Christopher Gallo Image

Christopher Gallo

holds a PhD in Biochemistry and Molecular Genetics. His practice at Axinn is focused on patent litigation. Christopher’s experience includes matters before federal district courts and the United States International Trade Commission in which he has been heavily involved in all aspects of litigation, from pre-filing investigation, through fact and expert-witness discovery, claim-construction, and trial. Christopher also has experience in patent reexaminations and in inter partes review proceedings before the Patent Trial and Appeal Board at the USPTO. Prior to joining the firm, Christopher worked as a postdoctoral fellow at the Johns Hopkins University School of Medicine.

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Recent Articles by Christopher Gallo

Curing the Drug Label as Prior Art Malady at the PTAB

Petitioners challenging patents covering pharmaceuticals and biologics often use drug product labels as prior art in the Patent Trial and Appeal Board (PTAB). To effectively use a label as prior art, a petitioner must show that it is a “printed publication” under 35 U.S.C. §§ 102 and 311(b). Past PTAB cases demonstrate, however, that proving drug product labels as prior art can be fraught with danger. But practitioners can employ best practices to guard against this. In Celltrion, Inc. v. Biogen, Inc., IPR2016-01614, Paper 65 (Feb. 21, 2018), the Petitioners relied on a copyrighted label for Rituxan that was published on the internet and available on the Food and Drug Administration’s (FDA’s) and on Biogen’s website all before the critical date. The Board held that the Petitioners did not provide sufficient evidence establishing that the drug label was indeed the one disseminated with Rituxan at the time it was proposed to be publicly available or that “persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Similarly, the Board held in Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01563, Paper 16 (Feb. 3, 2017), that a relied-upon Glucophage label had no source identifying information or indicia of when it became publicly available and the declaration attesting to its publication was not based on personal knowledge, but was merely conclusory.