Associate

Associate

(703) 584-3235

jzak@rmsc2.com

Areas of Practice: Chemical, Biotechnology, and Technology Patents, Client Counseling

Partnering with and learning from clients, James gained the experience necessary to achieve business goals through intellectual property protection.  Working with a diverse range of clients from large international corporations to small startups, his experience enables him to custom tailor support to specific client needs.  Having represented clients in diverse applications of the chemical and biological arts, he is able to adapt to the new advances in technology and business quintessential to intellectual property.

James began his career in Minnesota serving the needs of medical device manufacturers.  Accordingly, he focused on the unique chemical nature of the materials and pharmaceuticals underlying advances in care.  As a committee member of the Minnesota State Bar Food Drug and Device Law Section, James spoke about the importance of coordinating critical intellectual property with regulatory approval to secure markets for innovations in care.

Upon arriving in Virginia, James applied his knowledge in the chemical and biological arts to protecting the intellectual property underlying advances in more daily use products.  As such, James has prosecuted patent relating to materials enabling essential electronics, such a cell phones and computers, energy extraction, and refinery processes for materials used daily.  Prosecuting patents relating to the chemical, biological and analytical advances behind various diagnostic tools, James has continued his representation of medical device clients.

In effort to help others confront obstacles, while avoiding damaging mistakes, James has shared his knowledge through CLEs, publications and webinars.

Education: University of Minnesota College of Biological Sciences (B.S. Biochemistry / B.S. Neuroscience);
University of Minnesota Law School (J.D. Cum Laude).

Admitted: USPTO; Minnesota

Publications and Presentations: 

The Limits of the Patent Infringement Safe Harbor – May 7, 2013

CLEs Sponsored by the Minnesota State Bar Association Food Drug and Device Law Section

Discussed the limits of the Safe Harbor for patent infringement under
35 U.S.C. §271(e)(1) for those who infringe a patent to gather information required by the FDA.

 

Inter Partes Review and the 505(b)(2) Pathway – March 13, 2015

CLEs Sponsored by the Minnesota State Bar Association Food Drug and Device Law Section

Analyzed the advantages of the 505(b)(2) pathway for securing FDA approval of new drugs and applicability of Inter Partes Review to those seeking to use the pathway.

 

The Two Faces of Establishing Patentability of a New Chemical – June 24, 2015

CLE Sponsored by Fitch Even Tabin & Flannery

Examined application of the lead compound analysis put forth by the Court of Appeals for the Federal Circuit in determining patentability of novel compounds.

 

Navigating Patent Potholes Along the FDA’s Proposed ANDA / 505(b)(2) Pathway –
December 2, 2015

CLE Sponsored by Fitch Even Tabin & Flannery

Explored potential potholes within the FDA’s proposed rules implementing the Medicare Prescription Dug, Improvement and Modernization Act created by patent post grant review procedures for those attempting to maintain monopolies.

 

Chapter 3: “Inter Partes Review Closing the Gap Between Biotech 510(K) and 505(B)(2) Applications: FDA-Granted Monopolies for Patent Exclusivity”, Navigating Legal Issues in the Biotechnology Industry: Leading Lawyers on Staying Abreast of Supreme Court Decisions and Overcoming Challenges in Patent Filing (Inside the Minds), Thomson Reuters (January 1, 2015)

James ghost wrote this chapter exploring how inter partes review and 505(B)(2) drug approval applications may facilitate development and growth of small pharmaceutical companies.