Can you patent nature

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Scientists unearthed countless new objects and forces previously hidden from view: new sub-atomic particles and forces in physics; DNA and genes in biology; continental plates in earth science; and more.

Since , the quantity and funding of scientific research has, accordingly, exponentially increased. Beginning in the s, scientists and philosophers proposed that this growth was itself extraordinary. That is, sometimes events repeatedly, even always, occur in conjunction with one another that have no causal link between the two.

Separating repetitive accidents from repeatable causal events is the classical philosophical problem of induction. Natural complexity complicates this analysis. As a natural system becomes more complex, it becomes increasingly difficult to determine whether any observed natural relationships are either constant or causal. Isolating and identifying not simply which elements are responsible for a particular natural phenomenon, but which interactions of those elements give rise to it greatly hinders our ability to distill what causes a particular phenomenon.

In other instances, constancy and causality may exist at one level of complexity, but vanish entirely at another. A number of scientific philosophers similarly dispute the existence of constancy and causality in biology.

As the number of bodies increases, however, the law begins to break down. Strange though it may seem, for a larger number of N s, i. I do not think these distributions are real. Statistical mechanics works in a massive number of highly differentiated and highly complex situations. In the vast majority of these it is incredible to think that there is a true probability distribution for that situation; and proofs that, for certain purposes, one distribution is as good as another, do not go any way to making it plausible that there is one at all.

It is better, I think, to see these distributions as fictions. But that is the most to which we can legitimately aspire. The immune system, for example, produces antibodies, the workhorses of the immune system, in response to foreign macromolecules, or antigens. Such antibodies exist only due to human activity, and yet are created independently from human control. Second, the difficulties in defining such terms have led the Supreme Court to marginalize patent claim language.

Marginalization of Claim Language. In response to its troubles parsing claim language, the Court has marginalized, and in some cases, entirely discounted, the importance of claim language precision. In other instances, the Court has simply belittled the significance of claim language. Ultimately, this denigration of claim language has made claim drafting increasingly problematic. Technology-Specific Effects. Technologically-neutral language, however, can have technologically specific application.

Funk Brothers concerned the patenting of bacterial inoculants; Chakrabarty , recombinant bacteria; Mayo , medical diagnostic tests; and Myriad , human genes. Court of Customs and Patent Appeals. This difference in how patent eligibility is applied to biotechnology is not because these technologies do not raise the same concerns as those in the biological context. It is also surely not because nonbiological inventions are somehow less affected by natural complexity than their biological counterparts.

This recognition that patent eligibility is, itself, complex provides an important foundation for reform. Decomposition and Localization as Strategies for Natural Complexity. In neurobiology, for example, a portion of the left frontal cortex is responsible for producing speech, although not responsible for comprehending it. Harnessing decomposition and localization as strategies in simplifying complex problems first requires an understanding of where to begin. As an initial matter, one should recognize that the question is deceptively complex.

The internal combustion engine is not famous for being simple. All must be present and all must act in concert for the car to move at all. Nonetheless, in asking how the car physically moves, we can begin by isolating the locus of control by separating the system into car and driver.

Here, the system that is moving is the car itself, rather than the driver, alone. The driver is surely responsible for starting and operating the car, but it is the car that moves the driver, not the other way around. Once this is identified, we can decompose the car into various components—the engine, the drivetrain, and the wheels, for instance.

We can then localize each component to a particular function of the system: the engine is powered by gasoline and powers the drivetrain, the drivetrain powers the wheels, and so on. To be sure, decomposition and localization as strategies for simplifying complex phenomena has its limits. The appearance of emergent properties of complex systems—the behavior of which does not appear to be controlled by any particular mechanism of the individual, underlying components—makes decomposition and localization particularly difficult.

A Mechanistic Description of Patent Eligibility. Decomposition and localization appear to be especially apt strategies for solving the patent eligibility puzzle.

Constructed properly, such an analysis could also overcome the difficulties complexity generally imparts on the doctrine of patent eligibility by allowing for nuance among marginal eligibility cases, respecting claim language, and eliminating technological bias.

Identifying the Locus of Control and Decomposing Patents. It is the patent document itself—rather than extrinsic evidence, such as scientific norms, enforcement policies, or market effects—that ultimately controls whether a patent application falls within the bounds of patentable subject matter.

A patent can typically be decomposed into only two components: its claims and its specification. Under 35 U. The claims and the specification serve several functions. Claims claim. Burk and Mark A. Eisenberg famously highlighted the diversity of these approaches. At the same time, distinguishing merely broad patent claims from ones so broad they render themselves ineligible for patent protection remains a difficult task.

And while precisely resolving the contours of that question remains outside the scope of this Article, the best proposal thus far—the one proposed by Lemley, Risch, Sichelman, and Wagner—has identified five factors important to that inquiry: the generative potential of the claimed invention; the nature of invention in the industry; the pace of innovation in the field; the number of disclosed embodiments relative to the breadth of the claims; and the difference between the claimed invention and the prior art.

Whether, in making patent eligibility determinations, courts assess claim scope through the factors identified by Lemley, Risch, Sichelman, and Wagner, or others, any mechanistic description of patent eligibility should rely in part on an analysis of the scope of the contested claims.

In such instances, allowing method patents to essentially mimic these techniques—even if the particular patented use of the techniques otherwise met the remaining strictures of the patent statute—raises the specter of monopolizing the techniques themselves. Such an assessment would also reorient patent eligibility to claim language rather than scientific philosophy. Here, too, recent patent eligibility litigation proves instructive.

Building a Mechanistic Description of Patent Eligibility. Taken together, these three functions describe a mechanistic view of patent eligibility. At the same time, these factors are not always present at such extremes. There are, to be sure, close cases. And the precise metrics courts should use in analyzing these factors is well up to debate. Regarding overly broad claim scope, the factors proposed by Lemley, Risch, Sichelman, and Wagner do not appear to be an exhaustive list.

Like modern understandings of complex phenomena in the sciences, decomposition and localization here provide insight into how the poorly articulated, confusing, and seemingly contradictory area of patentable subject matter can be explained by reference to patents themselves, rather than unrelated discourses into scientific philosophy.

This is one of the principal strengths—not weaknesses—in decomposition and localization in legal analysis: it simultaneously roots legal decision-making in concrete identifiable legal factors while allowing courts the opportunity to engage in the underlying policy levers regarding technological innovation. The second function—distinguishing the claims and specification from the prior art—would seem to counsel against the validity of both the Mayo and Myriad patents.

Both were directed to core operational techniques in their respective fields—drug dosing in Mayo and sequencing in Myriad —that added only an informational component. Indeed, the Mayo patents themselves described them as such. Similarly, the operational techniques of many of the claims in the Myriad patents were also well-known to researchers at the time. The proximity between the Mayo and Myriad patents and core operational techniques in their fields strongly counsels in favor of finding the contested claims invalid.

The last function—the meaningfulness of the specification—likely cuts the other way, however. If a patient possessed the sequence variants disclosed in the patent specification, their risk for developing breast cancer increased by a calculable amount—also disclosed in the patents. Their claims do not appear overly broad, nor do their specifications disclose meaningless improvements, but their contributions above and beyond core operational techniques for diagnostics border on zero.

The Myriad patents, however, received almost universal censure from commentators and scientists alike. Without it, it would seem, patent eligibility may remain needlessly complex.

And worse yet, a branch of scientific philosophy, known as natural complexity, stresses the cognitive difficulties imposed on crafting general rules about a multi-elemental, multi-variable, interconnected concept of Nature. Today, after years of doctrinal accretion, patent eligibility has itself become complex. This analysis has several advantages to the current state of affairs: it frees patent eligibility from its focus on scientifically meaningless terms; it is likely to be politically palatable to both the Supreme Court and Congress; and it does not readily suffer from some of the difficulties patent eligibility currently poses on patent law, generally.

Such a test, regardless as to how it is ultimately crafted, is unlikely to be without its own uncertainties. But without decomposition and localization, patent eligibility will likely remain needlessly complex.

See, e. Times Mar. Diamond v. Diehr, U. Chakrabarty, U. Lemley, Inherency , 47 Wm. Lemley et al. Prometheus Labs. Holdings v. Metabolite Labs. Seed Co. Morse, 56 U. See MySpace, Inc. GraphOn Corp. So I can make claims on a device that utilizes my product. But if I patent a device now, could a future patent by a swift-moving company simply circumvent my own, if the scope of the ruling is narrowed or retracted outright?

Given the relatively new-to-the-U. So I could patent my natural product as long as I restrict the scope of my claim. But again, this is difficult to interpret, and claim scopes will probably need to be defined on a case-by-case basis, thus introducing an extra expense of at least time if not also money and the potential for subjectivity. Admittedly, there are some ridiculous patents out there that utilize natural products—patents have been granted in the last decade that apply broad plant extracts for a given use without even specifying a particular compound.

One can see where there may be a need for increased stringency. One might wonder what the current Guidance means for the discovery and implementation of new antibiotics, chemotherapeutics, vaccines, and more. Will the inability to patent natural biologics for pharmaceutical purposes deter companies from continuing to promote such products on the general market?

Perhaps companies will simply be forced to cleverly modify new compounds and other biologics from their original forms—not an unusual occurrence even prior to the Myriad ruling, if only to enhance the efficacy of a given drug or maintain a foothold in a market when an initial patent expires. This was also the issue in the early patents in this field, which predominantly related to insulin, vitamins, hormones and the like.

It can be argued that the act of purification or isolation would result in a rewardable contribution to the art. This reasoning still applies nowadays for — mostly novel — compounds isolated from plants or other organisms.

Many pharmaceutical compounds find their origin in nature salicylic acid, atropine, penicillin, taxol and isolating them has certainly contributed to the human knowledge base. However, in the last decades another form of patent on biological compounds is emerging where the invention does not so much reside in the purification or isolation of the compound, but in determining the function of the already known compound. Indeed, this relates to DNA sequences, such as genes and proteins.

And, of course, next to human genetic information there is still a wealth of naturally occurring substances genes and proteins in other animals, plants and micro-organisms that have yet to be unravelled.

Public concern Next to patent arguments, there is also an increasing public concern which should be taken into account. In Europe, the oppositions that have been filed against the Myriad patents resulted in such strong limitations of the patents on sheer patentability grounds that they are no longer a public concern. Further, as follows from the arguments above, patenting of DNA conflicts with the reward theory since the only contribution of the inventor is finding a use or application of the DNA.

The question now is whether the current view on patentability of naturally occurring substances such as DNA and the scope of such patents should be altered. Cefetra B. This means that any other use of a patented genetic sequence would be free from infringement.

Although a purpose-bound protection for naturally occurring substances seems justified in view of the reward theory, there are still some considerations to make. First of all, should there be a difference between biological material and non-biological material? For instance, if a new chemical compound, e. Secondly, imagine that an inventor improves upon a naturally occurring substance. According to the above system, absolute protection would then again be justified. Would that change, if after filing of the patent application, it appears that such an altered molecule can actually be found in nature?

According to the reward theory, the inventor was the first to provide the compound and to describe how to make it, and should therefore be entitled to absolute protection.