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Federal Circuit in PerkinElmer Finds Diagnostic Method Claims Patent-Ineligible

December 14, 2012

By: Deirdre E. Sanders

Hamilton Brook Smith Reynolds Alert

Continuing with a recent line of cases directed to fundamental patent eligibility issues, the Court of Appeals for the Federal Circuit has recently held in PerkinElmer, Inc. v. Intema Ltd. that certain claimed diagnostic methods were patent-ineligible subject matter under 35 U.S.C. § 101.  In the past few years, the Supreme Court and the Federal Circuit have been re-examining and restating the law of patent eligibility.  Although the PerkinElmer decision was designated nonprecedential by the Federal Circuit, it provides further insight into the Federal Circuit’s views on this topic and highlights the fact that the determination of patent eligible subject matter remains unclear.

In PerkinElmer, at issue was whether the claims, which were directed to methods of determining the risk of fetal Down’s syndrome, were patent-eligible.  The claimed methods involved assaying samples, measuring screening markers from ultrasound scans in the first and second trimesters and determining the risk of Down’s syndrome by comparing the measured levels of the screening markers with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies.

The Federal Circuit found that the claims are directed to a mental process, namely “comparing data to determine a risk level,” and to a law of nature, namely “the relationship between screening marker levels and the risk of fetal Down’s syndrome.”  Laws of nature, natural phenomena and abstract ideas are not patentable.  The Federal Circuit further found that Intema did not add anything to the claims to bring them within the scope of patent eligibility, because “[p]urely ‘conventional or obvious’ ‘presolution activity’ is normally not sufficient to transform an ineligible law of nature into a patent-eligible application of such a law.”

Recent Cases found Transformations Insufficient to Render Claims Patent Eligible

In reaching its decision, the PerkinElmer court considered two recent cases that found certain process claims ineligible under Section 101: Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012) (“Mayo”), and Association for Molecular Pathology v. PTO, 689 F.3d 1303 (Fed. Cir. 2012) (“Myriad”).

In Mayo, the Supreme Court held patent-ineligible a method of administering a compound to a patient, determining the level of metabolites and then determining the effective dosage of the compound.  Reversing a Federal Circuit holding, the Supreme Court found that the claims were not patent eligible because they are drawn to a law of nature and the transformations involved in the claimed steps were conventional and did not confer patentability.

In Myriad, the Federal Circuit found that a claimed method for identifying cancer-predisposing mutations in human gene sequences was unpatentable.  According to the Myriad court, the claims recited purely mental abstract steps, namely, comparing or analyzing gene sequences.  Although Myriad argued that the process was patent eligible because it required a transformation in the extracting and sequencing of the DNA, the Federal Circuit disagreed, finding that the transformative steps necessary to carry out the gene comparison were not part of the claims themselves.

In contrast, the Myriad court found patent-eligible a different claimed method which comprised comparing the growth rates of two sets of cells that had been altered with a cancer-causing human gene before and after treatment with a candidate drug.  According to the Federal Circuit, the host cells did not occur naturally and, thus, their inclusion in claims rendered the claims patent-eligible.

Conventional “Assaying a Sample” Step is Insufficient to Confer Patentability

Citing Mayo, the Federal Circuit rejected Intema’s argument that the assaying steps of its patent claims confer patent eligibility.  The court reasoned that the assaying could be performed without transforming the sample, “should science develop a totally different system for [assaying for a biochemical screening marker] that did not involve such a transformation.”

The Federal Circuit distinguished the claims from the patent-eligible method claims of Myriad, stating that the claims in PerkinElmer “include only ‘conventional steps, specified at a high level of generality,’ which are insufficient.”

Data-Gathering Steps Must Include More Than What Is Conventionally Known

The Federal Circuit also rejected Intema’s argument that the claims are patent-eligible because the recited measurement performed by an ultrasound scan involves the transformation of data into a visual depiction.  The court stated that “[n]o tangible output or visual depiction of the risk is required” and that “[t]he claims do not require that an ultrasound be taken, only that data from previous ultrasounds be assessed.”  The Federal Circuit further reasoned that even if the claims required an ultrasound to be taken, “the data-gathering steps are conventional and obvious extrasolution activity that cannot save the claims.”

The Path Forward is Unclear

The recent line of cases deciding what is and is not patent eligible subject matter does not offer a clear path for drafting defensible method claims. The PerkinElmer decision underscores the fact that the legal test for patent eligible subject matter remains a work in progress.  As a result, diagnostic method claims that just a few years ago would have been considered valid as patent eligible subject matter are now subject to question.

Although the Supreme Court granted certiorari in Myriad on November 30, 2012, the Court limited the grant to reviewing the question of whether isolated DNA molecules are patent-eligible, denying review of the patentability of Myriad’s diagnostic method claims.

For more definitive answers to these questions, we will have to continue to observe the development of the case law as more decisions emerge from the Supreme Court and the Federal Circuit.

In the meantime, strategic applicants in the diagnostic method patent field should present a number of claims of differing scope in their patent applications.  For example, applicants should consider adding claims containing specific steps and uses, unconventional or novel steps, and steps incorporating a machine or transformation which is demonstrably integral to the claimed invention.  A variety of claims will help to maximize options and flexibility to patent applicants in the face of the moving target of patent eligibility.


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