Supreme Court Impacts Medical Diagnostics Patent Claims

Prometheus Gets De-Livered Again:
Vacated and Remanded by the Supreme Court in the Wake of Bilski

Gregory J. Carlin   gcarlin@mcciplaw.com 

The Bilski decision was handed down by the Supreme Court after a long wait on June 28, 2010.  The Court upheld the Federal Circuit’s ruling that the claims at issue were not patentable subject matter.  For proponents of reduced patent coverage for business method claims it was a Pyrrhic victory.  The resulting language of the opinion makes it clear that the decision is very much restricted to the facts and that the machine or transformation test is not the sole test for patentable subject matter.  With lesser fanfare, the Court also granted certiorari on Mayo v. Prometheus Laboratories, Inc., issuing a decision the following day.  The decision in Prometheus was only a single paragraph, vacating and remanding the case to the Federal Circuit for further consideration in light of Bilski.

The question, then, for medical technology companies is whether, and to what extent, medical diagnostic technologies are patentable subject matter under 35 U.S.C. §101.  We try to answer the question below and provide some practical guidelines for our clients seeking to improve their chances for obtaining (or repairing) patent coverage of medical diagnostic methods.

Bilski v. Kappos

Highlights of Bilski include:

• The machine-or-transformation test is “important” but not the sole test for medical diagnostics.
• Patentable subject matter definitely includes “advanced diagnostic medicine techniques” that might qualify under criteria other than the machine-or-transformation test.
• A balance should be struck between protecting inventors and granting monopolies over application of general principles.

Despite agreeing with the outcome, the Court in Bilski chastises the Federal Circuit for holding that the sole test for patentable subject matter is the machine-or-transformation test.  In fact, the Court notes that the Federal Circuit should not read into the patent laws limitations and conditions that the legislature has not expressed and, further, that there is no ordinary meaning of the word “process” that would require it to be tied to a machine or transformation of an article.[i]  The Court also notes that it is incorrect to imply that the term “process” must be tied to a machine or transformation in the language of §100(b) which defines a process as a “process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”  Process, instead, stands alone as its own definition.

The Court also notes that nothing in the term “process” categorically excludes business methods and points out that §273, which provides the defense of prior use against business method patents, specifically contemplates the patentability of some business methods.  On the other hand, the Court states that “while §273 appears to leave open the possibility of some business method patents, it does not suggest broad patentability of such claimed inventions.” Despite this decision, the Court notes that the machine-or-transformation test is still “a useful and important clue” for determining whether some claimed inventions are processes under §101.

The Court also throws a lifeline to medical technology proponents by pointing out that the laws for patentability need flexibility for dealing with inventions in the “Information Age.”  It cites the amicus brief filed by the Biotechnology Industry Organization expressing concern about the machine-or-transformation test creating uncertainty as to the patentability of “advanced diagnostic medicine techniques.”  Instead of lumping diagnostics with business methods, the Court notes that §101’s terms suggest that new technologies (i.e., the “Information Age” technologies that include “advanced diagnostic medicine techniques”) may call for new inquiries other than the machine-or-transformation test which is more fit for processes of the “Industrial Age.”  The Court then immediately states that it is not commenting on the patentability of any particular one of the Information Age technologies.  Instead, the Court insists that a balance should be struck between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles.[ii]

Mayo v. Prometheus at the Federal Circuit

Highlights of Prometheus include:

• Drug administration is not a natural phenomenon and is transformative under the machine-or-transformation test.
• Determination of metabolite levels not otherwise apparent from mere inspection is transformative under the machine-or-transformation test.
• Transformations must be central to the purpose of the claims and confine the patent monopoly to qualify as patentable subject matter.

Because the Supreme Court made no substantive decision in Prometheus, it’s valuable to examine the Federal Circuit’s vacated Prometheus decision for insight as to where it will go on remand.  In its decision on Prometheus, the Federal Circuit relies entirely on application of its “sole” test for patentable subject matter, the machine-or-transformation test.

As a refresher, the Federal Circuit in Prometheus lays out the machine or transformation test as a two-prong test followed by two additional issues.  To be patentable subject matter under §101, the claimed process must be 1) tied to a particular machine or apparatus, or 2) transform a particular article into a different state or thing.[iii]  If one of those prongs is met, the test further requires that “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.”  Paraphrasing, the Federal Circuit in Prometheus uses the worrisome (for medical diagnostic proponents) language that mere “data-gathering steps” cannot be relied upon to prove that the claimed process is transformative.

The Federal Circuit examined Claim 1 of U.S. Pat. No. 6,355,623 (amongst others) in its determination that the subject matter was patentable under §101:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8×10⁸ red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8×10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Federal Circuit indicates that the administering and determining steps, (a) and (b), are independently transformative.  The “transformation is of the human body following the administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined.”[iv]  The Federal Circuit further states that:

The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.  More specifically, Prometheus here claimed methods for optimizing efficacy and reducing toxicity of treatment regimes for gastrointestinal and non-gastrointestinal autoimmune diseases that utilize drugs providing 6-TG by administering a drug to a subject.  The invention’s purpose to treat the human body is made clear in the specification and the preambles of the asserted claims.[v]

The Federal Circuit also finds that the claims are not merely natural correlations by stating that the “fact that the change of the administered drug into its metabolites relies on natural processes does not disqualify the administering step from the realm of patentability.”  Beyond just metabolic effects, the Federal Circuit also notes, the transformation includes administering the drug, which itself is not a natural process.

In examining another claim without the administering step, the Federal Circuit also endorses step (b) determining the level of 6-thioguanine as involving a transformation “for those levels cannot be determined by mere inspection.”  They require some form of manipulation, such as chromatography, to extract the metabolites from a bodily sample and determine their concentration.   Further, the Federal Circuit notes that the steps (a) and (b) are “central to the purpose of the claims” as the measurement enables adjustment of dosage and determination, by working a transformation on physical substances, sufficiently confines the patent monopoly.[vi]

The Federal Circuit also rules that the administering and determining steps are not merely data-gathering or insignificant extra-solution activity.  The administering and determining steps are part of the treatment protocol and are transformative, and sufficiently confine the patent monopoly.[vii]

Practical Tips in Light of Remand by the Court

The Supreme Court’s grant of cert on Prometheus only to then vacate it and send it back down to the Federal Circuit for further consideration is an interesting contrast with the Court’s language in Bilksi.  In Bilski the Court says that medical diagnostic methods are indeed patentable subject matter and designated the machine-or-transformation test an “important tool” in determining patentable subject matter.  One would think that because the decision in Prometheus by the Federal Circuit is based on application of the machine-or-transformation test on a medical diagnosis and treatment process, the decision would have been affirmed and not vacated.  It remains to be seen whether the Federal Circuit merely confirms its prior decision, or takes the remand as a hint to develop and apply a new test.  In the interim, inventors of medical diagnostic technologies are faced with decisions on filing and prosecution strategy.

It is our opinion that medical diagnostic technology patent owners should take a conservative approach by crafting at least some claims that would, at a minimum, meet the machine-or-transformation test as laid out by the Federal Circuit in its decision in Prometheus.  Meeting the machine-or-transformation test worked for Prometheus at the Federal Circuit and was endorsed as being an important tool by the Supreme Court.  Although showing promise that expanded criteria may be developed for “advanced diagnostic medicine techniques,” the Supreme Court left us with no guidance as to what those criteria might include.

Practical tips for meeting the machine-or-transformation test include:

• Add a step that includes administration of some agent or device, or taking a sample, in such manner that “transforms” the patient.
• Add a step that includes determining natural levels that are not apparent from mere inspection, i.e., require some tools or processes for revealing the information.
•  Clearly state the treatment purpose in the specification and preamble of the claims.

Patent owners may also want to review their portfolio for important technologies with broad or abstractly-worded claims and apply for reissue.  For patents that issued more than two years ago, a narrowing reissue should still suffice to introduce additional claim language carefully selected to meet the machine-or-transformation criteria.