Biotech Values

[mouton29]

re: MNTA - Solicitor General

<< I expect the Solicitor General to file a brief opposing cert in MNTA v. Amphastar as a matter of protocol, based on the action taken by the SG in the Classen case.>>

Since this post will be less comprehensible without the text of the Hatch-Waxman 271(e)(1) exception, I will start by quoting the key sentence:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States … a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

The SG brief in Classen opposed cert on two basic grounds, first, that while the Classen decision restricting application of the Hatch-Waxman 271(e)(1) exception to pre-approval activity was wrong, the subsequent Momenta decision interpreted Classen "narrowly in a manner that will cabin the adverse impact of the [Classen] decision and second, had the Classen court properly construed 271(e)(1) (i.e., not limited to pre-approval activity), the defendants would still not have been entitled to the bendfits of 271(e)(1), so a Supreme Court review would not help the defendant in Classen, and therefore a grant of cert would be inappropriate.

To understand the second point, here is a brief summary of Classen, based on the SG's description. Dr. Classen obtained a number of patents for the proposition that there is a relationship betwen timimg of certain childhool vaccinatioins and the onset of tyupe 1 diabetes. The CDC sponsored a retrospective study in which the medical histories of 1000 children was examined. Based on that study, the CDC concluded there was no such relationship. Dr. Classen sued Glaxo, the manufacturer of the vaccinatiions. After some back and forth between the district and appellate courts, the appelate court held that Glaxo was not entitled to the benefit of 271(e)(1) because the conduct in question was post approval of the vaccines. According to the SG, while post approval activity can be protected by 271(e)(1), that would not help Glaxo -- all it did was manufacture and sell the vaccine, it was the CDC that later on conducted the study. Glaxo submitted nothing to the FDA.

I don't see why either of these arguments means that the SG will oppose a grant of cert in the Momenta case. In fact, the second argument is related to one of the arguments that Momenta[ is making, that Amphastar has not "submitted" data to the FDA, it is just compiling safety data that probably will never be submitted to the FDA.

In fact the SG brief spends a fair amount of time discussing the word "solely" and the circumstances under which post approval activity would be considered to be "solely" related to the development and submission of information to the FDA. Moreover, the SG explicitly states that it "expresses no view on the correctness of the conclusion n the Momenta decision that the "submitted" requirement was satisfied or of the correctness of the conclusion by the court of appeals. In fact, at one point, it states that the Momenta "court's interpretation of the [Classen opinion] is not its most natural reading."

Bottom line, I think there is a pretty good chance that if the Supreme Court asks the SG for its view, it will favor a grant of cert to clarify what is a very uncertain and important area of the law.