Replies to post #121837 on Biotech Values

[investorgold2002]

I told ya - the inequitable conduct argument is the best argument ,IMHO they have even after the recent en banc opinion

I am betting they are going to win this case. pre-2014 launch was one of the reasons(of course I am happy with other alternative - 2014 copaxone launch)

[investorgold2002]

I guess TEVA thinks (or is optimistic) that they will win inequitable conduct and maybe that's why they are pushing for aggressive trial timelines?. But I think they will lose

But I guess if they lose in inequitable conduct they lose the patent case ?

[investorgold2002]

"Mylan's inequitable conduct affirmative defense"

is this consolidated(mylan + momenta) defense?

[mouton29]

The text of the order, I used the Acrobat OCR software to convert the image to text.


BARBARA S. JONES
UNITED STATES DISTRICT JUDGE
09 C
(
. 8824
(AJP)
Order
On April 4/ 2011/ Plaintiffs Teva Pharmaceuticals USAf
Inc., Teva Pharmaceutical Industries, Ltd., Teva Neuroscience,
Inc., and Yeda Research and Development Co./ Inc. moved against
Defendants Sandoz, Inc., Sandoz International GmbH, Novartis AG,
Momenta Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc., Mylan
Inc., and Natco Pharma Ltd. for a summary judgment finding of no
inequitable conduct. (Dkt.218.)

Upon review of all of the part s/ legal papers and postbriefing
letters regarding the implications of the Federal
Circuit/s en bane decision in . Becton
Dickinson and Company, Nos. 2008-1511/ 2011 WL 2028255 (Fed.
Case 1:09-cv-08824-BSJ Document 141 Filed 06/17/11 Page 2 of 2
Cir. May 25, 2011), the Court finds there are disputed issues of
material fact regarding Defendants' affirmative defense of
inequitable conduct. Accordingly, plaintiffs' motion for a
summary judgment finding of no inequitable conduct (Dkt. 218) lS
DENIED.

A bench trial regarding Defendants' inequitable conduct
affirmative de se will commence on July 11, 2011 at 9:30 a.m.
in Courtroom 17C of the United States District Court, 500 Pearl
Street, New York, NY 10007.
SO ORDERED:

[Regulardoc]

I am not a legal expert and wonder what actually is presented and who goes first in such a hearing relative to "Mylan's inequitable conduct affirmative defense?"

Also, anyone know at what time the trial begins and is there any expectation that some analyst/follower will post "musings" as the trial unfolds?

On another issue, agree with Dew's comments from the other day that Pradaxa has had no significant impact on enox sales. This "bridge therapy" concept is overdone. If a person were to present with an embolic stroke and atrial fibrillation, a vast majority of doctors would treat with either intravenous heparin for a few days and overlap warfarin or treat with enoxaparin and overlap with warfarin. I am unaware of the data in a subset of patients who present with acute embolic event and are started on Pradaxa alone. Doubt if that meets standard of practice. Uncertain if a patient were to receive LMWH or UFH what duration of treatment would be necessary until the Pradaxa "kicks in." With LMWH or UFH, one can follow the INR and decide to stop the LMWH or UFH once INR therapeutic for 24-28 hours.

While "bridge therapy" can also refer to some sort of treatment initiated for afib to prevent embolic events while waiting for warfarin to achieve therapeutic INR, the risk of embolism remains quite low for any 5-7 days prior to full anticoagulation and the vast majority of physicians would not start LMWH as a "bridge" until INR therapeutic in patients who do not present with embolic manifestations.

FYI, based on my clinical experience, about 50% of my atrial fibrillation patients first presented without any cardiac symptoms at all. Often an incidental finding (and usually on a Friday afternoon!).