AstraZeneca Defends SEROQUEL® From Teva

Posted on | July 31, 2008 | No Comments

2008-1480 AstraZeneca v. Teva
D/NJ 05-5333
Judge Joel Pisano

Teva appeals from Judge Joel Pisano’s grant of summary judgment in favor of Astra on Teva’s claim of inequitable conduct in the prosecution of 4,879,288, which covers the antipsychotic drug quetiapine, marketed by Astra a SEROQUEL®.  Teva had filed an ANDA seeking to sell a generic, 25 mg version of Seroquel.  Teva apparently had dropped its other defenses and was relying solely on inequitable conduct.

The PTO twice rejected Astra’s quetiapine patent application under obviousness–and twice Astra responded with argument and material that quetiapine was an "atypical" antipsychotic and was unexpectedly different from the prior art.  The second response carried the day.

Teva’s theories of inequitable conduct are based on Astra’s responses to the rejection–the court described them as follows:

Defendants allege that several acts on the part of Astra constitute inequitable conduct and, therefore, render the ‘288 patent unenforceable. Defendants’ first and primary argument is that Astra committed inequitable conduct because it misrepresented and/or omitted material information concerning certain prior art compounds in its prosecution of the ‘288 patent. Second, Defendants allege that, in response to a request by the patent examiner, Astra falsely asserted that generating data regarding a particular prior art compound would have been “very expensive.” Third, Defendants claim Astra deceived the PTO by representing that a record reference taught that a particular compound was a typical antipsychotic. Last, Astra failed to disclose to the PTO the death of a cebus monkey during testing of quetiapine. The Court will discuss each of these below.

To show inequitable conduct the defendant must show that the misrepresentation or omission was material and done with the intent to deceive the PTO.  The court found that none of Teva’s arguments could satisfy this test.

1. Omitted test results.  Astra’s failure to disclose its internal test data related to 4 of the many compounds tested was not material.  The court found that the results that were disclosed were done so to respond to the examiner assertion of prior art, so Astra was proper in producing test results related to the asserted, closest prior art.  The court also found insufficient evidence of intent to preclude summary judgment.

2. Expense of generating test data.  Astra advised the PTO that side-by-side testing of the Schmutz X prior art compound had not been done and doing so would be "very expensive."  The court found that Teva failed to put forth sufficient evidence that the statement was untrue, material, and done with intent.

3. Statement regarding prior art.  Astra described a reference cited by the examiner as disclosing only "typical" rather than "atypical" antipsychotics.  The prior art reference was provided in full (in German) with a summary in English.  Teva argued that the summary along with Astra’s prosecution statements mislead the PTO into believing that the reference was limited to "typicals" when, according to Teva, it didn’t discuss the issue at all.  The court reject the argument, concluding that enough information was given to the PTO for it to make its own conclusion about the reference.

4. Toxicity of quetiapine.  Astra disclosed and argued that quetiapine showed "no overt toxicity" in the recommended dosage.  Teva argued that the death of a cebus monkey shortly after dosing–which was not disclosed–showed that the statement and representations were false.  The court noted that a necropsy on the monkey did not list a cause of death, and further that Teva "pointed to nothing in the record that shows that the monkey died from the toxic effects of quetiapine; such a conclusion is speculative at best."  The court also found no evidence of intent to deceive–although Teva argued that Astra kept quite so as not to undermine its statement about lack of toxicity, the court found this "wholly insufficient to raise an inference of deceitful intent." 

More reading:

Opinion

Counsel:

AstraZeneca: McCarter English (Andrew Berry, Nicole Corona, Christian Samay, Jonathon Short, Mark Anania).

Teva: Lite, DePalma, Greenberg & Rivas (Allyn Lite, Michael Patunas). 

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