Replies to post #108125 on Biotech Values

[tinkershaw]

Dew,

I'm not sure if your math bears out on that. Although I suck at complex statistics. Each individual count is not correlated with any of the other individual counts, so 40% for one count and 5% for another count cannot necessarily be added up or combined to increase the chances of success. They each stand independently. There are 4 shots on goal, each with an individual chance of winning that is uncorrelated with any of the other shots on goal. If you take their average you get:

40/100, 30/100, 10/100, 5/100 = 85/400 = 21.25% chance of prevailing in total.

However, that is not very meaningful as there would be a 40% chance of prevailing on the first shot no matter the smaller percentage on the remaining shots, and a 30% chance on the second shot no matter the higher percentage of the first shot and lower percentage on the next shot, and so on. Having more shots on goal does not necessarily increase the odds of succeeding in total, although it does give another shot on goal.

Somneone who actually understood statistics better than I, please let me know if my math is wrong on this or not.

Thanks.

Tinker

[exwannabe]

Re: Copaxone litigation

My wild guesses are that MNTA has a 40% chance to prevail on the obviousness/double-patenting argument, a 30% chance to prevail on non-infringement, a 10% chance to prevail on indefiniteness, and a 5% chance to prevail on inequitable conduct. If you do the arithmetic, the above probabilities yield a 64% chance for MNTA to win the case by some method.

I am surprised you consider inequitable conduct that unlikely. From memory, I thought that TEVA had some significantly different descriptions in the EU patents, and this was not disclosed in the US application.

OTOH, I think you are too high on obviousness. The courts seam to defer to the USPTO on this. (Though you have this combined with double patents, which could be very strong).

EDIT: I assume from these you do not expect a summary judgement next spring.

[zipjet]

I don’t think MNTA is a favorite to win the case via any individual argument, but they have four ways to win, which makes MNTA a solid favorite to win the case via some argument.

a 64% chance for MNTA to win the case by some method.

I would put the "win" significantly higher.

If memory serves me, the COM patent expired BEFORE approval* of Copaxone in the US and all these process/methods patents were AFTER approval.

Fundamental to the concept of a patent is that in exchange for a limited monopoly term and associated profits, that the patent disclose sufficient information about the invention that those skilled in the art are able to practice the invention after the term expires. Classic quid pro quo.

IF you can create a drug by a process, obtain a COM patent and only after it expires disclose the process (or even claim improvements to the process), file new process patents and thus double or more the TERM of patent protection for the invention, you have abused the patent system unlawfully. JMHO

(I am not a patent lawyer - so I may be missing something important. There are a couple of them here that may be able to correct me if this is wrong and I am still learning.)

The argument I have just made could be coupled with misrepresentations in the patenting process to support the inequitable conduct theory for a win. Or it could be viewed as a statutory violation and invalidated on that basis.

I do think obviousness/double patenting is the most probable basis for invalidation.

But frankly, all that matters is whether one or more of the patents can block MNTA offering mC. I think the chance of the court blocking mC is very low, something under 10%.

MNTA's objective in this case is to get the judge (no jury here) to WANT to allow a mC or a gC. (Non-infringement conceivably could result in a mC yet deny a specific gC.)

If the judge buys the double patenting, abuse of patent term extension argument, she will find some theory to invalidate/avoid the patents.



ij

* http://www.labeldataplus.com/detail.php?c=8877