Volume 93, Issue 3

  • Patently Obvious: Why The District Court's Ruling in Association for Molecular Pathology v. USPTO is Incomplete -Kristin Wall
  • Nonobviousness Standards for Hardware and Software Before and After KSR: What is the Difference? -Michelle Friedman Murray
  • The Integrity of Section 101: A "New and Useful" Test for Patentable Subject Matter -Daniel J. Klein
  • Claim Preambles: Unnecessary Matters of Chance and Confusion -Kirk M. Hartung
  • Are Intellectual Property Rights Human Rights? Patent Protection and the Right to Health -Mirela V. Hristova


Patently Obvious: Why The District Court's Ruling in Association for Molecular Pathology v. USPTO is Incomplete

By: Kristin Wall 

In March of 2010, the United States Court of Appeals for the Southern District of New York invalidated Myriad Genetics' patents on the BRCA1/2 genes, which predict susceptibility to breast and ovarian cancer. Prior to this decision, the USPTO and the legal system at large accepted patents relating to human genes as patentable subject matter. In opposition to this standard, the District Court found that human DNA sequences are inherently products of nature and thus fail under 35 U.S.C. - 101. 

The Court should not have stopped there, however. The Intellectual Property Clause of the U.S. Constitution creates a standard for patentability based on inventiveness. Merely pinpointing the location of a particular gene sequence based on public informa- tion, as Myriad and other companies have done, does not meet this standard. Furthermore, isolating particular gene sequences is obvious under 35 U.S.C. - 103, and as such renders all gene sequences unpatentable. 

The social and economic implications of invalidating existing gene patents and pre- venting future patenting are many; while the financial incentive afforded those holding exclusive ownership rights may decrease, free exchange of ideas and the public's ability to receive diverse services will proliferate. 

Nonobviousness Standards for Hardware and Software Before and After KSR: What is the Difference?

By: Michelle Friedman Murray 

Conventional wisdom holds that the bar for nonobviousness for software patents is higher than the bar in other technology areas. Little attention has been paid to the nonobviousness standard for hardware. Hardware and software are both considered predictable arts. Hence, to the extent that hardware and software involve a high level of skill in the art, both hardware and software should have a high bar to proving non- obviousness. It is possible that the standard for nonobviousness in software is lower because of a difference in the level of skill in the art. In the 2007 decision KSR International Co. v. Teleflex Inc., the Supreme Court overruled the Federal Circuit's nonobviousness analysis using the TSM test, finding that an explicit teaching, suggestion, or motivation to combine prior art references in the prior art was not required to obviate the obviousness of patents based on the combination of multiple prior art references. 

Before KSR, the Federal Circuit's bar for proving nonobviousness was somewhat higher for software than for hardware. However, this seemed to be partly because of the level of skill in the art for the particular inventions, not for the technology area as a whole. The level of skill was high for all of the hardware patents considered in this paper, and for many of the software patents. However, the relevant level of skill in the art was low for some software patents, which caused the bar for proving nonobvious- ness to appear higher for software patents than for hardware patents. After KSR the difference in the nonobviousness standards between hardware and software standards decreased. Based on the limited number of relevant cases since KSR, there is now no discernible difference between the nonobviousness standards for hard- ware and for software. The standard for nonobviousness in hardware patents appears to have been affected more by KSR than the standard for nonobviousness for software patents, decreasing the gap between the standards. 

The Integrity of Section 101: A "New and Useful" Test for Patentable Subject Matter

By: Daniel J. Klein 

This Article seeks to highlight the Supreme Court's discordant treatment of unpatentable subject matter and suggests that courts should no longer look outside the language of - 101 for determining the scope of subject matter patentability. For over 150 years, the Supreme Court has analyzed subject matter patentability by invoking extra-statutory categories of unpatentable subject matter. In Diamond v. Chakrabarty, the Supreme Court distilled this jurisprudence into three categories - the trilogy: laws of nature, physical phenomena, and abstract ideas. 

However, Chakrabarty did not seek to define these categories, but merely stated them as though the terms had an inherent mean- ing. The trilogy and the various categorical exclusions that came before it reduced the underlying analysis of subject matter patentability into metaphysical labels, thus perpetuating extra-statutory subject matter requirements that demand courts and patent examiners to engage in highly subjec tive interpretations of the metaphysical qualities of an invention. Moreover, courts invoking these categorical exclusions have issued sweeping decisions as to the subject matter patentability of broad classes of science and technology. A long history of courts engaging in this approach has created a non-cohesive and inconsistent body of subject matter precedent. 

As such, an unpredictable legal landscape for patentable subject matter awaits inventions yet unknown and unknowable.  This Article proposes a substantive test for patentable subject matter based on an invigoration of the language "new and useful" in 35 U.S.C. - 101. The proposed test thus restores integrity to the statute and departs from the use of extra-statutory categorical exclusions. TheArticleapplies the proposed test to seminal Supreme Court decisions in which categorical exclusions were invoked to establish proof of concept by demonstrating that a similar outcome is often reached, but without a subjective interpretation of an invention's metaphysical qualities. 

The Article focuses on the decision in Association for Molecular Pathology v. USPTO (Myriad), in which all forms of isolated DNA were held to be unpatentable subject matter, as a case study in the consequences that hold when courts seek to apply extra-statutory categorical exclusions. The Article revisits Myriad to further validate the proposed "new and useful" test by demonstrating that, had it been applied, the reasoning would be simplified and the holding appropriately limited. 

Claim Preambles: Unnecessary Matters of Chance and Confusion

By: Kirk M. Hartung 

Whether a preamble of a patent claim con- stitutes a limitation to the claim has been an issue for more than 75 years. In the past 50 years, there has been much debate regarding claim preambles, and whether terminology in the preambles limits the scope of the claims. Most recently, a 2010 decision from the Court of Appeals for the Federal Circuit recognizes that the Court has struggled to make sense of when a preamble should be construed as limiting, and that the Court has not succeeded in articulating a clear and simple rule. Justice Dyk lamented that this lack of clarity as to whether a preamble should be construed as limited has lead to inconsistent case law, which one leading treatise has said it is "difficult to reconcile."  The vague and confusing rule on pre- amble terminology has never been addressed by the U.S. Supreme Court or the Federal Circuit sitting en banc. The solution seems simple, and consistent with Supreme Court precedent from more than a century ago. As the U.S. Court of Claims declared more than 40 years ago, "The necessity for a sensible and systematic approach to claim inter- pretation is axiomatic." 

Are Intellectual Property Rights Human Rights? Patent Protection and the Right to Health

By: Mirela V. Hristova 

We live in a world in which the creation, diffusion and manipulation of information has come to define an ever increasing array of economic, political and cultural activities. The attendant expansion of the intellectual property system to new, previously unaf- fected territories has become a paramount concern on theoretical and empirical levels alike. In particular, the intellectual property system has significant consequences that affect the enjoyment of various human rights. The thesis of this paper is that, since some intellectual property rights - those which protect the personality of the creator or inventor - can be conceptualized as human rights themselves, the conflict between them and other human rights is to be evaluated under a "relative priority" or "balancing" approach. The paper further applies this theoretical framework to the conflict between the human right to health and patents on pharmaceuticals, which incentivize the development of drugs by providing pharmaceutical companies with temporary exclusivity to market them. The paper ends by emphasizing that, while the right to health is particularly compelling and has forced the developed world to acknowledge its precedence over intellectual property rights, balancing may be much more complex when human rights of less clearly established contours are implicated.


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