Michele Wales, Ph.D., J.D.

As founder and principal of InHouse Patent Counsel, Michele brings over 18 years of valuable IP experience to the table.

Before starting InHouse Patent Counsel, Michele was the department head of Litigation and Intellectual Property at Human Genome Sciences (HGS). She created and managed all aspects of HGS’ extensive IP portfolio in the U.S. and abroad, directed all phases of HGS’ litigations and internal investigations, developed cross-functional processes, and evaluated numerous third party portfolios, freedom to operate analysis and litigation risks. She was at HGS from the beginning when their focus was on patent protection. She participated in the drug development process of multiple lead clinical candidates and was involved in bringing HGS’ first approved drug to market.

With experience running one of the most complex genomic portfolios in the biotech industry, Michele has an invaluable understanding of how a biotech company works. She also understands how to work with large pharmaceutical companies and how to match IP protection with your company’s business needs. She can readily help a company license, enforce licensing provisions and evaluate product and M&A due diligence. She can analyze freedom to operate risks on complex third party biotechnology portfolios and develop and implement strategies to minimize potential litigation and present this analysis to a company’s board of directors. When avoidance of litigation is not possible, Michele can develop successful litigation strategies consistent with your company’s business needs and effectively manage teams to carry out those strategies.

Before going to law school and receiving her J.D. from the George Washington National Law Center, Michele was a scientist. She was an honors scholar in Molecular and Cellular Biology at the University of Connecticut. She then earned her Ph.D. in Human Genetics and Molecular Biology from The Johns Hopkins Medical School. While at Hopkins, she co-discovered and characterized the novel tumor suppressor gene, HIC-1, which is associated with the development of many cancers. It was during this process of preparing and filing patent applications that Michele knew she wanted to protect and commercialize biotech inventions for others.

IP Strategy and Protection Experience: As a recognized leader in genomic biotechnology, protecting HGS’ intellectual property was one of Michele’s chief responsibilities. The blending of her law and science degrees allowed her to take what HGS scientists discovered and develop strategies to aggressively protect and defend it. HGS’ portfolio was repeatedly recognized by the Wall Street Journal as one of the “Top 10 Biotech Portfolios” in the industry and covered over 10,000 human genes, proteins and antibodies.

Litigation Experience: Michele’s scientific background also made her uniquely suited to analyze freedom to operate risks on complex third party biotechnology portfolios and direct HGS’ scientists to minimize potential litigation. When necessary, she developed litigation strategies and managed successful litigation teams — often against some of the best biotech attorneys in the industry. Michele managed the team that established the Utility Standard for gene based patents at the United Kingdom’s Supreme Court and the European Patent Office. Her team was nominated in 2012 by the International Law Office as “In-House Litigation Team of the Year.”

Licensing and Other Business Experience: Michele participated in multiple business development opportunities at HGS. She was a member of the senior operating committee charged with developing HGS’ vision and long term business strategy. She evaluated hundreds of portfolios for new product acquisitions or for freedom to operate risk. As the process progressed, she would negotiate licensing and settlement agreements. In this capacity and as a leader of HGS’ heavily-licensed IP portfolio, Michele developed strong relationships with IP counsel at numerous life sciences companies. She also has close relationships with law firms all over the world who represented HGS. Over the years, she has also worked closely with the leaders of the USPTO in developing processes and examination guidelines affecting gene-based patent applications.