McAndrews

About

  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

Disclaimer

  • 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 not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. The views expressed are solely those of the authors, and may not reflect the views of 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.

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September 16, 2007

Pharma News Briefs

  • The Federal Circuit reissued its July 11 opinion in Daiichi Sankyo v. Apotex as a precedential opinion, one day after denying Daiichi's petition for rehearing.  According to Hal Wegner, a major reason for making the decision precedential was Prof. Joseph Scott Miller's Rule 47.6(c) filing.
  • Biosimilars legislation is "off the table" for now.  The FDA bill is moving forward without it.  (Bloomberg; Pharmalot).
  • Novartis is set to launch its biosimilar Epoetin in Europe.  (msnbc.com).
  • Cubist Pharmaceuticals has asked the FDA to delist a patent on its lead product, Cubicin, from the Orange Book.  (The Street.com).
  • FDA issued final guidance on commercially distributed Analyte Specific Reagents, such as antibodies and nucleic acids.  (FDA Law Blog).
  • Dr. Reddy's and Teva settled their patent dispute over generic Zoloft.  Teva had alleged that Dr. Reddy's infringed its sertraline HCl polymorph patents.  (TMCnet.com).
  • Imclone and Repligen/MIT settled their patent dispute over Erbitux.  (Patent Prospector).
  • Ranbaxy vs. Pfizer worldwide Lipitor patent litigation scorecard: mixed results.  (MarketWatch.com).
  • Feroz Ali Khader has written a new book on Indian patent law, particularly as it relates to pharmaceuticals.  (Generic Pharmaceuticals & IP blog).
  • Mr. Kapil Sibal, Honorable Minister for Science and Technology in India, will be speaking tomorrow, September 17 at 4 pm at the George Washington University Law School.  (Flyer; Program).

Posted by in Conferences, FDA Announcements, Orange Book Issues, Paragraph IV Cases |

Comments

Cary

This comment is directed to the subject of Ranbaxy going after the patent on Lipitor. I find it hard to believe that Pfizer is going to let the patent on the number one selling drug in the world expire 1 second early. But on the other hand, this opportunity is too big for Ranbaxy to pass up. A favorable verdict would give them exclusive rights to sell a generic version of the medicine, for a limited period, at a price that is well below Lipitor's but gives Ranbaxy a huge profit margin.

So Ranbaxy will fight, and Pfizer will win. To the deepest pockets go the spoils.

Posted by: Cary | September 19, 2007 at 01:36 PM

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