Salient Lessons For Australian Applicants Of US Diagnostic Patent Applications

by FPA Patent Attorneys
Contact

In the latest decision concerning diagnostic method claims a US Court1 has provided some guidance to the diagnostics industry on the interpretation of the recent Supreme Court decisions in Mayo v Prometheus2 (Mayo) and AMP v. Myriad3 (Myriad). In applying the test from Mayo, the Court invalidated a patent on the basis that the claimed subject matter was not patent eligible. To confirm its decision, the Court then asked whether the particular method claims in question would pre-empt all future use of the natural phenomenon to which the claims relate. All future uses were found to be pre-empted as there was no practical and commercially viable alternative methods to those claimed.

The facts

Sequenom is the exclusive licensee of US patent no. 6,258,540 (’540) that issued to Isis Innovation Limited. The ‘540 patent was based on the discovery in the mid 1990’s that cell-free fetal DNA (cffDNA) could be detected in maternal serum or plasma samples and describes methods of non-invasive detection of cffDNA in maternal serum or plasma samples to determine the presence of a paternally inherited nucleic acid of fetal origin.

A representative claim of the patent in issue is as follows:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:
amplifying a paternally inherited nucleic acid from the serum or plasma sample; and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

Applying the Mayo patent eligibility test

The Court assessed each claim to consider whether each would meet the requirements set forth in Mayo as follows:

1. Is the claim a method / process claim (i.e. a claim with a series of steps)?;

2. Does the claim recite a patent ineligible concept (i.e. law of nature, mental process, natural phenomenon, abstract idea) that is a limiting feature of the claim?; and

3. Does the claim include additional elements or steps that are sufficient to ensure that the claim amounts to significantly more that the ineligible concept itself?

The Court held that the claims recited a natural phenomenon which is the presence of paternally inherited cffDNA in maternal plasma or serum. Therefore, the central issue was whether the claim included additional elements or steps that would be sufficient to ensure that the claim amounts to significantly more than the ineligible concept itself. The Court referred to the Mayo decision and re-iterated that a process claim would fail this step if the other elements were “nothing more than well-understood, routine, conventional activity previously engaged by researchers in the field”. Inventive or innovative use of the relevant phenomenon would be required.

The Court held that the amplifying and detecting steps were well-known and routine activity and pointed to statements in the specification that the preparation of serum or plasma from the maternal blood sample can be carried out by “standard techniques” and that “standard” nucleic acid amplification can be used. The Court also pointed to comments made during prosecution by the inventors that any well-known techniques for detection of DNA could be used to detect fetal DNA in maternal serum or plasma. A similar issue arose in PerkinElmer, Inc. v Intema Limited4 a discussion of which can be found at Protection of diagnostic inventions in the USA - implications of PerkinElmer, Inc. v Intema Limited.

Pre-empting all future uses

The Court then considered whether the claims in the ‘540 patent pre-empted all other uses of cffDNA, i.e. whether the claims would cover all future uses of cffDNA.

In response Sequenom provided articles that allegedly evidenced that alternative methods of using cffDNA existed. However, the Court held that the alternative methods were not commercially viable and therefore they were not evidence that all future uses of cffDNA would not be stopped by the patent. Supporting this conclusion, the Court noted that the evidence provided by Sequenom of alternative methods was from articles published well after the date of invention and the date the patent issued.

Lessons for Australian applicants

The interpretation of Mayo and Myriad in this latest decision appears to suggest the following:
a.  A claimed invention is not necessarily patent eligible because it relates to a use of a natural phenomenon;
b.  To be a patent eligible use of a natural phenomenon it must be an inventive or innovative use;
c.  An inventive or innovative use of a natural phenomenon will not arise from applying known technology / activity to the discovery of the natural phenomenon;
d.  It is critical that the use of the natural phenomenon does not pre-empt all future practical uses of natural phenomenon;
e.  Practical uses are commercially viable uses; and
f.  Claims cover the only commercially viable way of applying a natural phenomenon carry a higher risk of ineligibility for pre-emption.

1. Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 3:11-cv-06391-SI (N.D. Cal. Oct. 30, 2013)
2. Mayo Collaborative Services v Prometheus Labs., Inc. 132 S. Ct. 1289 (2012)
3. Association  for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)
4. PerkinElmer, Inc. v. Intema Ltd., Appeal no. 2011-1577, (Fed. Cir. 2012)

 

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.

© FPA Patent Attorneys | Attorney Advertising

Written by:

FPA Patent Attorneys
Contact
more
less

FPA Patent Attorneys 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.
Feedback? Tell us what you think of the new jdsupra.com!