Sharon E. Crane, Ph.D.

Counsel Washington, D.C.

T +1 202.654.4544

[email protected]

Biography

Dr. Sharon Crane lives and operates at the critical convergence of advanced molecular science and high-stakes patent law.

As Counsel in the Life Sciences Practice Group at Haynes Boone, Sharon provides biotechnology and pharmaceutical innovators significant strength - a legal shield engineered by an actual scientist. Long before she entered the courtroom, Sharon spent years at the lab bench, studying neuroscience and ultimately earning a Ph.D. in Molecular Biology and Genetics from the Johns Hopkins University School of Medicine, focusing on the mechanisms of infectivity of lentiviruses. This elite scientific baseline allows her to grasp the cellular and molecular mechanisms of breakthroughs as intimately as the inventors themselves, making her an invaluable partner for global corporations, elite research universities, and life science pioneers.

For clients navigating the highly contentious world of intellectual property, Sharon is an authoritative strategist across the full lifecycle of patent assets. Her practice encompasses complex prosecution, application preparation, and strategic portfolio design, including drafting applications utilizing cutting-edge CRISPR gene-editing platforms. However, her true hallmark is her mastery of adversarial patent proceedings. She has successfully managed more than 40 high-profile patent interferences, inter partes reviews (IPR), and post-grant reviews (PGR) before the USPTO Patent Trial and Appeal Board (PTAB). Her record includes defending breakthrough technologies in the high-growth field of non-invasive fetal diagnosis, where she has spearheaded critical prosecution, interferences, and hard-fought IPRs.

Sharon’s technical fluency makes her a go-to litigator for industry-defining biopharma matters. Notably, she has managed high-stakes patent prosecution and complex interferences surrounding Genentech’s foundational Cabilly antibody patents—widely regarded as some of the most commercially significant and intensely litigated assets in the history of therapeutic antibody production. Her appellate depth is further highlighted by her successful defense of 454 Life Sciences against Johns Hopkins University in the U.S. District Court for the District of Delaware, securing a critical win in an appeal of a patent interference relating to bead emulsion PCR technology.

Beyond her practice, Sharon is a voice on international patent framework policy and equity in the legal sector. She serves as the Secretary General and DEIA Committee Chair for FICPI International (the International Federation of Intellectual Property Attorneys) and has spent years chairing and participating in their working group on Biotechnology and Pharmaceuticals. Her involvement spans across major organizations including ABA-IPL and AIPLA. By pairing a scientific background with decades of sophisticated, battle-tested litigation experience, Sharon ensures that the life-saving technologies of tomorrow are unassailably protected today.

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: District Court Litigation
Life Technologies, Inc. v. Clontech Laboratories, Inc.: District of Maryland; Defended Clontech Laboratories, Inc. against a charge of patent infringement involving Life Technologies’ patent on reverse transcriptase with substantially no RNase H
In re Brimonidine Patent Litigation: District of Delaware; Defended Exela Pharmaceuticals in an infringement action under the Hatch-Waxman Act brought by Allergan regarding brimonidine tartrate used to lower intra-ocular pressure and help alleviate the symptoms of glaucoma
Geron Corporation v. Viacyte, Inc.: Northern District of California; Represented Viacyte in appeal from a patent interference relating to cultures of definitive endoderm cells
Cellectis S.A. v. Precision Biosciences Inc. et al: District of Delaware; litigation support for Precision Biosciences regarding I-CreI meganucleases
Precision Biosciences Inc. et al v. Cellectis S.A.: Eastern District of North Carolina; litigation support for Precision Biosciences regarding rationally designed meganucleases
Johns Hopkins University v. 454 Life Sciences Corporation: District of Delaware; Defended 454 in appeal of interference relating to bead emulsion PCR
Inter Partes Re-examination
Inter Partes Re-examination of U.S. Application Serial No. 95/000,440: Represented Maxygen; relating to G-CSF Analog Compositions and Methods
Patent Interferences
Fiddes v. Baird, Interference No. 102,229: Represented Genentech; relating to basic fibroblast growth factor
Cabilly v. Boss, Interference No. 102,572: Represented Genentech; relating to chimeric recombinant antibodies
Singh v. Brake, Interference No. 102,728: Represented Genentech; relating to using alpha factor to express proteins in yeast
Lee v. Barr, Interference No. 102,208: Represented Genentech; relating to insulin-like growth factor 1
Hitzeman v. Rutter, Interference No. 102,416: Represented Genentech; relating to expressing hepatitis B surface antigens in yeast
Glaxo Wellcome Inc. v. Cabilly, Interference No. 104,532: Represented Genentech; relating to expressing antibodies in Chinese hamster ovary cells
Gluckman v. Lewis, Interference No. 104,553: Represented Genentech; relating to treatment of neural degeneration with IGF-1
Zambrowicz v. Harrington, Interference No. 105,104: Represented Athersys; relating to non-targeted activation of endogenous genes
Nemerson v. Genentech, Interference No. 105,134: Represented Genentech; relating to human tissue factor related DNA segments, polypeptides and antibodies
Scripps Research Institute v. Genentech, Inc., Interference No. 105,135: Represented Genentech; relating to human tissue factor related DNA segments, polypeptides and antibodies
Short v. Punnonen, Interference No. 105,188: Represented Maxygen; relating to non-stochastic generation of genetic vaccines
Santarsiero v. DeLucas, Interference No. 105,403: Represented Fluidigm Inc.; relating to crystallization of proteins in nanoliter volumes
Howell v. Lentz, Interference No. 105,413: Represented Cytologic, Inc.; relating to methods of enhancing immune responses by removing soluble tumor necrosis factor receptor 1 from the blood
Yu et al (Human Genome Sciences, Inc.) v. Browning et al (Biogen Idec)/ Browning v. Yu, Interference No. 105,485; Represented HGS; relating to LymphoStat-B, a human monoclonal antibody that inhibits the biological activity of B-lymphocyte stimulator (BLyS)
Conzelmann v. Hong, Interference No. 105,503: Represented Wyeth; relating to recombinant infectious non-segmented negative strand RNA virus
Short v. Patten, Interference No. 105,532: Represented Maxygen Inc.; relating to polypeptide engineering
Gladstone Institutes v. Oregon Health and Science University, Interference 105,686: Represented OHSU; relating to methods for identifying an agent that inhibits Vif-mediated degradation of APOBEC3G in a cell
D’Amour v. Fisk, Interference No. 105,734: Represented Viacyte; relating to cultures of definitive endoderm cells
Johns Hopkins University v. 454 Life Sciences, Interference No. 105,857: Represented 454; relating to bead emulsion PCR
Dung v. Buehler, Interference No. 105,893: Represented Endo Pharmaceuticals; relating to oxymorphone hydrochloride salts containing low amounts of alpha-beta unsaturated ketone
Quake v. Lo, Interference No. 105,920: Represented Stanford; relating to non-invasive methods of detecting aneuploidy
Fan v. Lo, Interference No. 105,922: Represented Stanford; relating to non-invasive methods of detecting aneuploidy
Lo v. Quake, Interference No. 105,923: Represented Stanford; relating to non-invasive methods of detecting aneuploid
Lo v. Quake, Interference No. 105,924: Represented Stanford; relating to non-invasive methods of detecting aneuploidy
Fiers v. Sugano, Interference No. 105,939: Represented Biogen IDEC MA, Inc.; relating to recombinant DNA for producing human fibroblast interferon-like polypeptides
Lephart v. Setchell, Interference No. 105,950: Represented Cincinnati Children’s Hospital Medical Center and Australian Health & Nutrition Association Limited; relating to compositions and methods for making enantiomeric equol
Levin v. Pastorio, Interference 105,995: Represented Finchimica S.P.A.; relating to method for the synthesis of 5-amino-1-phyenyl-3-cyano-4-trifluormethyl sulfinyl
University of Western Australia v. Academisch Ziekenhuis Leiden, Interference No. 106,007: Represented Sarepta Therapeutics, Inc.; relating to antisense oligonucleotides for exon skipping
University of Western Australia v. Academisch Ziekenhuis Leiden, Interference No. 106,008: Represented Sarepta Therapeutics, Inc.; relating to antisense oligonucleotides for exon skipping
University of Western Australia v. Academisch Ziekenhuis Leiden, Interference No. 106,013: Represented Sarepta Therapeutics, Inc.; relating to antisense oligonucleotides for exon skipping
Seattle Children’s Research Institute v. Cellectis, Interference No. 106,052: Represented SCRI; relating to relating to Coupling Endonucleases with End-Processing Enzymes Drives High Efficiency Gene Disruption
Crescendo Bioscience, Inc. v. L. Douglas Graham, PGR2017-00020: Represented Crescendo; relating to methods for selecting treatment methods for rheumatoid arthritis based on an algorithm
Cani v. Kaplan, Interference No. 106,130: Represented Cani (Universite Catholique De Louvain, Wageningen Universiteit, The Akkermansia Company S.A.): relating to methods of treating metabolic disorders with Akkermansia.
Inter Partes Review and Post-Grant Review
IPR2014-00337; Represented The Board of Trustees of the Leland Stanford Junior University as Patent Owner in an IPR proceeding filed by Sequenom over patent 8195415, noninvasive diagnosis of fetal aneuploidy by sequencing. All claims were denied institution.
IPR2013-00390: Represented The Board of Trustees of the Leland Stanford Junior University as Patent Owner in an IPR proceeding filed by Sequenom over patent 8195415, noninvasive diagnosis of fetal aneuploidy by sequencing.
IPR2014-00160: Represented Endo Pharmaceuticals as Patent Owner in an IPR proceeding filed by Amneal Pharmaceuticals over patent 7851482, method for making analgesics.
IPR2013-00308: Represented The Board of Trustees of the Leland Stanford Junior University as Patent Owner in an IPR proceeding filed by Ariosa Diagnostics over patent 8296076, noninvasive diagnosis of fetal aneuploidy by sequencing.
IPR2016-00577: Represented Finchimica S.p.A. as Patent Owner in an IPR proceeding filed by Adama Americas, Adama Makhteshim, Makteshim Agan of North America, ADAMA Agricultural Solutions, and Control Solutions over patent 8304559, method for the synthesis of 5-amino-1-phenyl-3-cyano-4-trifluoromethyl sulfinyl.
PGR2017-00020: Represented Myriad Genetics, Oyster Point Blvd., and Crescendo Biosciences as Petitioners in a PGR proceeding against L. Douglas Graham over patent 9387246, treatment for methods for rheumatoid arthritis.
Some of these representations were handled by Sharon prior to joining Haynes Boone.
: American Bar Association, Intellectual Property Law Section
American Bar Association, Post Grant and Inter Partes Subcommittee
American Intellectual Property Law Association, Biotechnology Committee, Member
American Intellectual Property Law Association, Chemical Practice Committee, Member
American Intellectual Property Law Association, Diversity in IP Committee, Member
American Intellectual Property Law Association, Emerging Technologies Committee, Member
American Intellectual Property Law Association, PTAB Trial Committee, Member
American Intellectual Property Law Association, Women in IP Law Committee, Member
Federal Circuit Bar Association
Previous Chair of Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI) CET Group 5-Biotechnology and Pharmaceuticals
Co-Chair of Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI) DEIA and (previously) Webinar Series Committees
Secretary General of Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI)
Intellectual Property Owners Association, U.S. Post-Grant Patent Office Practice Committee, Member
International Association for the Protection of Industrial Property (AIPPI), Member
Maryland Patent Law Association: President 2001-2003; Vice President 1999-2001; Treasurer 1996-1999
New York Intellectual Property Law Association
U.S. Bar - EPO Liaison Council, Chair, 2006-200
: Included in Washington, D.C. Super Lawyers, Thomson Reuters, 2018-2025
: "Good News for Generics: SCOTUS Unanimously Holds Amarin Failed to Prove Hikma’s Skinny Label Induced Infringement," author, Haynes Boone Biotech Insights Newsletter, July 2026.
“One invention, Many Standards: Written Description in a Global Patent System,” AIPLA Advanced Chemical and Biotech Patent Institute, San Francisco, CA, May 11-12, 2026.
"Federal Circuit’s Holding on Patent Eligibility for Engineered Host Cells Dovetails With PERA," co-author, Haynes Boone Biotech Insights Newsletter, April 2026.
"Hope on the Horizon for Psychedelic Drug Treatment?," co-author, Haynes Boone Biotech Insights Newsletter, October 2025.
"Post-Grant Reviews: The AIA's Lesser-Used Stepchild -How to Use Them Effectively to Clear the Way to Practice Your Life Sciences Inventions," author, Haynes Boone Biotech Insights Newsletter, June 2025.
"What’s New at the USPTO and How Will It Shape Life Sciences IP?," author, Haynes Boone Biotech Insights Newsletter, March 2025.
"The Attack on Life Sciences Patents - Subject Matter Eligibility," author, Haynes Boone Biotech Insights Newsletter, December 2024.
“AI Ethics at the Boardroom Shaping a Responsible and Ethical Future,” ITechLaw World Conference, San Diego, CA, May 14-16.
“Charting Uncertain Waters: Claim Drafting in Light of Evolving Written Description and Enablement Requirements,” AIPLA Advanced Chemical/ Pharma Patent Practice Institute, Austin, TX, May 14-15, 2024.
Artificial Intelligence and Ethics, AIPLA Spring Meeting, Austin, TX, May 16, 2024.
21st Open Forum, Patent Stream Leader, FICPI, London, UK, October 4-7, 2023.
CLE Webinar Series on Hot Topics in Chemical and Pharmaceutical Patent Practice, Amgen Inc. et al. v. Sanofi et al., speaker, AIPLA, September 19-20, 2023.
“All Roads Lead to IP: Conversation between authorities of different Associations,” Asociacion Interamericana de la Propiedad Intelectual (ASIPI), December 7, 2022, Medellin, Colombia.
"Antibodies: The Challenges Facing Patent Applicants," speaker, IPWatchdog Life Sciences Masters 2022, Ashburn, VA, October 26, 2022.
“Eligibility: Whither the Patent System,” speaker, FICPI 2022 World Congress & ExCo, Cannes, France, September 28, 2022.
“AI and Drug Development: IP Implications for Protecting AI Discoveries,” speaker, IPWatchdog Live 2022, Dallas, TX, September 12, 2022.
“A Post Doc Bootcamp; Drafting Chemical Claims and Specification: Written Description,” speaker, AIPLA Advanced Chemical/ Pharma Patent Practice Institute, New Orleans, LA, May 20, 2022.
Council of Scientific Society Presidents 2022 Spring Leadership Workshop, speaker, Washington, D.C., May 2, 2022.
Orange Book & Biologic Patents at the PTAB, speaker, IPWatchdog PTAB Masters 2022. January 27, 2022.
"Infringement Without Borders in the Digital Age," moderator, FICPI Virtual Forum, November 2021.
"Connect, Share & Grow," speaker, Webinar Series on Subject Matter Eligibility, FICPI Virtual Forum, September 30, 2020.
Participation in “Will a Machine Replace Me? The Impact of AI and New and Emerging Technologies on IP Practice,” AIPLA Midwinter Meeting January 30, 2020.
“COVID-19 - Life Under Lockdown, webinar,” speaker, FICPI , April 22, 2020.
Pre-conference workshop, speaker, ACI 3rd Annual Summit on Life Sciences IP Due Diligence, Boston, MA, November 13, 2019.
Panelist, “Subject Matter Eligibility in the U.S.” for the panel “Is there a Coordinated Move in B+ and Elsewhere?”, Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI) World Congress, Toronto, Canada, June 6, 2018.
"CRISPR-Cas9 Patent Landscape and Legal Disputes," co-author, LES JAPAN NEWS Vol. 62 no. 2, June 2021.
"The Good, the Bad and the Ugly in Recent 101 Decisions," author, FICPI Journal, p. 29., Nov 2020.
"Subject Matter Eligibility Update: Proposals to Modify 35 USC 101," author, Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI), September 12, 2018.
"USA Court of Appeals for the Federal Circuit Decision Concerning On Sale Bar in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc," Fédération Internationale des Conseils en Propriété Industrielle (FICPI), August 23, 2017.
“Legal protection system of vegetable extractions and the biotechnological inventions applied to plants,” moderator, Asociacion Interamericana de la Propiedad Intelectual (ASIPI), Asuncion, Paraguay, March 16, 2015.
“Genetically Modified Organisms; Food for Thought,” speaker, Asociacion Interamericana de la Propiedad Intelectual (ASIPI), Havana Cuba, March 2013.
“The University of Rochester Overreaches,” author, Outs & Ins, vol. 4, no. 2, 2004.
“Degeneracy in the Legal Code: Can the PTO and the Federal Circuit Reach a Consensus Regarding Patenting Biotech Inventions?,” co-author, 4 The Journal of Biolaw and Business 39-42, 2000.
“Identification of the Transmembrane Fusion Domain in the Visna Virus Envelope,” co-author, 185 Virology 488-492, 1992.
"Identification of Cell Membrane Proteins that Bind Visna Virus,” co-author, 65 J. of Virology 6137-6143, 1991.
“Epitopes Responsible for Fusion and Virus Neutralization in the Glycoprotein of Ovine and Caprine Lentiviruses: A Challenge for Vaccine Development,” co-author, AIDS Vaccine: Basic Research and Clinical Trials. Putney, S.D. and D. P. Bolognesi (Eds.). Marcel Dekker, Inc. pp. 319-338, 1990.
“Fusion and Neutralization Sites on Visna Virus are Separate Epitopes,” co-author, Cell Biology of Virus Entry, Replication and Pathogenesis. Compans, R.W., A. Helenius and M. Oldstone (Eds.). Alan R. Liss, Inc. New York, pp. 1-12, 1989.
“Lentiviruses of Animals are Biological Models of the Human Immunodeficiency Viruses,” co-author, 5 Microbial Pathogenesis 149-157, 1988
“Separate Epitopes in the Envelope of Visna Virus are Responsible for Fusion and Neutralization: Biological Implications for Anti-fusion Antibodies in Limiting Virus Replication,” co-author, 62 J. of Virology 2680-2685, 1987.
“Identification of Chromaffin Granule-Binding Proteins. Relationship of the Chromobindins to Calelectrin, Synhibin, and the Tyrosine Kinase” co-author, Substrates p35 and p36, 262 The Journal of Biological Chemistry 1860-1868, 1987.
“Mnemonic Correlates of Unit Activity in the Hippocampus,” co-author, 399 Brain Res. 97-110, 1986
“An Electrophysiological Method for Examining the Effects of Potential Therapeutic Agents on Memory Function,” co-author, 444 Annals of the New York Academy of Sciences 494-495, 1985.
: Education
J.D., George Washington University Law School, 1994
Ph.D., Molecular Biology and Genetics, Johns Hopkins School of Medicine, 1990
B.A., Behavioral Biology, Johns Hopkins University, 1984
Admissions
District of Columbia
New Jersey
New York
U.S. Patent and Trademark Office
Court Admissions
United States Supreme Court
U.S. Court of Appeals for the Federal Circuit