VII. The French/American Dispute: First Phase
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A. Scientific Events Leading to the Dispute
1. Scientific Papers: HIV is Not an "HTLV":
August 1985 marked the beginning of the French/American dispute. Several events earlier in 1985 heightened tensions even before the confrontation in August. First was the publication in January/February 1985 of several scientific papers, including publication of the complete nucleotide sequences of LAI/LAV, LAI/IIIb, and a third early HIV isolate, ARV. One major revelation in these papers, a revelation in direct opposition to the prior theorizing of Gallo et al., was that the AIDS virus had little or no relationship to HTLV-I and/or the HTLV family of retroviruses.
A paper on the morphology of "HTLV-III" actually included Gallo and his associate, Dr. Flossie Wong-Staal, among the coauthors. Published in January 1985, the paper made clear that the AIDS virus was far more likely to be a member of the lentivirus (visna) family of retroviruses than a member of the oncovirus or "HTLV" families. First author of the paper was Dr. Matthew Gonda, the expert electron microscopist at the Frederick Cancer Research Facility who performed the majority of the most significant EM work for the LTCB in late-1983/1984. From the outset of his work for the LTCB on putative AIDS virus samples, beginning with LAV, Dr. Gonda identified the virus as a "lentivirus," clearly distinguishable from the HTLV family. Notably, Gallo et al. did not report Dr. Gonda's classification in their seminal papers.
The January 1985 Gonda et al. paper contained these very significant observations:
"HTLV-III ... is morphologically distinct from HTLV-I and II and type C viruses ... Morphologically, HTLV-III resembles visna and equine infectious anemia viruses, both members of the lentivirus family, more closely than HTLV-I or -II or type C viruses ...
"On the basis of their morphology, the viruses now classified as Lentivirinae are indistinguishable from HTLV-III. There are also other features that the lentiviruses have in common with HTLV-III, such as their cytopathic ... effects in vitro and their ability to produce persistent debilitating diseases in vivo. In contrast, HTLV-I and -II cause T-cell malignancies, immortalizing the infected cell" (Gonda et al., Science, 227, 1985, pp. 174 - 176).
The Gonda et al. paper made clear that the lentivirus classification of the AIDS virus was no mere academic issue, but an issue with important implications for understanding the very nature of HIV. Speaking of previously-identified members of the lentivirus family, Gonda et al. made these important, prophetic observations:
"... by a process called 'antigenic drift,' these viruses mutate rapidly in the env gene, thus allowing variants to escape the immune system and induce a new cycle of disease ... Isolates of HTLV-III also show heterogeneity in the env gene region ... This further similarity between HTLV-III and lentiviruses indicates that development of a vaccine to prevent AIDS may prove to be a considerable challenge (op cit., pp. 176 - 177).
Gonda et al. summarized the principal findings of their paper as follows:
"... a greater extent of nucleotide sequence homology exists between HTLV-III and visna virus than between HTLV-III and any of the other viruses ... The data provide strong evidence for a close taxonomic and thus evolutionary relation between HTLV-III and the Lentivirinae subfamily (op cit., p. 173).
Publication of the Gonda et al. paper occurred only over the strong opposition of Dr. Gallo. Dr. Gonda told OSI about the impassioned telephone call he received from Dr. Gallo and how he (Gonda) dealt with it:
"You know, I am at home. The guy is calling me from Japan or Germany or wherever it is, and he was very upset because I submitted a paper to him proving it was a lentivirus ...
"... he yelled and screamed and I sat there and listened to the first 15 minutes of his argument and I said, now you have to listen to mine ...
"I said ... something looks like a duck, I don't care if its feathers are black and white. It looks like a duck. It is still a duck. I am not going to call it something different" (8/13/90 OSI interview; transcript pp. 86 - 89).
Dr. Gonda spoke about his understanding of the origins of Dr. Gallo's angst:
"I think what they are saying, and I know that I have heard that the patent hinged on something being HTLV-related or something like that ... if it wasn't an HTLV then he had nothing" (op cit., pp. 99 - 102).
Dr. Gonda was so concerned about Dr. Gallo's telephone call that he reported it to the General Manager of the Frederick facility; according to Dr. Gonda, eventually even NCI Director Dr. Vincent DeVita was drawn into the controversy. Dr. Gonda and his boss, Dr. Raymond Gilden, seized on the clever expedient of a proposed schema for classification of the viruses that, due to an ingeniously-drawn border, placated Dr. Gallo without doing significant damage to the truth. Concerning the paper, Drs. Gonda and Gilden, for the most part, stood by their ground, although they did agree to remove from the paper several passages that Dr. Gallo deemed offensive. The paper was published, but the difficulties Dr. Gonda encountered illustrate vividly the fervor with which -- even at this late date -- Dr. Gallo continued to pursue HIV/HTLV linkages.
As for the sequence papers, the papers other than those by Gallo et al. also made clear how different the AIDS virus was from the known human retroviruses, the "HTLVs." Thus, the paper by Wain-Hobson et al., from the Institut Pasteur, reporting the sequence of LAI/LAV, concluded this:
"These data place LAV apart from the previously characterized family of human T-cell leukemia/lymphoma viruses" (Wain-Hobson et al., Cell, 40, p. 9).
A parallel paper by Dr. Jay Levy and his associates, reporting the sequence of the HIV isolate "ARV-2," reported that:
"... ARV-2 was as closely related to murine and avian retroviruses as it was to human T-cell leukemia viruses (HTLV-I and HTLV-II)" (Sanchez-Pescador et al., Science, 227, p. 485).
Most telling of all, a paper reporting the sequence of LAI/IIIb by an independent research team, comprising scientists from the CDC as well as from the private biotechnology firm, Genentech, reported this:
"Our results establish that LAV/HTLV-III has no nucleotide homology with previously characterized animal and human retroviruses ... (Muesing et al., Nature, 313, p. 450)
and this:
"... the HTLV-III genome seems to be entirely unrelated by nucleotide homology to previously characterized retroviral sequences, ... including HTLV-I and HLTV-II ..." (op cit., p. 456).
Muesing et al. noted that their data were "inconsistent" with the LTCB reports by Arya et al. (August 1984) and Hahn et al. (November 1984) of an HTLV-III/HTLV-I homology.
Muesing et al. added that:
"These results and the observation that the virus is morphologically distinct from the type C viruses ... lead us to propose that LAV/HTLV-III is a member of a novel class of retroviruses, perhaps including the equine infectious anaemia virus, which has a similar morphology and a serologically-related major core protein" (op cit., p. 457).
Dr. Gallo later said it was the sequence data that finally convinced him how different the AIDS virus was from HTLV-I and II. A July 1985 letter from Dr. Gallo to LeMonde's Claudine Escoffier-Lambiotte said this:
"... since the nucleic acid sequence data has become known, it is clearly much more different than we or the Pasteur group knew or even suspected before ... we all recognize now that they (LAV/HTLV-III) are only distantly related to HTLV-I or HTLV-II ..." (7/1/85 Gallo-to-Escoffier-Lambiotte letter; p. 3).
But in the January 1985 LTCB paper reporting the "HTLV-III" sequence, there was no such admission. Indeed, there were repeated references to similarities and linkages among HTLV-I, -II, and -III (Ratner et al., Nature, 313, 1985, pp. 277-284).
One immediate result of the demonstrated absence of HIV/"HTLV" homology was an important news article that appeared in the scientific media, an article dealing with what it correctly termed Dr. Gallo's "misclassification" of the AIDS virus. The article, published in the February 7, 1985 issue of New Scientist, was written by reporter Omar Sattaur.
Sattaur's article asserted that the publication of the sequences of LAV and HTLV-III proved that Gallo "has misclassified the virus that causes AIDS." Furthermore, said Sattaur, not only had this misclassification deprived the IP scientists of rightful recognition for their discovery of the AIDS virus, much more serious consequences were involved:
"While large sums of research time and money are spent on trying to understand how the AIDS virus fits into the HTLV group, thousands continue to die from AIDS" (O. Sattaur, "How Gallo Got Credit for AIDS Discovery," New Scientist, 2/7/85; p. 3).
Sattaur's story noted the IP team's long-standing belief that the AIDS virus might belong to the lentivirus group. The article quoted the chairman of the AIDS Working Group of the British Medical Research Council saying this:
"'HTLV-I and LAV have similarities in that they are both retroviruses that attack T-cells. But their genes are very distinct and they therefore cannot be closely related. Experience of taxonomy shows that it is wrong to rush to name a virus when you've got only partial information'" (op cit., p. 4).
The New Scientist article also dealt with the scientific, political, and financial implications of the obvious functional identity of the IP and LTCB prototype viruses. In this regard, Sattaur quoted IP scientist, Dr. Simon Wain-Hobson:
"'The viruses LAV and HTLV-III are so close that it proves that Montagnier was right and that he was the first to discover it'" (op cit., p. 3).
Sattaur described the patent and financial implications of the functional identity of the viruses:
"Deciding who has priority on the discovery of the virus is important for reasons other than to glorify the discoverers. The total U.S. market for diagnostic kits alone, to screen blood for the presence of the AIDS virus, is estimated at $80 million. Who receives the money from patent rights obviously depends on who first patented the procedure for isolating the AIDS virus" (op cit., p. 3).
Whether or not one accepts the proposition that "who first patented the procedure for isolating the AIDS virus" would determine "who receives the money from patent rights," the fact is that by the time of the Sattaur story, the IP patent application was no secret. As early as July 1984, the journal Nature reported that the IP (and its commercial ally, Genetic Systems, Inc. [GS]),
"... claims patent priority for the venture over the test developed by Dr. Robert Gallo ... The basis for the GS claim is that the Institut Pasteur in Paris filed for world-wide patent rights ... in September 1983 ..." (310, 1984, p. 174).
Dr. Gallo was quoted as saying that the LTCB test "can identify AIDS patients with 100 per cent efficiency," presumably based on the idiosyncratic study of Safai et al. Referring to the IP scientists and their GS affiliates, Dr. Gallo said,
"... 'they're only in it for the money'" (op cit.).
The scientific media were not the only ones who noted the patent/financial implications of the LAV/IIIb identity. The February 28, 1985 issue of The Financial Times carried a story by Paris reporter David Marsh, headlined, "French Evaluate AIDS Test as Patent Row Continues." Marsh's story described "a unique trans-Atlantic battle over patent rights which has not yet been resolved" (The Financial Times, 2/28/85; p. 8). The story also noted the different names Montagnier and Gallo had given their prototype AIDS virus isolates, adding this:
"Publication almost simultaneously in January this year by the French and Americans of the genetic structure of the two viruses ... showed them to be virtually identical" (op cit., p. 8).
The Financial Times story noted that the LAV/IIIb sequences also showed that the AIDS virus "... shows some significant differences from the earlier-discovered HTLV-I and -II viruses discovered by Dr. Gallo"; the story further noted that the AIDS virus, unlike HTLV-I and -II, "kills T-cells which control the body's immune response, whereas HTLV-I and -II make them multiply in an uncontrolled manner" (op cit., p. 8).
And the story added this:
"These two pieces of evidence, throwing doubt on whether the AIDS virus really forms part of the HTLV group, seem to clinch the Pasteur team's claim to paternity of the virus discovery. Much more than scientific prestige is at stake. Patent rights on the soon-to-be-marketed diagnostic tests -- as well as on an eventual vaccine for the disease -- will be worth a fortune both to the research institute and to the individual scientists who can prove they were first in the AIDS field" (emphasis added; op cit., p.8).
Omar Sattaur's February 1985 article evoked an outcry among Dr. Gallo's colleagues, who wrote a long letter to New Scientist, the theme of which was that:
"Dr. Gallo and his colleagues never reported close relatedness of HTLV-III to HTLV-I or to HTLV-II."
Presumably, the author of this letter, Dr. Dani Bolognesi, a close Gallo associate, never saw the Gallo et al. blood test patent, which contains the affirmation that:
"The biological properties of HTLV-III and immunological analysis of its proteins show that this virus is a member of the HTLV family and closely related to HTLV-II" (emphasis added).
Sattaur's story was but one of many in early 1985 that questioned the "HTLV-relatedness" claims of Gallo et al. concerning the AIDS virus. The name "HTLV-III" itself soon was called into question; and in March 1985, the International Committee on Taxonomy of Viruses commissioned a special subcommittee, under the leadership of now-NIH Director, Dr. Harold Varmus, to make an authoritative determination about the correct name for the AIDS virus. Dr. Gallo, who was determined to keep the AIDS virus in "his" "HTLV" family, immediately initiated an exchange of correspondence with Dr. Varmus about the nomenclature issue; Dr. Gallo's theme, propounded at extraordinary length and with great ardor, was that,
"'HTLV-III' is a fair, accurate, and safe term to use" (4/8/85 Gallo-to-Varmus letter).
Dr. Gallo's pleas were unavailing. In 1986, the subcommittee announced that "human immunodeficiency virus" ("HIV") would henceforth be the official name of the virus. Dr. Gallo refused to accept the new name, and because of the ongoing French/American dispute, not to mention their own awe of Gallo, HHS attorneys once again became involved in an issue that should have been resolved by scientific consensus.
On May 6, 1986, PHS attorney Richard Riseberg sent to attorney Darrel Grinstead an "Eyes Only" memorandum headed "HIV Designation." Riseberg told Grinstead about the international committee's decision to adopt the name "HIV." Riseberg said that,
"In view of the prestige of the subcommittee the new designation is likely to be adopted rapidly by the research community, although ... Bob Gallo and Max Essex opposed the change."
Riseberg said he expected that questions would soon arise within PHS concerning,
"... what effort, if any, PHS should make to resist the change and to what extent PHS should persist in using the traditional terminology in its own publications."
Riseberg told Grinstead he (Riseberg) believed the shift in terminology would not have any important, predictable effect on the ongoing litigation. Accordingly,
"... to the extent the new reference becomes widely accepted, there would be no legal objection to PHS switching as well."
However, Riseberg added this:
"In light of Dr. Gallo's opposition, I doubt that PHS would take the lead in adopting HIV."
2. Scientific Papers: Too Alike to be Different:
The other major revelation associated with the early-1985 publication of the sequences of the first HIV isolates was the confirmation of what had been observed earlier, based on comparisons of viral nucleic acids, namely that: (1) HIV isolates overall are markedly heterogeneous in their genetic make-up, yet (2) in contrast to other HIV isolates, LAI/LAV and LAI/"IIIb" were virtually identical.
Dr. Gallo and his associates attempted to deal with the obvious implications of the sequence identities of LAI/LAV and LAI/IIIb by, among other things, submitting the Ratner et al. letter to Nature. But the Ratner letter's indication, without substantiation, that the very close relationship of LAV and IIIb fell within the normal range for HIV isolates, plus the equally unsubstantiated argument that these isolates were so much alike because "the individuals from whom these isolates were derived acquired the virus at a similar time and place" -- these efforts did not head off the growing awareness on the part of alert scientists that "LAV" and "IIIb" were too much alike to be different.
One such scientist was NIAID laboratory chief, Dr. Malcolm Martin. As early as November 1984, Dr. Martin had concluded not only that the IP and LTCB prototype viruses were almost certainly identical, but that the LTCB virus was descended from the IP virus, and not the other way around. Dr. Martin's November 1984 conclusions were based in part on his discovery of the existence in LAI/LAV of a Hind III polymorph identical to that found by Gallo et al. in LAI/IIIb. In a November 23, 1984 memorandum to the record, Dr. Martin wrote this:
"... I learned from presentations by both the Pasteur and Gallo groups that a restriction polymorphism of the LAV/HTLV-III [IIIb] proviral DNA exists; at least two species of viral DNA are present in infected cells. This clears up an enigma we had encountered during the week of November 11, 1984 when we were analyzing the viral DNA present in infected A3.01 cells (LAV). The interpretation of our experiments is that two discrete species of proviral DNAs containing an extra Hind III and an extra SacI (SsI) site ... are present in infected cells in a 2:1 ratio. Both proviral DNAs are present in LAV and HTLV-III virus stocks. I obtained my pool of the LAV virus on April 13, 1984 ... Since Dr. Gallo's laboratory provided a sample of the HTLV-III virus to Montagnier in mid-May, 1984, our results would indicate that the LAV variant was present in the French virus stock at least one month earlier ..."
With the early-1985 publication of the nucleotide sequences of the IP and LTCB viruses, Dr. Martin believe it was important to focus the attention of the scientific community on their evident molecular identity. Accordingly, in March 1985, Dr. Martin and an NIAID colleague, Dr. A. B. Rabson, published a "Minireview" in the journal Cell, titled "Molecular Organization of the AIDS Retrovirus." The Rabson/Martin review included a number of important observations about the common and distinguishing features of the three principal AIDS virus isolates to date: LAV, IIIb, and ARV, which Rabson and Martin termed, collectively, "the AIDS RV."
The most volatile observations in the Rabson and Martin review concerned the molecular relationships of different AIDS RV isolates to each other. Rabson and Martin noted that the Shaw et al. (1984) and Luciw et al. (1984) reports:
"... indicate that AIDS RVs isolated from different individuals exhibit striking structural heterogeneity as monitored by restriction enzyme polymorphisms" (op cit., p. 479).
Further, said Rabson and Martin:
"... superficial inspection of published cleavage maps and Southern blots suggests that HTLV-III and LAV are closely related to one another, whereas ARV and many other isolates are substantially different" (op cit., p. 479).
Rabson and Martin reviewed the recently-published LAV, IIIb, and ARV-2 sequences; their analysis of the sequences showed that while LAV and ARV differed from each other by 9.3 percent, LAV and IIIb differed from each other by only 1.8 percent. Rabson and Martin said this:
"A comparison of HTLV-III [IIIb] and LAV proviruses generated virtually identical results, indicating that HTLV-III was no more different from LAV than molecular clones of HTLV-III were from one another. In contrast, striking differences were apparent when LAV was compared to ARV" (op cit., pp. 479-480).
The Cell review concluded with these comments about the LAV/IIIb relationship:
"The analysis of nucleotide sequence heterogeneity presented in Table 1 indicates that HTLV-III and LAV are virtually identical. This result is surprising in view of their independent isolation and published reports, cited above, which show that extensive restriction enzyme polymorphisms exist among different AIDS RV isolates" (op cit., p. 480).
B. Issuance of the Gallo et al. Blood Test Patent
On May 28, 1985, the United States Patent and Trademark Office (USPTO) awarded patent number 4,520,113 to Drs. Gallo, Popovic and Sarngadharan, the named inventors of the LTCB HIV blood test. PTO's action in issuing a patent on the Gallo blood test came despite the fact that another patent application for substantially the same invention -- the IP application -- had been submitted to PTO months before the submission of the Gallo application.
PTO officials told Subcommittee staff they issued a patent to Gallo et al. because they were unaware of the existence of the IP application. PTO records show that from the time the IP application was submitted -- December 5, 1983 -- to the time of issuance of Gallo et al., the IP application was assigned to no less than three different patent examiners. None of these examiners performed the vital process of "briefing" the IP application, i.e., abstracting its claims and entering them into PTO's then-antiquated central records system. Because the IP application had not been briefed, its existence was not identified when the Gallo et al. examiner performed the last-minute "interference search," in which the claims of an about-to-be issued patent are checked against the claims of other pending applications. The fact that Dr. Gallo and his fellow "inventors" had not disclosed to PTO their knowledge and use of LAV was another significant reason why PTO issued a patent to Gallo et al., with no consideration of the IP prior art.
PTO's slow pace in examining the IP application was less remarkable than the near-record rapid pace of prosecution for Gallo et al. It is in this area that concerns about apparent inequitable handling by PTO of the IP and LTCB blood test patent applications are most obvious.
At the outset, the Gallo et al. application was assigned to a low-workload PTO unit, on grounds that the claimed invention involved use of radioactive labelling and thus, was deemed to be high priority. The decision to assign Gallo et al. to the low-workload, high priority unit was made by PTO. Yet the IP application, whose invention also included use of radiolabelling, was assigned by PTO to a high-volume, high backlog unit, guaranteeing a protracted examination process.
The examination processes for the LTCB and IP applications -- performed by the same examiner -- also were dramatically different. PTO issued but a single office action on the Gallo et al. application, passing it to issuance in a near-record seven months (April-November 1984; the further delay in publication of the patent, to May 1985, appears to have been due to the HHS contract attorney's failure to promptly pay the issuance fee).
The examiner's review of Gallo et al. was manifestly inadequate; e.g., she identified but dismissed Barre-Sinoussi et al.; she failed altogether to identify such significant publications by the IP scientists as Vilmer et al. In contrast, once the PTO examiner finally began her examination of the IP application (in June of 1985), she issued innumerable office actions, raising one "red-herring" issue after another, including issues the IP attorneys successfully rebutted as "totally erroneous in law and in fact" (IP Response to PTO Office Action, December 16, 1985, pp. 8-9). On one occasion, the examiner even attempted to assert that Dr. Montagnier's own presentation (at the July 1983 meeting of the NCI AIDS Task Force) might be a bar to an IP patent.
Other curious actions of the PTO examiner relating to the blood test patent application of Gallo et al. occurred in the Spring of 1985, just before the Gallo patent issued. On May 31, 1985, the PTO examiner sent to Gallo et al. a notice that prosecution of the "610" CIP (one of the follow-up applications to the parent LTCB blood test patent) would be suspended for six months because,
"... a reference relevant to the examination of this application may soon become available."
PTO's citation of a "reference relevant to the examination of this application" appears to have been a citation to a paper by Casey et al., that was about to be published in The Lancet, in August 1985. The Casey et al. paper was important because, among other things, it reported that the amino acid sequence of the LAI/LAV core protein was identical to that of LAI/IIIb. Because of these findings, the Casey et al. paper, following its publication, was cited by the PTO examiner as evidence that LAV and HTLV-III were functionally the same virus, and therefore, that the work of Montagnier et al. was prior art to Gallo et al. Using Casey et al., the PTO examiner repeatedly rejected the claims of Gallo et al. in two CIPs to the parent blood test patent. (See the PTO chronology appended to this report for further information about the PTO examiner's use of Casey et al.)
Several aspects of the May 1985 PTO suspension notice on the 610 CIP are worthy of note. Since the examiner believed the forthcoming reference was relevant to the examination of the 610 CIP, it would be reasonable to believe the reference could be relevant to the parent blood test patent as well (the same individual examined both the Gallo et al. parent application and the Gallo et al. CIPs). Yet there is no indication that the Casey et al. reference was considered vis-a-vis the about-to-be issued Gallo et al. blood test patent. Notations on the copy of the suspension letter indicate the letter was prepared on April 22, 1985, over a month prior to issuance of the Gallo et al. blood test patent, yet the patent was permitted to issue with no apparent consideration to the implications of Casey et al.
The May 28 issuance of the Gallo et al. blood test patent reportedly came as a great shock to the IP scientists and patent attorneys, along with the attorneys for Genetic Systems, Inc., U.S. licensee for the IP HIV antibody blood test. The attorneys, apparently, had been operating under the assumption that, since the IP application was submitted well before the application of Gallo et al., the IP scientists were certain to be awarded the patent on the HIV blood test.
There are indications that shortly after the issuance of the Gallo et al. patent, IP/GS patent attorneys contacted PTO to inquire about the IP application. What is certain is that on June 10, 1985, the examiner who had just passed Gallo et al. to issuance was presented with the IP blood test patent application by one of her supervisors, and told to expedite its handling.
According to the examiner, when she reviewed the IP blood test patent application, she recognized that the IP application and the just-issued Gallo et al. patent were "directly related." The examiner said PTO recognized it had erred by missing the IP application during prosecution of Gallo et al.: "We screwed up." Importantly, the examiner said that had she become aware of the existence of the IP application during prosecution of Gallo et al., she would have suspended that prosecution, examined the Pasteur application thoroughly, and,
"... probably would have thrown them into an interference."
But this did not happen, and the losers in the process were the real discovers of the AIDS virus and true inventors of the virus antibody blood test, Montagnier et al. Because of the failure of Gallo et al. in their duty of disclosure to PTO, because of PTO's own negligence in leaving the IP application untouched for years, and because of the incompetent examination of Gallo et al., the PTO examiner, at the time she passed to issuance Gallo et al., was not aware of the IP application nor even of the IP scientists' prior art. Because Gallo et al. received the patent on the HIV blood test, the IP scientists, although they discovered the AIDS virus long before Gallo et al., although they created and used the HIV blood test long before Gallo et al., were significantly disadvantaged, and were forced to shoulder the burden of petitioning for an interference. Even when the IP requested an interference, it was nearly nine months before the interference was granted, and over two years before the IP scientists finally were awarded a U.S. patent, in late 1987, nearly four years after they filed their U.S. patent application.
C. The Initial Challenge
On August 6, 1985, IP attorneys, plus attorneys for Genetic Systems, met with officials of HHS to formally register their objections to the Gallo et al. blood test patent. Dr. Raymond Dedonder, the then-IP Director, led the IP/GS delegation. Participants for the United States included Lowell Harmison as chair, Harmison's "Senior Assistant," Dr. Ann Rose, HHS attorney Darrel Grinstead, Thomas Byrnes (DOJ), NIH patent attorneys Leroy Randall and Thomas Ferris, NCI's Dr. Peter Fischinger and Dr. Berge Hampar, and Robert Auber of the Patent Licensing Program, National Technical Information Services (NTIS).
Several sets of handwritten as well as more formal notes of the August 6 meeting exist. According to a memorandum prepared for HHS Secretary Margaret Heckler's Chief of Staff by the HHS Executive Secretariat's Tim Miller (present at the meeting), the "basic claim" of Dedonder et al. was that Gallo et al. "... either knowingly or mistakenly appropriated Dr. Montagnier's invention..." Further, according to Miller, the IP/GS delegation,
"... made three oral demands which they say are necessary to avoid litigation over who should be credited with the HTLV-III patent and who should derive the commercial benefits:
(1) Recognition that Dr. Montagnier of the Pasteur Institut was the true inventor of the HTLV-III test kit and diagnostic method of detecting AIDS;
(2) Genetic Engineering Systems would share in past and future royalties from the sale of the HTLV-III test kits; and
(3) Reissuance of the HTLV-III patent previously issued to Dr. Gallo (which presupposes that the Pasteur Institut and Dr. Montagnier would be listed as the inventors or, at least, joint inventors with Dr. Gallo's group)" (emphasis in original; 8/7/85 Miller-to-Haddow memorandum; p. 1).
According to the Miller-to-Haddow memorandum, Pasteur's patent counsel, Gerard Weiser, identified several potential causes of action in the U.S. Court of Claims, which Weiser reportedly "emphasized ... would be made public" should HHS refuse to accede to the French demands, including:
"... claims of breach of contract, conversion, unjust enrichment, prejudice to the Pasteur Institut, anti-trust violations against the U.S. licensees, a class action by AIDS victims, failure of government counsels to deal candidly in filing the U.S. patent application, and misappropriation of confidential information by the Gallo group" (op cit., p. 2).
Weiser reportedly identified several means by which these causes of action could be pursued, including filing for an interference at the PTO, based on a claim of "derivation." According to Miller, this is "a polite way of claiming theft." The Pasteur delegation concluded its presentation by requesting a written response from HHS by September 6.