i would like to start with claim construction and then move on to the real party and interesting issues in the proceedings below a panel of the p t a be held for the first time that an indisputable a toxic composition pharmaceutical composition reasonably and very broadly to mean a composition suited for pharmaceutical use the panel below ignored judge starr explained construction never performed its own clean construction but worked backwards apparently from its conclusion that the prior art anticipates the seven for five patent claims so look you've got a composition too and it's all in the focal wall of the  to be approximately one hundred milligrams it did achieve the scene x and you see parameters but it was with a toxic substance and there's no evidence to the contrary it's a highly toxic substance has to do with the parental p k parameters so i'll i'd like to address each one on the subject of the p k parameter as i say as i mentioned a moment ago because the dogs weigh ten to twelve kilograms each  the average weight of which is seventy five and a half kilograms that would mean a dosage of seven hundred fifty five milligrams of product so so i believe your honor and submit respectfully that it's an apples to oranges comparison but but moving beyond that but there is an ordinance seems to assume again that the claims are limited to humans well yes and again jetstar cat found that the claims are limited to humans we respectfully submit that to humans wouldn't apply if the claim covered beagles if the claim covered beagles that would be right your honor but our position certainly is that our claims cover humans because  pharmaceutical composition did not completely exclude all possibility of texas well when that we're not saying that no toxicity can be tolerated we're not saying that of course we're all familiar with chemotherapy and other other certain types of drugs which have toxicity what we are saying is m f b ten forty one has toxicity but no therapeutic benefit no therapeutic   our position is that a pharmaceutical composition has to have a sump form of established they're a pubic benefit and if you've got a product that's purely toxic and that has no proven therapeutic manifest and there doesn't seem to be any dispute in this case that and the beat ten forty one has no proven therapeutic benefit i thought it was the point th was was to inject less to admit not inject to administer its product to the beagles and determine the p k parameters there's nothing in the kind study that that talks about the therapeutic benefit in fact the beagles were healthy that's what the article sets they weren't sick beagles who were then treated and cured or in some way their condition improved that's not at all in the article the kind of article talks about p k parameters it does issue we submit your honor that the p t have aired in two significant respects and first of all as a matter of statute and regulation we submit the statutes and regulations are unambiguous and do not permit the p to have to do as it did and second and equally important regardless of the first point the case does not fall within the interests of justice and i'd was we have to spend a lot of time and resources fighting this battle we got a lot of resistance we had to go through discovery of you that's because of us to talk and resources yes i have yes but maybe that was with bad judgment because all of was was updating with the name of the obviously parent company well the different party but i'd like i'd like to truly put this in the perspective of the american vence act remember your honour's that that statute was enacted in order to provide an alternative pathway for petitioners and as we all know the prior regime was different one of those is a disclosure of all of the real parties in interest and in the regulations that were instituted to implement that statute and in particular i'm citing section forty two point one hundred sixteen the judgment is this is really this late filing at least under the provision that talks about the interests of justice well i think the regulations have to be read in that read in their entirety and we start with forty two point one zero six it says a include your real party in interest in your original filing it was defective and we will not allow retroactive hewett did the people have in this case it would conclude that m c i is actually a real party interest or they'd just simply allow it to be added a an amendment in which they represent that the parent is a real party in interest was not filed with any kind of reservation of rights or anything like that simply sent but they've taken the position that it wasn't a real party  interest or and that the notion that the parent company is sort of an area that will party interest of a subsidiary would be correct right well we're not claiming that inherently a parent is always going to be a real party in interest we agree that that's not that's not a principle of law but we had we had developed sufficient evidence in our view that in this particular case it was a real party in interest where the market they follow up because they read with you but because they that they that this was not a blunder or not mission by clarke or anything like that that the deposition testimony taken from two in house attorneys at merck including a very senior person was a vice president that testimony indicated it was a deliberate decision it was it was considered contemplated but it was deliberate because they didn't think m c i was a party just at least that's their explanation well yes and no your honor they do say that in along the way but in response to the specific question they invoked legal they said it's a legal strategy they invoke privilege and we're not challenging the invocation of privilege but at the same time i think everybody can see that this wasn't a clear yes conscious opportunity for a retroactive filing under the interest of justice and your honors if i may just add another thought to this and they determined there was no prejudice there was if there was a finding of no prejudice y never back date the petition filing date if to do so would be a violation of three fifty our position is is the only outlet provided in the regulations is forty two point one o foresee which trucks about a clerical or typographical error or their position on that point is they say well that's makes it clear that that we always have to back date in those circumstances but it doesn't think we can never back date and others sure but once the director had promulgated regulations that specifically identify the the backdating issue and limited the back decisions by the p t b that's how they consistently interpreted their own regulations if they aren't our deference to hear that to the extent they're interpreting their regulations to say the interest of justice probably the person they the entity to raise our standing has chosen not to do it so i think that's a very significant point but beyond that moving into the merits of our this we need to there's no ambiguity there's no ambiguity here the interest i'm just to set forth and i submit your honour's that the court does not need to formulate a definition i would submit that if that if the court were to find that a deliberate strategic decision to withhold a real party and interest from the petition somehow means the interest of justice just because the adversary has not met a and invented burden to establish prejudice that would exercised its discretion in allowing us to add a party of interest i have a couple of points here first the board spent a considerable amount of time looking at this wasn't a fly by night evalu first found that main had not presented enough evidence to oppose opposition to oppose institution at the institution freeze and then it held to teleconferences and in its final written decision so it carefully considered this issue looking at real world facts is there a party that would have been a real party in interest or even a pretty much don't have to be named in petitions for i p r if there had been such a party that existed at the time the petition  the inquiry we're talking about here whether and aren't guys actually named in the petition is a leading requirement and that is fully within the board's discretion to figure out exactly i mean obviously you've got a situation in which the board is is permitted to accept the statements on the face of the petition that these are all the real parties in interest but it can't be the case that that therefore if that's a completely false statement the board can just ignore it every time even if it creates a time i mean the board's own regulations are pretty logical here they're saying ok we're going to accept it on its face well assess the military have it after the fact and the way the regulations they say if we find that someone else should have been the real party in interest then that's the new filing date and that's very consistent with the fifteen be so why why are we even talking about that a national look an assumption that all the real partisan interest to apple and i don't mean to limit it to the initial look what the regulations provide the board to do is in its discretion determine if the petition is sufficient and that includes whether the real party interest has been properly named and if there should be an amendment leader it's that is expressly permitted under rule forty two point five and main is ignoring that rule and there's a and i think the conversation this morning frankly resolves the issue if they are so on firm super tough position there was a point that the board did not consider the just report construction that's incorrect at appendix ninety one it clearly acknowledged that storks decision but of course the board wasn't applying that phillips standard it was applying a recent a broadest reasonable construct but it would still have to be reasonable i mean that but it does exist of course said it only makes sense for this to have to apply to humans and and looked at all the elements of the claim not just some of the things that were said and this was patients that logically this pharmaceutical company action and that the blood parameters that were outlined have to apply to humans right no your honor and i frankly our view is on that construction that's the where and in vivo terms on that construction the district court was wrong even under its owner but certainly from the broadest reasonable interpretation it does reach animals and that's for two reasons the claims for don't limit themselves to humans and when you look at the specification it hasn't humans once it's talking about admin limited to humans the district court then said but even if limited to humans that doesn't prohibit some level of toxicity right on that issue the toxicity issue  suitable composition term and i've a couple of responses on that the first is that patentability is not the same as f d a and what maine is arguing here is an f d a standard in its view i could not have been afforded pharmaceutical composition because it was toxic and thus not suited for pharmaceutical use that was it school argument about pharmaceutical composition toxicity not the sort of w factor and i will point out that there was and there's another term in the patent drug and that is where maine's made some of these arguments but have not pursued or challenged the determination that qaida is a drug so it's really not toxic doesn't change anything i think the board also found the claims obvious and so whether it's limited to humans or whether the sliding scale the board was also correct in finding the claims obvious i'm happy to address question on the review ability of it in the first instance wife i won the support on ponte directly addressed the review ability of questions under three twelve a to do and drew a line between that and the review ability of questions about anything but we do have under the a p a the ability to review the board's application of its own regulations right well in general yes but not when congress has decided that something is not reviewable and here section three twelve three for fourteen d says that certain things in the institution question are final and on appeal a point to the question is if it's because we have the overlay of three fifteen bt whether or not the the on review ability of institution decisions allows the board to ignore its own regulations and even where three fifteen b might otherwise it specifically addressed the question of when it's a question of three twelve a two real party in interest it's not reviewable because that is a question about not about the real world that a petition was filed by m s d e in a timely manner and that it would have been timely for even if m c i had filed its own petition separately on that same day and that would have also been timely and that is precisely the situation that is addressed in life i won at footnote nine and it talks about the electic case and it talks about petition fails to identify all real parties in interest under three twelve eight to the director can and does allow the petition to as a real party in interest and that's in the context of a you're saying that under the a p i we guard list of what the regulations are we can't review whether or not the board perhaps ignored its own regulations that spite the notice and comment that said this is how it's going to work in this scenario that's right because congress specifically said that these things are final and not appealable and that overcomes a p the a p is general preference for review now there are still exceptions as the supreme court impose a pointed out fo ordinary questions at the institution phase including the sufficiency of a petition under section three twelve as soon as i know that we believe we have jurisdiction and so that we're looking at the regulations you agree i take it that the only pocket available for the backdating was that in the interests of justice that's right i and how do you define that term well that it's not really a question about definitions i think i think it's more a question of  two decisions from this court that in our view firmly address and establish review ability in our contacts one is worlds versus bungy the other is applications and internet time versus  x and world's gross's bungy the court stated that under thirty five u s c three twelve a true and i p r petition may be considered only if and i'm skipping some of the wording the petition identifies all real parties in interest and the court went on to say correctly identifying all real parties in interest is important as the determination may impact whether a petition may be instituted and it cites section three fifty eight so so it seems to me that we're well past the point that the solicitor has identified and we are now well within an established set of case law that that has determined that a review of a real party in interest of terminations by the p identify a real party in interest that was not one of these might minor minor technicalities that are of no particular importance to the country in world versus bungy the courts that it is important  if i can speak very briefly very briefly as the red light is on one place i just want one more minute on the on the claim construction i just want to leave the court with the following thought there's a there's a difference between a drug and a pharmaceutical composition and a drug in the sense of say a molecule may be toxic but when when formulated in a any composition the toxicity could be mitigat that could happen so those are really two two distinct concepts that i just want to leave the court with and then in the context of m at the ten forty one there is no evidence that an oral dosage of and that the ten forty one in any