Leah M. Brackensick

Leah Brackensick focuses her practice on intellectual property disputes with an emphasis on patent litigation in the life sciences and pharmaceutical industries. Leah has experience in Hatch-Waxman litigation, general patent litigation, patent interference proceedings and trade secret litigation. Leah represents companies in all aspects of federal intellectual property litigation, including pre-litigation regulatory activities, Paragraph IV certifications and notice letters, initial filings, fact and expert discovery, claim construction, motion practice and trial.

Leah is Co-Chair of the St. Procopius Legal Aid Clinic.

While in law school, Leah participated in Washington University’s Entrepreneurship & Intellectual Property Clinic where she counseled clients regarding copyright, trademark, patent and trade secret rights. Leah also spent a summer during law school in Alexandria, VA, where she was part of the U.S. Patent and Trademark Office’s Patent Experience Extern Program in the biotechnology and organic chemistry technology center. There she evaluated the patentability of patent applications and drafted office actions.

Leah’s representative experience includes:

• Representing patent owner in patent infringement litigation concerning four patents related to compositions comprising α and β polymorphs of rifaximin for the treatment of traveler’s diarrhea and hepatic encephalopathy
• Representing generic drug manufacturer in paragraph IV Hatch-Waxman patent infringement litigation concerning numerous patents related to oral formulations of a vesicular monoamine transporter 2 inhibitor indicated for the treatment of tardive dyskinesia (Ingrezza®)
• Represented generic drug manufacturer at a federal bench trial in paragraph IV Hatch-Waxman patent infringement litigation concerning one patent relating to an oral extended release formulation for the treatment of overactive bladder (OAB) (Myrbetriq®); trial held
• Represented The Broad Institute, Inc. in the second patent interference proceeding involving claims to CRISPR-CAS9 systems for use in eukaryotic cells; resulted in PTAB decision in favor of the client
• Represented generic drug manufacturer in paragraph IV Hatch-Waxman patent infringement litigation concerning one patent related to oral formulations for the treatment of type 2 diabetes in adults (Januvia®); resulted in settlement
• Represented generic drug manufacturer in paragraph IV Hatch-Waxman patent infringement litigation involving multiple patents concerning oral formulations indicated for the treatment of major depressive disorder and schizophrenia (Rexulti®); resulted in settlement
• Represented generic drug manufacturer in paragraph IV Hatch-Waxman patent infringement litigation involving numerous patents concerning oral pharmaceutical compositions and x-ray powder diffraction peaks of stereomerically pure apremilast for the treatment of certain types of psoriasis and psoriatic arthritis (Otezla®); trial held