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September 18, 2009

Patented Treatment

Prometheus Labs got patents (6,355,623; 6,680,302) on "methods for calibrating the proper dosage of thiopurine drugs, which are used for treating... autoimmune diseases." "[N]on-responsiveness and drug toxicity may complicate treatment in some patients. To that end, the patents claim methods that seek to optimize therapeutic efficacy while minimizing toxic side effects." The claims go to two steps: 1) administer the drug, and 2) determine "the levels of the drug's metabolites." Yes, drug treatment is patentable.

Prometheus Laboratories v. Mayo Collaborative Services (CAFC 2008-1403) precedential

Prometheus Labs sued Mayo.

Mayo persuaded the district court to grant "summary judgment of invalidity, arguing that the patents in suit are invalid because they claim unpatentable subject matter under 35 U.S.C. § 101. Specifically, Mayo contended that the patents impermissibly claim natural phenomena--the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity--and that the claims wholly preempt use of the natural phenomena."

The court reasoned that, as construed in the November 2005 summary judgment order, the claims have three steps: (1) administer the drug to a subject; (2) determine metabolite levels; and (3) be warned that an adjustment in dosage may be required. The court stated that the fact that inventors framed the claims as treatment methods does not render the claims patentable. Rather, the court found that the "'administering' and 'determining' steps are merely necessary data-gathering steps for any use of the correlations" and that "as construed, the final step--the 'warning' step (i.e. the 'wherein' clause)--is only a mental step." Invalidity Opinion, 2008 WL 878910, at *6. The court noted that the warning step does not require any actual change in dosage and that "it is the metabolite levels themselves that 'warn' the doctor that an adjustment in dosage may be required." Id.

Second, the district court found that those correlations were natural phenomena and not patentable inventions because the correlations resulted from a natural body process.

The CAFC extensively wove Bilski in.

The issue before us is whether the claims meet the requirements of § 101, so we begin with the text of the statute. Section 101 provides that:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.

35 U.S.C. § 101. According to § 100(b), "[t]he term 'process' means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or materials." 35 U.S.C. § 100(b). But, as noted in In re Bilski, this definition of process is "unhelpful" because the definition itself uses the term "process." 545 F.3d 943, 951 n.3 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009). Thus, we turn to the case law to guide our understanding of what constitutes statutory subject matter under § 101.

The Supreme Court has construed § 101 broadly, noting that Congress intended statutory subject matter to "include anything under the sun that is made by man." Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). It is well-established, however, that this sweeping statement does not indicate that § 101 is unlimited and embraces every discovery:

[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity. Such discoveries are "manifestations of . . . nature, free to all men and reserved exclusively to none."

Id. (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)). More specifically, the Court has held that a claim to a process is not patent-eligible if it claims "laws of nature, natural phenomena, and abstract ideas." Diamond v. Diehr, 450 U.S. 175, 185 (1981); see also Gottschalk v. Benson, 409 U.S. 63, 67 (1972) ("Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.").

At the same time, it has also been established that "while a claim drawn to a fundamental principle"--i.e., a law of nature, natural phenomenon, or abstract idea--"is unpatentable, 'an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.'" Bilski, 545 F.3d at 953 (quoting Diehr, 450 U.S. at 187). The key issue for patentability, then, at least on the present facts, is whether a claim is drawn to a fundamental principle or an application of a fundamental principle. Although this inquiry is hardly straightforward, following the Supreme Court, we articulated in Bilski a "definitive test" for determining whether a process is patent-eligible under § 101: "A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Id. The machine-or-transformation test is a "two-branched inquiry," i.e., the patentee "may show that a process claim satisfies § 101 either by showing that his claim is tied to a particular machine, or by showing that his claim transforms an article." Id. at 961.

The machine-or-transformation test has two further aspects: "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." Bilski, 545 F.3d at 961-62 (citations omitted). "This transformation must be central to the purpose of the claimed process." Id. at 962. Thus, in most cases, one cannot ground the transformative nature of a process in a step that is "insignificant extra-solution activity" or merely a "data-gathering step." See id. at 963 ("Further, the inherent step of gathering data can also fairly be characterized as insignificant extra-solution activity."). In other words, if steps of a method are included for the purpose of data-gathering rather than being "central" to the purpose of the process, the patentee likely cannot rely on the data-gathering steps to prove that the claimed process is transformative and thus drawn to patentable subject matter. See id. at 963 (stating that mere data-gathering will not, "at least in most cases, . . . constitute a transformation of any article").

The Supreme Court has also made clear that the patent eligibility of a claim as a whole should not be based on whether selected limitations constitute patent-eligible subject matter. See Bilski, 545 F.3d at 958 (citing Diehr, 450 U.S. at 188; Parker v. Flook, 437 U.S. 584, 594 (1978)). As noted in Diehr, the Court has specifically stated that it is "inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis." 450 U.S. at 188. Moreover, it is improper to consider whether a claimed element or step in a process is novel or nonobvious, since such considerations are separate requirements set forth in 35 U.S.C. §§ 102 and 103, respectively. Bilski, 545 F.3d at 958 (citing Diehr, 450 U.S. at 188-91).

All the arguments led the appeals court to this natural maxim:

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.

[T]he methods of treatment claimed in the patents in suit squarely fall within the realm of patentable subject matter because they "transform an article into a different state or thing," and this transformation is "central to the purpose of the claimed process." See Bilski, 545 F.3d at 962. The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug's metabolites that enable their concentrations to be determined.

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. As Prometheus points out, quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law. Transformations operate by natural principles. The transformation here, however, is the result of the physical administration of a drug to a subject to transform--i.e., treat--the subject, which is itself not a natural process. "It is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter." See Bilski, 545 F.3d at 962. The administering step, therefore, is not merely data-gathering but a significant transformative element of Prometheus's claimed methods of treatment that is "sufficiently definite to confine the patent monopoly within rather definite bounds." Id. (quoting Benson, 409 U.S. at 70).

The determining step, by working a chemical and physical transformation on physical substances, likewise sufficiently confines the patent monopoly, as required by Bilski.

The crucial error the district court made in reaching the opposite conclusion was failing to recognize that the first two steps of the asserted claims are not merely data-gathering steps.

The CAFC resolved that "[t]he presence of a mental step does not detract from patentability."

We agree with the district court that the final "wherein" clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus's claimed methods as a whole. The data that the administering and determining steps provide for use in the mental steps is obtained by steps well within the realm of patentable subject matter. The addition of the mental steps to the claimed methods thus does not remove the prior two steps from that realm.

As we explained in Bilski,

[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter. After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under § 101.

545 F.3d at 958 (citations omitted). Such is the case here... When viewing the treatment methods as a whole, Prometheus has claimed therapeutic methods that determine the optimal dosage level for a course of treatment.

Using natural processes in the course of treatment does not obviate patentability.

The claims cover a particular application of natural processes to treat various diseases, but transformative steps utilizing natural processes are not unpatentable subject matter. Moreover, the claims do not preempt natural processes; they utilize them in a series of specific steps. See Diehr, 450 U.S. at 187 ("Their process admittedly employs a well-known mathematical equation, but they do not seek to preempt the use of that equation. Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process."). Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle. See Bilski, 545 F.3d at 954 (characterizing the machine-or-transformation test as "a definitive test to determine whether a process is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself"). The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of transformative steps comprising particular methods of treatment. See id. ("[A] claimed process that transforms a particular article to a specified different state or thing by applying a fundamental principle would not pre-empt the use of the principle to transform any other article, to transform the same article but in a manner not covered by the claim, or to do anything other than transform the specified article."). It is clear that these methods of treatment are § 101 patentable subject matter.

Reversed and remanded.

Posted by Patent Hawk at September 18, 2009 1:22 AM | § 101

Comments

Has anyone figured out what is different in the "revised" release of the Prometheus decision as opposed to the original release of the opinion?

Thanks

Posted by: step back at September 18, 2009 1:49 AM

Step Back,

Apparently, only an error in naming one of the law firms.

Posted by: EG at September 18, 2009 4:57 AM