Legal Case Summary

Cadence Pharmaceuticals Inc. v. Exela Pharma Sciences LLC


Date Argued: Fri Nov 07 2014
Case Number: OT-13-033
Docket Number: 2593790
Judges:Not available
Duration: 23 minutes
Court Name: Federal Circuit

Case Summary

**Case Summary: Cadence Pharmaceuticals Inc. v. Exela Pharma Sciences LLC** **Docket Number:** 2593790 **Court:** [Insert court name if known; otherwise, specify jurisdiction] **Date:** [Insert date if known; otherwise, specify relevant date range] **Parties Involved:** - **Plaintiff:** Cadence Pharmaceuticals Inc. - **Defendant:** Exela Pharma Sciences LLC **Background:** Cadence Pharmaceuticals Inc. initiated legal proceedings against Exela Pharma Sciences LLC, alleging various claims related to pharmaceutical products or practices. The case likely arose from issues such as patent infringement, contract disputes, competition, or regulatory compliance within the pharmaceutical industry, though specific allegations would need to be detailed from the case filings. **Key Legal Issues:** - The core legal issues in this case may revolve around intellectual property rights, particularly concerning patents or trademarks held by Cadence Pharmaceuticals. - The conduct of Exela Pharma Sciences may be scrutinized for infringement of these rights or failure to comply with industry regulations. - There may be additional issues regarding trade secrets, unfair competition, or business torts depending on the specifics of the claims. **Proceedings:** - [Insert a summary of court proceedings, including any motions filed, court rulings, or significant hearings if available.] - The parties may have engaged in discovery processes, leading to the exchange of evidence relevant to the case. - The court may have scheduled hearings to address preliminary motions, including motions to dismiss or for summary judgment. **Outcomes:** - [If available, include the outcome of the case, such as a ruling from the court, settlement details, or ongoing trial information.] - The impact of this case on Cadence Pharmaceuticals and Exela Pharma Sciences may follow from any injunctions, damages awarded, or public announcements related to the court's decision. **Conclusion:** The Cadence Pharmaceuticals Inc. v. Exela Pharma Sciences LLC case represents significant developments within the pharmaceutical industry and highlights critical legal issues regarding intellectual property and competitive practices. Further details from the case materials would provide greater insight into the specific claims, defenses, and final resolutions. **Notes:** - For comprehensive details, consulting court documents or legal databases may be necessary to fill in specific dates, outcomes, and the nature of the claims. - This case summary serves as a general overview and should not be considered legal advice.

Cadence Pharmaceuticals Inc. v. Exela Pharma Sciences LLC


Oral Audio Transcript(Beta version)

Mr. Ward, I see that you reserved three minutes in the time for rebuttal for us. Correct, Your Honor. Okay. We're ready when you are. Thank you, Your Honor. May I please the court? The district court aired in finding that Excel infringed the two on eight claims under the doctrine of equivalence for two reasons. First, the district court failed to apply the initiation doctrine. Find no equivalence as a matter of law. And second, the district court clearly aired in finding that cadence's evidence showed equivalence. I'd like to talk about initiation first. Now the district court can strew claim one to require that the acetaminophen be in solution before the dissolved oxygen content is reduced below 2 ppm. On the other hand, it's undisputed that Excel adds its acetaminophen to water only after the oxygen content is below 2. District court rightly found no literal infringement, but wrongly found infringement under the doctrine of equivalence using a fact-based, insubstantial differences test

. This was error that the court should have applied the initiation for all limitations, doctor. Specifically, what difference does it make when the acetaminophen is added with purposes for the doctrine of equivalence whether it's before the deoxygenation or before the deoxygenation during the entire process or at a certain point in time in the process as long as it's in there? But you have substantially the same result. The issue here, Your Honor, no, that's not correct. That's the fact that they inquire that the district court made that it should never have gotten to because what the court should have done is looked at this and said that the claim requires the acetaminophen to be in before. Excel puts it in after that falls strictly within and straightly in the rationale of the planet bingo case. In a planet bingo, what happened there was the claim required a winning combination to be chosen before the first ball was picked. The accused infringer, their winning combination is not chosen to laugh at that first ball was picked. The district court level, the patent he argued, there's no real difference between before and after if you do it is basically the same thing. The court ignored that evidence and said no, we have a situation here where we have a polar opposite or an antithesis. And so we're not going to look at that factual evidence. We're not going to look at that determination. And it made a summary judgment ruling of no infringement. The court of word seems to be your assessment of this vitiation doctrine is not correct because you seem to be saying that well the court should first look to see if the claim reads directly on the accused and if not

. Then the question is well, is there a vitiation? And if there's vitiations, then you don't look to see whether there's substantially the same function way result. But that's not really what our law says that you look first to see whether there could be an equivalence, whether there could be some evidence to show that it's substantially the same function way result or an insubstantial difference. If there is no way a reasonable juror could reach that conclusion or if there's no proper legal basis for the equivalence determination, only then would you conclude that there's vitiation. That's squarely what we said in the depuse fine case. Your honor, if you look at the plan at Bingo case and the more case and you go back to Hilton Davis case, the court talks about certain instances where you have certain differences that are such on their case that no reasonable fast finder could find equivalence. For example, in the more case, it was a majority versus a minority. In the facts there were one, the patents he required, but a strip go the majority of a sheet. The accused infringers strip went 47.8%. Both on at the trial court and on the appellate level, the argument was we should have been able to say that 47.8 is insubstantially different from 50.01. In both cases, in the appellate court here, the federal circuit said that's not, you're not allowed to do that here because these words, majority of the minority are such that no reasonable fact finder could say that they're equivalent

. And that's what we have here. That's the same in plan at Bingo. The court and plan at Bingo said these words before and after when this ball is chosen or such that no reasonable fact finder could say equivalence is present. And so they didn't get to that. But you can't read those cases again for some rigid black and white doctrine that would obviate the reliance on the doctrine of equivalence. Every time there's a difference between the claim and the accused structure. Because otherwise, you just simply read out the doctrine of equivalence and that's not right. Do I agree with that, Your Honor? Well, I mean, what you said a moment ago at the beginning of your comment was that in those cases, the plan at Bingo case and the more case that no reasonable juror could conclude that there was an equivalence. And that would call into play the so-called vitiation conclusion. In effect, vitiation is simply a legal conclusion reached when there is no proper basis to conclude that something's equivalent. It's not the other way around. But Your Honor, in some of these cases, what I'm saying, you're in plan at Bingo and more, for example, the vitiation conclusion was reached without a consideration of the evidence because these were some rejoicement decisions. Mr

. Ward, let me take an oval somewhere else different. In your opening grade, you rely on examples from the 222 to argue it should be invalidated in his obvious. Yes. Where in the record is your expert testimony regarding that issue? Our expert testified regarding the 222. I will give you the site, Your Honor. Our expert Dr. Palmieri went to cited example 2.2 at A20934 to 35. And what he said was, again, I'm sorry. A20934 to 35. And there, Dr. Palmieri was talking about example 2.2 of the 222 pattern

. And what he said was, and what the example says is that it discloses that based on work that they did, that the acetaminophen contrary to what the previous conventional wisdom was, may actually react first with the oxygen in the solution. And that's the testimony he made. And he said, one seeing that would then know that you'd like to remove as much of the oxygen from the system as possible. There's other evidence in the 222 pattern as well, Your Honor. There's evidence that the patent itself says the ability of the pan's on removal of oxygen from the carrier. Claim 2 of the patent itself talks about a formulation where the aqueous medium is deoxygenated. And so it recognizes deoxygenation is important. And Dr. Schunen, Tadenes' expert, to find deoxygenation is meaning removing as much oxygen as possible from a system. So there's definitely motivation in the 222 pattern to remove as much oxygen as possible. And the way that you do that was known. It was known from the papers of Dr. Paul Meieri and Dr

. Schunen that were preceding the 218 pattern by many, many years. And there was also an admission in the 218 pattern that it was easy to remove oxygen or deoxygenate all solutions in air tight tanks. And so one reading the 222 would understand they should remove as much oxygen as possible, which is common sense. If oxygen damages the system causes degradation, get rid of it. And you know how to do it. And you have a reasonable expectation of success because the technique to do so has been around for a long time and the patent says they're easy to do. And then when you get to the secondary considerations, if you agree with us on that there's no infringement with either with respect to the initiation doctrine because there was no evidence, then there's no nexus between the commercial product and many of the secondary considerations. So they're out. But even if you don't agree with that, the problem that we had here was that the district court said that the 222 pattern that these commercial products are also embodiments of the 222 pattern and embodiments of the 218 pattern. And it never made any any analysis of what the 218 pattern added to the commercial product that was not present from the 222. And under the Ohio Willowood case, that's not sufficient to show these secondary considerations such as commercial success, long felt need licensing and praise because there's no separation between. That that was due to the 222 pattern versus that, which was due to the 218 pattern. Judge Lynn, I would like to come back briefly to one one remark you made

. I'm not we're not advocating for the abolition of the doctrine of equivalence. What we were saying is that in certain instances, such as the one we have here, no fact finding is necessary. And I realize in brilliant instruments and some other cases has been pushed back from the court saying it's not a situation. It's not we're not just talking about binary choices. We're not talking about a situation. Well, we don't have the literal thing. So it's not present. That's initiation. That's not what we're talking about. We're talking about a situation where you use these types of words before and after. That's one that was chosen in line ofingo where somebody looks at this and they know without engaging in the fact finding. You said in front of being a didn't make sense to change the order of the step of things. And here it does make sense

. They never got into the issue of whether it made any sense to change the order. That was the argument that the patent he made it made it made no difference whatsoever. Whether that winning combination was chosen right before the first ball or right after the first ball in the court said we're not going to we're not going to delve into that. And that's what we're saying here. You don't you don't you don't get to that point because these words before and after in the way this claim was drafted. No reasonable fact finder confined infringement under the doctor approvals. I'd like to briefly just get to one other infringement issue on the 218 patent. And that is the issue of the pressure step. Pressure step was found to the optional when I'm talking about there is reducing the pressure to below 65,000 passcals. Showing to be optional the district court found it to be optional. We believe and we believe the evidence clearly shows based on the file history that that is a requirement. And it's it's a requirement because the examiner said it was requirement. And then the patent he distinguished his invention from the prior art to to to patent

. Based on the pressure step, but it isn't the product to talk about the backing package step. It isn't that an option. No, it's not your honor. At the very least it's not optional based on the on the prosecution history. Does it optionally modify that step? The word option in the claim. Optionally in the claim appears one phrase before it. So there isn't there is there is an argument that it doesn't modify it. There's an argument that it doesn't. Our point is what you do. What's your argument? Our argument is even if the claim said it's optional. It is no longer optional because of what happened in the file history. That's our argument and we say it's despite what it says in the claim. If you read the claim is saying it's optional

. The file history clearly shows that it's not because the inventors relied on it to distinguish it over the two to two patent and called it the pressure requirement. I see him into my rebuttal sir. Stop. Okay. Thank you. Thank you. Shuler. Good morning, ma'am. Please the court. Unten Shuler and I'm arguing today on behalf of both. Caden's and former top at the outset unless the court would like me to address a different subject. I will start with equivalents. I will start with the case. You know, Excel is up to to cast this is a before versus after per safe formulae rule. You know, squarely for close we think by the spring courts decision in labor tank, which emphasizes that. Equivalents is not the prisoner of formula. It can't be considered a vacuum. In fact, things that that for some purposes may be different. In other instances might be equivalent. Ambition is not some sort of exception. As the court noted, it is simply the outcome of the instantial differences. What do you say to your opponents argument, I asked you the application of a plan to be able to this case. I would say three things. First, that you can't formulaically or, you know, do a per se before it could never be the same as after. But more fundamentally, they're factually wrong. This isn't a situation of before versus after

. You know, Excel is up to to cast this is a before versus after per safe formulae rule. You know, squarely for close we think by the spring courts decision in labor tank, which emphasizes that. Equivalents is not the prisoner of formula. It can't be considered a vacuum. In fact, things that that for some purposes may be different. In other instances might be equivalent. Ambition is not some sort of exception. As the court noted, it is simply the outcome of the instantial differences. What do you say to your opponents argument, I asked you the application of a plan to be able to this case. I would say three things. First, that you can't formulaically or, you know, do a per se before it could never be the same as after. But more fundamentally, they're factually wrong. This isn't a situation of before versus after. The district court found in the evidence show that Excel and bubbles both before and after. They have the acetaminophen. And the district court found that that was insubcantially different than bubbling before. The second point I would make is that it's, this is a method step. And the activity that's specified is the oxygenation of the solution by bubbling with at least one inner gas. To until the oxygen content is below two parts per million. Now, the opposite of the oxygenation will be oxygenation. The opposite of an inner gas would be a non-intergares gas like oxygen. The opposite of until below two parts per million would be until above. So the antithesis of this particular method step would be oxygenation of a solution by saturating it with a non-intergares gas. To achieve a higher oxygen content than what is specified. And so that's the second point we would make. The district court's findings, by the way, were very specific

. The district court found in the evidence show that Excel and bubbles both before and after. They have the acetaminophen. And the district court found that that was insubcantially different than bubbling before. The second point I would make is that it's, this is a method step. And the activity that's specified is the oxygenation of the solution by bubbling with at least one inner gas. To until the oxygen content is below two parts per million. Now, the opposite of the oxygenation will be oxygenation. The opposite of an inner gas would be a non-intergares gas like oxygen. The opposite of until below two parts per million would be until above. So the antithesis of this particular method step would be oxygenation of a solution by saturating it with a non-intergares gas. To achieve a higher oxygen content than what is specified. And so that's the second point we would make. The district court's findings, by the way, were very specific. The district court found that Excel is argon blankening is bubbling. That's at A39. It also found that the argon bubbling deoxygenates the solution. That's at A17. It also found that Excel employs argon bubbling after it adds the acetaminophen. That's at A17 and obtains a final dissolved oxygen content of below 0.5 parts per million. Now, in the context of this claim, the method step at issue, given that Excel has challenged none of those predicate findings, those clearly erroneous. The district court plainly did not initiate those claims at issue. The other point we would make is that this court has held that the initiation effectively, excuse me, requires to find out that no reasonable fact finder could find equivalents. And here we had a fact finder that found equivalents. So Excel has to identify something that the district court did. That was so unreasonable that in other words, the fact finder was so unreasonable that no reasonable fact finder could have found equivalents

. The district court found that Excel is argon blankening is bubbling. That's at A39. It also found that the argon bubbling deoxygenates the solution. That's at A17. It also found that Excel employs argon bubbling after it adds the acetaminophen. That's at A17 and obtains a final dissolved oxygen content of below 0.5 parts per million. Now, in the context of this claim, the method step at issue, given that Excel has challenged none of those predicate findings, those clearly erroneous. The district court plainly did not initiate those claims at issue. The other point we would make is that this court has held that the initiation effectively, excuse me, requires to find out that no reasonable fact finder could find equivalents. And here we had a fact finder that found equivalents. So Excel has to identify something that the district court did. That was so unreasonable that in other words, the fact finder was so unreasonable that no reasonable fact finder could have found equivalents. And yet, when this court asks this morning, Excel is still cannot identify. What's the substantial difference? What difference does it make? And the district court plausibly found here that the two processes are essentially interchangeable. That's A45. That the result is the same regardless of the timing of the addition of the acetaminophen. That's an A46. And that adding acetaminophen before or after the deoxygenation step would have no impact on the stability of the final product. That's that A45. Would you address the construction by the court of acquies solution? Yes. Our argument is obviously that the court can affirm based on equivalents. But we also believe that the district court aired in several fundamental ways with regard to acquies solution. The first error is that the district court departed from the ordinary meaning without any adequate basis. The undisputed information in the record, which is Dr. Bern's declaration, was that the ordinary meaning of acquies solution to those scientists in the field is simply does not require the addition of the acetaminophen

. And yet, when this court asks this morning, Excel is still cannot identify. What's the substantial difference? What difference does it make? And the district court plausibly found here that the two processes are essentially interchangeable. That's A45. That the result is the same regardless of the timing of the addition of the acetaminophen. That's an A46. And that adding acetaminophen before or after the deoxygenation step would have no impact on the stability of the final product. That's that A45. Would you address the construction by the court of acquies solution? Yes. Our argument is obviously that the court can affirm based on equivalents. But we also believe that the district court aired in several fundamental ways with regard to acquies solution. The first error is that the district court departed from the ordinary meaning without any adequate basis. The undisputed information in the record, which is Dr. Bern's declaration, was that the ordinary meaning of acquies solution to those scientists in the field is simply does not require the addition of the acetaminophen. The only thing that Excela offers on appeal to defend the district court's claim construction is the notion that it's an antecedent in an antecedent has to have the same meaning throughout the claim. But this court held a micro-processor that that's not the case. That the patenties use of a term with an antecedent does not require the vote terms have the same meaning. Now, the third problem is that the district court read out a preferred environment. Example A to the specification indicates that bubbling was that the solution was formed with continuous bubbling. The only testimony on that was again from Dr. Bern who said people of ordinary skill in the art would understand that means bubbling the water and then continuing to bubble as you add the other ingredients. That embodiment is read out by the district court's construction, which is rarely, if ever, the correct result. If we were to adopt your claim construction, would we be reading out or making the entire claim non-sensical because we'd be talking about a different active principle? We don't believe so, Your Honor. We believe that in fact the next point I was going to make is that the patenties were very clear that certain times during the method step, you do have to have the active principle. They distinguish that from their use of the bare term aqueous solution. So those two terms, this court's first sentence indicate are presumed to have different meanings. And it makes sense

. The only thing that Excela offers on appeal to defend the district court's claim construction is the notion that it's an antecedent in an antecedent has to have the same meaning throughout the claim. But this court held a micro-processor that that's not the case. That the patenties use of a term with an antecedent does not require the vote terms have the same meaning. Now, the third problem is that the district court read out a preferred environment. Example A to the specification indicates that bubbling was that the solution was formed with continuous bubbling. The only testimony on that was again from Dr. Bern who said people of ordinary skill in the art would understand that means bubbling the water and then continuing to bubble as you add the other ingredients. That embodiment is read out by the district court's construction, which is rarely, if ever, the correct result. If we were to adopt your claim construction, would we be reading out or making the entire claim non-sensical because we'd be talking about a different active principle? We don't believe so, Your Honor. We believe that in fact the next point I was going to make is that the patenties were very clear that certain times during the method step, you do have to have the active principle. They distinguish that from their use of the bare term aqueous solution. So those two terms, this court's first sentence indicate are presumed to have different meanings. And it makes sense. One point where they specified you have to have the active principle is when you put it in the vial and top it. You can't put the acetaminophen in after it's been topped. They also said at the end of the claim method, which is a preamble, obviously you're going to, if you follow the steps, you will come up with a aqueous solution of acetaminophen that contains the acetaminophen and has the prolonged stability. But in other instances, they said you just simply have to have an aqueous solution. And that makes sense because they were giving those two terms different meanings. In fact, the district court admitted in its claim construction order that the construction that are adopted renders the claim redundant. And that's problematic particularly where the redundancy departs from the ordinary meaning of the term aqueous solution. In less than any further questions on that, I'm happy to address any other issues or happy for the country. Thank you. Thank you. I'd like to go back to the Viciation very quickly. Viciation, we're saying it's a narrow doctrine. It's not we're not trying to overtake the doctrine of equivalence

. One point where they specified you have to have the active principle is when you put it in the vial and top it. You can't put the acetaminophen in after it's been topped. They also said at the end of the claim method, which is a preamble, obviously you're going to, if you follow the steps, you will come up with a aqueous solution of acetaminophen that contains the acetaminophen and has the prolonged stability. But in other instances, they said you just simply have to have an aqueous solution. And that makes sense because they were giving those two terms different meanings. In fact, the district court admitted in its claim construction order that the construction that are adopted renders the claim redundant. And that's problematic particularly where the redundancy departs from the ordinary meaning of the term aqueous solution. In less than any further questions on that, I'm happy to address any other issues or happy for the country. Thank you. Thank you. I'd like to go back to the Viciation very quickly. Viciation, we're saying it's a narrow doctrine. It's not we're not trying to overtake the doctrine of equivalence. It's narrow, but it does apply here based on planetingo. Mr. Schubert, we've updated the Viciation doctrine. You've reordered it. You want us to find Viciation before we even find equivalence. What I'm saying is that there are certain situations where you don't need to engage in fact finding. And that's what happened in both the more case and the planetingo case. And what the district court judge here did is he engaged in fact finding and says, well, because I find these differences to be insubstantial, there can be no Viciation. And I think that's doing a little bit backwards. But in planetingo, there was a determination that there could be no equivalence. There was a determination. There was all about whether the winning combination predetermined combination, whether that language in the claim predetermined combination, could be determined before the game starts or after the game begins. And the conclusion the court raised was that the winning combination cannot be predetermined under these circumstances, if unless it's determined before the game begins

. It's narrow, but it does apply here based on planetingo. Mr. Schubert, we've updated the Viciation doctrine. You've reordered it. You want us to find Viciation before we even find equivalence. What I'm saying is that there are certain situations where you don't need to engage in fact finding. And that's what happened in both the more case and the planetingo case. And what the district court judge here did is he engaged in fact finding and says, well, because I find these differences to be insubstantial, there can be no Viciation. And I think that's doing a little bit backwards. But in planetingo, there was a determination that there could be no equivalence. There was a determination. There was all about whether the winning combination predetermined combination, whether that language in the claim predetermined combination, could be determined before the game starts or after the game begins. And the conclusion the court raised was that the winning combination cannot be predetermined under these circumstances, if unless it's determined before the game begins. So there was no possibility. No restable juror could find otherwise. What they said was that. And it's entirely consistent with all of the other cases where we've in a fact used the word Viciation simply as a conclusion to reflect the fact that no reasonable juror could find equivalence to try to make that into a doctrine in and of itself that supersedes or overshadows the determination of equivalence is simply not supported. And I'm not trying to say that it is what I'm trying to say is there are certain circumstances. In that case, they found predetermined meant before. And so they looked at before and after and they said before and after, no reasonable juror could find equivalence game over. Let me say one thing about claim construction. I think all you have to do is read the claim. The claim is that it has a preamble that says the solution contains a see the benefit. And then it talks about the solution, the antecedent basis. It's black letter law. It's very clear what this claims about

. So there was no possibility. No restable juror could find otherwise. What they said was that. And it's entirely consistent with all of the other cases where we've in a fact used the word Viciation simply as a conclusion to reflect the fact that no reasonable juror could find equivalence to try to make that into a doctrine in and of itself that supersedes or overshadows the determination of equivalence is simply not supported. And I'm not trying to say that it is what I'm trying to say is there are certain circumstances. In that case, they found predetermined meant before. And so they looked at before and after and they said before and after, no reasonable juror could find equivalence game over. Let me say one thing about claim construction. I think all you have to do is read the claim. The claim is that it has a preamble that says the solution contains a see the benefit. And then it talks about the solution, the antecedent basis. It's black letter law. It's very clear what this claims about. And I see him out of time. And so I thank you very much. Thank you very much. My my solicitations for ending a discussion of plan of being old with game over.

Mr. Ward, I see that you reserved three minutes in the time for rebuttal for us. Correct, Your Honor. Okay. We're ready when you are. Thank you, Your Honor. May I please the court? The district court aired in finding that Excel infringed the two on eight claims under the doctrine of equivalence for two reasons. First, the district court failed to apply the initiation doctrine. Find no equivalence as a matter of law. And second, the district court clearly aired in finding that cadence's evidence showed equivalence. I'd like to talk about initiation first. Now the district court can strew claim one to require that the acetaminophen be in solution before the dissolved oxygen content is reduced below 2 ppm. On the other hand, it's undisputed that Excel adds its acetaminophen to water only after the oxygen content is below 2. District court rightly found no literal infringement, but wrongly found infringement under the doctrine of equivalence using a fact-based, insubstantial differences test. This was error that the court should have applied the initiation for all limitations, doctor. Specifically, what difference does it make when the acetaminophen is added with purposes for the doctrine of equivalence whether it's before the deoxygenation or before the deoxygenation during the entire process or at a certain point in time in the process as long as it's in there? But you have substantially the same result. The issue here, Your Honor, no, that's not correct. That's the fact that they inquire that the district court made that it should never have gotten to because what the court should have done is looked at this and said that the claim requires the acetaminophen to be in before. Excel puts it in after that falls strictly within and straightly in the rationale of the planet bingo case. In a planet bingo, what happened there was the claim required a winning combination to be chosen before the first ball was picked. The accused infringer, their winning combination is not chosen to laugh at that first ball was picked. The district court level, the patent he argued, there's no real difference between before and after if you do it is basically the same thing. The court ignored that evidence and said no, we have a situation here where we have a polar opposite or an antithesis. And so we're not going to look at that factual evidence. We're not going to look at that determination. And it made a summary judgment ruling of no infringement. The court of word seems to be your assessment of this vitiation doctrine is not correct because you seem to be saying that well the court should first look to see if the claim reads directly on the accused and if not. Then the question is well, is there a vitiation? And if there's vitiations, then you don't look to see whether there's substantially the same function way result. But that's not really what our law says that you look first to see whether there could be an equivalence, whether there could be some evidence to show that it's substantially the same function way result or an insubstantial difference. If there is no way a reasonable juror could reach that conclusion or if there's no proper legal basis for the equivalence determination, only then would you conclude that there's vitiation. That's squarely what we said in the depuse fine case. Your honor, if you look at the plan at Bingo case and the more case and you go back to Hilton Davis case, the court talks about certain instances where you have certain differences that are such on their case that no reasonable fast finder could find equivalence. For example, in the more case, it was a majority versus a minority. In the facts there were one, the patents he required, but a strip go the majority of a sheet. The accused infringers strip went 47.8%. Both on at the trial court and on the appellate level, the argument was we should have been able to say that 47.8 is insubstantially different from 50.01. In both cases, in the appellate court here, the federal circuit said that's not, you're not allowed to do that here because these words, majority of the minority are such that no reasonable fact finder could say that they're equivalent. And that's what we have here. That's the same in plan at Bingo. The court and plan at Bingo said these words before and after when this ball is chosen or such that no reasonable fact finder could say equivalence is present. And so they didn't get to that. But you can't read those cases again for some rigid black and white doctrine that would obviate the reliance on the doctrine of equivalence. Every time there's a difference between the claim and the accused structure. Because otherwise, you just simply read out the doctrine of equivalence and that's not right. Do I agree with that, Your Honor? Well, I mean, what you said a moment ago at the beginning of your comment was that in those cases, the plan at Bingo case and the more case that no reasonable juror could conclude that there was an equivalence. And that would call into play the so-called vitiation conclusion. In effect, vitiation is simply a legal conclusion reached when there is no proper basis to conclude that something's equivalent. It's not the other way around. But Your Honor, in some of these cases, what I'm saying, you're in plan at Bingo and more, for example, the vitiation conclusion was reached without a consideration of the evidence because these were some rejoicement decisions. Mr. Ward, let me take an oval somewhere else different. In your opening grade, you rely on examples from the 222 to argue it should be invalidated in his obvious. Yes. Where in the record is your expert testimony regarding that issue? Our expert testified regarding the 222. I will give you the site, Your Honor. Our expert Dr. Palmieri went to cited example 2.2 at A20934 to 35. And what he said was, again, I'm sorry. A20934 to 35. And there, Dr. Palmieri was talking about example 2.2 of the 222 pattern. And what he said was, and what the example says is that it discloses that based on work that they did, that the acetaminophen contrary to what the previous conventional wisdom was, may actually react first with the oxygen in the solution. And that's the testimony he made. And he said, one seeing that would then know that you'd like to remove as much of the oxygen from the system as possible. There's other evidence in the 222 pattern as well, Your Honor. There's evidence that the patent itself says the ability of the pan's on removal of oxygen from the carrier. Claim 2 of the patent itself talks about a formulation where the aqueous medium is deoxygenated. And so it recognizes deoxygenation is important. And Dr. Schunen, Tadenes' expert, to find deoxygenation is meaning removing as much oxygen as possible from a system. So there's definitely motivation in the 222 pattern to remove as much oxygen as possible. And the way that you do that was known. It was known from the papers of Dr. Paul Meieri and Dr. Schunen that were preceding the 218 pattern by many, many years. And there was also an admission in the 218 pattern that it was easy to remove oxygen or deoxygenate all solutions in air tight tanks. And so one reading the 222 would understand they should remove as much oxygen as possible, which is common sense. If oxygen damages the system causes degradation, get rid of it. And you know how to do it. And you have a reasonable expectation of success because the technique to do so has been around for a long time and the patent says they're easy to do. And then when you get to the secondary considerations, if you agree with us on that there's no infringement with either with respect to the initiation doctrine because there was no evidence, then there's no nexus between the commercial product and many of the secondary considerations. So they're out. But even if you don't agree with that, the problem that we had here was that the district court said that the 222 pattern that these commercial products are also embodiments of the 222 pattern and embodiments of the 218 pattern. And it never made any any analysis of what the 218 pattern added to the commercial product that was not present from the 222. And under the Ohio Willowood case, that's not sufficient to show these secondary considerations such as commercial success, long felt need licensing and praise because there's no separation between. That that was due to the 222 pattern versus that, which was due to the 218 pattern. Judge Lynn, I would like to come back briefly to one one remark you made. I'm not we're not advocating for the abolition of the doctrine of equivalence. What we were saying is that in certain instances, such as the one we have here, no fact finding is necessary. And I realize in brilliant instruments and some other cases has been pushed back from the court saying it's not a situation. It's not we're not just talking about binary choices. We're not talking about a situation. Well, we don't have the literal thing. So it's not present. That's initiation. That's not what we're talking about. We're talking about a situation where you use these types of words before and after. That's one that was chosen in line ofingo where somebody looks at this and they know without engaging in the fact finding. You said in front of being a didn't make sense to change the order of the step of things. And here it does make sense. They never got into the issue of whether it made any sense to change the order. That was the argument that the patent he made it made it made no difference whatsoever. Whether that winning combination was chosen right before the first ball or right after the first ball in the court said we're not going to we're not going to delve into that. And that's what we're saying here. You don't you don't you don't get to that point because these words before and after in the way this claim was drafted. No reasonable fact finder confined infringement under the doctor approvals. I'd like to briefly just get to one other infringement issue on the 218 patent. And that is the issue of the pressure step. Pressure step was found to the optional when I'm talking about there is reducing the pressure to below 65,000 passcals. Showing to be optional the district court found it to be optional. We believe and we believe the evidence clearly shows based on the file history that that is a requirement. And it's it's a requirement because the examiner said it was requirement. And then the patent he distinguished his invention from the prior art to to to patent. Based on the pressure step, but it isn't the product to talk about the backing package step. It isn't that an option. No, it's not your honor. At the very least it's not optional based on the on the prosecution history. Does it optionally modify that step? The word option in the claim. Optionally in the claim appears one phrase before it. So there isn't there is there is an argument that it doesn't modify it. There's an argument that it doesn't. Our point is what you do. What's your argument? Our argument is even if the claim said it's optional. It is no longer optional because of what happened in the file history. That's our argument and we say it's despite what it says in the claim. If you read the claim is saying it's optional. The file history clearly shows that it's not because the inventors relied on it to distinguish it over the two to two patent and called it the pressure requirement. I see him into my rebuttal sir. Stop. Okay. Thank you. Thank you. Shuler. Good morning, ma'am. Please the court. Unten Shuler and I'm arguing today on behalf of both. Caden's and former top at the outset unless the court would like me to address a different subject. I will start with equivalents. I will start with the case. You know, Excel is up to to cast this is a before versus after per safe formulae rule. You know, squarely for close we think by the spring courts decision in labor tank, which emphasizes that. Equivalents is not the prisoner of formula. It can't be considered a vacuum. In fact, things that that for some purposes may be different. In other instances might be equivalent. Ambition is not some sort of exception. As the court noted, it is simply the outcome of the instantial differences. What do you say to your opponents argument, I asked you the application of a plan to be able to this case. I would say three things. First, that you can't formulaically or, you know, do a per se before it could never be the same as after. But more fundamentally, they're factually wrong. This isn't a situation of before versus after. The district court found in the evidence show that Excel and bubbles both before and after. They have the acetaminophen. And the district court found that that was insubcantially different than bubbling before. The second point I would make is that it's, this is a method step. And the activity that's specified is the oxygenation of the solution by bubbling with at least one inner gas. To until the oxygen content is below two parts per million. Now, the opposite of the oxygenation will be oxygenation. The opposite of an inner gas would be a non-intergares gas like oxygen. The opposite of until below two parts per million would be until above. So the antithesis of this particular method step would be oxygenation of a solution by saturating it with a non-intergares gas. To achieve a higher oxygen content than what is specified. And so that's the second point we would make. The district court's findings, by the way, were very specific. The district court found that Excel is argon blankening is bubbling. That's at A39. It also found that the argon bubbling deoxygenates the solution. That's at A17. It also found that Excel employs argon bubbling after it adds the acetaminophen. That's at A17 and obtains a final dissolved oxygen content of below 0.5 parts per million. Now, in the context of this claim, the method step at issue, given that Excel has challenged none of those predicate findings, those clearly erroneous. The district court plainly did not initiate those claims at issue. The other point we would make is that this court has held that the initiation effectively, excuse me, requires to find out that no reasonable fact finder could find equivalents. And here we had a fact finder that found equivalents. So Excel has to identify something that the district court did. That was so unreasonable that in other words, the fact finder was so unreasonable that no reasonable fact finder could have found equivalents. And yet, when this court asks this morning, Excel is still cannot identify. What's the substantial difference? What difference does it make? And the district court plausibly found here that the two processes are essentially interchangeable. That's A45. That the result is the same regardless of the timing of the addition of the acetaminophen. That's an A46. And that adding acetaminophen before or after the deoxygenation step would have no impact on the stability of the final product. That's that A45. Would you address the construction by the court of acquies solution? Yes. Our argument is obviously that the court can affirm based on equivalents. But we also believe that the district court aired in several fundamental ways with regard to acquies solution. The first error is that the district court departed from the ordinary meaning without any adequate basis. The undisputed information in the record, which is Dr. Bern's declaration, was that the ordinary meaning of acquies solution to those scientists in the field is simply does not require the addition of the acetaminophen. The only thing that Excela offers on appeal to defend the district court's claim construction is the notion that it's an antecedent in an antecedent has to have the same meaning throughout the claim. But this court held a micro-processor that that's not the case. That the patenties use of a term with an antecedent does not require the vote terms have the same meaning. Now, the third problem is that the district court read out a preferred environment. Example A to the specification indicates that bubbling was that the solution was formed with continuous bubbling. The only testimony on that was again from Dr. Bern who said people of ordinary skill in the art would understand that means bubbling the water and then continuing to bubble as you add the other ingredients. That embodiment is read out by the district court's construction, which is rarely, if ever, the correct result. If we were to adopt your claim construction, would we be reading out or making the entire claim non-sensical because we'd be talking about a different active principle? We don't believe so, Your Honor. We believe that in fact the next point I was going to make is that the patenties were very clear that certain times during the method step, you do have to have the active principle. They distinguish that from their use of the bare term aqueous solution. So those two terms, this court's first sentence indicate are presumed to have different meanings. And it makes sense. One point where they specified you have to have the active principle is when you put it in the vial and top it. You can't put the acetaminophen in after it's been topped. They also said at the end of the claim method, which is a preamble, obviously you're going to, if you follow the steps, you will come up with a aqueous solution of acetaminophen that contains the acetaminophen and has the prolonged stability. But in other instances, they said you just simply have to have an aqueous solution. And that makes sense because they were giving those two terms different meanings. In fact, the district court admitted in its claim construction order that the construction that are adopted renders the claim redundant. And that's problematic particularly where the redundancy departs from the ordinary meaning of the term aqueous solution. In less than any further questions on that, I'm happy to address any other issues or happy for the country. Thank you. Thank you. I'd like to go back to the Viciation very quickly. Viciation, we're saying it's a narrow doctrine. It's not we're not trying to overtake the doctrine of equivalence. It's narrow, but it does apply here based on planetingo. Mr. Schubert, we've updated the Viciation doctrine. You've reordered it. You want us to find Viciation before we even find equivalence. What I'm saying is that there are certain situations where you don't need to engage in fact finding. And that's what happened in both the more case and the planetingo case. And what the district court judge here did is he engaged in fact finding and says, well, because I find these differences to be insubstantial, there can be no Viciation. And I think that's doing a little bit backwards. But in planetingo, there was a determination that there could be no equivalence. There was a determination. There was all about whether the winning combination predetermined combination, whether that language in the claim predetermined combination, could be determined before the game starts or after the game begins. And the conclusion the court raised was that the winning combination cannot be predetermined under these circumstances, if unless it's determined before the game begins. So there was no possibility. No restable juror could find otherwise. What they said was that. And it's entirely consistent with all of the other cases where we've in a fact used the word Viciation simply as a conclusion to reflect the fact that no reasonable juror could find equivalence to try to make that into a doctrine in and of itself that supersedes or overshadows the determination of equivalence is simply not supported. And I'm not trying to say that it is what I'm trying to say is there are certain circumstances. In that case, they found predetermined meant before. And so they looked at before and after and they said before and after, no reasonable juror could find equivalence game over. Let me say one thing about claim construction. I think all you have to do is read the claim. The claim is that it has a preamble that says the solution contains a see the benefit. And then it talks about the solution, the antecedent basis. It's black letter law. It's very clear what this claims about. And I see him out of time. And so I thank you very much. Thank you very much. My my solicitations for ending a discussion of plan of being old with game over