Replies to post #105412 on Biotech Values

[DewDiligence]

Bottom line for MNTA re expiration of US Copaxone patents:

All nine of the patents at issue in Teva’s lawsuit against NVS/MNTA in the US District Court expire on May 24, 2014. As discussed in the documents for this suit (#msg-54150823), Teva tried to include additional patents in the case against NVS/MNTA that have a later expiration date, but the Judge refused to allow those patents to be admitted. Unless this ruling by the District Court is overturned on appeal, NVS/MNTA do not have to be concerned with any US Copaxone patents that run beyond May 24, 2014.

Teva’s patent lawsuit against Mylan is separate from Teva’s suit against NVS/MNTA, and hence Teva may be able to get the District Court to admit patents into the suit against Mylan that are not at issue in the suit against NVS/MNTA. I think Teva’s mentioning the Sep 2015 expiration date in the second paragraph of its 9/21/10 press release about the Mylan suit (http://www.tevapharm.com/pr/2010/pr_959.asp ) is yet another instance of disingenuous behavior (a/k/a FUD), but it’s up to the District Court to decide what the proper expiration date of those patents is. Fortunately, this is Mylan’s problem, not MNTA’s problem (and not mine).

[jbog]

Dew,

Teva is very cagey when it files its data but from the following press release it looks that in Nov 2009 Teva added three more patents on top of the original 7 orange book claims. So it looks to me that the 2015 date has to be tied to one of these 3 additional patents. It also looks that Teva has every intention to obtain a new patient for their reduced dosage which will carry that dosage protection well into the 2020's.

As this pertains to this thread, when Teva says they have protection until 2015, they are talking outside the normal orange book.



Press Release

Teva Files Amended Complaint Against Monenta/Sandoz to Include Infringement of Three Copaxone®-Related Patents

Jerusalem, Israel, November 10, 2009 -

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today it is seeking to amend its existing complaint against Momenta Pharmaceuticals, Inc./Sandoz Inc. to include patent infringement of three additional patents related to the characterization of COPAXONE® (glatiramer acetate injection). The proposed updated complaint has been filed under seal with the U.S. District Court for the Southern District of New York along with a motion requesting that the Court grant Teva leave to amend.

Teva originally filed suit against Momenta/Sandoz in August 2008 for infringement of multiple patents (seven in the Orange Book which extend through May 24, 2014), covering the chemical composition of COPAXONE®, pharmaceutical compositions containing it and methods of using it. Teva seeks leave to amend its complaint to include the additional patents related to the characterization of the active ingredient in COPAXONE®. These patents do not expire until several years after the patents currently in litigation.

COPAXONE® is a highly-complicated product to develop and manufacture, and given the inability to fully characterize the active ingredients of COPAXONE®, Teva has serious doubts about any generic applicant's ability to demonstrate conclusively that the composition of its product is identical to that of COPAXONE®. Internal research at Teva has indicated that even minor changes in the synthetic process and/or molecular weight distribution of a glatiramoid (glatiramir acetate-like substance) can have severe ramifications on the safety and mechanism of action of the product.

Teva contends that any company that files an application for any glatiramoid, via an ANDA or 505(b)(2) application, should conduct pre-clinical testing as well as full-scale, placebo-controlled clinical trials with measured clinical endpoints in MS patients to establish safety, efficacy and immunogenicity in this patient population.

Teva remains committed to vigorously defending its COPAXONE® intellectual property rights against infringement wherever they are challenged and intends to pursue all relevant regulatory avenues via the U.S. Food and Drug Administration (FDA). In September 2009, Teva received a Paragraph IV certification notice from Mylan Pharmaceuticals Inc./Natco Pharma Ltd. relating to their ANDA containing a Paragraph IV certification for COPAXONE®. On October 16, 2009, Teva filed a lawsuit in the U.S. District Court for the Southern District Court of New York with respect to Mylan's filing. A trial date has not been set.