intend to get into any confidential information so at this point in terms of the issues novartis takes a frontal attack that section one fifty six cannot cannot a very mechanistic approach that satisfying one fifty six requirements to get the p t e in the first place is immunity a shield a defense from any double patenting type of argument that can be raised and it logically creates a problem that nowhere in section one fifty six the text of one fifty six itself doesn't say that double patenting is excluded from one of the defenses and if you take that approach and import double pathing as a defense or as an exclusion from section one fifty six p g a attacks then there's no logical reason why section one of two defenses one of three defenses one twelve defenses and equally to be raised in a  challenge so in the red brief they have consistently taken the approach that this man mystic approach a satisfying one fifty six requirements is the end of that is the end of the question they say this repeatedly for it and read brief from twenty six to twenty  but what's important to understand is at the very same time when one fifty six was being promulgated back in one nine hundred eighty four they all say the congress included as very specific exclusion in section two eighty two in the defense of section and they said specifically when it comes to patent term extensions in section one fifty six you're not allowed to challenge the due diligence period congress knew what it was doing when it sat here's one fifty six as are granted p later in section two eighty two as a defense they've taken that as a carve out in congress if they don't like the fact that double platinum can be used to remove patent term extension they can fix it and they have taken all those opportunities to fix it congress is also done so in another section in section one twenty one it says in the divisional practice that there is a safe harbor you cannot use double patenting against a patent that i divisional of a parent and you can't use double patent so congress is well aware of these situations and they can take action should they choose to but let's focus our attention exactly on what this situation is here originally we had the two to nine compound patent set to expire in february of twenty fourteen however at the very last day right around the patent expiration the patent term extension with actually granted it and kicked it out until february of twenty t to one claim claim forty eight that has been extended which is a method of use claim within the two to nine compound of the two to nine patent now we note that in the final judgment claim forty six was also included but claim forty six was actually not part of the p t e and therefore it died its natural death back in february of twenty fourteen and when we look at that we see the five six five patent specifically claims from golmaal again there is no dispute absolutely no dispute that fingall a lot is the basic chemical compound that has receded in the five six five patent and then when you add to that what these what do these patents claim th the compound in the method of use of using that compound as i mentioned before and then in addition the five six five cat patent claims the method of use novartis took various actions to ensure that these patents were listed in the orange book peats when the n d a was granted in september of twenty ten they had a thirty day period under a law under three fifty five b one to list the patents that they thought that they could list in the orange book that claimed guideline their n d a approved product is thirty day period to do so so you look at your arsenal of all your patents that you have and you make a decision strategically that very analysis that's used to determine whether in fact these patterns are not related in our ezra case these patterns are not continuations of each other they're completely unrelated you know in terms of their lineage or their ancestry and that in addition in this particular case you know both the underlying two to one pattern ha lived its whole life i mean it naturally expired in february of twenty nineteen the method of use patent the five six five has lived its full twenty year life but to the extent that there are distinctions that can be made is that the precise issue in the literally said the issue that was presented before them was whether the term a double patenting can be used to cut off a p t e for a patent that had already been terminated despite that's not the issue here the holding in  also said the same thing related to the fact the holding in the issue as presented did discuss the fact that there was a troll disclaimer that was already in place the preacher made it the natural life of that pattern and then whether p t e could be stacked on to that patent so in this in that as i said so in this case we are not in that situation where we have patents that are being prematurely terminated we are not having any issue of lineage and whether one patent is being used against what we are saying is that and just to be more direct what we are focal point here is on what happened in that sixty day period of time nothing in the market the high tech artist had various choices to make now in the merck ace there was no choice to make they could not have made the proper choice because in the merck case that other patent did not cover you could not have been subject to a p t e more crude not have selected both and then during the p t e process evaluate the patents and then when the p t was ready to be granted normally the m p allows you that choice select which one you're actually going to select this is what we've always been arguing that novartis had these options available to it it ought to have taken that diligent approach it has to make the choice of when to apply for p t e the patents that it applies to and then ultimately the patent that it selects for the p t e has to be a thoughtful choice a thoughtful choice that says when this five six five patent in this case expires how does one practice the invention of the five six five patent without running afoul of the two to nine patent one can't there's been no dispute that there can be no practicing of the five six five patent in this case  dues no language about choice because there was no choice to make what i quoted the legislative history about a flexible choice because an earlier bill had restricted the pat down or to take particular statements here in by congressman waxman and congressman bliley in the house report i would note that they had specifically said that in selecting p t e all other aspects of the patent law do apply right and all other the court i'm jane love for you have a police section one fifty six commands that the p t o shall extend the term of one patent selected by the patent holder as partial compensation for the time lost during f d a review in this ca only one patent was extended only one application for extension was island and only one extension certificate was granted as was argument that the extension on this one patent effectively extended another has no precedent and proper even if it extends into the time that was cut off by a terminal disclaimer to obviate a double patenting rejection the merck opinion says quote the terminal disclaimer did not for clo term is entitled to be extended so it is here as read does not even question this point as a identifies no requirement in section one fifty six that was not fulfilled by the patent holder as this court explained in merck section one fifty six legislative history supports its reading of the law congress rejected a draft bill that applied p t e to only the first issued patent instead the law makers wanted the patent holder to have flexibility to choose as they put it the most important  was inconsistent with the idea that expired patents are dedicated to the public as or is mistaken the expiration of a patent has the effect of terminating exclusionary rights ranted only in that patent there may exist other that's correct your honor i guess another way another example could be if the patent that extended by say five years under section one of their ad in fact in should have been instead of going just five years beyond the first issue it's going six or seven years beyond the first issue because it should have but did not get some of this  hard to say your honor without the rest of the facts of the case in order to see if there is actually something unjust going on there is clear record from this court in the iliad case that shows the patent term extension being an exception to double patenting that footnote was brief in its dicked of the case but it is there and it may have an assumption underlying it that everything else was proper and therefore there would be an exception in your question as where there was something improper in that there was mean the pharmaceutical context congress permits the situation to exist multiple patents and those multiple patents covering an approved product works directed by congress they expressly wrote into section one fifty six that the can select one of them for an extension weighing other policy concerns congress narrowed the nature of that extension that is the whole scope of the original patent claim is not extended the rights granted under section one fifty because section one fifty six granted only a narrow right limited to fingal a month for the approved use the public could practice the five six five patent upon its expiration in for example methods for mammals other into a double patenting reference again as well as wrong obviousness type double patenting is a doctrine created to stop unjustified extension of the patents are section one fifty six is a law commanding extension of term if the statutory requirements are met and it is the epitome of a justified circumstance a patent term extension double patenting does not apply to the limited rights granted within a patent term extension here as are attempts to create an issue where there is none of the five six five patent was never a double patenting reference against that you two nine patent it would have been impossible for the five six five patent to be a double patenting reference because the five six five patent was filed months after the two to nine patent issued in other words the five six five patent application was not in existence when the two to nine patent was undergoing examination as was argument ignores the fact as wrist position would frustrate the purpose of section one fifty six according to as root once that you two nine patent received the patent term extension the five six five patent was suddenly converted into a double patenting reference it cannot be that the patent term extension once granted is immediately taken away judicially created doctrine to undo congresses and have big u s language and purpose that mature into law consistent with the two thousand and seven mark decision this court recognized in the two thousand and fourteen gilliatt decision that section one fifty six term extensions an exception to the general rule although it's not as holding as i mentioned the footnote correctly states how section one fifty six squares with the judicially created doctrine obviousness type double patenting simply does not apply to extensions under section one fifty six elsewhere the patent statute itself confirms that double patenting cannot be used to invalidate a term extension section two eighty two sets out affirmative defenses to patent infringement section two eighty two c is particularly directed to invalidity of term extensions under one fifty sex it only states that a material failure to comply with section one fifty six briefs as rose reliance on the non binding district court case no hardesty breckenridge is inappropriate it's not binding on this court even if it were binding the section one fifty six extension was not at issue in that case the district court explicitly stated quote it is not the section one fifty six extension that is at issue here the double patenting reference in question in breckenridge was eligible as a reference before the p t o award and after and the party stipulated in that case  double patenting here the five six five patent was not eligible as a double patent in reference and the parties have not stipulated to double patenting finally even if as we were right ten lastly three minutes ago we don't get to s pleadings as were declined to bring up any evidence before summary judgment or trial there was no claim construction no expert testimony no evidence and double acting so even if as a right the double patenting could apply here as or h now you're on i wanted to respond to judge chance question regarding what defense might be available for double patterning whether the patenting struggle as i might i don't see that inexorable conduct is in section one fifty six or in section two eighty two i can't see anywhere in those statutes that allow us now a double patterning only to be made for an echo will conduct and why not all conduct why now why here why that one and if you take novartis at face value the mechanistic approach to satisfying section one fifty six is an absolute immunity once during the p t e there is no defense at all whether under section one one one zero two one of three one twelve that can be made or it is also mentioned extensions there may be changed expiration dates it's a holy on remarkable proposition to have said no artist also criticized as well for not establishing certain facts regarding the five six five patent it was our contention that the judge was wrong the facts were established and they were clear and they were undisputed there was no further expert an expert testimony would have been needed no expert would have been able to testify  that these patents actually belong at that point in time there was a sufficient evidence to hold that the double patenting is a proper basis and with that