Replies to post #135598 on Biotech Values

[zipjet]

"...the purpose of the safe harbor is to facilitate market entry ..." Judge

That statement and the others noted by posters suggests* the appeal will not get anywhere.

ij



* It is worth noting for the non-lawyers that appellate judges often will ask questions that may suggest they are leaning one direction when they are not. At times the questions are just to help them think about the issues. That is not what I believe happened but you rarely can be certain until you see the opinion.

[pollyvonwog]

I thought the MNTA lawyer did a poor job this point getting tied up on whether of not the FDA called out the MNTA test.

I agree he was fumbling, but at the same time she wouldn't let up on it. It seems like he was trying to get to that main point, but she kept harping on whether MNTA's test is required for approval...

[stockbettor]

I suspect the Hatch-Waxman argument is going nowhere fast, In the closing moments one Judge ask the Amp. lawyer if their argument would make all mfg control patents useless in this case.

At the end of the discourse the Judge said "That is not the purpose of Hatch-Waxman. I was there , I wrote that"

I thought that was an odd statement from Chief Judge Rader, but sure enough, he was a legislative counsel for a number of years in the House, and there is no reason to doubt that he wrote the relevant Hatch-Waxman provisions at issue here. From his CAFC bio:

Before appointment to the Court of Federal Claims, Chief Judge Rader served as Minority and Majority Chief Counsel to Subcommittees of the U.S. Senate Committee on the Judiciary. From 1975 to 1980, he served as Counsel in the House of Representatives for representatives serving on the Interior, Appropriations, and Ways and Means Committees.

Combining this background with the fact that he wrote the majority opinion in Celsis in Vivo issued 2 weeks ago upholding a PI against an infringer of process patents, I like the chances that the PI here will be upheld. A link to the Celsis opinion can be found here:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=70811441