The USPTO has provided updated guidance in relation to patent eligibility of inventions involving natural products and principles in view of the Myriad and Prometheus decisions. The updated guidance provides a number of new examples specifically relating to the patent eligibility of subject matter such as vaccines, diagnostic methods and genetic screening.

Vaccine/composition claims

Example 28 confirms that isolated products of nature are not patent eligible, whereas a product of nature that has been structurally or functionally altered is patent eligible. For example, a claim directed to a vaccine comprising live attenuated pigeon flu virus was considered to be patent eligible, as the attenuated flu virus includes at least one mutation that reduces virulence compared to the naturally occurring flu virus. Conversely, a claim directed to a vaccine comprising Peptide F and a pharmaceutically acceptable carrier was deemed not to be patent eligible, as Peptide F is naturally occurring and the pharmaceutically acceptable carrier may be water – thus, the claim encompasses an isolated naturally occurring product. The Peptide F claim, however, was considered patent eligible if (a) the pharmaceutically acceptable carrier was selected from a group consisting of a cream, emulsion, gel, liposome, nanoparticle or ointment, because the claimed composition would have structural and physical differences compared to the naturally occurring counterpart, or (b) if the Peptide F is mixed with an adjuvant, as the immunogenicity of the mixture is higher than the mere sum of the immunogenicity of the individual (naturally occurring) components.

Diagnostic methods

Claims defining diagnostic methods that rely on a natural principal are frequently considered by the USPTO as encompassing a law of nature and therefore not patent eligible. Example 29 provides guidance that diagnostic method claims can be patent eligible provided they omit reference to the law of nature, for example, steps relating to diagnosis. Diagnostic method claims can also be patent eligible if they include steps that were not routine or conventional, or include a non-conventional treatment step.

In example 29, claim 1 defines a method of detecting a protein, JUL-1, (a newly identified protein marker) in a plasma sample using an antibody. This claim is considered to be patent eligible.  However, claim 2, which adds a step of diagnosing julitis when JUL-1 is detected, is not considered to be patent eligible because the correlation between detecting JUL-1 and the disease is considered to be a law of nature. Further claims, claims 3 and 4, limit the method of claim 2 to specific antibodies that were not considered to be used routinely or conventionally to detect JUL-1 at the time of the invention and therefore the claims are considered patent eligible. Claim 5 of example 29 confirms that the inclusion of a treatment step that is not a conventional step that those in this field would routinely practice also renders a diagnostic claim patent eligible.

Genetic screening

Example 31 relates to claims directed to screening gene alterations. This example confirms that claims defining the comparison of two pieces of information and that imposes no limits on how the comparison is performed are not patent eligible. Example 31, however, also details of number of genetic screening claims that are considered to be patent eligible because they define the use of methods that were not routine or conventional in identifying gene alterations.

Concluding remarks

The updated guidelines are a useful resource for applicants and reflect the USPTO’s current approach for applying 35 USC § 101 to life science technologies. It is, however, likely that applicants in the life sciences field will face uncertainty regarding patentable subject matter eligibility, particularly as 35 USC § 101 has become an attractive target for revocation.