Injury-in-Fact and Standing to Appeal from the AIA-Trial Decisions

New petition for writ of certiorari in an interesting Hatch-Waxman and the question of Article III standing in appeals of AIA-Trial Decisions.

Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation (Supreme Court 2020)

Introducing generic alternatives that compete with previously approved drugs requires market approval through the Food and Drug Administration (“FDA”). To do so, competitors submit an Abbreviated New Drug Application (“ANDA”) that relies on the safety and efficacy data of the previously approved brand name drug. When that previously approved drug is covered by a patent, however, the mere act of filing the required ANDA subjects the competitor to an immediate patent infringement suit by the brand name company. Such suits are common. By filing an infringement action, the brand name company obtains an automatic 30-month stay during which the FDA cannot approve the competitor’s ANDA.

The real and immediate risk of an infringement suit extends equally to all members of joint ventures that work towards FDA market approval. Petitioners formed a joint venture with a manufacturing partner to develop a generic alternative to Respondent’s brand name drug. Fearing an infringement suit, Petitioner challenged the validity of Respondent’s patent through an administrative proceeding created by Congress under the Leahy-Smith America Invents Act. Petitioner did not prevail on the challenge and appealed the adverse decision.

The questions presented are:

i. Did the Federal Circuit categorically and erroneously preclude redress for injured members of joint ventures in the pharmaceutical industry by only recognizing (1) the manufactuing partner in the joint venture, and (2) the partner applying for FDA marketing approval in the joint venture, as having demonstrable injury-in-fact for Article III standing?

ii. Did the Federal Circuit err by rejecting the Leahy-Smith American Invents Act’s statutory estoppel provisions as a basis to demonstrate injury-in-fact for Article III standing?

Petition.  The petition here was filed by Terry Stanek Rea, former PTO Deputy Director (and Acting Director).

12 thoughts on “Injury-in-Fact and Standing to Appeal from the AIA-Trial Decisions

  1. 4

    What’s the issue here? I couldn’t tell from the post. (Explaining the facts of the case to readers of the blog would help.)

    1. 4.1

      I was confused by the write up as well. After a bit of internet research, it seems that Argentum is what might be termed a “reverse patent troll”–it doesn’t itself make or market any products, it just advises generic drug companies on challenging pharma patents and coordinates the process. After the initial inter partes review lost, all of the companies that Argentum had lined up to actually make or sell the generic drug settled out, leaving Argentum alone. Since Argentum does not make or sell any products, it will not itself be filing an ANDA, and it has no likelihood of infringing the patent, and so the Federal Circuit said it is suffering no injury for Article III standing. But as long as it is bound by the adverse inter partes review judgment, it will be unable to partner up with other generic drug companies to challenge this patent, since no one will want to risk being tagged as the privy of Argentum and bound under 315(e) estoppel. I can sort of see both sides here.

      1. 4.1.1

        Do you see the attempted boot-strapping?

        Your notion of “reverse patent tr011” is nothing more than the type of UNAFFECTED party vis a vis Lujan that lacks the required Article III (minimal floor-) standing necessary to have a place in the Article III fora while satisfying the (purposefully chosen AND different) place for “any and all” to challenge in the NON-Article III fora (in front of the Administrative Agency of the Executive Branch).

        This gambit must
        as a simple matter of Separation of Powers issue (and expressly so because Desired Ends are floated as the reason to do this without critical recognition of the Means being attempted.

        As the have pointed out from the start.

        I do note that it is easy to see the Desired Ends. As attorneys, more than the easy view is required.

      2. 4.1.2

        Thanks. Too bad that was too much effort for Dennis to make when reporting.

        Given what you wrote, I have no sympathy for Argentum. The people behind it knew (or should have known) the rules when they set up Argentum’s business model. Argentum can’t have it both ways.



          It is — and always has been — known of the limitations outside of an Article III fora.

          As you note, Argentum (or ANY other ‘anybody can challenge’ participant in a Part One of Two Parts SPLIT forum set-up) can’t have it both ways.

  2. 3

    “Rut-row. Sorry. We see, ‘patent’ in the petition.”

    Run away we must.

    No. Cert. For. You.

    — SCOTUS

  3. 2

    Question presented ii. is significantly different than question presented i.

    This calls to mind numerous past posts on the efforts to bootstrap from the first forum which does not require Article III standing into a second forum which DOES require Article III standing and the impropriety of such bootstrapping.

    Congress KNEW what it was doing with setting up such a two-part system (in part because I was at least one who informed my elected representatives of the inadvisability of doing so in the days of passage of the AIA).

    That two-part system cannot de facto create the ‘bootstrapping’ “injury in fact just by opening up part I of the two part system to everyone.

    A clear distinction from question presented i. must be maintained.

    1. 2.1

      But, both CAFC standing questions are impacted in the same case. Petitioner Argentum Pharmaceuticals LLC brings this petition for a writ of certiorari from the CAFC decision in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., 956 F.3d 1374 (Fed. Cir. 2020). Argentum was one of eight petitioners in the IPR.
      Has the CAFC’s standing requirement for IPR petitioner appeals ever been challenged before at the Sup. Ct., argued as covered in the AIA itself? The argument here is presumably that being hit with mandatory AIA IPR statutory estoppel is enough of an injury for IPR decision Article III court appeal standing and not precluded by Hatch-Waxman?
      Given the huge public impact cost impact of preventing generic equivalent drugs, this is a case the Sup. Ct. ought to seriously consider.

      1. 2.1.1

        I fully “get” what the argument is.

        It’s a BAD argument that bootstraps the “anybody in” from the part 1 Forum INTO the (expressly limited) part 2 Forum.

        Has anybody challenged?

        Does that matter?

        Your Ends just do not justify the Means.

        No Way No How.

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