United States Asks Supreme Court to Affirm on cDNA, Reverse on Isolated, Unmodified DNA

by McDonnell Boehnen Hulbert & Berghoff LLP

Department of Justice (DOJ) SealIn an amicus brief filed last month in Association for Molecular Pathology v. Myriad Genetics, Inc., the United States asks the Supreme Court to affirm the judgment of the Federal Circuit that cDNA is patent-eligible and reverse the judgment of the appellate court that isolated but otherwise unmodified DNA is patent-eligible.  The government argues that:

Synthesized genetic materials such as cDNA are patent-eligible subject matter because they do not occur in nature but instead are the product of significant human creativity.  By contrast, isolated but otherwise unmodified DNA is not patent-eligible.  The public's ability to study and use native DNA would be unduly compromised if changes caused by the extraction of naturally-occurring substances from their native environments were sufficient to trigger patent-eligibility.  And while the process of isolating DNA entails physical changes, those changes do not significantly alter the structure or function of the relevant DNA segments.

The government explains that "[c]reating cDNA requires significant manipulation and alteration of naturally occurring genetic materials rather than simply the extraction of those materials from their native environment," adding that "[i]ssuing patents on cDNA creates no risk of preempting other uses of the raw materials from which cDNA is created."  However, the brief argues that "isolated but otherwise unmodified genomic DNA" molecules -- like DNA molecules claimed in Myriad's patents -- are not patent eligible because "[t]he process of isolation does not transform those molecules into human-made inventions."  Thus, "[i]solated DNA . . . is not patent-eligible because it has merely been "isolated" -- i.e., extracted from its cellular environment and separated from extraneous material -- rather than significantly altered by human intervention."

To prevent claims to isolated DNA from preempting the use of the underlying native DNA, the government contends that "the mere act of culling a natural product from its environment to exploit its preexisting natural qualities -- however useful those qualities may be -- should be treated as insufficient to create patent-eligible subject matter."  In explaining the government's change in position on DNA molecules -- before the district court, the government had noted that "the USPTO's position" on whether "DNA molecules" are patent-eligible "remains as set forth in its utility guidelines" -- the brief states that:

The district court's judgment in this case, however, prompted the United States to reevaluate whether such patents are consistent with the settled principle that patent protection does not extend to products of nature.  Based on that review, the United States concluded that, although the PTO has properly issued patents on cDNA and other synthesized genetic materials, isolated DNA is not patent-eligible subject matter.

In reassessing its position, the government looked to the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  Although Mayo concerned process claims rather than composition claims, the government argues that the decision "provides useful guidance for determining whether particular modifications to a naturally occurring substance are sufficient to render the modified substance patent-eligible."  And while "[n]ot every nuance of Mayo's process-claim analysis applies directly to patents directed to compositions of matter," the brief argues that "the law-of-nature and product-of-nature exceptions to Section 101 do, however, reflect the same basic principle:  a person should not receive a patent for simply discovering the existence and useful properties of something that already exists in nature."

In contrast with isolated but otherwise unmodified genomic DNA, the government argues for the patent-eligibility of cDNA molecules.  In particular, the government states that:

With exceptions not relevant here (such as retroviruses that use cDNA-like structures to replicate themselves), cDNA molecules generally do not occur in nature, either in isolation or as contiguous sequences contained within longer natural molecules.   . . .  To create cDNA, a scientist therefore does not simply remove existing cDNA from its natural environment.

According to the government, "cDNA is thus analogous to the genetically modified bacterium in Chakrabarty."  Countering the petitioners' argument that cDNAs are not patent-eligible because they contain the same protein-coding information as DNA in the body, the government notes that:

[T]he properties of any product originally derived from nature, including the bacterium in Chakrabarty, can be traced to the operation of natural principles.  While the coding properties of cDNA molecules' exons are determined by nature, those properties operate within a molecule (a DNA strand with the regulatory and intron regions spliced out) that does not exist in nature and that has increased utility relative to naturally occurring genetic materials or isolated but unmodified DNA.  The fact that a cDNA incorporates nucleotide sequences whose significance is derived from nature therefore does not mean that the molecule as a whole is a product of nature.

As for Myriad's composition claims, the brief points out that "[a]bsent the 'isolated' limitation, claim 1 of the '282 patent, for example, would encompass the native BRCA1 gene in the human body, which 'cod(es) for a BRCA1 polypeptide'," and that "[i]n their pre-isolation form -- i.e., as a portion of a larger native gene within a cell -- the BRCA sequences clearly are products of nature."

In addressing Myriad's reliance on early lower-court decisions upholding patents on natural compounds that have been so refined and purified through human intervention as to become a substance different "in kind" from the natural product, the government explains that:

Those decisions indicate that certain purification processes -- i.e., processes that involve human manipulation of a substance that has been removed in impure form from its natural environment -- may sometimes result in an altered substance that has structural features and⁄or operative properties that render the product markedly different from the impure substance that occurs in nature.  For instance, cDNA could be thought of as a "purified" gene, as it incorporates into a single contiguous, synthetic molecule only the coding regions of the naturally occurring gene.  But isolated DNA reflects no such transformation.  [Rather], isolated DNA has simply been removed from its natural environment within the human body, with minor structural changes that have no effect on its intrinsic properties . . . .  To label the process of removing DNA from a cell "purification," and to hold the culled DNA segments patent-eligible on that ground, would "make patent eligibility depend simply on the draftsman's art," without reference to the nature and extent of the underlying transformation, or the consequences for the public's ability to use the underlying substance.

In response to the argument that Congress' failure to amend U.S. patent law to prohibit the patenting of isolated DNA implies congressional approval of such patents, the government argues that "[i]n these circumstances, Congress's failure to enact legislation abrogating the PTO's practice of issuing isolated DNA patents does not give rise to any inference of congressional endorsement of the PTO's interpretation."  The brief notes that "although bills relating to patents on genetic materials have occasionally been introduced in Congress, there is little 'evidence that Congress considered . . . the precise issue presented before the Court.'"  In particular, the government explains that "[b]ecause 'Congress takes no governmental action except by legislation,' and bills can be proposed and rejected for any number of reasons, none of these bills raises any inference that Congress approved the PTO's practice of granting patents on isolated DNA."

As for the "concern that invalidating patents on isolated DNA would unduly disturb the 'settled expectations' of biotechnology patent holders and investors," the government notes that "[a] patentee's legitimate expectations . . . are always tempered by the possibility that a court could subsequently disagree with the PTO and hold that the patent is invalid under Section 101 or other provisions of the Patent Act."  Finally, with respect to the argument that isolated DNA should remain patent-eligible in order to encourage biotech innovation, the government acknowledges that "[t]he prospect of patent protection for isolated genomic DNA has undoubtedly encouraged valuable discoveries," but counters that "[a]s between the reliance interests of patent holders whose research efforts may have been prompted in part by the PTO'ss patenting standards, and the public interest in avoiding undue restrictions imposed by patents that effectively preempt natural laws and substances, the interest of the public has consistently been given precedence."

Patent Docs plans to review a number of the briefs filed in this case, including the briefs on the merits filed by the petitioners and the respondents, as well as several of the amicus briefs that were filed.  According to the docket for this case on the Supreme Court website, amicus briefs have been filed by the Juhasz Law Firm, P.C., the American Medical Association et al., GeneDx and Law Professors, the National Women's Health Network et al., Federation Internationale Des Conseils En Propriete Intellectuelle, CLS Bank International, the United States, the International Center for Technology Assessment et al., Genformatic LLC, Academics in Law, Medicine, Health Policy and Clinical Genetics, James D. Watson, Ph.D., Fifteen Law Professors, Sigram Schindler Beteiligungsgesellschaft mbH, the AARP, Kali N. Murray and Erika R. George, the Institute of Professional Representatives Before the European Patent Office (EPI), the Ethics & Religious Liberty Commission of the Southern Baptist Convention and Prof. D. Brian Scarnecchia, Eric S. Lander, the American Intellectual Property Law Association, the Canavan Foundation et al., Professor Eileen M. Kane, Knowledge Ecology International, and InVitae Corporation.

On Monday, the Supreme Court set argument for this case for April 15, 2013.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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