Replies to post #109824 on Biotech Values

[zipjet]

Thanks North for clearing that up for me.

It does strike me as odd that a company would have to wait until the products hit the shore to fight the import when they know it is coming.

But this is not my field.

At least we will be able to follow the briefing and see how the attorneys argue this.

ij

[ThomasS]

TEVA/MNTA: Wouldn't the product presumably have to enter US jurisdiction in order for the FDA to prosecute the Teva aNDA? Doesn't matter where, just "if" the FDA had a sample?
On another front, wouldn't data on an infringed product, provided to the U.S. FDA, qualify as de facto infringed product?

I like the earlier analogy of MNTA going "all-in" on this and requiring Teva to either call or get up from the F------ table.

[ThomasS]

TEVA/MNTA: On the flipside:

>>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.

...If Teva prevailed on that argument, wouldn't it suggest that Teva is even further from FDA approval since no product (of the infringed, approvable variety) had yet reached FDA hands? Obviously, it takes quite awhile for approval after the FDA has it.

Win-win for MNTA.

[hptaxis]

By entering the US, does that necessarily mean FDA approval? For argument sake, it has entered the US by being submitted to the FDA. Or does it have to be on the open market and available to the public? This would seem to be a broad interpretation since there must have been case law on products not yet made available for public sale, but infringing on patents and blocked from any sales.

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.

From below, it appears the mere manufacture (makes) will cover the complaint.

35 U.S.C. 271 Infringement of patent.

(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_271.htm

[dewophile]

in the complaint mnta/sandoz ask the court to recognize that teva has/is/or will (i.e has not yet but has intent to infringe) the patents. they also tacitly acknowledge that teva may not have product ready for sale in the US by asking the court to block the import of the product.

That the Court determine that Teva has infringed, is infringing, or willinfringe, one or more claims of United States Patent No. 7,575,886;
(b) That the Court determine that Teva has infringed, is infringing, or will infringe, one or more claims of United States Patent No. 7,790,466;
(c) That the Court enter a preliminary injunction restraining Teva, its officers, agents, attorneys, servants, employees, and all persons in active concert or participation with them, from selling, offering to sell, or importing into the United States an enoxaparin product made using a method that infringes
one or more claims of either United States Patent No. 7,575,886 or U.S.
Patent No. 7,790,466;...

based on your post it does not sound like there is legal basis for asking the court to block imports of the product on the basis that teva has intent to infringe, but nevertheless the mnta lawyers have asked the court to do just this