A Cautionary Tale for Patent Applicants

02 April 2013 Personalized Medicine Bulletin Blog

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.

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