Appellate Standing, Biosimilars, and the Federal Circuit

Guest post by Jonathan Stroud (Unified Patents) and Saurabh Vishnubhakat (Texas A&M Law). 

After a long wait, the Federal Circuit last month decided Momenta Pharms. v. Bristol-Myers Squibb Co. (Fed. Cir. 2019), dismissing Momenta’s appeal of an adverse PTAB decision based on standing and mootness concerns.  (The PTAB had instituted Momenta’s petition for inter partes review of Bristol-Myers Squibb’s patent on certain formulations of an immunosuppressive agent, but ultimately sustained the patentability of all the challenged claims.  Momenta, a biosimilar applicant, had sought inter partes review preemptively, with no prior infringement suit by BMS.)  The Federal Circuit’s conclusion that Momenta lacked Article III standing has important implications for access to appeals in unsuccessful PTAB challenges.

Building on Professor Crouch’s initial analysis of the Momenta decision, we explore the Federal Circuit’s developing case law on what counts as an adequate injury for a petitioner to have appellate standing from a PTAB decision.  Of particular interest is the persistent ambiguity about how potential future patent infringement and the PTAB estoppel provisions of the AIA affect standing to appeal.

The Stakes of Appellate Standing

Article III standing applied on appeal has always imposed an asymmetric burden on the system for administrative patent revocation.  Patent owners who appeal can almost always show the requisite injury for standing in the form of adverse effects on some or all of their patent rights.  Unsuccessful petitioners, meanwhile, may not be able to show enough injury through potential patent infringement.  Ironically, this especially true of those very parties who benefit the most at the margins from having access to administrative review—precisely because they could not otherwise have established standing to seek declaratory relief in federal court.

In effect, the more proactive and preemptive a challenge might be, the less likely that party is to be able to prove standing on appeal, adding another reason not to act until after litigation has begun.  The asymmetry of this burden is especially salient in domains like pharmaceutical drugs and biosimilars, where the incentive to test the validity of patents has important social consequences, and the complexities of those decades-long disputes create fact patterns that can be difficult to unpack.

The Momenta Appeal

At the time of its 2015 petition for inter partes review, Momenta was working with Mylan to develop a biosimilar counterpart to Orencia®, the branded biologic drug whose active ingredient was covered by the BMS patent.  Momenta’s plan was to enter the market as a biosimilar applicant under the Biologics Price Competition Act of 2009 (more detail here), which provides a pathway to generic competition for complex biologic drugs akin to the “Hatch-Waxman” Act provisions that govern small-molecule generic drug approval.  Momenta first sought inter partes review of the ‘239 patent covering a formulation of Orencia®.

Unsuccessful in inter partes review, Momenta appealed the decision in early 2017.  One major issue in the case (which one of us has discussed here in greater detail) was whether Momenta, who had no active district court litigation against BMS and had faced no direct threats of infringement and had not yet manufactured a competing product, had standing to maintain its appeal.

Momenta argued in briefing and at oral argument that the inter partes review was akin to an expensive “freedom-to-operate” action that resulted in immediate harm, presenting a “fork in the road” in its development process.  Momenta concluded that losing the ability to appeal would force it to abandon its research efforts and leave millions of dollars wasted.  BMS replied that any such harm was speculative and that the case law does not support Momenta’s standing.

In late 2018, almost a year after the oral argument concluded—but shortly before the Federal Circuit issued its opinion last month—Momenta sent a letter notifying the court that Momenta had initiated a conversation with Mylan “to exit [Momenta’s] participation in the development of M834, a proposed biosimilar of ORENCIA®.”  Thus, Momenta no longer had the same interest in the appeal.  BMS pushed to have the case dismissed as moot, though Momenta countered in a series of further letters that it still had a stake in the case and standing to appeal, noting that “[t]he concreteness of that stake is bolstered by the estoppel provision [of 35 U.S.C. § 315(e)], which the Board’s adverse decision already triggered.”

The Federal Circuit held that the case was largely moot given those recent developments, and dismissed the appeal.  As one of us wrote recently, this case “shows the difficult position the court and parties are put in when standing is raised based on proactive business decisions revolving around patent challenges, and also demonstrates how principles of mootness and ripeness bleed into the standing inquiry easily.”

The Potential for Infringement as an Injury

For five years now, the Federal Circuit has been actively exploring the boundaries of Article III standing on appeal from administrative action.  For instance, in 2014 in the inter partes reexamination context, the court in Consumer Watchdog v. Wis. Alumni Research Found. explained that appeals based on vague public interest concerns in invalidating the patent, without a particularized or personal injury, is not enough. There, WARF had obtained a patent related to human embryotic stem cell cultures, and Consumer Watchdog challenged the patent as ineligible subject matter.

On appeal, however, Consumer Watchdog framed its argument in terms that the patent helped “loot taxpayer funds and force research overseas” and that a challenge benefited the public at large.  As the party “seeking to invoke federal jurisdiction,” Consumer Watchdog bore the burden of establishing Article III standing, which included proving that it suffered an “injury in fact.”  The court found it had not alleged facts sufficient to demonstrate such an injury.

In the 2017 Phigenix v. Immunogen case, Phigenix filed an inter partes review but failed.  On appeal, Phigenix alleged harm apart from the threat of direct patent infringement—namely, that the existence of the patent was preventing others from taking a license to patents owned by Phigenix.  This blocking effect, the argument went, caused economic harm that is cognizable in standing.  The court allowed that alternative forms of economic harm were permissible and accepted the legal framework, but ultimately held that Phigenix had failed to meet its burden.

The court suggested that arguing possible or speculative future economic interest based on conclusory expert declarant testimony was not necessarily enough.  The Phigenix decision also laid out the burdens of production and persuasion for appellate standing, suggesting that the requirements apply only to the party seeking to invoke the court’s jurisdiction: the appellant.  It also allowed that such evidence can be produced for the first time on appeal.

On the other hand, in the nonprecedential PPG Industries v. Valspar Sourcing, the Federal Circuit found sufficient economic harm to establish standing on appeal from inter partes reexaminations.  The PPG opinion held that PPG’s launched product and customer inquiries suggested a concrete stake in the outcome and noted that “[t]his stake is enhanced by the ‘estoppel provisions contained within the inter partes reexamination statute.’”

As for standing arguments related to infringement potential itself, the Federal Circuit JTEKT v. GKN Automotive has explained that there may be certain situations in which a PTAB petitioner has no infringing product on the market at the relevant time but may still be able to show Article III standing.  However, in such situations, the petitioner must establish “concrete plans for future activity that creates a substantial risk of future infringement.”  On that case’s own facts, JTEKT had sold no infringing goods, had not finalized its product design, and had not shown any concrete plans for future activity that would run afoul of GKN’s patent rights.  The court similarly concluded in RPX v. ChanBond that petitioner RPX was not engaged in any activity that even potentially infringed the patent being challenged.  This necessary specificity of future plans means that PTAB challenges even from direct market competitors may ultimately lack standing to support an appeal.

For direct competitors, however, standing to appeal may still be available where the parties are engaged in a live commercial dispute presenting a “significant risk” of infringement based on “significant involvement in research and commercial activities” involving the subject matter of the patent.  As the Federal Circuit held in DuPont v. Synvina, evidence showing that the petitioner in that case had an operating facility capable of infringing a method of manufacture  was enough to confer standing.

Understood in this context, Momenta is a dispute in which the patent challenger was engaged in likely-infringing activity at the outset, but lost its direct stake through an “intervening abandonment of the controversy” by ending its collaboration with Mylan on an Orencia® biosimilar.  The case is notable both for its high stakes on appeal and the fact that the biosimilar applicant was clearly engaged in an expensive, years-long dispute over a billion-dollar biologic product.

Although Momenta may still be able to receive royalties on any relevant biosimilar that Mylan may later develop, the court found this to be the sort of speculative future economic interest that proved inadequate in Phigenix.  As in ChanBond, the lack of any current activity that might potentially infringe undermined Momenta’s argument for revived standing, and the lack of any concrete plans going forward meant that the safety valves of JTEKT or DuPont were of little help.  In the end, the Momenta decision dodged the more contentious issue of just how much investment, how much potential for future infringement, and how much certainty there must be about that future harm, are ultimately enough to confer Article III standing.

Estoppel as an Injury

Throughout most of these cases, there has also been a thread of discussion about whether the strong statutory estoppel of 35 U.S.C. § 315(e), applied after the final written decision issues in an inter partes review, constitutes an independent injury capable of sustaining standing.  It is unclear whether the presence of estoppel “bolsters” or supports a finding of injury or is simply irrelevant.  The court seems to have entertained the middle road in Momenta, never finding that estoppel alone could constitute injury, but with appellants arguing that it supports their overall arguments about the existence of a genuine Article III case or controversy.

The “petitioner” estoppel of § 315(e) estoppel has two prongs.  One applies back to the PTAB itself; the other, to outside forums.  The plain language of the statute bars the maintenance of either another PTAB proceeding or an argument in a federal-court or ITC action that a patent is invalid based on any ground that was actually raised or reasonably could have been raised in the initial inter partes review.  Moreover, estoppel applies not only to the petitioner but also to their real parties in interest and privies.

Running through the various opinions on standing is an argument that the legal detriment of estoppel is at least a factor in, if not a deciding vote for, finding standing on appeal.

In Altaire Pharms. v. Paragon Bioteck, a case where the court found standing in a post-grant review, the court pointed to estoppel as compounding the harm.  As previously noted, the court found in the non-precedential PPG Industries case that the petitioner’s “stake is enhanced by the ‘estoppel provisions contained within the inter partes reexamination statute.’” And in Momenta, the appellant argued that that “[t]he concreteness of that stake is bolstered by the estoppel provision, which the Board’s adverse decision already triggered,” citing 35 U.S.C. § 315(e).

In JTEKT, on the other hand, the panel rejected appellant’s argument that inter partes review estoppel constituted a separate injury in fact, an issue the appellant there has raised in a petition for certiorari to the Supreme Court.  RPX Corp. argued something similar in their opposition to the motion to dismiss their appeal, and have likewise made that argument the basis of a petition for certiorari, which, it should be noted, has drawn a “call for the views of the Solicitor General” from the high Court.

These arguments appear to be grounded in Justice Kennedy’s concurrence in Lujan, where he noted that “Congress has the power to define injuries and articulate chains of causation that will give rise to a case or controversy where none existed before.”  But few actual cases exist holding that a statute itself creates standing, and it seems clear that the Federal Circuit, at least, is unconvinced that this argument holds water, certiorari petitions or no.

The Federal Circuit’s conclusion in Momenta that estoppel cannot constitute an injury-in-fact when Momenta “is not engaged in any activity that would give rise to a possible infringement suit” is potentially far-reaching.  Standing to appeal depends on whether there is adequate injury-in-fact at the time of appeal—but estoppel, of course, lasts indefinitely.  This is a significant disparity for petitioners, one that doubles down on the asymmetric burden that petitioners already face with regard to Article III standing.

Implications for Biosimilars

Although the opinion did not address it, it is noteworthy that Orencia® is listed in the Purple Book, which identifies what biological products the FDA has determined to be “biosimilar to or interchangeable with a reference biological product.”  In another PTAB appeal decided just a few weeks prior to Momenta, the Federal Circuit in Amerigen Pharms. v. UCB Pharma (Fed. Cir. 2019) held that the listing of a patent in the FDA Orange Book (a Paragraph III certification) can constitute an injury sufficient to support Article III standing.

Accordingly, appellants confronted with administrative challenges prior to open district court litigation may be left scratching their heads and wondering just when standing kicks in and whether it continues through the life of any given appeal.  That makes challenging biologics patents especially fraught with uncertainty.  It also pushes would-be PTAB petitioners toward later or more reactive filing of inter partes review petitions rather than early filing of post-grant review or inter partes review challenges prior to a district court litigation.  Given the complex regulatory schemes at work, it seems likely that these parallel proceedings will even further complicate ANDA and ABLA-related litigation and the related approval processes rather than streamline them.

Conclusion

We conclude that the Momenta decision has ultimately done little to ease concerns about who does and does not have standing to appeal.  It is an important development in the ongoing evolution of Article III standing for appeals from PTAB trials, to be sure, as well as an informative survey of the relevant case law.  Still, it may have created further confusion by injecting the issue of mootness into the debate.  While courts have no control over the parties’ positions or the status of any particular appeal, the Federal Circuit’s decision making seems to reflect some discomfort with taking evidence on appeal in the first instance—as, for example, the D.C. Circuit does.  This reluctance has led to longer briefing schedules and more complicated and uncertain appellate fact patterns.  The weight of that uncertainty ultimately falls upon the parties and Federal Circuit panels themselves.

= = = =

Prof. Saurabh Vishnubhakat is an Associate Professor at the Texas A&M University School of Law and the Texas A&M Dwight Look College of Engineering, and is a former USPTO advisor.  Mr. Jonathan Stroud is Chief Intellectual Property Counsel at Unified Patents Inc., an Adjunct Professor at American University Washington College of Law, and a former USPTO examiner.  The arguments presented here are the authors’ and should not be imputed to Unified Patents, the USPTO, or to any other organization.

26 thoughts on “Appellate Standing, Biosimilars, and the Federal Circuit

  1. 8

    It might be interesting if someone (IPO, AIPLA, etc.) undertook a large scale survey to learn to what extent lack of petitioner standing to appeal combined with the estoppel provisions stops entities from filing IPRs in the first place.

    1. 8.1

      I agree; an excellent idea.

  2. 7

    The subject cert petition in RPX Corporation v. ChanBond LLC, No. 17-1686 (What level of injury-in-fact is required to appeal of a PTAB IPR final decision?) is listed in another Patently-O post today, noting the request for the views of the Solicitor General.
    J.S. I was also puzzled by your “And don’t get me started on counterclaims” since there aren’t any in IPRs. Are you referring to patent owners hit with IPRs filing merely retaliatory IPRs against patents of the IPR petitioner even though they are not being sued on those patents? [Those could of course have petitioner Fed. Cir. appeal standing issues, as they should.]

    1. 7.1

      I was only referring academically to whether counter claimants need to establish standing as well. As in, plaintiff sues (has standing), defendant counterclaims (doesn’t). As they’re “invoking the Court’s jurisdiction,” at least in a manner of speaking. I didn’t mean in the context of appeals from PTAB proceedings. Although you could imagine a situation where appeals were consolidated, or where there was mixed PTAB decision—would an appellee have “standing” to counter-appeal that the Board erred when finding some claims patentable? That sort of thing.

      1. 7.1.1

        Both sides always have to be able to show (have) standing in the Article III forum (and that, throughout the proceedings).

        For some reason, this is often made to be some mysterious or ambiguous thing.

        1. 7.1.1.1

          …this stems from the “Case or Controversy” requirement (and reflected in the “No advisory opinion” nature of the Article III forum).

  3. 6

    Nice overview! You say that “But few actual cases exist holding that a statute itself creates standing.” This is not correct; the U.S. Supreme Court has held and found statutory standing since Warth v. Seldin, 422 U.S. 490, 501 (1975) (5:4) (Powell, J., for the Majority). That is, the actual or threatened injury required may exist solely by virtue of “statutes creating legal rights, the invasion of which creates standing, even though no injury would exist without the statute.” Linda R.S. v. Richard D., 410 U.S. 614, 617 n. 3 (1973); O’Shea v. Littleton, 414 U.S. 488, 493 n.2 (1974). Examples include United States v. SCRAP, 412 U.S. 669 (1973); Trafficante v. Metropolitan Life Ins. Co., 409 U.S. 205 (1972); Gladstone Realtors v. Village of Bellwood, 441 U.S. 91 (1979). For a good example of the congressionally created interest and the injury to it, see Havens Realty Corp. v. Coleman, 455 U.S. 363, 373–75 (1982) (Fair Housing Act created right to truthful information on availability of housing; black tester’s right injured through false information, but white tester not injured because he received truthful information). Post Lujan there are several additional cases. Also standing on appeal from an agency adjudication is different then the analysis before the district court, because in the standing on appeal analysis the injury in fact must lie in the final administrative adjudication. Could you also explain why you did not discuss ASARCO Inc. v. Kadish, 490 U.S. 605, 619 (1989) (finding an Article III controversy where petitioner challenged “a final judgment altering tangible legal rights”), a case which is pertinent to your discussion; or Virginia v. Hicks, 539 U.S. 113, 121 (2003) (Scalia, J.) (the standing inquiry is directed at those who invoke the court’s jurisdiction) (party has experienced an alteration of “tangible legal rights . . . that is sufficiently ‘distinct and palpable’ to confer standing under Article III); and finally since several of the companies which were denied standing on appeal, were publicly traded, the appeals court should have found standing on appeal because the adverse IPR opinion would highly probable reduce market share or a very likely drop in their share price; Village of Euclid v. Ambler Realty Co., 272 U.S. 365, 386 (1926) (6:3) (Sutherland, J. joined by Taft, Holmes, Brandeis, Sanford, Stone, JJ.) (Holding that a City’s zoning ordinance that “greatly . . . reduce[d] the value of appellee’s lands and destroy[ed] their marketability for industrial, commercial and residential uses” constituted a “present invasion of appellee’s property rights”) (Finding standing because plaintiff has suffered an injury in fact based on the decrease in the market value of Plaintiff’s property as a result of the City’s designation is a sufficiently concrete injury for Article III purposes.). Any way, just my initial thoughts I wanted to share with you.

    1. 6.1

      You make a series of good points. We’re aware of the cases you cite and that it does indeed happen that other Circuits and the Supreme Court have found that certain statutes do create standing where none existed before (after all, patents themselves are statutory rights that confer standing); but I would argue that those cases are the exception, not the rule, particularly post-Lujan, and they generally follow a much more limited fact pattern—where the Government creates something that itself becomes subject to appeal. We could speculate all day whether that’s right or wrong for policy reasons; and there are plenty of exceptions. But I don’t think it’s wrong to say that post-Lujan the Circuits have approached standing gingerly when the arguments are derived solely from statutorily created administrative adjudication.

      The main reason we didn’t mention or get into ASARCO (which you’re right to flag) was time and space concerns; you’ll note that my company cited ASARCO in an amicus brief in the Personal Audio LLC v. EFF appeal, and ASARCO is cited and discussed in the Dowd & Stroud article at length. So we’re well-aware of it and what it stands for.

      I (personally) don’t disagree with you that there are strong arguments (particularly policy ones) that standing can be created by Congress, and I think that it’s a possibility in many cases; but I also think that, looking solely at the binding Federal Circuit cases that have come out on this issue, particularly recently, it seems unlikely that the Federal Circuit can (because of precedent) or will (because of a bent toward infringement reads) lean more toward finding appellate standing based on statutorily created rights stemming from administrative adjudication alone—indeed, panels have already rejected such arguments.

      That’s not to say such arguments might not be persuasive at the Supreme Court level; just that we are bound by the Federal Circuit’s reasoned judgment here, and at least in the context of the PTAB, the Circuit panels seem to view the estoppel and other provisions as (possibly) supportive but insufficient alone to confer standing. Obviously, dissatisfied appellants who have been dismissed have already petitioned for certiorari on this issue, which I for one find endlessly fascinating.

      1. 6.1.1

        Thank you Jonathan; I will read your article and your amicus brief in Personal Audio LLC later tonight and rewert to you with my comments tomorrow.

      2. 6.1.2

        The question (vis a vis IPRs) is NOT whether standing was created.

        Congress knowingly created a bifurcated two-fora animal with a split in standing.

        THAT type of thing is just not the same as creating a right, for which a cause may inure that then provides for Article III standing.

        What we have here instead is a rather NA ked attempt to bootstrap INTO the Article III forum, for which our system of government does not provide (and does not provide even for Congress, as the correct branch to write patent law).

      3. 6.1.3

        Jonathan, I now have read your (and Matt’s) article and your amicus brief amicus brief filed in Personal Audio LLC. I simply do not agree that these amicus breef arguments would be successful, because there is special US Supreme Court case law which deals with standing on appeal from a prior agency adjudication based on a federal statute. The leading case on this procedural posture is Federal Communications Commission v. Sanders Brothers Radio Station, 309 U.S. 470 (1940) (8:0) (Roberts, J.) (Private Interest Plaintiff case) (It is within the power of Congress to confer Art. III standing to prosecute an appeal.) (Court held that a rival station which would suffer economic injury by the grant of a license to another station had standing to appeal under § 402 (b) (2) of the Act.) (“likely to be financially” injured is enough for prosecuting/standing to appeal) (A party may bring a claim of statutory violation when Congress has expressly granted a right to review to a party aggrieved by the claimed statutory violation). Note: Sanders Brothers was reinforced by Scripps-Howard Radio, Inc. v. FCC, 316 U.S. 4 (1942) (Private Interest Plaintiff) (Frankfurter, J.). In Clarke v. Sec. Indus. Ass’n, 479 U.S. 388, 394 n.8 (1987), the Court is citing to Sanders Brothers as an example of a case that involved a statute that gives review/standing on appeal to all persons adversely affected or aggrieved by a final agency action/adjudication; After 1990, Sanders Brothers is not cited again in a Court opinion (as far as I can tell) until eighteen years later, when the majority opinion in Federal Election Comm’n v. Akins (1998) relies on Sanders Brothers and its progeny to read the special statutory review provision at issue there as one that, because it uses the “party aggrieved” language, “casts the standing net broadly—beyond the common‐law interests and substantive statutory rights upon which ‘prudential’ standing traditionally rested.” 524 U.S. 11, 19 (1998). I note that you and Matt do not discuss this line of cases starting with Sanders Brothers in your article. Two final comments; first, there is another Constitutional Clause which could be the basis for Congress having the power to create statuary standing without injury of fact; and second, in my humble opinion, the current statutory standing discussion should rather focus on the right and remedy relationship doctrine; see Gonzaga Univ. v. Doe, 536 U.S. 273, 283 (2002) (stating that “determining whether a private right of action can be implied from a particular statute” requires “determin[ing] whether Congress intended to create a federal right” in that statute; .” Bell v. Hood, 327 U.S. 678, 684 (1946) (“Where legal rights have been invaded, and a federal statute provides for a general right to sue for such invasion, federal courts may use any available remedy to make good the wrong done.”); this line of cases could be particular helpful to avoid dismissal because of the alleged Lujan announced “irreducible constitutional minimum” requirement of “injury in fact”; There is no barrier to considering statutory standing before Article III standing. See Ortiz v. Fibreboard Corp., 527 U.S. 815, 831 (1999) (“statutory standing . . . may properly be treated before Article III standing”); Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 92 (1998). I hope my above comments are helpful.

        1. 6.1.3.1

          Jonathan, Since Lujan, there at least 14 statuary standing cases holding that a violation of stature confers standing, the leading case is Massachusetts v. EPA, 549 U.S. 497, 516–17 (2007) (5:4) (Stevens, J. delivered the opinion of the Court, joined by Kennedy, Souter, Ginsburg, and Breyer, JJ. Roberts, C.J., filed a dissenting opinion, joined by Scalia, Thomas, and Alito, JJ. Scalia, J., filed a dissenting opinion, joined by Roberts, C.J., and Thomas and Alito, JJ.):
          “Congress has the power to define injuries and articulate chains of causation that will give rise to a case or controversy where none existed before. … In exercising this power, however, Congress must at the very least identify the injury it seeks to vindicate and relate the injury to the class of persons entitled to bring suit.” Quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 580 (1992) (Kennedy, J., concurring in part and concurring in the judgment; joined by Souter, J.); citing in turn Warth v. Seldin, 422 U.S. 490, 500 (1975) (“The … injury required by Art. III may exist solely by virtue of `statutes creating legal rights, the invasion of which creates standing.”). Because a majority opinion by Scalia, J. in Lujan is made possible only by counting Justice Kennedy’s Concurrence, its consideration is important in interpreting the holding of Lujan. Note: Like Akins and Laidlaw, Massachusetts v. EPA does much to return standing analysis to a sounder footing that gives significant weight to legislative judgments. And in Summers v. Earth Island Trees Inst., 555 U.S. 488, 5001-01 (2009) (5:4) (Kennedy, J., concurring) Justice Kennedy again affirms his Lujan Concurrence. More recently, In Campbell-Ewald Co. v. Gomez, 136 S. Ct. 663 (2016) (6:3) (Ginsburg, J.) every Member of the Court assumed that the un-consented receipt of a single text message in violation of the Telephone Consumer Protection Act was a constitutionally cognizable Art. III injury-in fact; See 136 S. Ct. 663, 679 (2016).

    2. 6.2

      Excellent discussion. A thought experiment. The party with questionable standing brings a declaratory judgment action in the venue of choice. The defendant then has to decide whether to file a mandatory counterclaim. On the filing of the counterclaim the Plaintiff/Counterclaim defendant then files an IPR. Obviously, this is not foolproof, but if it does not provoke a counterclaim then the Plaintiff can try the action or dismiss.

      1. 6.2.1

        LRG,

        Your thought experiment will not get to the crux here.

        The DJ action is an action in an Article III forum, for which Article III standing is required.

        IF you have that Article III standing, then the subsequent venture into the forum that does not require Article III standing – and the subsequent attempted bootstrapping INTO an Article III forum – is not reached for your given stated conditions.

        The real crux here is the attempted boot-strapping into the Article III forum.

        Congress knowingly created a bifurcated fora arrangement, knowing full well that the item under attack may be attacked by those lacking true Article III standing.

        What appears to be underway is NOT ONLY the change in nature of the item being attacked (from a Private personal property item to a Public franchise property item), but ALSO a mirror “creation” of an additional “Public” right of challenging the underlying right (the underlying right NOT being possessed by the challengers that otherwise LACK Article III standing related to that initial right).

  4. 5

    A nice survey of the Fed. Cir. decisions requiring “standing” or “a case or controversy” for petitioner [versus patent owner] appeals from IPR decisions.
    But note that the affected petitioners are only the distinct minority of petitioners that LOSE IPR challenges of relevant claims, because if they won in the IPR, the PTO Solicitor will defend the IPR decision against the patent owner’s appeal [not allowing an ex parte appeal]. Furthermore, only a relatively small percentage of the minority of petitioners losing their IPR challenges [claims not held invalid] have succeeded in reversing such IPR decisions on appeal even where they had standing. So even if the Fed. Cir. expanded standing grounds it would not change a significant number of outcomes.
    The bigger question some are asking is: will some party denied standing for an appeal be able to get a cert grant to challenge the Fed. Cir. standing requirement by arguing that the IPR statute grants a right of appeal for any losing party?

    1. 5.1

      I responded with a much longer comment, but it appears to have been swallowed whole by the Internet. In short, I’d direct you to the Solicitor’s falling intervention numbers, the Personal Audio LLC v. EFF case, and our earlier dialogue on this blog about intervenor standing. And don’t get me started on counterclaims. If you’d like to wonk out on any of this, feel free to email me at jonrstroud@gmail.com. I could talk about this all day.

      1. 5.1.1

        Thanks Johnathan [both of you] for a nice substantive dialogue in these comments.
        My comments were merely to point out the low odds of this issue making a difference in very many actual outcomes. I have no clue how any cert decision ever granted on statutory-only appellate standing in these IPR decision cases would come out, just a feeling that the present Court is not in favor of encouraging more litigation.
        But I was intrigued by your remark that “I’d direct you to the Solicitor’s falling intervention numbers.” Are you referring to just these disputes where the only issue the Fed. Cir. decides is lack of standing? Or were you referring to my comment that normally the PTO Solicitor will defend against patent owner ex parte appeals from IPR decisions against patent owners when the petitioner does not participate further?

        1. 5.1.1.1

          The latter. The Solicitor has been intervening less and less. I took your comment to mean that the Solicitor would intervene on behalf of an appellee every time, which 1) an appellee need not show independent standing, and 2) I’m not so sure the Solicitor would. They are being choosy about what cases they get involved in. I think intervention where an appellee has settled or dropped out is more of a professional and practical courtesy to preserve the two-party structure of appeals than anything (though of course they want to defend the agency on appeal if needed, and if the Solicitor agrees with the positions the Board took). This is getting off on a tangent, but Prof. dmitry Karsheit had a great article suggesting that the Solicitor and the Board’s position on appeal need not and may not always line up. It was at issue in the additional briefing in Knowles, but the panel punted by ruling the Director had independent standing there, which, who am I to argue with that? Professor V. and I had a polite disagreement about intervenor standing on Patently O months ago, though we agree where the Fed Circuit has come out thus far. Happy to take these discussions offline. I enjoy this stuff.

          1. 5.1.1.1.1

            Yes, the most famous situation I recall where “the Solicitor and the Board’s position on appeal need not and may not always line up” was where the Solicitor withdrew from the pending Fed. Cir. appeal on software-on-a-disk claims, so it never got a Fed. Cir. decision, leading to years since of such Beauregard claims.

            1. 5.1.1.1.1.1

              Software on a Disk is a bit of a misnomer.

              Whether on a disc, or some other tangible media, software is not software until it is put into tangible media.

              The thought of software is not software.

              Aspects (admittedly different aspects) of IP protection — vis a vis protection for expression — cannot inure unless a putting into tangible media occurs.

  5. 4

    This is a long and academic-sounding post, but it tries to hard to make something out of a case that added little, if anything, to the standing analysis. For instance, the authors write “the Momenta decision dodged the more contentious issue . . . “. Not so. The Momenta decision didn’t “dodge” that issue; it wasn’t presented because there was no longer any real dispute. Anyways, it’s another little case that unfortunately continues the Federal Circuit’s misplaced emphasis on the “infringement” analysis when assessing standing.

  6. 3

    A rather unconvincing article, attempting to gin up some “controversy” on the “ambiguity” of future actions that may generate the bedrock floor of standing.

    (And let’s not forget that one of the authors – even with a note that the opinions here are personal – is intimately involved with a company that has its own (separate) standing/Real Party in Interest issues at stake with the IPR process.

  7. 2

    Thanks for your thorough review of standing and its implications for biosimilar patent strategy.

    I was puzzled about the discussion of listing. Take the sentence “Although the opinion did not address it, it is noteworthy that Orencia® is listed in the Purple Book, which identifies what biological products the FDA has determined to be “‘biosimilar to or interchangeable with a reference biological product.’” I don’t get why the FDA’s listing in the Purple Book a licensed biological product that could potentially be a reference product for a biosimilar product is noteworthy or could have any bearing on injury. The Purple Book is not the Orange Book. It is the “artificial infringement” provision of Hatch-Waxman amendments, which is not applicable to biosimilars, that creates standing when a particular certification is made about a patent listed in the Orange Book. There is no equivalent “artificial infringement” provision for biological products and the Purple Book is relevant only to regulatory exclusivity, not to patents.

    I’m just wondering if I missed your point.

    1. 2.1

      Jim — not at all. You’re right that, as it stands and without further legislative intervention (Senators introduced a bill last week on this), the Purple Book and the BPCIA provisions don’t create an artificial act of infringement; there’s also no per se requirement for listing or punishment for not listing (as far as I understand things).

      But clearly listing is relevant in this context. The listing shows that the innovator’s patent covers the drug in question. If Momenta planned to file an aBLA (and likely planned to market a biosimilar) on that reference product, the fact that the patent in question was listed would at least show that Momenta’s potential aBLA or biosimilar would likely put them into (at least eventually) a concrete dispute over the validity of the patent in question. It certainly wouldn’t ITSELF constitute that injury, the risk of filing of a Paragraph III or IV *might.* On that you’re right. But then listing in the Orange Book itself doesn’t create the controversy; it’s just notable.

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