2006-P(GM)-0247) which was initially scheduledto be awarded by June 13,2007. In fact, the dollar amounts on the 14expired contracts are far greater than the actual dollars spent. The reason. for this is that it is practically impossible to forecast accurately how many

patent cases and associated task orders will be issued during any givenyear. It is dually as impractical to forecast which finns will receive ~hatportion of the unknown workload. .Therefore, dollars placed on each ofthe contracts are at the maximum that could feasibly be issued. Thefollowing illustrates the dollars placed on the 14 expired contracts forOption Year Four plus the 6 month extension through June 13,2007against the actual dollars spent for Option Year Four and the extensionperiod (through April 2007).

Contract No.263-

02-D-0029

02-D-0026

02-D-0028

02-D-0020

02-D-0021

02-D-0052

02-D-0024

02-D-0027

02-D-0025

02-D-0023

02-D-0022

02-D-0055

02-D-0053

03-D-0054

ContnctAmount

$16,934,250.00

$16,729;500.00

$26,607,000.00

$15,276,000.00

$15,273,750.00

$10,204,500.00

$17,296,500.00

$14,992,500.00

$17,494,500.00

$18,058,732.50

$18,774,750.00

$17,805,000.00

$18,493,500.00

$17,708,250.00

~~~

. $241,648,732.50 $20,531,456.41 $221,117.,276.09 .

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Option Year Four

Actual Dollars.

Spent (throughApril 2007)

$894,764.63Variance$16,039,485.37

. $1,121,286.85

$714,264.92

$5,177,376.83

$2,488,510.43

$29,367.00

$4,331,738.47

$280,892.00

$1,314,371.52

$504,856.98

$2,537,782.86

$512,328.70

$534,816.72

$89,098.50

$15,608,213.15

$25,892,735.08.

$10,098,623.17

$12,785,239.57

$10,175,133.00

$12,964,761.53

$14,711,608.00

$16,180,128.48

$17,553,875.52

$16,236,967.14

$17,292,671.30

$17,958,683.28

$17;619,151.50

~~

JOFOC NarrativePatent Legal Services

When the Proiect Beeane.

The patent legal service ~ontracts for OTT began on December 1~, 1991. Twelvecontracts lor patent legal services were awarded under RFP# 263-91-P( 63 )-0442using full and open competition procedures. The contracts were awarded for abase year of 12 months with four, 12 month option periods. Award documents arenot available in the Office of Acquisitions, NllI for all of these contracts.However, some back up information exists. The chart below was developedbased on this infonnation and provides the initial award amount per contract forthe base year and the total contract value for all years.

Contract #263-92-D-0202263-92-D-0203

263-92-D-0204263-92- D-0205263-92-D-0206

263-92- D-0207263-92-D-0208

263-92~D-0209263-92-D-0210

263-92-D-0211263-92-D-0212263-92-D-0213

The requirement continued with a follow-on, RFP# 263-96-P(AH)-OOI9, using full andopen competition procedures. The contracts were awa,rded for a base year of 12 monthswith four 12 month option periods. Most of the records for the awards resulting fromthis solicitation are no longer available in the Office of Acquisitions, NIH. However,the information listed below was compiled based on documents housed in OTT. Thesecontracts were awarded with an effective date of 12/13/1996.

Contract #

263-97 -D-0025263-97~D-0020263-97-D-0015263-97-D-0021Zo3~97-D-0017263-97-D-0022263-97-D-0018263-97-D-0019

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Il- 1\

Page 4 of8

ContractorAllegretti & WitcoffBirch. Stewart, Kolasch& BirchBrowdy & N eimark

, CaJPat Consulting

Cushman, Darby& CushmanFoley & Lardner

Base Year$170K$158K

5- Year$1.21M$1.16M

$153K$l1K$173K

$1.04M$76K$1.33M

$621K$474K

$3.93M$3.32M~obbe.~arten.Olsen

& BearLeydig, V oit & MayerLowe, Price, LeBlanc& BeckerMorgan & FinneganNeedle & RosenbergTownsend & Townsend

$l11K$166K

$840K$1.19M

$961K$411K$885K

$6.83M$2.98M$6.10M

Base Year 5- YearContractor

. $1.48M$12.5M$12M$12.5M$12.3M$lOM$10.9M$l1.5M$12M

Townsend & Townsend & CrewMedlen & Carroll $1.87M

$1.89M$1.98M

Fish & Richardson.Merchant and GouldKlarquist SparkmanMorgan and FinneganKnobbe. Martens, Olsen & Bear .Leydig, V oit & Mayer

$1.58M$2.24M$ 1. 84M$ 1. 87M

JOFOC NarrativePatent Legal Services

Contract # Contractor Base Year 5- Year263-97-D-0023 Needle & Rosenberg $1.98M $12.87M263-97-D"OO24 Spencer & Frank $l.5M $9.25M263-97-D-0014 Competitive Technologies $575,850 $3.38M263-97-D-0210 Lowe, Price, LeBlanc & Becker $544~950 $S.2M

Fourteen contracts were awarded as a result of solicitation RFP# 263-0l-P(AH)-OO64using full and open competition procedures. The contracts were awarded for a base.year of6 months commencing on June 15,2002 with four 12 month option periods. Asix month extension for the period December 14,2006 through June 13,2007 wasprovided utilizing FAR 52.217-8, Option to Extend Services. The following IS a list ofthe fourteen contracts, their base year amount and ceiling price which incJudes the sixmonth extension through June 13,2007.

Upon expiration of the fOUl1een contracts listed above, purchase orders were awardedunder simplified acquisition procedures to thi11een of the contractors (all but HellerEhrman which disbanded) for a period of performance from June 14.2007 through July.

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'.

JOFOC Narrative Page 6 of8Patent Legal Services

25,2007 for $100,000 each. The JOFOC to provide 12 bridge acquisitions for the periodJuly 26, 2007 through January 25, 2008 is proposed for twelve of these contractors, listedunder Part I, item 2 of this narrative. Perkins Coie is not included in the JOFOC since the'fIrm declmed further work with NIH/OTT after expiration of the purchase order.

~

f. Future Plans

As stated in passages above, the. purpose of the bridge acquisitions the twelve current.contractors is to provide enough time to evaluate, negotiate and award multiple contra~t~ ..A - ,,~~in the follow on competition which is currently in the evaluation stage. . ( QUan+i 1--<1 ~proposals were received in response to the cunent solicitation (RFP# 263-2006-P(GM)- .

0247). In order for the Technical Evaluation Panel to adequately evaluate all of theproposals, allow for a substantial negotiation process and review, award and transfer of. existing cases to new contractors, bridge acquisitions with the current contractors for six

months is essential.

Part D. Facts and Reasons to Justify Other than Fun aDd Open Competition:

1. The statutory authority selected to justify other than full and open competition isunder the authority 41 D.S.C. 253( c )(1) as set forth in FAR 6.302-1.

It is imprac!icable to seek competition for the six month period while negotiationsunder RFP #263-2006-P(GM)-O247 are active. Ninety-four questions were.answered and substantive changes made to the Statement of Work in threeamendments to the RFP prior to the deadline for proposals, causing the .solicitation process to be elongated. (CWa:m-i~-f~t1Jproposals were received inresponse to RFP# 263-2006-P(GM)-Q247 and the evaluation of these proposals iscomplex in nature. Furthermore, based on the nature of the requirement, it isimpossible for new conn-actors to assume responsibility for the patent case loadimmediately and meet the deadlines necessary for filing with the USPTO and

. foreign entities. The expired fourteen contracts as well as the active solicitation

. build in a transfer period which is roughly 30 days to deal with the intricacies

associated with transferring the extensive case files from one legal film toanother. In actuality, the transfer of case files has taken longer than 30. days as isevident with files transferred from Heller Ehrman and Perkins Coie to othercurr~t contractors. As illustrated above. the active patent prosecution docket is

. in excess of 1,300 cases and theOTT issues hundreds of task. orders to the

current contractors annually. These task orders are linked to families of patentcases which are in various s~ges of the patent application process or prosecution.The complexity and level of detail involved in dealing with these cases excludesthe possibility of work being transferred to new .contractors for such a brief periodof time. = .

2.

3. An announcement on FedBizOpps at www.fbo.gov was posted on May 23) 2007stating the government's intent to negotiate on a sole source basis with the current

iJOFOC Narrative "

Patent Legal Services

contractors to retain patent legal services. The notice infonned interested partiesthat they may identify their interest and capability to respond to the requirementor submit proposals to the Contract Specialist by July 9,2007, at 4PM EST. Twosources (SciTech Patent Art Services and Bambi Faivre Walters, PC) respondedto the notice by the deadline (see enclosed CBD Response Memo).

4.

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GN'~S~Sf\)O~C§;- \. S

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5. As stated in Part IT, item 2 of this docUment, not only would competition for thesix month period be duplicative of the efforts under the current solicitation, it isUJifeasible given the nature of the work involved and the time frame. Interruptionof service would result in signjficant hann to the U.S. Government in the loss ofintellectual property rights in the United States and foreign countries inconnection with multiple patent cases. .

at least a year in advance of the expiration of the patent legal contracts. The. ~~urrent solicitation is subs~tia11y different from the current contracts i~ that . ~..hseven areaS ot technology wIll be procured separately andRFP# 263-2 06.,. ~ JA

7 IS for a ase pena 0 mon S WIt nille 12 month options.-

Page 7 of8

x

<K-it

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JOFOC Narrative (

Patent Legal Services

With such a lengthy period of performance it is prudent to state that acquisitionplanning and the acquisition process for recompetition will run more smoothlyin the next competition.

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Page 8 oi8

~

Independent Government Cost EstimateWithheld. .Pages 1 3

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CBD RESPONSE MEMORANDUM

July 11,2007DATE:

FROM:

TO:

Contracting Officer, NIH/OD/OM/OLAO/OA

Nlli Competition Advocate (Station Support) .Through: Director, DAPE, OCM, OAThrough: Principal Official Responsible for Acquisition and Director,OCM,OA

SUBJECT: Justification for Other than Full and Open Competition(Class Justification)

The subject acquisitions, proposed to be accomplished by other than full and opencompetition, were mIDounced in the Federal Business Opportunities (www.fbo.goy) onMav 23. 2007, with Numbered Note 22 cited.

for ready reference.Copy attached

?ming the 45-day period required by Numbered Note 22. the Contract Specialist, ErinFlynn, received a request in writing from Bambi Faivre Walters (request attached). Ms.Flynn sent her a copy of the Statement of Work from the 2002 contracts. The 45-dayperiod required by Numbered Note 22 expired on July 9, 2007. Two capabilitystatements (Bambi Faivre Walters>PC and SciTech Patent Art Services, Inc.) were

. received prior to the expiration date. Copies oft~e evaluations are attached. Each ofthe

~~~~

three Technology Licensing Specialists from OTT that reviewed the capability statementsare not required to make progranunatic or administrative recommendations or decisionsconcerning the proposed action or those associated with RFP# 263-2006-P(GM)-O247.Each of the reviews attached fmds the two fums to be incapable of performing theservices required in the Statement of Work. Approval is requested.

Attachment

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I!!1J!~'ilJ l,i; t

~dhFoteni T. Tiffany

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Individual Technical ReviewsPages 1-6 Withheld