The counterplan solves the aff, link turns the advantages, and resolves the innovation net benefit
Rose 12 [Simone A., Professor of Law, Wake Forest University, writes and publishes in the area of intellectual property (IP), “Semiconductor Chips, Genes, and Stem Cells: New Wine for New Bottles?,” American Journal of Law & Medicine, 38 (2012): 113-157, pg. Cambridge Journals Digital Archive, ALB]
No one can predict the outcome of the appeal of the Association for Molecular Pathology case or the new embryonic stem cell prosecution before the PTO. Nevertheless, the disputes over isolated gene patentability and invalidation of the WARF embryonic stem cell patents provide motivation to evaluate whether isolated bioproducts are properly placed within the patent intellectual property regime. In addition to current subject matter and non-obviousness problems, scholars have raised antitrust, utility, morality,31 and the need for greater access as grounds for excluding isolated bioproducts and other upstream bioproducts from the Patent Act.32
Removing these products from the patent regime, however, may prove disastrous to society. The biotechnology33 industry relies on bioresearch patent portfolios to attract venture capital, generate licensing revenue, and cover the cost of continued isolated bioproduct research and development.34 Arguably, a lack of corporate funding will stall this research because federal funding is insufficient to bridge any resulting gap.35 This, in turn, will stall economic growth and future development of much needed downstream bioproducts with specific utility.36
So, if isolated bioproducts are not patentable, is this one of the rare occasions for Congress to step in and offer some type of sui generis intellectual property protection for isolated genes, stem cells, and related bioproducts? Is it time for legislation that would strike the appropriate balance between innovation and access, despite isolated bioproducts’ failure to meet the patent social bargain that requires novelty, utility, and non-obviousness?37 Are we no longer one-size-fits-all and in need of another paradigm to meet the constitutional mandate to promote the “Progress of Science and the useful Arts?”38 In other words, are isolated genes and stem cells a new and valuable type of intellectual property “wine” that needs a new and different type of intellectual property “bottle” for adequate protection?39
If so, what factors should Congress consider when evaluating whether to go beyond the patent social bargain and add an additional set of exclusive rights to promote the progress of the “useful Arts?” In the past, Congress has taken a dim view of any type of sui generis, or stand-alone, intellectual property protection beyond patent and copyright and refused to create sui generis statutes for computer programs and databases.40 Indeed, there are only two instances of Congress providing sui generis intellectual property protection in the past 100 years.41
This Article makes a case for sui generis intellectual property protection for isolated genes, stem cells, and related bioproducts by analogizing how early semiconductor technology similarly warranted sui generis protection to appropriately balance access and innovation.42 I use the term “isolated bioproducts” to describe bioproducts that have been isolated from the human body without any additional biological manipulation. Thus, isolated bioproducts that have undergone sufficient human engineering to be clearly distinguishable from their in vivo counterparts, such as complementary DNA (cDNA), are excluded from the scope of this Article.43
In Part II, I establish that because isolated bioproducts, such as genes or embryonic stem cells, are one step away from falling outside the scope of patent protection as either obvious in light of prior art or patent-ineligible products of nature, we must look to alternative intellectual property legislation to preserve the incentive to innovate and increase our knowledge base. As part of this discussion, I criticize the Federal Circuit’s recent decision in the Myriad case. I argue that in finding isolated genes patentable subject matter under section 101, the court focused too heavily on promoting innovation and the twenty-year industry reliance on the PTO guidelines rather than on the constitutionally mandated balancing of access and innovation to promote “Progress.” I conclude Part II by noting that the questionable patentability of isolated genes and stem cells provides the motivation to explore how a sui generis intellectual property statute for basic isolated bioproducts could serve as an alternate property paradigm to fill any potential “progress gap.”
Sui generis solves the aff and the net benefit – eliminates “progress gap” for non patentable biotech
Rose 12 [Simone A., Professor of Law, Wake Forest University, writes and publishes in the area of intellectual property (IP), “Semiconductor Chips, Genes, and Stem Cells: New Wine for New Bottles?,” American Journal of Law & Medicine, 38 (2012): 113-157, pg. Cambridge Journals Digital Archive, ALB]
The question then becomes: should we explore alternative sui generis intellectual property protection for patent-ineligible isolated bioproducts, like stem cells, genes, and gene sequences, to close the potential “progress gap?” A “progress gap” will exist if isolated bioproducts are patent-ineligible,60 but an alternative propertization scheme is necessary to continue innovation.
A prerequisite for sui generis intellectual property protection is that the “progress gap” technology is already innovative—the product of significant and continuing research and development. The technology must also be part of an industry with great potential to promote “progress” by stimulating both intellectual and economic growth. Semiconductor technology met these criteria in the mid1980s,61 and isolated bioproduct technology currently fits the bill.
Isolated bioproducts are part of the rapidly growing global biotechnology industry. In the United States, the biotechnology market is highly innovative and has experienced growth rates averaging between eight and ten percent per year for the past five years.62 From its inception, the biotechnology industry has continued to invest heavily in research and development, although analysts predict that the sluggish global economy will lead to a decline in innovation spending for 2011.63