BIOTECHNOLOGY/CHEMICAL/PHARMACEUTICAL CUSTOMER PARTNERSHIP MEETING
WEDNESDAY, SEPTEMBER 8, 20101
Christian Chace
SPE, Art Unit 2187
Marti Hearst
External Affairs
Patent Reengineering Team
Patents End-to-End IT Project
Slides presented discussed what is Patents End-to-End:
It is a New IT System for Patent Examination:
Allows to be Free from constraints of legacy systems
Based on text rather than scanned images of pages.
Flexible, scalable, and leverages modern technologies
Utilizes open standards
Well documented and readily supported
Overall Goal:
USPTO’s Patent automation systems are a collection of systems (some dating
back to the 1970s), that have evolved independently.
The USPTO ultimately seeks to develop a system architecture which will
incorporate a re-design of the pre-examination, examination and post-examination
processes.
Goals include:
Open Standards
Maintainability, Scalability
Optimization of cost and time
Visibility of information
Data Usability and interfaces
State of the art search and comparison tools
Collaboration technologies
Stakeholder participation in design
Currently to achieve goal, several tasks are running in parallel:
New software architecture, testing of latest tools, user research and
process re-engineering.
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Notes prepared by Paul D. Pyla, Esq. The content of these notes only represent the views of the preparer.
Gathering of Stakeholder input (internal) Timelines:
June:
Business Goals: Survey (online)
July-September:
Task Analysis: Interviews, Focus Groups, and Online Input
October-December:
Iterative Testing of Mocked-up Interfaces, Interviews, Focus Groups, and Online Input
Patent Process Reengineering Team
Goal:
To streamline the patent application process to meet the challenges of adapting to rapidly
evolving technologies and stakeholder priorities, while ensuring success in meeting the
goals of timeliness, quality, and efficiency.
Reengineering Team Scope and Priorities (See slides 6-7)
Reengineering Initiatives (See slides 8-9)
Planned Actions (See slides 10)
Presenters then opened the discussion to list what external stakeholders would like to see
different (e.g., Format of patent submissions, etc.).
Mary Till
Office of Patent Legal Administration
Best Practices for§ 156 Patent Term Extension (PTE)
Best Practices for§ 156 Patent Term Extension (PTE)- See slide 2 for topics discussed.
Hatch-Waxman Act - sought to balance interests of innovator pharmaceutical companies
with those of the generic manufacturer industry.
Title I of Hatch Waxman balances the reliance on innovator clinical data by the
generic manufacturer with market exclusivity for the innovator company.
Title II of Hatch-Waxman balances the safe harbor provisions of § 271(e)(1) with
the patent term extension provisions of §156
Eligible Products:
Drug Products (New drugs, antibiotic drugs, human biological products, new
animal drugs, or veterinarybiological products).
Medical Devices
Food Additives
Color Additives
See slides 5-7 for relevant regulatory review periods, § 156(d)(1) application
requirements and timely filed § 156(d)(1) application information
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Interim Extension under 35 U.S.C. 156(d)(5)
Added in 1993, product not approved, patent expiring while product is
undergoing continued review by the regulating agency.
Clinical work is done. Agency is conducting approval review. Statutorily settime
frame for application submission.
Timely filed section 156(d)(5) and subsequent § 156(d)(5) interim extensions
§ 156(d)(5)(A) defines the period within which to file application for interim
extension as, “beginning 6 months, and ending 15 days before such term is due to
expire.”
§ 156(d)(5)(C) defines the period within which to file a subsequent application for
interim extension as, “the period beginning 60 days before, and ending 30 days
before, the expiration of the preceding interim extension.”
Interim Extension under 35 U.S.C. § 156(e)(2)
§ 156(e)(2) product approved, patent expiring before certificate of extension can
be granted. No statutorily set time frame for application submission.
Timely filed § 156(e)(2) interim extension
§ 156(e)(2) does not contain a statutory time period for application submission.
37 C.F.R. 1.760 indicates that any request for interim extension under 156(e)(2)
should be filed at least 3 months before the patent expires.
Two situations can give rise to multiple applications for PTE
(1) when multiple patents claim the approved product, or a method of using or
manufacturing the approved product, patent owners may file multiple applications
and choose the one to receive the extension at the end of the PTE process (see 37
C.F.R. § 1.785).
(2) multiple approvals for the same product on the same day (35 U.S.C. §
156(c)(4)).
Combination Products
Multiple active ingredients drug products
Arnold Partnership v. Dudas
Synergy?
Drug/device combination products
Seeking or Pending Reissue during PTE Processing
Product receives approval, the patent owner has a 60 day window within which to
submit an application for term extension (35 U.S.C. § 156(d)(1)).
Sometimes reissue of the patent for which extension has been sought is
undergoing prosecution.
Sometimes during the processing of the patent for which extension has been
sought, a reissue application is filed for the patent.
See slide 15-19 for effect of reissue on PTE and case law summaries
See pages 20-21 for Frequent PTE Questions and Answers
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For more information regarding PTE, see slide 22 for contact Information:
Benjamin Borson
Borson Law Group, LLP
Section 101, Utility and Patentable
Subject Matter in the Discovery Arts
Please see the entire set of slides
Bennett Celsa,
QAS, TC1600
Broadening Reissues
Please see the entire set of slides
Sequence Submission Update
Now a form on the uspto.gov website for filing a CRF transfer request under 37 CFR
1.821(e).
– Form PTO/SB/93 for filing either in paper or by EFS-Web.
When filing a sequence listing via EFS-Web
– A sequence listing filed as a PDF file satisfies only the requirement under
R.821(c), i.e. it is equivalent only to a paper copy and is not a computer readable
form (CRF). In contrast, a sequence listing filed as an ASCII text (TXT) file of
will satisfy the requirements for both the "paper" copy under R.821(c) and the
CRF under R.821(e).
– It is not necessary to file a CRF transfer request under Rule 821(3) if the required
sequence listing (i.e. “paper copy”) under Rule 821(c) is filed as an ASCII (TXT)
file. If a sequence listing ASCII text file is filed along with the transfer request,
the ASCII file will be treated as both the “paper copy” under Rule 821(c) and the
computer readable form under Rule 821(e) and the transfer request will not be
processed.
Please see Section I of the Legal Framework for EFS-Web
http://www.uspto.gov/patents/process/file/efs/guidance/New_legal_framework.jsp.
NEXT MEETING:
Wednesday, December, 8, 2010
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