Up Coming Engagements

Speaking Engagements
Speaker, "Patents & FDA Regulation of Pharmaceutical Products," FDA News Webinar, October 22, 2020

Speaker, "IP Strategies for AI in the Life Sciences," IIPLA 6th Annual Meeting 2020, Dubai, UAE, January 29-30, 2020

Speaker, "IP Strategies for Generics and Biosimilars," Portfolio management strategies for Generics & Biosimilars, Barcelona, Spain, September 25-27, 2019

Speaker, “Navigating the Patent Dance and Other Legal Hurdles to Get Biosimilars to the Market”, 2nd Biosimilars Market Access and Commercialization Strategies Summit, Boston, MA, September 17-18, 2018
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Speaker, "Financial & Business Formation Strategies for Start-Ups & Chemical-Related Businesses", 256th American Chemical Society meeting in Boston, MA on August 21, 2018

Speaker, “Human Biological Material & Data Transfer Agreements”, MAGI Clinical Research Conference, Arlington, VA, May 22, 2018

Speaker, “The Current State of the BPCIA and the Anti-Patent Climate”, BioTech Pharma Summit: Biosimilars & Biologics, Porto, Portugal, March 22, 2018

Speaker, “Obtaining Patent Protection While Operating in an "Anti-Patent" Climate”, World Biosimilar Congress Europe 2017, Basel, Switzerland, November 1, 2017
 
Roundtable Speaker, “State of the BPCIA after the Supreme Court's ruling in Amgen v. Sandoz”, World Biosimilar Congress Europe 2017, Basel, Switzerland, October 31, 2017

Workshop Speaker, "Biosimilars: The Current State of the Biologics Price Competition and Innovation Act (BPCIA) and Overview of the Anti-Patent Climate," BioProcess International Conference & Exhibition, Boston, MA, September 25, 2017 

Speaker, ““The BPCIA Patent Dance: Recent Trends, Developments and Court Decisions,” hosted by the Knowledge Group, August 9, 2017

Speaker, “Pharmaceutical Patents”, FIP Webinar, May 30, 2017
 
Speaker, “Innovators & Biosimilar: Challenges of Operating in an ‘Anti-Patent’ Climate”, 10th Biosimilars & Follow-On Biologics Congregation 2017, London, UK, May 9-10, 2017
 
Speaker, “Obtaining Patent Protection in an ‘Anti-Patent’ Climate”, BioTech Pharma Summit: Biosimilars & Biologics, Porto, Portugal, March 30-31, 2017
 
Speaker, “Patent Battles Between Brand-Name and Generic Products and the Challenges in Maintaining and Obtaining Market Share”, Navigating the American Pharmaceutical Sector: Policy, Politics, Pricing, and Payment program, Harvard T.H. Chan School of Public Health, Boston, MA, December 5-8, 2016
 
Speaker, “Obtaining Patent Protection in an ‘Anti-Patent’ Climate”, World Biosimilar Congress Europe 2016, Basel, Switzerland, November 14-15, 2016
 
Speaker, “Navigating the BPCIA after Amgen v. Sandoz”, 4th Biosimilars & Biobetters Congress and 3rd Peptides Congress, London, UK, April 18-19, 2016
 
Speaker, “Legal Roadmap: Navigating the BPCIA to Get Your Biosimilar to Market”, World Biosimilar Congress Europe 2015, Basel, Switzerland, November 9-10, 2015
 
Roundtable Speaker, “The State of the BPCIA after Amgen v. Sandoz”, World Biosimilar Congress Europe 2015, Basel, Switzerland, November 9-10, 2015
 
Panelist, “Biosimilars Around the World: Leveraging Regulatory, IP, Pricing, and Safety Lessons Learned So Far”, American Conference Institute's 6th Annual Summit on Biosimilars, Manhattan, NY, June 1-3, 2015
 
Speaker, “Navigating the BPCIA after Amgen v. Sandoz”, Business of Biosimilars Conference, Boston, MA, October 21-22, 2014
 
Roundtable Speaker, “Developing Biologics in Emerging Markets”, Business of Biosimilars Conference, Boston, MA, October 21-22, 2014
 
Panelist, “BPLA’s Biotechnology Committee Biotech and Pharma IP Forum: Current Issues”, Boston, MA June 19, 2012

In The Media

Books
Author, "Billion Dollar Patents: Strategies for Finding Opportunities, Generating Value, and Protecting Your Inventions," JTB Publishing, November 2019.

Author, “Intellectual Property and Healthcare Technologies,” Springer Publishing, December 2013.
 
​Author, Chapter, “Patent Law Relevant to Early Drug Development,” Early Drug Development – From A Drug Candidate to the Clinic, Wiley (forthcoming).

Author, Chapter, “Patents and Intellectual Property,” Global Medical Device Regulatory Strategy, Regulatory Affairs Professionals Society (2016).

Author, Chapter, “Licensing Issues in Nanotechnology,” Nanotechnology Commercialization for Managers and Scientists, Pan Stanford Publishing (February 9, 2012).
 
Author, “Medical Device Innovation: Practical Guidance from FDA, Industry, Venture Capitalist, Legal, IP and Academic Experts,” FDLI Monograph Series, Food and Drug Law Institute.
 

Publications
“What the Patent Dance of the Biosimilars Act Means for Biosimilars,” Journal of Commercial Biotechnology, July 2014, Vol. 20, No. 4.
 
“Patents, Patients, and the Changing Tide in U.S. Biotech Patent Law,” Nature Biotechnology, September 2014, Vol. 32, No. 9.
 
“USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation?”  Journal of Commercial Biotechnology, July 2014, Vol. 20, No. 3.
 
“Evergreening Patents: The Indian Supreme Court Rejects Patenting of Incremental Improvements,” Journal of Commercial Biotechnology, July 2013, Vol. 19, No. 3.
 
“Myriad: Debate Over Gene Patents Continues,” Biotechnology Healthcare Journal, Fall 2012.
 
“Medical Process Patents Now in Limbo,” Biotechnology Healthcare Journal, Summer 2012.
 
“Gene Patent Reform: Still in Doubt” Biotechnology Healthcare Journal, Winter 2011.
 
“The Biosimilars Act: Promoting or Discouraging Development of Generic Biologics?” Biotechnology Healthcare Journal, Winter 2010.
 
“Maximizing the Lifetime Value of a Product Through the Patent Term and Beyond,” FDA Update, May/June 2010.
 
“Building a Biotech Patent Portfolio in the Changing Patent Landscape,” Corporate Counsel, May 2010.
 
“How a Patent Eligibility Case Could Affect Personalized Medicine,” Biotechnology Healthcare Journal, pgs. 23-26, Spring 2010.
 
"In M&A deals, don't underestimate the power of your patent portfolio," Mass High Tech, December 16, 2009.
 
“Navigating the FDA Process: Patent Strategy For Combination Products,” FDA Update. November/December 2009.
 
“Commercialization Potential of Silver Nanomaterials.” Nanotechnology Law & Business Journal. Vol. 6, Issue 2. (co-author)
 
“Combination Products Require Careful Patent Strategy.” The Journal of BioLaw & Business. Vol. 12, No. 1, 2009. (co-author)
 
“Strategies for Speeding Up the Prosecution Process in the Emerging Technology Sector.” Lawyers Weekly.  (co-author)
 
"Protect IP for Combination Products Carefully," Mass High Tech, Vol. 27, No. 11, March 13, 2009. (co-author)
 
“Nanotechnology License Pitfalls.” Journal of Intellectual Property Law & Practice. Oxford University Press. 2009 4(3):176-180. (co-author)
 
Can an Internet Reference Be a "Printed Publication"? 2009 B.C. Intell. Prop. & Tech. F. 012101.
 
"High Court Reshaping the Landscape for Patents," Boston Business Journal, Vol. 28, No. 35, September 26, 2008. (co-author)
 
"U.S. Supreme Court Cases Impact Life Sciences Patents," The Journal of BioLaw & Business, Vol. 11, No. 1, March 2008. (co-author)

"Leveraging a Life Sciences Patent Portfolio in the Changing Patent Landscape," The Journal of BioLaw & Business, Vol. 10, No. 4, December 2007. (co-author)
 
"When Standards of Care Change in Mass-Casualty Events." American Journal of Nursing. Vol. 107, Issue 9, September 2007. (co-author)
 
"Early Detection and Surveillance for Emerging Infectious Diseases." Online Journal of Issues in Nursing. Vol. 11 No. 1, January 2006.  (co-author)