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Theodore Cohen

 
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  • Acadia Remains On Track With Pimavanserin Program [View article]
    Don't get angry, PTSD Trader. It's pretty clear Realtor_k is caught in a terrible short position or is kicking himself for having sold too soon.

    Be well.

    Ted
    Sep 23 08:20 AM | 1 Like Like |Link to Comment
  • Celgene: Do The Revlimid Polymorph And Use Patents Matter? [View article]
    Thanks for the reply.

    Ted
    May 8 07:51 AM | Likes Like |Link to Comment
  • Celgene: Do The Revlimid Polymorph And Use Patents Matter? [View article]
    I just saw this on the CELG Investor Village board. Can you explain in layman's terms?

    Litigation alert


    Towards the end of today the following stipulation was filed. It eliminates any question that Natco's proposed generic would infringement certain, but not all, of the patents Celgene is asserting. I don't know which of the patents are involved here, meaning whether they are the ones with long out expiration dates, or the ones more close in. The stipulation leaves defendants free to challenge these patents as invalid or obvious. Remember that by its motion regarding the Canadian deposition Natco is offering to give up any "unenforceability" challenge to these patents. The reason for this stipulation is not given. One guess is that defendants don't have any viable way to argue for non-infringement and they are concerned about exposure for attorneys' fees, per that very recent Supreme Court decision. But that is just a guess. What's interesting is that they are making this concession even before the contested meanings for the Markman hearing are decided. It is possible that the terms up for the Markman don't operate in the claims of these patents, so the Markman arguments can't help the defendants with infringement exposure for these patents. Again a guess.




    STIPULATION AND [PROPOSED] ORDER REGARDING INFRINGEMENT


    Plaintiff Celgene Corporation (Celgene) and Defendants Natco Pharma Limited

    (Natco), Arrow International Limited, and Watson Laboratories, Inc. (collectively, the

    Defendants, which for purposes of this stipulation also includes Watson Pharmaceuticals, Inc.,

    Actavis Inc., Watson Pharma, Inc., and Anda, Inc.), by their undersigned counsel, hereby

    stipulate and agree that:

    WHEREAS Celgene represents that it owns United States Patent Nos. 6,045,501 (the

    ’501 patent), 6,315,720 (the ’720 patent), 6,561,976 (the ’976 patent), 6,561,977 (the

    ’977 patent), 6,755,784 (the ’784 patent), and 8,315,886 (the ’886 patent) (collectively,

    the Celgene Patents);

    WHEREAS Natco represents that it filed Abbreviated New Drug Application (ANDA)

    No. 201452 seeking approval to engage in the commercial manufacture, use, and/or sale of

    generic 5, 10, 15, and 25 mg lenalidomide capsules (Natco’s ANDA Products) before the

    expiration of the Celgene Patents;

    WHEREAS Defendants proposed to enter a stipulation regarding their infringement of

    the Celgene Patents;

    Case 2:10-cv-05197-SDW-MCA Document 304 Filed 05/07/14 Page 2 of 4 PageID: 9417




    NOW THEREFORE, the parties, their successors, and assigns hereby stipulate, and will

    not contest before this Court or any court on appeal, that:

    1. If approved by the FDA, the distribution of Natco’s ANDA Products in the United

    States would constitute infringement of each asserted claim of the Celgene

    Patents, specifically, claims 1 and 3-9 of the ’501 patent; claims 1-5, 7-8, 11-19,

    21, and 23-28 of the ’720 patent; claims 1, 3-6, 8, 10-13, and 15 of the ’976

    patent; claims 1-7, 9, 11-21, 23, and 25-30 of the ’977 patent; claims 1-7, 9, 11-

    21, 23, and 25-30 of the ’784 patent; and claims 1-7 of the ’886 patent

    (collectively, the Asserted Claims).

    2. Nothing herein shall be construed as precluding, restricting, or limiting discovery

    concerning the validity of the Asserted Claims, including, but not limited to,

    secondary considerations of nonobviousness.

    3. Nothing herein shall be construed as precluding, restricting, or limiting

    Defendants’ obligation to provide discovery concerning ANDA No. 201-452, and

    to comply with L. Pat. R. 3.6(j).
    May 7 09:22 PM | Likes Like |Link to Comment
  • Addressing Revlimid Patents Questions From Celgene's Q1 2014 Call [View article]
    Thanks, Daniel. I appreciate the quick and insightful response.

    Ted
    Apr 28 01:51 PM | Likes Like |Link to Comment
  • Addressing Revlimid Patents Questions From Celgene's Q1 2014 Call [View article]
    Thank you, Mr. Ravicher. This is one of the best overviews of the situation I have seen in the financial literature.

    If possible, would you address the matter of 'unclean hands' on the part of the generic company as well as their attempts to hide a critical witness (the ex-CELG employee who stole the drug from Celgene on their behalf) from Celgene's legal team?

    Ted
    Apr 28 10:08 AM | 2 Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Don't mention it.

    Ted
    Mar 31 02:55 PM | 1 Like Like |Link to Comment
  • What's Up With Vical? [View article]
    I don't see any big mystery here. If you click on the link, you see the Confidential Treatment Order granting an extension of the previously granted confidential treatment of Exhibit 10.57 attached to the 10-K/A filed March 3, 2009. If you look at the Exhibit filed with that 10-K/A, you'll see that the confidential treatment relates to specific financial terms under the company's license of technology from the University of Michigan. This is very standard practice to prevent potential competitors and sublicensees from learning the specific deal terms, which could give them a competitive advantage. The request and grant of an extension simply suggests that the licensed technology is still of interest and that the company still believes (and the SEC agrees) that there is still value in protecting this information.

    Ted
    Mar 30 09:30 PM | 1 Like Like |Link to Comment
  • What's Up With Vical? [View article]
    We all get the picture, SS113. You don't like the company or the president. I don't think you could make it any, well, simpler.

    Thanks for your opinion(s).

    Ted
    Jan 27 12:27 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    All of Vical's programs are based on the same core technology, which is their patented method of delivering genetic material (DNA or RNA) into living cells in the body. Once delivered, that genetic material is designed to cause production of the specific protein it encodes. Some applications use DNA (typically in closed loop form called plasmids) in a simple saline solution. Others use DNA plasmids in a lipid or polymer formulation. Some are injected into muscle. Some are injected into tumor lesions or other tissues. The delivery location, formulation and specific gene encoded within the plasmids determines which protein will be produced, in what quantity, for what duration, and in what location within the body. After that, the produced proteins will cause the specific biological or physiological effect for which they are selected. In the case of a vaccine, for example, the encoded protein would be one from the target pathogen. The desired physiological effect would be to develop an immune response against that protein to provide advance protection against the pathogen bearing that same protein.

    In the case of Allovectin, the selected protein(s) were designed to trigger an immune response against the cancer cells prevalent at the injection site. In the case of the AnGes angiogenesis treatment, the selected proteins were designed to induce production of new blood vessels at the injection site.

    So while the underlying gene delivery mechanism is the same, the encoded proteins really have unique mechanisms which differentiate the products.
    Jan 24 03:59 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    No. And much to early to speculate.

    Ted
    Jan 18 11:44 AM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Inept! They have no dedicated CFO, as I pointed out above. The original filings never should have been made in error.

    Ted
    Jan 17 01:29 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Well, one good thing is that we're not going to have to wait very long (relatively speaking) to learn the results of the herpes vaccine trial.

    Ted
    Jan 16 07:28 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Indeed.
    Jan 16 05:57 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    I simply asked the question "What's up with Vical?," Monzie. And I did raise the question in the Comments section above regarding how the purchases were tagged (P vs. A). Regardless of whether or not people read the Form 4's (and 4/A's) as did you and I, I think the matter was a valid topic for airing on Seeking Alpha.

    That said, like you, I was surprised the stock held up as well as it did when the Form 4/A's were issued.

    Ted
    Jan 16 05:57 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Remember, the CFO departed April 1, 2013 (from the From 8-K, March 15, 2013):

    "On March 15, 2013, Jill M. Broadfoot notified us that she was resigning as the Company’s Senior Vice President, Chief Financial Officer and Secretary. On the same date, we entered into a separation agreement with Ms. Broadfoot. Pursuant to the terms of the separation agreement, Ms. Broadfoot’s last day of employment will be April 1, 2013 and she will be entitled to receive severance benefits consisting of continued base salary payments and the payment of health insurance premiums for a period of 12 months, plus a payment equal to her cash bonus paid in the previous year. Ms. Broadfoot will also receive accelerated vesting on all her unvested stock awards as if she had remained employed by the Company for 12 months from the date of termination. In addition, the post termination exercise period for Ms. Broadfoot’s stock options will be extended to 12 months. In exchange for the severance benefits, Ms. Broadfoot provided the Company with a general waiver and release of claims. The Company’s obligation to pay the severance benefits will also be subject to certain confidentiality, non-solicit and non-competition obligations."

    http://bit.ly/1atx2yE;FilePath=013>;File...

    VJ became the acting CFO. I think this was a case of someone not being familiar with the forms and their proper completion. An honest but totally unnecessary mistake for a company to make.

    Ted
    Jan 16 05:47 PM | Likes Like |Link to Comment
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