The title to the Public Patent Foundation (“PUBPAT”) news release said it all: “PUBPAT Receives Substantial Victory in Lipitor Patent Challenge: Pfizer Concedes to Give Up Original Broad Patent Claims. Or, does it? PUBPAT touted that in the challenge it filed last year against Pfizer Inc.’s patent on Lipitor, “Pfizer has conceded to significantly narrow the patent to specifically exclude the form of atorvastatin tested in its early clinical trials for Lipitor.”
The press release goes on to state that “This is a substantial victory for the public,” said Dan Ravicher, PUBPAT’s Executive Director. “Pfizer has been caught with its hand in the cookie jar and is correctly giving up the undeserved breadth of the patent it was originally issued.” (See U.S. patent 5,969,156)
Well, the amendments clearly give up some subject matter (amorphous atorvastatin) so the claims are in fact narrower. However, I would argue that the real question is “Does this matter to Pfizer?” I would say the answer is “Probably not.”
For a different kind of patented invention (say, an electronic device), this getting your broad claim narrowed could be devastating since the disclaimed subject matter (product) could be easily marketed immediately as an equivalent. However, the present patent covers Form I crystalline atorvastatin calcium trihydrate, which is the active ingredient in the drug Lipitor, and the only form approved by the FDA.
Therefore, you could argue that competitors are now free to make, use and sell the amorphous solid form of atorvastatin but they would need to get FDA approval for that form in order to sell it in the U.S. But, FDA approval usually requires 10 to 12 years of development and 100 – 800 million dollars in development costs. And, this could all be for a drug that may not work as well. The FDA approval process thus creates a second layer of exclusive protection.
Competitors are not going to spend this type of time and money to effectively gain a “generic” version of the drug (as they would not have exclusivity). The best a competitor could hope for is that they could take some of the market share away from Pfizer but they could only gain that market share by cutting the price. However, this could effectively prevent them from recouping the R&D costs since the competitor would not have had the benefit of years of exclusivity. Companies would generally be better off waiting until the drug is off patent and then marketing a true generic.
It might be possible for a competitor to file an FDA application using the Abbreviated New Drug Approval (ANDA) process to gain approval but it requires a showing that the proposed drug is the same as, or bioequivalent to, the FDA approved drug (which seems unlikely given the declarations by Pfizer in this case that the drugs are indeed different).
I think Pfizer has come out pretty well in this re-exam.
