| Biography | Professional Experience Keith McWha has both private practice and corporate in-house experience in counseling clients on a wide variety of legal issues. Mr. McWha has extensive experience in all aspects of intellectual property, including prosecution, litigation, opinions, transactional matters, due diligence, and client counseling. Mr. McWha has counseled clients concerning intellectual property portfolios and rendered opinions on validity, infringement and freedom to use on a wide array of technologies. Mr. McWha has experience with matters before the U.S. International Trade Commission concerning Section 337 Investigations. Mr. McWha also has significant experience in performing due diligence on intellectual property portfolios for mergers and acquisitions. Mr. McWha's regulatory practice focuses on biological products, medical devices, pharmaceuticals, and cosmetics. He counsels U.S. Food and Drug Agency (FDA)-regulated companies on legal and regulatory compliance involving the FDA. Mr. McWha handles FDA issues related to product submissions and approvals, promotional and marketing activities, labeling, good manufacturing practices (GMP) compliance, and related enforcement issues. He also counsels on clinical investigations, and has experience with IDEs, PMAs and 510(k)s for medical devices. Prior to working at Day Pitney, Mr. McWha was partner at a large New York law firm specializing in intellectual property law, and was in-house counsel for a large medical device and diagnostic company. Mr. McWha has extensive experience in the medical device area, and is also a named inventor on several U.S. and international patents dealing with medical devices. Mr. McWha is a registered patent attorney with significant experience in obtaining and enforcing patent protection. Mr. McWha is also a member of the firm's Nanotechnology practice group that has members with advanced degrees in materials science, chemistry, physics, and chemical engineering fields. Mr. McWha has specific experience in nanotechnology for drug delivery, batteries and other related nanodevices. He is a frequent blogger on Day Pitney's The Nano Newswire blog. Keith McWha was appointed on July 1, 2011, to the board of directors of the Juvenile Diabetes Research Foundation International ("JDRF"), Northern New Jersey & Rockland County Chapter. Election to the board is for a two-year term. JDRF is located in New York City and is dedicated to finding a cure for Type 1 diabetes and its complications through the support of research. JDRF is the largest non-governmental funder of diabetes research in the world, and has provided more than $100 million to diabetes research worldwide. News, Publications & Presentations · Chapter author, "Bankruptcy-Related Issues and Concerns for IP Owners in International Business Deals," Protecting IP Rights in International Business Transactions, Aspatore Books, November 1, 2011 · Co-author, "The Supreme Court Reaffirms the Clear-and-Convincing Standard for Patent Invalidity," Day Pitney Alert, June 15, 2011 · Quoted, "Patent reform legislation looks likely to pass this year, significant amount of momentum," Pharmawire, February 15, 2011 · Co-author, "U.S. Supreme Court Leaves Door Open for Some Business Method Patents," Day Pitney Alert, June 30, 2010 · Quoted, "High Court All Over the Map in 'Bilski,'" National Law Journal, June 29, 2010 · Quoted, "Bilski Ruling Continues Battle Over Business Patents," Blog of Legal Times, June 28, 2010 · Featured, "Day Pitney Attorneys Attending International Trademark Association Meeting in Boston," Day Pitney Press Release, May 24, 2010 · Quoted, "Supreme Court: When Do Ideas Deserve Patents?" TIME Magazine, November 18, 2009 · Quoted, "High Court Justices Greet 'Bilski' Arguments With Doubt, Disdain," National Law Journal, November 10, 2009 · Co-author, "Medical Diagnostic Claims Patent-Eligible After Bilski," Day Pitney Alert, October 5, 2009 · Speaker, "The District of New Jersey New Local Patent Rules: You Need to Hit the Ground Running" Day Pitney Webinar, June 24, 2009 · Speaker, "Launching a Product in a Competitive Market: Avoiding IP infringement and developing a product that immediately differentiates itself," Medical Design and Manufacturing Conference, June 8, 2009 · Speaker, "How to Protect Your Intellectual Property Without Breaking Your Budget," Day Pitney Webinar, May 5, 2009 · Quoted, "Gilead's hypertension drug darusentan will likely receive patent extension, attorneys say," Pharmawire, April 14, 2009 · Featured, "Day Pitney LLP Expands its Intellectual Property Practice in New York with the Addition of Keith J. McWha," Day Pitney Press Release, January 14, 2009 Professional Affiliations · American Bar Association · American Intellectual Property Law Association · New York Intellectual Property Law Association · New Jersey Intellectual Property Law Association · New Jersey State Bar Association |