Invalidity, Patentability

In a long-awaited decision in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., the U.S. Supreme Court held on June 13, 2013 that naturally-occurring, isolated genes are not patentable because they do not constitute patentable subject matter under the Patent Statute.  With this decision, another chapter has been written in the evolving law of “statutory subject matter,” which concerns what types of things can be patented regardless of how new (i.e., novel and non-obvious) they are.

The patent holder, Myriad, identified the precise location and sequence of two genes, BRCA1 and BRCA2.  Mutations of these genes were determined to be associated with a significant increase in a risk of breast cancer.  Myriad ultimately used the isolated genes to develop a test for breast cancer.  However, they obtained patent claims on the isolated genes themselves.  The issue of whether methods of using the isolated genes to test for breast cancer was not decided.

“Genes” are portions of a DNA molecule that affect certain hereditary traits.  Thus, the claims at issue in Myriad concern isolated DNA sequences.  Techniques for performing the isolation are well known.  The difficulty arises in identifying which genes are relevant for a particular disease or condition (e.g., breast cancer) and the location of the genes.  Myriad identified the location of the BRCA1 and BRCA2 genes on chromosomes 17 and 13 (humans have 22,000 genes on 23 pairs of chromosomes).

Conflicting Perspectives: Chemistry and Biology

In arriving at its holding, the Supreme Court held that isolated genes are not eligible for patent protection because of the well- established rule that “laws of nature” cannot be patented.  In other words, one cannot patent something that simply exists in nature.  However, the Myriad opinion reveals that there are two competing frameworks through which to view the issue of whether an isolated gene is merely a product of nature: 1) chemistry, and 2) biology.

From a chemical perspective, DNA is a very long molecule defined by strands of nucleotides that bond to form a double helix.  A particular gene is only a portion of the molecule.  Thus, the sequence that defines a particular gene does not exist in isolated form in nature.  To obtain the isolated sequence, chemical bonds must be broken.  Thus, chemically, an isolated gene is different from the DNA molecule from which it is extracted.

From the biological perspective, however, the genetic information in the isolated gene sequence is unaltered relative to the DNA molecule from which the gene sequence originates.  The nucleotide sequence is the same as are the proteins that are encoded by the sequence.  Thus, the Supreme Court held that “Myriad did not create anything.  To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” Slip opinion at 12. The Court went on to hold that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 [statutory subject matter] inquiry.”  Id.

The Court adopted the biological perspective to hold that the isolated gene is merely a product of nature, and therefore, ineligible for patent protection.  The Court explained its rationale as follows:

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule.  Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. 

Slip Opinion at 14.

What Is the Impact of Myriad on Biotechnology Companies?

The Myriad opinion acknowledges that the Patent Office has created “reliance interests” by adopting a policy of granting isolated gene patents.  One of the judges in the Federal Circuit Court of Appeals (Judge Moore) found such reliance interests compelling enough to hold that isolated genes should be eligible for patent protection.  However, the Supreme Court disagreed, holding that such concerns are better directed to Congress.  We did a brief search for U.S. patents that claim “isolated DNA” and found that over 2800 of them had been issued.  The actual number of patents impacted by Myriad is likely much higher because of the variations in claim language used to cover isolated genes.

Myriad did not hold that methods of using isolated genes to identify individuals with susceptibility to breast cancer could not qualify for patent protection.  Thus, Myriad and others may be able to protect their discoveries by patenting methods of use.  In addition, the Myriad opinion upheld claims directed to “complementary DNA” or “cDNA” because their nucleotide sequences differ from those in the naturally occurring DNA molecule.  It is unclear from the opinion how lucrative a monopoly on a cDNA would be and whether it would prevent others from exploiting the basic discovery of the location and identity of the relevant genes for detecting breast cancer.

Some commentators have noted that trade secret law also provides an important means for Myriad to monetize its investment in discovering the BRCA1 and BRCA2 genes.  http://www.patentlyo.com/patent/2013/06/myriad.html.  One commentator indicated that Myriad maintains a database of gene mutations used in its testing as a trade secret.  Id. The database may provide a competitive advantage notwithstanding the loss of patent protection.  Myriad suggests that perhaps biotechnology companies may want to consider protecting isolated genes and their biological significance as trade secrets and avoid disclosing them in patent applications.