The PTAB denial of the Bass IPR petitions on Acorda's Ampyra patents: not quite as being reported in the popular press

Further to an earlier IPBiz post, there has been discussion of PTAB's denial of Kyle Bass's petition on Acorda's Ampyra.

The reason for denial by PTAB turned on the issue of whether or not two poster presentations (that of Goodman and that of Hayes ) were printed publications suitable for mounting an IPR challenge.

These two references were mentioned in an Information Disclosure Statement (IDS) by the patentee. So the Bass team did not identify any new "smoking guns" but rather used information they obtained from the patentee's IDS.

PTAB quickly disposed of any idea that the patentee "admitted" Goodman and Hayes were prior art:


Petitioner asserts that the Goodman poster “constitutes prior art under
35 U.S.C. § 102(b) because it was published at least as early as September
18–21, 2002 (a fact admitted by the ’685 patent applicants in an October 1,
2012 IDS, see Ex. 1043, at Reference No. C416).” Pet. 18. Petitioner also
contends that the Hayes poster “constitutes prior art under 35 U.S.C.
§ 102(b) because it was published on Sept. 30–October 3, 2001, more than
one year prior to December 11, 2003 (a fact admitted by the ’685 patent
applicants in an October 31, 2011 IDS, see Ex. 1033, at Reference No.
C148).” Id. at 19. Exhibits 1043 and 1033 present portions of Information
Disclosure Statements (“IDSs”) for Application No. 13/187,158 (“the ’158
application”), which issued as the ’685 patent.

Patent Owner acknowledges that relevant IDSs submitted during
prosecution of the ’158 application state that the Goodman and Hayes
posters “were ‘presented.’” Prelim. Resp. 11–12 (citing Ex. 2033, 3,
“C416”; Ex. 2031, 12, “C148”). Patent Owner contends, however, that
“even if Petitioner claims that the posters were displayed at meetings, this
does not establish that the posters are printed publications” that qualify as
prior art under § 102. Id. at 12 (citing In re Klopfenstein, 380 F.3d 1345,
1349 n.4 (Fed. Cir. 2004)). We agree.

First, the submission of an IDS does not constitute an admission that a
cited reference is material prior art. ResQNet.com, Inc. v. Lansa, Inc., 594
F.3d 860, 866 (Fed. Cir. 2010); Abbott Labs. v. Baxter Pharm. Prods., Inc.,
334 F.3d 1274, 1279 (Fed. Cir. 2003)); see also 37 C.F.R. § 1.97(h) (stating
that the filing of an IDS “shall not be construed to be an admission that the
information cited in the statement is, or is considered to be, material to
patentability as defined in § 1.56(b)”). Moreover, in this case, the relevant
IDSs themselves state expressly that “[i]dentification of the listed references
is not meant to be construed as an admission of Applicants or Attorneys for
Applicants that such references are available as ‘prior art’ against the subject
application.” Prelim. Resp. 19 (quoting Ex. 2031, 2; Ex. 2033, 1).



The second point raised by PTAB was whether or not the two posters were printed
publications, which could be reviewed by PTAB in an IPR proceeding. PTAB did not
determine whether they were, or were not, printed publications but rather that petitioner Bass had not
presented evidence that they were. Thus, in theory, these Ampyra patents are still
subject to attack based upon Goodman and Hayes (tho may be not by Bass).

PTAB wrote:


Second, as also noted by Patent Owner, a “determination of whether a
reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case
inquiry into the facts and circumstances surrounding the reference’s
disclosure to members of the public.” Klopfenstein, 380 F.3d at 1350;
Prelim. Resp. 12–18. Several factors “aid in resolving whether or not a
temporarily displayed reference that was neither distributed nor indexed was
nonetheless made sufficiently publicly accessible to count as a ‘printed
publication’ under § 102(b).” Klopfenstein, 380 F.3d at 1350. Because
Petitioner does not indicate that the Goodman and Hayes posters were
distributed (rather than presented) or indexed, we consider those factors
now, which include: “[1] the length of time the display was exhibited, [2]
the expertise of the target audience, [3] the existence (or lack thereof) of
reasonable expectations that the material displayed would not be copied, and
[4] the simplicity or ease with which the material displayed could have been
copied.” Id.
The “duration of the display is important in determining the
opportunity of the public in capturing, processing and retaining the
information conveyed by the reference.” Id. Along those lines, “[t]he more
transient the display, the less likely it is to be considered a ‘printed
publication.’” Id. at 1350–51. Here, we agree with Patent Owner that
Petitioner presents insufficient evidence as to how long the Goodman or
Hayes poster was presented at any scientific meeting. Prelim. Resp. 13–14.
The only credible evidence of record indicating that the posters were
presented at all is in the form of IDSs stating that the posters were
“presented.”

Similarly, Petitioner presents insufficient evidence in relation to “the
expertise of the target audience,” i.e., anyone who actually saw either poster.
Id. at 14–15. Petitioner likewise presents insufficient evidence in relation to
any reasonable expectation that one could have copied the poster material, or
evidence regarding the ease with which the poster material could have been
copied. Id. at 15–16. Overall, evidence of record fails to demonstrate that
the posters nonetheless were made sufficiently publicly accessible. For
example, evidence of record does not indicate adequately how long the
posters were presented to anyone, or to whom exactly, or what conversations
anyone might have had with authors about the posters.

In addition, our review of the posters themselves indicates that they
both present relatively dense material in a small space. Ex. 1008, 2;
Ex. 1009, 1. As stated by the Federal Circuit, the “more complex a display,
the more difficult it will be for members of the public to effectively capture
its information.” Klopfenstein, 380 F.3d at 1351.



The bottom line:


We are not persuaded that Petitioner has made a threshold showing
that the posters were sufficiently publicly accessible to qualify as a “printed
publication” under § 102(b). Petitioner has not demonstrated adequately that
the Goodman poster (relied upon in all grounds) or the Hayes poster, as
presented in the Petition, constitute prior art to the ’685 patent.



The Klopfenstein case involved posters, and it is worthwhile to view
"how" the MPEP views the issue:


MPEP 2128.01 Level of Public Accessibility Required

(...)

IV. PUBLICLY DISPLAYED DOCUMENTS CAN CONSTITUTE A “PRINTED PUBLICATION” EVEN IF THE DURATION OF DISPLAY IS FOR ONLY A FEW DAYS AND THE DOCUMENTS ARE NOT DISSEMINATED BY COPIES OR INDEXED IN A LIBRARY OR DATABASE

A publicly displayed document where persons of ordinary skill in the art could see it and are not precluded from copying it can constitute a “printed publication,” even if it is not disseminated by the distribution of reproductions or copies and/or indexed in a library or database. As stated in In re Klopfenstein, 380 F.3d 1345, 1348, 72 USPQ2d 1117, 1119 (Fed. Cir. 2004), “the key inquiry is whether or not a reference has been made ‘publicly accessible.’” Prior to the critical date, a fourteen-slide presentation disclosing the invention was printed and pasted onto poster boards. The printed slide presentation was displayed with no confidentiality restrictions for approximately three cumulative days at two different industry events. Id. at 1347, 72 USPQ2d at 1118. The court noted that “an entirely oral presentation that includes neither slides nor copies of the presentation is a ‘printed publication’ for the purposes of [pre-AIA] 35 U.S.C. § 102(b). However, an oral presentation at a scientific meeting or a demonstration at a trade show may be prior art under 35 U.S.C. 102(a)(1)’s provision: “otherwise available to the public.” See MPEP § 2152.02(e). Furthermore, a presentation that includes a transient display of slides is likewise not necessarily a ‘printed publication.’” Id. at 1349 n.4, 72 USPQ2d at 1122 n.4. In resolving whether or not a temporarily displayed reference that was neither distributed nor indexed was nonetheless made sufficiently publicly accessible to count as a “printed publication” under pre-AIA 35 U.S.C. 102(b), the court considered the following factors: “the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied.” Id. at 1350, 72 USPQ2d at 1120. Upon reviewing the above factors, the court concluded that the display “was sufficiently publicly accessible to count as a ‘printed publication.’” Id. at 1352, 72 USPQ2d at 1121.

(...)

II. ORALLY PRESENTED PAPER CAN CONSTITUTE A “PRINTED PUBLICATION” IF WRITTEN COPIES ARE AVAILABLE WITHOUT RESTRICTION
A paper which is orally presented in a forum open to all interested persons constitutes a “printed publication” if written copies are disseminated without restriction. Massachusetts Institute of Technology v. AB Fortia, 774 F.2d 1104, 1109, 227 USPQ 428, 432 (Fed. Cir. 1985) (Paper orally presented to between 50 and 500 persons at a scientific meeting open to all persons interested in the subject matter, with written copies distributed without restriction to all who requested, is a printed publication. Six persons requested and obtained copies.). An oral presentation at a scientific meeting or a demonstration at a trade show may be prior art under 35 U.S.C. 102(a)(1)’s provision: “otherwise available to the public.” See MPEP § 2152.02(e).



**As to Klopfenstein, the PTAB text


In addition, our review of the posters themselves indicates that they
both present relatively dense material in a small space. Ex. 1008, 2;
Ex. 1009, 1. As stated by the Federal Circuit, the “more complex a display,
the more difficult it will be for members of the public to effectively capture
its information.” Klopfenstein, 380 F.3d at 1351.



is a bit of a stretch, because Klopfenstain was considering ease of copying.

From Klopfenstein:


Finally, the ease or simplicity with which a display could be copied gives further guidance to our § 102(b) inquiry. The more complex a display, the more difficult it will be for members of the public to effectively capture its information. The simpler a display is, the more likely members of the public could learn it by rote or take notes adequate enough for later reproduction. The Liu reference was made up of 14 separate slides. One slide was a title slide; one was an acknowledgement slide; and four others represented graphs and charts of experiment results. The other eight slides contained information presented in bullet point format, with no more than three bullet points to a slide. Further, no bullet point was longer than two concise sentences. Finally, as noted earlier, the fact that extrusion lowers cholesterol levels was already known by those who worked with SCF. The discovery disclosed in the Liu reference was that double extrusion increases this effect. As a result, most of the eight substantive slides only recited what had already been known in the field, and only a few slides presented would have needed to have been copied by an observer to capture the novel information presented by the slides.



There is no appeal from a denial of petition. Here, the denial of the petition was based on a failure of evidence that the documents were printed publications. There was no determination whether the posters were or were not "printed publications," and
no determination that if they were printed publications, whether there was a reasonable likelihood that petitioner could have prevailed on at least one claim.


Relevant links:

Paper 15 in IPR2015-00720 related to US 8,663,685, entered August 24, 2015

MPEP 2128 “Printed Publications” as Prior Art

In re Klopfenstein, 380 F.3d 1345 in which the CAFC concluded


Upon reviewing the above factors, it becomes clear that the Liu reference was sufficiently publicly accessible to count as a "printed publication" for the purposes of 35 U.S.C. § 102(b). The reference itself was shown for an extended period of time to members of the public having ordinary skill in the art of the invention behind the '950 patent application. Those members of the public were not precluded from taking notes or even photographs of the reference. And the reference itself was presented in such a way that copying of the information it contained would have been a relatively simple undertaking for those to whom it was exposed — particularly given the amount of time they had to copy the information and the lack of any restrictions on their copying of the information. For these reasons, we conclude that the Liu reference was made sufficiently publicly accessible to count as a "printed publication" under § 102(b).



Reuters: Hedge fund manager Kyle Bass loses challenges to pharma patents which includes text


On Monday, the patent office disagreed with Bass that the Ampyra patents were not new or were obvious when compared with previously known ones, and therefore should never have been granted in the first place.

The decision means the patents will not be further scrutinized, which could have led to cancellation.



which, as noted above, is an inaccurate report by Reuters.

**The Wall Street Journal noted:


Use of IPR challenges against drug patents has raised concerns in the pharmaceutical industry, which has lobbied Congress for changes to the IPR process. The patent board’s ruling Monday against Mr. Bass, however, may signal that challenging pharmaceutical patents through IPR won’t be as easy as some industry officials have feared, said Gerald Flattmann, lead outside counsel for Acorda in its IPR proceedings with Mr. Bass.



But, Acorda was saved only by a failure of evidence by Bass, not by a substantive ruling on validity. The pharma industry is right to worry about IPRs.


**As one small footnote, Ampyra is not a disease-modifying treatment for MS, in contrast to Copaxone or Tecfidera.