Diagnostics 101: The Expanding Doctrine of Preemption
By Reza Ghafoorian, M.D., Esq.
Until Supreme Court pushed it into the forefront in the BILSKI decision, 35 USC 101 used to loom in the background of patent prosecution. Since BILSKI, the notion of abstract ideas and natural phenomena–to be aligned with “ideas” (e.g., mathematic formula or natural relationships) has quickly crept into biotechnology patent prosecution and seriously crippled efforts to secure patent protection for biomedical discoveries, especially in the diagnostic area.
Today, 35 USC 101 purview encompasses determining patent eligibility for claims reciting natural phenomenon or natural products. Courts began defining the scope of patent eligibility for bio-method claims in MAYO followed by MYRIAD, which paved the way to patent ineligibility of naturally occurring bio-products. Now, claims which rely solely on a natural correlation to render a diagnosis or recite only a natural product, such as an isolated gene or cell, are considered patent ineligible unless the claims add “significantly more” to the claimed natural law/product. In MAYO, “the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts:” (A) Determine whether the claims at issue are directed to a patent-ineligible concept; (B) if the answer is yes, then consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether additional elements ‘transform the nature of the claim’ into a patent-eligible application. According to the Supreme Court, “the second step of this analysis is a search for an ‘inventive concept’- i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’
SEQUENOM represents yet another recent court decision in a string of controversial decisions about scope of patent eligibility under 35 USC 101. In SEQUENOM, the Federal Circuit held that the “principle of preemption is the basis for the judicial exception to patentability.” More specifically, the court held that a claim is patent ineligible under 35 USC 101 even when it preempts practice of natural phenomenon using one out of several different well-known, routine and conventional practice methods. To clarify, if a method of diagnosis recites a correlation between gene expression and a disease and employs Polymerase Chain Reaction to measure gene expression, the claim is preemptive for that natural law (i.e., patent ineligible) even when the expression of the claimed genes can be measured by means other than PCR.
The following are examples of natural phenomenon claiming of which would subject the claim to 35 USC 101 purview:
1) A relationship between expression levels of one or a set of naturally occurring markers and a disease. (i.e., diagnosis or classification claims); or
2) A relationship between the expression of a set of naturally occurring markers and progression of disease (i.e., prognosis claims).
In claims a “relationship” associated with a natural phenomenon is often presented by expressly or inherently reciting a “comparing.” For example, a claim for diagnosing bladder cancer may include the steps of determining expression levels of certain markers and comparing the expression levels of the markers to control. In view of the recent court decisions, these “relationships” are considered mere discoveries which do not include interference of the hand of man. Thus, they are not “made by man.”
Under 35 USC 101, patent eligibility hinges on whether a claim recites more than a natural phenomenon and whether it preempts others from practicing the entire natural law. In other words, a natural phenomenon in a claim must be meaningfully applied to render the claim patent eligible. Mere recitation of the natural phenomenon, without something “significantly more,” preempts others from using that natural phenomenon.
Therefore at its core, determining whether a claim subject matte recites an ineligible subject matter, 35 USC 101 has three main prongs:
- A) Whether a natural phenomenon is recited in the claims, such as, by reciting a correlation or natural relationship;
- B) Whether the claims preempt others from using a natural phenomenon in its entirety; and
- C) Whether the claims add something “significantly more” to the claimed natural phenomenon.
There is an inherent stress between the first two prongs of 35 USC 101 which will eventually lead to further expansion of the current scope of the statutes. To analyze the relationship between the first two prongs of the 35 USC 101 statute, let us consider the following set of claims:
Example Claim 1. A method, comprising:
administering to a subject with immune-mediated gastrointestinal disorder a drug providing Chemical A.
Example Claim 2. A method, comprising:
administering to a subject with immune-mediated gastrointestinal disorder a drug providing Chemical A;
determining the level of Chemical A in said subject;
wherein the level of Chemical A 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 Chemical A greater than about 400 per pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
As discussed above, the concept of a natural phenomenon requires either a natural product or a natural relationship or correlation. One way of identifying the natural relationship is by determining whether the steps expressly or impliedly recite a step of “comparing” to control. Without this correlation a claim may not fall within the purview of 35 USC 101. Furthermore, because claims must recite an entire natural phenomenon or natural relationship to fall within the purview of 35 USC 101, making a claim narrower or broader does not always affect patent eligibility under the current interpretation of this statute. This aspect of 35 USC 101 distinguishes it from 35 USC 102 or 103 statutes, under which broadening or narrowing claims would inevitably include or exclude prior art to determine patent eligibility. For instance, 35 USC 101 would not capture the broadly drafted Example Claim 1. In contrast, the purview of 35 USC 101 encompasses the narrower Example claim 2, which recites a correlation and relationship between the disease and the level of the drug metabolites.
The fact that a broader claim language may not invoke 101 is in direct conflict with the preemption prong of the same statute as it is now interpreted by various courts. Accordingly, the requirement that a claim must recite a whole natural relationship before it falls within the scope of 35 USC 101 inevitably causes a stress with the preemption requirement. In order for both prongs A and B to coexist, courts must further reconcile these two forces, which reconciliation will likely lead to expansion of purview of 35 USC 101, as discussed further below.
Thus far, the courts have applied a one-way test in defining the relationship between the first two prongs of 35 USC 101: When a claim recites a whole natural phenomenon without steps which add “significantly more,” the claim is considered patent ineligible and necessarily preempts others from practicing the entire natural phenomenon. For example, the SEQUENOM court considered the issue of preemption moot because the claims recited a natural phenomenon in its entirety. Therefore, it is safe to assume that if the first prong is satisfied, the second prong is automatically satisfied and the claims inherently and always will preempt others from practicing the claimed natural phenomenon. However, the court did not provide guidance about how to apply the preemption prong to a claim which does not recite a natural phenomenon in its entirety (i.e., does not satisfy the first prong).
Consider the Example Claim 1:
A method, comprising: administering to a subject with immune-mediated gastrointestinal disorder a drug providing Chemical A.
The Example Claim 1 fails to perfect the required natural relationship because it does not recite a natural correlation. Accordingly, the Example Claim 1 does not invoke the first prong of 35 USC 101. In fact, Example Claim 1 may be considered a routinely examined claim reciting a new use of an old compound. The new use of an old compound presents a man-made process not covered under 35 USC 101 and also patent eligible under 35 USC 102 and 103. However, Example Claim 1 may cover different aspects of utility. One aspect of Example Claim 1 encompasses the method of Example Claim 2 (i.e., reciting an impermissible natural relationship). If Example Claim 1 is allowed, it necessarily preempts others from practicing the method of Example Claim 2. Yet, no guidance exists regarding whether to apply the preemption prong to a claim which encompasses different utilities including a patent ineligible utility.
Currently, broad claims which encompass a patent ineligible utility are allowed without considering application of 35 USC 101. Eventually, the courts will have to reconcile the stress between the first two prongs of 35 USC 101, which reconciliation may lead to further expansion of the statute and catastrophic restrictions in the field of bio-diagnostics. As discussed above, this expansion has already begun as evidenced by the claims which were held patent ineligible by the court in SEQUENOM:
- A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:
amplifying a paternally inherited nucleic acid from the serum or plasma sample; and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
In SEQUENOM, the court revealed some inter-relationship between the first two prongs of 35 USC 101. According to the this holding, the court expanded the scope of 35 USC 101 to capture any manipulation of a natural phenomenon or natural product, such as methods of discovering, identifying, isolating or amplifying the natural phenomenon using generally well-known, routine and conventional methods. The SEQUENOM court has essentially presented yet another broader hybrid test to reach upstream methods related to and leading to discovery of natural phenomenon. This new broad test seems to be a hybrid consisting of the directives of MAYO and MYRIAD. By this hybrid test, court required that if a claim “begins and ends with a natural phenomenon” (including a natural relationship – MAYO or natural product – MYRIAD) the claim is patent ineligible. This test applies regardless of how innovative or routine it is to, for example, discover an element in nature. The new hybrid test may render patent ineligible a claim reciting any complex method of manipulation of a natural product or phenomenon using routine or well-known methods even if this effort is directed to identifying natural relationships or products not previously discovered. At least under 35 USC 103 obviousness rejection, applicants could argue secondary considerations, such as failure of others, commercial success, or unexpected results, to overcome the obviousness rejection.
The SEQUENOM court in effect reduced the importance of the preemption prong at least for instances when a natural phenomenon is expressly or impliedly recited in a claim and the claim “begins and ends with the natural phenomenon.” However, the court has not yet opined on the importance of the preemption requirement in claims which do not recite but preempt natural phenomenon, such as Example Claim 1. When the court is faced with this scenario, it must again reconcile the relationship between preemption and natural phenomenon. This time, the preemption prong will prove more important than the natural phenomenon prong.
One logical outcome of reconciling the first two prongs of 35 USC 101 in claims which do not recite the natural phenomenon will lead to further expansion of 35 USC 101 to include sanctions against broad claims (e.g., Example Claim 1) which encompass as one utility a natural phenomenon. Under such regime, if one aspect of a claim falls within the purview of 35 USC 101, such as in Example Claim 1, the courts may require amending the claim to exclude from its patent monopoly the preemptive subject matter. One manner of achieving this is by requiring that the claim employ narrow transitional language, such as “consisting of.” Regardless of how the claims are amended, the expansion of 35 USC 101 power seems inevitable in the near future.
On a positive note, this and similar conflicts arising out of the current interpretation of 35 USC 101 and the ever expanding purview of this statute may encourage congress to statutorily redefine 35 USC 101 to relieve bio-diagnostics from the current state of affairs which preempts the prospect of commercial success for much of the industry.
 See, BILSKI v. KAPPOS, 61 U.S. 593, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010)
 See, MAYO COLLABORATIVE SERVICES, DBA MAYO MEDICAL LABORATORIES, et al. v. PROMETHEUS LABORATORIES, INC., 566 U.S. _, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)
 ASSOCIATION FOR MOLECULAR PATHOLOGY v. MYRIAD GENETICS, 569 U.S. _, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)
 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618 (December 16, 2014)
 See, ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC., Decision No. 2014-1139, 2014-1144, 8 (Fed. Cir. 2014)
 Id.; see also DIGITECH IMAGE TECHS., LLC v. ELECS. FOR IMAGING, INC., 758 F.3d 1344, 1351 (Fed. Cir. 2014) (Without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.).
 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC., Decision No. 2014-1139, 2014-1144, 8 (Fed. Cir. 2014)
 See, SEQUENOM, at 14, citing ALICE CORP. v. CLS BANK INT’L, ___ U.S. ___, 134 S. Ct. 2347, 2354 (2014) (“We have described the concern that drives this exclusionary principal as one of pre-emption”). For this reason, questions on preemption are inherent
 See, SEQUENOM, at 14-15.
 See, DIAMOND v. CHAKRABARTY, 447 U.S. 303, 206 U.S.P.Q. 193 (1980)
 Example Claim 2 was drafted based on the disputed claim in MAYO, supra.
 See, SEQUENOM, supra, at 14-15.
 See, SEQUENOM, supra, at 10.