Gretchen L. Temeles, Ph.D., assists clients in formulating comprehensive global patent strategies to further their business goals. She focuses her practice on patent procurement and patent portfolio management in the biotechnology, chemical, and pharmaceutical industries. Dr. Temeles counsels clients from multiple industry sectors including established specialty chemical, diagnostic, and medical device companies, midmarket biotech companies, early-stage startup companies, and universities. Her experience includes both U.S. and international patent prosecution, patent landscape analyses, freedom-to-operate searches, patent due diligence, non-infringement and invalidity opinions, and European opposition proceedings. Dr. Temeles works with clients to balance their patent and trade secret portfolios and assists clients with transactional work, including material transfer agreements, sponsored research agreements and licensing agreements. Dr. Temeles has experience in pre-litigation and litigation matters in molecular diagnostics.
Dr. Temeles has counseled clients on patent matters encompassing a wide range of technologies including food processing and food safety, precision medicine and diagnostics, biologics, medical cannabis and cannabinoids, environmental remediation, oil and gas production, probiotics and nutraceuticals, genetic and tissue engineering, pharmaceuticals, over-the-counter medications, transgenic plants, veterinary treatments and products, vaccines, stem cells, medical devices, and screening technologies. These matters cover a variety of therapeutic areas including cancer biology, inflammation, cardiovascular disease, neurologic disorders, infectious disease, wound care, nutraceuticals and reproductive biology.
Dr. Temeles’ previous experience as a scientist in the biotechnology industry helps her provide practical, real-world advice to clients. Dr. Temeles was a research scientist and group leader in a biotechnology company, where she worked on target identification and small molecule drug discovery. Previously, she held research positions at the University of Pennsylvania, and Merck Sharpe and Dohme Research Laboratories. Dr. Temeles is a co-inventor on two U.S. patents and has authored peer-reviewed scientific papers.
Dr. Temeles holds degrees from Temple University Beasley School of Law (J.D.); Yale University (Ph.D., Biology); and the University of Pennsylvania (B.A., cum laude).
Areas of Practice
- Intellectual Property Law
- Represented one of the fastest growing health and wellness companies in the United States in a $100 million exclusive global license agreement with a leader in engineering and industrialization of biology. This collaboration will advance biosynthetic cannabinoid production to bring new cannabis products to market to efficiently meet growing and selective consumer demand while ensuring greater supply chain security.
- Manages a patent portfolio for a large specialty chemical company. Prepares and prosecutes patent applications in the U.S. and non-U.S. jurisdictions in matters relating to food safety, food packaging, oil and gas production, environmental remediation, water treatment, and agricultural technologies. Counsels client on prosecution strategies, freedom to operate, patent infringement and invalidity assessments.
- Manages patent portfolio for a molecular diagnostics company. Prepares and prosecutes patent applications in both the U.S. and non-U.S. jurisdictions in matters relating to immunoassays and detection methods.
- Counsels a leading diagnostics company. Works on patent due diligence and invalidity and non-infringement analyses.
- Advises a company in the emerging cannabis industry.
- Advises an early-stage molecular diagnostics company. Prepares patent applications and advises on filing and prosecution strategies.
- Advises an early-stage biologics company. Prepares patent applications, advises on filing and prosecution strategies, and technology-related transactional matters.
- Secured patent coverage for an over-the-counter formulation.
- U.S. Patent and Trademark Office
- Temple University Beasley School of Law, J.D., 2009
- Yale University, Ph.D., Biology, 1987
- University of Pennsylvania, B.A., cum laude, 1974
- Duane Morris LLP
- Associate, 2010-present
- Fish & Richardson P.C.
- Associate, 2010
- Technology Specialist, 2005-2010
- Message Pharmaceuticals
- Project Manager, Compound Characterization, 1999-2004
- Project Manager, Cell-Based Assay Systems, 1997-1999
- Research Scientist, 1996-1997
- Gen Trak, Inc.
- Contract research position in molecular diagnostics, 1996
- University of Pennsylvania, Department of Biology
- Postdoctoral Fellow, 1990-1995
- University of Pennsylvania, Department of Human Genetics
- Research Associate, 1985-1990
- Merck Sharp and Dohme Research Laboratories
- Postdoctoral Researcher, 1982-1985
- Ben Franklin Technology Partners of Southeastern Pennsylvania
- Life Sciences Technology Advisory Committee
Life Sciences Pennsylvania, partnerships in science planning committee, reviewer
University City Science Center QED program, advisor
Pharmaceutical Consultants Consortium, Advisory Board member, 2010-2014
- University of Pennsylvania, Center for Technology Transfer
- Triage Committee, 2004-2005
Contributor, Duane Morris Cannabis Industry Blog
Author, "Patent Litigation in the Cannabis Industry - 2 Cases to Review," The Legal Intelligencer, March 25, 2019
Author, "Business As Usual at the Patent and Trial Appeal Board: The First Cannabis Related Patent and Trial Appeal Board Decision at the United States Patent and Trademark Office," Duane Morris Blogs, January 16, 2019
Quoted, "3 Takeaways From The PTAB's Cannabis Experience," Law360, January 11, 2019
Author, "Cannabis Patents: Patent Litigation in an Emerging U.S. Industry," Cannabis Law Journal, September 2018
Quoted, "Why Patent Lawyers Are Watching This Colorado Cannabis Case," The Recorder, August 8, 2018
Co-author, "IP Protection and the Cannabis Industry: Strategies and Trends," The Legal Intelligencer, April 2, 2018
Author, "Cannabis at the Cutting Edge - Patents for a New U.S. Industry," Daily Marijuana Observer, January 8, 2018
Author, "Cannabis: Patenting Opportunities in an Emerging U.S. Market," Cannabis Law Report, December 18, 2017
- Co-author, "Who owns federally funded inventions?" IP Value 2012: Building and enforcing intellectual property value - An international guide for the boardroom, Intellectual Asset Magazine, 49-52 (2011)
- Author, "Who Owns U.S-Government-Funded Inventions?," GenericsWeb newsletter InnSight, August 2011
- Co-author, "Supreme Court Rules That Federally Funded Inventions Are Not Automatically Owned by Universities," Duane Morris Alert, June 8, 2011
- Co-author, "Intellectual Property Law and Employees," Bloomberg Businessweek, November 16, 2010
- Co-author, "Beyond KSR: How the Courts and the United States Patent and Trademark Office Have Decided Biotechnology and Chemistry Cases," Industrial Biotechnology, Volume 3, Number 3: 198-202 (2007)
- Co-author, "Use of cDNA Arrays to Assess Translational Regulation of Gene Expression Reveals VHL-Mediated Repression of TNF- α Synthesis," Molecular and Cellular Biology 23: 2316-2328 (2003)
- Co-author, "Transient Polyadenylation of a Maternal mRNA Following Fertilization of Mouse Eggs," J.Reprod. Fertil. 109: 223-8 (1997)
- Co-author, "Temporal Pattern of IGF-I Expression During Mouse Pre-Implantation Embryogenesis," Molecular Reproduction and Development 37: 21-26 (1994)
- Co-author, "Stage-Specific Expression of a Family of Proteins That Are Major Products of Zygotic Gene Activation in the Mouse Embryo," Developmental Biology 144: 392-404 (1991)
- Co-author, "Modulation of Protein Expression Associated with Chemically Induced Differentiation of Neuroblastoma Cells. Fifth Symposium on Advances in Neuroblastoma Research," Prog. Clin. Biol. Res. 366: 157-163 (1991)
- Co-author, "Immortalization of Stimulated Lymphocytes by Transfection with Oncogenic DNA. Proceedings of the First International Symposium on Biotechnology: Monoclonal Antibodies in the Treatment of Human Disease," IRL Press, McLean, Va., pp. 55-67 (1987)
- Co-author, "Mutant ras-encoded Proteins with Altered Nucleotide Binding Exert Dominant Biological Effects," Proc. Natl. Acad. Sci. U.S.A. 83: 952-956 (1986)
- Co-author, "Yeast and Mammalian ras Proteins Have Conserved Biochemical Properties," Nature 313: 700-703 (1985)
- Co-author, "Expression and Characterization of ras mRNA's from Saccharomyces cerevesiae," Molecular and Cellular Biology 4: 2289-2305 (1984)
- Co-author, "Saccharomyces cerevesiae Synthesizes Proteins Related to the p21 Gene Product of the ras Gene Found in Mammals," Molecular and Cellular Biology 4: 23-29 (1984)
- Co-author, "TNF-α RNA stability and mRNA translation Are Not Coordinately Regulated," RNA Society of North Carolina Meeting, October 2001
- Co-author, "TNF-α mRNA Levels Show a Biphasic Expression Pattern That Results from Both Transcriptional and Post-Transcriptional Events," American Society for Biochemistry and Molecular Biology Meeting, Boston, 2000
- Co-author, "Analysis of CNI-1493 and Destabilizing Elements in TNF-α mRNA," American Society for Cell Biology, Washington, D.C., 1999
- Co-author, "Specific Factors from DU-145 Prostate Carcinoma Cells That Bind cis-acting Elements in the 5'UTR of the IGF-I Receptor," American Society for Cell Biology, Washington, D.C., 1999
- Co-author, "CNI-1493 and Destabilizing Elements in TNF-α," RNA Society Meetings, Madison, Wisconsin, 1998
- Co-author, "Identification of Regions in the 5'UTR of the IGF-I Receptor mRNA That Bind: Proteins: An Approach to Prostate Cancer," 'Proteins that bind RNA' meetings, Avalon, New Jersey, 1998
Selected Speaking Engagements
Presenter, "Cannabis 202: IP Issues Facing the Cannabis Industry," Duane Morris Cannabis Webinar Series, June 18, 2019
Speaker, "Patenting in the Cannabis Industry," Pot of Gold? The Business of Cannabis, Philadelphia, April 4, 2019
Speaker, "Patenting in the Cannabis Industry," Pennsylvania IP Forum, July 19, 2018
Panelist, "Trademarks, Patents, and Intellectual Property in Cannabis," CannabisLearn, Philadelphia, Pennsylvania, May 1, 2018
Presenter, "Cannabis 102: Intellectual Property, Trademark and Branding, and Marketing," The Duane Morris Cannabis Webinar Series, February 27, 2018 (video playback)
- Speaker, "Intellectual Property, Licensing, & Regulatory Considerations for Emerging Technologies," AIPLA Webinar, October 4, 2016
- Moderator, "What's Hot, What's Getting Funded," 2013 New Jersey Technology Counsel Regional Commercialization Summit, Philadelphia, Pennsylvania, December 5, 2013
- Moderator, "Making the Connection," 2012 New Jersey Technology Counsel Regional Commercialization Conference, Wilmington, Delaware, December 6, 2012
- "Securing IP Protection in India for Methods of Treatment" panel presentation at the Pharmaceutical Consultants' Consortium meeting, Chesterbrook, Pennsylvania, September 10, 2012
- Moderator, "IP On a Shoestring- Maximize What You Need to Do with IP," 2011 NJTC Regional Commercialization Conference, Newark, Delaware, December 8, 2011
- "New Uses for Old Compounds," panel presentation at the Pharmaceutical Consultants' Consortium of New Jersey meeting with Neurotez,Inc., Parsippany, New Jersey, May 24, 2011
- "IP Strategies for Immunotherapeutic Vaccines," panel presentation at the Pharmaceutical Consultants' Consortium meeting with VitaSpero,,Inc., Chesterbrook, Pennsylvania, February 15, 2011
- "The Patent-eligibility of DNA Claims," Delco IP Forum, Media, Pennsylvania, January 13, 2011
- "The Patent-eligibility of DNA Claims," Duane Morris IP Practice Group, Philadelphia, Pennsylvania, December 16, 2010
- "Vanderbilt v. Icos: A Blockbuster Drug and One of the Murkiest Concepts in the Muddy Metaphysics of Patent Law," Fish & Richardson Biotech Forum, June 15, 2010
- "Maximizing IP Value," Pharmaceutical Consultants' Consortium meeting, Immunomic Therapeutics, Chesterbrook, Pennsylvania, June 14, 2010
- "Protecting bioengineering inventions," Introduction to BioEngineering class, Temple University, Department of Engineering, Philadelphia, Pennsylvania, February 23, 2009
- "Takeda v. Alphapharm: Obviousness, Drug Discovery and Brown Fat," Fish & Richardson Biotech Forum, July 17, 2007
- "IP Considerations for Startup Companies," Biotechnology Entrepreneurship Symposium, Louisiana State University Health Sciences Center and Wharton Small Business Development Center, Malvern, Pennsylvania, April 24, 2007
- "IP Considerations for Startup Companies," Delaware Biotechnology Institute, Tech Breakfast, Newark, Delaware, April 18, 2007