Hearing Statement: The CREATE Act
Washington,
Jun 10, 2003 -
The stunning success scientists achieved in rapidly identifying the cause of severe acute respiratory syndrome (SARS) is a recent example of how unprecedented collaboration among government and private labs can save lives and protect the public’s well-being.
The reaction to the SARS virus demonstrates that in an increasingly connected world, it is necessary for our public and private organizations to adapt to new challenges and develop new ways of doing business.
Understanding this, Congress enacted a series of Patent Law Amendments in 1984. One of these amendments, codified at 35 USC §103 (c), created a “safe harbor” for inventions that were the product of a collaboration involving co-inventors within a single company. The amendment changed the U.S. patent system to reflect the manner in which companies actually conduct their internal research activities.
The legislative history makes clear that Congress intended to discourage individuals from attempting to use nonpublic information, also known as “secret prior art,” to challenge the issuance or validity of a patent where co-inventors voluntarily exchanged confidential information concerning a prior invention developed by one or more of the research partners.
What the legislative history leaves unclear and significantly, what we are here to explore today, are the arguments for and against expanding the secret prior art exception to collaborations involving researchers at more than one organization.
Unlike 1984, today’s biotech, pharmaceutical, and nano-technology companies conduct much of their research with partners such as universities or other public or private organizations.
Discovering new therapies for cancer, heart disease, Alzheimer’s, and arthritis is neither simple nor inexpensive. Solving any complex biotech problem requires the integration of numerous disciplines and the involvement of scientists, engineers, and researchers who are located at multiple organizations. Anything that discourages open communication or causes a “chilling” effect among researchers is likely to prevent or delay this vital research. Critics of the Federal Circuits’ 1997 Oddzon decision believe its’ effect has been negative.
The patent system serves the public best by promoting innovation, encouraging communication among researchers, and removing barriers to patents.
Recognizing the need to adapt the patent law to this new research paradigm, the Ranking Member, Mr. Berman, and I introduced H.R. 2391, the Cooperative Research and Technology Enhancement (CREATE) Act of 2003, along with nine cosponsors (most of whom are on this subcommittee).
The CREATE Act’s purposes are:
1) To promote communication among “team researchers” located at multiple organizations;
2) To discourage those who would use the discovery process to harass co-inventors who voluntarily collaborated on research resulting in a patentable invention;
3) To increase public knowledge; and
4) To accelerate the commercial availability of new inventions.
Last year, this Subcommittee conducted an oversight hearing on the topic. The legislation discussed today addresses concerns raised at that hearing.
We are fortunate to have excellent witnesses with extensive experience relating to the intersection of patent law, cooperative research, technology transfer, and biotech issues. I look forward to their testimony. The Ranking Member and a cosponsor of the CREATE Act, Mr. Berman is recognized for his opening statement.
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