Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: fred hayes who wrote (3501)	11/6/2002 4:49:22 PM
From: Icebrg	Read Replies (1) \| Respond to of 10345

At least it seems that someone tries to gain approval for a generic version of Skelaxin. I found the following information on Bio's site: SECTION 3. ACCELERATED GENERIC DRUG COMPETITION. This section attempts to address several controversial legal issues associated with the approval of generic drug applications where the pioneer product claims to be protected by patent. Section 505(j)(5) of the Food, Drug, and Cosmetic Act (the "FD&C Act") sets forth a complicated mechanism under which the effective date of approval of an abbreviated new drug application ("ANDA") for a generic drug is predicated on the patent status (if any) of the pioneer or "listed" drug. Moreover, the first sponsor to submit a substantially complete ANDA, and who commits to challenging the pioneer’s patents, may enjoy a significant advantage over subsequent ANDA filers. Under current law, an ANDA must include a certification with respect to the status of any patents which claim the listed drug (or which claim a use for which the listed drug is approved). The certification must state (1) that patent information has not been filed; (2) that the patent has expired; (3) the date the patent will expire; or (4) that the patent is invalid or will not be infringed if the ANDA is approved. If the generic sponsor makes the fourth certification (called a "paragraph IV certification"), the sponsor must provide notice to the patent owner and holder of the approved new drug application ("NDA") for the listed drug. The notice must include a detailed explanation of the generic sponsor’s basis for claiming that the patents are invalid or will not be infringed. FDA is authorized to approve the first ANDA with a paragraph IV certification, effective immediately, unless the pioneer sponsor or patent holder brings an infringement action against the ANDA sponsor within 45 days of such notice. If such an action is brought, FDA is prohibited from approving the ANDA for a period of 30 months, unless the time is lengthened or shortened by the court that is overseeing the patent litigation. This is known as the "automatic 30-month stay provision." Moreover, section 505(j)(5) includes an offsetting benefit for the first ANDA with a paragraph IV certification. Under current law, FDA is prohibited from approving a second or subsequent ANDA with a paragraph IV certification until 180 days after either of the following two "triggering" events: (1) the drug that is the subject of the first ANDA with a paragraph IV certification begins "commercial marketing" or (2) there is a "decision of a court" holding the pioneer’s patent to be invalid or not infringed by the generic, whichever is earlier. Section 3 makes several changes to this statutory scheme. First, it clarifies that a "decision of a court" for purposes of the second of the two 180-day exclusivity triggers must be a decision of a court from which no appeal can or has been taken. Second, it provides that a settlement order or consent decree that includes a finding that the relevant patents are invalid or not infringed will also trigger the start of the 180-day period. Next, section 3 provides that the 180-day period shall be forfeited by the "previous applicant" and become available to the next applicant submitting a paragraph IV certification in any of six instances: 1. the previous applicant fails to market the drug within 90 days of the approval of the ANDA; 2. the previous applicant withdraws the application; 3. the previous applicant amends the "paragraph IV" certification to a certification that the patent will expire on a certain date (either voluntarily or after litigation); 4. the previous applicant fails to get "tentative approval" of the application within 30 months of its filing, unless there is a change in requirements for tentative approval, or other extraordinary circumstances; 5. if after the date on which the previous application is submitted, new patent information is submitted for the listed drug and the previous applicant fails to challenge the patent that is the subject of the new information within 60 days after the information is submitted; or 6. The Secretary of Health and Human Services determines, after consultation with the FTC, that the previous applicant has engaged in anticompetitive or collusive conduct or other conduct intended to unfairly monopolize the "commercial manufacturing" of the relevant drug. Section 3 provides that if the first applicant forfeits the 180 day exclusivity period due to one of the six factors described above, the next applicant submitting an ANDA with a paragraph IV certification (even if the certification is for a different patent than the certification contained in the first ANDA) is entitled to the exclusivity period. This latter provision appears to address two other longstanding issues: (a) the issue of whether "rolling exclusivity" is available and (b) the problem of different applicants certifying to different patents. Finally, section 3 makes the 180-day period available only if, within 50 days after notice to the patent holder of the filing of the ANDA, an infringement action is brought by or against the holder of the listed drug. Comment: The basis for the 180-day rule was to "reward" the first generic company that challenged the pioneer company’s patents perhaps even to provide an incentive to do so. The are, however, several reported instances in which the provision has in fact been used to delay the entry of generic competition. For example, the first sponsor with a paragraph IV certification may delay gaining market entry, reportedly after negotiations with the manufacturer of the "listed" drug, by not pursuing deficiencies noted by FDA during an ANDA review, or by not going to market after gaining approval. In these instances, all subsequent ANDA sponsors will be blocked from gaining final approval, because neither of the two 180-day triggering events will have occurred (i.e., there is no "commercial marketing" and there has been no "decision of a court"). FDA’s effort to limit this type of activity by regulation by requiring that only a sponsor who has "successfully defended" itself in patent litigation against the pioneer is entitled to 180-day exclusivity was stricken by the United States Court of Appeals for the D.C. Circuit in Mova Pharm. Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998). As noted in the comments to Section 2, this type of activity is being investigated by the FTC.