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- The post-trial docket filings are now in pacer. There is ton of info, testimony, arguments,counter-arguments to digest, and it is mind-numbing. Inequitable conduct, Non-infringement, Enablement, and Indefiniteness arguments all there. Sandoz's lack of enablement defense ("appropriate calibration of sec standards to measure molecular weight of copolymer") and to lesser extent non-infringement arguments seem strong. Also, separately Mylan submitted a major amendment to their ANDA in April 2011 (this aligns with my earlier blog posting on valuation of generic copaxone). Also, the language in the filing makes it appear that MNTA's ANDA is closer to approvable state(For eg: "post-approval product to be marketed by Sandoz will contain a different molar ratio as described in Sandoz’s Findings of Fact and Conclusions of Law". This is just one example). For filings 326(MNTA), 327 & 328 (both TEVA's) also needs to be read before you get the full picture.
I am inclined to say that judgement will not be rendered anytime soon(at least 2 months) as the judge may need time to see these final trial briefs.
Here are some key points(i'll cover the enablement defense in another blog post):
Non-infringement - MNTA's generic copaxone does not conform to molar fraction ratio as in Teva's patent. They also say they have 30% more tyrosine. Importantly, MNTA's generic copaxone also does not conform to molecular weight limitations (5-9kda) in Teva's patent(Note: this was the "unexpected finding" or novelty over the 550 patent). Infact, the specific range of molecular weight of MNTA's copaxone is concealed. But it does appear to be <22kda (the point where in-vivo tests -where some mouse died at 22kda). It is not clear to me how these differences will affect FDA approval and the generic's equivalence label. Process of making copaxone, MNTA definitely appears not to use Teva's process including "Test reaction".
Teva's response in 327 :
Test Reaction; "Even if the Court were to determine that Sandoz’s process does not literally meet the
“test reaction” limitation, then Sandoz’s process is equivalent to that limitation. See Boehringer
Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1351 (Fed. Cir. 2003)
(“Under the doctrine of equivalents, a claim limitation not literally met may be satisfied by an
element of the accused product if the differences between the two are ‘insubstantial’ to one of
ordinary skill in the art.”). The purpose of predetermining the time and temperature by test
reaction in the asserted claims is to ensure that the reaction provides copolymer-1 of a
predetermined molecular weight. Sandoz simply uses viscosity as a surrogate for time in order
to ensure that it achieves the predetermined 7,300 daltons average molecular weight."
Molar ratio: No technical expert testimony provided on Molar ratio. Also, the older lot of Sandoz's copaxone had the same molar ratio. The new "briefing book" lot does not have it.
"If Sandoz did not have a non-infringement argument based on the four lots in the
then a fortiori, it could not have a non-infringement argument with respect
to the Briefing Book lot. The existence of the Briefing Book therefore can only be viewed as a
pretext for Sandoz’s attempt to make a new non-infringement argument at the eleventh hour.
In any event, Sandoz’s new non-infringement argument, presented without any expert "
Molecular weight: The evidence presented by Plaintiffs at trial was directed to the issue
of whether Sandoz’s product infringed the claims as construed by the court. Sandoz does not
dispute in its FOF/COL that its product meets the “average molecular weight” limitations under
the Court’s construction. Since the Court rejected Sandoz’s supplemental claim construction before trial, the weight average molecular weight (“Mw”) of Sandoz’s product is irrelevant to the infringement inquiry, and Plaintiffs were not required to offer any proof as to the Mw of Sandoz’s product in order to prove infringement
For the reasons stated above, the Court should deny Sandoz’s attempt to reargue claim
construction and should not restrict the construction of “average molecular weight” to
copolymer-1 with Mw less than 10 kDa.
Inequitable conduct - Teva, apparently did not disclose "April 1994 data table" in-vivo data b/w molecular weight 9kda & 22kda to the PTO when they filed for the patent in May 1994. This data was actually non-toxic in the in-vivo mouse test.Instead they provided to PTO "inaccurate/unreliable" RBL test & an arbitrary cut-off(30% and 50% can yield different correlation to toxicity) which made to show the PTO that there was toxicity beyond 9kda. Teva had internally discussed the problems with using RBL test as measure for toxicity for years. The patents in suit would not have been issued (due to prior art, patent 550 talks molecular weight up to 22kda) if the examiner had the data that showed the 9kda-22kda was not toxic.This data was withheld from the PTO.
Teva's response in 327 : No technical expert testimony provided to indicate if the above was material to patentabality
|Docket Text: RESPONSE in Opposition to Defendants' Proposed Findings of Fact and Conclusions of Law (Redacted). Document filed by Teva Neuroscience, Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc., Yeda Research and Development Co. Ltd.. (Hashmall, David)|
|Docket Text: REPLY to Defendants' Proposed Findings of Fact and Conclusions of Law (Redacted). Document filed by Teva Neuroscience, Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc., Yeda Research and Development Co. Ltd.. (Hashmall, David)|
|Proposed Findings of Fact|
|Docket Text: PROPOSED FINDINGS OF FACT AND CONCLUSIONS OF LAW. Document filed by Momenta Pharmaceuticals, Inc., Sandoz Inc..Associated Cases: 1:08-cv-07611-BSJ -AJP, 1:09-cv-08824-BSJ(Doyle, David)|
|Docket Text: RESPONSE to Plaintiffs' Proposed Findings of Fact and Conclusions of Law (redacted). Document filed by Momenta Pharmaceuticals, Inc., Sandoz, Inc.. Filed In Associated Cases: 1:08-cv-07611-BSJ -AJP, 1:09-cv-08824-BSJ(Doyle, David)|
|Docket Text: REPLY to Plaintiffs' Opposition to Sandoz, Inc. and Momenta Pharmaceuticals, Inc.'s Proposed Findings of Fact and Conclusions of Law (redacted). Document filed by Momenta Pharmaceuticals, Inc., Sandoz, Inc.. Filed In Associated Cases: 1:08-cv-07611-BSJ -AJP, 1:09-cv-08824-BSJ(Doyle, David)|
|Docket Text: RESPONSE to Plaintiffs' Proposed Findings of Fact and Conclusions of Law (redacted). Document filed by Mylan Inc., Mylan Pharmaceuticals Inc., Natco Pharma Ltd.. Filed In Associated Cases: 1:08-cv-07611-BSJ -AJP, 1:09-cv-08824-BSJ(Solano, Ricardo)|
|Docket Text: REPLY in Support of Post-Trial Findings of Facts and Conclusion|
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