Michael Davitz, Partner at Axinn, Veltrop & Harkrider and Practice Center Contributor, recently sent in this article he wrote with colleague’s Josephine Liu and Stacie Ropka discussing recent case law on the patentability of process claims.
Not all inventions are patentable. The Federal Circuit recently handed down its decision in Myriad[i] and the Supreme Court will be hearing Prometheus[ii] in the term beginning in October 2011. The issues in both Myriad and Prometheus highlight the difficulty in determining when a claim directed to a process is patentable subject matter under § 101, a determination that is particularly troubling in many inventions related to the life sciences.
A first step for granting a patent is determining whether or not a patent application claims patentable subject-matter. In a line of cases from the late 70s to early 80s and reaffirmed in 2010, the Supreme Court explained that 35 U.S.C. § 101 is to be interpreted broadly and has articulated only three exceptions to what is patentable: (1) laws of nature; (2) physical phenomena; and (3) abstract ideas.[iii] With respect to process claims, the line between patentable “processes” and unpatentable principles or abstract ideas is not always clear. The Supreme Court has yet to provide a concrete test by which such a distinction can be made.[iv] It did, however, provide a hint in Gottschalk v. Benson stating that “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.”[v] From this pronouncement, the Federal Circuit formally presented and applied the machine-or-transformation test in In re Bilski.[vi]
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.[vii]
Although the Supreme Court agreed with the Federal Circuit’s ultimate holding in In re Bilski, it rejected the method-or-transformation test as definitive, declaring instead that it only provided a clue as to patentability.[viii] In doing so, the Supreme Court recognized that the patentability analyses for process claims applied to inventions from the Industrial Revolution may not be as useful when applied to inventions from the Information Age that are, for example, not expressly tethered to machines or other physical forms.[ix] Thus, although the need continues to exist, the analysis for making the determination must evolve as technologies evolve. However, because the Supreme Court has not itself provided alternative methods by which the patentability of process claims may be ascertained, the machine-or-transformation test remains the de facto test by which practitioners should evaluate and prosecute process claims.
At the forefront of this dialogue between the Federal Circuit and the Supreme Court to set the standard by which the patentability of process claims is to be determined, is the biotechnology industry. The Federal Circuit’s recent holding in Myriad and the Supreme Court’s acceptance of certiorari appeal for Prometheus Labs., Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010) (“Prometheus 2010”) have placed claims to therapeutic screening methods front and center. The process claims at issue in Myriad and Prometheus 2010 are emblematic of the types of claims that are drafted to processes involving computer technology, biotechnology, including stem cell research, and medical therapies, which are often not grounded in physical or other tangible forms.
In Myriad, the Federal Circuit partitioned and analyzed the process claims at issue in two groups, those drawn to comparing/analyzing DNA sequences and those drawn to screening potential cancer therapeutics.[x] The Federal Circuit concluded that the claims directed to comparing/analyzing DNA were unpatentable because they merely claimed an “abstract mental process” and contained no transformative steps.[xi] In contrast, patentee’s process claim directed to screening potential cancer therapies was patentable matter. Looking to the machine-or-transformation test to provide guidance on patentability, the Federal Circuit noted that the claim directed to screening potential cancer therapeutics included the steps of “growing” and “determining,” in addition to the “comparing” step.[xii] Reasoning that these steps indicated a transformation that is central to the purpose of the claimed process, the Court found that the addition of the “growing” and “determining” steps in the screening claim rendered the subject matter patentable under § 101.[xiii] As it now stands, the discussion in Myriad strongly suggests that process claims should explicitly recite transformative steps and that claims without such transformative steps are vulnerable to a § 101 challenge.
|A method for screening potential cancer therapeutics which comprises:
growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound,
determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and
comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
|A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises
analyzing a sequence of a . . . gene or . . . RNA from a human sample or
analyzing a sequence of . . . cDNA made from mRNA . . . .
A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises 
comparing a first sequence selected from the group consisting of a  gene . . .,  RNA . . . and  cDNA . . . from said tumor sample with a second sequence selected from the group consisting of  gene from a nontumor sample . . ., wherein a difference in the sequence . . . indicates a somatic alteration in the  gene in said tumor sample.
For now, the decision in Myriad is the final word. The biotechnology industry, however, is looking to the Supreme Court to shed some light on other alternatives in determining the patentability of process claims. All eyes are on the Supreme Court as it grants certiorari in Prometheus to consider the patentability of claims to a method of optimizing therapeutic efficacy comprising a “administering” and/or a “determining” step for a second time.[xiv]
In Prometheus Labs., Inc. v. Mayo Collaborative Services (“Prometheus 2009”), the Federal Circuit applied the machine-or-transformation test and concluded that the claims at issue were patentable because they were directed to a process that “transformed an article in to a different state or thing” the transformation being the central purpose of the process.[xv] Though Prometheus 2009 was vacated and remanded back to the Federal Circuit in light of the Supreme Court’s decision in Bilski v. Kappos, the Federal Circuit reached the same conclusion, explaining that the Supreme Court rejected the machine-or-transformation test only to the extent that it would be applied as a definitive test.[xvi] The Federal Circuit reasoned that the “administering” and “determining” steps in Prometheus’s claimed methods are “not ‘merely”’ data-gathering steps or ‘insignificant extra-solution activity’; they are part of treatment regimes for various diseases.”[xvii] Without specific guidance on which additional tests may be applied, the Federal Circuit once again looked to the machine-or-transformation test and merely paid lip service to Bilski v. Kappos by recognizing that the machine-or-transformation test guides but is not definitive in the patentability analysis.[xviii]
|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 . . . .
A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder . . . .
It is tempting to speculate that the Supreme Court has recognized the need for more guidance in analyzing process claims, but just what that guidance will be is unclear. Regardless of the outcome, the Supreme Court’s next decision in Prometheus is anticipated to provide yet another component to the ever evolving exercise that is determining patentability under § 101.[i]
[i] The question presented to the Supreme Court is:
Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.
[i] The Assn. for Molecular Path. v. U.S.P.T.O., 2011 U.S. App. LEXIS 15649 (Fed. Cir. July 29, 2011) (“Myriad”).
[ii] Mayo Collaborative Services v. Prometheus Labs., Inc., 2011 U.S. LEXIS 4764 (June 20, 2011).
[iii] See, e.g., Gottschalk v. Benson, 409 U.S. 63, 67-8 (1972); Parker v. Flook, 437 U.S. 584, 589 (1978); Diamond v. Diehr, 450 U.S. 175, 185 (1981); Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (“Bilski v. Kappos”).
[iv] Benson, 409 U.S. at 68 (holding claim directed to a method of programming a general-purpose digital computer to convert signals from binary-coded decimal form to pure binary form to be so abstract and sweeping as to cover both known and unknown used of BCD to pure binary conversion as to be unpatentable); Flook, 437 U.S. at 585 (reasoning that the identification of a limited category of useful, though conventional, post-solution applications of a mathematical formula does not create patent eligible subject matter); Diehr, 450 U.S. at 187 (holding that the process for curing synthetic rubber that includes a mathematical equation is patentable because rather than seeking to foreclose others from use of the equation, applicants are seeking only to prevent others from using the equation in conjunction with all of the other steps in the claimed process).
[v] 409 U.S. at 70.
[vi] In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008) (“In re Bilski”).
[vii] Id. at 954.
[viii] Bilski v. Kappos at 3226.
[ix] Bilski v. Kappos, at 3227.
[x] 2011 U.S. App. LEXIS 15649 (Fed. Cir. July 29, 2011). The Myriad case came to the Federal Circuit on appeal from the United States District Court for the Southern District of New York, which had concluded that all of the challenged claims were drawn to nonpatentable subject matter under the 35 U.S.C. § 101. Although the District Court decision was handed down before the Supreme Court decided Bilski v. Kappos, the Federal Circuit reasoned that Plaintiffs and Defendants had the opportunity to address that decision in developing arguments for the appeal briefs. The Federal Circuit affirmed in part and reversed in part. In addition to the patentability of the process claims, the Federal Circuit provided an opinion as to Plaintiffs’ standing to sue and the patentability of claims directed to a product, isolated DNA. In its opinion, the Federal Circuit held that there was standing on the part of at least one Plaintiff and that isolated DNA is patentable subject matter because it is not a product of nature.
[xi] Myriad, 2011 U.S. App. LEXIS, at *72.
[xii] Id. at 73.
[xiii] Id. at 74.
[xiv] Mayo Collaborative Services, 2011 U.S. LEXIS at *1.
[xv] 581 F.3d 1336, 1345-46 (Fed. Cir. 2009)
[xvi] Prometheus Labs., Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010).
[xvii] Id. at 1358.
[xviii] Id. at 1355-57.