SOURCES SOUGHT
R -- Patent Legal Services for FDA Technologies
- Notice Date
- 12/17/2015
- Notice Type
- Sources Sought
- NAICS
- 541110
— Offices of Lawyers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-16-223-12172015
- Archive Date
- 1/23/2016
- Point of Contact
- Elyse Kennedy, Phone: 2404027600
- E-Mail Address
-
elizabeth.kennedy@fda.hhs.gov
(elizabeth.kennedy@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT This is a Sources Sought Notice. The proposed North American Industry Classification System (NAICS) code for this acquisition is 541110. The purpose of this Sources Sought Announcement is to assist the Food and Drug Administration in conducting Market Research to identify sources of services that meet its requirements that are capable of providing Patent Legal Services for FDA Technologies that deal with the safety, efficacy, manufacture and security of: 1) food supply, nutrition and dietary supplements 2) drugs and biological therapeutics 3) medical devices and radiation emitting products 4) biologics including regulated products such as allergenics, blood and blood products, cellular & gene therapy products, tissue and tissue products, vaccines and xenotransplantion 5) animal and veterinary drugs and products, 6) tobacco products and 6) cosmetics FDA Technologies that require Patent Legal Services also include diagnostics and methods for the detection of pathogens, chemical agents and toxins, biomarker identification, bio-imaging, nanotechnology, software and personalized medicine. FDA research in the above FDA Technologies can lead to a discovery or new technology that results in multiple independent and/or distinct inventions. A contractor will be required to demonstrate the requisite scientific, technical and legal expertise to prosecute patent applications for inventions that cross multiple scientific and technical disciplines. These patent applications are prosecuted in the United States within a variety of United States Patent and Trademark Office (USPTO) Technology Centers. Patent applications within the FDA Technologies described above have been prosecuted in one or more of the following USPTO Technology Centers: • 1600 Biochemistry and Chemistry- examples of FDA Technologies prosecuted within this Technology Center would include drugs, cosmetics, immunology, gene therapy, blood and tissue products and chemical agents. • 1700 Chemical and Material Engineering -examples of FDA Technologies prosecuted within this Technology Center would include tobacco, management or destruction of hazardous waste or toxins. • 2100 Computer Architecture, Software, and Information Security -examples of FDA Technologies prosecuted within this Technology Center would include software used in medical devices • 2600 Communications - examples of FDA Technologies prosecuted within this Technology Center would include software solutions and instrumentation used in medical devices and diagnostics. • 2800 Semiconductor, Electrical and Optical Systems and components- examples of FDA Technologies prosecuted within this Technology Center would include spectroscopy and imaging systems such as radiation emitting products. • 3600 Transportation, Construction, Electronic commerce, Agriculture, National Security and License & Review -examples of FDA Technologies prosecuted within this Technology Center would include food safety, animal and veterinary products. • 3700 Mechanical Engineering, Manufacturing, Products -examples of FDA Technologies prosecuted within this Technology Center would include medical and surgical instruments, diagnostic equipment, devices and supplies. The Patent Legal Services sought will support the entire patent life cycle including the preparation, filing, prosecution and post issuance activities of patent applications filed in the United States Patent and Trademark Office (USPTO), as well as Patent Cooperation Treaty (PCT) applications and national stage applications filed in the U.S. patent office, foreign patent offices and other foreign patent authorities. DRAFT DESCRIPTION/SPECIFICATION/STATEMENT OF WORK 1. BACKGROUND FDA has ownership interests in inventions discovered by FDA investigators. Currently, FDA's patent prosecution activities are handled by contractor law firms under contracts which are managed by the National Institutes of Health, Office of Technology Transfer (NIH-OTT). Consequently upon award of this Contract the FDA Contractor may be asked to assume responsibility for cases previously prosecuted by contractors under the NIH-OTT contact. The FDA currently holds over 600 hundred active patents and patent applications and files 10 applications for new inventions per year on average. Historically, approximately two-thirds of provisional patent application filings go on to Patent Cooperation Treaty (PCT) stage and approximately one-half of those cases enter national phase. The most common national phase filings occur in the United States, Europe, Australia, Canada, Japan and China. It is expected that prosecution of most active cases will be transferred to the Contractor selected under this contract. The objective of this effort is to acquire Patent Legal Services from a contractor to support the entire patent life cycle, pre-grant and post grant, and provide protection for FDA owned intellectual property across all FDA's Technologies. These services consist of pre-grant prosecution activities for both U.S. and foreign patent applications such as patent search services, patent opinions, patent prosecution services, patent litigation, petitions, ancillary patent services and fee payment services. FDA also requires legal services that support infringement and Post-grant activities such as proceedings conducted by the Patent Trial and Appeal Board, Ex-Parte, Inter-Partes Review, covered business method reviews, post-grant review, interference, contested proceedings and licensing consultation. Post grant services include reissue, reexamination and interference activities for U.S. patents and patent applications and similar activities conducted before foreign patent offices. Contractor will also be required to perform transition activities for FDA's current patent portfolio. The transition activities will require Contractor to assume responsibility for patent prosecution related activities for FDA's active cases that were previously handled under the NIH legal contract. The majority of FDA's patent prosecution work has been handled within USPTO Technology Center 1600. Contractor is expected to demonstrate its ability to handle prosecution of patent applications for FDA Technologies that may fall within all of the USPTO Technology Centers listed above. 2. DRAFT STATEMENT OF WORK FOR PATENT SERVICES The Contractor shall perform all necessary Patent Legal Services in connection with the preparation, filing and prosecution of patent applications filed in the United States Patent and Trademark Office (USPTO), as well as Patent Cooperation Treaty (PCT) applications and national stage applications filed in foreign patent offices and other foreign patent authorities. The Contractor shall provide the following Patent Legal Services: 1) Patent Search Services 2) Patent opinions 3) Patent Prosecution Services: Prosecution of domestic and foreign patent applications including the preparation of patent applications from invention disclosures, preparation of amendments, briefs, interference papers, requests, notices and other papers as well as interviews with Patent Examiners. Prepare and file informal and formal drawings for USPTO, PCT and foreign patent applications. 4) Patent Litigation 5) Petitions 6) Ancillary Patent Services: Such services would include Obtain copies of patents, file histories, assignment records, as requested; Obtain signatures of inventors and/or designated authorities on legal papers and deliver to the USPTO and/or foreign patent offices, under very tight time constraints; Filing requests for corrections to patents; Secure all copies and translations of cited art and drawing to the extent required by the patent authority; Provide courier service to deliver papers to and from inventors and between FDA and the USPTO and/or foreign patent authorities; Translation services for foreign patent filings. Keep FDA informed of significant changes in domestic and foreign patent laws that would bear on strategies and procedures for current or future work. 7) Fee Payment services: Contractor will be responsible for management of the payment of patent filing fees as well as issue fees, maintenance or annuity fees for both domestic and foreign patent filings. 8) Infringement and Interference Services 9) Post-Grant Proceedings Domestic patent matters shall be handled in compliance with Title 35, US Code, and with Volume 37, Code of Federal Regulation and other applicable laws, regulations and current case law. The preparation and filing of provisional or utility patent applications will be based on invention disclosures in light of known prior art and any contemplated prosecution strategy. The claims shall cover a range of inventions including the broadest appropriate coverage reasonably permitted in view of the available prior art with claims directed to the aspects of the invention that provide the most commercially valuable patent results. Contractor will arrange for the timely deposit of organisms, cell lines and other biological materials that may be necessary to satisfy the requirements of applicable U.S. and foreign laws. The specifications, drawings and claims for all patent applications shall be in accordance with Title 35, United States Code; Volume 37, Code of Federal Regulations, other applicable U. S. legal authorities, and foreign patent laws. All foreign patent matters shall be handled by the Contractor or foreign associates under the direction of the Contractor, in accordance with the applicable statues, regulations, and case law of the particular foreign jurisdiction. All required infringement and interference services, and support for Post-Grant Proceedings will be handled by the Contractor in accordance with the applicable statues, regulation and case law of the particular foreign jurisdiction. REQUEST FOR INFORMATION (RFI) The Government requests responses from all interested businesses that may be able to meet the technical requirements of the Statement of Work. Submission requirement: 1. Page limit - Ten (10) 8 ½ X 11 pages; excluding cover page and table of contents 2. 1 inch margins (top, bottom and sides) 3. Times New Roman font - 12 point or larger; excluding tables, boxes, and graphics which may be 10 point or larger 4. Do not include promotional materials 5. To be received no later than January 8, 2015 6. Submission shall be e-mailed to Elyse Kennedy at Elizabeth.Kennedy@fda.hhs.gov Interested sources that have the capability to provide this support are requested to submit the following: • A technical capability statement to provide the patent preparation and assistance services listed. Please include company name, address, point of contact, e-mail address, telephone, and facsimile numbers, DUNS, TIN, CAGE code, and any "Doing Business As Name" as applicable. No statements as to your capabilities in response to this announcement will be binding in future procurements. Include with your technical capabilities statement the answers to the following questions: 1. What is your business type, size, and socio-economic status in reference to the projected NAICS code of 541110? 2. What is your experience in providing the services identified in 4. Draft Statement of Work for Patent Services to the Government and the commercial market? 3. Describe any experience in accepting the transfer of patent prosecution related activities for cases which were previously handled by another law firm. 4. Describe your manpower and management capabilities and capacity 5. Describe your capability to manage any conflict of interest issues that arise, whether personal or organizational. 6. Do you currently have a Government-wide Contract Vehicle that provides this service (Indefinite Delivery Indefinite Quantity Contracts, Government-Wide Acquisition Contracts (GWAC), Multi-Agency Contracts, Federal Supply Schedules (FSS), Basic Ordering Agreements (BOA), Blanket Purchase Agreements (BPA)? If yes, please provide the vehicle type and contract number. 7. What suggestions, if any, do you have for FDA's requirements (including evaluation criteria, contract line item structure, contract structure, contract type)? All interested parties must be registered in the System for Award Management (SAM) to be eligible for an award of Government contracts. lease see attached Sources Sought notice for Patent Legal Services for FDA Technologies attached.
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