Coalition for Affordable Drugs IV LLC (Petitioner) (“CAD”) v. Pharmacyclics, Inc. (Patent Owner)

IPR2015-01076 (US Pat. No. 8,754,090B2)
PTAB Final Decision Denying Institution of IPR
October 19, 2015

Brief Summary: Petition for IPR on the basis of anticipation and obviousness dismissed as CAD could not show alleged prior art qualified as a “printed publication”.

Summary: CAD requested IPR of claims 1 and 2 of the ‘090 patent encompassing “method[s] for treating mantle cell lymphoma in an invidual who has already received at least one prior therapy” therefor by administering 420-840 mg (“about 560 mg” in claim 2) of a particular Bruton’s tyrosine kinase (Btk) inhibitor to a patient. CAD challenged the claims for anticipation and obviousness in view of a published clinical trail document from clinicaltrials.gov and two other references. Pharmacyclics argued the clinical trial report was not a “printed publication” that qualifies as prior art under 35 USC § 311(b). The Decision explains that the burden of showing the document qualifies as prior art is on the Petitioner (Dynamic Drinkware, FC 2015). In Dynamic, the Petitioner relied upon theh filing date of a patent unlike here, the Board explains, where “it is not clear from the face of the webpage whether it qualifies…Petioner cannot simply state that [the document] is prior art to satisfy its initial burden of production.” “[K]ey” to this determination is “whether the reference was made ‘sufficiently available to the public interested in the art’ before the critical date” (In re Cronyn, FC 1989). To be “publicly accessible”, it must be shown that the document was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art excercising reasonable diligence[] can locate it” (Kyocera Wireless, FC 2008). The Board concluded CAD had not offered any persuasive evidence, only conclusory statements (including “nothing more than a conclusory statement that ‘[t]he prior art also includes” the clinical trial report by its declarant). The Board acknowledged that the document “indicates that it was ‘Updated: 2009_02_23’” but noted that “Petitioner provides no explanation or evidence of what that date means” (e.g., how the Feb. 23 date relates to the alleged Feb. 2 publication date or “the website’s publishing practices”). Thus, it concluded CAD could not “establish a reasonable likelihood that it would prevail”.

This entry was posted in Anticipation (35 USC 102), Inter Parties Review (IPR), Obviousness. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.