I recently wrote about Apple’s pending petition to the Supreme Court on the NHK-Fintiv Rule. Now Mylan Labs has followed up with an additional petition focusing on the same issues:
- Does the no-appeal provision of 35 U.S.C. § 314(d) “categorically preclude appeal of all decisions not to institute inter partes review?”
- Is the NHK-Fintiv Rule substantively and procedurally unlawful?
Mylan Labs. Ltd. v. Janssen Pharmaceutica, N.V. (Supreme Court 2021) [Petition]
“Categorically” <<<— must be some trigger word for SCOTUS.
Or at least an attempt at a trigger word.
I suspect the only way this will trigger the Scotus is if their specific facts should be appealable.
Might go better if they didn’t have a grammatical error in the second sentence of the petition.
You mean “Under NHK-Fintiv, the Board may deny a petition if it believes
that the parallel litigation has may proceed too far for IPR to be of any efficient use.” in the QP? If so, I agree it’s an error. But I want to quibble with your quibble a bit. I wouldn’t call that a grammar mistake; it’s just a plain typo.
If you meant an error somewhere else, then that means the petition has two mistakes and counting now.
Yes, it is grammatically incorrect with the extraneous word “has” in that sentence, and is a fairly minor error, but embarrassing nonetheless.
Yes, it reads like what too easily happens in last minute polishing of a draft: “believes..has may proceed..” was probably a desirable intended change from “has proceeded” to “may proceed” but forgetting to delete the “has.” Because Fintiv IPR denials are often not based on the actual proceeding of the trial court. Rather, as discussed later in this brief, they have been based on unrealistic beliefs of some APJs that judge-projected early trial dates are realistic, even though they are not, especially in Waco WDTC, where they quote that judges opposition to IPRs.
I agree with this assessment of the error’s genesis completely, with one small qualifier. Paul, did you mean “undesirable intended change” there?
And I stand by my assessment of it as a typo, not a grammar mistake. If it were the latter, someone would’ve had to write “has may proceed” deliberately, under the incorrect belief that it was grammatical. But as Paul notes, that’s not likely to be the case. There was no conscious belief that “has may proceed” represents proper grammar. Instead, the only deliberate action was (again, in all likelihood) adding/changing some words, followed by the inaction of omitting a further round of (thorough) proofreading.
In fairness, maybe there is or ought to be a third category of error between a typo, which typically is just a misspelled word, and a grammar mistake, where the words are fine but the syntax is broken. This one might fit better in such a middle category. But otherwise I think it’s classified more appropriately as a typo.
I do love the odd tangents this happen on this blog sometimes.
I wouldn’t call that a grammar mistake; it’s just a plain typo.
The two are not mutually exclusive.
I guess I follow an intent or knowledge standard and not a results standard. See above in 2.1.2.1. Also case in point my last sentence has the mistake “this happen”. I meant to write “that” but wrote “this” instead. My grammar skills are solid enough that I know “this” would have been wrong; I wasn’t laboring under the mistaken impression that it was correct. While “this” wasn’t misspelled either, I just didn’t mean to type it. So my intent was in a good place grammatically, but for some reason my fingers didn’t cooperate. They could have easily typed “tha” or “tht” too. No one would really consider those grammar errors. So while I agree with you that to some extent it’s a continuum, it’s still closer to the typo end IMHO. And going by the intent standard, it’s a typo as well.
This attitude is symptomatic of a deeply unwell culture.
? I am not certain what point you are trying to make.
pp. 32-33 of this hard-hitting [but as usual, long odds] Cert Petition cites some 22 or so other so far unsuccessful APA and other legal attacks on PTAB “Fintiv Rule”* discretionary IPR institution denials.
*NOT a Rule, just an adopted PTAB precedent, which I assume the new PTO Director could overrule if she or he wanted to the next time it comes up, especially after the recent Sup. Ct. Arthrex decision?
As we have discussed, THIS part of the AIA (open discretion) has no such requirement for formal rule making.
Congress really screwed the pooch here.
Re: Cert Question No. 2 here: “Is the NHK-Fintiv Rule substantively and procedurally unlawful? This is a PTO administrative law practice issue that needs here the usual detailed expert inputs from David Boundy, M. David Hoyle, and/or Ron Katznelson. But, as I had asked before, will they express the same strong critical views of the impropriety of this kind of highly informal PTO practice here given the result of decreased IPR institutions? Or, substantively rebut the subject arguments in this Cert Petition here or in an amicus brief? It would be educational for those of us who did not specialize in administrative law.
Inventors agree that POP and guidance posted on a website is unlawful and that NPRM is required. See link to usinventor.org
Josh, the link you posted to: usinventor.org seems to say that NO formal rulemaking was done by the PTO for implementing the AIA, and that is not correct. See, e.g., “Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Rules and Regulations”
That needs to be edited to clarify. I think it’s accurate that the rulemaking did not take into account the impact on the economy – “the effect on the economy” under 316(b). Our pleadings are posted at link to usinventor.org.
Consideration in IPR rulemaking of “the effect on the economy” under 316(b)” was considered, in fact reducing the huge cost of patent litigation was the expressed intent of Congress for both reexaminations and IPRs. Not surprisingly, some trial lawyers and inventors have disputed that, but it is indisputable that hundreds of U.S. companies as lawsuit defendants have greatly reduced their patent litigation expenses with IPRs. As I have noted here many times, if you want to successfully attack and eliminate IPRs you need legally credible and economic credible studies support to convince Congress they made a mistake, not hanging your hat on some minor technicality that is not going to be a draconian judicial cure. The “Fintiv + Waco” double whammy treatment discussed here is ingenious, but limited, in IPR avoidance by some plaintiffs. But it may not survive, like prior WDTX Waco and EDTX venue transfer refusals.
Instituting review of every patent that meets the low subjective hurdle of “reasonable likelihood” is not what Congress intended. They recognized that jeopardizing patents of small businesses, increasing cost and duration of commercial disputes would not be good for the economy. If every valuable patent had to go through a $500K adversarial review with a 1 in 6 chance of survival then small businesses would not be able to participate in important areas of innovation.
That has proven to be precisely the problem created by the PTAB. It has been weaponized by large incumbents to unfairly attack smaller competitors – about 40% of of the 12,000 petitions.
Congress said in Section 316 that the “Director shall prescribe regulations” that “consider the effect on the economy and the integrity of the patent system”.
That has not occurred.
You can’t just assume that invalidating lots of patents is good for the economy. It sure isn’t good for the integrity of the patent system.
Seems like a lot of question begging going on here.
Are the patents really “valuable”?
Are the businesses in fact “small”? Even if so, are they actually “participat[ing] in important areas of innovation” in a meaningful way?
Is it “weaponiz[ing]” a system by using it to potentially invalidate patents if that system was originally designed to … potentially invalidate patents?
Is it an “unfair[] attack” to initiate an IPR in response to an infringement suit brought voluntarily? Are (small or not) entities that only engage in licensing truly “competitors” to (large or not) “incumbents”?
I don’t assume the other direction of course, but like I said, it seems like plenty of unproven assumptions are at work here.
Lots of support at usinventor.org. More at link to law360.com and link to supremecourt.gov Arthrex Amicus.pdf#page=22
See above: admin law pales when Congress has its way with the pooch.
(The lesson: do NOT write an unfettered discretion to an Administrative Agency)
anon, i think theres a few issues here being conflated.
1) whether the director is abusing his discretion?
2) whether congress stripped federal judiciary of jurisdiction to review director’s actions.
Imagine director institutes guidelines (formal or informal) that says “I will not institute any IPR petition where the petitioner is an African American.” That is clearly not within his authority, despite so called “unfeterred discretion” (for one, it violates 14th amendment). HOWEVER, as congress created the lower federal courts, congress could in theory strip lower federal courts of their jurisdiction to hear a challenge to such a rule, even when the directory clearly acts contrary to law. In this case, if a challenger met the requirements for original jurisdiction at SCOTUS, then SCOTUS could hear the challenge even though fed judiciary couldnt.
I think the focus here, even if not so clear, is whether congress indeed stripped the federal judiciary of jurisdiction over challenges to director’s actions, such that even if they do obviously violate the law, the fed judiciary could not hear it (but scotus could, if original jurisdiction is met).
You are focused on the second question, which is “what is the director’s authority”. The director’s discretion is clearly bound at least in some ways (imagine if he said “no petitions for african americans.”). I think SCOTUS, and there is good precedent for this, would read that the discretion granted to the agency is bound by other parts of the the act. Imagine if the fee is spelled out by statute– “IPR shall cost $15,000” and the director, using his discretion, says “I will not institute IPR unless petitioner pays $30,000”, thus directly contradicting congressional passed statute.
So the director can clearly abuse his discretion contrary to law (think “no blacks allowed to file petition”), but congress may have stripped fed court jurisdiction to hear such a challenge. THats first hurdle. Second hurdle is scope of authority.
Quadmoist,
Ah, you insert a bit of a fallacy in that you are inserting a fact pattern NOT present with a statement as to a clearly improper reasoning when NO reasoning whatsoever need be provided.
The Office simply need not give ANY reason for its institution decision and the ENTIRE lack of provision of a reason would fall within HOW Congress wrote the law (which IS the point being made).
Lacking the affirmative “bad cause” we simply do not arrive at the question of stripping from the judiciary the cause you seek to insert.
There is NO violating of the intent of Congress in the fact pattern present. Your “first hurdle” is simply not there.
Paul,
David filed an amicus in Cisco Systems, Inc. v. Ramot at Tel Aviv University Ltd., no. 20-2047 (Fed. Cir.). The most interesting and detailed briefing by the parties on the issue is probably in Apple et al. v. Iancu, no. 20-cv-6128-EJD (N.D. Cal.).
Any APA challenge to the NHK/Fintiv guidance will need to explain why the exception of 5 USC 701(a)(2) for “agency action [] committed to agency discretion by law” is not applicable. Apple makes an interesting argument in its briefing in the N.D. Cal, but I have not run through the case law to evaluate it.
Additionally, any challenge to lack of notice-and-comment will need to explain why the NHK/Fintiv guidance does not qualify under the “general statements of policy” exception of 5 USC 553.
Nice additions.
Links?
Thanks John. I would think that their best argument might be that nothing in either the APA or IPR statutes granting agency discretion can be interpreted so broadly as to allow an agency guidance or rule to be clearly inconsistent with the clearly expressed intent of its subject statute? That would also seem to me appealing to the [recently increased] numbers of Sup. Ct. justices who have expressed negative views in recent years about federal agency rulemaking or jurisdiction exceeding or being inconsistent with their statutes in general, such as their decisions on certain EPA rules and FTC compulsory monetary compensation awards.
“to be clearly inconsistent with the clearly expressed intent of its subject statute?”
Facts not in evidence.
One party’s mere assertion that the “expressed intent of the statute” has been ‘harmed’ with the degree of discretion is not true at all on a factual basis.
As already noted, Congress simply provided NO SUCH ‘intent,’ and instead provided an open ended and unlimited amount of discretion.
Now if you want to make the different argument that Congress may not provide such an unlimited level of discretion, you may well have a path of discussion.
Your comment here though does not make it onto the path and remains in the weeds.
J. Doerre,
Lack of notice and comment rulemaking is not the only bar against applying POPs such as NHK/Fintiv. Simple lack of Federal Register notice trumps the exception you cited. The APA bars agency reliance on official or unofficial “policies” not published in the Federal Register. 5 U.S.C. § 552(a)(1) (“Each agency shall separately state and currently publish in the Federal Register … (C) rules of procedure, … (D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency.”) (emphasis added). The emphasized text corresponds to the PTAB POPs. APA § 552(a)(1) also states: “… a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published.” Id. The PTO did not publish the POPs in the Federal Register and thus they cannot be binding. Natural Resources Def. Council v. National Highway Traffic Safety Admin., 894 F.3d 95, 106 07 (2d Cir. 2018) (“It is a basic tenet of administrative law, set out by the APA, that a substantive regulation does not have legal effect … until it has been published in the Federal Register.”) (citing 5 U.S.C. § 552(a); NRDC v. EPA, 559 F.3d 561, 565 (D.C. Cir. 2009) (“Agencies must publish substantive rules in the Federal Register to give them effect”); and Morton v. Ruiz, 415 U.S. 199, 232 35 (1974)).
Ron,
You presume that the discretion provided by Congress MUST be delimited by the Office.
That simply is a not so.
This is an error of Congress — to which, the APA does not ameliorate.
The discretion IS “institute” or “not institute.”
That is the sum total of what Congress had to say on the matter. ALL else may be satisfied with a stony silence of the point-blank (in a ‘pseudo-Rule 36’ manner) decision on the action.
There simply may be an entire lack of ‘rule making process’ that you want to be there — and directly BECAUSE of the way that Congress wrote THIS law.
Anon,
It is true that the Director has plenary discretion to institute or not to institute. But that does not translate to an exemption from promulgating regulations for exercising his discretion. While Congress could have done a better job, 35 U.S.C. § 316(a)(4) commands that “[t]he Director shall prescribe regulations … establishing and governing inter partes review under this chapter and the relationship of such review to other proceedings under this title” (my emphasis). Any procedures to deny institution of IPR necessarily specify when “establishing” of IPR should not take place and are “governing” IPRs “under this chapter.” Moreover, any procedures that deny institution based on the “relationship of such review to other proceedings under this title” are discretionary, but according to § 316(a)(4), shall be promulgated by regulations.
Yet, instead of promulgating regulations as expressly required by statute, the PTO chose to use POPs to regulate the “relationship of such review to other proceedings.” See Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357 et al., Paper 19 (Sept. 6, 2017) (denial factors re: multiple petitions); Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9 (Oct. 28, 2020) (AIA §§ 314(a), 315(c), denying institution and joinder motion – analysis of General Plastic factors based on follow-on copycat petition); Valve Corp. v. Elec. Scripting Prods., Inc., IPR2019-00064, -00065, -00085, Paper 10 (May 1, 2019) (AIA § 314(a), deny institution – General Plastic factor 1 applies to joined Petitioner).
More detailed analysis of the Director’s obligations to promulgate regulations on institution — not just on discretionary denials — and to include therein considerations of the four statutory factors in § 316(b) are forthcoming in my article on the subject.
I should add that the scope of the requirement that the Director shall “prescribe regulations” … on “the relationship of such review to other proceedings under this title” includes all proceedings under Title 35, including under 35 U.S.C. § 271 — infringement actions in federal district court. Therefore the NHK/Fintiv rules governing “relationship” of IPRs to § 271 proceedings are within the scope of the regulations that the Director shall prescribe under § 316(a)(4). Contrary to Anon’s suggestion above, Congress was not “stony silent.”
Thanks Ron, the combination of all three of your very substantive comments here on what is clearly very substantive yet ad hoc rulemaking directly tied to parallel patent litigation, and not even Federal Register publication, would make for a good amicus brief, which I hope you or someone else will file.
Ron,
I think that you are overreading “establish” in the view of what Congress wrote as far as the discretion to institute or not.
The “establishing” that you are referencing is a different animal.
Further, your attempt to tie “relationship of such review” is ALSO off in that the review that you mention is DIFFERENT than the institution decision, and is only in regards to items for which that institution decision has been in the affirmative and thus to which “review” has become a real thing.
I am looking forward to your article, but I do hope that you pause and consider the separateness of the institution decision and ANYTHING else that may come after such a decision.
By the way, my point is NOT to whether or not the actions of the Office by way of POP are appropriate – my point is instead to the singular event of the unfettered discretion of the institution decision point itself.
Thus the litany of cases you provide on “relationship of such review — once existing — to other proceedings is NOT material to the point that I have presented.
Anon,
I understand your logical point. You are entitled to have your interpretation of the statute and the term “establishing” as “separated” from Institution. You provide no alternative meaning, however, for the term “prescribe regulations … establishing” IPRs that is different from regulations “governing” IPRs. Statutory language must not be read as carrying superfluous phrases.
Your interpretation would also require further explanation. For example, if Congress did not intend that the regulations the Director shall “prescribe” under §§ 316(a) and 326(a) must cover institution decisions, why would it instruct the Director to ensure by regulations the protection from any “improper use of the proceeding, such as to harass”? §§ 316(a)(6) and 326(a)(6). One cannot read into this requirement a scope limited merely to post-institution harassment where articulated Congressional intent was clearly about some decisions to deny institution considering “the importance of quiet title to patent owners to ensure continued investment resources.” H.R. Rep. No. 112-98, pt. 1, at 48 (2011) (Warning against institution of AIA trials “as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent [as] such activity would divert resources from the research and development of inventions.”)
Moreover, in a related policy consideration, Congress also mandated that “[i]n prescribing regulations under this section, the Director shall consider the effect of any such regulation on … the ability of the Office to timely complete proceedings instituted under this chapter.” 35 U.S.C. §§ 316(b) and 326(b). This cannot cover only post-institution regulations. This clearly anticipates regulations for pre-institution assessment of the complexity of the case under petition and the Director’s denial of institution when he determines that given the available PTAB resources and the statutory deadlines for completion, there is inability “of the Office to timely complete proceedings.”
Congress clearly intended to have these important protective policy considerations encoded in regulations on institution decisions and not to leave those to PTAB APJs who have no statutory authority to promulgate regulations on the fly under the least participatory system imaginable.
Ron,
Not superfluous at all – the ‘establishing’ is everything after the decision to institute. That is, everything that would need be put in place ONCE an item to be reviewed is established.
If there is NO institution, there simply is no ‘there’ there, so the necessity of going through the rigmarole simply does not attach for the FULL discretionary choice NOT to institute.
As I noted, this is a carte blanche power written by Congress (in plain and direct words).
IF you want to attack that provision separately (for example, as an Unconstitutional provision of legislative power to the executive branch), then a different set of arguments may be developed (along the lines of past Congressional actions that shared authority without the necessary constraints and directions).
But the path that you want to take simply does not attach for the institution decision all of its own.
Anon,
We agree on many issues but with all due respect, you simply repeat your argument and avoid answering my point on the difference between your interpretation of “establishing” IPR — “everything after the decision to institute” IPR — and “governing” IPR, which already includes “everything after the decision to institute.” Clearly superfluous.
You also have no apparent answer on my points about the coverage of institution decisions in the requirements for regulations under §§ 316(a)(6) and 316(b).
By the way, ALL of your caveats ONLY apply AFTER an institution decision is made TO institute, and thus ALL of your ‘reasons’ are in full accord with my views. ALL of the concerns after an institution decision CREATES something that IS ‘in review’ are still protected by the appropriate safeguards OUTSIDE of the institution decision itself.
And just because that decision has been delegated to Boards, the actual words of Congress are NOT to the Board (so your aim at the APJs is a misfire).
Ron,
It only appears (to you) that I ‘have no answer’ because you continue to want to SEE something that simply need not be there.
The bottom line here is that Congress wrote what they did: the institution decision point is an unfettered allocation of decisional power.
IF that decision IS to institute, then ALL of your concerns raised here are THEN met by the ‘establishing’ (and these still are separate from the institution decision itself). The way that Congress wrote this allocation of authority is clear in that IF the decision is to NOT institute, then there is nothing more anyone could do. In this way, there is NO superfluity for the instances of non-institution. There are NO mechanisms TO BE covered under the APA (or other mechanism) because there simply is no ‘there’ there.
I really do hope that you pause long enough to entertain what I am telling you BEFORE you write your work. For an intellectual exercise that you might enjoy, take the view that I am correct and figure out how that would affect your aim.
It would not be time wasted.
Anon,
It is quite apparent that you did not read my explanations if you still believe that “ALL of your caveats ONLY apply AFTER an institution decision is made.” They clearly do not. It is one thing to reason why my conclusions as to pre-institution are incorrect, but quite another to ignore them altogether as if they were not made.
I am therefore at the end of my line in this discussion. That said, like you, I believe that Congress gave too much discretion to the Director on the issue of institution. But it is wrong to read into the statute an open-ended discretion unrestrained by rulemaking requirements that require articulation of reasons and public participation in fashioning the rules for institution.
Ron,
If ‘you’ are saying “No” to institution, which of ANY of your caveats are implicated?
It is not that I have ignored your caveats — I have not — it is that your caveats remove themselves in a decision to not institute.
Take your time and think about this point before you seek to dismiss it.
Anon,
My point is that the Director should not be able to say “NO” or “YES” to institution without a regulation that governs this institution decision. The institution regulation must specify how the Director is to exercise his discretion in arriving at a “NO” or YES” decision in all instances including those involving “relationship to other proceedings under this title.” The Director’s discretionary power cannot be arbitrary and capricious — he must give notice (by regulations) how the discretion is to be exercised.
My point is that the current single institution regulation in 37 CFR 42.108(c) is insufficient and must be augmented with all the statutory factors that Congress directed. See comments to the PTO on that issue in Sections 2-3 of our comments at link to ieeeusa.org.
Ron, Your “should” is merely a desired state – and is not in accord with how Congress actually wrote the AIA.
I fully “get” that you want a different result.
As would I.
I am merely pointing out that which you appear to know (circa your footnote 7 in the IEEE missive), and yet for some reason cannot seem to bring yourself to accept.
The first step to change is accepting what is.
Anon,
Why do you still ignore the points I made on pre-institution regulations requirements? Congress did not vest the powers you attribute to the Director. Footnote 7 in our comments merely cites to the courts’ understanding of the Director’s discretion.. These decisions, however, do NOT condone the Director exercising that discretion with POPs and without regulations. You apparently still do not get the distinction between discretion and regulations for exercising that discretion. I also suggest you read the CAFC decisions in Windy City and Aqua Products. These decisions apply to any POP and equally to POPs on institution decisions. According to you, these decisions are contrary to Congressional enactment.
The PTO is simply wrong and the courts will tell it so again for the third time after Windy City and Aqua Products.
On,
You are conflating the issue of “POP” per se (which I already stated was not the point that I am discussing) with the plain words of Congress.
Again, I “get” that you want the institution decision to be something necessarily controlled by the ‘proper’ things that DO come into play AFTER the institution decision, but that is a “want.”
So yet again, take a step back and consider: if the institution decision is a “No,” are ANY of the issues of your concerns in play?
If not, then THAT should tell you something.
Anon,
You apparently do not comprehend my several points. Your arguments are on non relevant matters and repetition here would be fruitless.
I’m done.
Sorry Ron – but I have comprehended full well your points – and it is you that refuse to acknowledge the fact that someone else has made OTHER points. You want to claim that only I am being repetitious – but you are the one refusing to budge at all.
I do “get” why you are so wed to your notion, but that’s a choice you are making.
It’s just not the best one, as all that I am doing is asking you to consider the notion of how a decision of “No institution” eviscerates your concerns.
Ron,
Publication in the Fed. Reg. is another potential issue that is worth thinking about. Of course, “[t]he Administrative Procedure Act’s requirement for publication of regulations in the Federal Register does not affect persons who have ‘actual and timely notice of the terms’ of the regulation.” United States v. Mowat, 582 F.2d 1194, 1201 (9th Cir. 1978) (quoting 5 USC 552(a)(1)).
J
J, I feel sure that no one filing IPR petitions gets sent any notice by the PTO of Fintiv “rules” even now. Also, unless a defendant retained for their IPR a regular IPR practitioner closely following this new PTAB decision practice, and had filed their IPR petition recently enough to know about it, no notice at all.
Paul,
My comment was more thinking about the particular challengers in these cases, all of whom are pretty sophisticated. Generally, any party sophisticated enough to want to spend money fighting this issue has probably known about it for awhile. Moreover, Apple was actually the other party in the Fintiv case.
Also worth noting that the PTO sent out a notice on May 7, 2019 regarding NHK and a notice on May 5, 2020 regarding Fintiv. I still have both of them in Outlook.
Comments are closed.