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.
This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. The current situation is then akin to buying a microscope and then claiming a patent on whatever components of life found there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious? Can you even place a patent on a computer virus? How much more foolish to claim there is patent protection on a virus or other component of a self replicating organism that might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.
Paul
http://healthjournalclub.blogspot.com/
I always thought that the USPTO was really reaching in its defense of gene patents when arguing that the isolated and purified form of a gene is somehow different from what occurs in nature, but a summary judgement is surprising given that this seems to be overturning precedent set by the patenting of such naturally occurring biologics as adrenaline and even yeast. Is the court effectively overturning those precedents or is it drawing a distinction between DNA as a “physical embodiment of information” and everything else?
Of course, from a practical perspective, the declining cost of direct sequencing should eventually make the whole issue irrelevant for genetic diagnostic purposes.
As a molecular biologist, I find that the ruling is all obvious stuff. The basic principle of patents is that you can patent an invention, not a discovery. The USPTO got really goofy in the 90s and approved patents all sorts of natural phenomena. They’ve been consistently knocked back to sense. I was close to the ridiculous Johns Hopkins broccoli sprout patent, and that hinged on the same issues and resulted in the same conclusion.
Many thanks for this concise summary.
Two questions for you:
1) Looking at Myriad’s patents, I notice that the claims do not include anything specifying that this is a method to detect susceptibility to breast cancer. Of course, this is discussed in other sections the patent(s), but do you think that this was a weakness of the patent? Would explicit claims of “a method for detecting risk of cancer,” with some sort of risk algorithm, have made a difference?
2) Given the nature of the summary judgement, are there any limitations on what the Appeals Court is allowed to consider or rule upon?
Thanks in advance for considering my questions.
This decision seems to rely heavily on a recent (2006) dissent by Justice Breyer in the case of Lab Corp v Metabolite, which was ultimately denied cert by SCOTUS.
In that case, the five conservative Justices tacitly supported the lower court ruling in favor of the patent holder in a situation somewhat analogous to the Myriad case.
It seems that Judge Sweet is on weak ground here.
1) Austin, re: products of nature and whole-genome sequencing. Prescient comments/questions – they are addressed in the follow-up post but, yes, I think the information content of DNA (which I’m not at all sure will hold up) is the distinction drawn. I further agree that the arrival of whole-genome sequencing is what is creating the fundamental tension that must be resolved. This decision is a step in that direction, but hardly the final word.
2) Neuro-conservative, re: appeal to the Federal Circuit. The summary judgment posture shouldn’t really limit what the higher court considers or bases its own decision on. If an issue wasn’t raised in the briefs below, it could be considered waived, but even that wouldn’t necessarily stop the court from using it as a basis for a decision. I think we can feel comfortable that the Federal Circuit will give this a thorough review.
I think I’ve answered your other questions either in the follow up post or over on the Genetic Future comment string.
This is really good news for research and all those of us in the biotechnology research community who believe that ultimately, all research should benefit the human race. Monopolistic and restrictive methods being misused by companies claiming to have sunk millions of dollars in research and hence justifying the disproportionate and, in my opinion, almost criminal costs of many of the existing health care diagnostics should really be curbed. A patent is awarded to foster the spirit of research and not to stifle it. Just because a company has been protected under the patent act does not mean it has the right to exorbitantly charge for diagnostic tests and treatments. Many of the clauses of gene patenting seem absurd and if it were not for the fact that they have such far-reaching and disastrous effects on so many lives, we might have laughed at the USPTO actually granting such rights. I sincerely hope that this judgment will pave the way for a more rational and just system of protecting inventors as well as the people for whom the research was intended in the first place. Thank you for featuring the finer points of the judgment. Though I am not from the legal profession I found some of the aspects extremely enlightening.
The information is very useful.
Earlier the isolated and purified gene sequences were patentable subject matter….from this ruling can we say that to be a patentable subject matter….mere purified form of a native DNA without any limitations is not sufficiant?
please explain me if the court decesion directs to any specific limitations.
Regards.
Ultimately, I think most biotech companies went for the cheap, low hanging fruit to produce “results” to show their investors. Any half-decent master’s student with access to a PCR machine and a sequencer could, in theory, sequence some new gene and patent it. That’s totally ludicrous. Any scientist worth his lab notebook knew it 20 years ago, and now the court system has finally realized it. Soon, investors will realized it as well, and it will change the funding paradigm of biotech. You have to come up with a real compound or method to actually change the phenotype which the gene controls. The sequence will help you do that, but it’s not patentable. Hell, it’s in the public domain at NCBI. Real medicine requires real research, not some tech in the basement with a sequencer. I’m glad this ruling came down. Finally we can get the bull out of the way and real companies looking for real results will survive and prosper, and the pseudo scientists can go home and be lab techs.