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« Plaintiff(s) File Petition for Rehearing in AMP v. USPTO -- Update | Main | Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) »

August 30, 2011


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Well, to be "fair and balanced" the defendants petitioning for rehearing in this case should also be careful of what they ask for. An en banc Federal Circuit could also potentially overturn the panel's ruling on the patent-eligible isolated DNA/method claims.

The plot thickens, eh?

As I wrote in two different posts on http://www.pharmapatentsblog yesterday, I think it is interesting that the ACLU Petition for Rehearing did not restate the points alleged about Dr. Ostrer in their August 29 letter to the court, but rather cited his membership in an organization concerned with "gene patenting."

"The plot thickens, eh?"

"As thick as a trickle pudding" to use the words of Mr. Canfield from In Harm's Way, Courtenay. If this case makes it to an en banc hearing before the Federal Circuit, it will be one big judicial donnybrook.

Well, EG, I think defendants have posed a very specific, threshold question that may make asking for rehearing worth the risk - does the court have the institutional competence to hear the case? Judge Moore was certainly concerned about this question, and so the panel could (in the first instance) revisit just this point (especially since the plaintiffs raised jurisdictional issues as well).

In some ways, the best outcome - it delays the cert petition so that the Supreme Court can decide Prometheus before considering cert in Myriad, and if Prometheus comes down a certain way it may answer at least the method claim part of the Myriad decision. And if the Federal Circuit decides no standing, it raises interesting questions about how the case is presented for cert.

As well as giving us all something to write and think about for a good while longer.

Thanks for the comment.

I have one question regarding the whole dr Ostrer standing issue. Who took over for him at NYU and why are they not involved in the suit?

Also I has a question for Kev, what do you think about idea no. 5?


Dr. Noonan notes: And if the Federal Circuit decides no standing, it raises interesting questions about how the case is presented for cert.

If there is no standind, there is no cas e to present cert. for.

Or am I missing something?

Dear 6:

To answer your second question first, the answer is simple: generic drug makers (generally) do not do discovery research. The cost of developing a drug is amortized over the cost of all the failures (that still cost money to pursue), and then there is the regulatory costs. Now, we could just let the market decide, but then we would have "the market" instead of the FDA vetting drugs. Not a good idea - even of the FDA makes mistakes they are good faith mistakes, and "the market" tends to be amoral - if it is cheaper for lots of poor people to die or be injured so "good" drugs can be developed for the rest of us, "the market" has no problem with that.

So no, I don't think this is an idea "so crazy it might work."

As for Dr. Ostrer, the court specifically found that he had standing based on his statements of being "ready, willing and able" to do the testing and his intent/commitment that he would do the testing if/when Myriad's patents were invalidated. I don't think NYU is a party to the suit (and I don't think you can force them to join), so if defendants are correct and Dr. Ostrer can no longer perform the tests in his new position his basis for standing is gone.

"As well as giving us all something to write and think about for a good while longer."


Now that Classen came out today with a majority opinion (by Newman and Rader), an "additional views" opinion (by Newman and Rader) and a dissenting opinion (by Moore), how true. As Sherlock Holmes would say, "the game is truly afoot," and the judicial donnybrook at the Federal Circuit (and potentially at the Supreme Court) is about to begin in earnest.

"so if defendants are correct and Dr. Ostrer can no longer perform the tests in his new position his basis for standing is gone."

I see what you're saying, but one would presuem that NYU would want to join if they already let their head of dept. join up. So if they wanted to join, what would the situation be there? Too late for them to join? Too late for the new head of their dept to join? Because they're essentially saying that his standing went away when he left that place, there should then be an opportunity for the new person in that position to join I would think. They can't just drag out a lawsuit until standing goes away and not allow anyone to continue the case. Such would be absurd. One would think if he had standing back at day 1 then that would be sufficient.

I don't really see how you were responding to my second question. You seem to think they're advocating just letting the market handle everything and doing away with FDA approval. I don't think they are. They're talking about taking all the monopoly rent money that currently goes into the pockets of non-generic corporations and putting aside a chunk of that, approx equal to what corps spend on it now, for R&D (as well as FDA approval costs I would presume) and then take the rest and put it towards subsidized employement.

In other words, take the job, and huge profits, of coming up with new drugs away from big drug companies and give both to the gov and let the gov use the profits to create subsidized employment.

Or was your entire point that the drug companies don't actually make 300 billion, or even a good chunk of 300 billion, as profit, but instead they actually spend all 300 billion on research and FDA approval etc? Because the facts, at least as cited in the article don't seem to support that.

The wiki shows all the same numbers and some citations for the numbers that these guys showed and indicate that there is a ~17% return.

Still seems like an overall pretty decent idea to me. I mean sure, it's a move towards some limited communism (or at least a gov planned econ), and as much as I hate the communism, where else are we headed when machines take nearly all our jobs?

We have a lot to gain under that plan it seems like. The people who have the job of coming up with new treatments can focus on best helping the population rather than how best to make a dime.

And not only that, the people currently being employed won't have to be so worried about the risks involved or their company going under.

Well, 6, I have a fairly large circle of friends/acquaintances who come from a country where the government handled these types of things and they would tell you it didn't work out too well. Frankly, I am in favor of a world based on the philosophy of "from each according to his abilities, to each according to his needs," but we as a species don't seem to be ready for this as a workable principle of our civilization.

I'm not willing to do the experiment again. It's said that madness is doing the same thing over and over and expecting a different outcome. By that standard, doing what the author suggests would be madness.

As for the other question, NYU has had plenty of opportunities to join this lawsuit and has not. So I expect they don't want to. As for substituting them now, "you dance with them that brought you." I don't see the court permitting NYU to join at this late date.

Dear Skeptical:

The standing decision would be reviewable, and the Supreme Court could grant cert on the entire case if it wanted to (with the idea that under principles of judicial economy if they decided the Federal Circuit was wrong on standing there would be no recourse for plaintiffs to appeal the substantive decision thereafter).

Thanks for the comment.

But Dr. Noonan, if the court grants cert on the standing question, they can only answer THAT question and cannot try to the case on the merits, can they?

One man's "judicial economy" is another's abrogation of standing TO TRY the case, no?

"Well, 6, I have a fairly large circle of friends/acquaintances who come from a country where the government handled these types of things and they would tell you it didn't work out too well"

All the best ideas get messed up by people.

Dear Skeptical:

The Court could certainly decide standing as a threshold question, i.e., they could come to their conclusion on standing, and if their conclusion was that the CAFC got it right then they would themselves be precluded from writing a precedential opinion on the merits. BUT if they decided that even one of the named plaintiffs had standing, then I suppose they could reach the merits. Which is the scenario I had in mind; sorry if I was unclear.

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