1 the create act and other interesting ip tidbits brian r. stanton, ph.d. director, division of...
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The CREATE Act and Other Interesting IP Tidbits
Brian R. Stanton, Ph.D.Director, Division of PolicyOffice of Technology TransferNational Institutes of HealthU.S. Department of Health & Human Services
Patent Lawyers Club of Washington29 March 2005
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U.S. Patent and Trademark Office
Is everything the same, only different?
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Commissioner for Patents
Nicholas P. Godici
To Retire March 29th
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U.S. PTO Senior Staff
• John DollDeputy Commissioner for Patent Planning and Resources
• Peggy FocarinoDeputy Commissioner for Patent Operations
• Joe Rolla (NTE 1 year?)Deputy Commissioner for Patent Policy
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USPTO Director Initiatives
Reexamination – Special Dispatch
• PCT– Timeliness of Actions
• BPAI Appeals– 60% never make it
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USPTO Director Initiatives
• Search Quality– Search Grids– Search Recordation– Search QR
• Patentability Conferences– Quality & Training
• 2nd Pair of Eyes– Redefine
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USPTO Director Initiatives
• e-filing probably in XML tagged format– All follow on papers must be e-filed
• Limited number of claims– 2 – 3 independent / 20 – 30 dependent
• Patentability search– With explanation of each reference with respect to
claims
• Mandatory telephone restriction elections• Mandatory interview either before or right after first
action• 2 month shortened statutory time for response
– With no extensions
• Mandatory appeal
Accelerated Examination InitiativeAccelerated Examination Initiative
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UPR Applications Filed
0
50000
100000
150000
200000
250000
300000
350000
400000
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
FY 04 355,527
6.6% above FY 03
FY 05 plan 375,080 (5.5% above FY 04)
118,235 as of 1/28
Current projection102.6% over plan
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FY 04 UPR1 Applications Filed
Technology Center FY 04 FY 03 to FY04 Growth Rate
1600 - Biotechnology and Organic Chemistry 38,164 -1.2%
1700 - Chemical and Materials Engineering 49,334 -0.5%
2100 - Computer Architecture Software and Information Security 34,653 17.9%
2600 - Communications 48,210 16.1%
2800 - Semiconductor, Electrical, Optical Systems 81,144 7.6%
3600 - Transportation, Construction, Electronic Commerce 47,489 4.8%
3700 - Mechanical Engineering, Manufacturing and Products 56,533 5.5%
UPR Total 355,527 6.6%
1 “UPR” = Utility, Plant, and Reissue Applications
FY 05 TC filings not yet available. Initial processing imposes a two to four month delay in assignment to a TC.
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FY 04 Patent Pendency
Technology CenterAverage 1st Action
Pendency1 (months)
Average Total Pendency 2
(months)
1600 - Biotechnology and Organic Chemistry 19.2 29.9
1700 - Chemical and Materials Engineering 17.9 27.6
2100 - Computer Architecture Software and Information Security
33.3 41.1
2600 - Communications 31.4 40.5
2800 - Semiconductor, Electrical, Optical Systems 14.0 23.9
3600 - Transportation, Construction, Electronic Commerce 15.6 24.1
3700 - Mechanical Engineering, Manufacturing and Products
15.2 24.1
UPR Total 20.2 27.6
1 “Average 1st action pendency” is the average age from filing to first action for a newly filed application,
completed during 4th quarter FY 2004.2 “Average total pendency” is the average age from filing to issue or abandonment of a newly filed
application, completed during 4th quarter FY 2004.
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FY 05 Patent Pendency (as of 12/31/04)
Technology CenterAverage 1st Action
Pendency (months)1Average Total
Pendency (months)2
1600 - Biotechnology and Organic Chemistry 20.2 29.7
1700 - Chemical and Materials Engineering 18.1 28.2
2100 - Computer Architecture Software and Information Security
34.2 41.9
2600 – Communications 31.2 40.8
2800 - Semiconductor, Electrical, Optical Systems 14.3 23.9
3600 - Transportation, Construction, Electronic Commerce 16.6 24.8
3700 - Mechanical Engineering, Manufacturing and Products 15.6 24.2
UPR Total (as of 12/31/2004) 20.7 26.8
FY 05 Target 20.7* 31.0
1 “Average 1st action pendency” is the average age from filing to first action for a newly filed application, completed during 1st quarter FY 2005.
2 “Average total pendency” is the average age from filing to issue or abandonment of a newly filed application, completed during 1st quarter FY 2005.
* Assuming current input and output estimates, the agency should achieve first action pendency of 21.3 monthsby the end of FY 2005.
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1600 1700 2100 2600 2800 3600 3700 Total* Design
New Applications1 9/30/2003
43,358 52,388 66,645 85,917 57,528 45,622 50,280 457,254 11,704
New Applications1
9/30/200455,402 63,923 71,778 97,380 77,651 56,738 65,005 508,878 18,451
Overall Pending Applications2
9/30/200382,827 92,412 88,387
121,558
118,899 87,153 91,170 737,944 22,533
Overall Pending Applications2
9/30/200495,006 105,447
102,440
138,822
137,458101,09
7108,039 809,323 27,599
TC Application Inventory
1 “New Application inventory” is the number of new applications designated or assigned to a technology center awaiting a first action.
2 “Overall Pending Application inventory” is the total number of applications designated or assigned to a technology center in an active status. Includes new applications; rejected awaiting response; amended; under appeal or interference; suspended; reexams and allowed applications awaiting grant publication.
* Total inventory includes approximately 55,000 applications awaiting processing 9/30/2003, and approximately 22,000 applications awaiting processing 9/30/2004.
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Inventory by Art Examples
High Inventory Art AreasMonths of Inventory* Low Inventory Art Areas Months of Inventory*
1614, 1615, and 1617 – Drugs, Bio-affecting and Body Treatment
47 – 53 1620 – Organic Chemistry 17
1743 – Chemical Analysis 371734 – Adhesive Bonding and Coating Apparatus
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2127 – Computer Task Management 622125 – Manufacturing Control Systems and Chemical/ Mechanical/Electrical Control
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2611 – Interactive Video Distribution 722651, 2653 – Information Storage and Retrieval
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2836 – Control Circuits 44 2831 – Electrical Conductors 9
3620 – Business Methods 34 – 106 3651 – Conveying 9
3731 and 3737 – Medical Instruments, Diagnostic Equipment
46 – 543742 – Thermal and Combustion Technology
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*The number of months it would take to reach a first action on the merits (e.g., an action addressing patentability issues) on a new application filed as of Jan 2005 at today’s production rate. Today’s production rate means that there are no changes in production due to hiring, attrition, changes to examination processing or examination efficiencies, and that applications are taken up in the order of filing in the given art unit/area. Of course, USPTO is taking aggressive steps to ensure changes that will significantly lower the inventory rates in high-inventory art areas.
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1600 1700 2100 2600 2800 3600 3700 Corps
FY 04 % First Action Allowances
13.0%
17.8%
10.3%
13.5%
27.1%
12.1%17.9%
17.4%
FY 05 % First Action Allowances Through 1/11/05
12.5%
15.7%
9.7%13.6%
28.8%
14.1%17.0%
17.5%
TC 1st Action Allowances*
* TC First Action Allowances are calculated from first action counts received by an examiner. A first action restriction performed by an examiner is not a ‘first action count’ and thus an allowance following a first action restriction is included as a first action allowance count. A first action allowance following the filing of an RCE is included. An examiner receives both a first action count and a disposal count for first action allowances.
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Quality of Products
Fiscal Year 2004
1600 1700 2100 2600 2800 3600 3700 DesignFY 04 Total
FY 05 Target
Application In-Process
Review Compliance
Rate1
76.4% 83.1% 88.3% 74.2% 86.8% 79.6% 81.7% 90.4% 82.0% 84%
Patent Allowance Error Rate2
4.40% 8.03% 3.05% 2.53% 3.39% 7.54% 9.01% 3.28% 5.32% 4.0%
1Compliance is the percent of office actions reviewed and found to be free of any in-process examination deficiency (an error that has significant adverse impact on patent prosecution).
2Patent allowance error rate is the percent of allowed applications reviewed having at least one claim which is considered unpatentable on a basis for which a court would hold a patent invalid. “Allowance” occurs before a patent is issued, so these errors are caught before any patent is actually granted.
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Hires and Attritions
1600 1700 2100 2600 2800 3600 3700 CorpsDesig
n
FY 04 Hires 75 35 115 116 31 26 45 443 15
FY 04 Attritions 30 26 58 82 58 43 39 336 4
FY 05 BOY Examiner Staff
417 440 563 658 742 422 439 3681 72
FY 05 Hiring Goal 100 35 200 150 160 90 125 860 20
FY 05 Hiring Summary (2/7/05)*
26 16 42 46 68 18 13 229 0
New Hire Percentage of Total
24% 8% 36% 23% 22% 21% 28% 23% 28%
*Includes hires on board and confirmed and pending offers
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Patents e-Government Initiatives
• EFS Web Interface pdf1 application submission
• Tri-lateral Dossier Access with EPO• Priority Document Exchange• Patent’s File Wrapper (PFW) - Moving from
electronic image based applications (IFW) to electronic text based applications (PFW)
1 “pdf” is an internationally accepted standard format for electronic documents.
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The CREATE ActThe CREATE Act
35 U.S.C. 103(C) As Amended by the Cooperative Research and Technology Enhancement (CREATE)
Act
Enacted December 10, 2004
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“The CREATE act provides a … means of extending the ‘safe harbor’ provisions of current patent law that treats inventions of a common owner similarly to inventions made by a single person.”
108th Congress, 2d session H.R. Report 108-425
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The CREATE Act: Section 103(c) of Title 35, The CREATE Act: Section 103(c) of Title 35, United States Code:United States Code:
103(c)(1) remains the same -
Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.
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The CREATE Act 35 U.S.C.103(c)(2)The CREATE Act 35 U.S.C.103(c)(2)
For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if--
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The CREATE Act 35 U.S.C.103(c)(2) (cont.)The CREATE Act 35 U.S.C.103(c)(2) (cont.)
(A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;
(B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and
(C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.
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For the purposes of CREATE, the term joint research agreement means:
A written Contract, Grant, or Cooperative Agreement
which is entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.
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“Congress … intend[s] the writing to demonstrate that a qualifying collaboration existed prior to the time the claimed invention was made and that the claimed invention was derived from activities performed by or on behalf of parties that acted within the scope of the agreement.” 108th Congress, 2d session H.R. Report 108-425
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The Grant Concern
While the Act uses the term “grant” broadly, it is unclear whether merely labeling it as such without the exchange of information between the parties on the claimed invention is sufficient to establish a JRA.
Based upon the Congressional report, it can be argued that Congress did not intend that a simple financial award, although called a “grant” would be considered a JRA under this Act.
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Joint Research Agreements could also include:
CRADAs Material Transfer Agreements (MTAs) Clinical Trial Agreements (CTAs) InterInstitutional Agreements (IIAs) Others
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§ 1.109 Double patenting
5. Section 1.109 is added to read as follows:
(a) A double patenting rejection will be made in an application or patent under reexamination if the application or patent under reexamination claims an invention that is not patentably distinct from an invention claimed in a commonly owned patent. This double patenting rejection will be made regardless of whether the application or patent under reexamination and the commonly owned patent have the same or a different inventive entity.
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§ 1.109 Double patenting
A judicially created double patenting rejection may be obviated by filing a terminal disclaimer in accordance with § 1.321(c).
(b) A double patenting rejection will be made in an application or patent under reexamination if the application or patent under reexamination claims an invention that is not patentably distinct from an invention claimed in a non-commonly owned patent by or on behalf of parties to a joint research agreement…
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§ 1.109 Double patenting
…in which the inventions claimed in the application or patent under reexamination and in the other patent were made as a result of activities undertaken within the scope of the joint research agreement.
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§ 1.321 Statutory disclaimers, including terminal disclaimers
(1) Comply with the provisions of paragraphs (b)(2) through (b)(4) of this section;
(2) Be signed in accordance with paragraph (b)(1) of this section if filed in a patent application or be signed in accordance with paragraph (a)(1) of this section if filed in a reexamination proceeding;
(3) Be signed by the patentee or by the applicant, or an attorney or agent of record, of the disqualified patent or application; and
(4) Include a provision that the owner of the rejected application or patent and the owner of the disqualified patent or application each:
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§ 1.321 Statutory disclaimers, including terminal disclaimers.
(4)(iii) Agree that such waiver and agreement shall be binding upon the owner of the rejected application or patent, its successors, or assigns, and the owner of the disqualified patent or application, its successors, or assigns.
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PART 3—ASSIGNMENT, RECORDING AND RIGHTS OF ASSIGNEE§ 3.11 Documents which will be recorded
(c) A joint research agreement or an excerpt of a joint research agreement will also be recorded as provided in this part. A joint research agreement or excerpt of a joint research agreement submitted for recording by the Office must include the name of each party to the joint research agreement, the date the joint research agreement was executed, and a concise statement of the field of invention.
10. Section 3.31 is amended by adding a new paragraph (g) to read as follows:
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Issue: § 1.71 Detailed description and specification of the invention
Should the USPTO require notification of first filing party or require signatures of both parties before an applicant may invoke the CREATE Act?
Should the specification be amended in both applications. If the party of the first filing has already issued as a patent, should the amendment be required via certificate of correction or other appropriate mechanism?
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Issue: § 1.71 Detailed description and specification of the invention
Should the USPTO require the patent applicant to notify any party identified as a party to a Joint Research Agreement (JRA) whether or not they have a conflicting application or patent?
Should the PTO require both parties to a JRA to affirm that a JRA was in place and both parties are requesting the benefits of CREATE?
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ISSUE: § 1.71 Detailed description and specification of the invention
(ii) A concise statement of the field of the claimed invention.
Should the USPTO clarify the standards by which amendments to the specifications to include the ‘field of the claimed invention’ would be judged vis-à-vis ‘new matter?’
Are the requirements of 1.71(g)(1)(ii) consistent with the requirement of 1.104(B) since the ‘scope of the JRA’ may be different from the ‘scope of the claimed invention?’
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Issue: § 1.109 Double patenting
The USPTO is silent if an obviousness type double (ODP) patenting rejection will be made against both the 1st to file and the later filed application if both are pending. Since CREATE extends the ‘common ownership’ provision of 103(c) it is possible that the 1st to file might be rejected under ODP. If the ODP is predicated upon a pending application, would it be desirable, as a matter of patent examination policy, for the USPTO to allow the first filed application to issue to avoid creating a legal and financial burden on the party of first filing.
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Issue: § 1.109 Double patenting
Should the USPTO address how it will handle situations in which a first filing applicant refuses to sign a terminal disclaimer.
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Interesting Patent Cases
What is utility?Research Exemptions?
The Fate of Written Description?
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Research Exemptions
• “Experimentation on the invention?”• AIPLA’s proposal…will it work?• 35 USC 271(e)(1)…drifting standard?
– Merck KGa v. Integra
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35 U.S.C. 271 (e)(1)
• It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other process involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
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Merck KGa v. Integra
• 2003: CAFC limits safe harbor provision of 35 USC 271(e)(1)– Judge Newman dissenting
• 2005: Supreme Court issues cert.
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Merck: Amicus Briefs
• In Support of Merck: – NYIPLA, EON Labs, AARP, Consumer Project
and the Electronic Frontier, PhRMA, Sepracor, Genentech, Biogen, US Government, Eli Lilly, Wyeth, and Pfizer
• In Support of Neither Party: – AIPLA, BAR Association of the District of
Columbia, San Diego IPLA, and BIO
• In Support of Integra: – Benitc, Vaccinex, Applera, Invitrogen, WARF
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Utility…
Is there a reasonable standard?
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In re Fisher
• “First generation” EST• Comprising language• The rejections:
– Utility– Written description (Lilly type)
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In re Fisher
• Appeal from the USPTO BPAI• EST technology
– Testing utility standard– Written description test a “no-go”
• Amicus Briefs– Eli Lilly, AAMC, NAS, Baxter, Dow,
ACMG– Affymetrix– Genentech
