In a recent final written decision (Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017)), the Board determined that the Coalition for Affordable Drugs (“Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (“the ’135 patent) were obvious. The claims recite methods of treating a subject suffering from a disorder associated with hyperlipidemia and/or hypercholesterolemia. Petitioner asserted these claims were obvious because the alleged prior art taught applying step-wise escalating doses of a microsomal triglyceride transfer protein (MTP) inhibitor to treat hyperlipidemia and hypercholesterolemia. As in cases we have previously discussed here and here, the Petitioner failed to satisfy its burden of proof because it did not show that the alleged prior art qualified as a “printed publication.”
The ’135 patent is directed to a method of treatment with an MTP inhibitor, which is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments in reducing atherogenic lipoprotein levels in humans. According to the ’135 patent, the “invention is based on the surprising discovery that one may treat an individual who has hyperlipidemia and/or hypercholesterolemia with an MTP inhibitor in a manner that results in the individual not experiencing side-effects normally associated with the inhibitor, or experiencing side-effects to a lesser degree.” The treatment involves a dosing regimen, “wherein said administration comprises at least three, step-wise, increasing dose levels of the MTP inhibitor wherein a first dose level is from about 2 to about 13 mg/day, a second dose level is from about 5 to about 30 mg/day, and a third dose level is from about 10 to about 50 mg/day…, and wherein each dose level is administered to the subject for about 1 to about 5 weeks.”
The Petitioner challenged the claims of the ’135 patent as being obvious based on two different combinations of references. At issue in only one of the obviousness challenges discussed here was whether a slide set purportedly prepared by Dr. Evan Stein for PPD, Inc. for an investor event (i.e., Analyst Day on February 5, 2004), qualified as prior art as a printed publication. In the slide set (“Stein”), Dr. Stein discusses MTP inhibitors and proposes a development plan in which test subjects are treated with low doses and then stepped-up with increasing doses of an MTP inhibitor based on safety. Stein was presented on that day and was simultaneously available on a webcast. The Petitioner, citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004), contended that the presentation itself of Stein qualified as a printed publication under § 102(a) because “a skilled artisan could have captured (or recorded), processed and retained the relevant material.”
As set forth in Klopfenstein, the factors to be considered in determining qualification as a printed publication are: (i) the length of time the display was exhibited; (ii) the expertise of the target audience; (iii) the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied; and (iv) the simplicity or ease with which the material displayed could have been copied. Klopfenstein, 380 F.3d at 1350. The court said that it is only by “considering and balancing these factors can we determine whether or not [a] reference was sufficiently publicly accessible to be a ‘printed publication.’” Id.
The Patent Owner argued that the Petitioner has not met its burden of demonstrating that Stein is prior art. Among other things, the Patent Owner argued that the Petitioner did not prove by a preponderance of the evidence that the slide set qualified as a printed publication because the “Investor Day” audience were business people, and not skilled artisans, and there was insufficient evidence of the public availability of the slides. The Patent Owner argued that the Petitioner has not provided any evidence that the slides were displayed at all, much less for how long.
The Board said that the determination of whether a document is a “printed publication” under 35 U.S.C. § 102 “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. “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).
The Board found that the Petitioner had not met its burden of establishing that the Stein presentation itself constitutes a printed publication under Klopfenstein, because the Petitioner did not provide any evidence establishing the expertise of the target audience. The Board stated that “although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, the Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” The Board found that a press release advertising that PPD would hold an analyst day on February 5, 2004, did not mention hyperlipidemia, hypocholesteremia, MTP inhibitors, or any information relating to the topic of the presentation and, therefore, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. Because there was nothing in the press release discussing MTP inhibitors, the Board declined to credit the Petitioner’s expert’s testimony that “[a] person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter.”
The Board stated that “although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.”
As a result, the Board concluded that the Petitioner did not meet its burden of demonstrating by a preponderance of the evidence that Stein constitutes a printed publication under 35 U.S.C. § 102. Because Stein could not be considered prior art, the Board found that the Petitioner cannot demonstrate under § 103 that the combination of Stein with the secondary reference render the challenged claims obvious. This case is another reminder that petitioners must be careful to put sufficient evidence in the record to demonstrate that alleged printed publications qualify as prior art.