Replies to post #109966 on Biotech Values

[RockRat]

What makes this different from most other drug copying, in which quality checks and assays to make sure at each step in the synthesis what you've got is what you wanted to get, is that most of those assays are in the public domain or are cheap and easy to license. In the copying and manufacture of complex mixtures like enoxaparin and copaxone, they are not. It might be hard to prove. Teva might in court say they used a certain process that does not infringe. Without replicating it, who is going to know that it would not work? Would some third party be allowed to have a go at that while the court twiddles its thumbs? Dunno.

Regards, RockRat

[iwfal]

I believe he is referring to possible usage of MNTA patented measures to discover the contents of something, not to produce it

Lets step through the (very opaque) language that has been cited here:

In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product

Well, this would seem to apply - discovery is 'non-commercial'. But there is a following clarifier


unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product.

So, if they used something non-commercially AND aren't yet selling it there is still the possibility of remedy.

But all of this is academic since the complaint says:

manufacturing generic enoxaparin for commercial sale using the methods claimed in the '886 patent and offering those products for sale in the United States.

Teva has infringed, and continues to infringe, or has induced others to infringe, the '466 patent, either literally or under the doctrine of equivalents, by, inter alia, manufacturing
generic enoxaparin for commercial sale using the methods claimed in the '466 patent and offering those products for sale in the United States.

[jbog]

One of the patents deals with the testing procedures during production so I would think teva would have to satisfy some type of different quality control program. I can't see them using two different procedures, one for approval and one for production.

[Biowatch]

a distinction between a) using someone else's patented methods to discover something and b) the possible lack of usage of those patented methods in the manufacturing of a copy of the brand name drug.

Yes, that is exactly the distinction I tried to make.

I was referring to the research and development phase. Manufacturing products for sale is an entirely different kettle of fish in terms of using methods patented by others.