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Avanir Pharmaceuticals, Inc. Message Board

  • placesontherun37 placesontherun37 Jan 8, 2014 3:29 PM Flag

    Dan Ravicher vs. Jack Blumenfeld; Point/Counterpoint:

    I have read Dan's SA piece and still think that Avanir/CNS will win on the '282 and '484 patents in dispute..

    Dan makes many sweeping, opinionated statements without any case law back up or citations to the same in his article.

    Dan:

    Avanir concedes that both DM and Q were known for quite some time before the '282 and '484 patents and that it was known they could be combined to treat PBA

    Jack/The Facts:

    Avanir conceded no such thing...just read its briefs..

    Dan:

    I find Avanir's argument quite weak and expect the judge will side with the generics on the issue. Any reasonable human being knows it is always better to take the least amount of a drug possible in order to get the desired effectiveness. Heck, it's even cheaper for the drug company to use less ingredients if it can get away with doing so. Thus, I think it would have indeed been obvious to try using lower amounts of Q in a DM+Q combination to see if the necessary effectiveness could still be produced. This is just common sense, which the Supreme Court has said is a critical factor courts are to consider when deciding whether a patent is obvious (and thus invalid)

    Jack/The Facts:

    KSR vs. Teleflex:

    Often, it will be necessary for a court to look to interrelated teachings of multiple
    patents; the effects of demands known to the design community or present in the
    marketplace; and the background knowledge possessed by a person having
    ordinary skill in the art, all in order to determine whether there was an apparent
    reason to combine the known elements in the fashion claimed by the patent at issue.
    KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007).

    Post-KSR, both the Federal Circuit and this Court require a motivation or reason to modify or combine the prior art to arrive at the asserted laims. See, e.g.Broadcom Corp. v. Emulex Corp., 732 F.3d 1325 (Fed. Cir. 2013) (affirming denial of JMOL of obviousness because POSA would not have been motivated to modify the
    prior art)

    Sentiment: Strong Buy

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    • semiequipmentgodoftheyear semiequipmentgodoftheyear Jan 19, 2014 4:49 PM Flag

      rayconmanscamer is in trouble

    • I am currently engineering a product to be patented that does not nearly take the huge amount of money, time, and efforts to get a Med through the FDA and follow-up processes. I have been a shareholder of avnr for years and understand the tribulations that avnr had to go through to get its lead product NEUDEXTA into the marketplace. If patents can be breached because a generic company sees an opening to capitalize on the reasearch and development of others, particularly in the med sector, the impact will certainly thwart some future innovators from finding capital for developmental meds. As any science educated person will tell you, tweaking compounds and mixtures is a developmental process and tweaking compounds is not intuitive nor automatic especially when such compounds are related to introduction into the human physiologic system.

      Sentiment: Strong Buy

    • There is no doubt that it was expected and incumbent upon Avanir and anyone else trying to develop dex/quin to look for the minimum effective dose.
      As Mr. Ravitcher says, it is common sense. And it is also, therefore the basics of R&D of drugs, especially dangerous drugs that have enough quinidine to significantly prolong the QT interval.

      • 2 Replies to rayonmanl
      • I might add that I was truly unimpressed with Dan's SA article. I was expecting much more from someone with his background. He did not delve into case specifics and instead attacked the judge and rendered heavily couched opinions with no legal backing. The case law on the books controls here, not someone's opinion as it being "expected and incumbent". That's a big logical leap to make in the face of abundant contrary case law, referenced repeatedly by Avanir's attorneys in its briefs.

        Sentiment: Strong Buy

      • Making statements of conclusion while ignoring relevant patent law and factual chronology makes no sense. No doubt? No one did until Avanir did. There were no blocking patents. You are just wrong. Improper hindsight. CCE. Secondary considerations of non-obviousness. The case law supports Avanir. Bald statements of opinion are just that.

        Sentiment: Strong Buy

    • probably the FDA will wait the court decision. In any case, the FDA should decide after the summer. 40 months are rather normal for generics. BUT NOW THE PROBLEM FOR US IS NOT IS DAN IS RIGHT OR JACK IS RIGHT. THE PROBLEM IS WHAT THE COURT WILL DECIDE. The final decision could be even longer because who will be defeated will present an opposition to the 2nd grade of judge.

    • Places, thanks for your detailed factual rebuttal. Don't you get the impression that this was a half hearted effort by this attorney and that the superficiality of his arguments indicates he wasn't willing to dedicate much time to this project?

      • 3 Replies to rzrbackrob
      • Having re-read Dan's deficient 5 page release several timesnow ...I keep thinking of good old but now gone to that great Wendy's in the sky senior pitchwoman, Clara Peller..."Where's the beef!! Newsflash.. Its not there, actually..

      • Dan is a busy guy with a lot on his plate. I tend to agree. He has clearly not really dug in and read even 50 of the the 471 D.Is on this case file...He did not attend the trial. He takes some real pot shots at Judge Stark, too, stating essentially that he is a tyro, newly appointed, wet behind the ears FDC judge, with no background in science, pharma, and the like. He drips derision toward Judge Stark, like this Rhodes Sch/Oxford/Yale Law educated jurist needs his "help" and the "help" of the Galderma FC panel...I found this offensive, to be honest...

        Sentiment: Strong Buy

      • Razor and Place Thanks! Anti-Patent Attorney Dan spent no time researching supporting case law... As if Dan was rushed to get his short attack out the door quickly...

        Sentiment: Strong Buy

    • I actually think his article argues MORE for Avnr than the reverse. The very simplistic way he's approached these legal issues....barely citing the law involved at all. He says it should have been obvious for avnr to use lower amounts completely ignoring how low the amounts they were using were in the first place. Q was used at the 600mg to 1200mg level SAFELY in heart patients. 150mg was WELL below that and in fact..only about 1/10th of the upper limits. Even the generics own witness said it was safe. Dan just goes on to speculate how they should have used even lower. He provides no reasoning for that however or motivation...basically just saying that they should have used 1% of the amount used in heart patients. Because that is what N ultimately became.

      His article is nothing more than rampant hindsight speculation. Looking back 10 and 20 years ago and saying in hindsight..they should or shouldn't have done this or that. And that simply is not how the law operates.
      Again...he ignores the law even. Cites NO references. How odd is that for a patent atty?

      Frankly..i expected something more from him. An article citing many legal references and his attacking Avnr using legal issues. Instead..it sounds like a 6th graders term paper. A bullying effort to try to say that avnr will lose.

      Shorts had better cover if that's his best attempt.

      ~TS
      jmho

      Sentiment: Strong Buy

    • Jack/The Facts:

      Cavallo v. Star Enter. , 892 F.Supp. 756, 765 n.18 (E.D.Va. 1995)). Cavallo further explains that, “as is common with anecdotal case reports, no dose-response relationship was established.”Id.at 767. The single patient case report in example 2 would thus have been insufficient to establish a concentration-effect relationship for DM/Q and PBA.

      Sentiment: Strong Buy

      • 2 Replies to placesontherun37
      • u out ought to write a seeking alpha article place

      • Dan:

        Avanir tries to support its argument that the patents were not obvious by suggesting it was a surprise to realize that a lower amount of Q could still be as effective as the higher amount (evidence of "surprising results" can be a factor suggesting an invention is not obvious). However, Par and Impax rebut this argument with evidence in the prior art that lower amounts of Q (as small as 5mg) could still cause the desired effect in the body that would increase the level of DM in the blood, which is precisely the function being performed by the Q in the DM+Q combination. Indeed, an Abstract published by the inventors of the '282 and '484 patents years before they applied for the patents showed that 5mg of Q caused a 15X increase in DM blood levels. Thus, Avanir's argument that it was surprising that reducing Q could still work is unpersuasive to me.

        Jack/The Facts:

        Dan ignores the long standing doctrines of impermissible hindsight and secondary considerations of non-obviousness. He never mentions the CCE standard in his piece.

        Also..

        Defendants’ argument is also inconsistent with Defendants’ expert testimony, which
        established that a POSA in 2002 would not have reasonably expected the DM blood
        concentration in example 2 to be associated with efficacy in the majority, or even a quarter ,
        of PBA patients. DI 446 at 34; (FF 138, 196.) This testimony shows a POSA would not have had a
        reasonable expectation of success in treating PBA with DM blood levels of 43-55 ng/ml. See
        Amgen, Inc. v. Chugai Pharm. , 927 F.2d 1200, 1208 (Fed. Cir. 1991) (finding no reasonable
        expectation where expert testified there was “no more than a fifty percent chance of success” in
        reaching the invention). Moreover, as previously explained, these blood levels were inconsistent
        with the prior art as a whole. DI 446 at 7-10; (FF 57-59, 107, 110-125.) 1 Thus, a POSA would
        not have been motivated to target DM blood levels of 43-55 ng/ml.

        Sentiment: Strong Buy

 
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