GEN Exclusives

More »

Legal Affairs

More »
Mar 1, 2013 (Vol. 33, No. 5)

Diagnostic Tests and Patent Eligibility

Will the Federal Circuit’s Negative Treatment Chill Innovation?

  • Click Image To Enlarge +
    Michael J. Belliveau, Ph.D.

    In PerkinElmer, Inc. v. Intema, Ltd., the Court of Appeals for the Federal Circuit (CAFC) revisits the subject of patent eligibility as it relates to diagnostic methods and invalidates the claims of a diagnostic test for Down’s syndrome as being patent-ineligible. This decision is significant as it reveals a continued expansion of the Section 101 invalidity defense since the Supreme Court’s decision in Prometheus Labs, Inc. v. Mayo Collaborative Services and portends an evolution of the law in a dangerous direction for diagnostics companies seeking to protect their innovations through the U.S. patent system.

  • The Importance of an “Inventive Concept”

    The Intema case involved claims from U.S. Patent No. 6,573,103 for prenatal diagnostic testing for Down’s syndrome. The diagnostic test in question includes the steps of (i) measuring one or more known biomarkers from the first trimester and one or more biomarkers from the second trimester, and (ii) determining the risk of Down’s syndrome by comparing the measured levels with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

    In an earlier decision, a District Court had previously found the ‘103 claims to satisfy the test for patent eligibility because the claims are directed to a data-gathering method that included measuring steps that satisfied the so-called “machine-or-transformation” test for patent-eligibility.

    On appeal, the CAFC panel reversed the District Court’s finding of patent-eligible subject matter based on the Supreme Court’s Mayo decision as well as the Federal Circuit’s decision in AMP v. Myriad Genetics. “The key distinction, which bears on our decision today…is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter.”

    According to the panel, the claimed methods do not contain an “inventive concept” (defined by Mayo as “other elements or a combination of elements…sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself”). Rather, they recite “nothing more than ‘well-understood, routine, conventional activity previously engaged in by researchers in the field.’”

    In supporting its ruling, the panel relied heavily on the similarities between the Intema claims and the Myriad claims. The Myriad claims found to be patent-ineligible were directed to comparing measured biological information (DNA sequences from wild-type and mutant BRCA genes). The Myriad panel found no requirement that an assay must actually be performed. Consequently, the claimed methods could be practiced simply by comparing two printouts of DNA sequences.

    Turning to the Intema claims, the panel acknowledges that the claims require the steps of “measuring” and “determining,” but concludes that neither step “added enough to the statements of ineligible subject matter to direct the claims, not to the ineligible concepts themselves, but to applications of those concepts.”

    According to the panel, “the ‘measuring’ steps are insufficient to make the claims patent-eligible. They merely tell the users of the process to measure the screening markers through whatever known method they wish.” Moreover, the panel notes that while the biomarker measuring could be performed through the use of ultrasound, “[t]he claims do not require that an ultrasound be taken, only that data from previous ultrasounds be assessed.”

    Regardless, “[e]ven if required as part of the claimed processes, the data gathering steps are conventional and obvious extrasolution activity that cannot save the claims.” The panel further opines that the “determining” step is not sufficient to confer patent eligibility because it “requires the ineligible mental step of ‘comparing’ the measured markers…to determine the risk of fetal Down’s syndrome.”

    The panel concludes that “anyone who wants to use this mental step or natural law must follow the claimed process.” This, according to the panel, results in impermissible preemption of a natural law.

    The Intema ruling suggests that the inclusion of general data gathering steps that are “conventional and obvious” is not sufficient to convert a patent-ineligible mental step into a patent-eligible diagnostic test, even if it satisfies the “machine-or-transformation” test. Consequently, if there is a particular assaying or detection step, it may be required to be recited in the patent claim. Alternatively, inclusion of a post-determination treatment step may provide the requisite application of the natural law to avoid a finding of patent-ineligibility.

    The conundrum is that these patent-based strategies are not universally satisfactory. Many biomarkers are assayable using a variety of methods, effectively rendering claims requiring specific assays inadequate as barriers to competition. Similarly, requiring a treatment step may allow competitors to avoid infringement simply by omitting the treatment step. While the CAFC’s recent expansion of the concept of “joint infringement” in its ruling in Akamai Technologies, Inc. v. Limelight Networks, Inc. could be beneficial to the patentees in this regard by allowing for a finding of infringement by a competing diagnostics company simply by showing that treatment occurred, Akamai still must pass Supreme Court scrutiny. Even then, the legal application of Akamai to combined diagnostic and treatment steps remains untested.

  • The Future of Patent Protection in Diagnostics Remains Cloudy

    How does one protect a diagnostic test that is based on the newly identified correlation between a well-known, easily assayed marker and a disease or disorder without also requiring a treatment step? In view of the Intema decision, there may not be an adequate strategy that relies upon patents. Commentators have suggested that a diagnostics company may be better served by maintaining its discovered correlation as a trade secret.

    Maintaining a diagnostic test as a trade secret, however, presents numerous commercialization and regulatory challenges. Others have suggested that the Congress could create a regulatory exclusivity for diagnostic tests akin to that provided to new drugs and biologics. While feasible, this solution does not appear forthcoming in the near term.

    In sum, the patent-eligibility of many claims to diagnostic tests remains in doubt. The Intema decision, while not expanding on the underlying law, represents an application of the Mayo and Myriad decisions that will be concerning to diagnostic companies. What remains unknown is whether these decisions will result in a slowing of innovation in the field of diagnostics. Only time will tell.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Climate Change and Disease

Are the incursions of dengue fever and West Nile virus into North America just the tip of the iceberg of insect-borne diseases that are migrating due to a warming planet?