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WBBA’S 2010 FEDERAL POLICY PRIORITIES
The Washington Biotechnology & Biomedical Association (WBBA) is the state's leading advocate for advancing the life sciences in Washington State. Our (WBBA) Mission is to translate Innovation to Realization… from breakthrough discoveries to better health solutions. We accomplish this mission through advocacy, enterprise support and the enhancement of research collaboration. By partnering with member organizations, we will provide better health solutions in multiple ways.
- Innovation – working closely and supporting our research institutions, inventors and entrepreneurs to broaden the impact of breakthrough discoveries.
- Capital – facilitating access to capital, especially early stage funding.
- Talent – helping to recruit, train and retain the talent needed to grow life sciences in Washington.
- Environment – ensuring that Washington is a great place to start, grow and retain the organizations needed to remain competitive and prosperous.
Federal priorities will in part be dependent on what emerges as the final healthcare reform bill.
Biosimilars/Follow on Biologics
WBBA supports enactment of a pathway for biosimilars that is science-based, emphasizes patient safety and promotes on-going innovation to create new diagnostics, therapeutics and treatments for unmet medical needs. The appropriate period of data exclusivity and adequate patent protection, clinical trial requirements for biosimilars, and interchangeability are key issues.
In 2010, WBBA will:
- Continue to work in support of an appropriate pathway until a final bill is created; and
- Work to understand and communicate to WBBA members the implications of any legislation creating a pathway once a bill is passed.
Medical Device Excise Tax
The current proposed medical device excise tax has the potential to disadvantage our medical device industry, reduce job creation and threaten the fragile ecosystem for medical innovation.
In 2010, WBBA will:
- Continue to work to defeat or at the very least to mitigate the proposed medical device excise tax; and
- Work to understand and communicate to WBBA members the implications of any legislation which is passed and signed into law.
Patent Reform
As Congress continues to craft patent reform, WBBA urges inclusion of the following reforms:
- Full funding for the agency responsible for granting patents – the United States Patent and Trademark Office (USPTO). This can be most effectively achieved by giving the USPTO more flexibility in setting its user fees, and by permanently ending fee diversion, thus ensuring that all fees collected by the USPTO are used to improve the efficiency of the patent system.
- Transition to a first inventor-to-file system that incorporates an appropriate “grace period” so as to encourage both the prompt filing of patent applications and the early public dissemination of research results.
- Willful infringement reforms that would specify that the litigants must first resolve the validity and infringement of the patent before turning to willfulness, as well as clarify the conditions under which courts can determine that willful infringement occurred.
- Repeal of the Best Mode description requirement, which has no counterpart in foreign patent laws and serves largely as an often-abused defense in patent litigation to attack the subjective state of mind of the patent applicant.
- Restore a rebuttable presumption of irreparable harm and inadequacy of remedies at law when evaluating a request for a permanent injunction following a finding of patent infringement, so that the right to exclude – which is the essence of the patent right –
- is not undermined.
In 2010, WBBA will:
- Continue to advocate for full funding of the USPTO
- Work with our partner BIO for patent reform which supports innovation in life sciences.
- Work to understand and communicate to WBBA members the implications of any legislation which is passed and signed into law.
Comparative Effectiveness Research (CER)
WBBA recognizes that CER may hold some keys to improving health outcomes and reducing health care costs. CER should not be structure to impede patient access to new diagnostics or therapeutics nor should it dampen investment in innovation.
In 2010, WBBA will
- Continue to advocate for CER which encourages ongoing research and development for better health outcomes
- Work to understand and communicate to WBBA members the implication of any legislation which is passed and signed into law as part of health care reform.
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