Rubin v. the Gen. Hosp. Corp.
| Decision Date | 28 April 2011 |
| Docket Number | Civil Action No. 09-10040-DJC |
| Parties | DR. BERISH RUBIN and DR. SYLVIA L. ANDERSON, Plaintiffs, v. THE GENERAL HOSPITAL CORPORATION, Defendant. |
| Court | U.S. District Court — District of Massachusetts |
Plaintiffs Drs. Berish Y. Rubin and Sylvia L. Anderson ("Drs. Rubin and Anderson" or "Plaintiffs") brought this action against The General Hospital Corporation ("MGH" or "Defendant") to correct inventorship of two patents under 35 U.S.C. § 256 and invalidate those patents under 35 U.S.C. 102(f). Defendant moves for summary judgment with respect to the two remaining counts of the complaint on the grounds that the Plaintiffs, who did not engage in any collaborative efforts with the named inventors of the two patents, cannot obtain relief under section 256. For the reasons set forth below, the Court agrees with the Defendant and its motion for summary judgment is GRANTED.
The following facts are undisputed unless otherwise noted. The invention claimed in the two patents relate to the discovery of two genetic mutations that are associated with Familial Dysautonomia ("FD"). (Compl. ¶¶ 10).1 FD, also known as Riley-Day Syndrome, is an autosomal recessive disorder characterized by developmental arrest in the sensory and autonomic nervous systems and primarily affects the Ashkenazi (Eastern European) Jewish population. (Pl. Opp. Ex. 16, MGH-P000009067). Individuals with FD are affected with a variety of symptoms including decreased sensitivity to pain and temperature, cardiovascular instability, recurrent pneumonias, vomiting crises, and gastrointestinal dysfunction. (Pl. Opp. Ex. 16, MGH-P000009067). No cure exists for FD; approximately one-half of those afflicted die by age thirty. (Def. Memo at 2). Identifying the mutations enables prenatal diagnosis of FD which allows for detection of potential carriers who are at risk for having a child afflicted with the disease. (Def. Memo at 2; Pl. Opp. Ex. 53, RA 00406). Knowledge of the gene associated with FD would also facilitate the development of effective therapeutic approaches for individuals with FD. (Pl. Opp. Ex. 53, RA 00406).
The two patents involved in this case are U.S. Patent Nos. 7,388,093 ("the '093 patent") and No. 7,407,756 ("the '756 patent"). Both patents concern inventions relating to the discovery of two genetic mutations associated with FD, referred to as the major mutation and the minor mutation, respectively:
1. '093 Patent
This patent, entitled, "Gene For Identifying Individuals with Familial Dysautonomia," is directed to "[a] kit for assaying for the presence of a mutation associated with Familial Dysautonomia in an individual comprising primers 18F (SEQ ID NO:82) and 23R (SEQ ID NO:84) that are capable of amplifying a region of IKBKAP of sufficient size to detect a FD1 [major] mutation at position 34,201 of SEQ ID NO:1 or a FD2 [minor] mutation at position 33,714 of SEQ ID NO:1, wherein said region amplified comprises a FD1 [major] mutation at position 34,201 of SEQ ID NO:1 or a FD2 [minor] mutation at position 33,714 of SEQ ID NO:1." (Compl. Ex. A ['093 patent, Claim 1]). The remaining claims of the '093 patent also concern the major and minor mutations associated with FD. (Compl. Ex. A ['093 patent, Claims 2-10]).
2. '756 Patent
This patent, entitled, "Methods for Detecting Mutations Associated With Familial Dysautonomia," is directed to "[a] method for assaying for the presence of a mutation associated with Familial Dysautonomia in a human subject, said method comprising detecting the presence of a FD1 [major] mutation wherein the thymine nucleotide at position 34,201 of SEQ ID NO:1 is replaced by a cytosine nucleotide, or a FD2 [minor] mutation wherein the guanine nucleotide at position 33,714 of SEQ ID NO:1 is replaced by a cytosine nucleotide in DNA or RNA from a biological sample from said human." (Compl. Ex. B ['756 patent, Claim 1]). The remaining claims of the '756 patent also concern the major and minor mutations associated with FD. (Compl. Ex. B ['756 patent, Claims 2-8]).
MGH was responsible for the preparation of the '093 and '756 patents before the United States Patent and Trademark Office ("USPTO"). (Compl. ¶ 4). Two MGH employees, Dr. James F. Gusella and Dr. Susan A. Slaugenhaupt ("the MGH scientists"), are the named inventors of the '093 and '756 patents (Compl. ¶¶ 2, 16) and MGH is the record assignee of both patents. (Compl. ¶ 7).
Plaintiffs Drs. Rubin and Anderson are principal investigators in the FD field. (Compl.} 6). At some point in 2000, they claim they discovered that two mutations in the gene encoding a protein called IkB kinase complex-associated protein (IKAP) were responsible for FD and prepared an article entitled, "Familial Dysautonmia Is Caused By Mutations Of the IKAP Gene" (the "article") for publication. (Compl. ¶ 13).
The Plaintiffs and the MGH scientists have never worked together on FD research. There is no suggestion in the record that the Plaintiffs conferred, cooperated, interacted or even consulted with the named inventors. The only connection to the MGH scientists that Plaintiffs rely upon are: the fact that they were aware of the MGH scientists' research on the subject matter; that they considered aspects of the MGH scientists' published work in their own research along with other publications; and that Dr. Gusella reviewed the abstract of Dr. Rubin's article and used it to build upon his own research. (Pl. Opp. at 7-8). On December 20, 2000, Dr. Rubin wrote to Dr. Stephen Warren, the editor of the American Journal of Human Genetics ("Journal"), and attached a manuscript of the article for review and publication, identifying four individuals whom he believed to be qualified to review the manuscript and identifying Drs. Slaugenhaupt and Gusella at MGH as individuals who should not review it. (Compl. ¶ 17; Pl. Opp. Ex. 73). Drs. Rubin and Andersonalready knew that the MGH scientists were working in the FD field at the time. (Compl. ¶ 16). Drs. Rubin and Anderson submitted the article for publication to the Journal on December 21, 2000 and the article was published on January 22, 2001. (Compl. ¶ 13). The article described and identified the major and minor mutations and the region of the IKAP gene where the FD mutations are found. (Compl. ¶¶ 14-15).
On December 22, 2000, Dr. Gusella became aware of an abstract of the article written by the Plaintiffs that had arrived in his office from the Journal for review and acknowledged that upon seeing it, he believed the Plaintiffs had "identified the two mutations that [MGH scientists] had discovered several months earlier and were reported in the paper that we were prepared to submit." (Def. Memo Ex. 21, Gusella Tr. 24:17-24).
Shortly thereafter, on January 6, 2001, Drs. Slaugenhaupt and Gusella filed a patent application claiming inventorship of the'756 and '053 patents (U.S. Serial No. 60/260/080). (Compl. ¶ 16). Drs. Rubin and Anderson allege that Dr. Gusella and his colleagues read the abstract and used the information, then publicly unknown, in the patent application without the knowledge or consent of Dr. Rubin or Dr. Anderson. (Compl. ¶¶ 20-25).2 At that time, Drs. Rubin and Anderson had filed no patent application and only had a draft patent application dated December 19, 2000. (Pl. Resp. to Def. Statement of Facts ¶ 5). Drs. Rubin and Anderson subsequently filed their own provisional patent application (U.S. Serial No. 60/260, 080) on January 17, 2001. ThePTO issued the MGH scientists the '093 patent on June 17, 2008 and the '756 patent on August 5, 2008. (Compl., Exs. A, B).
On January 12, 2009, Drs. Rubin and Anderson filed the instant complaint against MGH, seeking complete substitution of inventors pursuant to 35 U.S.C. § 256 (Count I), to be added as co-inventors also under 35 U.S.C. § 256 (Count II) and to invalidate the two patents under 35 U.S.C. § 102(f) (Count III). (Docket #1). On November 22, 2010, the Court (Saris, J.) adopted Magistrate Judge Robert Collings' report and recommendation and dismissed Count III as duplicative of the other counts.
MGH has now moved for summary judgment on the remaining two counts under Fed. R. Civ. P. 56. This matter was transferred to this session on January 27, 2011 and the Court heard oral argument on March 15, 2011. Because a suit for the correction of inventorship of an issued patent arises under 35 U.S.C. § 256 and hence the patent laws, the Court has jurisdiction under 28 U.S.C. § 1338(a).
Summary judgment is appropriate if there is no genuine dispute as to any material fact and the undisputed facts show that the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). "An issue is genuine if the evidence of record permits a rational factfinder to resolve it in favor of either party." Borges ex. rel. S.M.B.W. v. Serrano-Isern, 605 F.3d 1, 4 (1st Cir. 2010) (internal quotation marks and citations omitted). "A fact is material if its existence or nonexistence has the potential to change the outcome of the suit." Id. at 5. The moving party bears the burden of showing the district court the basis forits motion and identifying where there exists a lack of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).
"Once the moving party has accomplished this feat, the burden shifts to the nonmoving party, who must, with respect to each issue on which she would bear the burden of proof at trial, to demonstrate that a trier of fact could reasonably resolve that issue in the her favor." Borges, 605 F.3d at 5 (citing Celotex, 477 U.S. at 324). "If the nonmovant fails to make this showing, then summary judgment is appropriate." Id. The Court must view the facts in the light most favorable to the non-moving party, drawing all...
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