Court Invalidates Myriad Gene Patents

Yesterday, the district court for the Southern District of New York held Myriad's patents for the BRCA1 and BRCA2 genes invalid.  Myriad had previously sought--and was granted--patents on these genes related to breast cancer diagnostics.  

In Association for Molecular Pathology and ALCU v. USPTO and Myriad, Judge Sweet issued a ruling that the patents, representing "isolated DNA" were actually products of nature and therefore non-patentable subject matter under 35 U.S.C. Section 101. 

Highlights of findings and legal reasoning from the opinion include:

• Characterizing discovered genes as "isolated DNA" for purposes of receiving a patent is essentially a "lawyer's trick" circumventing the prohibitions against patenting the DNA in the human body because in practice, it achieves the same results.
• NIH funded $2 million dollars to the University of Utah, in addition to providing six researchers from the National Institute for Environmental Health Sciences (NIEHS, a subdivision of NIH) who worked on the identification of BRCA 1.
• Previously, a dispute arose between Myriad and NIH over the exclusion of NIEHS scientists as co-inventors on BRCA1.  Eventually, Myriad agreed to list NIEHS scientists as co-inventors and pay royalties, however as of 2005 no royalties had been paid.
• Acknowledges that previous case law and Congressional history allow for broad scope in patenting (see Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980)), but also recognizes 35 U.S.C. 101 is "not without limits."  The Supreme Court has explicitly recognized three areas in which subject matter may not be patented including: 1) laws of nature; 2) physical phenomena; and 3) abstract ideas because too much patent protection can actually impede, rather than promote, the pursuit of science and useful arts
• Although Congress created a presumption of validity for issued patents, the presumption appears "far from absolute" as approximately 40% of patents challenged in courts have been found to be invalid
• Myriad's argument that invalidating the patents would constitute a taking and violate the Fifth Amendment or violate the United States' obligation under TRIPS is invalid
• TRIPS Articles 8.1 and 27.3 allow governments to take into account public health concerns when dealing with intellectual property issues and to exclude patentability of diagnostic, therapeutic or surgical methods on the grounds of public interest
• Held that "the clear line of Supreme Court precedent and accompanying lower court authorities . . . establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter.  Rather, the purified product must possess 'markedly different characteristics' in order to satisfy the requirements of Section 101."
• None of the structural and functional differences argued by Myriad between the native and isolated DNA claimed in the BRCA1/2 patents render the claimed DNA "markedly different" because of the "ovrerriding importance of DNA's nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form.  The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature."
• Rejects Myriad's proposition that the court must focus on the differences, rather than the similarities, with regard to the issue of novelty in a patent claim finding that under Myriad's test, any invention would pass muster and all claims would be patentable.  Courts must therefore examine the claim as a whole.
• Mere differences in purity (between the isolated DNA and that found in nature) is insufficient in establishing subject matter eligibility
• The splicing differences represented by the cDNA in the case were the result of naturally occurring splicing and "Therefore, not  only are the coding sequences contained in the claimed DNA identical to those found in native DNA, the particular arrangement of those coding sequences is the result of the natural phenomena of RNA splicing." Furthermore, the claimed cDNA sequences for BRCA1 are actually found in the genome. 
• Utility of the isolated DNA is primarily a function of the nucleotide sequencing between the native and isolated BRCA1/2 DNA.
• The isolation and identification of BRCA1/2, while requiring technical skill and labor, was actually the mere application of technique well-known to those practicing in this particular field.
• Transformations associated with isolating and sequencing human DNA is merely data-gathering and are not central to the purpose of the claimed process (invalidating Myriad's method argument)
• The claimed "process" of analyzing and comparing the DNA sequencing "is the scientific method itself" and therefore not patentable because it is a basic scientific principle.

The full opinion is available for download here.

This decision will almost certainly be appealed and some believe that the Federal Circuit will reverse the Southern District of New York's opinion.  Regardless of the outcome at the appellate level the losing party will likely appeal to the Supreme Court and a final result could be a long time coming. In the meantime, we can celebrate the fact that at least one federal court (or, more accurately, at least one federal judge) has found gene patents to be invalid subject matter under 35 U.S.C. 101.

Krista Cox