It is not news that GLP-1 agonists sold by Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide) are surging in demand and could become one of the influential drugs ever. That demand contributed to a shortage of the active ingredients in Lilly’s and Novo Nordisk’s drugs. During that time, drug compounders stepped into meet the supply the brands couldn’t provide. The FDA recently announced those drug shortages were over. The compounders sued the FDA, the brands intervened, and the cases are proceeding on an expedited basis. What’s the status of the cases? And, even if the drugs are returned to the shortage list, can Novo Nordisk and Lilly resort to their patents to maintain their GLP-1 monopolies?
Read MoreOne of the common refrains from the pro-patent drug chorus is that patents are necessary to protect and incentivize expensive research and development by pharmaceutical companies. While that may be true in some cases, there are examples where it is clearly not. One current example includes deuterated analogs for ruxolitinib. One company researched which deuterated analogs among thousands of possibilities might be useful, whereas a different company cornered the market on all deuterated analogs based upon two sentences in patent disclosure years ago. Guess who wins.
Read MoreThe American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other. The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc. The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.
Read MoreThe anti-CGRP market is heating. Amgen’s ($AMGN) Aimovig® received FDA approval in May 2018, and Teva’s ($TEVA) Ajovy® received approval in September. Hot on their heels, Eli Lilly’s ($LLY) Emgality® just received FDA approval at the end of September. The drugs will all be sold for essentially the same price of $6900 / year. Given the tight competition, can Teva use its patents to kick anyone off the market?
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