All genetic research requires examining isolated genes. PERA requires patent eligibility for isolated genes

Section 101(b)(1)(D) of the Patent Eligibility Restoration Act states that “An unmodified human gene, as that gene exists in the human body” is not patentable. However, Section 101(b)(2) creates two exceptions in which the human gene or natural material would not be considered unmodified and therefore patent eligible. These two exceptions are if the gene or natural material is:

• Isolated, purified, enriched, and otherwise enriched by human activity; or

• Employed in a useful invention or discovery.

A gene cannot be studied or tested inside the human body, it must be isolated, purified, sequenced, and amplified, essentially creating a man-made product that can then be used for diagnostics and testing. Under current law because of the Myriad1 decision, the isolation, purification, etc., of a gene is not eligible for a patent. In your opinion, if PERA became law: 1. Would the exceptions in section 101(b)(2) of the bill mean that “isolated genes” are now patent eligible?

Yes, if PERA were enacted, genes isolated from the body would be patent eligible because PERA expressly requires that result.

2. As written would section 101(b)(2) abrogate the Myriad decision?

Yes. The Myriad decision stated, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…” Section 101(b)(2) of PERA includes a condition that states a gene or natural material is considered to be modified if it is isolated, purified, enriched, or otherwise altered by human activity. Thus, this section of PERA directly reverses the unanimous decision from the Myriad case. This is not an accident. Section 2, paragraph (5), part (A) of PERA states that “[a]ll judicial exceptions to patent eligibility are eliminated.” Thus, it is the intent of PERA to abrogate Myriad and all other Supreme Court precedent defining patent subject matter eligibility.