Myriad Decision by Federal Circuit Explains Patent Eligible Subject Matter for Biological Sequences and Screening Process Claims
by Dan Constantinescu, Ph.D.
The Federal Circuit handed down its opinion in Association for Molecular Pathology v. Myriad July 29, 2011, reversing, in large part, the district court's holding that the claims are not directed to patent eligible subject matter as required by 35 U.S.C Section 101. The Court made the following holdings with respect to patent eligibility:
(1) Myriad's composition claims to BRCA1 and BRCA2 DNA sequences and to certain alterations associated with a predisposition to breast and ovarian cancers are patent eligible subject matter.
(2) Myriad's process claims for analyzing or comparing a subject's BRCA1 and BRCA2 DNA sequences with wild-type sequences to identify cancer-associated alterations are not patent eligible subject matter.
(3) Myriad's process claim for screening potential cancer therapeutics using transformed cell lines expressing altered BRCA1 and BRCA2 DNA sequences is patent eligible subject matter.
The Court concluded that the composition claims to isolated DNA sequences are patent eligible because the claims "cover molecules that are markedly different--have a distinctive chemical identity and nature--from molecules that exist in nature." The Court observed that isolated DNA is different from native DNA as found in a cell because "[i]solated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule." The Court also distinguished isolated DNA from the lines of cases dealing with purified natural elements, noting that "isolated DNA is not purified DNA. Purification makes pure what was the same material, but was previously impure. Although isolated DNA must be removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body."