Christopher Ohly is a trial lawyer. He has successfully tried both jury and non-jury cases in a number of federal and state courts and regulatory agencies. He has argued more than 25 cases in federal appellate courts in several judicial circuits, as well as a number of others in state appellate courts, and he has participated in controversies before the U.S. Supreme Court.

A former Assistant U.S. Attorney, Mr. Ohly concentrates his practice in complex business litigation. He has served as lead counsel in intellectual property lawsuits, including Hatch-Waxman generic pharmaceutical litigation, and has recently focused on patent litigation over biosimilar therapeutic and diagnostic products. He has also served as lead trial counsel in cases involving trademarks, securities regulation, shareholder and partnership derivative actions, accounting malpractice, tax, white collar criminal charges, international issues and other corporate and commercial disputes.

Publications

"The 'Safe Harbor' May Be Safer than Expected—Or Maybe Not: The Conflict Created by Momenta Pharmaceuticals v. Amphastar Pharmaceuticals," (co-author) Bloomberg/BNA Pharmaceutical Law & Industry Report (August 24, 2012)

"The America Invents Act: USPTO Implementation – Inter Partes and Post Grant Review," Maryland State Bar Journal (forthcoming, Fall 2012)

"Patent Reform Act at a Glance," (co-author) The Recorder (October 3, 2011)

"Therasense: Another Case for Rejecting Rigid Rules," Intellectual Property & Technology Law Journal (August 2011)

"There Is No Orange Book: The Coming Wave of Biological Therapeutics," (co-author) Journal of Intellectual Property Law & Practice (2011)

"Evergreening Biologics," (co-author) Journal of Generic Medicines (July 2011)

"The America Invents Act of 2011," Intellectual Property & Technology Law Journal (June 2011)

"Inequitable Conduct: Therasense En Banc," SpicyIP Blog, (March 27, 2011)

"Microsoft, Therasense And Burdens Of Proof," (co-author) Law360 (February 17, 2011)

"The Hatch-Waxman Act: Prescriptions for Innovation and Inexpensive Medicines," (co-author) University of Baltimore Journal of Intellectual Property Law (Spring 2011)

"Patent Marking: Is Forest Group a Solo or the Start of a Flood?" Spicy IP Blog (July 3, 2010)

"What's New? — Isn't it Obvious?" Journal of Intellectual Property Rights (India)  (September 2008)

"It Is Not So Obvious: The Impact of KSR on Patent Prosecution, Licensing and Litigation," (co-author) American Intellectual Property Law Association Quarterly Journal (Summer 2008)

"Omeprazole is Over — Or Nearly So," INNsight (June 2008)

"Tamoxifen Ruling Eases Hatch-Waxman Settlement," IP Law Bulletin (November 2005)

"Arthur Andersen: Document Retention Redux," http://www.mondaq.com/ (September 2005)

"Duty to Preserve Relevant Electronic Communications Arises Without Regard To Whether Opposing Litigant Requests Them, New Jersey State Rules," http://www.mondaq.com/ (August 2005)

"In GAAP We Trust," CPA Journal (found in electronic form at http://www.nysscpa.org/cpajournal/2002/0802/nv/nv1.htm and http://www.nysscpa.org/cpajournal/2002/1002/nv/nv2.htm) (August and October
 2002)

"A Functional Analysis of Claimant Eligibility," International Law of State Responsibility for Injuries to Aliens, University Press of Virginia (1983)

"Advice and Consent: International Executive Claims Settlement Agreements," 5 California Western International Law Journal 271 (1975)

"International Seabed Resources: The U.S. Position," 15 Virginia Journal of International Law 903 (1975)

Speeches and Presentations

"Safe Harbor or Stormy Port? Analyzing How New 271(e)(1) Controversies Will Impact Paragraph IV Disputes," American Conference Institute's Seventh Annual Paragraph IV Disputes, New York, N.Y. (May 7, 2013)

"The Complete Guide to Formulating a Biosimilars Patent Strategy Following the Implementation of the FDA’s Approval Pathway," American Conference Institute, Biotech Patents 2012, Boston (November 2012)

"The FDA’s Proposed Biosimilar Approval Pathway Guidance Documents – Scientific and Quality Considerations (and Q&A)," PLI Webinar (Aug. 15, 2012)

"An overview of the newly released final 2012 EU guidances on biosimilars on monoclonal antibodies (mAbs) and impact on comparability of mAbs EU EMA vs USA FDA," (panelist) Biopractice.com webinar (July 25, 2012)

"Practical Implications of a 12 Year Exclusivity Period: Strategically Defining and Calculating Exclusivity," American Conference Institute, Biosimilars 2012, N.Y. (May 2012)

"Defining Uncertainties and Opportunities in Biosimilar Patent Litigation," CBI Summit on Biosimilars, Washington, D.C. (March 2012)

"A Glimpse of the Future – US Biosimilars Litigation Considerations," Biopractice.com webinar (December 15, 2011)

"Laws and Regulations Governing Biologics, Biosimilars and Biobetters," The Emerging Biologics Business program (September 23, 2011)

"Biosimilars and Patent Litigation Strategies," Business of Biosimilars and Biobetters Conference Workshop (September 19, 2011)

"Are Genes Patentable in the United States?" BioPractice.com webinar (August 26, 2011)

"Therasese Transformation: Familiar Territory for a Former Prosecutor," Pittsburgh IPLA (October 2010) [click here for presentation slides]

"Hatch-Waxman: Prescriptions for Innovative and Inexpensive Medicines — The Generic Perspective," AIPLA Spring Conference (May 2010) [click here for presentation slides]

"Discovery Strategies and Pre-trial Maneuvering Tactics for Brand Names and Generics," Paragraph IV Disputes, American Conference Institute, New York, N.Y. (April 2010)

"The Inventor: Tackling Infringement by Effectively Describing the Development History and Background of the Patented Product," Paragraph IV On Trial, American Conference Institute, New York, N.Y. (November 12, 2009)

"E-Discovery: Rules and Standards — Strategies for Manageable and Cost-Effective Discovery of Electronically Stored Information," University of Virginia School of Law (October 2009)

"Tackling Infringement by Effectively Describing the Development History and Background of the Patented Product — Cross-Examination of the Inventor," Paragraph IV On Trial, American Conference Institute, New York, N.Y. (November 19, 2008)

"E-Discovery and Computer Forensics: Selecting and Managing Experts — Strategies for Admission of Electronically Stored Information," Strafford Publications Webinar (October 21, 2008)

"Indian Patent Law — Section 3(d) in Perspective," Cambridge Health Institute, Global R&D Congress: Discovery and Development Operations in Emerging Regions (May 2008)

"Utilizing to Your Advantage Evolving Standards for E-Discovery," ACI Fourth Annual Life  Sciences Counsel Guide to Document Management, E-Discovery, and Litigation  Readiness (April 2008)

"Patent Law Reform," NASABA, George Washington Law School (September 2007)

"Impact of Patent Law Reform on Small and Medium Businesses in India and USA," U.S. — Indian-American Chamber of Commerce (September 2007)

"Electronic Discovery: What Every Judge Needs to Know," Instructor, National Judicial College (March  2007)

"E-Discovery" Lecture, National Judicial College, Widener Law School (March 2007)

"E-Discovery Primer," Widener Law School (January 2007)

"Complying with Document Preservation and Production Obligations," ACI Conference on Conducting Forensic Investigations (December 2006)

"Regulation FD: Managing Disclosure and Internal Controls, and Assessing Compliance Program Effectiveness," ACI Conference on Pharmaceutical Corporate Governance (October 2006)

"Preservation Policies for Document Retention that Enable Effective Investigations, the Complete Corporate Counsel's Guide to Internal and External Investigations," American Conference Institute (June 2006)

Awards and Honors

AV Rated — Martindale-Hubbell

Washington, D.C. Super Lawyers — Intellectual Property Litigation

Who's Who in the World

Who's Who in America