Wednesday, 30 November 2011 21:34

PASSING OF THE LIPITOR PATENT

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Today, a U.S. patent covering the cholesterol drug Lipitor® expires. During the life of the patent, Pfizer, which owns the ground-breaking drug and the patents thereto, could prevent others, namely generic drug makers, from offering or selling drugs in the U.S. that fall within the protected claims of the patent. As of today, with the expiration of the patent, Pfizer’s exclusivity for this particular patented drug formulation ends, opening the arena for generic competitors to enter the marketplace.
 
In view of the loss of this major asset, Pfizer has been creative in finding other means of protecting their cash flow, which was based in large part on Lipitor® sales. Some of the more interesting and uncommonly aggressive maneuvers they are taking include offering the same or lower co-pay for the brand name Lipitor® drug as generics, as well as blocking agreements with some insurers and pharmacy benefit managers to keep generics from being offered to customers. Whether other Big Pharma companies adopt similar tactics when the patents of their blockbuster drugs “fall off the patent cliff”, as many are scheduled to in the near future, remains to be seen.
 
In the meantime, Pfizer is reported to be shifting its focus to biologics and specialty medicines, reducing its size, and expanding sales of existing drugs in developing countries. It should also be noted that some patents covering other aspects of Lipitor® have some remaining life span, though they may only cover narrow embodiments or limitations.
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Jessica Hauth

Ms. Hauth earned her bachelor's degree in Chemistry and her master's degree in Biochemistry, Cell and Developmental Biology from Emory University, and her law degree from the University of Miami School of Law. She has published her research in the areas of developmental biology, genetics, heterochromatin assembly and maintenance, and RNAi use and characterization. She is a member of the American Chemical Society, American Intellectual Property Law Association, Dade County Bar Association, and Phi Alpha Delta. She is admitted to practice law in Florida state courts, as well as in the United States District Court for the Southern District of Florida. As a Registered Patent Attorney, she concentrates her practice on Patent Prosecution and Intellectual Property Litigation.