Mr. Upadhye has extensive experience dealing with legal and regulatory matters in the pharmaceutical and medical device industries. Mr. Upadhye joined the firm from an international AmLaw 100 firm where he headed the life sciences/FDA department. He previously worked at Apotex, Inc., in Toronto, Ontario, where he was the global head of intellectual property. Before joining Apotex, Inc., Mr. Upadhye was the U.S. head of intellectual property at Sandoz, Inc. in Princeton, NJ. As the former head of intellectual property at two leading pharmaceutical companies, he interacted with all levels of technical and business management and counseled in matters such as product selection, research and development support, FDA regulatory affairs, litigation management, and product launch management. As a senior member of the executive team he routinely advised and coordinated legal efforts regarding global litigation in patent, trademark, and copyrights. More specifically, he counseled on early market opportunities for generic drug clients, particularly in the field of “Paragraph IV” brand-generic pharmaceutical matters. His specialties include development of strategy and tactics in Abbreviated New Drug Application matters, patent opinion work on infringement and freedom to operate, patent litigation in the drug and medical device spaces.
 
Health E-Insights: Tell our readers a little about the new partnership at Amin Talati & Upadhye.

Mr. Upadhye: I have been privileged to be chief legal officer for several global companies and a partner in global firms. Amin Talati & Upadhye provides the platform to provide concentrated, highly skilled, and efficient services to clients. The former Amin Talati firm has deep expertise in food, drug, nutraceuticals, and intellectual property law. By joining this foremost health industry law firm, I have a better platform for my drug and device clientele.
 
Health E-Insights: What’s your area of expertise?
 
Mr. Upadhye: My core expertise is in pharmaceutical patent and FDA law. I have been the chief of IP and regulatory law at several pharma companies. I also wrote the book on pharma IP and FDA law. I consider myself a legal solutions architect that helps clients solve problems. I use my deep industry expertise, contacts, and experience to help solve problems. My classic IP work is in generic pharma law. My FDA expertise is in navigating the complex approval requirements, helping obtain market exclusivity, but also with GMP compliance, supply chain management and integrity, and launch management.
 
Health E-Insights: Do you envision pharma taking a larger role in the supplement industry?
 
Mr. Upadhye: Yes and no. Classic Big Pharma was once only involved in pharma. Then growth pressures caused Big Pharma to get into areas such as vaccines, diagnostics, consumer health products, veterinary, devices, and OTCs. Then Big Pharma decided that it was too broad and needed to return to its core competency, thereby shedding many business units. So, I would say that as supplements and nutritionals provide a value opportunity for growth, sales, and profits, we can see Big Pharma entering that space.
 
Health E-Insights: What is the biggest challenge facing the health industry?
 
Mr. Upadhye: The trite response is cost and access as that is what is thrown around nowadays. But it is important to really drill down and analyze what is costly or where access is denied. For example, healthcare costs can be related to drug prices, office visits, tests, hospital stays, unneeded or extra services charged, and some fraud and abuse. But it’s unfair to target any particular industry like the drug industry for drug pricing, as pricing of drugs is just one component of costs. We also need to do better at providing the right access at the right points in the healthcare spectrum. For certain people, the Affordable Care Act has finally provided some affordable insurance thereby now providing access to healthcare. Sometimes preventive care taken today, though at a cost, is more cost effective later, and insurance today provides access to preventive care.
 
Health E-Insights: What things do you do outside of work to help you be better at your job?
 
Mr. Upadhye: I spend lots of time with my family. I find they are really able to keep me grounded, which helps me at work. I also am very interested in project management/LEAN Six Sigma so I can help operationalize my work.
 
Health E-Insights: Is there something about you people would find surprising?
 
Mr. Upadhye: I play ice hockey, which is not typical for people of Indian heritage. Plus, I write a lot of articles and books as academic scholarship.
 
Health E-Insights: What makes you laugh the most?
 
Mr. Upadhye: My son is 11 and has a very keen sense of humor. He is so witty and quick in cracking jokes, but in a nice way and not sarcastic at all. He makes me laugh.

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Sheldon Baker is well-known for creating nutraceutical brand marketing and public relations campaigns. He serves as vice president strategic engagement for the American Herbal Products Association. For Health E-Insights interview consideration, contact him at Sheldon@NutraInk.com. And follow him on Twitter @NutraInk.