In-house and private practice attorneys, life sciences executives and representatives, consultants, agency and university officials
On March 29, 2010, the U.S. District Court for the Southern District of New York issued its decision in Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 09-Civ-4515. The Court struck down patent claims covering "isolated DNA molecules" on the breast cancer genes BRCA1 and BRCA2 as well as therapeutic methods that involved "comparing" and "analyzing" a human genome against these genes to determine a patient's genetic propensity for breast cancer. In particular, Judge Sweet found the patent composition claims covering BRCA1 and BRCA2 were not "markedly different" from native DNA as it exists in nature, and therefore unpatentable phenomena of nature under 35 U.S.C. Section 101. Judge Sweet also found the method claims, which covered various breast cancer assays of patient DNA, were unpatentable as abstract mental processes under 35 U.S.C. Section 101. The opinion also included a footnote suggesting that claims to DNA are to be treated differently than other subject matter in determining patentability: "[t]he conclusions reached in this opinion concerning the subject matter patentability of isolated DNA, however, are based on the unique properties of DNA that distinguish it from all other chemicals and biological molecules found in nature."
If upheld, this decision casts doubt on the validity of so-called "gene patents," and even if it is struck down, the decision (which solicited a flood of amicus briefs) illustrates the tension in the industry on this topic.
In this one-hour TeleBriefing, our distinguished panel of experts will discuss the implications of this landmark decision and offer practical advice for the IP and life sciences communities.
Introduction & Overview
Elizabeth Ann Howard, Ph.D., Esq., Moderator
Orrick Herrington & Sutcliffe LLP / Menlo Park, CA
Sandra Elaine Wells, Ph.D., Esq., Vice President and Chief IP Counsel
Affymetrix / Santa Clara, CA
Hansjorg Sauer, Ph.D., Esq., Deputy General Counsel for Intellectual Property
Biotechnology Industry Organization / Washington, DC
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Elizabeth Howard is Co-Chair of the life sciences practice at Orrick Herrington & Sutcliffe LLP. Ms. Howard focuses her practice on patent infringement litigation, with an emphasis on the life sciences. Her practice also includes trade secrets disputes and handling anti-counterfeiting matters in the pharmaceutical industry. In addition to litigating in numerous federal district courts and California state courts, Dr. Howard has appeared before the U.S. Patent and Trademark Office in interference proceedings, and arbitrated before the International Chamber of Commerce.
Hans Sauer is Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO), a major trade association representing over 1,100 biotechnology companies from the medical, agricultural, environmental, and industrial sectors in the United States and internationally. At BIO, Mr. Sauer advises the organization's board of directors, amicus committee, and various staff committees on patent and other intellectual property-related matters. Prior to his current position, Mr. Sauer was Chief Patent Counsel for MGI Pharma, Inc., in Bloomington, MN, and Senior Patent Counsel for Guilford Pharmaceuticals Inc. in Baltimore, MD. Mr. Sauer has 15 years of professional in-house experience in the biotechnology industry, where he worked on several research and drug development programs, being responsible for patent prosecution and portfolio oversight, clinical trial health information privacy, and sales and marketing legal compliance.
Sandra Wells is VP and Chief IP Counsel, Affymetrix. Sandra joined Affymetrix in 2001 and currently leads the IP team there, with responsibilities including in-house preparation and prosecution of patent applications, assessments of 3rd party patents, IP strategy, licensing and patent litigation. Affymetrix is a pioneer in microarray technology that today enables whole genome analysis of genetic variation and gene expression. Ms. Wells has a Ph.D. in Molecular Biology and is registered to practice before the U.S.P.T.O.