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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended for other attorneys. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-2017

« FDA Releases Omnitrope Citizen Petition Response | Main | Federal Circuit Hears Oral Arguments in Integra v. Merck, After Remand from Supreme Court »

June 06, 2006

Comments

sheetal chopra

Dear sir

It is highly appriciable that your orenge book blog site is very.

You are requested to pls. clarify following:

1. Is there some site available from where we can get district court decisions free of cost. We can easily get the decisions of court of appeals from fedcir.gov BUT i do not have any idea regarding availability of district court decisions.

2. With reference to a recent case "Apotex V. FDA" I wish to ask that

- If Teva was the Ist to file ANDA which got approval also then how come Apotex filed a declaratory judgement. B/s unless Teva markets the drug for 180 days no other company shall be able to sell its generic version even if it gets declaratory judgement.Then whatwas the advantage to apotex in filing declaratory judgement and how can this type of declaratory judgement can trigger 180 day exclusivity?

It will be grat if you please clarify my queries.

Regards
sheetal

Aaron

Sheetal, thanks for your comment.

1. the best place to access district court filings, including opinions, is on PACER: http://pacer.psc.uscourts.gov/.

2. According to the D.C. Circuit, Apotex filed a declaratory judgment action in order to start the clock running on Teva's 180-day exclusivity period before Teva was even ready to launch its product. It's not true that "unles Teva markets the drug for 180 days no other company shall be able to sell its generic version." Rather, a "court decision" can also start the 180-day clock. Apotex hoped to start the clock and be ready to market its own generic Pravachol after the 180 days had elapsed, and that Teva still wouldn't have been ready to launch its own product at that time. That way, Apotex would have been the first to market.

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