Replies to post #109807 on Biotech Values

[hptaxis]

MNTA 1 TEVA 0

I would say that TEVA has an "outside" chance of prevailing. It reads like an apparent admission. We can use your patent processes outside the US where they are not patented to export our product to the US! Why would they include that terminology in a PR? Is this their strategy? If this is their argument, I would love to see the judge's face/expression. LOL

TEVA PR [BW]: http://www.thestreet.com/story/10937424/1/teva-comments-on-patent-infringement-lawsuit-filed-by-momenta-and-sandoz.html

[oldberkeley]

Zip- Are there some quotation marks missing in this? Is it the writer or Teva saying the last two sentences, especially the words "baseless allegations"?

[DewDiligence]

“Outside the U.S.” = Italy (eom)

[marthambles]

35 U.S.C 271:

Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. 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 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. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after -

(1) it is materially changed by subsequent processes; or

(2) it becomes a trivial and nonessential component of another product

[akasidney86]

Teva is not saying that the patents aren't infringed because of ex-US manufacture, they're saying that they use a different process that doesn't use the patented processes (886 and 466) and thus don't infringe. In other words, their (partners) manufacturing process is different... which of course returns us to question #1: does their (partners) copy using their (partners) own manufacturing and measurment technologies meet the FDA criteria for approval. To date, the FDA's answer to that question has been no.

While there may be many roads to Rome, MNTA clearly feels that there's only one road to t-enox approval... and they just blew a bridge on the only road in.

[north40000]

Zipjet, in light of the reasonable inference from TEVA's PR that no product has yet entered the U.S. because it is made and tested abroad, I think my earlier hypothesis that:

>>At the moment, I would expect TEVA to file a motion to dismiss (1) for failure of the complaint and its exhibits to state a jurisdictional case or controversy, and (2) for asking the District Court for an advisory opinion. <<

now holds more water. 35 U.S.C. 271(a) and (g) cannot apply until product made by a process that is patented in the U.S. actually enters the U.S.