Biotech Values

[tinkershaw]

Interestingly, there is little intellectual property protection on Copaxone

That is consistent with some legal analysis that was made known to me from a friend. The two issues are insufficient disclosures and enablement issues. Both of which are technical patent law terms.

Enablement requires that the specification portion of the patent must enable one skilled in the art, at the time of the invention, to make use of the invention without undue experimentation.

And the insufficient disclosure aspect (which is the current issues being pursued by MNTA) involve not providing sufficient disclosures in a manner sufficiently clear to it to be carried out by a person skilled in the art. This disclosure also must describe the "best mode" of making the invention. Ironically, TEVA's misappropriation of trade secret complaint goes against TEVA on the "best mode" argument as TEVA cannot be keeping trade secrets as to methods to better produce copaxone that are not in the patents.

All in all, TEVA's comments have hurt them, on these issues, as the patents may be very vulnerable on these issues, and TEVA's comments about manufacturing problems, trade secret theft, can be used against them. All in all, the patents are short on both enablement and disclosure teachings.

Teva can argue that many of the missing steps were known in the art at the time, and thereby not necessary to disclose, but that to me appears to be weak if you cannot instruct how to produce the therapeutically effective composition of the compound. Which is more precise and the relevant issue in my opinion.

But it is interesting that as early as 1996 the weak patent protection was identified in a trade journal. The disclosure issue has a lower burden of proof, but the enablement issues are still in play if MNTA's counsel decide to go that route as well.

From this high level summary, you can see why summary judgment was denied. One argument Teva can make is that the descriptions are adequate if you combine them with what was known in the state of the art at the time, and that is a factual inquiry that is not undisputed. That alone would defeat summary judgment. But because it can defeat a summary judgment motion does not make it an effective argument at trial.

There do appear to be issues that could have been resolved at summary judgment as well. So I have to think the summary judgment issue was actually a close call.

I have not delved into the details of the lawsuit, but from a high level view point, TEVA is definitely on the defensive in this suit, and delaying is their best strategy (which they have accomplished very well to this point).

Tinker