United States: A Cautionary Tale For Patent Applicants

When should a patent application be filed? Should it be filed prior to submission of a manuscript or abstract for peer-review or just prior to publication? In highly competitive technologies, it is prudent to file as soon as possible or run the risk of losing potential patent rights to a competitor. While such was good business practice prior to adoption of the first-to-file provisions of the America Invents Act ("AIA"), it is now imperative to file as soon as possible.

Familial Dysautonomia Caused by Mutations of the IKAP Gene

Familial Dysautonomia (FD) (also known as Riley-Day Syndrome) is an autosomal disorder that affects the development and survival of sensor and sympathetic neurons. FD causes cardiovascular instability, gastrointestinal dysfunction, recurrent pneumonia, vomiting crises, and decreased sensitivity to pain and temperature. There is no reported cure for the disease. Thus, in the 1990s, several groups of investigators sought to understand the genetic basis of the disease to the end of developing the diagnostics and aiding in the development of therapeutic approaches.

Dr. Berish Y. Rubin and Dr. Sylvia L. Anderson identified two genetic mutations causative of FD. On December 20, 2000, they submitted a manuscript describing the mutations to the Editor of the American Journal of Human Genetics ("Journal") for publication. At the time of submission, Dr. Rubin wrote to the Editor of the Journal and identified scientists whom Drs. Rubin and Anderson believed to be qualified to peer-review the article. Dr. Gusella was identified as a possible expert. However, Dr. Gusella was identified as a competitor and for that reason, the Editor was advised not to send the manuscript to him. Nevertheless, the Editor sent the manuscript to Dr. Gusella for review. Dr. Gusella declined to review it.

On December 28, 2000, a manuscript authored by Dr. Gusella and his colleagues was sent to the same Editor for publication. Both articles were published in the January 22, 2001 edition of the Journal.

Both parties filed patent applications describing the FD mutations and claiming their diagnostic use. Dr. Gusella and his co-inventors filed an application on January 6, 2001. Dr. Gusella's patent application was assigned to The Massachusetts General Hospital ("MGH"). Eleven days later on January 17th, Drs. Rubin, Anderson and their co-inventor filed an application on the same subject matter. Although the U.S. Patent Office encouraged Drs. Rubin and Anderson to initiate an interference to determine priority of invention, no such steps were taken.

Correction of Inventorship Requires Collaboration

Drs. Rubin and Anderson filed suit against MGH in the United States District Court for the District of Massachusetts requesting their addition as co-inventors to the Gusella patent filing under 35 U.S.C. Section 256 (correction of inventorship), or alternatively, to invalidate the patents under 35 U.S.C. Section 102(f). The district court granted summary judgment in favor of Dr. Gusella and MGH on the ground that remedy under Section 256 is not available. The district court reasoned that Drs. Rubin and Anderson could not be added as co-inventors because the two groups of researchers did not collaborate. Drs. Rubin and Anderson appealed to the Federal Circuit. In a nonprecedential opinion, the Federal Circuit agreed with the district court that the issue between the parties is one of priority of invention and therefore should be resolved with an interference procedure in the U.S. Patent and Trademark Office (Rubin v. The General Hospital Corp) .

Analysis Under the AIA

This case is interesting because it highlights a key change to the patenting process under the AIA as compared to the old patent statute. The AIA amended Section 102 of the Patent Act and eliminated interference proceedings. New Section 102 recites in part:

"Conditions for patentability; novelty

(a) Novelty; Prior Art- A person shall be entitled to a patent unless–

(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or

(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

(b) Exceptions-

(1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION- A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if–

(A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

(B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.

(2) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS- A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if–

(A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor;

(B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or ...."

Under the AIA, the first inventor or joint inventors to file an application on an invention will be awarded the patent (provided the other provisions of patentability are met). Thus, the Gusella January 6, 2001 application would be prior art to the Rubin and Anderson January 17, 2001 application under 35 U.S.C. Section 102(A). Thus, if the competing applications had been filed on or after the March 16, 2013 effective date of the first-to-file provisions of the AIA, Drs. Rubin and Anderson would be unable to challenge the MGH patent on the ground they were the first to invent the technology. A derivation proceeding to remove the MGH application as prior art could be pursued under the AIA pursuant to Section 102(B)(2) provided Drs. Rubin and Anderson could establish that Dr. Gusella obtained the subject matter of his application from a review of the Rubin and Anderson manuscript. However, based on the facts of the issue as described in the Federal Circuit's opinion, Dr. Gusella did not review the Rubin and Anderson manuscript and therefore did not his derive his application from it.

Thus, Rubin v. The General Hospital Corporation should remind patent applicants to file patent applications as soon as possible.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions