United States: Old Drug Label Still Requires Authentication of Publication Date

In IPR2016-01566 (Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH), the PTAB denied institution of an inter partes review of U.S. Patent No. 9,173,859, in part, because Petitioner –Mylan – failed to provide sufficient evidence to support a threshold showing that the proffered drug label was a prior art printed publication.

Under 35 U.S.C. § 311(b), an IPR challenge is limited to patents and printed publications. An IPR petitioner bears the initial burden to make a "threshold showing" that the proffered evidence is a prior art printed publication, including proving the date of publication.

Here, the challenged patent claims cover methods for treating type 2 diabetes with and pharmaceutical compositions comprising: linagliptin and metformin. Metformin is the generic name for Glucophage® and Glucophage® XR approved by the FDA in 1994 and 2000, respectively, for treating type 2 diabetes. Petitioner presented a drug label marked as "FINAL PRINTED LABELING" for Glucophage® and Glucophage® XR to support its obviousness contention. The drug label is also marked as "Revised January 2001." Petitioner's expert asserted in his declaration that "the drug was sold on February 2001," which is well before the priority date (May 4, 2007) of the challenged patent.

The PTAB found that the drug label itself does not contain any indicia as to its publication date. Petitioner's expert failed to "provide a sufficient explanation or foundation to establish his personal knowledge" as to the alleged February 2001 publication date of the drug label. Thus, the PTAB concluded that Petitioner had failed to meet the threshold showing that the drug label was a prior art printed publication.

A take-away from this PTAB decision is that an IPR petitioner who relies on a printed material other than the conventional patent publications and journal articles must provide sufficient evidence to establish the public accessibility of the material. Such evidence can simply be a statement of personal knowledge in the form of a declaration. See FLIR Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411 (PTAB Sept. 1, 2016), Paper 10 at 19-20 (finding that the statement of an employee's personal knowledge was sufficient to establish the publication date of an undated user's guide).

Other IPR decisions on the "printed publication" issues in the pharmaceutical art include: Frontier Therapeutics, LLC v. Medac Gesellschaft Fur Klinische Spezialpraparate MBH, IPR2016-00649 (PTAB Sept. 1, 2016), Paper 10 at 21-23 (finding that a "printed package insert" for a drug sold before the critical date was not a prior art printed publication); Coalition for Affordable Drugs IV LLC v. Pharmacyclics Inc., IPR2015-01076 (PTAB Oct. 19, 2015), Paper 33 at 4-8 (finding that a clinical trial protocol retrieved from www.clinicaltrials.gov was not a prior art printed publication); Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-0720 (PTAB Aug. 24, 2015), Paper 15 at 3-5 (excluding two meeting posters as printed publication for failing to establish public accessibility); Biomarin Pharmaceutical Inc. v. Genzyme Therapeutic Products LP., IPR2013-00537 (PTAB Feb. 23, 2015), Paper 9 at 11 (basing an institution decision in part upon a press release).

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