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Category: U.S. Patent and Trademark Office

Myriad Gene Patent Decision: A New Era in DNA Diagnostic Testing?

by Shaukat A. Karjeker

In the race to map the human genome, many of the organizations involved obtained patents on gene sequences that they identified.  These patents were granted regardless of whether the applicant had determined any role or function of the sequence.  As a consequence, other researchers were effectively “blocked out” of research and development on the patented DNA sequences, unless they were able to negotiate a license.

The unanimous opinion by Hon. J. Clarence Thomas, in Association for Molecular Pathology, et al v. Myriad Genetics, Inc., et al. completely changes the biotech and medical research landscape: DNA is a naturally-occurring composition and therefore not patentable.  With a single stroke, the Court has opened the flood gates for the development of customized gene-based medicine.  All issued patent claims to DNA sequences are now invalid, the DNA sequences are effectively “in the public domain,” and the sequences may be used in research and development without any need for (costly) licenses.

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New Patent Rules Blocked by an 11th Hour Injunction

By Vincent J. Allen

On the day before the new continuation rules discussed in our previous newsletter were to go into effect, a federal judge in Virginia issued an injunction against the Patent Office that prevented the Patent Office from changing the rules on November 1, 2007 as scheduled.  GlaxoSmithKline filed suit in Virginia claiming that the new regulations are vague, arbitrary, and capricious.

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The PTO’s New Accelerated Examination Program—Heaven Sent or Pandora’s Box?

By Zach W. Hilton

In March, the United States Patent and Trademark Office (“PTO”) celebrated the issuance of the first patent under its new accelerated examination program.  This patent issued from an application filed on September 29, 2006.  Implemented in August 2006, the accelerated examination program allows an applicant to dramatically shorten the time an application spends in the examination process.

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