Jazz Pharmaceuticals: Does the Federal Circuit Really Understand the Dichotomy in the Printed Publication Bar?

By Eric Guttag
July 19, 2018

I have written twice in the past for IPWatchdog about the nuances of the ‘printed publication’ bar.  The first was in 2009 which discusses the case of In re Lister where the patent applicant barely avoided a potentially fatal “printed publication” bar based on his own copyrighted manuscript that was searchable in two commercial databases, but only after the critical “bar date.”  See CAFC Rules Patent Applicant’s Own Copyrighted Manuscript Not Publicly Accessible.  The second was the 2012 case of Voter Verified, Inc. v. Premier Election Solutions, Inc. where a Federal Circuit panel ruled that an article (the “Benson” article) obtained from online periodical was a “printed publication” bar available as “prior art” under 35 U.S.C. § 103. See Voter Verified: Online Periodical Held to be Printed Publication.

In that second article, I pointed out that the “printed publication” bar is really two distinct and parallel doctrines that the Federal Circuit has all too often (unfortunately) commingled and conflated.  The first, more active form is the “dissemination” doctrine.  Under the “dissemination” doctrine, the courts focus primarily on the following three factors:  (1) who received the document (i.e., who was the “relevant audience”); (2) how widely was the document circulated (i.e., how many copies of the document were disseminated to the relevant audience); and (3) how long (or temporarily) was the document in circulation.  See, for example, the seminal 1928 case of Jockmus v. Leviton authored by Judge Learned Hand.

The second, more passive form is the “publicly accessible” doctrine (sometimes referred to as “constructive publication”).  Under the “publicly accessible” doctrine, the courts focus on where the documents are stored and especially whether those documents are “catalogued or indexed in a meaningful way.”  See, for example, the 1989 case of In re Cronyn.  As I sadly noted in my second article regarding the 2006 case of Bruckelmyer v. Ground Heaters, Inc., the majority opinion of the Federal Circuit (authored by Judge Lourie) pays lip service to the requirement that the documents be “catalogued or indexed in a meaningful way” in ruling that two cancelled drawings figures remaining in the file wrapper of a Canadian patent constituted a “printed publication” bar.  As dissenting Judge Linn correctly observed, those two cancelled drawings figures remained in file wrapper of that Canadian patent “by sheer happenstance,” and were otherwise “not indicated” as being present in that file wrapper, i.e., those cancelled drawings figures were not “catalogued or indexed in a meaningful way.”

In my second article discussing Voter Verified, I characterized that case as the latest example of the Federal Circuit being oblivious to the parallel existence of these two doctrines (and especially the very different requirements for each of these distinct doctrines) for applying the “printed publication” bar.  But sadly again, I must write a yet a third time about how the Federal Circuit continues this regrettable conflation and commingling of this dichotomy in the “printed publication” bar in the recent case of Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC.  Once more (sigh), our “usual suspect” is Judge Lourie who wrote the opinion in Voter Verified.

The Jazz Pharmaceuticals case involves a “family of patents” relating to a drug distribution system for tracking prescriptions of a “sensitive drug.”  The key issue in this case was whether a meeting announced in a May 14, 2001 Federal Register Notice made certain background materials posted before that meeting, as well as the meeting minutes, transcript, and slides posted after that meeting (referred to collectively as the “ACA materials”) sufficiently accessible to the public to constitute “prior art” under 35 U.S.C. § 103 per the “printed publication” bar.  Amneal Pharmaceuticals filed an inter partes review (IPR) petition involving seven of these patents which relied upon these ACA materials as the relevant “prior art.”  PTAB agreed with Amneal Pharmaceuticals that a person of ordinary skill, exercising reasonable diligence, would have been able to locate these ACA materials based upon this May 14, 2001 Federal Register Notice which provided a hyperlink to these ACA materials.  As also noted in the statement of facts in Lourie’s Federal Circuit opinion (joined by Judges Newman and Reyna), PTAB ruled that these ACA materials were “public accessible” on the FDA website listed in that May 14, 2001 Federal Register Notice no later than October 4, 2001, over two months prior to the critical date of December 17, 2001.

In arguing for reversal of PTAB’s ruling of invalidity, Jazz Pharmaceuticals protested (quite rightly in my opinion) that Amneal “failed to submit any evidence of searchability or indexing” as it related to these ACA materials being “publicly accessible.”  Amneal countered that “neither indexing nor searchability is required under the relevant case law.”

The Federal Circuit panel (per Lourie) agreed with Amneal, stating that “substantial evidence supports [PTAB’s] finding that the ACA materials were publicly accessible.”  To get to this conclusion that these ACA materials were “publicly accessible,” Lourie’s opinion first cites to the following four cases:  (1) Massachusetts Institute of Technology (MIT) v. AB Fortia; (2) In re Klopfenstein; (3) Cordis Corp. v. Boston Scientific Corp.; and (4) Medtronic, Inc. v. Barry.  But Lourie’s reliance upon any of these four cases for these ACA materials being “publicly accessible” is completely misplaced in my opinion.  Instead, each of these four cases involves the “dissemination” branch of the “printed publication” bar in that the materials in all four cases were distributed (e.g., given) directly to the relevant audience.  Indeed, Lourie’s statement that these ACA materials were “disseminated more broadly and for a longer duration to persons of ordinary skill than the materials disclosed in those cases” (i.e., in MIT, Klopfenstein, and Medtronic) is an utter canard as these ACA materials (as far as I can tell from Lourie’s opinion) were never actually “disseminated” (i.e., distributed) in same sense that the materials in those three cases were “disseminated.”

So how does Lourie’s opinion make this totally false “leap of logic?”  Quite shockingly (at least to me), that “leap of logic” is based squarely upon the 2014 Federal Circuit panel decision in Suffolk Technologies, LLC v. AOL Inc., authored by current Chief Judge Prost (joined by Chen and then Chief Judge Rader).  In Suffolk Technologies, the patent claims were deemed anticipated under 35 U.S.C. § 102(b) based upon a Usenet newsgroup post (referred to as the “Post”) which was made nine months before the claimed priority date of the allegedly infringed patent.  The accused defendants (AOL and Google) motion for summary judgment of invalidity was granted by the Eastern District of Virginia based upon the “Post” being a “printed publication” bar.  On appeal, Suffolk Technologies (the patent owner) argued that the “Post” was not a “printed publication” bar for the following two reasons:  (1) the audience for the “Post” was “not those of ordinary skill in the art”; and (2) locating the “Post” would be “too difficult” because it was “non-indexed and non-searchable.”

Prost’s opinion disagreed, responding first to the second reason postulated by Suffolk Technologies (i.e., locating the “Post” would be “too difficult” because it was “non-indexed and non-searchable).  Prost’s initial basis for disagreeing with Suffolk Technologies is reasonable and at least plausible for the “publicly assessible” branch of the “printed publication” bar, as it says “Suffolk overstates the difficulty in locating the Post after publication” because “Usernet newsgroups were organized in a hierarchical manner” and thus “someone interested in CGI could easily locate a list of posts in this newsgroup.”  But her second basis for disagreeing gives me pause as it says that “a printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication,” again citing to Klopfenstein, and MIT.  In particular, Prost’s disagreement with the reasoning of Suffolk Technologies which says that the “present case” is more similar to” the situation SRI International, Inc. v. Internet Security. Systems., Inc. (authored by Rader and ruling that materials posted on an FTP server were not “publicly accessible) once again commingles, as well as conflates the differences between the “dissemination” and “publicly accessible” branches of the “printed publication” bar.  Prost’s view that Suffolk Technologies’ “analogy” to SRI International “is inapplicable here” relies upon facts relevant to supporting a “printed publication” bar under the “dissemination” branch, not the “publicly accessible” branch she initially starts with:  (a) the “dialogue with the intended audience was the entire purpose of the newsgroup postings”; and (b) the Post “elicited at least six responses over the week following its publication.”  In other words, the relevant audience had actually received/seen the “Post” material which is consistent with applying the “dissemination” branch, but not the “publicly accessible” branch of the “printed publication” bar.  Indeed, Prost’s further statement that “many more people may have viewed the posts without posting anything themselves” is pretty much irrelevant if the “dissemination” branch of the “printed publication” bar has been satisfied which focuses on whether the relevant audience has actually received/been given the material, and not on whether it might have read/reviewed that material (which is assumed).  Indeed, Prost completes her mindless conflation of these two branches of the “printed publication” bar when she says that “the Post was sufficiently disseminated to be considered publically accessible.”

Unfortunately, Lourie’s opinion in Jazz Pharmaceuticals (equally mindless in my opinion) simply latches onto Prost’s words in Suffolk Technologies that a “printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of it publication” to reject Jazz Pharmaceuticals’ entirely valid point that there was no substantial evidence provided to PTAB on the “searchability or indexing” of these ACA materials when he says later:  “neither indexing nor searchability was required.”  That might be true if these ACA materials had actually been disseminated (distributed) to the relevant audience.  But “squint as I may,” I see nothing in the factual record described by Lourie in his opinion that says (at least clearly to me) that anyone in the relevant audience had actually received these ACA materials (or had at least had these ACA materials given/distributed to them) prior to the critical December 17, 2001 date.  Indeed, what evidence that was relied upon by PTAB for the “printed publication” bar says, at most, there was “sufficient motivation” for “one of ordinary skill” to “locate[] the [May 14, 2001] Federal Register Notice and FDA website,” and that with such “motivation,” a “person of ordinary skill would be capable of locating that [May 14, 2001 Federal Register] Notice.”  But that is far short what is required by either the “dissemination” branch (i.e., actual distribution to the relevant audience), or the “publicly accessible” branch (i.e., “cataloguing or indexing in a meaningful way,” which, for materials posted on an Internet website, requires more than simply “motivation” to “locate” such materials that may be otherwise unsearchable or not easily searchable) of the “printed publication” bar.  See Guttag, “Applying the Printed Publication Bar in the Internet Age:  Is It as Simple as Googling for Prior Art”, where I discuss the importance of the ease of “searchability” for materials posted on Internet websites in the context of the Lister and SRI International cases involving the “publicly accessible” branch of the “printed publication” bar.  Or as I said in my earlier 2012 IPWatchdog article, “if you can’t readily find the electronically posted document by doing a reasonable search (with appropriate search terms) via the Internet, how can you say that the document is ‘publicly accessible’ to be a “printed publication” bar?”

Admittedly, the point I’m making here about the application of the “printed publication” bar in the Jazz Pharmaceuticals case is somewhat subtle.  But that point is nonetheless highly relevant in keeping this important dichotomy in the “printed publication” bar from being improperly blurred and conflated in future cases before PTAB, the district courts, and especially, the Federal Circuit.  Given that documents and other materials are being increasingly (and perhaps even exclusively) posted on Internet websites (including those of various local, state, and federal governmental agencies) makes such confusing and continued conflation of this dichotomy in the “printed publication” bar by Federal Circuit (as evidenced most by Lourie) extremely bothersome and worrisome to me.  I would also suggest that the Jazz Pharmaceuticals case presents an excellent opportunity for a rehearing en banc by the Federal Circuit to hopefully avoid further (and in my opinion improper) “blurring” of this previously recognized dichotomy between the “dissemination” and “publicly accessible” branches of the “printed publication” bar.

*© 2018 Eric W. Guttag.

The Author

Eric Guttag

Eric Guttag  
Mr. Guttag has over 38 years of corporate and private intellectual property law experience on patent, trademark, copyright, trade secret and unfair competition matters, computer and Internet law, including patent application drafting, prosecution, and patentability studies; infringement and validity studies; international patent prosecution; patent and know-how licensing; consulting, confidentiality, clinical study and research agreements; trademark searches and opinions; trademark registration and prosecution; trademark freedom-to-use studies and trademark litigation and dispute resolution.

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