Guest Post by Ted Sichelman, University of San Diego School of Law
As any diligent reader of Patently-O would know, the Federal Circuit is considering en banc whether to retain the written description requirement—and, if so, in what form—in the pending case, Ariad Pharmaceuticals v. Eli Lilly & Co.
Lilly, which was found liable in the district court, argues in its en banc brief that the Federal Circuit should retain a strong and independent written description requirement. In the event Lilly’s arguments are successful—and Ariad’s patent is invalidated—Lilly stands to save roughly $250 million (in present value) of potential damages and likely settlement payments. (For an explanation of the calculation, click here.)
Yet, in another case pending at the Federal Circuit, Lilly v. Teva, Lilly—as the patentee—is on the other side of the fence on the written description issue. Specifically, Lilly appealed a finding that some of its patents are invalid for lack of written description. If Lilly wins this appeal, assuming infringement holds up, it stands to gain roughly $750 million (in present value) in on-going profits from the sale of its blockbuster osteoporosis drug Evista. (Ironically, Evista is one of the accused infringing drugs in Ariad.)
Thus, in simple dollar terms—focusing on Lilly’s pending patent cases at the Federal Circuit—Lilly has more money to gain by losing the Ariad appeal than winning it. Presumably, Lilly has other financial interests motivating its position in Ariad. For instance, Lilly has been subject to more than several accusations of infringement over the years and its financial wherewithal to engage in intensive R & D may make its patents relatively immune to written description attacks.
But, even so, Lilly might not care as much as the usual appellant if it loses the Ariad case. To be fair to Lilly and its lawyers, I have not seen any evidence showing that they have not vigorously argued their case. Nevertheless, Lilly’s large financial interest in Teva is concerning, especially given that Ariad could be one of the most important Federal Circuit decisions in recent years.
So when I read Lilly’s en banc brief to the Federal Circuit in Ariad, I was surprised that Lilly did not disclose its position in Teva. And it seems very unlikely that Lilly’s lawyers in Ariad were unaware of the issue in Teva, since at least three of them are working on both cases. Moreover, the district court in Teva mentioned the pending Ariad case in its final order, noting that it was bound by existing precedent to apply an independent written description requirement.
The Federal Circuit has a rule that requires litigants to disclose certain information about other pending cases. The applicable rule, Fed. Cir. R. 47.5, reads in relevant part:
Each principal brief must contain a statement of related cases indicating: …. (b) … any case known to counsel to be pending in this or any other court that will directly affect or be directly affected by this court’s decision in the pending appeal. If there are many related cases, they may be described generally, but the title and case number must be given for any case known to be pending in the Supreme Court, this court, or any other circuit court of appeals.
In my view, one could read the rule such that Lilly should have disclosed the Teva case in its Ariad brief. Unfortunately, the scope of this rule is sufficiently ambiguous to be construed otherwise. In particular, it is unclear whether “related cases” in the preamble of Rule 47.5 is, so to speak, a “limitation”—namely, does a case qualifying under Rule 47.5(b) need to be a “related case” in addition to meeting the requirements stated in that sub-section, or does that sub-section fully define the kinds of “related cases” that need to be disclosed? Arguably, the latter is the better reading, but it does not seem compelled by the language of the rule. Moreover, it is unclear exactly what “directly affect or be directly affected by this court’s decision” means. Since the rule contemplates that there may be “many related cases,” arguably this clause should be read broadly, but again, such an interpretation does not seem mandated by the rule.
What does seem clear, though, is that the roughly $750 million Lilly potentially has to gain in Teva from losing the Ariad case is important information that any Federal Circuit judge would want to know when reading Lilly’s briefs and listening to its arguments. As such, the Federal Circuit should clarify the scope of Rule 47.5—like it has done in a few cases (here and here)—or explicitly revise the rule to ensure that parties are clearly required to disclose cases like Lilly v. Teva.
For example, the Federal Circuit could—similar to DC Circuit Local Rule 28(a)(1)(C)—define a “related case” as including “any pending case involving at least one of the same parties and the same or similar issues.” Such a definition would capture cases like Lilly v. Teva, but would not overly burden litigants. With this sort of rule in place, potentially contrary interests of parties in other cases—particularly those worth large sums—would be appropriately unveiled on appeal.
Ted Sichelman is an Assistant Professor at the University of San Diego School of Law, where he teaches patent law and other intellectual property courses. He has neither represented nor has any financial interest (other than from market index funds) in Ariad Pharmaceuticals, Eli Lilly, or Teva.
Now, if there were an example, one describing how to make and use the subject matter of the claim, would you still think there is a section 112, p. 1 problem?
If the Example failed to disclose a sequence or a deposit number for the claimed plasmid, then, yes, of course there is a problem. I know this must be very difficult for you to understand, Ned, but that’s because you practice in an art unit where filed applications of the lowest quality are routinely allowed by the laziest Examiners on the planet.
TJ,
I agree that the better–though, not ineluctable– reading is that “related case” does not limit the two sub-clauses.
Under this interpretation of the rule, I also agree the Federal Circuit should expressly amend the rule to limit disclosure to situations involving at least one overlapping party, retaining the “describe[] generally” provision for the reasons stated in my earlier post.
So, under these assumptions, I think we’re in agreement.
Malcolm, I am trying to get you to identify exactly which part of Section 112, p. 1 you believe to be implicated by you example. The claim as filed is directed to an invention for which there are no examples, but which is enabled from what is described.
Now, if there were an example, one describing how to make and use the subject matter of the claim, would you still think there is a section 112, p. 1 problem?
Ted,
Agree that we basically agree on policy concerns. Our disagreement is whether the current rule can plausibly be interpreted to create a good remedy. It seems we have two variables: (1) what constitutes “directly affect”, and (2) what constitutes a “related case”.
If both come out the way you propose, then the rule ends up basically requiring disclosure of cases that (1) involve similar issues (“directly affect”) and (2) have at least one common party (“related case”). So a very broad definition of what constitutes direct effect is narrowed by the interpretation of what constitutes a related case. The key is that you need both interpretations to stick, or you will create a very large loophole. You cannot invoke the disclose “generally” provision without limiting disclosure to cases involving an overlapping party, or parties will get away with very general disclosures even when specific cases are of special importance.
As for the interpretation of “related case,” you have already noted the problem. The more plausible reading, I think, is that the two sub-clauses themselves define what is a related case.
TJ,
Regardless of the route to the final rule, it seems we generally agree on what it should look like as a matter of policy.
Although I did not state as much in the post, I do think the “many cases” provision is sensible. Because my proposal is limited to “any pending case involving at least one of the same parties and the same or similar issues,” it seems that it would be rare for any litigant on appeal to have so “many cases” pending in district court that it could invoke the exception and describe them “generally.”
However, in such a rare situation, I do not see a need for a litigant to specifically list each and every case in the district courts involving them or other parties raising the same or similar similar issues. As long as the cases are generally referenced in the briefs, the clerks could search on Westlaw or Lexis without too much trouble for the relevant cases, if the judges so desire. Alternatively, if the disclosure raised specific concerns, the court could request more information from the parties by a suitable order.
I’m interested to hear your take.
Ted,
I think we can largely agree to disagree on the details. I think the burden of disclosing all known court of appeals cases on an issue would be onerous in the same way that disclosing all known prior art is onerous. Not impossibly onerous; but sufficient that the rule needs to be clearer before I would be convinced this is what it required.
What I would be curious about is your emphasis on the fact that district court cases can be disclosed “generally.” Suppose that Lilly v. Teva is still in district court when the Lilly brief is due, in that Lilly waits until after filing its brief to notice an appeal. I would imagine that all the policy reasons behind your concern are still valid. But at least if I understand you correctly, you would accept a disclosure that “there are many cases pending in the district court that are affected by this court’s decision on whether a written description requirement exists.” That seems a rather large loophole to me.
It was stated that Lilly would gain with an Ariad victory. I respectfully disagree. Ariad has shown how they respond by disclosing the Lilly lawsuit prior to releasing the news about the patent approval. I would expect them to claim other Lilly compounds if Ariad won since this case started over 7 years ago and there has been many compounds in Lilly’s pipeline.
Extending Evista a few extra years would also extend Ariad’s cash flow … but it would not gain anything financially from Teva for their generic version unless Ariad sued them correct? So in that case both Ariad and Lilly would lose wouldn’t it? But Lilly has already written off Evista and Xigris when their patients expire with their recent actions. Where Ariad needs that money but then must share it with the other plaintiffs.
An Ariad victory could also affect Amgen’s victory and the other 48 companies apparently warned about their infringement back in 2002. I’m sure the CEO would pressure others as well.
Ariad has already rescinded several of their original when it was reviewed and rejected by the USPTO which points a weakness in the patent.
The jury trial was award based upon weak and misleading evidence, which I believe was one of the conclusions by this court earlier this year.
Innovation would be stifled by glut of ambiguous patents that claim everything with little factual truth which would result from an Ariad victory.
the claim clearly identified the invention
No, it didn’t. It clearly identified something that *could* be invented but a clear description of the claimed invention would require work to be done that the applicant failed to do. The point is that Applicant didn’t “invent” the claimed plasmid, as evidenced by the Applicant’s failure to describe the composition in a manner that would indicate that the Applicant had, in fact, legally conceived of the composition.
I assume the whole point of the OP is that one party should not be allowed to advance two contradictory legal theories at the same time.
I sense a first amendment problem if one is not allowed to do this.
So, what I am left with is that the real reason for the rule involves whether the party is arguing two contradictory fact theories at the same time. This makes more sense to me and, in my book, should be banned.
MM, said, “But Applicant wasn’t in possession of the gene when he filed. He/she did not describe the gene (or the plasmid) with sufficient precision to be entitled to a patent. This is a written description problem.”
But what aspect? “Invention” or “Make and Use.”
Clearly the statute requires one to describe how to make and use. That was not done here. However, the claim clearly identified the invention, assuming it was filed with the application.
So, MM, please clarify exactly what you mean.
Regarding lack of written description support for original claims, I submit the following hypo:
Applicant identifies a new microbe by sequencing a small portion of its genome (say, its ribosomal RNA sequences). The microbe is called “organism X”. Without doing anything more, applicant files a patent application describing the new microbe and claiming “A plasmid comprising an isolated gene encoding a DNA polymerase and a promoter for expressing said gene, wherein said gene has a nucleic acid sequence identical to a gene from microbe X.”
Anyone can tell you that it is well within the skill level of a molecular biologist to sequence and/or clone the gene into a plasmid without undue experimentation.
But Applicant wasn’t in possession of the gene when he filed. He/she did not describe the gene (or the plasmid) with sufficient precision to be entitled to a patent. This is a written description problem.
“It’s unfortunate that you feel the need to engage in ad hominem attacks, instead of sticking to the arguments. ”
They’re just there to flavor the otherwise bland horrendous loss you take on the arguments.
I write for my readers.
“With that said, I disagree with your contention that two statements are “100% in line.” In particular, Lilly aruges in its Ariad brief that “[a]n amended claim warrants the same inquiry [as an originally filed claim], and there is no logical reason to treat such claims differently.” Yet, in its Teva brief, it states that “it is presumed that such original claims have written description support” (citing In re Wertheim).”
What you don’t understand is that there is no conflict there.
I’m available at whatever rate D charges his students to point out to you why.
examiner6k@yahoo.com to schedule an appointment. We’ll work out a payment plan later.
“However, Lilly’s assertion in Ariad that “there is no logical reason to treat” amended claims differently from original claims would arguably imply that any presumption in favor of finding written description for original claims is unwarranted. ”
That is actuall 100% correct. I’d say you’re right on the cusp of understanding. As an initial estimate I feel like only a few hundred dollars will probably be sufficient to get you the rest of the way.
6,
It’s unfortunate that you feel the need to engage in ad hominem attacks, instead of sticking to the arguments.
With that said, I disagree with your contention that two statements are “100% in line.” In particular, Lilly aruges in its Ariad brief that “[a]n amended claim warrants the same inquiry [as an originally filed claim], and there is no logical reason to treat such claims differently.” Yet, in its Teva brief, it states that “it is presumed that such original claims have written description support” (citing In re Wertheim).
Any plausible reading of the latter statement implies that there is no presumption that “amended” claims have “written description support”–and, indeed–that has been the rule. However, Lilly’s assertion in Ariad that “there is no logical reason to treat” amended claims differently from original claims would arguably imply that any presumption in favor of finding written description for original claims is unwarranted. (On this point, see the final paragraph of Lizardtech v. Earth Resource Mapping (Fed. Cir. 2005), which tilts towards such a view.) Of course, a strained interpretation could reconcile the two positions, but–on what I believe is the most straightforward reading–the implications of the statements are in tension, if not contradictory.
In sum, I disagree with your position that Lilly “argued ‘by the book’ in both cases.” Rather, Lilly’s position in Ariad is a quite an aggressive reading of existing precedent.
Oh, no wonder the post was so bad, I always forget to look for the “guest post” tag. I’d appreciate it if you could put it in BLOCK LETTERS D.
“Here, I mean “other side” in the sense that Lilly potentially stands to gain”
Yeah I know, and I know why you’re concerned, but really? Are you one of D’s 2Ls or something? Imo, just ask D to wipe the whole thread from the face of the earth. You may yet save face.
“However, in Ariad, Lilly contends that there should be no difference in analysis between original and amended claims:”
That is 100% in line with what you say they argued in the original case. They argued “by the book” in both cases from what you’ve put up so far. And fyi the book doesn’t conflict with itself.
From what you’ve written the only things I glean are that you don’t understand “by the book” 112 1st very well, and/or you don’t understand what Lilly is saying very well in regards to one of the two cases.
“As such, I do not think it would be onerous for Lilly to list its other cases involving written description.”
Perhaps not.
TJ,
Even for your Phillips v. AWH example, I still disagree that a broad interpretation is necessarily onerous. Even under the most aggressive interpretation of Rule 47.5, litigants would only need to list those cases of which they are aware. Moreover, for cases not at the Supreme Court or a circuit court, parties could list them “generally” (e.g., “there are numerous cases in the district courts, ITC, and BPAI involving issues of claim construction”).
Nonetheless, I think a better rule would limit “related cases” to those involving “at least one of the same parties.” Contrary to your position, my proposal could fit within the current rule if “related case” in the preamble of Rule 47.5 is interpreted as a “limitation” on sub-sections (a) and (b). In that event, the Federal Circuit could find–without amending the rule–that “related case” necessarily includes at least one overlapping party.
6,
You state: “Plus D, you say that Lilly is on the ‘other side’ of the issue in that other case, but probably not really.”
Here, I mean “other side” in the sense that Lilly potentially stands to gain–to wit, a particularly large sum–from a weak or eliminated written description requirement. On this ground alone, I believe as a policy matter, disclosure should be required.
As for your particular argument that Lilly is not arguing for the elimination of the written description in Teva, this is correct (at least on briefing to date). However, as I state in my comment of 11:11 am, Lilly did take a position in its briefs in Teva that I believe is in tension, if not contrary, to its arguments in its Ariad en banc brief.
Last, Lilly does not have many pending patent infringement lawsuits, much less many lawsuits involving written description. Based on a search of federal dockets on Westlaw’s CourtExpress (which mirrors PACER), for actions filed in district court in 1999 or later, Lilly has only been involved as plaintiff or defendant in 69 patent cases. Since most cases are resolved or settled within three years, presumably, Lilly has no more than 20 cases pending at any given time. If we take the number of pending cases that involve written description, it’s very likely to be no more than ten, probably five, cases at any given time. As such, I do not think it would be onerous for Lilly to list its other cases involving written description.
Ted,
I have no problem with your proposal as a policy matter. I was only speaking about the current rule. I don’t think your proposal works within the current language because that language makes no distinction between whether the party is also a party in the other case or not. Every other written description case will be “directly affected” by Ariad. Imagine what Phillips and AWH Corp. would have had to disclose!
“A few people are misunderstanding Ted’s point. It doesn’t matter whether Lilly is *arguing* two contradictory things. All it matters is that Lilly stands to *benefit* from losing the Ariad case”
I frankly don’t see where Lilly is pulling any punches in its brief. In any event, please let us know when Lilly’s counsel shows up for oral hearing without a tie.
Ted’s post at 11:29 AM seems to provide the substantive answer to my question at 7:29 AM.
Thanks Ted.
6, as usual, your posts are meaningless. Why do you bother?
Mark,
You ask: “In these days of computer searchable data bases, why is it necessary to ‘disclose’ anything that is already in the public record?”
Although Lilly’s briefs in Teva are available online, full disclosure to the judges of “related cases” is much more likely to result when the onus is on the litigants to disclose what they already know–rather than on the law clerks, who would need to spend many hours searching legal databases.
Thus, to the extent the disclosure rules are not onerous for the parties–and I think my proposal at the end of the post sets a fair balance–I think they are sensible.
TJ,
You state, “I have always understood ‘directly affected’ to mean ‘affects the outcome for some reason other than stare decisis, such as collateral estoppel, law of the case, or because the parties are litigating over an extremely limited pool of funds.’” Although I think this is a plausible interpretation, my view is that the rule is ambiguous as written. There is no indication that I could find in the Federal Circuit’s case law that mandates a narrow reading. Nor could I locate any “legislative history,” so to speak, explaining what the Federal Circuit thought this language meant when it was adopted.
Indeed, the language of the rule is not limited to affecting “outcomes,” as you argue. A plausible plain language reading is that the Teva case “will … be directly affected” if the Federal Circuit eliminates the written description requirement. On this ground, one could read very well read the rule as requiring disclosure. Of course, as I stated in the post, the rule is not so clear, and I think a contrary interpretation is also plausible.
You also argue, “But if ‘directly’ affected is given a broad reading, Lilly will be forced to enumerate basically every case it knows with a pending written description issue, whether or not Lilly is a party. If counsel ran across the case while searching PACER, it must be disclosed. That seems kind of onerous.” I disagree with this reading. Specifically, the rule does not require a party to “enumerate … every case … [it] ran across … while searching PACER.” Rather, the rule contemplates that there may be “many related cases,” in which event, “they may be described generally,” unless the case is pending in the “Supreme Court, [the Federal Circuit], or any other circuit court of appeals.” In this regard, for any given case, I doubt there are many other pending cases at the Federal Circuit, other circuit courts, or the Supreme Court with the same or similar issues on appeal of which a given party is aware. So I do not think the rule would necessarily be onerous if read broadly. As such, your argument does not mandate reading the rule narrowly.
More importantly, you do not address my proposal at the end of the post, which is limited only to “any pending case involving at least one of the same parties and the same or similar issues.” Such a rule would not be onerous, since parties should be aware of their own cases pending in federal court involving the same or similar issues.
I didn’t refresh before posting, so I didn’t see Ted’s response.
A few people are misunderstanding Ted’s point. It doesn’t matter whether Lilly is *arguing* two contradictory things. All it matters is that Lilly stands to *benefit* from losing the Ariad case, because it would automatically win the Teva case were that to happen.
Fisher, Steven, and Patent_Medicine,
Regardless of what Lilly is arguing in the Teva case, if the written description requirement is eliminated in Ariad, then Lilly’s “particle size” patents would most likely be found valid. In the event infringement is found, Lilly would stand to gain roughly $750 million (in net present value) in additional profits. This financial interest is, enough, in my mind, to warrant disclosure on policy grounds. (As I mentioned in the post, I do not think Rule 47.5 mandated disclosure in this case, though it could plausibly be read otherwise.)
Nonetheless, although I did not have space in the post to address it, I do think Lilly’s arguments in Teva are in tension, if not contrary, to its arguments in Ariad. Specifically, Lilly argued in one of its briefs below in Teva: “The inventors did intend to apply their invention to raloxifene particles however formulated because their ‘invention also provides pharmaceutical compositions containing or formulated using the said particulate compound of the invention.’ This alternative language was contained in originally presented claims, and it is presumed that such original claims have written description support. In re Wertheim, 541 F.2d 257, 264 (C.C.P.A. 1967); see also M.P.E.P. § 2163 I.A. (‘There is a strong presumption that an adequate written description of the claimed invention is present when the application is filed.’).” See 2009 WL 2611775 (filed June 22, 2009) (internal citations omitted).
However, in Ariad, Lilly contends that there should be no difference in analysis between original and amended claims: “The same standard must apply to both [original and amended claims]…. For both original and amended claims, a written description of the invention may either be satisfactory of deficient depending on whether the patent specification, including the original claims, provides a demonstration that the patent applicant actually invented and was in possession of the claimed subject matter. . . . An amended claim warrants the same inquiry [as an originally filed claim], and there is no logical reason to treat such claims differently.” 11/9/09 Brief, at 33-35.
Thus, while I do not believe Lilly’s specific legal position in Teva should play in a role in whether Lilly should–as a policy matter–be required to disclose its interest in Teva, I believe Lilly’s position below in Teva is in tension, if not directly contrary, to its argument in Ariad.
Plus D, you say that Lilly is on the “other side” of the issue in that other case, but probably not really. They’re probably not disputing WHETHER OR NOT THERE REALLY IS A WD REQ. They may be having an issue under WD where they are arguing that they met the WD req, but that hardly makes this a related case. They’re a huge company and no doubt have lots of lawsuits going on relating to 112 1st.
“especially given that Ariad could be one of the most important Federal Circuit decisions in recent years.”
It won’t be. Problem solved.
If Lilly is asserting in one appeal that section 112 requires the Written Description Requirement, and in another it acknowledges or acquiesces to the requirement for sake of argument while asserting that the facts show that it met the requirement, it’s not clear why the review court would need the cross-referencing of cases.
True these are both cases related to patents. However the Lilly case is about a specific compound with proof of concept examples conducted by Lilly whereas Ariad’s patent is more general and based on concepts with no proof of these concepts being validated by Ariad. That is why the common term for Ariad’s patent is “broad“. Based on the differences between these cases Lilly’s approach, in my opinion, would be valid.
“My advice: disclose anything close.”
Andrew,
I’m with you on this one. What’s the downside from disclosing what you think might be a related case? I’m sure judges, like us mere mortal patent attorneys, don’t like to be “blind sided” because someone who should of been forthcoming wasn’t. If Eli Lilly’s attorneys get grilled on this issue, they’ll wish they had followed your advice.
Caveat: I haven’t read either case. But is Lilly really arguing both sides of the issue, or are they arguing that “there’s no separate WD requirement” (in Ariad), and “the patents at issue do/do not comply with the WD requirement” ? If it’s the second, I see no wrongdoing here.
How did Lilly argue re: Written Description against Teva?
In these days of computer searchable data bases, why is it necessary to “disclose” anything that is already in the public record?
Good issue. But as to the existing interpretation of Rule 47.5, I don’t think there is any doubt that Lilly is on solid ground. The rule requires disclosure of any case that would be directly affected, with the vagueness in the word “directly”. But if “directly” affected is given a broad reading, Lilly will be forced to enumerate basically every case it knows with a pending written description issue, whether or not Lilly is a party. If counsel ran across the case while searching PACER, it must be disclosed. That seems kind of onerous.
I have always understood “directly affected” to mean “affects the outcome for some reason other than stare decisis, such as collateral estoppel, law of the case, or because the parties are litigating over an extremely limited pool of funds.”
This came up for me recently. I argued case #1, and it was submitted after oral argument. In my opening brief for case #2, I had to think about whether I should mention case #1 as related. It really depended on the breadth of the opinion in the first case, which had yet to be issued. I erred on the side on disclosure, stating that case #1 was “potentially related” under Federal Circuit Rule 47.5.
Good thing I did, since the opinion in case #1 came out earlier this week, and I submitted a FRAP 28(j) letter brief in the second case, taking the position that case #1 supports one of my arguments in case #2. Had I not mentioned the first case as potentially related, I might have faced some angry questioning at oral argument.
My advice: disclose anything close.
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