RNAi Litigation

Archive for June, 2012

[Case 1:11-cv-10484-PBS Document 73 Filed 06/25/12]

• Defendants admit that the Bass review was published on April 28, 2000. Defendants further admit that Dr. Bass commented on page 237 of the Bass review that “If RNAi involves an RNase III-like enzyme, it might explain why the small RNAs observed by Zamore and Tuschl range from 21-23 nucleotides. The initial cleavage might produce dsRNAs comprised of sense and antisense 23-mers, but the 3’ overhangs would be more accessible to single-strand-specific nucleases present in the extract, and trimmed to 21 and 22 nucleotide pieces.” Defendants further admit that the Bass review states at page 236 that “the identity of the RNAi nuclease has not been determined.” Insofar as the allegations of this paragraph purport to state legal conclusions, no response is required. To the extent a response is required, the allegations of paragraph 43 are denied. Defendants are without knowledge or information sufficient to form a belief as to the truth of the remaining allegations set forth. On that basis, Defendants deny each and every remaining allegation contained in this paragraph.

• Defendants admit that an email bearing Dr. Tuschl’s name in the “From” line and Dr. Zamore’s name in the “To” line, and with a subject line that reads: “Re: slide for banburry [sic]” was attached to the October 7, 2010 Declaration Of Marco J. Read the rest of this entry »

[from Case 1:11-cv-10484-PBS Document 70 Filed 06/11/12]

Section 256 states: Whenever through error a person is named in an issued patent as the inventor, or through error an inventor is not named in an issued patent and such error arose without any deceptive intention on his part, the Director may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.

The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent in which such error occurred if it can be corrected as provided in this section. The court before which such matter is called in question may order correction of the patent on notice and hearing of all parties concerned and the Director shall issue a certificate accordingly. 35 U.S.C. § 256.

I. INTRODUCTION

This case is the latest battle in the continuing war over patent rights in the field of RNA interference (“RNAi”), also known as gene silencing.RNAi is a process whereby a double-stranded RNA molecule inserted into a cell directs the destruction of messenger RNA before it can be translated into a protein. It has great potential therapeutic value. The University of Utah (“UUtah”) brings this Second Amended Complaint against state officials at the University of Massachusetts (“UMass”) and other research institutes, alleging that Dr. Brenda Bass, a professor on its faculty, should be named either the sole inventor or a joint inventor on two patents–U.S. Patent No. 7,056,704 and U.S. Patent No. 7,078,196–-collectively referred to as the “Tuschl II” patents, named after Dr. Thomas Tuschl, the first named inventor. The complaint requests the Court to order the U.S. Patent and Trademark Office (“USPTO”) to correct inventorship, to issue a declaratory judgment, and to require the defendants to cease violating federal patent law by naming Dr. Bass as a sole or joint inventor. The claims of the Tuschl II patents are directed to methods of preparing a particular type of double-stranded RNA molecule that can mediate RNAi. The molecule has a “3′ overhang,” a sequence of nucleotides on one end of an RNA strand that hangs over the other RNA strand and make up a double-stranded RNA molecule. The defendants press two motions to dismiss UUtah’s lawsuit. First, the UMass official defendants contend that the Supreme Court has exclusive subject matter jurisdiction pursuant to 28 U.S.C. § 1251(a) because the case involves a controversy between instrumentalities of two states: UUtah and UMass, one of the current holders of the Tuschl II patents. Second, all defendants argue that UUtah has failed to state plausible claims for sole or joint inventorship of the patents. After a hearing, the Court DENIES the pending motions to dismiss.

II. ANALYSIS

A. Subject Matter Jurisdiction
Defendants first contend this Court does not have subject matter jurisdiction over the claims against the UMass state officials because they are barred by sovereign immunity.

Generally speaking, “State[s] . . . can[not] be sued as defendant[s] in any court in this country without their consent, except in the limited class of cases in which a State may be made a party in the Supreme Court of the United States by virtue of the original jurisdiction conferred on [the Supreme Court] by the Constitution.” Cunningham v. Macon & B. R. Co., 109 U.S. 446, 451 (1883). “Claims against a state official in his official capacity are treated as claims against the state.” Negron-Almeda v. Santiago, 528 F.3d 15, 21 n.2 (1st Cir. 2008).

The Ex parte Young doctrine is a narrow exception to this rule. The doctrine permits an action in federal court against state officials seeking prospective relief to enjoin a continuing violation of the U.S. Constitution or federal law. “[W]here prospective relief is sought against individual state officers in a federal forum based on a federal right, [sovereign immunity], in most cases, is not a bar.” Idaho v. Coeur D’Alene Tribe, 521 U.S. 261, 276-77 (1997). This exception is predicated on the legal fiction that, when a plaintiff seeks prospective relief and not retrospective monetary relief that would be paid out of the state’s treasury, the suit is only against the state official and not against the state itself. See Pennhurst State School & Hosp. v. Halderman, 465 U.S. 89, 102 (1984). Whether a request for relief is prospective requires a “straightforward inquiry into whether the complaint alleges an ongoing violation of federal law and seeks relief properly characterized as prospective.” Verizon Md., Inc. v. PSC, 535 U.S. 635, 645 (2002)(internal quotations ommitted). A federal court can order prospective relief that has an impact on the state treasury, provided that the impact on the state treasury is only an ancillary result of requiring that the state official conform his or her conduct to the dictates of federal law. See Edelman v. Jordan, 415 U.S. 651, 667 (1974).

The Federal Circuit has held that the Ex parte Young doctrine can be invoked in a patent infringement action against state officials. Pennington Seed, Inc. v. Produce Exch. No. 299, 457 F.3d 1334, 1341-42 (Fed. Cir. 2006); see id. at 1343 n.5 (noting that a state official’s refusal to perform a duty can itself be a violation of federal law); Xechem Int’l., Inc. v. Univ. of Tex. M.D. Anderson Cancer Ctr., 382 F.3d 1324, 1334-35 (Fed. Cir. 2004)(Newman, J., additional views)(suggesting, but taking no view on whether, the Ex parte Young doctrine may be available in correction of inventorship claims against state university officials). Read the rest of this entry »

Dr. Bass’ often mentioned minireview published in April 2000 about seven months before the priority date of the Tuschl II invention apparently was not persuasive to independent investigators, Drs. Zamore (UMass) and Tuschl (Max Planck), who were strongly motivated to reduce to practice the invention eventually known as Tuschl II. Furthermore, Dr. Bass apparently never attempted to test her hypothesis about the structure siRNA.

I don’t think their can be any argument about impact of Dr. Tuschl’s two papers published in January and May of 2001 (left sidebar). This work opened up a new paradigm for investigating cell biology and genetics … in my opinion, above the impact of PCR and gene cloning. Tuschl’s two papers proved that siRNA was immediately useable in research, like PCR, whereas in the early years of gene cloning much preparation was required to make cloning work. It took me a year to clone the human beta-actin gene in 1982 and another six months to be sure because of the hundreds of pseudogenes.

A quick check of the citation of Tuschl’s two papers today in Google Scholar shows that the two papers combined have been cited a phenomenal >10,600 times by other research papers while Dr. Bass’ minireview has been cited just over 400 times (not too shabby either). Dr. Tuschl’s papers taught almost any molecular biologist how to silence genes whereas Dr. Bass’ paper may not have taught anyone. The only question that remains is did she teach Dr. Tuschl? There were many others ’skilled in the art’, including Dr. Zamore, that apparently were not taught by Dr. Bass’ minireview. Otherwise, others conceivably could have reduced to practice siRNA in a few weeks after reading Dr. Bass’ minireview. There was also the productive atmosphere of collaboration in Tuschl’s department at Max-Planck between Tuschl’s and Klaus Weber’s labs that led to a more persuasive demonstration siRNA gene silencing in human cells as shown in their May 2001 Nature paper (figure at the bottom of the left sidebar). Read the rest of this entry »

This Motion Hearing occurred on May 30th. Judge Saris ruled on the Defendants two motions to dismiss on June 11th: “Defendants’ motions to dismiss (Docket No. 54 & Docket No. 57) are DENIED.”

THE COURT: In the meantime, let’s just go back on the record. Meanwhile, I’m going to take this under advisement because in thinking through some of the issues, I’m not sure.

It’s a novel and very interesting constitutional and Ex Parte Young set of issues, so that I’m going to take under advisement. But wherever this is, I believe sufficient allegations have been made at the very least with respect to inventorship, especially on the joint inventorship level, so there should be some discovery that gets started, whether it’s going to be before a master in the Supreme Court or whether it’s here. So I’m trying to think about — a lot is known now about this because we had very expedited and very thorough discovery. Have you had access to that?

MR. BERMAN: No, we didn’t. We have access to some of the records, but we weren’t party to the discovery, and we would need some basic testimony from the Tuschl inventors.

THE COURT: Well, before we do all that, I first want you to — was it all sealed? Do you remember?

MR. GINDLER: It was all sealed. Your Honor, may I ask one thing?

THE COURT: Yes.

MR. GINDLER: Which is that the jurisdictional question is very important because it is a binary outcome in the sense, either this case belongs before the original and exclusive jurisdiction of the Supreme Court, in which case there is no jurisdiction to proceed here at all, or it’s not. And I would like to ask, before we begin the process of whatever discovery should take place, that we have a ruling from your Honor on this threshold jurisdictional question.

THE COURT: Denied. It will go somewhere. This is going somewhere. This is not going away, whether it’s before the nine Justices or whether it’s right here. And so at the very least, I want to get this going. I don’t want it to take the period of time that it takes often to write these things up. That’s what I don’t want. I am convinced that there’s enough alleged to at least be a collaboration under the very broad Federal Circuit case law. I’ve got to think about sole inventorship. I’m actually less sure about the jurisdictional issues than I am about the allegations going forward. So it will go forward somewhere, and I think what we need to do from the beginning is negotiate a protective order — I don’t know how much is trade secret, I don’t know how much is confidential — to give Dr. Bass access to the materials from the discovery, subject to a protective order if there is one needed, in the first litigation. And, second of all, you may want to do a few — a document production from her as to what — I mean, it’s two ways. Have you given them automatic disclosure yet?

MR. BERMAN: We haven’t done anything.

THE COURT: Because most of what they have I’m going to have to believe has been produced in that first litigation. It was so extensive and so hard fought. There were so many depositions. You need to start there because I don’t want you to reinvent the wheel. We’re going to incorporate those depositions.

And the second thing is that you — I don’t know whether there was a deposition of Dr. Bass. Was there?

MR. BERMAN: Dr. Bass produced everything that she has in the litigation. There was a subpoena to her; she produced it.

THE COURT: Was she actually deposed?

MR. BERMAN: She was not deposed. She was interviewed.

THE COURT: All right, well, it may be that a deposition of her might be in order. It may be that there should be some targeted depositions on the interaction with Dr. Bass. But I don’t want to start from the beginning because so much was done. Just look at the depositions and get that going. And then I will make certain decisions about whether it’s here or in the Supreme Court or wherever that this goes forward, because as far as I can tell, let’s say I were to dismiss it, let’s say you won on the jurisdictional grounds and it would be without prejudice, I don’t even know how [to] refile one of these things in the Supreme Court, but it could take — then you’ll move to dismiss on some grounds up there, maybe the exact same grounds, and then it will take another year or two. Read the rest of this entry »

Judge Saris stated to the Plaintiff’s attorney at the end of this last ACT “You may prove to much” … I think hinting at invalidation of Tuschl II. If the plaintiff can prove that Dr. Bass invented siRNA in the spring of 2000 using as evidence her paper and slides from her meeting presentations that spring, wouldn’t this invalidate the Tuschl II invention which was reduced to practice in October or November of 2000 in Tuschl’s lab at Max-Planck? This would not, of course, be the goal of UUtah.

Dirk Haussecker raised this issue some time ago in a comment here:

“Even IF Dr. Bass had been in possession of the beneficial 3′ overhang feature in spring of 2000, i.e. before Tuschl understood his invention (got his cloning results and tested the 3′ overhung siRNAs for gene silencing), didn’t Dr. Bass choose to disclose her invention in public, without the filing of a patent application?

I therefore cannot imagine for Alnylam to settle in a way that it can be eventually interpreted by the USPTO as an admission that Bass had priority over Tuschl, as in my understanding of US patent law the Tuschl II patent application would be invalidated by such disclosure.”

Attorney Carlson: 35 U.S.C. Section 115 [says] that “The applicant shall make an oath that he believes himself to be the original and first inventor of the process, machine,”

Judge Saris: But he’s an honorable man in the scientific community.

Attorney Carlson: … we don’t have any basis to question the good faith of the named inventors here. They may well be acting under poor advice. They may be naive.

THE COURT: ….Let me hear the response.

MR. BERMAN: Mr. Carlson is going to do it.

THE COURT: All right, so where does it say – you certainly say she invented it in the briefs. Where does it say in the Second Amended Complaint that she invented this double-stranded molecule with the 3-prime?

MR. CARLSON: Your Honor, neither of the inventors say they invented the process of synthesizing, and the word is “annealing” or bringing together single-stranded RNA to form double-stranded RNA, nor did Dr. Bass. It was invented a long time ago, and that’s why the inventors don’t claim that. What they say and when they’re describing the preferred embodiment –

THE COURT: You are a patent lawyer.

MR. CARLSON: Actually I’m not a patent lawyer, but I am a patent litigator.

THE COURT: A patent litigator.

MR. CARLSON: Yes. Column 13, your Honor, they’re describing the preferred embodiment, and they’re describing at Line 21 RNA synthesis. They’re describing, “Here’s how we did it.” And what they say about that is, “Standard procedures were used for in vitro transcription of RNA from PCR templates carrying T7 or SP6 promoter sequences, so, for example, Tuschl, et al, 1998.” And then they go on to describe the standard procedures that they use for synthesis of RNA and annealing or bringing together of RNA strands to form double-stranded RNA.

In the complaint we allege that in the 1990s Dr. Bass was working with double-stranded RNA. Double-stranded RNA doesn’t ordinarily occur in organisms. They get them sometimes from viruses. Viruses have double-stranded RNA, but living organisms –

THE COURT: Does she say somewhere that she invented a
25 double-stranded RNA molecule with a 3-prime overhang?

MR. CARLSON: Absolutely. Absolutely, your Honor.

THE COURT: What paragraph?

MR. CARLSON: Well, okay, we start with Paragraph 35 on Page 9: “As far back as 1993, Dr. Bass understood that Dicer cleaves longer strands of dsRNA into short dsRNA in the staggered cuts that leave 3-prime overhangs of about two nucleotides in length.” And then we go on and on to outline from the following paragraphs all of her discoveries over the years with respect to this molecule, until we get to Paragraph 42 where she reads a prepublication version of the Zamore article that she was asked to write a review upon, and it says, “She immediately recognized that the protein produced by –” it says “K12H4.8 gene –” It’s a gene of a type of worm called C. elegans that she had been working with. And it’s Dicer, the protein is Dicer.

THE COURT: Right, right.

MR. CARLSON: “– had all the properties necessary –”

THE COURT: So am I right, she was getting it from a worm, and he was getting it from a fly?

MR. CARLSON: Yes, the enzyme, right, the RNase III enzyme was in the lysate of the fly embryos. They didn’t know it. They didn’t know what was doing –

THE COURT: Right. It was the same kind of enzyme that was doing the cleaving, but they came from different natural elements, a worm and a fly egg? Is that it?

MR. CARLSON: Yes, yes, and as Dr. Bass –

THE COURT: So they were coming to it from different discoveries.

MR. CARLSON: They were using different enzymes of the same family. They’re RNase III enzymes, and one came from the lysate from a fruit fly, and one came from a worm, and Dr. Bass cites other examples of –

THE COURT: Because they exist — this lysate exists in nature.

MR. CARLSON: The lysate does not exist in nature. What is significant about what the Tuschl I inventors were doing compared to what Dr. Bass did is that what they were doing was in vitro. So what they did was something that doesn’t exist in nature. They took the embryos of fruit flies, and they extracted the contents, and they made a solution out of that. So you don’t even have fruit fly embryos or cells in there. What you have is the contents.

THE COURT: I see. So they took out the contents and made a synthetic substance.

MR. CARLSON: Yes, yes, right.

THE COURT: And how about the worm, that was natural?

MR. CARLSON: Yes, yes. So Dr. Bass began looking in her studies for the gene sequence of the worm that would produce that particular product, the Dicer. And that’s what you need in order to begin and go down and figure out what actually goes on here because you need to find something that binds to that and then cleaves double-stranded RNA that has the same motif or sequence of nucleotides in it. Read the rest of this entry »

The dialogue below reminds me of a misunderstanding that I had with two valued colleagues of mine during my years at NIH. I had moved on to the Pauling Institute in Palo Alto and was two years down the road when my colleague there, Jerry Latter, pursued an idea that I had first described to my colleagues at NIH three years earlier. This was simply about determining the identity of proteins separated in 2-D gels using multiple amino acid labeling - the same protein profile in 21 gels each with a different amino acid label. I didn’t think of this as intellectual property; it was just a neat trick based on a novel way of normalizing radioactive labeling using a novel polypeptide with a known amino acid sequence. In fact, it was Klaus Weber, Tuschl’s colleague and co-author, with postdoc Joel Vandekerckhove who sequenced this novel polypeptide which was a mutant human beta-actin. We published this sequence in Cell in 1980.

Jerry got excited about the power of protein profiling and did the experiment which worked well. He gave a well-received and spirited talk at a meeting which I didn’t attend at Argonne Labs. Shortly afterward I received a conference call from my two valued colleagues at NIH. The upshot of the call was that they thought it was their idea and they should have been a part of the study. I retraced with them the origin of the idea which was based on a unique cell strain that expressed this mutant actin. The mutant actin was shifted in the gel away from the wildtype actins and therefore the ratio of labeling the mutant versus the wildtype actins allowed us to normalize the labeling with specific amino acids in other polypeptides in the gel pattern. The guys at NIH did not have this cell line. All I wanted to see was if this approach was sensitive enough to detect the single amino acid exchange in the mutant actin (Gly244 to Asp244). It wasn’t sensitive enough. My colleagues at NIH had to revise their memory of how this idea came about and we all remained good friends. But this misunderstanding has stuck in my mind because of another similar misunderstanding by another former colleague in a completely separate incident.

Jerry by the way was remembered for his inspiring talk and was recruited to Cold Spring Harbor Labs by Jim Garrells and James Watson where he became head of the Quest Protein Profiling Facility and then head of Information Technology. After that Jerry was recruited to Rockefeller University where he is now VP of IT. It all started with an inspired idea followed by an inspired talk at a scientific meeting.

Judge Saris: “I think enough has been alleged under the dicta on collaboration or connection…. I don’t think at a motion to dismiss stage I’m there.”

Attorney Gindler: “Wouldn’t you have liked to have been a Drosophila fly yourself at that table?”

MR. GINDLER: …Your Honor, joint inventorship requires collaboration, and collaboration –

THE COURT: Or connection.

MR. GINDLER: It requires a real affirmative effort on the part of two or more people. In other words, here’s what the Federal Circuit said in Kimberly-Clark, perhaps one of the most cited cases: “The statutory word ‘jointly’ is not mere surplusage. For persons to be joint inventors, there must be some element of joint behavior.” And the case goes on to say that the invention must be the, quote, “Product of collaboration of the inventive endeavors of two or more persons –”

THE COURT: Or connection, “some quantum of collaboration or connection” in Kimberly-Clark, which I read this morning.

MR. GINDLER: I’m just reading this: “Product of collaboration of the inventive endeavors of two or more persons working toward the same end and producing an invention by their aggregate efforts.”

That didn’t happen here. The only thing which is alleged to be collaborative is interaction at two conferences. First, there’s an interaction at the Banbury conference, okay, at which Dr. Bass presented on this role of Dicer in enzyme and its role in RNA interference. None of the Tuschl II inventors were even at that conference.

THE COURT: But Zamore was, right?

MR. GINDLER: Dr. Zamore was there.

THE COURT: Is he here, by the way? No. But they all hung out together, because that was the first litigation that I know about. They were all –

MR. GINDLER: They weren’t hanging out together at the Banbury conference.

THE COURT: No, but I’m saying back here.

MR. GINDLER: Back here they weren’t all hanging out together. They worked at different places.

THE COURT: They were all talking. They were all interacting, and they had collaborative agreements and joint inventorship agreements. I spent a year and a half on this case.

MR. GINDLER: Me too, your Honor.

THE COURT: You and I both did.

MR. GINDLER: People who work in a given field of science talk and they share ideas. That’s what scientists are supposed to do, but that doesn’t make them inventors on each other’s inventions like other things. To say that’s the rule would have the exact opposite effect of what should be going on. You don’t want to chill interchange between inventors at conferences, at meetings, at dinners. You want to encourage it. But that can’t be fodder in the kind of very general allegations made here for joint ownership of a patent. This was a conference at which Dr. Bass presented on the role of Dicer to Dr. Zamore, and there’s the implication that Dr. Zamore must have then told Dr. Tuschl. And if he did, why does that show collaboration? That’s just a one-way presentation by somebody to somebody else.

THE COURT: Can I just say this: I’m not sure on some of these other jurisdictional issues. I have to think through. They’re hard for me. I think enough has been alleged under the dicta on collaboration or connection.

MR. GINDLER: Your Honor, the only thing that has happened here is, there was a conference at which none of the
Tuschl II inventors was present. There is another conference, the Uppsala meeting, where Dr. Tuschl and Dr. Elbashir were there, but there’s no allegation they actually were present when Dr. Bass gave her presentation; and that there was a dinner held at which Dr. Tuschl happened to be seated near Dr. Bass, and they talked about their experiments. The only other things alleged in the complaint –

THE COURT: But isn’t that in and of itself enough to — the very broad dicta that there are no bright lines, it’s fact-specific, it can be building on an article, it can be discussion. I don’t think at a motion to dismiss stage I’m there. I understand some of your other arguments and I’m going to move to them, but the dicta, when I went back and read, is so broad.

MR. GINDLER: I think, your Honor, if you look at the Kimberly-Clark case, the language which I think is the most –

THE COURT: I read it this morning.

MR. GINDLER: The language that’s most important is, you have to have multiple persons working toward the same end and producing an invention by their aggregate efforts.

“Aggregate efforts” means working together. If I tell you something that I did, you say, “Well, that’s very, very interesting –”

THE COURT: What if I said to you, “Hey, try out the three-prime jagged end. I tried that out in my lab, and it really made a difference, and I think the difference is this lysate, the enzyme, you know, that did the cleavage.” And let’s say then Tuschl says, “That’s exciting. We were working with the Drosophila fly, and we hit an enzyme that similarly did things, and it’s exciting because this is –” because he’s a brilliant man — “I think that this could really help.” I’m — Read the rest of this entry »

It has never been clear to me that Dr. Bass ever reduced to practice Dr. Tuschl’s invention although speculation can be a problem in prior art. She knew very well what the end-product of an RNase III reaction was, but not what the active best-mode structure of siRNA was for achieving intracellular RNA interference. In addition, there was the first time demonstration that siRNA worked in human cells using Klaus Weber’s elegant (though non-inventive) assay shown on the left sidebar. I suggest that if Dr. Bass’ description in 2000 was persuasive and enabling, either Dr. Zamore or Dr. Tuschl or someone else who read her paper or heard her talks would have reduced the invention to practice within a month and probably would have recognized Dr. Bass as a co-inventor. In support of this concern there is that pesky patent Figure 12 (left sidebar) that indicated that short RNAi duplexes were far less effective in RNAi than the larger duplexes.JL

Some other thoughts about this inventorship issue.

The following statement may be the reason Judge Saris must deny this motion to dismiss the case. JL.

Judge Saris: “…I don’t understand the science well enough, and I am not sure that I can even take into account some of the representations about what is or isn’t skilled in the art for me to do that on a motion to dismiss. As soon as I’m there, I deny your motion.”

MR. GINDLER: Your Honor, we also have a motion to dismiss that challenges the sufficiency of the pleadings, and essentially the University of Utah has two theories: Either Dr. Bass is the sole inventor or Dr. Bass is a joint inventor.

So I want to address each of them because they each involve some different points. Dr. Bass cannot be named as the sole inventor under Section 256 for at least two different reasons, and one is that Section 256 cannot be used as a vehicle to resolve priority disputes; in other words, who invented first.

THE COURT: They’re not asking for that.

MR. GINDLER: They are saying that, and it’s in Paragraphs 31, 32, and 33 of the complaint. Paragraph 31 says, “Dr. Bass conceived the inventions of all of the issued claims of the Tuschl II patents, and at least some pendin claims of the Tuschl I, well before any date asserted by the currently named inventors.”

Paragraph 32, “Dr. Bass reduced her inventions to practice well before any date asserted by the currently named inventors of Tuschl I and Tuschl II.”

Paragraph 33 –

THE COURT: Yes, but she’s not asking to invalidate it based on prior art.

MR. GINDLER: No. She’s asking to be named –

THE COURT: She’s saying, “I invented it, not them.”

MR. GINDLER: She says, “I invented it first.”

THE COURT: Right, “I invented it and told them about it.”

MR. GINDLER: Correct, and you cannot use Section 256 to resolve a priority fight or the –

THE COURT: She’s just saying she’s the inventor.

MR. GINDLER: She’s saying that she invented first, okay?

THE COURT: Well, if she said she invented second, she wouldn’t have a claim.

MR. GINDLER: That’s also correct, but what Section 256 — this is the Rubin case that we cited. It’s a decision by Judge Casper from this district.

THE COURT: Right.

MR. GINDLER: It’s all but a year old, and that’s a case where somebody said, “We invented first, and therefore the patent should be corrected.”

THE COURT: Right, it was done on summary judgment, wasn’t it?

MR. GINDLER: That case was done on summary judgment, that’s correct. But here the allegations are crystal clear. She says that she invented first. That’s the basis for her saying, “I should be the sole inventor. I invented first, and therefore I get the patent.” They even make this point in their opposition brief to our motion.

THE COURT: Excuse me, but can I ask you this: By definition, wouldn’t any claim of sole inventorship essentially mean that she invented before someone else?

MR. GINDLER: Not necessarily, and that’s the point –

THE COURT: Can you give me an example that wouldn’t.

MR. GINDLER: Sure. It’s the example that the Rubin case gave, which is, you could have a group of people who are collaborating together to come up with an invention. And it may be the case that while they’re off collaborating together, not all of them meet the test to be an inventor.

THE COURT: A significant contribution.

MR. GINDLER: Right, you have to. So you can have collaboration, and what the Rubin case points out is that that’s the goal of Section 256. It’s a savings clause. It allows that when people work together and they make a mistake in terms of who should be on the patent, just one of them, all three of them, you can go and fix that. What you can’t use it for is to have someone say, “I invented first.” That is literally what’s alleged in Paragraphs 31 to 33 of the complaint, and it’s the argument that’s also made in the opposition, although the University of Utah said otherwise. It’s on Page 11.

THE COURT: No, but can I ask you, suppose you had a situation — play law school with me for a minute — you’re just not so far from this case, the allegations are — you have different people all in the same field; they all hang out together, they do cell; and they’re sitting around at a dinner table, and one person says, “This is what I was doing in my lab, my God, and this three-prong, you know, and this is what happened, and I was able to cleave this, that, and the other thing, and it’s so exciting what we’re able to accomplish,” and then someone else runs into the Patent Office. Read the rest of this entry »