a registered patent attorney at Axinn, has nearly two decades of patent litigation experience, serving as lead counsel to clients in a multitude of venues including U.S. district courts, Patent Trial and Appeal Board (PTAB), U.S. Court of Appeals for the Federal Circuit (CAFC), and the U.S. International Trade Commission. Aziz’s practice focuses on the Hatch-Waxman Act, having litigated over seventy such cases in the last ten years. Although many of his cases have focused on pharmaceuticals, he has also represented clients in the banking, medical device, Internet security, robotics, software, and GPS technology industries and has handled other matters beyond patent disputes, including trademark and copyright cases.
For more information or to contact Aziz, please visit his Firm Profile Page.
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.