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Sunday, June 16, 2013

AMP v Myriad Genetics

The Supreme Court in Association for Molecular Pathology v. Myriad Genetics has held that "isolated" nucleic acid sequences are not patentable but that synthetic nucleic acid sequences (e.g. cDNAs) are patentable.  Further, it appears that claims to vectors, kits and synthetic primers are patentable.  The USPTO has already issued guidance to examiners as to how to address claims to isolated nucleic acids (see attached link) http://www.uspto.gov/patents/law/exam/myriad_20130613.pdf.  Briefly, the USPTO has stated

"As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally  occuning nucleic acids or fragments thereof, whether isolated or not, as being ineligible bsubject matter under 35 U.S.C. § 101. Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally­ occuring nucleotides has been altered (e.g., a man-made variant sequence), remain  eligible. Other claims, including method claims, that involve naturally occurring nucleic  acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility." 







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