Shashank Upadhye has one of the most recognizable brands in the world of brand and generic drug development. As the former chief in-house counsel at three leading pharmaceutical companies (Apotex, Inc., Sandoz-Novartis, and Eon Labs, Inc.) and as a division counsel for a medical device company (The Cook Group), he is known for spearheading innovative business and legal strategies to protect existing drug or device patents – or challenge those of a competitor.
A prolific writer and frequent speaker, Shashank is the author of dozens of articles, been interviewed or presented at 200+ conferences at key industry conferences nationally and internationally. Further, he writes the 1400+ page leading book on navigating complex U.S. laws of FDA brand/generic drug development: Generic Pharmaceutical Patent & FDA Law, now in its 14th Edition (2022). The book took an initial 3 years to write and he spends weeks each year to update it.
He has previously worked in global large and small boutique law firms. This coupled with his in-house experience results in him providing practical, business savvy, and cost effective results. He has spearheaded complex projects, managed budgets worth more than $50 million, and built legal and alignment teams. He also helped his clients build governance and compliance programs, with a focus on executive strategy, succession planning, and structure. These efforts help provide the toolkit for boardroom practice and experience.
Because of his long background in the industry and law firms, he is adept at managing projects efficiently and with an intense quality focus. He has completed certifications and course work in LEAN Six Sigma and as a Project Management Professional.
Hatch Waxman Act Practice Combined With Trusted Business Savvy
Shashank is widely regarded as one of the leading Hatch-Waxman “Paragraph IV” attorneys in the country. His clients range from small pharmaceutical development companies to Fortune 500 companies. Brand pharmaceutical companies trust him to protect their brand products from other branded and generic competitors. Generic companies turn to him to overturn brand patents in Paragraph IV litigations, aimed at bringing generic versions of medicines swiftly and effectively to the marketplace. Shashank’s experience over the last 25 years has involved patent litigation on compounds/compositions of matter; polymorphs and crystal forms; formulations; methods of use; manufacturing and packaging of drugs and devices. Because drug development must result in timely approval of the drug, Shashank helps clients strategize for rapid development and approval of the drug. For example, initially the client began development with the typical Paragraph IV mentality. That strategy would have involved spending money on patent litigation and delays in drug application approval. Shashank examined the situation, proposed an alternative Section viii strategy, worked with the FDA to permit the Section viii strategy, and the helped obtain rapid drug approval, without patent litigation expenses. More importantly, other generic companies had pursued the Paragraph IV litigation process and did not have approval. Our client was able to “jump” over other generic company applicants and enter the market first. In another example, our client developed a strong non-infringement strategy but we anticipated that the patentee would seek to complicate and elongate impending litigation. We developed a strategy to front-load the legal work and discovery so that the trial judge would schedule an early trial. We prevailed on getting a trial date within months instead of years considering our non-infringement position and potential future antitrust concerns. The patentee withdrew its suit upon facing the early trial.
Medical Device Patent and FDA Representation
For medical device companies, he helps with navigating the Safe Harbor Act provisions under the so-called Bolar exemption (35 U.S.C. 271(e)), and representing medical devices in typical patent infringement actions. Because of this background, he also assists companies in moving device applications along through to clearance of 510(k) applications. He is particularly sensitive to statements made in regulatory filings that might implicate future patent infringement. For example, the 510(k) premarket notification and clearance procedures require identification of the predicate device against which the “substantial equivalence” is measured. Applicants must carefully craft statements in the 510(k) dossier to ensure that patent law doctrine of equivalents is not implicated.
505(b)(2) Specialist – Drug Reformulation and Re-positioning
He also maintains a robust practice with drug re-positioning and life cycle management. He helps pharmaceutical clients with the 505(b)(2) NDA process, with an emphasis on creating savvy business and legal strategies around intellectual property, FDA, and supply chain. Given Shashank’s background in generic drug development and Para. IV litigation, he helps 505(b)(2) applicants formulate a patent acquisition portfolio strategy, identify gaps in the pending patent portfolio, map the patent strategy onto the FDA regulatory strategy, work with the FDA on obtaining data or market exclusivity, and planning for future generic competition. He assists 505(b)(2) applicants to interpret the “innovative change” and “conditions of approval” standards and whether a 505(b)(2) will be blocked by an exclusivity. For example, he assisted a client in dealing with the FDA on which Reference Listed Product would be most suitable for reference in the (b)(2) application. Initially the client had picked an RLD that would have had significant patent infringement complications and delayed (b)(2) approval. We helped convince the FDA that a different RLD, with no patent infringement issues, would be more appropriate. The client was able to enter the market upon NDA approval, with no legal issues. We have also advised clients on developing new chemical entities that could be filed as (b)(2) applications, yet qualify for NCE exclusivity and by-pass another’s NCE exclusivity.
At The Forefront of Biosimilars
Shashank also helped pioneer the legal framework around biosimilars under the new 351(k) application process. We have experience in stem cells, nucleic acids, antibodies (chimeric and humanized), vaccines, and other biotechnologies. We help companies navigate the BPCIA regime, in counseling to litigation.
FDA Interactions, Approvals, and cGMP Compliance
The practice of pharmaceutical and medical device law requires in interdisciplinary understanding of patent and FDA law. Shashank works with regulatory agencies to unblock obstacles to approvals. He helps clients build the administrative record for future Administrative Procedures Act (APA) challenges to spur approvals or obtain/unblock exclusivities. For example, recently a client had worked with the FDA to develop bioequivalency standards for which the FDA responded. After developing the product and filing it, the FDA changed the bioequivalency standards rendering all previous work worthless. He challenged FDA’s arbitrary and capricious decision to require one set of testing to conduct yet then change the testing procedures. He appealed this case to the DC Circuit of Appeals.
Shashank has a robust counseling and compliance practice where he advises clients on matters relating to drug approval, drug marketing, supply chain management, and marketing and data exclusivity issues. He also assists clients with FDA enforcement defense and counseling, including:
- Good Manufacturing Practices (GMP) issues such as Form 483 Observations, Warning Letters, import alerts, and detensions
- 180-Day marketing exclusivity and forfeiture
- label/label carve-outs and advertising review
- guidance and compendial reviews for impact on drug marketing
- Citizen Petition drafting or responses
Investor Advice and Due Diligence
Investors or companies retain us to provide insight and advice surrounding an investment. Our clients are investment analysts, hedge funds, family offices, high net worth individuals, investment companies, and the drug company itself. For drug companies, we help the company plan for questions from investors and how to respond to them, especially when the company is on an investor roadshow. We help vet the pitch deck to ensure that it is truthful and accurate to avoid investment fraud issues.
We help investors with IP/FDA due diligence to vet out timelines, patent protection, FDA exclusivities, etc. In other words we can help find the “warts” in a company’s IP & FDA strategy to help the investor walk-away or drive down the valuation of the investment. For example, we helped an investor vet out a possible drug development investment. Our analysis showed that all major relevant patents would expire before the drug company would obtain FDA approval for marketing. Further, we determined that the company would not obtain meaningful FDA exclusivities post-approval. We advised the client that upon FDA approval only marginal patents would exist thereafter, many purported patents that provided the “runway to Year 20XX” would not block competitors and not be Orange Book listable, and the patents would not provide meaningful patent protection against generic companies. To this end, the company’s timelines and market expectations on the pitch deck were exposed as unrealistic.
We also provide patent litigation analysis in ongoing pharma patent cases. Because of our experience and intimate knowledge of the process, we can help educate investors on realistic outcomes, timelines, and other milestones. We can provide customize written reports or oral presentations. We can also participate in on-demand investor conference calls.
He is a USA Hockey® Level 3 certified ice hockey referee, and a PADI® certified Master Scuba Diver; someday, he plans to invent (and patent) a way to play underwater hockey. He is also very active in the Boy Scouts of America (now Scouts BSA) where he has roles of Scoutmaster, Wilderness (bushcraft) Survival guide, Leave No Trace/Outdoor Ethics guide, Merit Badge Counselor, and Eagle Scout coach/mentor. In his other spare time, he studies asymmetric and guerilla warfare.
- L.L.M. (I.P. Law, with Honors), Univ. of Illinois at Chicago
- J.D., New England Law – Boston
- B.A. in Business Administration, Brock University (Canada)
- B.Sc. in Biochemistry, Brock University (Canada)
- Certified Lean Six Sigma Yellow Belt
- Project Management Professionals (PMP) – 36 hours coursework completed
Board of Director Education and Certification Program, UCLA Anderson School of Management
- New York
- U.S. Patent Office
- IAM Global 1000 IP Practitioner
- IAM Intellectual Asset Managers
- Recognized as Top Global IP Practitioner
- Illinois SuperLawyers
- International Advisory Experts Award Winner
- Published by S. Upadhye, “Inducement to Infringe Is Not A Strict Liability Test,” LinkedIn (August 30, 2016)
- Published by S. Upadhye, “Data Falsification/Data Integrity – You can run but you cannot hide,” LinkedIn (June 16, 2016)
- Published by S. Upadhye, “The Culture of cGMP Compliance – More Falsified Data,” LinkedIn (June 1, 2016)
- Published by S. Upadhye, “Does Drug Quality Matter? Do Lives Matter?,” LinkedIn (September 22, 2015)
- Upadhye, Shashank, “There’s a Hole in My Bucket Dear Liza, Dear Liza: The 30-Year Anniversary of the Hatch-Watchman Act: Resolved and Unresolved Gaps and Court-Driven Policy Gap Filling,” William Mitchell Law Review: Vol. 40: Iss. 4, Article 4 (2014)
- Shashank Upadhye & Adam Sussman, A Real Separation of Powers Or Separation of Law: Can An Article I Administrative Agency Nullify An Article III Federal Court Judgment?, 25 Fordham Intell. Prop. Media & Ent. L.J. 1 (2014)
- Published by S. Upadhye and B. Lang, “FDA, Patent, Antitrust, And Property Takings Laws: Strange Bedfellows Useful To Unblock Access To Blocked Drugs”; 20(1) B.U. J. SCI. & TECH. L. 84-130 (Winter 2013).
- “Do You Have A Green Card?” Published by S. Upadhye in NASABA Quarterly (Spring), May 3, 2010.
- Published by S. Upadhye, “Introduction to the Canadian Brand and Generic FDA-Patent Linkage System”; Vol. 3(1), pages 9-22, Sungkyunkwan University (South Korea) Journal of Science & Technology Law. (Spring 2009)
- Published by S. Upadhye, “To Use Or Not To Use: Reforming Patent Infringement, The Public Use Bar, And The Experimental Use Doctrine As Applied To Clinical Testing Of Pharmaceutical And Medical Device Inventions”; Vol. 4(1) Minn. Intell. Prop. Law Rev. 1 (Dec. 2002).
- Published by S. Upadhye, “Understanding Patent Infringement Under 35 USC 271(e): The Collisions Of Patent, Drug And Medical Device Laws”; 17 Santa Clara High Tech. & Comp. Law Review 1 (Dec. 2000).
- The International Watercourse: An Exploitable Resource For The Developing Nation Under International Law?; 8(1) Cardozo Int’l. & Comp. Law Journal 61 (Spring 2000).
- Understanding Willfulness In Patent Infringement: An Analysis Of The Advice Of Counsel Defense; 8(1) Univ. of Texas Intell. Prop. Law Journal 39-70 (Dec. 1999), available on Hein Online [subscription required].
- Published by S. Upadhye, “Trademark Surveys: Identification Of The Relevant Universe Of Consumers Who Must Be Confused”; 8 Fordham I.P., Ent. & Media Law Journal 550 (June 1998).
- Published by S. Upadhye, “Rewriting The Lanham Trademark Act To Ban The Importation Of Gray Market Goods”; 20 Seton Hall Legislative Journal 59 (1996).
- Published by S. Upadhye, “Open Sesame: Criminal Mutual Legal Assistance Treaties Provide The Keys To Unlock Swiss Bank Secrecy Laws”; 1 New Eng. Journal Int’l. & Comp. Law 99 (1994).
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