Louisiana Challenge’s AstraZeneca on Antitrust Claims for Asserting Invalid Drug Patents

In March 2015, the state of Louisiana filed suit against AstraZeneca alleging antitrust violations based upon the company’s actions of using its patent rights to keep generic versions of Toprol-XL off the market in Louisiana.  AstraZeneca does have patent coverage, but the state argues that the patents are both invalid and unenforceable. Read the Original State Law Complaint filed in the Parish court of East Baton Rouge.

Now, AstraZeneca has filed a notice-of-removal of the state court lawsuit to Federal Court. The plea for removal argues that the case requires determination of a substantial question of patent law (as well as other federal questions).   Under 28 U.S.C. 1441(a), removal is allowed for “any civil action brought in a State court” so long as the Federal District Court has “original jurisdiction” over the case.  In general, this is thought of as “federal question jurisdiction.”

Since Louisiana is not alleging a federal cause of action, the courts will look to the Supreme Court’s analysis in Gunn v. Minton, 133 S.Ct. 1059 (2013) to determine whether the implicit Federal Questions are substantial enough to warrant divesting jurisdiction from the state court.  Gunn was a patent law malpractice action that required determination of a number of patent law issues (such as the experimental use exception to Section 102). In that case, however, the Supreme Court found that the the patent questions were not of sufficient importance to “the federal system as a whole.”

There are a number of ways to distinguish this case from Gunn. In particular, in Gunn the Supreme Court found it important that the outcome of the legal malpractice claim would have “no broader effects.”

[A state court decision on malpractice] will not stand as binding precedent for any future patent claim; it will not even affect the validity of Minton’s patent. Accordingly, there is no “serious federal interest in claiming the advantages thought to be inherent in a federal forum.”

Gunn (quoting Grable).

Here, the outcome of the Louisiana case could have a major impact on how courts across the country handle AstraZeneca and its patents, and how courts will consider allegations of patents improperly listed in the Orange Book.  This leads me to the tentative conclusion that the patent (and other federal) questions may well be substantial enough to allow for a Federal Question.  If so, the colorful Attorney General Buddy Caldwell may soon be face-to-face with the Federal Circuit. (Read the Notice of Removal).

71 thoughts on “Louisiana Challenge’s AstraZeneca on Antitrust Claims for Asserting Invalid Drug Patents

  1. 9

    AZ’s patents were eventually deemed to be invalid. Big deal. That doesn’t make AZ’s asserting them before that time, or listing them in the OB before that time, an antitrust violation. Beyond the usual showboating by a politician, this case sounds to me like a cheap attempt to steal money from a company that actually made some. And if it were to proceed it would spell death for the patent system.

  2. 8

    A little OT but a great article from ol robert reich. Even if you hate him and think he’s dum b he’s still not bad at analyzing what has occurred as an economist.

    Check it out, IP and patents in particular get a mention, front and center.

    link to prospect.org

    1. 8.1

      6, I think his analysis for IP for pharma is somewhat correct, but like a lot of economist they don’t get IP for CS/EE because it came after they were educated. They typically don’t understand computers or information processing and tend to day things like you just write down what you want and some boy makes it work, or they seem to confuse machines that process information with their own brains.

      But, I actually respect RR a lot and think most of what he says is right. I think too that put within the big picture of RR’s paper there can be only one conclusion that the anti-patent movement is being funded and pushed by big corp. That the weakening and destruction of the patent system is being pushed by most of the big players but not those that are making money from it like big pharma and IBM. Had big pharma gotten its way of bifurcating patent law with the AIA there would be no other patents now worth anything.

      So, read the big picture of RR’s paper. Big corp is shaping the law and now most of the big corp wants no more patents. If they could only bifurcate, then they would get their way. (Note too that it is not hard to figure out that the Fed. Cir. Google judges favor pharma and punish all other patents. The trick they are trying to find is a way to end patents for all other but pharma.)

      I would expect many disruptive comments to follow from the Google paid blogger MM.

      1. 8.1.1

        You would think that the obvious path of promoting protection for the means of innovation MOST accessible by “the common man” would be an ideal for such left-leaning folk….

        The dichotomy of Malcolm’s attacks against this mechanism, against software per se simply stands in sharp contrast to that path.

        He ever seeks to disparage and belittle software and to seek to place the number one form of innovation outside of the domain of patent protection.

        He “claims” at the same time the non-compatible “stand” against “grifters” and “1%ers”… (and yes, he constantly pushes for patents only for the expensive “but for” rationale.

        Read the Reich article with a mind open to the understanding that the patent system has been under attack by both the Left and the Right, and you will see that this is a position paper for the Left in a post-patent era. Throw in the continuing (gratuitous) attack on patents from the typical Left policy view (while omitting the complicity in allowing the Right to play regionalism in cost factor switching – the real reason why the U.S. has the highest pharmaceutical costs of any advanced nation – we simply pick up the lost profits from the poorer nations – and those portions of the screed can be seen for the typical Left propaganda that they are.

      2. 8.1.2

        “I think too that put within the big picture of RR’s paper there can be only one conclusion that the anti-patent movement is being funded and pushed by big corp. ”

        I thought his paper was itself “anti-patent” in your mind? He’s against the recent expansion of IP that you’re for bro.

        “Big corp is shaping the law”

        I agree he is saying that, but he’s saying that IBM’s etc, the pro patent people are what’s ruining the econ for everyone else because they skimmin off the top and sending it to their bottom line.

        1. 8.1.2.1

          (Preface this that I have a great respect for RR.)

          6, my point is that RR is saying that big corp is shaping all law right now and that patent law has without question over the last 10 years weakened patents. Therefore, it is the big corps that are pushing the laws to weaken patents.

          1. 8.1.2.1.1

            “6, my point is that RR is saying that big corp is shaping all law right now”

            Right I understand that.

            “and that patent law has without question over the last 10 years weakened patents. Therefore, it is the big corps that are pushing the laws to weaken patents.”

            ^It’s at that point that you seem to miss the part RR is saying about patent law having been absurdly strengthened and expanded from the 80’s and 90’s.

            “Therefore, it is the big corps that are pushing the laws to weaken patents.”

            Perhaps so, but that’s after still other big corps absurdly strengthened them, correct?

            1. 8.1.2.1.1.1

              6, yes I agree according to RR.

              I don’t get why so many leftwing people are against patents. I really don’t. From what I’ve seen they tend to give more money and power to workers at large corporations and tend to give small companies bargaining chips with big companies. That is from first hand experience, so maybe I am wrong in the aggregate. Doesn’t seem likely, but I admit it is possible.

              1. 8.1.2.1.1.1.1

                Yeah I hear you. Just from my small tastes of what goes on outside that’s generally what I see as well.

                That said, RR just got done telling you why he’s against the strengthening that took place in patents (rather than just patents period). It’s because it allows the rich to continue to siphon off wealth and aggregate more and more unto themselves, thus hurting the overall economy (because the peons don’t have as much money to spend to spur demand or start new businesses etc). I also think there’s a pretty good chance he’s probably right in the aggregate. Last time we saw the numbers on ownership big corp had by far the most, and of course its the execs/owners that benefit from big corps patents.

                I also think this is a bit of why folks like MM are always seeing a lot of what goes on as “grifting” even if it isn’t entirely illegitimate. And why folks like anon, ever believing that if a lot of that stuff is legal then its good, or that that stuff is good in and of itself, are so against MM on that.

                1. You need I pay better attention 6, as I am the one that adds in the innovation thinkers and NOT just the law (as well as you paying attention to exactly who wants the patent laws weakened).

                2. “as I am the one that adds in the innovation thinkers”

                  You “add in” the “innovation thinkers”? What do you add these “thinkers” into? And who are the “innovation thinkers”?

                3. 6 plays the part of Frick…

                  Obviously, adding into the conversation here and if you paid attention and knew anything about innovation, you would not have to ask a question that the archive have the ready answer to.

            2. 8.1.2.1.1.2

              that’s after still other big corps absurdly strengthened them, correct?

              No.

              Both you and Robert have not been paying attention to exactly who has been weakening patent law.

              Mere claims that the “Evi1 Right” want stronger patents just does not wash with who benefits most from stronger patents.

              You have to think of this on a comparative basis, and that patents even the playing field.

              1. 8.1.2.1.1.2.1

                patents even the playing field

                What “playing field” are you referring to?

                1. And Malcolm plays the part of Frack, with his b@nal attempt at dissembling with a Vinnie-Barabarino-style question.

                  Obviously, if you had been paying attention, the evening out has to do with disruptive innovation and the fact that even a single well placed patent right can be a game changer that the larger and well established firms do not like and this attempt to diminish the power of patents, as they would rather compete on non-innovation factors like size and established presence.

                  You really need to get a better script, Malcolm.

                2. disruptive innovation and the fact that even a single well placed patent right can be a game changer that the larger and well established firms do not like

                  So instead of answering the question directly, you revert to some b.s. mythology about “disruptive innovation.”

                  Reich is supposed to be paying attention to “disruptive innovation”? LOL. He’s not some kool-aid drinking stooge like your buddies at IP Watchdog, “anon.”

                  Nice try.

                3. Clearly your lack of understanding of disruptive innovation is a bug and not a feature of your ability to inte11igntly contribute to the conversation, Malcolm.

                  May I suggest that you cease the typical low level ad hominem posts of yours, educate yourself on innovation, and then come back and attempt to contribute to the discussion.

                  This is in NO WAY related to your fixation with the Quinn blog, so your “nice try” is entirely a non sequitur.

    2. 8.2

      His May 2nd article “You Must Take Action Now” concerning stopping Big Corp and the Trans Pacific Partnership sounds r e e e e a l l y familiar…

    3. 8.3

      …and if you ant to take another tangent step on the prospect dot org web site, read the “Plowed Under” article and note the lack of actual main cause for pushing for more farm land (the simply out of wack and totally unsustainable level of human population)

      You won’t get the right answers until you start asking the right questions.

    4. 8.4

      6, RR is a socialist, nay, a Jacobin. Pure old school where the source of all inequality is property.

      What he fails to consider is that the source of all wealth is property.

      To an extent, wealth is power and might makes right, but the principle that all are equal before the law (L. Coke). Where law ends, tyranny begins.

      Thus, even the King must obey the law. The law protects the mighty and the weak.

      But, as we know, there is a problem in that lawyers are not cheap. That is why we have public defenders.

      Small companies who have little revenue simply cannot afford either an IPR or a patent suit against them. Perhaps we need public defenders?

      1. 8.4.1

        Should read, “The principle that all are equal before the law (L. Coke) somewhat negates the inherent advantages of wealth.”

      2. 8.4.2

        Ned, comment along the lines of your post (you are a bit too generous) is stuck in the filter – likely because I happen to reference a different historical figure who is rather (in)famous for the baiting of “the haves” versus “the have-nots.”

        1. 8.4.2.1

          anon, you actually believe that there is something worse than calling someone a Jacobin?

          1. 8.4.2.1.1

            First, yes “Jacobin” is not some all-get-out “worst” name ever.

            In fact, the name is somewhat muddled. See link to en.wikipedia.org

            Second, the actual historical name blocked by the filter is far more accurate – and far more of a nemesis to the U.S. government political foundation.

            A related person to the person blocked by the filter had a saying: the C@pitalists will sell us the rope with which we will hang them.” Another said: “…we’ll keep feeding you small doses of socialism until you’ll finally wake up and find you already have [banned word]. We won’t have to fight you. We’ll so weaken your economy until you’ll fall like overripe fruit into our hands.”

            So tell me Ned, which is the greater danger, the enemy who announces himself or the one who pretends to be your friend?

            1. 8.4.2.1.1.1

              Well, anon, the Jacobin morphed into the cells of Les Miserables, so at least Hugo saw them as heroes.

              But, as we know, the cell structure still exists. Traces back to the French Revolution where the Jacobins were banned, and assembly of more than 10 was outlawed.

              Central Committee. Cells. Jacobinism.

              1. 8.4.2.1.1.1.1

                And, just in case, anon, you do not know who you are dealing with, their flag is the red flag.

                When “French” declared war on Britain by a surprise attack on British ships in French harbors, they struck the tricolor flags and raised red flags, the flag of the Jacobins.

                The Jacobins were very much like that German socialist party lead by that Austrian house painter, who took the party flag and made it the flag of the nation.

                1. Ned,

                  I could not help but notice that you did not answer the questions I put to you at 8.4.2.1.1.

                  (ps, some may label you Jacobin in your penchant pursuit of your mantra without pause or reason or care for the counterpoints put to you)

  3. 7

    Wow.

    Malcolm raised a very interesting issue about whether state antitrust laws could make illegal activity entirely legal and sanctioned by Federal Law.

    I think not.

    Thus the whole set of allegations based on double-patenting and not on IC raise very serious preemption issues.

    Thanks Malcolm. Off to district court unless LA AG you amend your complaint to limit the case to Walker Process-type claims.

      1. 7.1.1

        anon, Walker Process involved a patent obtained based on fraud on the patent office. Are you aware of any case that extended the doctrine beyond fraud on the PTO?

        1. 7.1.1.1

          Ned, are you aware that your question has nothing to do with either Malcolm’s point or my drawing your attention that your comment is askew of Malcolm’s point?

          1. 7.1.1.1.1

            anon, apparently we are not communicating.

            What I am saying is that the Supreme Court has not authorized anything beyond fraud on the PTO.

            I don’t know how anyone would “know” that his or her patent is invalid because of double patenting without having been notified of such a requirement by the examiner, and there was a dissent in this case by Judge Schall that the ‘154 was not invalid for that reason.

            Moreover, the Supreme Court has not approved antitrust actions outside of Walker Process situation. My point is, that this is a substantial federal question of first impression that will control future conduct. The courts might approve the theory. It might not. But the whole issue is federal and must be decided by a federal district court.

            Strike this nonsense from the complaint, and I think it is nonsense, then the case stays in state court per Gunn.

            1. 7.1.1.1.1.1

              You are forgetting last year’s opinion in Actavis, which subjects settlements in Hatch-Waxman litigation to antitrust scrutiny. You are also forgetting that tying, although no longer unlawful per se, is subject to the rule of reason. The Supreme Court has not been afraid to subject acts of patent owners to antitrust scrutiny.

              Furthermore, even if there is a preemption argument, that is a defense, and thus, it does not raise a federal question. This looks to me like Louisville & Nashville RR v Mottley – lots of federal defenses raised, but no federal question inherent in the claim itself.

              1. 7.1.1.1.1.1.1

                Bi-lateral agreements are a horse of a difference color.

                Whether a state cause of action is preempted is to be decided by a state court?

                I don’t by that for a second.

                That is like saying that courts cannot review the PTO’s assertion of IPR jurisdiction. Something a bit unconstitutional in the whole notion, so it cannot be right.

                1. That’s exactly what’s happened in just about every FDA/product liability preemption case over the last decade. The Supreme Court ultimately can hear the question because it falls squarely within their jurisdiction. However, section 1331 does not embrace federal questions arising merely as a defense. That’s something I learned in my first semester of law school.

                2. McClelland v. Gronwaldt, 155 F. 3d 507 – Court of Appeals, 5th Circuit 1998 at note 13:

                  “The Supreme Court first applied what has come to be referred to as complete preemption in Avco Corp. v. Aero Lodge No. 735, Int’l Assn. of Machinists, 390 U.S. 557, 88 S.Ct. 1235, 1237, 20 L.Ed.2d 126 (1968), in which the Court not only held that a state action for breach of contract, where the contract in question was a collective bargaining agreement, was preempted by section 301 of the LMRA, but also held that although the plaintiff had relied solely on state law and had chosen to bring suit in state court, the preemptive power of the LMRA was sufficient that the claim nevertheless “arose under” federal law, thus creating federal question jurisdiction.”

                  link to scholar.google.com

                3. Sure, Ned, but the “complete preemption” doctrine is a very narrow and very rare subject. The Supreme Court has been clear that states have the ability enact antitrust law that is beyond the scope of the Sherman Act, and that the Sherman Act and other federal law does not preempt state antitrust claims. Complete preemption seems unlikely here, where the claim is antitrust law, because of this precedent.

  4. 6

    Dennis: the outcome of the Louisiana case could have a major impact on how courts across the country handle AstraZeneca and its patents, and how courts will consider allegations of patents improperly listed in the Orange Book. This leads me to the tentative conclusion that the patent (and other federal) questions may well be substantial enough to allow for a Federal Question.

    I agree (and hope) that this case has some impact on the behavior of companies abusing the patent system in an effort to evergreen old drugs and keep generics out of the market.

    But I’m having difficult seeing the substantial federal patent law question. AZ’s patents were garbage — that’s settled — and there seems to be good reason to suspect they were obtained inequitably for the sole, antitrust-violating purpose of keeping cheaper generics off the market in Lousiana and elsewhere. If, as the complaint alleges, AZ knew that the terminal disclaimers it failed to file were necessary but AZ chose not to file them for anticompetitive purposes, then no substantial patent law question need be answered to resolve the dispute under Lousiana’s antitrust/unfair biz practice laws.

    1. 6.2

      Astra knew terminal disclaimers were necessary? Huh?

      Knew?

      Astra did not “know.”

      No examiner entered a double patenting rejection and Judge Schall dissented from the holding by the majority that the ‘154 patent to metoprolol succinate was not double patenting an earlier patent to a pharma compound having an number of specific structural limitations.

      Who the frack has ever heard of someone voluntarily filing a terminal disclaimer without a double-patenting rejection? To pin an antitrust case on the lack of a voluntary terminal disclaimer seems would seem to place state law in conflict with Federal Law.

      In contrast, basing the state claim on IC IS consistent with Walker Process.

  5. 5

    This case presents an interesting inventorship issues, including which law controls the outcome.

    1971 — In Sweden, Astra employee Nitenberg synthesized metoprolol succinate.

    1982 – In Sweden, Astra employee Lars Lilljequist synthesized metoprolol succinate on behalf of Astra employees Curt Appelgren (“CA”) and Christina Eskilsson (“CE”).

    1984 — In Sweden, Lejus files patent application naming CA and CE as inventors. CA and CE had switched employers. The application discloses and claims metoprolol succinate.

    1985 –In Sweden, a lawsuit is filed by Astra asking for assignment on the basis that Nitenberg, not CA or CE, is the inventor of metoprolol succinate. Lawsuit settled — claims divided, divided claims to Astra, inventorship unchanged.

    1985 — US counterpart to original Lejus application filed. ‘197.

    1988 — US CIP filed claiming benefit of ‘197.

    1991 — US patent ‘897 issues on ‘197 claiming pharma compound of metoprolol succinate. Astra does not dispute that CA and CE are proper inventors.

    1992 –US patent ‘154 issues from continuation, claiming metoprolol succinate.

    Astra’s Swedish inside counsel consistently maintained that Nirenberg was the inventor of metoprolol succinate, and so informed US counsel handling prosecution of the ‘897 CIP for Astra (prosecution was transferred to Astra as well as ownership at some point.)

    Assume that under Swedish law, Nirenberg is the inventor of metoprolol succinate vis-a-vis CA and CE because they all worked for the same company, Astra.

    Next assume that CA and CE independently invented metoprolol succinate regardless that they worked for Astra. In an interference, CA and CE would be awarded priority.

    Let us next assume that us counsel determined that CA and CE independently invented and that under US law that the inventorship was correct as to any claim to metoprolol succinate.

    Thus, under US law, the inventorship of a claim to metoprolol succinate is correct and under Swedish law it is not. Does Swedish law control given the priority claim?

    Next consider that CA and CE could not be inventors under US law if they learned of the metotropol succinatte from Nirenberg. Assume that Astra’s inside counsel believed they did learn of metoprolol succinate from Nirenberg, directly or indirectly. It would seem all patents are invalid under 102(f) on a prior art basis, not so? This would seem to suggest that US counsel had a duty to correct inventorship or to inform the PTO.

    Finally, what difference does it make if Nirenberg is an omitted inventor from all the applications disclosing metoprolol succinate, when the only one that claimed metoprolol succinate is the ‘154. The inventorship appears to be correct with respect to the ‘197 and ‘897 patents. How does this affect the outcome?

    1. 5.1

      If the inventorship is wrong, the priority claim under the Paris Convention might be invalid. This could result in the loss of the priority claim and more prior art being available.

      1. 5.1.1

        So, if the inventorship is wrong in the priority application under Swedish law, the priority claim in the US application that claims priority to the Swedish application that does not name the proper Swedish inventors is not valid even if under US law the inventorship in the US case is correct.

        Is that correct. It seems reasonable.

        1. 5.1.1.1

          You raise a good question – who gets to say who the inventors are?

          Paris Convention requires the priority claim be made by the inventors or their successors in interest. In the US, under the old rules, the application is filed in the name of the inventors, not the assignee. I have not looked at the cases to see if the US courts would simply look at the face of the priority application for the inventors, or if it would look to see who the actual inventors are and require the priority claim to be made by them.

          In the facts that you recited, the case in Sweden regarding inventorship settled, rather than being decided. Accordingly, I think the actual inventorship is still an open question.

          As for the possibility of different inventors for the US and Swedish versions of a patent – I have not looked up any cases on it, but I can imagine at least some of the arguments raised by both sides concerning who must make the priority claim.

          1. 5.1.1.1.1

            Joe, can you imagine that a state court might first address an issue of patent law that has never been addressed by any federal court, and which may involve the consideration of international law and the Paris Convention, which may further involve Swedish law, and which may be a question of first impression even at the international level?

            Conflict of laws?

            I really haven’t addressed this issue since outside counsel recommend we litigate a contracts case in England on the representation that English law controlled. We lost, because English law was decisive, and it was different than US law on point.

            1. 5.1.1.1.1.1

              Hi Ned, it would be a stretch. I just appreciate the issues involved. Regarding the ultimate jurisdiction for the LA case, the question of priority may never come up.

              1. 5.1.1.1.1.1.1

                Joe, may not. And if the facts are as alleged, the “named” inventors certainly did not invent the composition metoprolol succinate given that they allegedly were asked to develop applications for the composition.

                Assuming the true inventor was not named, I don’t know how one could say any Paris Convention filing claiming metoprolol succinate could properly have the benefit of the Swedish priority case.

                What I see, therefor, is that the ‘154 patent is invalid either for not naming the proper inventors, or because of prior art, the compound disclosed in the Swedish application’s publication, and the ‘154 not being entitled to its priority.

  6. 4

    I’m tentatively with steve and chuckwoolery on this one – no federal jurisdiction.

    The complaint alleges three claims for relief, all of which are based on state law. The rule is that unless federal law provides the basis for the relief that is requested by the plaintiff, there is no federal law jurisdiction, even if some questions of federal law must be resolved. The defendant cannot synthesize a federal question by raising federal law issues in responsive pleadings. It appears that AZ has not filed an answer and is basing request for removal strictly on the complaint.

    The relief requested is based on LA Monolopies Act, LA Unfair Trade Practices Act, and LA common law unjust enrichment. There would not be federal original jurisdiction on these claims. I mean, Caldwell could not have filed this complaint in USDC. While there may be federal law questions to be resolved, state law clearly forms the basis for the relief requested. Besides, invalidity of the patents in question has already been determined by USDC and reviewed by CAFC.

    The only remaining question in the USDC case was inequitable conduct, which was remanded to USDC as not properly determined on summary judgement. The parties settled before that issue was fully litigated. Seems to me that determination of inequitable conduct, if that is even necessary, is well within the competency of a state court. It’s an issue to be resolved by the facts, which is why it wasn’t ripe for summary judgment in USDC.

    It would be ironic indeed if AZ’s own inequitable conduct before the PTO saves it from getting pounded into the Louisiana dirt by a state jury of gumbo afficionados.

    These jurisdictional issues are almost always interesting and worth following.

    1. 4.1

      Can someone clear this up?

      DC: AstraZeneca does have patent coverage, but the state argues that the patents are both invalid and unenforceable.

      steve: The patents were finally held invalid.

      Which is it? Does the state have “an argument” that AZ’s patents are invalid, or have AZ’s relevant patents been invalidated as a matter of fact?

    2. 4.2

      Babel,

      Under Gunn, the patent issue is not substantial because the resolution of the inventorship issue will not affect the validity of the patents: first because they have already been held invalid, and second because they have expired. The question is therefor entirely hypothetical, and the state court resolution will not be binding in federal courts.

      1. 4.2.1

        Is it the individual patent’s validity the driving factor or rather whether or not new patent law understanding may develop?

        Whether or not an individual patent is determined to be valid may fall to merely applying known and understood law with no danger that the understanding of that law would change (thus creating any effect on any other case and determination of validity for some other patent.

        I think the driver is more on the Rule of Law and less on any one application of the Rule of Law.

      2. 4.2.2

        Ned, yeah, I think we agree on the inventorship issue being the third string pitcher in this case, but we don’t agree on whether jurisdiction is a close call on this case. I don’t think it is.

        To clarify for those who haven’t read the complaint, according to para 126 the 2 patents at issue were held invalid in USDC due to double patenting viz the initial patent. This finding was affirmed by CAFC. The patents are invalid and were invalid when added to the Orange Book. Period. No need to litigate that fact in the state action; i.e. no federal law issue there.

        The patents were separately held invalid by the USDC b/c of IC. This finding was remanded and the litigation never completed.

        The state’s complaint goes to the use of the invalid patents to game the FDA/Orange Book system and, hence, the state’s Medicaid system. Seems to me the IC yada was put in the complaint so Caldwell can tell the jury what sort of people the AZ folk really are, in addition to being Swedish of course. Dirty conduct is the sort of stuff normal people on juries understand. Double patenting, not so much.

        1. 4.2.2.1

          Babel, but Walker Process and state antitrust claims both require IC. I do not believe IC is a red herring type of issue. It is central.

          Also, I believe there is no exclusive federal jurisdiction. I have not considered whether there is a basis for federal jurisdiction in the first place. I think there is a substantial question of inventorship under the patent laws involved here, and that may be enough.

          1. 4.2.2.1.1

            Ned,

            If you truly believe that the IC is central, than I am even more disappointed that you did not pick up on the discussion point I offered at post 1.1.1 concerning the AG’s incorrect choice of IC in the complaint paragraphs 82-83.

            1. 4.2.2.1.1.1

              anon, no I got it. I think his complaint might be subject to a demurrer because of it. But all he would have to do is hire a good patent attorney such as yourself to fix the complaint.

              1. 4.2.2.1.1.1.1

                I do not know the details well enough to draw a conclusion, but merely putting in the correct IC argument may not be enough (the argument has to be able to be sustained).

                As you mention above, there was no request for terminal disclaimers (and as I noted, the “silly” AG somehow wants a retroactive criminal element on losing a case to apply to an earlier time of filing (given that the IC component was wiped out, he does not have that to lean on right now).

                He should have reached out to someone of knowledge before he filed his complaint.

  7. 3

    There is no question of patent law properly raised by the complaint. The patents were finally held invalid. While Louisiana alleges inequitable conduct as background to support its antitrust claims, it lacks standing to seek a declaratory judgment of inequitable conduct in district court since it was not threatened with litigation for patent infringement.

    1. 3.1

      steve, I think the issue better framed as to whether the outcome in the state court case could affect the validity of the patents. Here, there is no question that the validity of the patents will not be affected for two reasons: first, because they have expired; and second, because they had been previously held invalid.

  8. 2

    I don’t see how this falls within federal jurisdiction after Gunn. Sure, there are patent law issues, but it’s plainly analogous to the malpractice context. In the malpractice case, the court has to decide the case-within-the-case issue, which has underlying issues of patent validity and/or infringement. But that doesn’t make it a case within federal jurisdiction.

    1. 2.1

      This will not support federal jurisdiction. The Court in Gunn held that to be substantial, the federal question must be a controlling issue of federal patent law that would be important to other parties in other cases. Because the issues here deal only with this particular patent, there is no substantial federal question. Adding a Walker Process claim in order to argue that there are broader implications beyond this patent doesn’t make this case any more federal than if it contained a single patent.

      1. 2.1.1

        must be a controlling issue of federal patent law that would be important to other parties in other cases.

        That was my understanding as well. Contrast this with Ned’s comments above.

  9. 1

    In re Metoprolol Succinate Patent Litigation, 494 F.3d 1011 (Fed. Cir. 2007). (CAFC affirms the Astra patents invalid for double-patenting, reverses and remand on the inequitable conduct issue for failure to disclose that Astra’s in house counsel in Sweden believed and had informed US counsel that another Astra employee invented the novel compound, not the inventors named in the US applications that resulted in the two patents at issue. Settled after remand.) link to scholar.google.com

    This case smells of Walker Process. However, the case depends, in my view, on proof that the Astra employee that in house counsel believed to be the inventor actually invented the concerned compound and not the named inventors. Clearly, CAFC law applies as to inventorship.

    Now, the patents have expired. Further, they have been held invalid. The ruling on inventorship, while interesting, cannot affect the patents in any patent case.

    Close question on whether this should be tried in a district court.

    1. 1.1

      On further review, it is not a close question. There is no basis for removal.

      1. 1.1.1

        Ned,

        Did you notice that the AG used the incorrect standard and the “before the Office” definition of inequitable conduct…?

        (Paragraphs 82-83)

        Another “nit” with AG James Caldwell’s writing is his lack of identifying the patents explicitly first (or at all**) prior to the use of abbreviated patent numbers. Unnecessarily sloppy for a document actually presented to a court.

        **he never actually gets around to identifying the ‘318 patent as U.S. Letters Patent 4780318, and only identifies the application that matured into the patent as “690197” instead of “06/690197.”

        I also think he misses quite badly with his accusations of unlawfulness, given as the party WAS playing the allowed game per the allowed rules. At the time of the so-called “sham litigation” there was no adjudicated state of unenforceability and you cannot call it “illegal” to retroactively apply a losing result to the prior initiation of a suit per the rules.

        His case may (or may not) have merit in some regards, but his sloppiness is a distraction.

        1. 1.1.1.1

          anon, if Nirenberg was the inventor if MS, then he only needed to named inventor of the ‘154 patent, the only one in the chain that actually claimed MS.

          But since this patent was a basis for the Orange book listing and the various lawsuits filed against the generic, the validity of this patent is material to the antitrust claim.

          The patent is unenforceable under Therasense only if the inventorship is in fact incorrect and Vista or the prosecutors knew that the inventorship was incorrect and failed to disclose this to the PTO.

          I think the facts are clear that the inventorship of the ‘154 patent was incorrect, that Astra and the US prosecutors knew this, and yet still obtained the ‘154 patent.

          This is classic Walker Process.

          Regardless, the complaint is confused and needs work.

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