Replies to post #109876 on Biotech Values

[mouton29]

<<I believe the question in this case is whether the sum of Teva's actions with respect to t-enox are sufficient to meet the "offers to sell" language in the statute.>>

Can they really be considered to have made an "offer to sell" a product that has not been approved by the FDA when in essence all they have been saying is that they will sell if and when the FDA approves? Were they in fact offering to sell, I strongly suspect it would violate various laws and FDA regulations, though I suppose patent law could in theory interpret words differently than other areas of the law. It seems to me this comes down to the issue North40000 raised, which is, can you seek an injunction against imminent but future infringement where there is no current infringement, as opposed to against future CONTINUED infringement? It is hard for me to believe that that is a question of first impression, that other patent holders have not sought an injunction prior to actual infringement. In fact, I thought the classic law school example of a case where an injunction was justified was where you neighbor was about to burn down your house. Of course, all of this assumes the sale in the US would constitute infringement.

[Biowatch]

Yeah, well, I doubt they'd build up an inventory unless they plan to sell it everywhere they can.

There are cases of small companies with patents on research and development procedures who learn too late that others utilized their patented methods to refine drug discovery and development.

When the other company is done with R&D and creates a drug that makes it to the market, my understanding is that patents "violated" during development mean nothing, as the final product is not covered by patented methods used to discover it.

Please correct me if I'm wrong.