RNAi Litigation

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.

THE COURT: So can I just ask you on the basic thing. I am a little concerned here that what the precedent of this would set is that you can invent something — and she obviously is a very intelligent woman, well respected in the field – and decide, “Well, I’m not going to seek a patent,” whether it’s for some ideology that this is naturally occurring and we need to leave it open or not. Then someone else goes and gets the patent, spends all the legal expenses, et cetera, in doing it. And then you just, after it’s all issued and tied up with a nice red bow, you say, “Oops, I’m the inventor. I just never bothered to file my own patent application.” That is a little troubling.

MR. CARLSON: It is, your Honor. However, Congress has provided in 35 U.S.C. Section 115 that “The applicant shall make an oath that he believes himself to be the original and first inventor of the process, machine,” the claimed subject matter. They have to be the first and original inventor. And so what you can’t do is take the invention of someone else that you learned about, whether or not it’s patented, and claim that for yourself.

THE COURT: But he’s an honorable man in the scientific community. Let’s assume for a minute this group of unbelievable scientists — I got persuaded of that in my first — believed that they were the first. I mean, you’re MIT. You’re the Max-Planck Institute. You’ve got the Whitehead Institute. These are the knock-dead institutions in this area. They believe they got it first. And then she comes along and says, “No, no, no, I got it first.” It’s a little hard to then say that she doesn’t have to go to the bother of getting a patent; she just says, “Move on over. It’s mine.”

MR. CARLSON: Well, first of all, she didn’t learn about the fact that they were taking her discovery and applying for a patent for it until later. But, secondly, I want to –

THE COURT: It’s hard to believe. It all came out in 2006.

MR. CARLSON: It came out in the context of the motion to extend discovery in the Whitehead litigation in order to allow the deposition of Dr. Bass because one side saw it in their interest to recognize that she was potentially the inventor of the subject matter here.

I also, though, wanted to comment that 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: They may think they did it.

MR. CARLSON: They may think they did it, and they may be right or they may be wrong, and that’s what this case is all about.

The question that counsel raised about Section 256 not being for resolving priority disputes, with all due respect, I think it’s silly. The inventor has to allege that they are the first and only inventor. That’s where the language in the briefing came from. It’s a reference to the oath of the applicant. That’s a requirement in order to get a patent. It doesn’t mean that every dispute is a priority dispute. But I also question the notion that Section 256 can’t be used to decide who the first inventor is. I think what that’s getting to is that you can’t decide sole inventorship versus the named inventors. Someone can’t come in and say that “I’m the sole inventor, and you have to substitute me for those people.” I think that’s what that’s getting to, and there’s just no support in the case law. The Court –

THE COURT: Do you have any case where that actually happened? It’s just so unusual.

MR. CARLSON: Absolutely. Oh, substituting one group of inventors or one inventor for the others?

THE COURT: Yes, to the exclusion of the others.

MR. CARLSON: Well, yes. Stark II is a Federal Circuit case.

THE COURT: Stark II actually knocks out all the other ones?

MR. CARLSON: For one patent. There are, I think, six patents in suit there. The plaintiff said, “I am the joint inventor of five of those, and I’m the sole inventor of one,” and the Federal Circuit agreed and knocked off all the inventors on the one patent and substituted the plaintiff, and on the others he was named joint inventor. And another example is one of the cases that was cited by the defendants, the Yeda Research case. It’s a case in which the defendant copied material from the person/entity who claimed to be the original inventor, and the court agreed and substituted the plaintiffs for the defendants on the patent. And there are other cases as well that do this, your Honor. It’s not an issue.

Now, what Rubin does and what the defendants are trying to do is say, well, you can do that but only if the parties collaborated, or sometimes they say if there was misappropriation or something to that effect. Well, there’s nothing in the cases that require that.

THE COURT: So you’re disagreeing with Rubin?

MR. CARLSON: I am respectfully disagreeing with the court in Rubin. I noted that it was originally your case and it got transferred.

THE COURT: Actually, it got bumped a number of times actually. I think it went through about three or four –

MR. CARLSON: Yes. And Rubin concerned joint inventorship and sole inventorship. And I think on joint inventorship, the court probably got it right; but on sole inventorship, the court got off on a tangent here where it started looking at cases in which there had been substitution. And it noted that in those cases, if you look at the facts that are recited, those were cases in which there had been some sort of like egregious conduct, some copying or something like that; and then it created this gloss, and it said, okay, so you can’t substitute inventors unless there is collaboration or copying, or whatever. And the fact is, there’s no case that holds that. There isn’t any case that’s ever said that that’s an element of the claim for substituting, and no cases, as far as I can tell, have ever cited the Rubin case or followed its holding on that.

THE COURT: Well, I mean, she just came on, so it just issued within the last year.

MR. CARLSON: Yes, and, you know, respectfully, and this is sometimes hard stuff, and this is perhaps one that’s an example of that, but there’s just simply no authority in any of the case law that any of these additional elements are required. And there’s really no reason for Congress, which is, remember, trying to enact a savings clause. The purpose of it is to save patents like the one your Honor ruled on where there’s been a mistake in inventorship, and so the patent is rendered invalid but for Section 256. Well, why would Congress want to distinguish between the sole inventor, where all the named inventors are wrong, right, so the named inventors their patent is invalid, right? It doesn’t mean the sole inventor — I mean, the sole inventor still has a claim to be sole inventor; and the named inventors, if they assert their patent, are going to get a defense that there has been improper joinder, and their patent is going to get invalidated.

THE COURT: But Just –

MR. CARLSON: But if 256 applied, it wouldn’t.

THE COURT: Because I was trying to think about it. It was like a mind, like a Sodoku puzzle. So if she wins and she gets named on this, but the gist of it is that she engaged in prior experiments that essentially did this for years, which is what she’s claiming, doesn’t that invalidate the patent?

MR. CARLSON: Well, no, because it was a process where she initially conceived parts of the invention, and as she worked over time came closer –

THE COURT: Wasn’t that prior art?

MR. CARLSON: No.

THE COURT: In other words, I was trying to think, well, all right, what are the ramifications of it? Suppose the evidence, she’s sort of the unsung hero of the gene-silencing world, that she’d been doing it for years, she didn’t claim the patent but it was prior art, does she then become the sole – I know I’m ahead of myself — but then does she become the solely named inventor on an invalid patent that the next infringer down the road can say, “This is now invalid”?

MR. CARLSON: No, it’s not because these were discoveries that she made. It all came together. She conceived the complete invention at the time when she read the draft of the Zamore article that she was to review.

THE COURT: So you agree it’s joint?

MR. CARLSON: No, your Honor. She was the only one to conceive of 3-prime ends. Therefore, she was the only one to conceive of the complete invention. And we would contend that the other –

THE COURT: But wouldn’t then that — I get that, that you’re saying that, and you certainly have allegations to that throughout your complaint; but then you would say, until she read the Zamore article, doesn’t that make them at the very least joint inventors?

MR. CARLSON: No, because the other limitations in the claim — and that’s what we’re focusing on when we’re talking about whether –

THE COURT: I keep saying Zamore. It gets stuck in my –

MR. CARLSON: That’s how I started, your Honor, too, but they’ve corrected me. It’s Zamore, yes. No, so she conceived of the complete invention. And the other aspects — and this is alleged in the complaint — the other limitations of the claims are either in the prior art, or they’re merely the exercise of a person of ordinary skill in the art.

THE COURT: Well, okay. I just say, I’m thinking you may prove too much. And so I do think I’ve got this issue. I don’t think I need a discussion on collaboration. But let me just go off the record for a minute, and then I’m going to come back on and discuss discovery.

(Discussion off the record.)

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