Friday 24 October, 2008

Clarithromycin Extended Release Tablets: CAFC Upholds Preliminary Injunction

Court of appeal for federal circuit court ruled that Sandoz could not start marketing its generic version of Clarithromycin Extended Release Tablets before the resolution of the patent trial with innovator Abbot.
The dispute was on preliminary injunction granted by district court in favor of innovator Abbot. preliminary injunction in equity, is an injunction entered by a court prior to a determination of the merits of a legal case, in order to restrain a party from going forward with a course of conduct until the case has been decided. If the case is decided against the party that has been enjoined, then the injunction will usually be made permanent. If the case is decided in favor of the party that has been enjoined, the injunction will usually be dissolved or dismissed. In most courts in the United States, the party seeking the preliminary injunction must demonstrate all four things together:
1) That there is a substantial likelihood of success on the merits of the case,
2) That they face a substantial threat of irreparable damage or injury if the injunction is not granted,
3) That the balance of harms weighs in favor of the party seeking the preliminary injunction
4) That the grant of an injunction would disserve the public interest. (Source: wikipedia)
The dispute was w.r.t factor 1 of preliminary injunction i.e substantial likelihood of success on the merits of the case. While the defendant (Sandoz) did raise a substantial question of the vulnerability of the patent, it did not provide any clear and convincing evidence of invalidity.
The presentation of sufficient evidence to show the likelihood of prevailing on the merits is quite different from the presentation of substantial evidence to show vulnerability
It is pertinent to mention here that obviousness grounds based on 3 prior art documents provided by Sandoz were sound and based on this one judge was against preliminary injunction. IPPharmdoc believe that there are chances of hearing en banc on the said issue.

Opinion of court

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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