Takeda’s PREVACID® Gets Split Decision Against Teva

Posted on | April 26, 2008 | No Comments

2008-1314 Takeda Pharma v. Teva Pharma
D/DE 06-cv-33

Teva appeals Judge Susan Robinson’s Order and Opinion finding Takeda’s patent, 4,628,098 not invalid and not enforceable: Teva had previously admitted that its ANDA for a generic form of PREVACID® infringed the ‘098.   Also tried last year to the court was infringement and validity re: 5,045,321.  The Order finds that patent valid, enforceable, but not infringed.

PREVACID® is an antibacterial containing lansoprazole, a particular benzimidazole, which is a member of class of drugs known as proton-pump inhibitors.  The ‘098 patent covers the lansoprazole compound itself, and expires on May 10, 2009.  Because lansoprazole is unstable, it is combined for pharmaceutical compositions with, for example, magnesium carbonate.  The ‘321 claims, in part, this combination and expires September 03, 2008.

With respect to the ‘321, the asserted claim required that "the benzimidazole compound being in contact with the basic organic salt evenly," which the court construed to mean that the compounds were "uniformly dispersed."  After reviewing the parties’ respective test data, the court found that Takeda failed to prove that the distribution of lansoprazole and magnesium carbonate in Teva’s product was "uniform."  While the court noted that the tests showed that the compounds might be close, touching, or even in "substantial contact," it did not show that the contact was necessarily even.

As for obviousness re: ‘098, the court reviewed early patents and research on PPIs, but concluded that there was no evidence that a person of ordinary skill would have been motivated to make the substitution from the prior art PPIs to discover lansoprazole, or that there would be any reasonable expectation of success in making that substitution.  Likewise, the obviousness challenge to the ‘321 fails because there is no motivation to combine lansoprazole with the stabilization compounds claimed.

The court also rejected Teva’s inequitable conduct argument, essentially that Takeda withheld research data showing that the claimed compound had a lower effectiveness than the 20x disclosed.  The court found the withheld data to be of "low" materiality and that Teva failed to prove intent.

As it stands, Teva will have to wait until at least May 2009 before it can market its generic product.  The decision was also reported at Orangebook Blog.

Documents:

20081314_Takeda_Order.pdf

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