'Are All Genes Equal?' by Samantak Ghosh in
Boston University Journal of Science and Technology Law comments
After years of public debate, the Supreme Court recently invalidated patents on human genes. The Court's opinion did not consider the patent-eligibility of biological products from other sources like bacteria and plants, or other non-genetic biological materials. Yet, given the unitary nature of the patent law, the ruling will have broad implications for the patentability of all biological products, human or non-human, genetic or non-genetic. But do these other biological products raise the same concern as human genes? This paper explores these questions and also seeks to examine their relevance through a survey. The survey indicates that people are more opposed to patents on human genes than to patents on genes from lower species. Likewise, the survey finds that people are more opposed to patents on human genes than to patents on human non-genetic materials. These distinctions have been largely ignored by courts and commentators. But the significance of these issues cannot be overstated. As the dust settles on the debate over the patenting of human genes, new questions about the patent-eligibility of other biological products are springing into life, and these considerations provide a richer context to these discussions.
Ghosh argues that
Of course, the public unease with human gene patents may be further exacerbated
by some mischaracterizations of the rights conferred by patents. Some have compared
gene patent ownership with slavery, or suggested that gene patent owners can do
whatever they want with our genes. These misleading suggestions coupled with the
media hype may have contributed to a greater sense of apprehension about gene patents
than warranted.
Whatever be the concerns that led to an overwhelming opposition to human gene
patents, it is quite clear that many of these concerns are much attenuated, or even nonexistent
when we consider biological products from other organisms. Neither can human
beings claim some possessory rights to biological materials from non-human sources, nor
is there a concern that patents on these products may impact access to human diagnostic
tests. While animal rights activists may still argue for a greater recognition of dignity of
animals, these claims get decreasing moral stridency as one goes down the species
chain to lesser evolved species like plants and bacteria. Thus, it is not surprising that the
greatest difference in the measure of support for gene patents is observed between those
of human and bacterial genes.
Similarly, the difference in public opinion between human genetic and nongenetic
materials can be explained by the fact that genes are deemed special. There is a
greater sense of value or respect associated with human genetic materials than nongenetic
materials. Genetic exceptionalism is understandable. Genetic information is
unique in its capacity to simultaneously identify individuals separately and relationally.
On one hand, DNA finger-printing is routinely used in solving crimes by identifying
individuals, and on the other hand, genetic information from individuals very often
implicate relatives, and in some instances, even ethnic groups. The longevity and
multi-generational characteristics of DNA also lends to its unique status among natural
products.
For lower organisms, while DNA still retains its aura as a fundamental molecule
of life, it does not raise many of the concerns implicated by human genetic information.
For instance, privacy interests are very modest if not virtually non-existent for nonhuman
species. This may explain why we do not observe a statistically significant difference in the opposition between genetic and non-genetic materials for lower
organisms.
An appreciation of these distinctions helps us understand why a case involving
human gene patents is a questionable vehicle for developing a doctrine on the patenteligibility
of all natural products. As the survey shows, human gene is an exceptional
biological product, both because it is a human biological material and a gene. After all, it
is often said, “[H]ard cases make bad law.” Even Glanville Williams who questioned
this over-used legal maxim was “certain [] that cases in which the moral indignation of
the judge is aroused frequently make bad law.” Just like the common man, it is
possible that the Justices’ moral outrage over the question of patenting human genes—
although it found no expression in the Myriad opinion—may have exceeded by their
concern over patents on other biological products. As Justice Holmes, so eloquently put
it,
Great cases, like hard cases, make bad law. For great cases are called great not by
reason of their real importance in shaping the law of the future, but because of
some accident of immediate overwhelming interest which appeals to the feelings
and distorts the judgment. These immediate interests exercise a kind of hydraulic
pressure which makes what previously was clear seem doubtful, and before which
even well settled principles of law will bend.
The Myriad gene patents case undoubtedly carries a number of elements that could
appeal to human feelings. Indeed, the very fact that it was such an emotive issue may
explain why amongst so many patents on so many different biological products, the case
that ultimately got challenged covered patents on human genes.
Finally, and perhaps more importantly, a nuanced understanding of these
underlying policy considerations may enable us to avoid the pitfalls of over and underinclusiveness
that appears to be a point of disagreement on patentable subject matter.
Instead of letting these issues lurk in the shadows of the dominant utilitarian concerns of
innovation we need to bring them to the forefront for they may provide us a richer
understanding of the concerns surrounding these patents. By bringing more granularity to
the picture, they may help us parse out the universe of biological products and facilitate a
more tailored approach. Particularly, where the empirical evidence is unclear these
factors may be weighed in to influence legislative efforts on categorical patentable
subject matter exclusions.
Public moral perception shaping patent law is not a radical notion. The
American patent law contains a number of restrictions on patent-eligibility and the scope
of patents that are primarily based on moral judgments, rather than their impact on
scientific innovation. For instance, concerns about the harmful effects of patent incentive
and disclosure of nuclear weapons technology lead Congress to ban patentability of such
innovations in 1954. Moral objection over the commodification of human beings was
similarly instrumental in the incorporation of the “Weldon Patent Ban” into patent law,
under which “no patent may issue on a claim directed to or encompassing a human
organism.” The exception in patent law that health care providers cannot be held liable
for the infringement of medical procedure patents is another example where ethical
concerns expressed by the medical community forced the Congress to limit the scope of
patent enforcement.
Interestingly, in a debate over the patent-eligibility of biological products
obtained from lower organisms, this study could provide ammunition to both opponents
and proponents of patents. Opponents could point out that public opinion weighs against
the granting of these patents. On the other hand, proponents of these patents may rely
on the fact that people are less opposed to these patents than to patents on human
genes. Besides, they could argue that public opinion is just one of the relevant factors,
and should be considered in conjunction with the incentivizing effect of patents, and the
absence of evidence of these patents adversely impacting future innovation or healthcare
access.
Given Myriad’s unclear guidance on this question, these debates are likely to play
out in the future. This paper hopes to provide a richer context to these future debates over
the patent-eligibility of natural products by providing another vantage point from which
to explore these questions.
...
“The myopic viewpoint thinks of a human gene as merely another chemical
compound, composed of various bases and sugars. But history and science teach us
otherwise.” Human genes occupy a special status in our society, thereby raising special
concerns over their monopoly. Whether this status and the concomitant concerns are
justified or not is another question. But given Myriad’s potential of invalidating many
more patents than just human gene patents, it merits asking whether the same concerns
that elicited public disconcert over human gene patents are relevant to these patents over
other biological products. This paper examines these questions and their implications.
The significance of these issues cannot be overstated. As the dust settles on the debate
over the patenting of human genes, new questions about the patent-eligibility of other
biological products are spurring to life.
'Commercialization of Genetic Resources: Leveraging of Ex Situ Genetic Resources to Shape Downstream IP Protection' (University of California Hastings College of the Law Research Paper No. 56) by Dana Beldiman
suggests that
Ex situ collections that hold genetic materials operate as contractual points of articulation between countries of origin and recipients and/or prospective developers. In that capacity, collections are in a position both to negotiate clarification of Convention on Biological Diversity obligations and, by virtue of their control over biological materials, to impose IP-related conditions on recipients.
This paper proposes the concept of a "rebundling" of IP rights: the prospective patentee would relinquish its entitlement to full exclusivity under patent law, in exchange for freedom to operate from a patent perspective plus access to other material recipients' technology. The "rebundling" could take the form of a patent pooling arrangement and would give multiple players a chance to participate in the market.
