Supreme Court Rules That Isolated Genes Are Unpatentable Products Of Nature

by Perkins Coie
Contact

On June 13, 2013, the Supreme Court issued its highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc.  The Court unanimously held that isolated genomic DNA is a product of nature and therefore is not patent-eligible under 35 U.S.C. §101.  The Court also held that complementary DNA (cDNA) molecules excluding “intron” portions of the natural DNA sequence are patent eligible.  The Court’s brief opinion raises a number of potential concerns for patents in the biotechnology and pharmaceutical area.

The case arose from a challenge by the Association for Molecular Pathology (AMP) to three patents assigned to Myriad Genetics, Inc.  All three patents contained claims to isolated DNA molecules defined either by nucleotide sequence or by the amino acid sequence of the encoded polypeptide.  Claims 1 and 2 of US Patent No. 5,747,282 are illustrative:

  1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
  2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

The Court began with a basic introduction to molecular biology and proceeded to describe the subject matter of the patents at issue:

Myriad discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. …  That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer.

After describing the claims at issue in the three patents, the Court stated that:

Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.

The Court went on to describe the Federal Circuit’s opinion, where a split panel held that both genomic DNA and cDNA were patent eligible: 

The central dispute among the panel members was whether the act of isolating DNA—separating a specific gene or sequence of nucleotides from the rest of the chromosome—is an inventive act that entitles the individual who first isolates it to a patent.  Each of the judges on the panel had a different view on that question.

In particular, the Court noted that Judge Lourie viewed the claimed DNA molecules as chemical compositions and found that the isolated genes were non-naturally occurring molecules, whereas Judge Moore, though concurring in the result, did not think that this was sufficient to make the genes patent-eligible.  Judge Bryson dissented from the panel’s holding, stating that “[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken.”

Proceeding to analyze Myriad’s claims, the Court stated:

It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.  The location and order of the nucleotides existed in nature before Myriad found them.

The opinion then contrasted the Myriad claims to those in Diamond v. Chakrabarty, where the Supreme Court ruled that a collection of modified bacteria was eligible for patent protection, concluding that:

In this case, by contrast, Myriad did not create anything.  To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

The opinion recognized the huge amount of work that Myriad had to undertake to find the BRCA1 and BRCA2 genes and show that they were associated with cancer susceptibility, but stated that “extensive effort alone is insufficient to satisfy the demands of §101.”

The next part of the opinion rejected Myriad’s argument that the claims fell outside the product-of-nature exception to Section 101 because isolating DNA from the human genome severs chemical bonds and thus creates a non-naturally occurring molecule.   According to the Court:

Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.  Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.

In so holding, the Court emphasized that “[Myriad’s] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.”  This analysis may surprise biochemists because the conventional scientific view is that a nucleotide sequence is a representation of a particular chemical structure.

The Court also dismissed Myriad’s arguments that the USPTO’s longstanding practice of granting patents on isolated gene sequences entitles it to deference.  In particular, the Court thought that the Justice Department’s decision to side with AMP undercut any claim of deference to the USPTO’s expertise.

On the other hand, the Court held that Myriad’s cDNA claims were patent-eligible under Section 101 because they covered a synthetic molecule consisting only of exons and omitting intron sequences found in the genomic DNA.  According to the Court, such cDNA is not a product of nature because removing the intron sequences creates something new even though the order of the exons is dictated by nature.

The concluding section of the Court’s decision took pains to limit the scope of the holding, noting that the decision focused on claims to isolated DNA itself and did not address patents on “applications of knowledge about the BRCA1 and BRCA2 genes” (presumably including methods of diagnosis and the like).  The Court also stated that it had not addressed the patent-eligibility of nucleotides in which the sequence was altered from a sequence found in nature. 

Implications of the Decision

First, despite the Court’s sweeping pronouncement, the practical import of the decision may be limited or nonexistent for many patent holders.  That is because many patents that contain isolated DNA molecule claims also contain other types of claims that are not affected by this Myriad decision.  For example, Myriad’s '282 patent contained numerous claims to transformed host cells, single-stranded DNA primers having the nucleotide sequence of the BRCA1 gene, and kits for detecting BRCA1 gene mutations.  None of these claims were challenged in the case. 

Nevertheless, and although the Court made some effort to limit the scope of its decision, the logic of the opinion raises issues regarding matters that previously were regarded as well settled in patent law.  Moreover, the decision calls into serious question the validity of a large number of patent claims and will require patent holders to decide whether action can or should be taken to try to strengthen the validity of those patents, for example, through reissue applications.

One immediate concern will be the impact of the Court’s decision on truncated gene segments, such as probe molecules, where the sequence of the molecule is identical to that found in the intact gene.  Indeed, the USPTO’s patentability guidelines issued in response to the Supreme Court's decision require examiners to reject any claim that is drawn merely to a truncated gene segment:

As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.

June 13, 2013 Memorandum to the Patent Examining Corps from Andrew H. Hirshfeld, Deputy Commissioner for Patent Examination Policy (underlining in original).

Another concern is the Court’s apparent belief that DNA molecules are primarily carriers of genetic information, rather than chemical compounds as they are conventionally viewed.  Although the Court’s statements may be limited to nucleic acid molecules, others may question the propriety of treating other classes of molecules differently from nucleic acid molecules.

Finally, the conventional view has long been that isolated molecules are patent eligible provided that they are claimed in a way that distinguishes them from the form found in nature.  For example, many patented antibiotics have been isolated from bacteria without altering the chemical structure of the molecule itself.  In those cases, patentability was founded on the proposition that the molecule did not exist in an isolated and purified form in nature.  The same was true for patents on purified peptides and proteins.  The validity of this view may be challenged in the future based on the analysis and holding in Myriad.

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.

© Perkins Coie | Attorney Advertising

Written by:

Perkins Coie
Contact
more
less

Perkins Coie 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.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

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.

Security

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.