Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

10 June 2013 Personalized Medicine Bulletin Blog

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to satisfy 35 U.S.C. Section 101.Last month, Intema petitioned the U.S. Supreme Court to reverse the Federal Circuit’s holding that the claims of U.S. Patent No. 6,573,103 are invalid as patent-ineligible under Section 101. Intema contends that the Federal Circuit erred by misapplying Mayo in a manner that creates erroneous, rigid rules for determining patent-ineligibility in cases involving laws of nature. Failure to reverse the Federal Circuit’s decision, Intema argues, will have the practical effect of rendering most diagnostic, screening and personal medicine tests unpatentable.

The ’103 Patent

U.S. Patent No. 6,573,103 (the ’103 Patent) entitled “Antenatal Screening For Down’s Syndrome” issued on June 3, 2003. All twenty-four claims relate to methods for determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome. Claim 1 is representative:

1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of:

measuring the level of at least one screening marker from a first trimester of pregnancy by:

 (i) assaying a sample obtained from the pregnant woman at said first trimester of pregnancy for at least one first biochemical screening marker; and/or

 (ii) measuring at least one first ultrasound screening marker from an ultrasound scan taken at said first trimester of pregnancy;

measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:

 (i) assaying a sample obtained from the pregnant woman at said second trimester of pregnancy for at least one second biochemical screening marker; and/or

 (ii) measuring at least one second ultrasound screening marker from an ultrasound scan taken at said second trimester of pregnancy; and

determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one screening marker from the second trimester of pregnancy with observed relative frequency distribution of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

The Federal Circuit’s Asserted Errors

Intema argues that the Federal Circuit erred when it ignored material differences between the claims of the ’103 Patent and the claims held invalid by the Supreme Court’s Mayo decision. Such errors include, for example:

  • the failure of the Federal Circuit to recognize the claims of the ’103 Patent are more than the use of a law of nature – the claims embody the use of data gathered was completely non-standard when developed, and improved screening efficacy;
  • the failure of the Federal Circuit to acknowledge that the measuring step, achieves a simple and useful test result using statistical analysis when it wrongly characterized the measuring steps as conventional and obvious presolution activity;
  • the failure of the Federal Circuit to give proper weight to the steps of selecting the measured marker levels during two separate trimesters of pregnancy and the integration of that in a carefully specified manner;
  • the Federal Circuit’s finding that the determining step is insufficient as being a “known and conventional” algorithm;
  • the Federal Circuit’s interpretation of the “assaying” portion of the measuring steps to be insufficient to impart patent-eligibility to the claims because it could be performed without transforming the sample should science develop a totally different system for assaying for a biochemical marker that did not involve such a transformation; and
  • the Federal Circuit’s error in concluding that a transformation, if it existed, would be insufficient relying on another rigid rule excluding all transformations from consideration under Section 101.

Personalized Medicine and Diagnostic Patents

The Supreme Court’s Mayo ruling has created uncertainty for diagnostic technologies that support and promote personalized medicine. Inventions simply defined by correlating a natural biomarker with a clinical outcome or therapeutic treatment are now ineligible for patent protection as a result of the Mayo decision. For inventions that offer more than a simple correlation, patent protection may still be available. However, how much “more” is necessary to move an invention involving a biomarker and correlation to patent-eligibility is still an open question. With that in mind, more clarity and direction would be welcome, provided the Supreme Court does not take the opportunity to further restrict patent protection for these important technologies.

PerkinElmer’s reply is due June 19, 2013.

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