The USPTO takes the law into its own hands

On the basis of the US Supreme Court landmark Myriad and Prometheus decisions, the US Patent and Trademark Office (USPTO) has recently, without any public consultation, issued new guidelines for determining patent eligibility of claims reciting or involving “laws of nature, natural phenomena and natural products”. Significantly, the guidelines appear to extend beyond the scope of the relevant Supreme Court decisions as they remove from patent eligibility any isolated product of nature.

In the last two years the US Supreme court has issued two landmark decisions in relation to the patent eligibility of “laws of nature” and “natural products”. Specifically, in March 2012 it was controversially held by the US Supreme Court, in Mayo Collaborative Services v Prometheus Laboratories Inc (the Prometheus decision), that a ‘relationship’ between the concentrations of blood metabolites and response to a therapeutic drug, claimed in patents owned by Prometheus Laboratories Inc was not patentable because it represented a “principle of nature”. Subsequently, in 2013 the US Supreme Court ruled that naturally-occurring DNA sequences are products of nature and not patent eligible merely because they have been isolated (Association for Molecular Pathology v Myriad Genetics Inc (the Myriad decision)). However, the Myriad decision gave no specific consideration to the patent eligibility of naturally-occurring products other than nucleic acid sequences, for example isolated cells and proteins, such as antibodies.

Summary

Presumably, on the basis of the Myriad and Prometheus decisions, the USPTO has recently, without any public consultation, issued new guidelines for determining patent eligibility of claims reciting or involving “laws of nature, natural phenomena and natural products”. Significantly, the guidelines appear to extend beyond the scope of the relevant Supreme Court decisions as they remove from patent eligibility any isolated product of nature. Thus, the new patentability standard introduced by the guidelines will potentially be detrimental to biotechnology innovators who develop important new medical products derived from natural sources and who rely on patent protection for bringing their innovation to market for the benefit of the general public.

The USPTO Guidelines

At the heart of the guidelines is the question, “does a claim as a whole recite something significantly different than the judicial exceptions of laws of nature/natural principles, natural phenomena and natural products?”

The guidelines state that a “significant difference” can be shown in multiple ways, such as:

  1. the claim includes elements or steps in addition to natural phenomena and natural products that practically apply the natural phenomena or natural products in a significant way, for example by adding significantly more to natural phenomena and natural products; and/or
  2. the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature.

The guidelines also contain six factors that weigh toward patent eligibility and six factors that weigh against patent eligibility.

Two key factors that weigh towards patent eligibility are:

  1. the claim relates to a product that initially appears to be a natural product but after analysis is determined to be non-naturally occurring and is markedly different from a naturally occurring product; and
  2. the claim includes additional elements/steps that impose meaningful limits on the scope of the claim so that others are not excluded from using the natural phenomena or natural products.

Markedly different

In relation to point (a) above, the guidelines indicate that the term “markedly different” means a significant difference that is more than trivial. However, a marked difference can result from routine activity or manipulation of natural products. For example, the preparation of cDNA is routine but cDNA is patent eligible. Likewise, a hybrid plant that is markedly different from a naturally occurring plant is considered patent eligible subject matter even though it may have been created via routine plant generation processes.

Examples provided in the guidelines demonstrate a “marked difference” on the basis of both a structural and functional difference relative to a naturally-occurring product. It is specified in the guidelines that a functional difference is not necessary in order to find a marked difference. However, the presence of a functional difference resulting from a structural difference makes a stronger case that the structural difference is a marked difference.

Meaningful limitations referred to in a claim

In relation to point (b) above, additional elements/steps that impose meaningful limits on the scope of the claim may include steps of administering a natural product at a specific dosage regime. Alternatively, a claim that refers to a process involving a natural principle may be patent eligible if it includes steps that define how the principle is applied and that allow others to use the natural principle in other ways.

Importantly, the guidelines indicate that combining naturally-occurring components does not overcome the patentability exclusion.

Conclusion

The new guidelines issued by the USPTO will impact claims directed to a broad range of different isolated products derived from nature including, but not limited to, proteins, bacteria, plants, antibiotics and cells (such as stem cells). The guidelines will also potentially affect claims directed to methods of diagnosis that are based on a naturally-occurring relationship. It is clear that patents directed to laws of nature, natural phenomena and natural products will require carefully drafted claims which define subject matter that is considered patent eligible in view of the new US patentability standard. There is little doubt that this area of US law will continue to evolve as the Courts consider the Myriad and Prometheus decisions.