Breaking: District Court Rules Myriad Breast Cancer Patents Invalid

The highly anticipated decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents, was handed down today. A copy of the opinion, from Judge Robert Sweet of the Southern District of New York is available here.

The opinion was released late this afternoon and it weighs in at 156 pages, so a more complete analysis will be forthcoming. [Edit 3/30: John Conley and I have published a more detailed review and analysis of the decision here: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims. For just the highlights, continue reading below.] However, there are a few crucial points that deserve an initial reaction.

1. The Plaintiffs Win. The ruling appears to be a nearly complete victory for the plaintiffs and their supporters, including the ACLU. With respect to Myriad’s issued patents on the BRCA1 and BRCA2 genes, Judge Sweet’s ruling invalidates both Myriad’s composition of matter claims (its patents on isolated DNA sequences to all or a portion of the breast cancer genes) and its method claims (those patent claims that relate to analyzing or comparing isolated DNA sequences in order to detect mutations in a patient’s BRCA1/2 genes that might cause breast cancer).

The overall tone of the Court’s ruling is best captured by this passage (from page 135):

The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.

Today’s ruling represents an essentially unblemished victory for the plaintiffs. The only claims on which they did not prevail – their constitutional claims against the USPTO – were dismissed, but that is a Pyrrhic victory for the USPTO and for Myriad. The Court based its dismissal, quite understandably, on the doctrine of constitutional avoidance – having otherwise invalidated the challenged patents, there was no need for the Court to rule on any Constitutional issues – and it did so without prejudice to the plaintiffs’ claims.

2. The Plaintiffs Win on Summary Judgment. Perhaps equally surprising as the invalidation of Myriad’s challenged patents is that the Court determined it could invalidate the patents on a summary judgment ruling. As we discussed last fall when the parties filed motions for summary judgment, a summary judgment victory for the plaintiffs – for a variety of both procedural and fact-specific reasons – seemed to be “the longest of longshots.”

The Court recognized this high threshold – Judge Sweet noted that the summary judgment standard is appropriate only when “no rational jury could find in favor of the nonmoving party because the evidence to support its case is so slight [and] there is no genuine issue of material fact” – and invalidated the challenged Myriad patents in spite of it. For the Court, the invalidity of the Myriad patents was not even a close call.

3. This Isn’t Over . Despite the complete victory for the plaintiffs, we have to keep in mind that this is just the first step on a long road for this particular piece of litigation, and for the future of gene patents more broadly. A district court opinion such as this one is absolutely certain to be appealed to the Federal Circuit, and it’s almost impossible to believe that we’ve heard the last pronouncement from a court of law on the fate of Myriad’s patents.

4. Key Provisions / Further Analysis. In the interest of time, I’ve included below some of the most eye-catching passages from the opinion as they appear. A more complete analysis of the Court’s reasoning, along with the implications of this decision for Myriad, gene patents and the future direction of biotechnology patenting and product development will be forthcoming. In the meantime, happy reading.

On Patentable Subject Matter:

Patentable subject matter must be ‘markedly different’ from a product of nature…products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product…‘purification’ of a natural compound, without more, is insufficient to render a product of nature patentable.

In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA ‘markedly different.’ This conclusion is driven by the overriding 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.

There will almost inevitably be some identifiable differences between a claimed invention and a product of nature; the appropriate § 101 inquiry is whether, considering the claimed invention as a whole, it is sufficiently distinct in its fundamental characteristics from natural phenomena to possess the required ‘distinctive name, character, [and] use.’ None of Myriad’s arguments establish the distinctive nature of the claimed DNA.

Invalidation of Composition of Matter Claims:

The entire premise behind Myriad’s genetic testing is that he claimed isolated DNA retains, in all relevant respects, the identical nucleotide sequence found in native DNA…Were the isolated BRCA 1/2 sequences different in any significant way, the entire point of their use – the production of BRCA 1/2 proteins – would be undermined.

The requirement that the DNA used be ‘isolated’ is ultimately a technological limitation to the use of DNA in this fashion, and a time may come when the use of DNA for molecular and diagnostic purposes may not require such purification. The nucleotide sequence, however, is the defining characteristic of the isolated DNA that will always be required to provide the sequence-specific targeting and protein coding ability that allows isolated DNA to be used for the various applications cited by Myriad. For these reasons, the use of isolated DNA for the various purposes cited by Myriad does not establish the existence of differences ‘in kind’ between native and isolated DNA that would establish the kind of subject matter patentability of what is otherwise a product of nature.”

Invalidation of Method Claims:

“The claimed process is not limited to any particular method of analysis and does not specify any further action beyond the act of ‘analyzing.’” Other of Myriad’s patent claims are similarly “directed to ‘comparing’ two gene sequences to see if any differences exist and do not specify any limitations on the method of comparison.”

Even if the challenged method claims were read to include the transformations associated with isolating and sequencing human DNA, these transformations would constitute no more than ‘data-gathering step[s]’ that are ‘not central to the purpose of the claimed process.’

Consequently, even if the method claims-in-suit were construed to include the physical transformations associated with isolating and sequencing DNA, they would still fail the ‘machine or transformation’ test under §101 for subject matter patentability.

Filed under: Badges, Bioinformatics/IT, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation
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