By Donald Zuhn —
In an amicus brief filed last Friday with the Federal Circuit in Association of Molecular Pathology v. U.S. Patent and Trademark Office, the Intellectual Property Owners Association (IPO) sets forth the organization's views regarding "two issues of vital importance to the proper functioning of the patent system." In response to the first issue of how immediate and substantial a controversy must be in order to create declaratory jurisdiction standing sufficient to challenge the validity of a patent, the IPO contends that an actual controversy of sufficient immediacy and reality is required, that such controversy was not present in the instant case, and therefore that the plaintiffs lacked standing in the instant case to bring a declaratory judgment action for invalidity. With respect to the second issue of whether isolated DNA qualifies as patentable subject matter under 35 U.S.C. § 101, the IPO asserts that it does. (For the sake of full disclosure, it should be noted that the IPO amicus brief was co-authored by Patent Docs author Kevin Noonan.)
On the issue of standing, the IPO begins by citing Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1339 (Fed. Cir. 2008), for the proposition that "a case or controversy must be based on a real and immediate injury or threat of future injury that is caused by the [patentee]." The brief next compares the facts in Association of Molecular Pathology with those in Prasco and SanDisk Corp. v. STMicroelectronics, Inc., 480 F.3d 1372 (Fed. Cir. 2007), noting that:
In contrast to the patentee in SanDisk, Myriad has not taken any affirmative action toward the plaintiffs that would create an actual controversy of sufficient immediacy and reality to warrant declaratory judgment jurisdiction. Like the plaintiffs in Prasco, there is no evidence that Myriad either (i) had any plans to assert its patents against any of the plaintiffs or (ii) had any knowledge that any of the plaintiffs were even considering engaging in any type of infringing activity with respect to the claims at issue.
Addressing cease-and-desist letters sent by Myriad to two of the plaintiffs (Dr. Ostrer and Dr. Kazazian) on May 21, 1998; May 29, 1998; and August 26, 1998, the IPO argues that "these decade-old letters should not be considered to be sufficiently immediate to show a justiciable controversy, particularly when there is no evidence that Myriad has taken any other actions against these two plaintiffs in at least 10 years." As for the researcher, non-researcher, and organization plaintiffs, the IPO concludes that each group "expressed at most a vague and unsubstantiated notion of being ready to engage in some undefined conduct that may or may not infringe Myriad’s patents at some undetermined time in the future."
The brief contends that the District Court's decision expands declaratory judgment jurisdiction such that "literally anyone might ask any federal court to invalidate any claim of any unexpired patent." Under the District Court's approach to declaratory judgment jurisdiction:
[A]ny corporation, association or individual might attack almost any patent as a form of protest or to seek leverage against the patentholder. Indeed, the present case appears to be just such a form of social protest against the principle of gene patents, based on nothing more than an unsubstantiated intent or desire to be free of the commercial constraint of well-established patent rights.
On the issue of the patent-eligibility of isolated DNA, the IPO notes that in Diamond v. Chakrabarty, 447 U.S. 303 (1980), "[t]he [Supreme] Court fashioned a straightforward test of whether a manufacture or composition of matter was patent-eligible: it must demonstrate the hand of man, something that is 'a product of human ingenuity ‘having a distinctive name, character [and] use.'" Describing the process by which DNA is "ioslated," the brief explains that:
In isolating the claimed DNA, an inventor typically identifies a cell that expresses a gene, obtains the mRNA from the cell and enzymatically converts it into DNA before it can be isolated. The enzymatic conversion is performed by a viral enzyme called reverse transcriptase that is absent from cells that have not been infected by a virus that produces the enzyme. Significantly, DNA copies of mRNAs encoding isolated human DNA do not exist without human intervention, i.e., prior to their synthesis by a researcher.
In view of this process, the IPO contends that claims to isolated human DNA satisfy the Chakrabarty requirement that patent-eligible subject matter show the hand of man.
The IPO argues that the District Court's decision, which concerns human DNA, "applies with equal force to isolated DNA from other organisms," and warns that "[b]anning patenting of isolated DNA from all known organisms would have widespread and deleterious effects on human health, nutrition, and progress." The IPO also notes that patents on isolated human DNA support the development of biologics, and that "[i]f the district court’s decision that patents on isolated human DNA are directed to patent-ineligible 'natural products,' then biologics perforce would be patent-ineligible as well." The brief also outlines how the District Court's decision, if affirmed, would adversely impact the personalized medicine industry by removing patents needed to promote investment and development. Finally, the brief contends that "[a]bsent patent protection [for isolated human DNA and patents on diagnostic uses of genetic information], and under the circumstances of multigenic causation (or at least association) of common diseases, the impetus will be to develop and protect this nascent technology using, inter alia, trade secret protection." The brief concludes that:
If the standard for patentable subject matter applied by the District Court were adopted, it could render broad categories of important inventions patent-ineligible, including most biologic drugs, antibodies, antibiotics, hormones, metabolites, proteins, and genetically-modified organisms and food. This in turn would have a devastating effect on the viability of large portions of the biotechnology, pharmaceutical and other industries, industries that are built upon the availability of valid and enforceable patent protection for the fruits of their costly and risky research efforts.
Briefing Update: Patent Docs has learned of three additional amicus briefs that were filed by last Friday's deadline:
• American Intellectual Property Law Association (AIPLA), in support of reversal, but in support of neither party (brief)
• Christopher M. Holman and Robert Cook-Deegan, in support of neither party (brief)
• Rosetta Genomics, Ltd., Rosetta Genetics, Inc., and George Mason University, in support of Defendants-Appellants, supporting reversal (brief)
We thank our readers for bringing these additional briefs to our attention and note that we are interested in securing copies of any other amicus briefs that may be filed in this appeal.
For additional information regarding this and other related topics, please see:
• "AMP v. USPTO — Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
Patent Docs 
Leave a comment