Eligibility Cannot be Raised in IPR Appeal

Neptune Generics v. Eli Lilly (Fed. Cir. 2019)
Mylan Labs v. Eli Lilly (Fed. Cir. 2019)

This appeal combines twelve different inter partes review (IPR) proceedings. In each case, the PTAB Board sided with the patentee — holding that the claims of Lilly’s U.S. Patent 7,772,209 were not proven invalid.  On appeal, the Federal Circuit has affirmed.

Premetrexed disodium is a drug treatment for malignant mesothelioma that works as a folate antagonist — blocking cell usage of folic acid necessary for rapid DNA replication.  The drug has major side effects addressed by the Lilly patent.  In particular, the claimed invention calls for a pre-treatment of a patient with folic acid and vitamin B12 in order to reduce the risk skin rashes, fatigue, etc.

The patent itself calls the idea here “surprising[] and unexpected[]” — since the pre-treatment with folic acid does not appear to reduce the therapeutic efficacy of the premetrexed disodium whose intent is to reduce folate availability.

The prior art already taught pre-treatment with folic acid, but not the combination with vitamin B12. The PTAB found the addition of vitamin B12 a non-obvious step — especially when considered in light of the FDA’s express skepticism of the treatment approach.

The challengers here focused on an obvious-to-try argument — pointing out that some of the side-effects of premetrexed disodium suggest vitamin-B12 deficiency.  On appeal, however, the Federal Circuit explained that other side-effects pointed away from a vitamin-B12 deficiency. Thus, according to the court, the PTAB’s conclusions of nonobviousness were supported by substantial evidence.

Post-Invention Statements to the FDA: In its application for a new drug treatment, Lilly explained to the FDA that the prior art “suggested that pretreating with folic acid and B12 was a no-risk, predictable way to lower pemetrexed-induced fatalities by lowering pretreatment homocysteine levels.”  This statement suggests strongly that the invention was obvious.  However, the Court rejected the post-invention statement by Lilly as “made through the lens of what they had invented” and therefore not actually indicative of the pre-invention prior art.

Patent Eligibility: Patent Eligibility cannot be challenged in IPR proceedings. Still, on appeal the patent challengers argued that the claims here are so far beyond the pale of eligibility that the court should simply reject the claims as a matter of law.  When questioned regarding appellate jurisdiction, the challengers cited the Administrative Procedures Act requirement that “a reviewing court shall decide all relevant questions of law. . . . This Court’s review is not limited to the grounds considered by the Board (either implicitly or explicitly) where the question is one of law. See In re Aoyama, 656 F.3d 1293, 1299 (Fed. Cir. 2011) (holding that this Court could reach indefiniteness for the first time on appeal since it is a question of law).”

On appeal here, however, the Federal Circuit refused the chance to opine on eligibility — holding that IPR proceedings are limited only to obviousness and anticipation, and appeals are likewise limited.

21 thoughts on “Eligibility Cannot be Raised in IPR Appeal

  1. 5

    The statement that “patent eligibility cannot be raised in an IPR” is true for challenging issued claims, but it’s an open question whether patent eligibility under 101 can be raised in opposition to a motion to amend in IPR. You can definitely raise 112 issues raised by new amendments, and there doesn’t seem to be a reason why that same rationale wouldn’t extend to 101 challenges.

    1. 5.1

      Amendments in an IPR are NOT truly examined.

      That in and of itself should wave a GIANT red flag.

  2. 4

    The given Link takes us to Paul Morinville. Does it need attention, perhaps?

    1. 4.1

      Which “given link” are you talking about?

      Are you posting on the wrong thread perhaps?

    2. 4.2

      Yes I get Paul’s appeal too.

    3. 4.4

      With the Morinville case being a lightening rod for 101 discussions, what are the chances that other legal issues concerned with this case will garner dialogue?

      1. 4.4.1

        Let me answer my own question:

        Zilch. Nada. Zero.

        FAR too many uninformed and malinformed people want to rant about 101.

  3. 3

    I am troubled by:

    However, the Court rejected the post-invention statement by Lilly as “made through the lens of what they had invented” and therefore not actually indicative of the pre-invention prior art.

    Admissions as to “prior art” are NOT taken on an “actually indicative” basis. Admissions — even if not true — are taken against the party making the admission (in the context of novelty/obviousness).

    Does this decision void those several sections of the MPEP taking the opposite result?

    1. 3.1

      Not to dispose of a good legal issue of admissions against interest, but a guess as to what happened, based on my own experiences, is that that the employees of a large company like this seeking some kind of government product approval may not even talk to the patent attorneys prosecuting the patent application and have no clue as to the potential patent effect of their submissions. I have even seen uncleared, uncoordinated, major corporate press releases re major corporate inventions or products that miss-describe the invention and/or the products containing the invention. Or even erroneously describing the product in a way that suggests infringement of some other companies patent.

      1. 3.1.1

        While your anecdotes may all well be true and accurate, they do not touch on the point raised here.

        Either this reasoning is legally incorrect, or this has now supplanted several sections of the MPEP.

        My view is that the reasoning of this decision is legally incorrect.

        1. 3.1.1.1

          My guess is the judge realized what Paul said is what happens in real life – some marketing person puts together a slide deck going to KOLs and make’s some statements that are discoverable and are used by the other side to weaken the patent position.

          Its seems reasonable to consider who made those statements as to its relevance to the prior art, ie, is the person making those statements a POSA or are they talking above their pay grade.

          1. 3.1.1.1.1

            As with the note to Les, any such “reasonableness” was NOT a part of the prior way admissions were treated.

            It simply did not matter if (or how) the admissions were made or their veracity. ANY such admissions are held against the patentee.

            Or at least were (again, per several sections of the MPEP).

            Open question then: does this decision now void those various MPEP sections?

          2. 3.1.1.1.2

            [T]he judge realized… some marketing person puts together a slide deck going to KOLs and make[s] some statements that are discoverable and are used by the other side to weaken the patent position.

            Maybe. In any event, the judges here hedged by making the decision non-precedential, so it does not disrupt settled law on patentee admissions as prior art.

            1. 3.1.1.1.2.1

              Thanks Greg – but Neptune IS precedential.

      2. 3.1.2

        What appears to have happened here is Lilly, in an effort to convince a skeptical FDA sought approval by saying what they were applying for was nothing new as it was suggested in the prior art, which is either true or false. If it is true, it should be counted against the patent. If it is false, it should be counted against the FDA approval. Instead, by some miracle, it is taken as true in front of the FDA and false, without penalty, by the Federal Circuit.

        1. 3.1.2.1

          That is not how admissions are treated Les – an admission’s accuracy (it being true or false) is NOT controlling.

          Leastwise, prior to this decision, that is how the law worked in the patent sphere for novelty/obviousness.

  4. 2

    Looks like this is the US patent that corresponds to the one recently adjudicated all over Europe, in particular up to the UK’s Supreme Court.

    Remarkable for me, for a patent litigated all over the world, is that the specification of the patent runs out after less than 10 columns in all. The prosecution through the EPO cruelly exposed an elementary deficiency in the drafting of the specification.

    Thoughts for those who draft (and those who set budgets for drafting): 1. you never know whch one of your efforts will go all the way to the Supreme Court and get litigated all over the world 2. Quality drafting is sound investment, because it will deter infringers, even as early as the 18 month emergence of the WO publication, and so achieve commercial objectives quicker and cheaper than having to fight a case through the courts.

    BTW, only one r in pemetrexed.

  5. 1

    On appeal here, however, the Federal Circuit refused the chance to opine on eligibility — holding that IPR proceedings are limited only to obviousness and anticipation, and appeals are likewise limited.

    This has been another episode of “Short Answers to Easy Questions.”

    1. 1.1

      This argument in the briefs was more interesting than I thought it would be. Mylan mainly relies on Comiskey for the proposition that the Federal Circuit can consider 101 for the first time on appeal below, even if the PTO didn’t (or couldn’t) consider it, and can rule that the patent is ineligible under 101 if there are no factual disputes that require resolution. The Comiskey case, 554 F.3d 967, is here. link to scholar.google.com After reading section I of that opinion, the argument in this case seems ambitious, creative, and a bit of a longshot, but not crazy.

      1. 1.1.1

        ….Eli Lilly’s response brief, though, explains why Mylan’s argument has to be wrong.

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