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370 DOMSCHKE & BLAHO

opment from conception to launch. The industry proof, trials in the U.S., trials outside U.S.,
subject matter expert Dr. Abhishek Datta, who infringement, infringement opinions, validity
is employed as CTO at a medical device start-up opinions, and damages and injunctions. Stu-
company, was recruited as course director. dents performed initial searches of the United
States Patent and Trademark Office website for
◉ Regulatory topics covered were the latest patents related to their planned projects.
regulatory developments presented at the 2015 The goal was to enable them to integrate the IP
conference Food and Drug Administration sequencing timeline into the product devel-
(FDA) Small Business Regulatory Education opment pathway.
for Industry (REdI). These topics included
the FDA and its regulations, establishment ◉ In addition to the comprehensive course mate-
registration, medical device listing, medical ial described above, the basics of smart pat-
device tracking, drug establishment regis- ent searching and smart patenting were
tration, drug listings, and an overview of taught by University Research Commer-
basic regulatory requirements. Details of cialization Manager Neeti Mitra at the CUNY
the FDA approval process were given, includ- Technology Commercialization Office. This
ing device classification, predicate devices, the workshop enabled the students to find,
de novo classification process, humanitarian understand, and evaluate patents related to
device exemption, product codes and regu- their products as well as enabled communica-
lation numbers, drug regulation, orange book, tion with legal experts to create successful pat-
types of drug filings, drug product exclusivity, ents. Topics included novelty and prior art
and Hatch-Waxman regulations. Regulatory searches as well as understanding the back-
pathways for medical devices were described, ground and purpose of the invention. Students
including 510(k), 513(g), and premarket were taught how to identify the key areas of
approval filings. Regulatory pathways for drugs invention, develop search strategies to iden-
included new drug applications, abbreviated tify similar patents, and find relevant key word,
new drug applications, and 505(b)(2) filings. international patent classification, and struc-
Students were assigned medical devices or ture data in relevant patent databases. Stu-
licensed drugs for which they researched the dents were encouraged to create a final search
regulatory pathway that led to its approval. set for analysis and to identify prior art. Smart
Further topics included strategies for inter- patenting topics included IP management,
actions with the FDA, clinical trial basics, and patent commercialization, strategies of defensive
select international regulations (European and offensive patenting, cross-licensing, in-
Union, Canada, etc.). licensing, out-licensing, fields of use, territories,
and time frames.
◉ IP discussions began with an overview
of patents. Topics included patent definition, ◉ Quality assurance (QA) is an essential part
content, terms, and acquisition. Students were of Stage 3. The MTM program includes
walked through a patent example that included comprehensive quality assurance classes and
a description of all its aspects (methods, ranges, an expert guest lecture. Classes in QA were
etc.). Other topics included requirements for taught in the first semester. Continued QA
patentability, freedom to operate, inventorship “refresher” lectures—to be placed through-
and proof of invention, trademarks and out the whole curriculum—are envisioned
copyrights, provisional and non-provisional for future cohorts. QA was covered in a series
applications, U.S. filing, international patent of guest lectures. Topics included FDA qual-
coverage and filing, patent examination, notice ity system regulation, quality policy, a quality
of allowance, patent maintenance, licensing, manual, and subsystems of a quality system
the university IP process, nondisclosure agree- (i.e., management using six systems: design
ments, patent enforcement basics, burden of controls, material controls, record controls,