Hey Hamoa, thank you for your post. I seek out your posts because they add greatly to the discussion and my knowledge. I have a small issue in the following statement:
"Defendants are asking Judge Du to:
1) rule that both the USPTO and FDA "clearly and convincingly" erred in judging the non-obviousness of Amarin's inventions, "
I believe the patent office has sole responsibility in determining whether a patent should be issued. Regardless, the defendants are not asking the judge to rule that both the USPTO and the FDA "clearly and convincingly" erred.
Rather, the defendants have the burden of proof to prove the patent is not valid due to obviousness which means the PTO erred in issuing the patent. The burden in substantial. Most civil suits are decided based on the preponderance of the evidence, which means the trier of fact weighs the evidence to determine whether more than 50% of the evidence supports the plaintiff's claim.
Clear and convincing evidence requires much more. I do not believe the courts have ever quantified what percent the evidence must be to be clear and convincing. In law school classes we debate whether it is 75% or more or whether it could be something less. What ever it equates to as a percentage, it is a very difficult burden to meet unless the evidence is there and the attorneys are good enough to make a stronger case than the opposing counsel.
I agree the judge doesn't make decisions solely on facts. Public policy also plays a role when policy is at issue. A weak patent system is contrary to public policy. To rule in favor of the defendants based on some small potential use for less than 12 weeks when the drug is intended to treat chronic conditions in my opinion, would be contrary to the intent of the law and violate public policy.
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