Since Kyle Bass founded Coalition for Affordable Drugs X LLC (CFAD) to challenge pharmaceutical patents, CFAD has filed numerous petitions with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (Office) seeking to institute inter partes review (IPR) proceedings to invalidate a number of pharmaceutical patents, including three patents owned by Anacor Pharmaceuticals, Inc., as previously discussed at Global IP Matters.  On October 21, 2016, the PTAB issued written decisions on the two IPRs filed by CFAD invalidating claims of U.S. Patent No. 7,056,886 (the ‘886 Patent) that covers Shire PLC’s drug Gattex®.

Gattex® is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).  The medicine helps the remaining intestine (bowel) absorb more and reduces the need for parenteral support.

Gattex® received FDA approval in 2012 and had sales of $67.9 million in 2014 and sales of $141.7 million in 2015.

The ‘886 Patent covers stable formulations of GLP-2 peptides and analogs, including the active ingredient in Gattex®.  The ’886 Patent discloses the use of a phosphate buffer, the amino acid L-histidine and a bulking agent of either sucrose or mannitol to increase stability of certain GLP-2 peptides.  The claims set forth combinations of GLP-2 peptides and peptide concentrations, pH levels, L-histidine concentrations, and different bulking agents and concentrations.

The ’886 Patent claims were challenged in two IPR petitions filed by CFAD in April 2015.  The first IPR challenged claims 46-52 and 61-75 (IPR2015-00990) and the second challenged claims 1-45 (IPR2015-01093).  In October 2015 the PTAB instituted review of all claims challenged in the first IPR and review of claims 1-27, 31-40, and 44-45 of the second IPR.  In the final written decisions issued last week, the PTAB concluded that all instituted claims are obvious.

Claims 46-52 and 61-75 were challenged as being obvious over six prior references.  The PTAB concluded that each limitation of the claims was known in the prior art since “the claimed GLP-2 formulation is nothing more than a combination of known ingredients for a predictable result of stability as confirmed by routine testing.”  (IPR2015-00990, pages 20-21.)  The PTAB stated that “[t]he preponderance of evidence of record shows that the identification of the optimal sugar and amino acid to add to a formulation for stability purpose was nothing more than routine experimentation.”  (Id. at page 26.)  The PTAB considered the patent owner’s arguments on secondary considerations but found them unpersuasive.  In response to the patent owner’s surprising and unexpected results arguments, the PTAB relied on Petitioner’s arguments that the results presented in the ‘886 Patent are not commensurate in scope with the claims at issue.  In response to the patent owner’s commercial success arguments, the PTAB stated that “it is unclear if the sales are due to the stability of the product, or to the active agent,” which is disclosed in the prior art. (Id. at pages 30-35.)  Having found all challenged claims obvious over the prior art, the PTAB held claims 46-52 and 61-75 unpatentable.

Claims 1-27, 31-40, and 44-45 were also challenged as being obvious over six prior references, five of which overlapped with those cited in the first IPR.  Similar to the first decision, the PTAB concluded that each limitation of the claims was known in the prior art, namely that “the claimed GLP-2 formulation is nothing more than a combination of known ingredients for a predictable result of stability as confirmed by routine testing.”  (IPR2015-01093, pages 17-18.)  Using analysis similar to that in the first decision, the PTAB concluded that all challenged claims are obvious over the cited prior art and held these claims unpatentable.

It is unclear as of this date what next step Shire PLC will take.  Stay tuned for further updates.