IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics

by McDonnell Boehnen Hulbert & Berghoff LLP

IPO #2In an amicus brief filed last week in support of respondents Myriad Genetics, Inc. et al., the Intellectual Property Owners Association (IPO) asked the Supreme Court to affirm the Federal Circuit's decision in Association for Molecular Pathology v. Myriad Genetics, Inc. that claims to isolated human DNA are patent-eligible.  The IPO brief opens by noting that "[w]hile Petitioners and their amici provocatively refer to the subject matter at issue in this case as 'human gene patenting,' this term inaccurately characterizes the claims in Myriad's patent," and that "what is claimed is a specific sequence of isolated human DNA."

The IPO argues first that isolated human DNA constitutes patent-eligible subject matter.  Citing Diamond v. Chakrabarty, the brief reminds the Court that it "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.''"  The IPO argues that "[t]he Court's Chakrabarty test is the proper standard for patent-eligibility, not the imposition of bright line, categorical rules applying broad, categorical prohibitions such as that advanced by Plaintiffs and their amici," and thus, "[a]nything that evinces the 'hand of man' is patent-eligible" (emphasis in brief).

MyriadAccording to the IPO, isolated human DNA satisfies the requirement in Chakrabarty that claimed subject matter show "the hand of man," and therefore is patent-eligible.  With respect to the characteristic of being "isolated," the brief notes that "the entire genetic complement (or genome) in the cell comprises about six billion nucleotides of DNA," and that "[a]n individual gene typically comprises about 1,000 of these nucleotides."  The brief points out that "to isolate a gene requires these specific 1,000 nucleotides to be separated from the remaining (approximately) 5,999,999,000 nucleotides in the cellular genome."

The IPO next addresses the impact of other Supreme Court decisions on the Myriad case, arguing that no other precedent controverts Chakrabarty.  Noting that the Court recently addressed the issue of patent eligibility in Mayo Collaborative Services v. Prometheus Labs., Inc., the brief states that the Court's concerns about the scope of patent eligibility "arise when the claims produce no more than information (inform a relevant audience about certain laws of nature)."  Citing the Court's decisions in O'Reilly v. Morse, Gottschalk v. Benson, Parker v. Flook, and Bilski v. Kappos, the brief contends that "[i]n each of these decisions, the Court found a lack of patentable subject matter because the claimed method provided little (or nothing) more than abstract information as opposed to concrete inventions that 'promote the Progress of . . . the useful Arts.'"  Contrasting these cases with Myriad, the brief states that:

Unlike the method claims in Mayo, Benson, Flook and Bilski, Myriad's composition of matter claims at issue here are not broadly preemptive. They are both specific and concrete and as such do not implicate the policy concerns enunciated by this Court in those cases where preemption rendered claims patient-ineligible.  Rather than being directed to mere information, the claims at issue are drawn to a useful and concrete composition of matter that falls within the statutory classes of patentable subject matter defined by Congress in Section 101 of the patent statute.  Since Myriad's claimed inventions "evince the hand of man," they are directed to patentable subject matter per Chakrabarty.

Turning to Petitioners' argument that isolated human DNA is patent ineligible because it constitutes a product of nature, the IPO counters that "[t]his contention is incorrect as a matter of law and as a matter of fact."  The brief explains that:

The claimed isolated human BCRA1 and BCRA2 DNA are not "products of nature" because, as claimed, they are not found in nature.  These isolated human DNAs are never found "isolated" in nature.  First, they are not merely associated with contaminants (like the "intracellular material" contaminating cellulose in the Wood Paper Patent Cases); they are intrinsically (and covalently) attached to and are a part of the physical and chemical structure of the chromosomal DNA, and their isolation requires them to be separated from this DNA, i.e., to be present in an entirely new chemical structure.  . . .  [I]n other (cDNA) embodiments the claimed isolated human DNA is also not merely "isolated" but chemically changed in the process, first by the cell in making mRNA, and again by the inventor in converting the mRNA into cDNA.  Thus, the claimed subject matter is different, physically and chemically, from the DNA present in nature.

The brief continues by arguing that:

[Another] line of reasoning, enunciated by the Court in Funk Brothers and recited with approval in Chakrabarty and more recently in Mayo, is that claims cannot encompass a "natural law" or "phenomenon of nature."  Myriad's claims to isolated human DNA do neither.  These claims recite man-made manufactures or compositions of matter, not phenomena.  They are tangible, physical compounds, having particular and specific structures capable of being elucidated and described.  They do not foreclose anything other than making, using, selling, offering to sell, or importing these specific and particular chemical compounds.

The IPO also takes the Petitioners to task for "wrongly equat[ing]" the patenting of isolated human DNA with the patenting genetic information.  While acknowledging that "[t]here is no dispute that genetic information, standing alone, is not patentable subject matter and does not belong to one of the statutory categories required for patent-eligibility," the IPO argues that "[p]atent claims to isolated DNA only cover the isolated DNA itself, and not the genetic information per se."  The brief also argues that:

The dichotomy between patent-eligible isolated human DNA and patent-ineligible genetic information is consistent with precedent.  For example, in O'Reilly v. Morse, 56 U.S. 62, 63 (1853), the ability to use electricity for communication was found to be patent-ineligible, but the specific telegraph invented by Morse was determined to be patent-eligible.  Algorithms per se have also been held to be patent-ineligible, Parker v. Flook, 437 U.S. 584, 585 (1978); Gottschalk v. Benson, 409 U.S. 63, 64 (1972), while the use of an algorithm (an equation) in a patented process has been found to be patent-eligible, Diamond v. Diehr, 450 U.S. 175, 177 (1981).

The brief next discusses the adverse impact that a ban on isolated human DNA patenting would have on the development of biologic drugs and personalized medicine.  The brief also suggests that "[a]bsent patent protection, 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 predicts that "[u]nder these circumstances, innovation in genetic-based diagnostics would be severely limited, since there would be no incentive (indeed, there would be strong disincentives) to disclose the genetic basis of the diagnostic assay," and that as a result, genetic information "as a trade secret, could be kept out of the public domain indefinitely."

The brief concludes by arguing that isolated human DNA patenting does not impede research.  In support of this conclusion, the brief cites a study performed by the American Association for the Advancement of Science on the effects of isolated human DNA patenting on basic research in the U.S., Germany, the U.K, and Japan, the study finding that "intellectual property rights had little negative impact on the practice of science."  Suggesting that "[p]erhaps the best measure of [research] activity is the number of research reports in public databases that reflect ongoing basic scientific research in peer-reviewed scientific journals," the brief notes that "[w]hile reported estimates differ depending on the search term used, a simple search of 'brca1 or brca2' resulted in 10,652 publications [in the scientific literature]."  The brief then adds that:

If [Myriad's] patents had a chilling effect on basic research, the expectation would be that the number of scientific research reports would have declined in the face of these patents.  On the contrary, the number of such publications has steadily increased each year, which is precisely what would be expected if these patents had no significant effect on basic scientific research.

What these patents do, of course, is prevent commercial activity -- using the patented isolated human DNA or performing the patented methods for profit.  This is a legitimate exercise of the patent grant.


Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.