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Mission and Guidelines
Issues and Strategic Rationale:
- The PTO plays a central role in the continued success of the biotechnology industry. Patents are necessary to recoup the investment of entrepreneurs in biotechnology because of the huge investments in research and the long lead times between an idea and a marketed product.
- 90% of biotechnology companies have no products on the market. For many companies, their entire market valuation is tied to their patent rights. Strong, predictable and timely intellectual property protections are critical for the continued success of this promising industry.
- PTO funding has not kept pace with the demands of the biotechnology sector. PTO patent filings are to increase by 12% in FY 2002 and are projected to exceed 80% increase in application filing by Fiscal year 2006.
- For biotechnology inventions, the wait time for obtaining patent protections may increase from its current levels to as long as 5 years. The PTO's biotechnology group receives about 38,000-40,000 new applications per year. This number is expected to increase in the coming years.
- PTO fee diversion and the increasing number of patent filings in the biotech arena will impact the QUALITY of patents issued. Even as the PTO's work load increases, patent fees continue to be diverted to the general budget.
- Clearly the PTO must change the way it does business in the 21st Century.
Mission:
To raise the profile of the PTO funding issue with the Administration and Congress; to communicate the industry's perspectives to the PTO; to ensure that the PTO has the resources necessary to meet the demands of the biotechnology industry; and to ensure that any PTO restructuring scheme benefits the biotechnology industry.
Responsibilities:
- The PTO Working Group is responsible for addressing PTO restructuring legislation and regulations.
- The working group may commission studies, develop policy papers to be reviewed by the full IP Counsels' Committee and may from time to time organize briefings for government officials.
- The working group will monitor and evaluate work product from the Patent and Trademark Office.
- The working group will work with BIO staff to brief members of Congress on PTO work product and process related issues.
- The working group will make recommendations to the full committee on legislation and practice related to PTO.
- Working group members may be asked to formulate comments and testimony on various PTO related regulations, legislation etc.
Policy Approval Process:
Substantive matters designed to become the official position of BIO are sent as recommendations of the PTO Working Group to the IPC committee for review. Upon approval of the full IPC committee, the recommendations are sent to the Board of Directors Standing Committee on Intellectual Property for first review. The Standing Committee on Intellectual property will discuss and, as appropriate, determine changes in the recommendations. The standing committee will then either return the substantive matter to the IPC and then the working group for further comment and revision or refer the matter to the full Board of Directors for consideration.
Eligibility for Participation:
Must be a member of BIO and meet the requirements of the membership in the full IPC committee.
Past Accomplishments:
The PTO Working Group has helped develop BIO's position and testimony on the PTO's strategic plan. The working group has helped to organize briefings of congressional members and staff on PTO related issues, such as PTO appropriations and legislation to streamline the re-examination process. The working group is actively working with other PTO users e.g. the AIPLA, the IPO, the ABA-IPL section and INTA to achieve consensus on PTO related issues.
Obligations: The working group meets twice a year to examine issues, focus and strategy. Tactical meetings will be held on an ad hoc basis throughout the year.
Contact Information: Lila Feisee, director, intellectual property, lfeisee@bio.org;
Louise Rogers, Coordinator for Legal Affairs, lrogers@bio.org. Address:
1201 Maryland Avenue, SW,
Suite 900,
Washington, DC 20024-2149,
(202) 962-9200
fax: 202-488-6301 website: www.bio.org.
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