by Dennis Crouch
Merck Sharp & Dohme Corp. v. Microspherix LLC (Fed. Cir. 2020)
The Federal Circuit here affirms the PTAB IPR final determination that Merck failed to prove the Microspherix claims invalid. US9636401; US9636402; US8821835. Microspherix sued Merck — accusing Merck’s implantable contraceptive of infringing. Merck responded with the three IPR petitions.
The patents here cover implantable therapeutic/diagnostic devices that also have a radiopaque marker that helps find the device after insertion. As originally filed, the claims were directed to “brachytherapy” — slow release of radioactive agents to treat cancer. However, the claims were expanded in various continuation applications to broadly claim any “therapeutic, prophylactic, and/or diagnostic agent”
The interesting legal question on appeal has to do with the timing of the asserted prior art reference Zamora. The chart below shows the patent filings in question, and each party argued that the opposing non-provisional applications could not properly claim priority to their respective provisional applications.
Question 1: Does 102(e) (pre-AIA) apply in inter partes review?: 35 U.S.C. 311 limits IPR validity challenges “the basis of prior art consisting of patents or printed publications.” Under 102(e), Zamora’s 2001 non-provisional application became prior art once the resulting patent issued. However, as of its 2001 filing date, the application was neither a “patent or printed publication.” In its decision here, the court simply assumed that 102(e) prior art counts under the IPR statute (as it has done in prior cases as well) See In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1281 (Fed. Cir. 2015), aff’d sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016). Post-AIA 102(a)(2) does not have the same problem because the statute makes clear that it is the patent / published application that is the prior art.
Question 2: Does Zamora’s provisional date allow for further back-dating of the 102(e) date?: Here, the court explains that Zamora would get the 2000 prior art date of its provisional “if it was entitled to the date of the Zamora provisional.” The court quoted Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) in explaining that the “‘reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional
application provides support for the claims in the reference patent in compliance with’ the written description requirement.” Here, the court noted that 2001 Zamora claimed three options for placement of a radiopaque medium, but one of those was not present in the provisional application. That failure of written decription meant that Zamora’s prior art date was 2001, not Jan. 2000.
Question 3: Does Microspherix’s provisional date work as a priority date?: In considering priority claims, the courts generally operate on a claim-by-claim basis. Thus, in a complex patent family, a single patent may include claims with a variety of priority dates. One problem with our current system is that a patent only tells us the earliest claimed priorty date — not the actual priority date. The actual date is only realized and determined through ex post litigation. Here, Merck argued that some of the claims went beyond the provisional disclosure. On appeal, the Federal Circuit disagreed — explaining that the the written description requirement requires the disclosure to “reasonably convey” possession of the invention.
Here, the particular written description argument focused on the length of the claimed strands that were inserted into a body. The original provisional disclosed a variety of strand lengths, but none of them were longer than 1 cm (10 mm). Some of the patent claims claim strands without any length limitation, and Merck argued that Microspherix was not in possession of such a broad range of strand lengths. On appeal, the Federal Circuit agreed with the PTAB that the description found int he provisional “adequately supports the claimed strand recited in Microspherix’s patent
claims.”
OT, but in view of the popularity of IPRs frequently expressed in blog comments here [joke] the following excerpt from a law firm report in the AIPLA blog may be of interest:
” … Ever since inception of the AIA, the institution rate of IPRs has declined significantly almost every year. According to published PTAB statistics, the institution rate has fallen from a high of over 87% in 2013 to a low of 63% in 2019 and is only 55% so far in 2020.[1]
An analysis of the data reveals … the recent and dramatic increase in the rate of discretionary denials under 35 U.S.C. §314(a). … Over the past four years, discretionary denials have increased from only 5 petitions denied under §314(a) in 2016 to 75 petitions denied under §314(a) in 2019.[3] That number is expected to more than double in 2020.[4]”
[Including some IPRs recently denied in view of the status of fast-track WDDC trial dates set on the subject patents.]
[But that latter number would not seem to be a major % of the high total number of current IPR institution denials as this author was further suggesting.]
Your snark is not clearly aimed.
Would you expect anything other than a declining rate, given such things as low-hanging fruit, and the industry ability to adapt practices (along with such case results as the ‘all or nothing’ decision mode?
You say [joke], but that is rather flat.
see 2.3.1.2.1.1.
After you ‘see’ the response to your post, Mr. W. E. Coyote.
Here are some IPR statistics with trends favorable to patent owners just posted by the PTO for FY 2019:
48.8% of IPR petitions against patents were Not instituted. [Including 15.8% settled before institution.] 14.8% those instituted were settled after institution. None of these resulted in any cancelled claims, much less all contested claims.
Settlement is not necessarily pro-patent holder – let’s not make that assumption.
Anon, please explain why an IPR settlement is “not necessarily pro-patent holder”?
It seems to me that there is a mutual interest incentive for the IPR Petitioner to get a license and thus for both parties to end the costs of both the IPR and the related patent suit, and a mutual interest for both to leave the patent owners claims intact to use against any competitors. Neither the patent owner or the Petitioner may want to risk an actual binding IPR decision that could be unpredictably for, or against, patentability of some or all of the contested claims. [If the patent owner has good reason to think that none of their claims are at any risk of invalidation, then why would they settle?]
Paul,
It’s rather simple: settlement is “settling,” and reasons for settling are as diverse as you and I.
It is LESS a “mutual interest” and MORE a “CRP, maybe I can only get ____” – which must be realized as NOT necessarily either mutual or of the type of interest that may rise to meet a “pro” viewpoint.
“[If the patent owner has good reason to think that none of their claims are at any risk of invalidation, then why would they settle?]”
Your question carries a false premise that the risk of invalidation is an objective indicator that demarcates a “pro” position.
NOTHING could be further from the truth. Why do you think that most pro-patent people are upset with the larger picture that the score board is broken?
What does complaining that “the scoreboard is broken” [with no legislative influence] have to do with real world decision making factors that a real patent owner [and a real petitioner] should rationally make in the normal and unavoidable real world situation of a suit on a patent having triggered an IPR petition in response?
The “complaining” has every thing to do with the bigger picture that you are so intent on missing.
“rational” is driven BY the things that are being complained about. You seem to think that such have no bearing?
Really?
Wake up son.
See 2.3.1.2.1.1.
And again, see the response already provided to you.
Yes Paul I agree. But Lourie wrote both opinions.
Doesn’t make sense to me that a priority date for a disclosure should depend on whether the claims are enabled by the provisional application.
Seems like whatever is in the provisional should have the date of the provisional and whatever is not in the provisional but in the non-provisional should have the priority date of the non-provisional.
Weird too that the claims could potentially change if the patent was less than two years old.
And consider if there is a pending continuation. So I change the claims to unambiguously be supported by the provisional and now the whole application has the earlier date.
And then another IPR could be filed with the “new” prior art.
Doesn’t make sense.
Two years from issue is the time limit for filing a broadening reissue. Patent claims can be narrowed at any time during their lifetime via disclaimer, reissue, reexamination, interference, derivation proceeding or other post grant proceeding. Providing the application had adequate 112 support for added claim elements, and subject to any applicable intervening rights.
+1
Right you are Paul. Thanks for the correction.
Still weirder, though, as the provisional could pop in and out of being prior art. Could start as prior art, then not be prior art with a broadening reissue, and then a narrowing amendment could bring it back into prior art.
And does this mean that as a defense that a patent should include a claim that is supported by the provisional so that it gets the date of the provisional for prior art purposes.
Just weird.
Confusing the 112 enablement requirements for a valid provisional priority date benefit for the claims of its ultimate patent, versus the completely different question of the effective prior art date for a contents of the provisional for prior art purposes, seems to be what was going on in Drinkware, LLC v. Nat’l Graphics. But a later Fed. Cir. panel cannot overrule an earlier panel’s legal decision.
Paul, do you not think that Judge Lourie’s prefacing words “On this record” in the sentence following the citation of Drinkware, is the “tell”, the clue, the flag up, that Drinkware was wrongly decided?
I do.
This is a good point. In the Final Written Decision, the PTAB said the Petitioner only tried to show claims 1 and 9 had 112 support in the provisional. Maybe Judge Lourie was intimating that there were other arguments the petitioner could have made to fall within Drinkware, whether or not it was wrongly decided.
Perhaps, but as I said, “a later Fed. Cir. panel cannot overrule an earlier panel’s legal decision” per their precedents. So it will take another panel that feels forced to take a drink of Drinkware, which that gets en banc or cert review, to actually overrule it.
Paul,
That view of “cannot overrule another panel” is quaint.
Except for the fact that there is one HUGE Gordian Knot that rather dispels that quaintness.
Snowflake, why is it that no one wants to “engage” with your nonsense when all you do is snipe from the sidelines — with such nonsense?
Does it make you want to pound the table and make some more stuff up?
Now, do what is that you are only able to, sadly, do. [and let’s see if you can avoid the tells]
Engage and snipe from the sidelines do not go together.
Maybe the “engage” factor is explainable by YOUR 95+% and the number of anvils on your noggin.
As to the rest of your false premise rhetoric…
[yawn]
Night Writer, it is not that simple.
Congress has defined what constitutes the prior art. Whether you look at Pre-AIA 102(e) or AIA 102(a)(2), the prior art is the content of the application that has published, not necessarily the content of the provisional (which is not published). That being said, you may need to consider the effect of incorporating the provisional by reference.
After that, you have the problem of the date of the prior art. Pre-AIA 102(e) states that the filing date of the published application needs to be before the invention date, so the date does not seem to be the earliest priority date. In contrast, AIA 102(a)(2) states that the date is the effective filing date of the application, so it seems that the date is the priority date, even for subject matter not present in the provisional, provided that one claim is supported by the provisional.
I think the Federal Circuit is trying to address the sloppiness of the statute in a way that makes sense.
I can go along with that assessment, PiKa. Except that I would choose a word other than “sloppy” to describe the text of the Statute. Shifting to First to File while retaining notions of what is prior art from the old First to Invent regime is a recipe for bewilderment all round, and complete loss of bearings, in the forest of the law.
Here in the real forests of Bavaria we have the mythical (and highly amusing) horned being called the Wolpertinger. It is neither fish nor fowl but a mixture of different animals. See Wikipedia. Link below:
link to en.wikipedia.org
Funny how that came to mind, when reading your post.
Here is claim 2 of the Zamora patent (6,575,888):
That claim does not appear to include the limitation requiring the radiopaque medium disposed on the “external surface” of the tube. Therefore, couldn’t Zamora claim priority to the provisional application for claim 2, making the provisional filing date the 102(e) date, at least for claim 2?
Or does the court require all of the claims in a prior art reference to be supported by the provisional before it gets the provisional filing date? Dynamic Drinkware and Wertheim appear to have involved cases where none of the claims had 112 support in the earlier application. But what happens if some of the claims are supported?
Good questions. As previously noted re Dynamic Drinkware v. National Graphics (Fed. Cir. 2015) that very strange decision as to the prior art date of the provisional application contents for its patent badly needs en banc or cert reversal, not just a distinction as here in Merck Sharp & Dohme Corp. v. Microspherix. What logic or possible Congressional intent could there be in saying that a patent’s provisional application contents provide no prior art effect unless claimed, and thus that key prior art date could be changed backwards or forwards simply by changing the claims later, even in a reissue?
As for “The original provisional disclosed a variety of strand lengths, but none of them were longer than 1 cm (10 mm). Some of the patent claims claim strands without any length limitation, and Merck argued that Microspherix was not in possession of such a broad range of strand lengths.”
That kind of argument for non-“possession” or 112 non-enablement, or lack-of-species-support, for a generic claim might work in a chemical case, but not for a mechanical length claim unless that length was critical.
+1
For an English patent practitioner as old as me, the weird Drinkware logic (on which the current Decision is founded) has echoes of the pre-1978 English “prior claiming” regime of the Patents Act 1949. Fact is though, the the drafters of the 1973 European Patent Convention looked at “prior claiming” and decided to despatch it into oblivion, replacing it with the “whole contents” approach which, in the years since then, the rest of the world has adopted (except for the USA). By now, every patent attorney who knows anything about prep and pros outside his own country is so familiar with “whole contents” as to have difficulty assessing prior art effects in First to File country any other way than in line with “whole contents” thinking.
Not so, of course, with judges imprisoned by the binding precedent of US patent law.
Sometimes it makes sense to tear up a Statute with roots in the 19th century (or earlier) and replace it with a Statute that withstands the scrutiny of the patent user circles in today’s world.
In the USA Max the judges on the CAFC rarely are trying to straighten out patent law anymore. Their main goal is to weaken patents. It was different before Obama.
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