Replies to post #125827 on Biotech Values

[Regulardoc]

Operating on the "half-full theory," having the judge side with TEVA on claim construction issues leads to one less opportunity for appeal by TEVA down the road.

She tosses them a small bone, being sensitive to larger issues.

[RockRat]

"According to the document, TEVA has the burden of proof on infringement and at the trial MNTA/Sandoz will present evidence showing that their proposed GA [glatiramer acetate, i.e. Copaxone] product does not meet the asserted claims since it does not meet the molar ratio limitations (6:2:5:1) claimed in the patents and also does not use a "test reaction" as claimed in a manufacturing step. Further, since TEVA's patents claim that it is not possible to determine the molecular weight of individual polypeptides or their GA product, MNTA argues it is not possible for TEVA to prove infringement."

That last sentence is interesting. Could MNTA/Sandoz get approval w/o determining those molecular weights? If not, they are trying have it both ways, assuming they are able to. But if memory serves (don't have search on IHub), the tea leaves say the FDA might approve based on other criteria. What document is referred to in the first sentence (time to look at the relevant docket again?)? The implication is that MNTA reverse engineered the process (as opposed to completely characterizing the compound as they did with enoxaparin), then made some changes/improvements that skirt Teva's patents.

Can't remember what the consensus was regarding the success of the non-infringement approach, but I thought it was low. Now it seems as though it may be the strongest argument out there, and perhaps the easiest to show (as opposed to inequitable conduct, for example).

Apologies if this has been delved into by the board and I've simply forgotten. If that's the case, maybe I need to quit investing. But I don't remember us dissecting a document involving molar ratios and test reactions.

Regards, RockRat

[genisi]

Citi Alert: Copaxone Claims Construction Ruling Favors Teva
(no link for this item, got it by email)

>Conclusion: Judge Jones for the US District Court for the Southern District of New York (SNYDC) announced its patent claims construction ruling largely favoring Teva’s broader interpretation on major claims in its consolidated Copaxone patent infringement case against MYL/Natco & Sandoz/Momenta. This includes its definitions of “copolymer-1” and “average molecular weight” (see Figure 1). The court denied MYL’s motion for summary judgment of invalidity (due to indefiniteness), which follows an earlier denial (on 9/7/10) of Sandoz’s motion for summary judgment of indefiniteness. We believe these findings strongly support Teva’s arguments leading into its Sept. 7 th invalidity and non-infringement patent trial, as the claims construction interpretation appears to be the cornerstone of the upcoming trial (see our earlier 1/20/10 note). While the SNYDC has not yet ruled on the inequitable conduct trial (which ended on 7/22), we expect Teva to prevail. Our model assumes U.S. Copaxone sales of $2.82B in 2011E, growing to $3.14B in 2013E, and then declining to $2.84B in 2014E (LOE on 11/24/14, assuming 6-month pediatric exclusivity). We believe that Teva offers compelling value at its currently multiple of 6.5x our 2012E NEWCO (including Cephalon) EPS vs. its median forward P/E of ~14x over the last 5yrs. We maintain our estimates & Buy rating. <