Kyle Bass keeps on going…. here is the latest versus NPS Pharmaceuticals, Inc. And Celegene Corporation
Filed on behalf of Petitioner COALITION FOR AFFORDABLE DRUGS II LLC
By: Jeffrey D. Blake, Esq.
MERCHANT & GOULD P.C.
191 Peachtree Street N.E., Suite 4300
Atlanta, GA 30303
Main Telephone: (404) 954-5100
Main Facsimile: (404) 954-5099
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
COALITION FOR AFFORDABLE DRUGS II LLC
NPS PHARMACEUTICALS, INC.
Case No. To Be Assigned
Patent No. 7,056,886
PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,056,886 (CLAIMS 1-45) UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq.
Kyle Bass vs NPS Pharmaceuticals, Inc.: Petition For Inter Partes Review – Introduction
Coalition for Affordable Drugs II LLC (“Petitioner” or “CFAD”) respectfully requests an Inter Partes (“IPR”) review for Claims 1-45 of U.S. Patent No. 7,056,886, issued on June 6, 2006, to Isaacs (“the ’886 patent”) (Ex. 1003) in accordance with 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq. Independent claim 1 is directed to a formulation containing a peptide known as “glucagon-like peptide-2” (“GLP-2”) or an analog thereof. There is a reasonable likelihood that this independent claim and those claims depending therefrom are unpatentable because they would have been obvious to a person of ordinary skill in the art.
Formulations of GLP-2 and analogs thereof, and the therapeutic use of such formulations for treatment of gastrointestinal disorders were well known before the earliest effective filing date of the ’886 patent. Storage stable lyophilized formulations of a related peptide, glucagon, were also disclosed in the prior art. As shown herein, the combination of the cited prior art references discloses all of the limitations of the claimed GLP-2 formulations.
A person of ordinary skill in the art would have been motivated to combine these prior art references in order to form a stable GLP-2 formulation for therapeutic use because there was a known design need for storage stable formulations. It was known that formulations of peptides, including peptides such as glucagon, lack storage stability. A solution to this problem, provided by the prior art, was to lyophilize the formulation in the presence of L-histidine and sucrose or mannitol to increase storage stability. Furthermore, GLP-2 and glucagon disclosed in the prior art are structurally similar leading one of ordinary skill in the art to combine disclosures in the prior art references with a view to forming a stable GLP-2 formulation.
The combination of the prior art also provides a reasonable expectation of success in formulating GLP-2 in combination with L-histidine and sucrose or mannitol to create a storage stable lyophilized formulation. Through routine experimentation, a person of ordinary skill in the art would have easily substituted active ingredients having a similar physical and chemical profile to glucagon into stable formulations disclosed in the cited art. At the very least, storage stable lyophilized formulations taught in the prior art for glucagon would have been obvious to try with GLP-2.
The claimed subject matter represents nothing more than the predictable use of known components having known functions, and represents a strong case for obviousness that overcomes any evidence of secondary considerations. The Patentee has not argued and cannot argue that the claimed subject matter provides unexpected results because similar results are shown for storage stable formulations of glucagon in the cited prior art. To the extent Patentee alleges commercial success to rebut the obviousness of claims 1-45, no nexus between these claims and any alleged commercial success exists.
Thus, the claimed formulations of GLP-2 are obvious given the state of the art before the filing date of the ’886 patent. As a result, claims 1-45 are unpatentable and an IPR should be instituted on this basis.
II. 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 II LLC (“CFAD”), Hayman Credes Master Fund, L.P. (“Credes”), Hayman Orange Fund SPC – Portfolio A (“HOF”), 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. HCMF is a limited partnership. HCM is the general partner and investment manager of Credes and HCMF. HCM is the investment manager of HOF. HOM is the administrative general partner of Credes and HCMF. HI is the general partner of HCM. J Kyle Bass is the sole member of HI and sole shareholder of HOM. CFAD, Credes, HOF and HCMF act, directly or indirectly, through HCM as the general partner and/or investment manager of Credes, HOF and HCMF. nXnP is a paid consultant to HCM. Erich Spangenberg is 98.5% member of nXnP. IPNav is a paid consultant to nXnP. Erich Spangenberg is the 98.5% member of IPNav. Other than HCM and J Kyle Bass in his capacity as the Chief Investment Officer of HCM and nXnP and Erich Spangenberg in his capacity as the Manager/CEO of nXnP, no other person (including any investor, limited partner, or member or any other person in any of CFAD, Credes, HOF, HCMF, HCM, HOM, HI, nXnP or IPNav) has authority to direct or control (i) the timing of, filing of, content of, or any decisions or other activities relating to this Petition or (ii) any timing, future filings, content of, or any decisions or other activities relating to the future proceedings related to this Petition. All of the costs associated with this Petition will be borne by HCM, CFAD, Credes, HOF and/or HCMF.
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