Filed on behalf of Petitioner COALITION FOR AFFORDABLE DRUGS IV LLC

By: Jeffrey S. Ward (Reg. No. 32,774)

MERCHANT & GOULD, P.C.

10 E. Doty Street

Suite 600

Madison, WI 53703-3376

Telephone: (608) 280-6751

Facsimile: (612) 332-9081

UNITED STATES PATENT AND TRADEMARK OFFICE

_____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

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COALITION FOR AFFORDABLE DRUGS IV LLC

Petitioner

v.

PHARMACYCLICS, INC.

Patent Owner

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Case No. To Be Assigned

Patent No. 8,754,090

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PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,754,090

UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq.

Introduction

Coalition for Affordable Drugs IV LLC (“Petitioner”) respectfully requests an Inter Partes review (“IPR”) for Claims 1-2 of U.S. Patent No. 8,754,090 (“the ’090 Patent”) (Ex. 1001) in accordance with 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq. The ’090 Patent is assigned to Pharmacyclics, Inc. (“the Patent Owner” or “the applicant”).

The ’090 Patent has two claims directed to a method for treating mantle cell lymphoma (“MCL”) in a patient using a prior art pharmaceutical compound now known as ibrutinib, where that patient has already received at least one prior therapy to treat MCL. Claims 1 and 2 are anticipated by a prior art document describing a phase 1 clinical trial entitled Study of the Safety and Tolerability of PIC-32765 in Patients with Recurrent B Cell Lymphoma (February 23, 2009), https://clinicaltrials.gov/archive/NCT00849654/2009_02_23 (“NCT00849654”) (Ex. 1002) sponsored by the Patent Owner itself. That clinical trial document describes the use of a compound having the designation PCI-32765 in a dose escalation study. A person of ordinary skill in the art (“POSA”) would have understood that only two compounds could potentially be PCI-32765 – ibrutinib or a racemic mixture containing ibrutinib.

Further, the clinical trial document discloses the patients to be treated and the doses to be used. Given that the compound designated as PCI-32765 can be only one of two things (both of which have ibrutinib), the disclosure in the clinical trial document describes every element of the methods of claims 1 and 2. Those claims are therefore invalid as anticipated.

Even if claims 1 and 2 are not anticipated by the clinical trial document (which they are), those claims would have been obvious to a POSA at the time of the ’090 Patent over the clinical trial document in view of two other Patent Owner documents, a published patent application (Ex. 1003) and a press release announcing (Ex. 1004), that disclose information concerning ibrutinib. A POSA would have been motivated to combine the disclosure of the clinical trial document with the published application and the press release to result in a method of using ibrutinib in the claimed doses to treat relapsed or refractory MCL. This combination discloses every element of claims 1 and 2, thus a POSA would have a reasonable expectation of its success.

Indeed, the examiner of the application that resulted in the ’090 Patent recognized the obviousness of the claims during prosecution. The examiner repeatedly rejected the applicant’s proposed claims, causing the applicant to cancel all but two of them. The applicant ultimately persuaded the examiner to allow the claims by arguing that “ibrutinib demonstrates substantial improvement over existing therapies,” which were “not taught or suggested by the cited art.” (Ex. 1013 at 5.) These alleged “unexpected results,” however, should have been given no patentable weight because they were not made in comparison to the closest prior art (ibrutinib) and were merely the inherent result of an obvious method of treatment with ibrutinib.

For the reasons explained herein, Petitioner is likely to prevail on showing the invalidity of the challenged claims. Petitioner requests that the Board institute an IPR and cancel claims 1 and 2 of the ’090 Patent.

Kyle Bass: Mandatory Notices Pursuant To 37 C.F.R. § 42.8

A. Real Party-In-Interest

Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner certifies that Coalition For Affordable Drugs IV LLC (“CFAD”), Hayman Credes Master Fund, L.P. (“Credes”), Hayman Orange Fund SPC – Portfolio A (“HOF”), Hayman Sunnyvale Fund LP (“HSF”), Hayman Capital Master Fund, L.P. (“HCMF”), Hayman Capital Management, L.P. (“HCM”), Hayman Offshore Management, Inc. (“HOM”), Hayman Investments, L.L.C. (“HI”), nXn Partners, LLC (“nXnP”), IP Navigation Group, LLC (“IPNav”), J. Kyle Bass, and Erich Spangenberg are the real parties in interest (collectively, “RPI”). The RPI hereby certify the following information: CFAD is a wholly owned subsidiary of Credes. Credes is a limited partnership. HOF is a segregated portfolio company. HSF is a limited partnership. HCMF is a limited partnership. HCM is the general partner and investment manager of Credes, HSF and HCMF.

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