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Alzheimer's Institute of America Inc. v. Avid Radiopharmaceuticals

United States District Court, Third Circuit

July 1, 2013

ALZHEIMER’S INSTITUTE OF AMERICA, INC.
v.
AVID RADIOPHARMACEUTICALS, et al.

MEMORANDUM OPINION

Savage, J.

In its post-trial motion seeking judgment as a matter of law or a new trial, plaintiff Alzheimer’s Institute of America (“AIA”) challenges the jury verdict finding that Michael Mullan was not the sole inventor and that John Hardy, at least, was a co-inventor of the Swedish mutation inventions that are the patents-in-suit, and that the University of South Florida (“USF”) did not waive its rights to the inventions.[1] With the exception of its sufficiency of the evidence argument, AIA’s grounds for judgment as a matter of law are the same as those it made at the summary judgment stage.[2] Nothing occurred at trial or since our ruling on the summary judgment motions that has any effect on our interpretation of the law and its application to this case. For the same reasons given in our summary judgment opinion, [3] we reject AIA’s renewed arguments that the Florida regulation[4] is preempted by federal law, USF’s failure to comply with certain of the regulation’s requirements voided any ownership rights it may have had in the Swedish mutation invention, and the only manner in which USF could obtain legal title to the patents is via a written assignment pursuant to 35 U.S.C. § 261.

As to the sufficiency of the evidence, any reasonable jury could have concluded from the evidence that Hardy was a co-inventor of the patented invention. Likewise, there is ample evidence to support the jury’s finding that USF had not waived its ownership rights in the inventions. Therefore, we shall deny AIA’s motion for judgment as a matter of law.

The motion for new trial attacks jury instructions on inventorship and waiver, and evidentiary rulings excluding certain documents. The complaints about the jury instructions are derivative of those made in the motion for judgment as a matter of law, that is, AIA complains that the instructions were consistent with our rulings which AIA contend were legally incorrect. Because the jury instructions correctly stated the law and the precluded evidence was properly excluded, the motion for new trial will also be denied.

Co-Inventorship

AIA contends that there was a lack of “substantial evidence” upon which the jury could find that Hardy had made a “significant contribution to the conception” of the invention, qualifying him as a co-inventor.[5] Relying on Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991), AIA argues that there was no evidence that Hardy contributed to the “discovery of the location, structure, or physical properties of the Swedish mutation, as required for conception of a DNA invention under Amgen.”[6] As a corollary argument, AIA challenges the jury instruction on conception, claiming it failed to inform the jury that Hardy could only have been a co-inventor “if he contributed significantly to identification of the location and structure of the mutation.”[7](emphasis in original).

We start with the analysis of what constitutes a significant contribution to the conception of the Swedish mutation. Must it be as specific as AIA contends? Stated differently, to qualify as an inventor, did Hardy have to discover the precise “location, structure, or physical properties” of the Swedish mutation?[8]

AIA confuses contribution and conception. Its argument overlooks the fundamental difference between the two concepts. Two or more persons may work together, not necessarily in time and place, to reach the point of conception, but not all may be actively involved at the precise moment of conception. Each one of them is an inventor so long as he or she made a significant contribution to the conception. Hence, a qualifying significant contribution may precede conception.

AIA’s reading and interpretation of Amgen ignores the warning in Fina Oil and Chemical Co. v. Ewen, 123 F.3d 1466, 1474 (Fed. Cir. 1997), that the doctrine of simultaneous conception and reduction to practice “cannot be used . . . to show that because the first person did not conceive or reduce to practice the entire claim of the invention, he or she did not at least contribute in some significant way to the ultimate conception.” Instead, AIA seeks to impose a stricter standard for joint inventorship than the law requires. Applying AIA’s proffered standard would eliminate joint inventors and denigrate their significant contributions to an invention.

Joint inventorship is governed by the patent statute itself. 35 U.S.C. § 116. Two or more persons may be deemed joint inventors even though they did not physically work together on the invention or at the same time or make the same type or amount of contribution to every claim of the patent. Id. “This provision sets no explicit lower limit on the quantum or quality of inventive contribution required for a person to qualify as a joint inventor. Rather, a joint invention is simply the product of a collaboration between two or more persons working together to solve the problem addressed.” Fina Oil, 123 F.3d at 1473 (citing Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227 (Fed. Cir. 1994)). Nevertheless, not all participation in the developmental or experimental process constitutes contributionship for purposes of joint inventorship status. To qualify as a joint inventor, one must make a significant contribution to the conception of the invention. See Fina Oil, 123 F.3d at 1473. In other words, a joint inventor must make a significant contribution on the road to and not necessarily at reaching conception.

Viewing the evidence in the light most favorable to the defendants as the verdict winners, [9] we conclude that there was sufficient evidence to support the jury’s determination that Hardy was a co-inventor. To get there, the jury had to find that Hardy had made a significant contribution to the invention. Indeed, a reasonable jury could have concluded that both Mullan and Hardy had collaborated to discover the Swedish mutation. That Hardy was not present at the time and place when the identity and location of the mutation was confirmed does not mean he was not a co-inventor. There was abundant evidence that he and Mullan had been working together on the project to identify the Swedish mutation before and at the time of conception.

Evidence supporting the jury’s finding that Hardy was a co-inventor was provided by not only Hardy, but by others involved in the process. Hardy’s testimony was also corroborated by contemporaneous documents.

Hardy, after obtaining the DNA and pedigrees for families 139 and 144 from Dr. Lannfelt, [10] decided to conduct molecular genetic studies on those families.[11] He instructed Houlden to do a GT12 analysis on families 139 and 144.[12] After evaluating the results of that testing, Hardy concluded that because they suggested a mutation, exons 16 and 17 of that suspected gene should be sequenced.[13] Consistent with the plan to have the discovery occur in Florida instead of the United Kingdom, Hardy had the DNA samples sent to Mullan for sequencing.[14]

Hardy’s testimony was corroborated by Drs. Houlden and Duff. Additionally, his testimony was substantiated by laboratory notebooks and other documents created contemporaneously with the discovery of the Swedish mutation.

Dr. Houlden testified that Hardy had concluded that the GT12 data suggested a mutation on the APP gene of affected members of families 139 and 144. He stated that Hardy had told him to send DNA from those families to Mullan to be sequenced in Florida.[15]Houlden knew that Mullan and Hardy jointly wanted the new mutations discovered in Florida rather than in London.[16] Dr. Duff also corroborated Dr. Hardy’s testimony. She testified that although Drs. Hardy and Mullan knew there was a genetic abnormality in the Swedish families when they were in London, they deliberately held off on formally identifying the sequence mutations until they got to Florida.[17]

Having the sequencing done in Florida rather than in London could have been seen by the jury as nothing more than a step in furtherance of the conspiracy to avoid the inventions becoming the property of Imperial College or Athena. In that context, Hardy and Mullan were working together on the project. They could have been considered by the jury as both attempting to deceive Imperial College and USF by having the sequencing done in Florida. So it follows that the jury could have concluded that omitting Hardy as a co- inventor on the patent application was part of the ploy to defraud Imperial College and Athena.

The jury also had circumstantial evidence corroborating Dr. Hardy’s testimony. There were documents, prepared prior to the discovery of the Swedish mutation, that reveal Hardy’s proposed plan and process to discover the Swedish DNA. In his March 6, 1991 letter to Dr. Lieberburg, [18] Hardy wrote, “we intend to screen all the families we have for APP mutations by sequencing and also by linkage (we need to check whether there are families in which we can definitively rule out APP[)].” (emphasis in original). The letter, as a jury could reasonably conclude, proves that Hardy was involved in and directing the process to discover the mutation.

Hardy’s draft letter to Dr. Lieberburg dated April 30, 1991[19] further corroborates his testimony that he developed and directed the strategy to “assess whether affected individuals share a single copy of the APP gene [using the GT12 marker].”[20] He advised that if the affected individuals in a family share a single copy of APP, then “exons 16 and 17 [will be] sequenced.” Exons 16 and 17 were sequenced in all of the early-onset families collected at Hardy’s laboratory at Imperial.[21]

The ‘169 patent application itself, which was submitted by Mullan alone, provides what the jury could have found to be corroborating evidence of Hardy’s role. It recites that “We tested F144 for linkage between AD and GT12.”[22] (emphasis added). The evidence revealed that this step was done at Hardy’s laboratory at Imperial by Houlden at Hardy’s direction. The application further describes that the sequencing was jointly done and was the next step built on the previous one. “We therefore sequenced exons 16 and 17 of the APP gene . . . . “[23]

Hardy arranged to have the DNA sent to Mullan in Florida for the purpose of sequencing exons 16 and 17. He was not a mere messenger or deliveryman. This evidence – Hardy’s testimony, the corroborating testimony of Houlden, Duff and Goate, and the contemporaneous documents – was sufficient to permit the jury to find, clearly and convincingly, that Hardy was directing the process and substantially contributed to the invention. Thus, there is no basis for granting AIA judgment as a matter of law.

Waiver

AIA argues that there is an insufficient evidentiary basis for the jury’s finding that under either the Florida regulation or Florida common law, USF did not waive its rights in all inventions made by Mullan. It contends that, to the contrary, the evidence is “unequivocal” that USF intended to waive its rights to any inventions Mullan made prior to August 15, 1992.

The “unequivocal evidence” relied upon by AIA includes two letters: the May 4, 1992 letter, prepared by Clyde & Co. on April 29, 1992, and signed by George Newkome, USF’s Vice President of Research, on May 4, 1992;[24] and Newkome’s November 20, 1992 letter to Anthony Reading, USF’s then head of the Department of Psychiatry.[25] AIA selectively quotes a portion of one sentence in the May 4, 1992 letter – “[A]ll ownership of rights in any work carried out by [Hardy and Mullan] and inventions made by them before August 15, 1992 belong exclusively to Hardy and Mullan”[26] – as “unequivocally establish[ing]” Newkome’s intent to release all of USF’s rights in Mullan’s inventions conceived before the start of the new academic year. The November 20, 1992 letter, according to AIA, confirms USF’s intention to waive its rights to any inventions Mullan [and Hardy] made prior to August 15, 1992. AIA quotes the following language from the November 1992 letter:

[N]ow that Drs. Hardy and Mullan have signed their contracts for this academic year, all University of South Florida policies and procedures apply to them. This includes the inventions and works policies. It should be noted that all rights for intellectual property developed after August 15, 1992, under the auspices of Drs. Hardy and/or Mullan belong to the University of South Florida. Copies of the applicable USF policies and rules previously have been given to Drs. Hardy and Mullan, and an additional copy is attached hereto.[27]

AIA argues that this language reflects Newkome’s recognition that USF’s policies applied to Hardy and Mullan only after August 15, 1992, which was what it characterizes as the “key date” set forth in the May 4, 1992 letter. It claims the language also supports AIA’s contention that USF agreed to a “broad waiver” of its rights to any inventions made by Mullan prior to August 15, 1992.

There is ample evidence from which a reasonable jury could have found that Newkome did not intend to waive USF’s rights to the Swedish mutation invention.

There is evidence that when Newkome signed the May 4, 1992 letter, he did not intend to waive USF’s ownership rights to Hardy and Mullan’s inventions, but rather intended to draw a bright line between the work done by Hardy and Mullan on the London mutations at Imperial College and any new work that they would do later at USF. As characterized by Newkome, the May 4, 1992 letter referred to the disputes among Imperial College, Hardy and Mullan over ownership rights to the London mutations. Indeed, the letter’s language seemed to create that impression. Clyde & Co., who were Mullan and Hardy’s solicitors in the United Kingdom, wrote:

We act on behalf of Drs Hardy and Mullan in relation to certain matters in the UK. . . .
As you know Drs Hardy and Mullan have been involved in important developments in Alzheimer’s disease prior to and at St Mary’s Hospital in London, and we understand that you are already aware that the question of ownership and exploitation of inventions made by Hardy and Mullan and how they should be exploited have given rise to some difficulties here. . . .
We would like to avoid further complications at this stage in relation to Hardy and Mullan’s rights and in particular to avoid any further arguments about ownership or rights to exploit which might impede exploitation. . . .[28]

Newkome’s testimony provided the context for his signing the May 4, 1992 letter.

It supplied a basis for the jury’s finding that he did not intend to waive USF’s rights to the Swedish mutation.[29] Newkome testified that when he signed the letter, he was aware that Hardy and Mullan had discovered the London mutations while working at Imperial College and they had a dispute with Imperial College concerning ownership of those inventions.[30]In January of 1992, Mullan and Hardy had asked him and USF to intervene on their behalf with respect to their dispute with Imperial College. In light of that request, USF retained patent counsel for advice regarding the feasibility of applying for a patent in the United States related to the “inventions that they had patented in England, ” including “the two gene mutations discovered by them.”[31]

Mullan agreed that the language in the May 4, 1992 letter focused on the London mutations. He acknowledged that the language explicitly referring to Hardy and Mullan’s “involve[ment] in important developments in Alzheimer’s disease prior to and at St. Mary’s Hospital in London, ”[32] and the express desire “to avoid further complications at this stage in relation to Hardy and Mullan’s rights and in particular to avoid any further arguments about ownership or rights to exploit which might impede exploitation”[33] referred to the London mutations. Mullan also admitted that he believed that Newkome signed the letter because Newkome understood the work Mullan was doing was “in some way a follow through [of the work he] had been doing in Europe.”[34]

Mullan’s testimony regarding the letter could easily have been considered by the jury as consistent with Newkome’s testimony. According to Newkome, he signed the May 4, 1992 letter in order to “separate the intellectual property that was previously created at Imperial College in England by Hardy and Mullan. . . . [so] that anything that was created in England would belong to [Hardy and Mullan] or Imperial College.”[35] He stated that USF was “trying to make a distinct break, ”[36] and “really wanted to make sure that there was a distinct dividing line between the intellectual property invented in Imperial College versus that which would be invented at the University of South Florida.”[37] He explained that when he inserted the August 15, 1992 date in the letter, he “was trying to put a time frame on things that were being completed by them from Imperial College versus the new things that would be started at the University of South Florida.”[38] He gave Hardy and Mullan “their rights to things that were created under [Imperial College]” to allow Hardy and Mullan to “deal with Imperial College.”[39] In short, his testimony was that he wanted to avoid an intercollegiate battle with Imperial College over ownership rights to inventions that were created in London.

Newkome explained that he chose August 15, 1992 as the cut-off date for Mullan and Hardy to wrap up any issues surrounding their London mutation inventions while at Imperial College because it was the start of the new semester at USF.[40] He testified that he

signed [the May 4, 1992 letter] in such a way that it would end the very first part of the fall semester, the first fall semester they were there. So it started in August some date, 1992. So there was a demarcation. I expected them to complete all of the necessary stuff, to complete the publications, the extra stuff for patents and copyrights that belonged to Imperial College, because that is where they did the work originally. But they needed to clean things up. So I did that. And then what occurred is, is that on the first day, which is August 15th, 1992, they would be no longer accountable for anything at Imperial College. From then on, I expected them to have cleaned up all their loose ends in the summer and in the spring of 1992.[41]

There is ample evidence to support a finding that at the time he signed the May 4, 1992 letter, Newkome had no knowledge of the discovery of the Swedish mutation invention and consequently could not have known that it had been discovered while Mullan was employed at USF. Newkome testified that when he signed the letter on May 4, 1992, he believed that Mullan and Hardy had not yet begun any new research at USF. Prior to that time, neither Mullan nor Hardy had disclosed that they had done work or made any discoveries while at USF.[42] Nor did Mullan, Hardy or Sexton reveal anything about any such work at the ...


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