Vicki G. Norton, Ph.D.

Representative Matters

• Represented Quest Diagnostics Inc. in providing IP diligence and negotiation of IP issues in Quest’s $300 million (up to $450 million with milestones) acquisition of Haystack Oncology, a biotechnology company focused on innovative liquid biopsy and tumor-detection technology.

• Represented Allele Biotech in company side IP diligence in connection with its licensing agreement to expand Astellas’ access to Allele’s induced pluripotent stem cell (iPSC) technologies for various cell therapy programs.

• Secured for Allele Biotechnology key patents for its technology for re-programming stem cells without the danger of foreign or viral integrated DNA in methods which are especially adaptable for use in regenerative medicine technologies, which meet regulatory GMP requirements. Also represented Allele Biotech in company side IP diligence in connection with its outlicensing agreements for the technology, including an agreement to expand Astellas’ access to Allele’s induced pluripotent stem cell (iPSC) technologies for various cell therapy programs.

• Obtained patent for California Safe Soil, for its a nutrient rich fertilizer made from fresh food waste. California Safe Soil received a 2017 California Governor's Environmental and Economic Leadership award for its innovative technology that recycles organic food waste into fertilizer and feed for agricultural uses.

• Handled global patent strategy for leading Taiwanese biopharmaceutical company focused on antibody glyco-engineering, and obtained key patent for foundational glyco-engineering technology.

• Handled global patent strategy for Skysong Innovations’ pioneering technology in the field of nucleic acid origami therapeutics.

• Handled company-side IP diligence for OcuNexus' License & Collaboration Agreement with Eyevance Pharmaceuticals, in which Ocunexus out-licensed one of its drug candidates.

• Represented Quest Diagnostics in the sale of a stream of royalty revenue from commercialization of the drug candidate Ibrutinib to Royalty Pharma for $485 million in cash.

• Teva v. Watson, Case No. 10-CV-5078 (D.N.J. — C.Cecchi). Represented Watson Pharmaceuticals, Inc. in Hatch-Waxman Litigation against Teva Pharmaceutical Industries Ltd. concerning the Parkinson's disease drug AZILECT®, the active ingredient of which is rasagiline. The matter was settled during trial.

• Advised Quest Diagnostics on intellectual property matters in connection with Quest's definitive merger agreement with Celera Corporation.

• Counsel to a leading biopharmaceutical company in its defense against a demand for multi-million dollar damages in a patent infringement suit concerning a biologic drug useful in the treatment of rheumatoid arthritis; dismissal of the case on a motion following the close of discovery was affirmed on appeal.

• Counsel to a leading biopharmaceutical company and affiliates in actions brought for declaratory judgment that no royalties were owed for production of biopharmaceuticals, where a multi-billion dollar claim for royalties was at stake; cases brought by several biopharmaceutical companies against same patentee were consolidated in a multi-district proceeding; following discovery of invalidity and prior art witnesses the patentee filed a covenant not to sue and the case settled in a manner the client found favorable.

• Represented a trustee for a biotechnology liquidating trust in defense to claim of breach of license agreement; obtained dismissal of claims brought against the trust.

• Represented a manufacturer of fluorescent calcium indicator probes in defending against patent infringement claims, obtaining a settlement the client found favorable.

• Represented a manufacturer of nanoparticle technology in an action seeking a declaratory judgment of ownership; obtained settlement.

• Represented a producer of transgenic plant seeds in patent infringement actions, including cases consolidated for discovery with other cases brought by patentee in the same jurisdiction.

• Represented a leading manufacturer of life sciences products in a patent infringement suit involving energy transfer fluorescent indicators used in DNA sequencing; obtained summary judgment of infringement; after completion of discovery, the case settled in a manner the client found favorable.

• Represented a patentee in actions seeking damages for infringement of an injection molding patent.

• Handled client's trade secret and licensing diligence in connection with its acquisitions of a fertility diagnostic specialist and a diagnostic pathology service.

Areas of Practice

• Intellectual Property Law and Litigation

Admissions

• California
• U.S. Patent and Trademark Office (USPTO)
• U.S. District Court for the Central District of California
• U.S. District Court for the Northern District of California
• U.S. District Court for the Southern District of California
• U.S. Court of Appeals for the Federal Circuit
• U.S. Court of Appeals for the Ninth Circuit
• Supreme Court of the United States

Education

• University of California, Los Angeles School of Law, J.D., 1994
  - Managing Editor, UCLA Law Review
  - Order of the Coif
• University of California, Davis, Ph.D., 1990
• University of California, Davis, B.S., summa cum laude, 1981

Experience

• Duane Morris LLP
  - Partner, 2008-present
• Wilson Sonsini Goodrich & Rosati PC
  - Partner, 2004-2008
• Pillsbury Winthrop LLP
  - Partner, 2003-2004
• Brobeck, Phleger & Harrison LLP
  - Partner, 2002-2003
  - Associate, 2000-2001
• Lyon & Lyon
  - Associate, 1994-2000

Professional Activities

• American Intellectual Property Law Association (AIPLA)
  -Chair, Biotechnology Committee, October 2017-October 2019
• American Intellectual Property Law Association
  - Vice Chair, Biotech Committee, October 2015-October 2017
  - Co-Chair, Biologic Products and Competition Sub-Committee
• San Diego Intellectual Property Law Association
  - Member of Amicus Committee of the SDIPLA, 2006-2015
  - Board Member, 2000-2006
  - President, 2004-2005
• California State Bar
  - Committee for the Administration of Justice, 2006-2011(Chair 2010-2011)

Honors and Awards

• LMG Life Sciences 2024 Patent Strategy Attorney of the Year - California
• Daily Journal's Top Women Lawyers List, 2024
• Listed in IAM Patent 1000: The World's Leading Patent Professionals, 2024

• Listed in LMG Life Sciences Intellectual Property Stars, 2019-2024

• Daily Journal’s 2023 "Top IP Lawyer"

• Listed in The Best Lawyers in America, 2023 and 2024

• Recognized in the Top 250 Women in Managing Intellectual Property's IP List, 2022 and 2023

• Listed as a "Patent Star" in Managing Intellectual Property's IP Stars, 2022

• Named one of Daily Journal's "Top 25 Portfolio Managers/Patent Prosecutors," 2013
• Voted by peers as one of San Diego's Top IP Attorneys, 2005

Selected Publications

• Contributor, Duane Morris Life Sciences Blog
• Co-author, "Patent Primogeniture: First-Filed, First-Issued and Later-Expiring Patent in a Family Immune from a Finding of Obviousness-Type Double Patenting," Duane Morris Alert, August 19, 2024
• Co-author, "FDA Finalizes New Rule for Lab-Developed Tests," Duane Morris Alert, May 20, 2024
• Co-author, "USPTO Proposes Significant Fee Increases Impacting Patent Prosecution Practices," Duane Morris Alert, April 24, 2024
• Co-author, "White House Announces Framework for Use of March-In Rights Under the Bayh-Dole Act to Lower Drug Prices," Duane Morris Alert, December 11, 2023
• Co-author, "Coordinating IP and Regulatory Filings Can Minimize the Risk of Inequitable Conduct Before the PTO," Duane Morris Alert, August 8, 2022
• Co-author, "Silence Is Not Necessarily Golden for Negative Patent Claim Limitations," Duane Morris Alert, July 7, 2022
• Co-author, "Russian Sanctions Could Impact IP Holdings in Russia and Eurasia," Duane Morris Alert, March 25, 2022

• Quoted, "The Startup Drugmaker's Post-Helsinn Survival Guide," Law360, January 25, 2019

• Co-author, "What Your Competitors Don’t Know Can Hurt You - The Supreme Court Rules that Secret Sales Can Trigger the On-Sale Bar Under the AIA," Duane Morris Alert, January 24, 2019

• Co-author, "Think Twice Before Omitting an AI Entity as an Inventor," Daily Journal, April 18, 2018

• Co-author, "IP Protection and the Cannabis Industry: Strategies and Trends," The Legal Intelligencer, April 2, 2018

• Co-author, "Ten Years Of MedImmune: How License Agreements Changed," Law360, February 15, 2017
• Author, "How Drug Cos. Can Minimize the Risks of Right To Try Laws," Law360, June 30, 2015
• Co-author, "Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products," Duane Morris Alert, March 28, 2013
• "FDA's Draft Guidance on "Biosimilar" Pathway Leaves Key Questions on Specific Clinical Data Requirements and Interchangeability Unanswered," GenericsWeb InnSight, February 2012
• Co-author, "FDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009," Duane Morris Alert, February 13, 2012
• "U.S. FDA Proposes User Fees for Biosimilar Products Comparable to Fees for Branded Biologic Drugs," GenericsWeb INNsight, June 2011
• Co-author, "Supreme Court Rules That Federally Funded Inventions Are Not Automatically Owned by Universities," Duane Morris Alert, June 8, 2011
• "FDA Proposes Pre-marketing User Fees for Biosimilar Product Manufacturers Comparable to Fees for Branded Manufacturers," Duane Morris Alert, May 11, 2011
• Co-author, "Will the Future of Gene Patents Be 'Markedly Different' After Myriad?" World Intellectual Property Review, November-December 2010
• Co-author, "District Court Invalidates Claims to Isolated DNA Molecules and Methods of Their Use; Finds Subject Matter Ineligible for Patent Protection," Duane Morris Alert, March 31, 2010
• Co-author, "Smart Pill: So, Post-MMA, Who Gets First Slice?" IP Law & Business, August/September 2009
• Quoted in "Teaching Baby Biotechs to Play in the Big Leagues," Los Angeles Daily Journal, July 20, 2009
• "Managing Multi-Party Patent Cases: Avoiding Too Many Cooks in the Courtroom, 19(1) IPL Newsletter (Fall 2007)
• Co-author, "Effect of the Proposed PTO Rule Changes on Biotechnology Patents", cited in IP360 article, "New Study Supports Biotech Fears Over USPTO Changes," IP360 (July 13, 2006)
• "IP Issues for Microarrays," Biochips As Pathways to Drug Discovery, Andrew Carmen and Gary Hardiman, eds., 2006
• "What Nanotechnology Means for IP," Managing Intellectual Property, June 1, 2003
• Co-author, "Protecting Intellectual Property Overseas," San Diego Daily Transcript, August 1, 2002
• "Unnatural Selection: Preimplantation Genetic Screening and Proposed Regulation," 41 UCLA L. Rev. 1581-1650 (1994), reprinted in Reproductive Technologies, Carol Wekesser, Ed., 1996
• Co-author, "Histone Acetylation Reduces Nucleosome Core Particle Linking Number," 57 Cell 449-459 (1989)
• Co-author, "Nucleosome Linking Number Change Controlled By Acetylation of Histone H3 and H4," 265 J. Biol. Chem. 19848-19852 (1990)

Selected Speaking Engagements

• Speaker, "Infringement, Including Doctrine of Equivalents,"Advanced Chemical/Pharma Patent Practice Institute, May 20, 2022

• Speaker, "What Your Competitors Don’t Know Can Hurt You: Strategies to Avoid Secret Sales from Invalidating Your Patent," ACS National Meeting and Expo, San Diego, August 26, 2019

• Speaker, "Patent Boot Camp - Responding to 101 and 112 Rejections," AIPLA Spring Meeting, Philadelphia, May 14, 2019

• Speaker, "Right to Try Access to Experimental Drugs Under the Federal Right to Try Act," 9th Annual California ALS Research Network Meeting, Irvine, CA, January 11, 2019

• Presenter, "Obviousness of Antibodies and Other Biologics," American Intellectual Property Law Association, Webinar, September 19, 2018

• Presenter, "Cannabis 102: Intellectual Property, Trademark and Branding, and Marketing," The Duane Morris Cannabis Webinar Series, February 27, 2018 (video playback)

• Speaker, "Is it Easier to Win a Nobel Prize than to Obtain a patent: Impact of Patent Developments on Biomarker IP," AACC Philadelphia Local Section Symposium, San Diego, July 30, 2017
• Moderator, "Intellectual Property, Licensing, & Regulatory Considerations for Emerging Technologies," AIPLA Webinar, October 4, 2016
• Panelist: "Mars 101-International and Interplanetary Considerations for GMOs: Patents, Export control, Biodiversity and Regulation," AIPLA Spring Meeting, Minneapolis, May 18, 2016
• Co-moderated, "Whether to Pursue Enforcement of Patents Before the ITC and/or District Court, and Preparing for PTAB Challenges to Pre-AIA and Post-AIA Patents," AIPLA Annual Meeting, Washington, D.C., October 2015
• Speaker, "Biosimilars Latest Intellectual Property and FDA Issues," San Diego Intellectual Property Law Association Meeting, San Diego, February 26, 2015
• Panelist, "Global Patent and Product Liability Challenges," 17th Annual FDA-OCRA Educational Conference, Irvine, California, June 4, 2014
• Speaker, "Cabilly III and Other Notable Antibody Patents," IBC 23rd Antibody Engineering and 10th Antibody Therapeutics Conferences, San Diego, December 2, 2012
• Speaker, "Paragraph IV Disputes and Litigation: Federal Court, PTO Proceedings & ITC Actions," ACI Hatch-Waxman Boot Camp, San Diego, June 26, 2012
• Speaker, "How the Dynamics of Biosimilars Are Changing the Hatch-Waxman Landscape" American Conference Institute's Hatch-Waxman Boot Camp, San Diego, June 25, 2012
• Speaker, "An In-Depth Look at 180-Day Exclusivity," ACI Hatch-Waxman Boot Camp, San Diego, July 19, 2011
• Speaker, "180-Day Exclusivity," ACI Hatch-Waxman Boot Camp, San Diego, May 25, 2010
• Panelist, "Intellectual Property Management & Technology Licensing," NanoEquity Asia 2008, Singapore, May 28-29, 2008
• Panelist, "Nanotech IP and Licensing," NanoBioNexus, April 2007
• Chaired Panel Discussion, "From Bench to Bench" Chemistry and the Law Session, ACS Meeting, San Francisco, September 2006
• Chaired Panel Discussion, "The Convergence of IT and Biotechnology," FWE Meeting, September 2002
• Chaired Panel Discussion, "The Status of Nanotechnology," Nanotech Venture Fair, September 2002
• Panelist, "Patented Medicines: Bringing Life-Saving Drugs to the Developing World," April 19, 2002