Post-Myriad Strategies for Claiming Biotech Inventions in the United States

by Akerman LLP
Contact

The United States Supreme Court recently ruled that genes or other naturally-occurring pieces of DNA are patent ineligible subject matter in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. No. 12-398, slip op. (U.S. June 13, 2013), hereinafter Myriad. (View opinion here).

The Court in Myriad stated: "We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring." Slip op. at 1. Complementary DNA (cDNA) contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids, which appear in proteins. Only some DNA nucleotides code for amino acids. These nucleotides are known as “exons.” Nucleotides that do not code for amino acids, in contrast, are known as “introns.”  cDNA is thus an "exons-only" molecule. Slip. op. at 2, 3, 16.

According to the Court, cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments, since its creation results in an exons-only molecule, which is not naturally occurring and when introns are removed, something new is "unquestionably" created. Id. at 16–17. On this basis, the Court concludes that cDNA is not a “product of nature,” and therefore patent eligible under 35 U.S.C § 101, which provides that:
 

Whoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 
 

Id. at 17, 10. 

Comments on the decision have ranged from calling it a victory to a disaster, and everything in between, often forecasting dire consequences both for proponents and opponents of so-called "gene patents." In order to better assess future strategies, however, it is important to apply the holding to the patent claims at issue, such as claims 1, 2, 5, and 6 of U.S. Patent No. 5,747,282 ("the '282 patent"), identified as representative of the claims at issue in Myriad

Claim 1 of the '282 patent claims "an isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2." 

Since this claim is directed to a naturally occurring DNA sequence, it is invalid under Myriad. At least this much seems clear, since the Court explained that "Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together." Slip op. at 1; 14. 

Claim 5 of the '282 patent is a dependent claim that claims "an isolated DNA having at least 15 nucleotides of the DNA of claim 1." This claim also encompasses isolated naturally occurring DNA, and is therefore similarly invalid in view of Myriad

Claim 2 of the '282 patent is a dependent claim that claims "the isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1."

SEQ ID NO:1 is a cDNA molecule as noted by the Court. Claim 2 recites an isolated full-length cDNA sequence, which, according to Myriad, is non-naturally occurring and therefore patentable. Claim 2 appears to be a valid claim.

Moving on to claim 6 of the '282 patent, this is a dependent claim that claims "an isolated DNA having at least 15 nucleotides of the DNA of claim 2." This claim encompasses isolated fragments of non-naturally occurring cDNA, which appear to be patentable; however, claim 6 is written broadly enough to also encompass isolated fragments of naturally occurring DNA. As the Court noted, "very short series of DNA may have no intervening introns to remove when creating cDNA... [A] short strand of cDNA may be indistinguishable from natural DNA." Slip op. at 17. Claim 6, therefore, arguably may be invalid in view of Myriad, since a fragment of an "unquestionably" synthetic molecule may not be distinguishable from naturally occurring DNA.

As claim 6 of the '282 patent demonstrates, what may have initially appeared to be a straightforward distinction between the "synthetic" and the "natural" is anything but. Considering that the test for patent-eligibility has been considered by the Court to be a "threshhold" test," having such a gray area as to cDNA fragments may pose a challenge to patent practitioners drafting claims which are both broad enough to protect an invention, yet distinguishable from naturally occurring DNA.

The Court itself offered little guidance on how to apply the distinction. 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." Id. at 14. Myriad's "claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule." Id. at 15 (emphasis in original). The opinion concludes: "[w]e merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material." Id. at 18 (emphasis added). Assessing the informational content of DNA-related claims will likely blur the line which the Court has tried to draw because even the Court's own description of cDNA recognized that it contains "the same protein-coding information found in a segment of natural DNA." Slip op. at 1 (emphasis added).

In addition, the Court specifically expressed no opinion on yet another potentially inventive aspect of DNA, namely, "the patentability of DNA in which the order of the naturally occurring nucleotides has been altered." Slip op. at 18. 

In view of the above, U.S. Patent applicants wishing to obtain claims to DNA and other nucleic acids should take care not to define the DNA solely in terms of its information content, and likewise adopt other strategies to show that the claimed subject matter is "synthetic," such as in a recombinant form, and is not-naturally occurring. One such strategy gleaned from the opinion would involve expressing the molecule more in terms of chemical composition and describing the chemical differences between the isolated molecule as compared to its natural counterpart.

Given that this ruling, which related to DNA, will likely be applied to other (macro)molecules which are naturally-occurring in any organism, similar strategies will apply for patentees wishing to obtain claims to proteins, carbohydrates or lipids, for example. The informational content aspect of the court's reasoning may not be of any relevance for these molecules, however, since they do not encode information in the same way as DNA. 

The success of any of these strategies is speculative, at best. As many commenters have noted, the full implications of Myriad case will likely take years to resolve. 


 

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.

© Akerman LLP | Attorney Advertising

Written by:

Akerman LLP
Contact
more
less

Akerman 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):
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.