Biotech Values

[tinkershaw]

In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-Waxman exemption. The U.S. Supreme Court recently considered the scope of the Hatch-Waxman exemption in Merck v. Integra. The Supreme Court held that the statute exempts from infringement all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs.

Again, it supports my proposition. All uses of "compounds". Which is exactly what Bolar stated. Certainly an argument can be made that this can be extended to all uses of any patented process as well as a compound, but that is a very large expansion of the doctrine. Because here again, if a company uses another company's patented compound for help to develop an entirely new innovator drug, the original patent holder still has all their rights from the patent on their patented compound without diminishment.

In this case, if MNTA's patents can be used to create a new compound, with impunity, then MNTA really does not have any patent rights, as the entire basis of the patent is this enabling technique as it has no other value as it is the securing of this intellectual process and not the securing of some separate tangible compound that has independent value in and of itself.

I think my position on this is solid, but it is open for a colorful legal argument that I'm sure Teva will make to try to clutter up the works if nothing else.

And again, unless Teva has a non-violating process by which to do this, it is irrelevant to the commercial launch in the U.S. So again, if Teva has this non-violating process, then why so squeamish about it?

At this point we are speculating, and we don't have enough information to do anymore, but I think we have laid out the legal framework here, and that in fact Teva will need its own independent IP to commercially market here in the U.S. It is one thing to use MNTA IP to develop this drug (which I think is beyond the exception) but quite another to commercially market the product using the same enabling IP.

Tinker