Danielle Burns Email & Phone Number

Involved in the preparation and prosecution of patent applications; patentability, infringement, clearance, and validity opinions; and due diligence work, with a specialty in protecting and facilitating entry of biopharmaceuticals (including antibodies and antisense molecules), diagnostics and agricultural products(including transgenic plants) to market. Significant experience in opposing competitor patents and defending against third party oppositions. Brings commercial and strategic thinking to drafting and legal analysis with experience in key geographic markets including Australia, the US and Europe.Solid understanding of the global healthcare market including data and market exclusivities afforded to originator biologic medicines in several geographic markets. Provides companies with greater certainty and confidence in the regulatory market. Recently facilitated entry of biosimilar medicines into the US market by assisting in abbreviated biologics License Application (aBLA) submissions to previously approved and licensed reference products. Helped companies through “the patent dance” in which a biosimilar applicant and reference product sponsor exchange certain information regarding the aBLA. Assisted in first wave US litigation of patents identified in the patent dance.Extensive industry experience, having worked as a postdoctoral scientist at BIO21 involved in the expression and purification of proteins involved in Influenza-specific viral immunity. Graduated from the University of Melbourne with a BSc (Hons) majoring in Biochemistry and Immunology. Awarded the Australian Society for Microbiology 3rd Year Prize, the Exhibition Prize for Microbiology and the Peter J Doos Award. Also completed a PhD in Immunology at the University of Melbourne which examined the impact of natural variation in genes that control immunity; showed how very slight differences in certain immune response genes result in dramatic changes in the response to viral infection.

Listed skills include Biotechnology, Patents, Immunology, Patentability, and 17 others.