Ms. Wolff has over thirty years of experience advising pharmaceutical and biotech companies in a wide spectrum of intellectual property matters.  This experience includes twenty years in national law firms and over ten years as a founder of her own firm.  She has extensive experience in managing worldwide patent portfolios, conducting freedom to operate analyses for developing products, drafting invalidity and non-infringement opinions, and conducting due diligences for pharmaceutical, biotech, medical device and clean tech companies and their investors.  In addition to this prosecution and counseling work, Ms. Wolff has litigated chemical and biotech patents on antibodies, molecular diagnostics, DNA amplification techniques, drugs, formulations, genetic probes, viruses, and antigen assays.  She has also represented start-ups and mature public companies in a wide variety of intellectual property disputes including patent, trade secret, and breach of IP license actions.  Her litigation clients have included Onyx Pharmaceuticals, Masimo Corporation, Impax Laboratories, Mutual Pharmaceuticals, Phenomix, Biogen Idec, SICOR, Gen-Probe, AmpliMed, IDEXX, Intermedics, and Spectra-Physics. 

Ms. Wolff routinely develops patent and regulatory strategies and prosecutes patent portfolios for known chemical entities with novel indications.  As an example, Ms. Wolff obtained issued patents on a key salt and methods of treatment for Spinifex Pharmaceuticals, which was acquired by Novartis for $700 million. 

Ms. Wolff also has particular expertise in preparing and conducting pharmaceutical Hatch-Waxman litigation concerning generic drugs.  For example, Ms. Wolff successfully represented a pharmaceutical company in a cutting edge Lanham Act litigation against five manufacturers of unapproved quinine sulfate that resulted in consent judgments and a preliminary injunction in separate litigation against another manufacturer.  She also successfully represented a generic manufacturer of the antitumor drug Cisplatin in a bench trial which resulted in the invalidation of a patent which would have extended for an additional 15 years Bristol-Myers’ $50 million/year exclusivity on the drug.  In addition, she handled the appeal before the U.S. Court of Appeals for the Federal Circuit which affirmed the district court’s ruling in her client’s favor.

Ms. Wolff has prepared over 100 freedom to operate analyses and worked closely with clients to design around third-party patents.  For example, she was instrumental in developing a non-infringing formulation of the anesthetic propofol and obtained patent protection to prevent further generic competition.  Such strategic work led drove the acquisition of her client SICOR, Inc. by Teva for $3.4 billion.  Similar work has facilitated the launch of over 50 NDA, generic, and 505(b)(2) drug products.

Ms. Wolff has written and lectured on a variety of intellectual property topics, including a primer on Hatch-Waxman procedures and litigation, protecting IP for entrepreneurs, written description and enablement requirement for biotech inventions, coordination of FDA and patent prosecution strategies, 180-day exclusivity provisions, biosimilar strategies and polymorph patents.

Prior to UCLA law school, Ms. Wolff received her Bachelor’s degree in Chemistry with a concentration in Cell Biology magna cum laude from Bryn Mawr College in 1986.  During her junior year of college, she was a matriculated student at Cambridge University in England where she studied Pharmacology, Biochemistry, Inorganic chemistry and conducted basic research on metal colloids.  She received her Master’s degree in Organic Chemistry from the Massachusetts Institute of Technology in 1988.  Her research focused on analogues of chorismic acid, a key intermediate in the biosynthetic pathway for aromatic compounds in lower organisms.  Prior to attending law school, Ms. Wolff worked as a research scientist in the Cell Biology Department of Duke University Medical School designing and synthesizing 5-alpha-reductase inhibitors for the treatment of prostate cancer and osteoporosis.

Publications

• “Claim Construction and Proving Infringement: The Impact of Phillips, Festo and their Progeny” Practising Law Institute, September 2008

• “Research Tool Patents in Legal Limbo: The Last Chapter in Integra v. Merck” IP Law and Business, September 2007

• “Patent Misuse in the Pharmaceutical Industry: Developments in US & EU” Pharmaceutical Law Insight, February 2007

• “Biotech Roundtable: Proposed Legislation and New PTO Rules Affecting Life Science Companies” (Panel Discussion and Article) IP Law and Business, August 2006

• Nuts and Bolts of IP Due Diligence Continuing Education of the Bar, January 2006

• Intellectual Property Due Diligence in Connection with Investment, Acquisition, or Collaboration in a Technology-Based Entity State Bar of California Intellectual Property Section, January 2006

• Enablement and Written Description as Applied to Biotechnology Cases Practising Law Institute, September 2005

• “Satisfying the Written Description Requirement in Biotech Cases” IP Wire, November 2004

• “The Rise of Generic And ‘Branded Generics’ Cause Dramatic Increase in Pharmaceutical Patent Litigation” Intellectual Property Today, Vol. 11, No. 1, p. 18, January 2004

• “Rise of Generic Drugs Drives Up Volume, Intensity of Patent Litigation” San Diego Daily Transcript, May 2003

• “Generic Drug Wars–Big Business Spawns Big Patent Litigation” The Patent Journal, Vol. 1, No. 7, p.1, April 2002

• Patent Protection Impact San Diego Daily Transcript, June 21, 1995
  
  
• “Patent Appeals Court Addresses Obviousness and Enablement/Utility in Biotech Cases” San Diego Daily Transcript, June 21, 1995

• “Intellectually Speaking” San Diego Daily Transcript, December 17, 1993

Speaking Engagements

• “Orange Book Listings, De-Listings and Related Challenges,” American Conference Institute – Hatch-Waxman Boot Camp, July 2011

• “An Overview of the Statutory Dispute Resolution Mechanisms: Steering Clear of Any Potential Gaps in the Litigation,” American Conference Institute 2nd Annual Conference on Biosimilars, June 2011

• “Exploring Exclusivity and Forfeiture Dilemmas Relative to Paragraph IV Litigation,” American Conference Institute – Paragraph IV Disputes, December 2010

• “Biosimilars Legislation and Patent Litigation: Developing New Procedures and Strategies,” Stanford Law School, November 2010

• “Orange Book Listings, De-Listings and Related Challenges,” American Conference Institute – Hatch-Waxman Boot Camp, May 2010

• “Ethics Issues That Arise When Protecting Intellectual Property,” Practicing Law Institute – Common Ethics Issues in IP Transactions, February 2010

• “Drug Exclusivity Strategies: Protecting and Optimizing Your Pharmaceutical Assets,” March 2009

• Trade Secret Disputes – Navigating Muddy Waters,” Association of Corporate Counsel, Life Sciences Roundtable, June 2009

• “Claims Construction and Proving Infringement,” Practicing Law Institute: Patent Litigation, September 2008

• “Generic Biopharmaceuticals: Current Landscape and Future Perspectives,” Licensing Executives Society, May 2008

• “Follow-On (Comparable or Biosimilar) Biologics,” ACI’s FDA Bootcamp, May 2008

• “Biogenerics or Biosimilars,: Licensing Executives Society, San Diego, May 2008

• “The Federal Circuit’s Ruling in Festo XIII: Doctrine of Equivalents Further Eroded,” Practising Law Institute, September 2007

• “Developments in Enablement, Written Description and Non-Obviousness Requirements in Biotechnology,” Practising Law Institute, June 2007

• “Safe Harbor Update: The Scope of the Research Exemption Post-Integra,” American Conference Institute, June 2007

• “Developments in Enablement and Written Description Requirements as Applied to Biotechnology Cases,” Practising Law Institute, September 2006

• “Merck KGaA v. Integra: New Options for Biotechs?” September 2006
  
  
• “Polymorph Patents: The Shape of Things,” GPhA Annual Policy Conference, September 2006

• “ALM Biotech Roundtable: Proposed Legislation and New PTO Rules Affecting Life Science Companies” (Panel Discussion and Article), August 2006

• “180-Day Exclusivity,” American Conferencing Institute, June 2006
  
  
• “Angel Investor Forum: Panel on IP Due Diligence,” February 2006
  
  
• “Licensing Strategies after Merck v. Integra” Licensing Executives Society, February 2006

Education

• University of California, Los Angeles School of Law
  JD, 1992

• Massachusetts Institute of Technology
  MS Organic Chemistry, 1988

• Bryn Mawr College
  AB Chemistry, 1986, magna cum laude

Court Admissions

• Court of Appeals, Federal Circuit
• U.S. District Court, Central District of California
• U.S. District Court, Eastern District of California
• U.S. District Court, Northern District of California
• U.S. District Court, Southern District of California

Admissions

• California
• Registered to practice before the United States Patent & Trademark Office (USPTO)