Thursday, August 28, 2008

Scheduling Updates -- in the Schering Clarinex® (Descloratadine) Patent Lawsuits


First, by agreed order, Schering's reply to the Sandoz motion to dismiss is now due on September 9, 2008 (it was to be due August 26, 2008). [You'll recall that this suit, In Re Descloratadine Patent Litigation (MDL No. 1851, Case No. 3:07-CV-3930 US Dist. Ct. NJ), portends the potential arrival of generic versions of Clarinex® in the highly-lucrative United States markets -- well-over $700 million in yearly Schering revenue -- much earlier than previously-forecast by Schering-Plough.]

Next, and more substantively -- Winston & Strawn (trial and patent counsel for many of the companies sued by Schering in this matter) has proposed an overall case management schedule, as set forth in the below letter -- in the event that US Magistrate Judge Tonianne J. Bongiovanni does not ultimately enter it, I will so report. For now, assume that this case schedule will hold.

WINSTON & STRAWN

August 26, 2008


BY ECF & FEDERAL EXPRESS

Honorable Tonianne J. Bongiovanni, U.S.M.J.
United States District Court
District of New Jersey
Clarkson S. Fisher Federal Building
& U.S. Courthouse
402 East State Street
Trenton, New Jersey 08608
Re: Schering Corp. v. Sun Pharmaceutical Industries Ltd., et al.,
MDL No. 1851, Civil Action No. 07-cv-3930 (MLC) (TJB)

Dear Judge Bongiovanni:

We represent defendants Sun Pharmaceutical Industries Ltd. and Caraco Pharmaceutical Laboratories, Ltd. in the above referenced matter. We write Your Honor on behalf of the Plaintiff Schering Corp., as well as Defendants Mylan, Lupin, Perrigo, Orchid, Orgenus, Belcher, Geopharma, Sandoz, and Watson, seeking the Court’s approval of a summary judgment briefing schedule in this case. We do not write on behalf of Defendant Dr. Reddy’s Labs or Anchen.

Discovery has been proceeding since 2007, and the fact discovery period is set to expire on November 3, 2008. See Order Amending Scheduling Order (D.I. 293, 3:06-cv-04715-MLC-TJB). Expert discovery is then set to commence and expert reports are to be exchanged by mid-February. Id.

Defendants, with the exception of Dr. Reddy’s Labs and Anchen, and Plaintiff have agreed that, subject to Your Honor’s approval, the following summary judgment briefing schedule, as set forth in the enclosed Proposed Form of Order, would be appropriate: opening briefs to be filed no later than April 1, 2009, opposition briefs no later than May 1, 2009, and reply briefs no later than May 15, 2009.

If the enclosed Proposed Form of Order meets with Your Honor’s approval, we respectfully request that it be entered. Should Your Honor wish to discuss this matter, we would be happy to do so by phone or in person.

Respectfully submitted,

/s/ Melissa Steedle Bogad

Melissa Steedle Bogad


cc: All Counsel of Record (by email) (w/encls.)

UPDATED: I should have orginally noted that nothing in the above scheduling proposal letter makes an "at-risk" launch of a generic version of Clarinex RediTabs any less likely. The leading candidate -- of the existing defendants in this suit -- to possibly take that approach, is India's Orchid Pharmaceuticals.

1 comment:

Anonymous said...

Condor,

I've been noticing the structure of descloratadine on your site for a while. So yesterday when you highlighted it again I decided to look at the summary basis of approval.

I think you may want to see my recent comments at Ed Silverman's site Pharmalot.

http://www.pharmalot.com/2008/08/antipsychotics-raise-stroke-risk-in-dementia-patients/

I think you may find them very interesting.

Salmon