The opinion of the court was delivered by: MARILYN HALL PATEL
Plaintiff Chiron Corporation ("Chiron") brought this action against defendant Abbott Laboratories ("Abbott"), alleging infringement of U.S. Patent No. 5,156,949 ("'949 patent"), which pertains to an immunoassay test for the HIV virus. In its answer, Abbott alleges as two of its defenses inequitable conduct and prior invention. Now before the court are cross-motions for summary judgment on these two defenses.
Having considered the parties' arguments and submissions, and for the reasons set forth below, the court enters the following memorandum and order.
After the first documented cases of what is now commonly called Acquired Immune Deficiency Syndrome ("AIDS") occurred in the United States in 1981, researchers identified the Human Immunodeficiency Virus ("HIV") as its primary cause.
Antibody tests called "immunoassays" were developed thereafter, in order to detect the presence of antibodies to HIV in human blood and thus serve as a means of determining whether the blood is infected with the virus. This action arises out of the development and patenting of these immunoassays.
A. General Background on HIV
HIV's genetic material is RNA. Although HIV's RNA contains an entire blueprint for HIV, HIV lacks the ability to reproduce by itself. Thus, HIV must use the genetic material of a host cell (such as a human white blood cell) to reproduce itself. HIV enters the host cell, releases its RNA, and makes a DNA copy of its RNA. This DNA copy is then incorporated into and becomes part of the genetic material of the host cell, which begins to make copies of the HIV virus, spreading the infection and often killing the host cell.
When the human immune system detects the presence of HIV, it responds with HIV antibodies and defensive cells. Antibodies are unique molecules formed by the immune system in response to infection, and HIV-specific antibodies are formed as part of the immune system's defensive efforts. These antibodies bind to the HIV virus, and the presence of these antibodies in a human blood sample indicates a current or prior encounter with the HIV virus or part of the virus.
B. Development of an HIV Immunoassay
Immunoassays can be used to detect viral antibodies, and an HIV immunoassay thus can detect the presence of HIV in human blood. Detection is made possible by the reaction or binding that occurs between viral peptides and virus-specific antibodies, a process known as "immunoreactivity." The immunoassays used to detect HIV can be constructed with either natural polypeptides or recombinant polypeptides. An HIV immunoassay using natural polypeptides can be constructed by growing live, fully intact HIV in large quantities, breaking the HIV into pieces, collecting the proteins, sticking them to a surface, and then washing blood over the surface. If HIV antibodies are present in the blood, they bind to the proteins and remain attached to them when the blood is washed from the surface. To detect the HIV antibodies bound to the HIV proteins, enzymes that change color or fluorescent markers that emit light can be used to attach to the antibodies.
The problem with a natural polypeptide immunoassay is that it requires growing large amounts of live, intact HIV, which exposes workers to risk of infection and requires expensive laboratory facilities. Thus, as research began in 1984 on creating an HIV immunoassay, scientists sought to use recombinant DNA technology to make proteins and partial proteins from HIV's outer layer, called the envelope ("env"). Because scientists suspected that the env was immunoreactive, the focus in 1984 was to identify DNA fragments that encoded env polypeptides. In late Spring 1984, a number of teams were fast at work trying to develop such a test, including projects at Chiron, DuPont, and a collaborative project between the National Institutes of Health ("NIH") and Centocor ("NIH/Centocor"). All three teams attempted to create an env based recombinant DNA immunoassay.
To make an artificial env protein or polypeptide, large quantities of HIV genetic material are required. This material can be obtained by copying or cloning HIV's genetic material and making many DNA copies. As scientists decipher the genetic material, they display it on maps showing where genes are located in relation to one another in the material. In order to locate the env region of HIV, scientists from both the NIH and Chiron studied maps of other viruses that they believed would be structurally similar to HIV. Based on study of those viruses, the scientists determined that the genes for HIV's env likely would be in the right half of HIV's genetic material, and began looking for it there.
Between June 1984 and September 1984, the NIH ran sequencing reactions designed to map the nucleotide sequence of an HIV-clone called BH-8. The NIH collaborated with DuPont, Centocor, and Dana-Farber to map the nucleotide sequence of HIV DNA fragments in BH-8, as well as two other HIV clones, BH-10 and BH-5. DuPont received clone BH-10 from Dr. Flossie Wong-Staal of the NIH on or about July 6, 1984, and began generating nucleotide sequence data from BH-10 on or about July 18, 1994. By September 1, 1984, DuPont had run sequence reactions on DNA fragments that spanned what has now been determined to be the entire env region of BH-10's DNA. DuPont obtained U.S. Patent No. 4,861,707, issued in 1989 based on a February 1987 application, which states that a BglII-BamHI BH-10 DNA fragment encodes an immunoreactive polypeptide from the env region.
The NIH gave the BH-10 and BH-8 clones to Dr. Nancy Chang at Centocor on July 20, 1984, and also gave Centocor a restriction map for BH-10, BH-8, and BH-5. At some point after July 20, 1984, Dr. Chang and her colleagues started working on expressing recombinant env proteins through random and directed cloning. On or about July 26, 1984, Dr. Chang met with Dr. Scott Putney, an outside scientist who was working with Centocor on its HIV research, to plan Centocor's HIV clone research. A July 31, 1984 laboratory notebook entry by one Centocor scientist is entitled "Sequencing of SstI-HindIII fragment." This fragment -- SstI-HindIII -- is a BH-8 fragment that contains approximately 76% of the env region of BH-8. Dr. Chang drafted a statement, dated August 27, 1984, stating that Centocor had "sequenced a segment (about 3,500 base pairs long) of [HIV's DNA] encoding most of the env gene."
On October 10, 1984, Centocor filed U.S. Patent Application No. 659,339 ("'339 application"), which is still pending. The '339 application purports to set forth, inter alia, an env based recombinant MIV immunoassay, and lists the following expression vectors: "OmpA, pIN (A, B, and C), lambda pL, T7, lac, Trp, ORF and lambda gtll." It does not identify the HIV clones upon which it relies as starting material. The '339 application lists only Dr. Chang as an inventor, and lists Centocor as the assignee. It does not indicate that Dr. Chang deposited any of the HIV clones with the American Type Culture Collection ("ATCC")
on or before October 10, 1984, or refer to any ATCC deposit relating to HIV clones. On or about August 22, 1984, Dr. Wong-Staal, Dr. Robert Gallo, Dr. Beatrice Hahn, and a fourth NIH scientist deposited BH-10 and BH-8 with the ATCC, and filed U.S. Patent Application No. 643,306 ("'306 application"), purporting to set forth the process for cloning the complete HIV genome.
On August 9, 1984, Dr. Hahn and others submitted an article to the journal Nature that was published on November 8, 1984 as Molecular Cloning and Characterization of the HTLV-III Virus Associated with AIDS, 312 Nature 166 (1984). The article contains the first description in a scientific journal of BH-10, BH-8, and BH-5. On November 29, 1984, Dr. Chang, Dr. Wong-Staal and others submitted an article to the journal Nature which was published on January 24, 1985 as Complete Nucleotide Sequence of the AIDS Virus, HTLV-III, 313 Nature 277 (1985). On December 21, 1984, Dr. Chang and others submitted an article to the journal Science called Expression in Escherichia of Open Reading Frame Gene Segments of HTLV-III, which was published in April 1985. That article states that polypeptides produced from "fragments of HTLV-III DNA derived from BH-10" (numbers 127, 121 and 113) were immunoreactive. Figure 3 of the '339 application is a printout showing 3112 nucleotides from the HIV genome. Of the 3112 nucleotides there displayed, 883 fall within the env region of HIV, though the env nucleotides are not identified on the figure as such. The "Best Mode" section of the '339 application contains three separate embodiments of a recombinant HIV immunoassay. The second embodiment specifically discusses as examples the random breakage of three HIV DNA fragments -- EcoRI-EcoRI, KpnI-KpnI, and EcoRI-HindIII -- into 200-500 base pairs. The '339 application does not describe a method for obtaining HIV clones from the native virus.
On January 23, 1985, Centocor filed U.S. Patent Application No. 693,866 ("'866 application") with the PTO. The '866 application purports to set forth the complete nucleotide sequence of BH-10, BH-8, and BM-5. The '866 application lists only Dr. Chang as an inventor, and names Centocor as the assignee.
Clones 113, 121 and 127 described in the '866 application are from the env region, but not from the portion of the HIV env region for which sequence information was included in Figure 3 of the '339 application.
By October 1, 1984, Chiron had run sequence reactions on DNA fragments that spanned what has since been determined to be the entire env of HIV. On October 31, 1984, Chiron filed U.S. Patent Application No. 06/667,501, the ancestral patent application that subsequently led to the '949 patent, which was issued on October 22, 1992 to Chiron.
The '949 patent teaches that DNA fragments as short as 21 nucleotides can be used to generate immunoreactive polypeptides from HIV's env.
C. The Steimer Declaration
During the pendency of the application that later became the '949 patent, Chiron scientist Dr. Kathelyn Sue Steimer submitted a Rule 132 Declaration to the PTO, which she signed on September 14, 1990. The version of this declaration in the official PTO file does not have a mailroom stamp or other date stamp indicating when it was received at the PTO. However, the declaration was submitted with a Supplemental Response, which is date-stamped as having been received by the Board of Patent Appeals and Interferences on September 20, 1990. In her declaration, Dr. Steimer states that her expert opinion was that "the state of the art in October 1984 was at best speculative with respect to the general usefulness of recombinant antigens in immunoassays." She based this conclusion on a number of factors, including (1) Chiron's failure to develop a similar recombinant immunoassay for use with Hepatitis A virus (HAV), and (2) the fact that naturally derived HIV DNA varies greatly due to transcription error, while recombinant DNA does not, with the result that recombinant based immunoassays might not succeed in binding to actual HIV antibodies. Based on this assessment, Dr. Steimer made the critical conclusion that, "in October 1984 those of even greater than ordinary skill in the art could not have had any reasonable expectation that a HIV diagnostic using a recombinant antigen would have been as effective as the 'native' HIV diagnostic then known."
In a submission filed with the government in May 1984, Chiron stated that it "is developing vaccines to protect cats against infection by the retrovirus FeLV. We believe that these efforts will have great significance in understanding, diagnosing, and perhaps treating and preventing AIDS since some of the fundamental pathological features are shared by FeLV and the retrovirus associated with AIDS." In April 1986, Chiron filed a patent application claiming, in part, "[a] particle immunogenic against HAV infection which particle comprises a polypeptide having an amino acid sequence capable of forming a particle when said sequence is produced in a eucaryotic host, and an epitope of HAV." This patent application is for an HAV vaccine, not an HAV assay or diagnostic, and does not mention the use of recombinant HAV polypeptides in a diagnostic.
On July 2, 1990, Examiner Christine Nucker forwarded a PTO Form 850 to the Board of Patent Appeals and Interferences in Interference No. 102,432. This interference involved a potential conflict between claims in the pending Chiron patent application (Application No. 07/138,894, which ultimately issued as the '949 patent and which was the subject of the Steimer Declaration), and a patent application by Essex et al. (Application No. 07/539,370). On the Form 850, Nucker indicated that there were allowable claims in the pending application that were in potential conflict with the Essex application, necessitating an interference. Specifically, under the section entitled "The claims of this party which correspond to this count," Nucker wrote "60-81 (allowable)." These are the claims that ultimately appeared as claims 1-22 of the '949 patent as issued.
In her March 1992 Notice of Allowability for the '949 patent, Examiner Nucker listed the communications from Chiron upon which she relied and to which she was responding. Dr. Steimer's declaration is not listed as such a communication. Other than the final Notice of Allowability, there is no evidence in the record that the PTO took any action subsequent to Dr. Steimer's declaration.
The invention described in the '949 patent is an immunoassay reactive with human AIDS sera based on recombinant DNA proteins from the env region of HIV.
Under Federal Rule of Civil Procedure 56, summary judgment shall be granted:
against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial . . . since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial.
Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986). The party moving for summary judgment has the "initial responsibility of informing the district court of the basis for its motion, and identifying those portions" of the record showing the absence of a genuine issue of fact. Id. at 323. The burden then shifts to the nonmoving party to present evidence sufficient to support a verdict in its favor on every element of its claim for which it will carry the burden of proof at trial. Id. at 322-23. "If the [nonmoving party's] evidence is . . . not sufficiently probative . . . summary judgment may be granted." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986).
Where the moving party has the burden of proof on a claim or defense raised in a summary judgment motion, it must show that the undisputed facts establish every element of the claim or defense. Meyers v. Brooks Shoe Inc., 912 F.2d 1459 (Fed. Cir. 1990). When the defendant in a patent infringement case moves for summary judgment on an affirmative defense, the elements of which the defendant must prove by clear and convincing evidence, the non-moving party must simply produce enough evidence to allow a rational trier of fact to find that there is not clear and convincing evidence. As a result of this unusual posture, the non-moving party's burden to come forward with evidence to prevent summary judgment is less stringent than that normally placed on a non-moving party. Schneider (USA) Inc. v. C.R. Bard Inc., 1990 U.S. Dist. LEXIS 18962, 18 U.S.P.Q.2D (BNA) 1076, 1080 (Mass. 1990).
The court's function on a motion for summary judgment is not to make credibility determinations, Anderson, 477 U.S. at 249, and the inferences to be drawn from the facts must be viewed in a light most favorable to the party opposing the motion. T.W. Elec. Serv. v. Pacific Elec. Contractors Ass'n, 809 F.2d 626, 631 (9th Cir. 1987).
Abbott bases its inequitable conduct defense solely on Chiron's submission of the Steimer Declaration to the PTO in conjunction with Patent Application No. 07/138,894. Abbott argues that the Steimer Declaration contains material misrepresentations and omissions, and that it was intended to deceive the PTO. Specifically, Abbott contends that the declaration misrepresents the state of the art in 1984 by concluding that at that time, there could be no reasonable expectation that a recombinant DNA based immunoassay could be effective, and that it fails to mention previous work done by Chiron itself with recombinant DNA immunoassays for other viruses. Abbott also argues that it is irrelevant to the inequitable conduct defense whether the Steimer Declaration actually was received and considered by the PTO in making its allowability determination.
In response, Chiron argues first that the Steimer Declaration cannot form the basis of an inequitable conduct defense because it was submitted months after the claims had already been found allowable by the PTO. In the alternative, Chiron argues that the declaration does not contain material misrepresentations or omissions, and even if it does, there is insufficient evidence of intent.
The party asserting an inequitable conduct defense bears the burden of proving both intent and materiality by clear and convincing evidence. Braun Inc. v. Dynamics Corp. of America, 975 F.2d 815, 822 (Fed. Cir. 1992); see also Halliburton Co. v. Schlumberger Technology Corp., 925 F.2d 1435, 1443-44 (Fed. Cir. 1991). Accordingly, Abbott must prove by clear and convincing evidence that the Steimer Declaration contained material misrepresentations or omissions and that Dr. Steimer intended to deceive the PTO.
Information is material if "there is a substantial likelihood that a reasonable examiner would consider [the information] important in deciding whether to allow the application to issue as a patent." 37 C.F.R. § 1.56(a); Halliburton, 925 F.2d at 1440. A finding of materiality alone, however, is insufficient to support a finding of an intent to deceive, which is a separate element of inequitable conduct. Thus, in attempting to prove inequitable conduct, the accuser may not rely solely on the materiality of information allegedly withheld. Braun, 975 F.2d at 822. To support a finding of inequitable conduct, the "involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive." Kingsdown Medical Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 876 (Fed. Cir. 1988), cert. denied, 490 U.S. 1067, 104 L. Ed. 2d 633, 109 S. Ct. 2068 (1989). Gross negligence is not in and of itself sufficient to establish inequitable conduct; rather, deceitful intent must be shown. Halliburton, 925 F.2d at 1442-43; Kingsdown, 863 F.2d at 876; see also Hewlett-Packard Co. v. Bausch & Lomb Inc., 882 F.2d 1556, 1562 (Fed. Cir. 1989) (reckless indifference to the truth insufficient to show intent), cert. denied, 493 U.S. 1076, 107 L. Ed. 2d 1031, 110 S. Ct. 1125 (1990).
At the threshold, the court must determine whether the PTO actually considered the Steimer Declaration in deciding to grant the '949 patent. As Chiron points out, the Steimer Declaration was filed several months after Examiner Nucker made an initial determination of allowability, and other than the issuing of the final notice of allowability in March 1992, there is no direct evidence that the PTO took any action in response to (or otherwise considered) the declaration. In addition, Chiron has submitted two declarations from its putative expert stating that in his opinion, the PTO did not consider the Steimer Declaration. Goolkasian Decl. P 12; Goolkasian Supp. Decl. P 7. However, as Abbott argues, it would have been proper for the PTO to consider the declaration subsequent to the initial allowability determination, and there is circumstantial evidence that such consideration likely occurred.
Chiron is correct that Nucker made at least an initial finding of allowability of the claims in the '949 patent no later than July 2, 1990, when she forwarded the Form 850 to the Board of Patent Appeals and Interferences ("BPAI") based on claims 60-81 in the pending application.
Chiron also is correct that, pursuant to PTO rules, before Nucker could have sent the Form 850 to the BPAI, she first had to determine that the claims listed therein were otherwise patentable to Chiron. See Manual of Patent Examining Procedure ("MPEP") §§ 2305, 2306, 2307.02 (5th ed. 1994); see also 37 C.F.R. § 1.606 ("Before an interference is declared between an application and an unexpired patent, an examiner must determine that there is interfering subject matter claimed in the application and the patent which is patentable to the applicant subject to a judgment in the interference.").
However, this initial determination is not necessarily final, see MPEP at § 2341; 37 C.F.R. § 1.641, and the examiner-in-chief had the power to consider the Steimer Declaration as part of a sua sponte patentability analysis before making a final allowability determination, 35 U.S.C. § 135. Furthermore, there is evidence in the record, albeit circumstantial, that the PTO may actually have considered the Steimer Declaration subsequent to the filing of the Form 850. Specifically, the following circumstantial evidence is relevant to Abbott's allegation. On July 19, 1989, Examiner Nucker notified Chiron that she had rejected some of the claims in the application on the basis of obviousness. In direct response to that notice, Claims 60-81 were added by Chiron on January 19, 1990. Subsequently, on February 14, 1990, the PTO held an interview with a Chiron representative, at which Examiner Nucker was present. The report of that interview states that all claims were discussed, and that agreement was not reached on the issues discussed. The report sets forth two issues that apparently were discussed, one of which was: "diff. between lysate and recombinant assay (heterogeneity from innoculate (diff. isolates) mutations in culture) due to hypervariation regions -- recombinant homogenous antigen."
In late September 1990, Chiron filed its Supplemental Response with the PTO, which included the Steimer Declaration, an amendment of inventorship, and a supplemental list of references. The submission purported to be in further response to Nucker's July 19, 1989 action, though it also referenced the February 1990 interview.
In her declaration, Dr. Steimer directly addressed the problem cited in the report of the February 1990 interview referenced above -- the difference between a lysate (native) produced and a recombinant produced assay due to the heterogeneity of the native antigen (resulting from natural variations in the amino acid sequence) and the necessarily homogeneous nature of the recombinantly produced antigen. Steimer Decl. P 8. Thus, it appears that the Steimer Declaration responded to questions raised by Nucker in the February 1990 interview that had, subsequent to the interview, not been answered any other way.
It is clear that on interference, the BPAI may consider patentability and may recommend rejection of a claim even if it is not involved in the interference. 37 C.F.R. §§ 1.655, 1.659; MPEP §§ 2314, 2355, 2359. The examiner-in-chief, who is responsible for declaring the interference, and the BPAI, have the entire application file. 37 C.F.R. § 1.609; MPEP § 2311. Furthermore, until the interference is declared the examiner continues to have jurisdiction over the pending application. 37 C.F.R. § 1.614(C); MPEP § 2314. In this case the interference was declared on or shortly before September 28, 1990. Until that time, Examiner Nucker (or another examiner) continued to have jurisdiction.
The Initial Memorandum so heavily relied upon by Chiron's expert bears the handwritten legend at the top: "Ready for Declaration - MLC Caroff - (9/28/90)" and the number "102432", which is the case number for this interference. Goolkasian Decl. Ex. 2. This legend is not explained on the document or by the parties. It may relate to the Notice of Declaration required by 37 C.F.R. § 1.611 and MPEP § 2311. In any event, Chiron's supplemental response, which included the Steimer Declaration, is stamped "Received" by the BPAI on September 21, 1990, seven days before Examiner-in-Chief Caroff declared the interference pursuant to section 1.610 of the regulations and MPEP § 2311. At any of these stages, the examiner, the examiner-in-chief, and the BPAI would have had the Steimer Declaration and likely would have considered it since it specifically addressed issues that remained outstanding.
The BPAI's ruling in favor of Chiron's claims came down on September 27, 1991, and the formal notice of allowability on claims 60-81 went out on March 20, 1992. In that notice, Examiner Nucker stated as her reason for allowability that:
applicants were the first to realize the importance of utilizing recombinantly produced HIV envelope proteins as antigen standards in immunoassays for anti-HIV antibodies. By generating the envelope proteins recombinantly it is possible to control for the high rate of mutation seen in these proteins when produced by virally infected cells. This control ...