LA BioMed’s Patent Case against Cialis Revived by Federal Circuit

by Dennis Crouch

LA BioMed v. Eli Lilly (Fed. Cir. 2017) [appeal decision ipr2014-00752] [appeal decision ipr2014-00693]

In a new pair of decisions, the Federal Circuit has again rejected the PTAB’s obviousness findings as inadequate and remanded for further proceedings.  As she has done in the past, Judge Newman agreed with the merits dissented from the remand – arguing that the challenger should not be so freely given what amounts to a new trial.

Lilly filed several separate IPR petitions against LA BioMed’s U.S. Patent No. 8,133,903 which covers a method of treating penile fibrosis which often leads to erectile dysfunction.  The IPR petitions were prompted by LA BioMed’s 2013 lawsuit alleging that Lilly’s popular Cialis drug led to infringement.  The basic idea here is that repeated treatments with Cialis has a long-term positive impact on the fibrosis.

In the two initiated IPR’s, the PTAB determined (1) the asserted prior art reference did not anticipate the challenged ‘903 claims (14-693 IPR); and (2) the asserted prior art references did render the challenged claims invalid as obvious (14-752 IPR).

Here, the claims are directed to a dosing regimine of a known drug treating an issue that it was already known to treat.  The particular claims require “a continuous long term regimen . . . at a dosage up to 1.5 mg/kg/day for not less than 45 days” for treating “an individual with … penile tunical fibrosis …”

On anticipation, the court drew a fine-line with its closest case being AstraZeneca LP v. Apotex, Inc. where the Federal Circuit affirmed that method claims for “once-daily dosing would likely survive an anticipation challenge by a prior advertisement that disclosed twice-daily dosing.”  Here, the prior art suggested “chronic administration” of the drug while the patent particularly requires 45 days of dosage.  A close reading of the prior art led the court to limit “chronic” to “daily administration for at least three days” and less than three-weeks (since the prior art’s study only lasted for three weeks).  Affirmed as Not Anticipated.

On obviousness, the PTAB found the claims obvious.  On appeal, however, the Federal Circuit rejected the PTAB’s claim construction of the requirement of treating “an individual with … penile tunical fibrosis.” In particular, the PTAB allowed-in prior art treating erectile dysfunction even if penile fibrosis had not been formally diagnosed.  On appeal, the Federal Circuit held the PTAB’s approach “reads that limitation out of the claim” since ED may have other causes (such as psychological).  Based upon this linguistic argument, the court made the leap that – therefore “it is unreasonable to use the symptom of erectile dysfunction as a proxy for penile fibrosis.”  In the eyes of the court, this distinction eliminated the motivation-to-combine the references since they did not directly address the penile fibrosis issue.

As mentioned above, the majority ordered a remand to the PTAB to make new findings on the motivation to combine.  Judge Newman dissented from that approach – arguing that the PTAB/Lilly had their chance and that the judgment should be final on appeal.

Provisional Priority:  A final note on the case involves LAB’s claim for priority to its early-filed provisional patent application.  As you might expect, the court ruled that it was not entitled to such priority because the provisional did not expressly disclose the claim limitation of 1.5 mg/kg/day.

 

 

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

17 thoughts on “LA BioMed’s Patent Case against Cialis Revived by Federal Circuit

  1. I think that Judge Newman’s dissent has the right of it here. If the challenger cannot make a convincing case in their allotted 18 months, then they are done. There is no statutory room for a remand, because the statute only allows for 18 months pendency max (35 U.S.C. §316(a)(10)). 18 months have long since elapsed since this IPR was instituted, so there simply is not statutory power for the PTAB to conduct a remand (although the CAFC does not want to hear this).

    1. How does that fit with your prior “unfair penalty” view?

  2. DC On obviousness, the PTAB found the claims obvious. On appeal, however, the Federal Circuit rejected the PTAB’s claim construction of the requirement of treating “an individual with … penile tunical fibrosis.” In particular, the PTAB allowed-in prior art treating erectile dysfunction even if penile fibrosis had not been formally diagnosed. On appeal, the Federal Circuit held the PTAB’s approach “reads that limitation out of the claim” since ED may have other causes (such as psychological). Based upon this linguistic argument, the court made the leap that – therefore “it is unreasonable to use the symptom of erectile dysfunction as a proxy for penile fibrosis.” In the eyes of the court, this distinction eliminated the motivation-to-combine the references since they did not directly address the penile fibrosis issue.

    I haven’t read the decision yet … but this seems a bit nuts.

  3. It would appear that so far as the CAFC is concerned, KSR never happened, because TSM is mandatory to find obviousness.

    1. I am coming to the same conclusion myself, Martin. Elsewhere on the internet, Paul Cole made what I considered the intriguing but provocative suggestion that when the SCotUS declined to take cert. in Sequenom, they signaled that they are growing bored with patentability, and consider themselves done with the subject for the foreseeable moment. I think that this is a plausible supposition, although too soon to say for certain (if McRo were to petition for cert, and the SCotUS were to decline, this would be strong evidence for the hypothesis).

      Even if the SCotUS is not done with patentability matters, if lower courts think that the SCotUS is done with patentability, then the logical outcome would be for the system to start reverting to mean. TSM and MoT both arose for a reason. The SCotUS’ saying “these are useful tests, but not exclusively controlling” does not change any of the sort of natural selective pressures that gave rise to the evolution of TSM and MoT, and if there is no longer a disruptive top predator (i.e., the SCotUS) in the ecosystem to prevent the reemergence of TSM and MoT, those same selective pressures and going to lead to the same evolutionary outcome anew.

      I suspect that this is what we are seeing happen right before our eyes.

      1. Perhaps Greg, or it could simply be that the CAFC ideologically likes the TSM test and will use it until they are forcefully stopped from using it (again). I don’t know if the court is “done” with subject matter cases, but as with venue, my guess is that if they see something coming down legislatively, they will quickly find a case of interest.

        Ned, I’m not skilled in the art of ED (!) (yet anyway) so I don’t know if penile fibrosis would be a problem “in the prior art”, but I surely wonder about obviousness/enablement in some of these patents.

        I mean, check out patent 9,539,077. Does the inventor have this invention in hand, or is it an aspiration?

    2. Martin, KSR required that the problem be known in the prior art.

      This is obviously correct, otherwise one can take any claim, find its elements in the prior art, and declare the claim obvious due to some flaky made up motivation.

    3. It seems the opinion states only that a “combination rationale” requires TSM. I don’t think KSR held that TSM is not required in some obviousness rationales, it just held that it is not required in all obviousness rationales.
      That being said, I have no idea why the Board is trying to invalidate the claims because the claim combine “elements” disclosed in the prior art. The “elements” seems to be things like treating a patient diagnosed with a particular disease (found in one reference), administering the treatment (found in another reference), and stopping the disease (somewhere else). I would not have picked a combination rationale.

  4. “…arguing that the challenger should not be so freely given what amounts to a new trial.”

    Indeed, this one-sided several-bites-at-the-apple game is quite unfair to patent owners, most of whom are not wealthy enough to keep defending themselves over and over.

    1. An appealing concern, but out of thousands of IPRs only a handful have been remanded back to the PTAB by the Fed. Cir. Also, a “new trial” is not what I understand normally happens on such remands – allowing new evidence or cross-examination is highly unlikely.

      More than enough money is riding on this case, and more than 80% of all IPRs are filed against patent owners who had enough money to already sue the petitioner in a district court case, which triggered the IPR.

      1. “…more than 80% of all IPRs are filed against patent owners who had enough money to already sue the petitioner in a district court case, which triggered the IPR.”

        So you’d be OK with a ‘standing’ requirement, then – to prevent the other 20% from saying e.g. “do what I say or I’ll challenge your patent, regardless of merit, and you can’t afford to defend it ha-ha-ha”?

    2. patent owners, most of whom are not wealthy enough to keep defending themselves over and over

      Spare us the crocodile tears.

      You need money? Stop huffing the patent glue and reconsider your extortion threats.

        1. He means nothing should be patented, no patents are valid and no patents should every be enforced.

          1. I know what Malcolm means – the question mark is to how does this type of post of Malcolm’s fit within ANY view of a healthy ecosystem?

            Prof?

      1. MM, I try not to often engage where the tone is so hostile, but I’m gonna go out on a limb and take another shot here…cuz believe it or not, not all of us who lean pro patent are necessarily “maximalists” or your enemy all the time…

        Ya know, most patent “grifters” you so often object to are (or represent) the big boys anyway…my problem is with patents being a sport of kings, where those who can afford to play the game can still “troll” with impunity but those who can’t cannot even get/keep truly reasonable protection.

        Yes – small companies have trolled too, and yes IPR and the “new” 101 have largely stopped that, but at the cost of also equally hindering *legitimate* patent protection for small companies generally (and without even the benefit of stopping the *larger* ones who troll too!).

        In sum – to whatever extent you want to be anti patent, fine, but please at least consider supporting policies and mechanisms that don’t let the big guys largely “buy their way” out of it by sheer ability to keep fighting.

        1. Ken, 11 years Malcolm has been posting in the same mode.

          Do you really think that he is going to change because of your post?

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