Myriad: 基因专利性的新标准

Myriad: 基因专利性的新标准

6月13日，美国联邦最高法庭公布了Myriad一案的判决。其中，法庭认为分离自然产生的DNA不具有专利性而cDNA具有专利性。

同日，USPTO公布Myriad备忘录，阐述了USPTO 新的DNA专利性判断标准：

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 occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject 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 occuning 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.

但是，无论最高法院的Myriad判决还是USPTO的备忘录，它们对DNA专利性的判断标准仍旧相对笼统。具体的标准只能等待后续的专利诉讼和审查案件来加以补充。比如说，Myriad及其共同原告于7月9日在尤他中区联邦地区法庭起诉Ambry Genetics，认为后者侵犯了其5个BRCA1/BRCA2专利。其中部分专利是Myriad一案中涉及的专利。这一次，Myriad精心选择了这5个专利及其权力范围，认为它们在Myriad一案后仍旧有效。(patentlyo.com)

如果Ambry Genetics积极应诉，或者同时提起专利复审的话，这一案中关于专利性的判决结果将很有可能具体化Myriad判决，并为基因专利的专利性设定新的标准。

附录：Myriad及其共同原告宣称被告Ambry侵犯的专利及其权力范围。