Replies to post #120635 on Biotech Values

[investorgold2002]

"The emphasis in an argument for inequitable conduct will have to be on the materiality of the information in question."


Don't you think the fact that they did not adequately discuss 2 clinical studies where they concluded Copolymer of 11K-23K DA mol weight is safe during the prosecution of patent, is MATERIAL ENOUGH for patentability of this patent which claims "Copolymer of 5-9KDA mol weight is less toxic"

[investorgold2002]

BUT FOR STANDARD

"The Federal Circuit also adopted a "but for" standard, requiring courts to "determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.""

This bodes well for inequitable conduct case against TEVA on Copaxone.

[investorgold2002]

Correct answer is:
Previously, there was a "sliding scale" standard on materiality and intent to deceive...meaning if materiality is high , intent to deceive could be low[or materiality is low , but intent to deceive high] and you could still win inequitable conduct
Now that is gone. Both materiality and intent to deceive needs to be there

Materiality - "but for" standard is required
intent to deceive - can be indirect but there should clear and convincing evidence brought forward ....just negligence or gross negligence would not be enough

So , yes now the standards for inequitable conduct has been raised.
Intent to deceive part might be tricky and hard to prove (unless something comes forward in TEVA's testimony in the trial)

http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1511.pdf