Rubin v. General Hospital Corp. (Fed. Cir. 2013)

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On March 28, the Federal Circuit in Rubin v. General Hospital Corp. affirmed judgment by the District Court for the District of Massachusetts dismissing the suit brought by Drs. Berish Rubin and Sylvia Anderson against The General Hospital Corporation requesting correction of U.S. Patent Nos. 7,388,093 and 7,407,756, which are assigned to General Hospital.  The '093 and '756 patents are directed to genetic mutations that cause the inherited disease Familial Dysautonomia (FD), also known as Riley-Day Syndrome, and methods for detecting FD.

Massachusetts General HospitalDrs. Rubin and Anderson at the Department of Biological Sciences of Fordham University, and Drs. Slaugenhaupt and Gusella at Massachusetts General Hospital, had been independently conducting research to determine the genetic mutations disclosed in the '093 and '756 patents.  Drs. Rubin and Anderson identified two mutations in the gene encoding IkB kinase complex-associated protein that cause FD, and on December 20, 2000, submitted a paper describing these mutations to the American Journal of Human Genetics.  When submitting the paper, Dr. Rubin asked the Editor of the journal to not send the paper to Dr. Gusella and his colleagues at Mass General for peer-review.  On December 22, 2000, the Editor sent the abstract for the paper to Dr. Gusella.  Dr. Gusella declined to review the full paper, and on December 28, 2000, Drs. Gusella and Slaugenhaupt submitted their own paper identifying the same two mutations to the same journal (as of October 2000, Dr. Gusella had noted that his group had identified 184 candidate mutations, and as of December 12, 2000, further noted that the responsible mutations had not yet been identified).  Both papers were published in the January 22, 2001 issue of the journal.

On January 6, 2001, Drs. Gusella and Slaugenhaupt filed a provisional application describing the two mutations and claiming their diagnostic use.  On January 17, 2001, Drs. Rubin and Anderson filed their own provisional application describing the two mutations and claiming their diagnostic use.  The application filed by Drs. Gusella and Slaugenhaupt eventually resulted in the issuance of the '093 and '756 patents.  During prosecution of their application, Drs. Rubin and Anderson decided not to initiate an interference in the U.S. Patent and Trademark Office, despite the examiner's suggestion that they do so.

Rather than initiate an interference, Drs. Rubin and Anderson filed suit against Mass General seeking correction of inventorship of the '093 and '756 patents under 35 U.S.C. § 256.  They argued that Dr. Gusella's receipt of their abstract permitted Dr. Gusella's group to select and confirm the identity of the FD mutations and file their provisional patent application, and Drs. Rubin and Anderson asked to be substituted as the inventors of the '093 and '756 patents, or added as joint inventors.  Granting Mas General's motion for summary judgment, the District Court held that the inventorship could not be changed under § 256 because there was no "collaboration" between the two teams of scientists, and that Drs. Rubin and Anderson could not be added as joint inventors because they did not meet the requirements of § 116 for joint invention.  With respect to the correction of inventorship, the District Court also held that the complete substitution of inventorship is not a matter for § 256, but rather, is a claim for priority of invention of the subject matter, and priority should be resolved in an interference, not under § 256.

On appeal, the Federal Circuit determined that "the district court correctly ruled that the independent relationship between these teams of scientists, and the nature of this communication of information, do not support joint invention in accordance with §116, or warrant change or substitution of inventorship under §256."  The panel added that:

We agree with the district court that, whatever actions were taken after the Rubin/Anderson Abstract appeared uninvited on Dr. Gusella's desk, ultimately the dispute is of priority of invention; that is, which team was the first to conclusively identify the operative mutations.  The district court recognized that even if Drs. Gusella and Slaugenhaupt had completed this identification before they saw the Rubin/Anderson identification, it would still be necessary to determine priority of invention in order to resolve the patent rights.

The panel, therefore, concluded that the District Court acted within its authority in directing the parties to the USPTO to determine priority of invention, and affirmed the District Court's judgment of dismissal.

Rubin v. General Hospital Corp. (Fed. Cir. 2013)
Nonprecedential disposition
Panel: Circuit Judges Newman and Bryson and District Judge Fogel
Opinion by Circuit Judge Newman

 

Topics:  Biotechnology, Human Genes, Inventors, Patents

Published In: Civil Procedure Updates, General Business Updates, Health Updates, Intellectual Property Updates, Science, Computers & Technology Updates

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.

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