g.
Quote: (i) Obviousness
"It is about whether or not it was “unexpected,” in light of the available prior art, that administering pure EPA to patients with high TG levels would not increase bad cholesterol, while simultaneously reducing Apo-B levels.
The good thing:
(a) The entire primary prior art references relied upon by the generics were previously before the Examiner or discussed by the Examiner during prosecution of the patents.
(b) The burden of proving obviousness is on the generics, and it is a relatively high one. The generics must show that the patents are invalid based upon a “clear-and-convincing-evidence” standard. If the case really comes down to a close call, and the court correctly applies the standard, that suggests that the court should in theory rule against invalidating the patents.
HOWEVER, please notice:
(a) There is precedent of courts invalidating patents based upon prior art previously considered during prosecution.
(b) We do not have all documents, do not know all arguments … but we know - re. the Hayashi study – that the examiner accepted as true Dr. Lavin’s opinion that the prior art did not teach administering purified EPA to patients with triglycerides of at least 500 mg/dL, which the parties now agree was incorrect, Defendants only seek to show that the asserted patents were issued based on factual mistakes about the prior art..."
I am not certain about the current opinions in the PTO...But I would like to add some information...The effect of trig lowering by EPA did not result in substantial increase in the LDL-C ("bad cholesterol") and that was not obvious since all other trig lowering drugs did and there was plenty of "prior art" substantiating that fact..The increase in LDL-C secondary to trig lowering resulted in a CRL for Lovaza...My day to day involvement suggested the PTO examiner made a mistake in his initial rejection of the patent..The original PTO examiner did not simply "change his mind"...The patent was reviewed by his superiors and they ruled the patent was not obvious...
I don't know much about Hayashi...And don't remember any discussion about whether it worked or not on trigs over 500 mg/dl...
APO-B is the main protein in both VLDL and LDL-C...The most likely cause of elevation of LDL-C during trig lowering is the fact VLDL is converted into LDL-C if the trig levels in VLDL drop below a certain level..(they are both APO-B)...and this is all the more reason EPA's ability to decrease Trigs and not increase LDL-C was so unexpected...
":>) JL
AI
