Breaking: Supreme Court Affirms Bilski
This morning the Supreme Court released it’s highly anticipated opinion (pdf) in the Bilski v. Kappos case. The Court affirmed the Federal Circuit’s rejection of petitioners’ patent (a method for commodities hedging), although Justice Kennedy’s majority opinion rejects the Federal Circuit’s conclusion that the so-called “machine-or-transformation test” is the sole test for determining patent eligibility of a “process” under §101 of the Patent Act.
Justice Kennedy’s opinion does make clear, however, that simply rejecting the machine-or-transformation test as the exclusive test does not mean that the Court is taking a broad view of business method patents, or of process patents more generally. As he writes:
With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles. Nothing in this opinion should be read to take a position on where that balance ought to be struck.
Bilski has been closely watched because of what it might mean for the future of biotechnology patents. Now that we finally have an opinion from the Supremes, what, if anything, can we conclude? We’ll check back in later today with more detailed analysis of the opinion and some preliminary answers to that question. In the meantime, happy reading.
Is Something Brewing with Bilski?
A few tidbits of news for conspiracy theorists and others who are still waiting for the Supreme Court’s Bilski decision:
According to the Court’s case information service, Bilski is still “awaiting decision.” No news there. But in a recent comment, Chief Justice Roberts indicated that the Court would finish its work for the term by the end of June. The Court typically issues opinions on Mondays and Thursdays, and the last one of those in June is next Monday, June 28th. So whatever the Court is going to do with Bilski, it will apparently do it at the start of next week. Still no clue as to what that might be. Except . . .
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Betting on Bilski: The Supreme Court and Biotechnology Patents
There is a two-part question that we are frequently asked these days: “When is Bilski going to be decided and what’s the decision going to be?”
The first part of that question is easy to answer. Bilski will be decided soon. Need something more specific? Bilski will be decided sometime between today and the end of June or beginning of July, when the Supreme Court’s current term ends.
The second part of the question involves predicting the future. We’re happy to take a shot at that, but only after a few caveats. First, these predictions are for entertainment purposes only. Betting on Supreme Court decisions is illegal in most states and several foreign countries, so don’t. Second, pay no attention to alleged inside information about what the Court is going to do or when it’s going to do it. There are no credible Supreme Court leaks—the Court is tighter than Putin’s old KGB (or his new FSB). Third, remember that it takes the votes of four justices for the Court to take a case. So we can presume that at least four justices wanted to say something about Bilski. But we don’t yet know what that might be. With those disclaimers, let’s proceed to the prognostication.
WARF Reexamination Takes Another Bite Out of Biotech Patents
Two months ago, the Myriad gene patent litigation generated a slew of national and international coverage. We said, “Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims.” “Is the DNA patent dead?” asked CNN. Wired (apparently answering CNN) declared the “End of Gene Patents Will Help Patients, Force Companies to Change.” Everyone, it seemed, either had an opinion on what the Myriad decision meant for the future of biotechnology or was looking for somebody who did.
It’s not surprising that the Myriad litigation has dominated the headlines. The ACLU’s challenge to Myriad Genetics was a first-of-its-kind frontal attack on gene patents. But with Myriad now on appeal to the Federal Circuit, and a final resolution to that particular piece of litigation likely several years away, a variety of other legal developments are slowly but surely reshaping the biotechnology patent landscape. In the next few years, while frontal attacks such as Myriad are likely to occupy the press and policymakers, those interested in forecasting the future of biotechnology patents will be paying equally close attention to the various collateral attacks on gene, protein, association, diagnostic, and other biotechnology patents and claims.
Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims
Late on the afternoon of Monday, March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York issued a jaw-dropping summary judgment ruling (pdf) in Association for Molecular Pathology v. USPTO that invalidates certain of Myriad Genetics’ patents related to the BRCA 1 and 2 breast and ovarian cancer susceptibility genes. In a post written immediately after the release of the opinion, Dan gave a thorough summary of the ruling. Our objective here is to offer a bit more depth on what the ruling means—and what it doesn’t mean. On the one hand, Judge Sweet’s order is radical and astonishing in its sweep. On the other, it will be some time before we have any idea what impact it will ultimately have.
We should first disclose that one of us (John) has a dog in this fight, albeit a small one. In 2003, (along with biologist and patent lawyer Roberte Makowski), John published an article in the Journal of the Patent and Trademark Office Society entitled Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (pdf). In that article, Roberte and John laid out an argument for challenging Myriad-style patents on “isolated” genes as claiming products that are only trivially different from the naturally-occurring versions. Judge Sweet cited this article and, in several parts of his opinion, followed the roadmap it created. So, if you oppose the Myriad patents, you’re welcome; if you like them, we’re sorry.
What Summary Judgment Means. As Dan noted, and John first wrote last fall, it is rare for plaintiffs to win on summary judgment. For either side to receive summary judgment, it must show that there are no disputed issues of fact that require a trial to resolve, and that, on the undisputed facts, the law mandates judgment in its favor. This standard is especially hard for a plaintiff to meet, since it bears the burden of proof at trial. At the summary judgment stage, a defendant can usually create an issue of fact and thereby avoid summary judgment just by saying “they have the burden of proof at trial, and a jury might not believe them.” Although this is an unusual case in that the basic facts—most notably Myriad’s patent claims and the fundamental biology and genetics that makes possible those claims—really are not in dispute, a summary judgment ruling for the plaintiffs nonetheless sends a clear message about how strong this particular judge thought their case was—and how weak he thought Myriad’s was.
The Road to Invalidation. The court broke Myriad’s patent claims into two major groups: (i) those claiming isolated DNA sequences and (ii) those claiming methods for comparing or analyzing gene sequences to identify the presence of mutations corresponding to a predisposition to breast or ovarian cancer (p. 2). Both sets of patents were rejected under Section 101 of the Patent Act, which enumerates the permissible categories of patentable subject matter: processes, machines, manufactures, and compositions of matter. As the judge noted, a long history of cases forbids claims on laws of nature, abstract ideas, and natural phenomena, which include products of nature.
Bilski and Biotechnology: The Supremes Speak Up
The Supreme Court heard oral argument in the Bilski case yesterday (pdf of full transcript). The Justices’ questions evinced unmitigated hostility to Bilski’s claim on a method of hedging commodities risks, and to business method patents generally. Detailed analysis of the oral argument is available from ScotusBlog, Patent Docs and Blawg IT. The decision in Bilski will have far-reaching consequences for patents on methods of analysis, data interpretation, and performing certain tasks, and at the GLR we have several times noted the potential significance of the case for biotechnology patent law.
The Justices may not be reading the GLR (or are they?), but they are well aware of Bilksi’s potential implications. In argument, Justice Sotomayor commented that if the Court upheld the Federal Circuit’s Bilski decision she would “have no idea what the limits of that ruling will impose in the computer world, in the biomedical,” but expressed concern that upholding Bilski’s machine or transformation test could “destroy industries” by “shoe-horning technologies that might be different.” And Justice Ginsburg, while remarking that Bilski “could be decided without making any bold steps,” conceded that “we know that things that we haven’t yet contemplated may be around the corner, and when they happen, we will deal with them.”
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Duke Finds a Second Alzheimer’s Gene—What Does It Mean?
The recent discovery of a gene linked to Alzheimer’s disease provides a timely context for revisiting the significance of gene patents. Researchers at Duke University Medical Center recently announced that they have identified a second gene (called TOMM40) associated with an increased risk of late-onset Alzheimer’s, which affects people over the age of 65. A team of Duke gene hunters originally identified the first Alzheimer’s gene (APOE) in 1993. Although the announcement prompted warnings about the need for further confirmation, the Duke researchers hope that the analysis of which versions, or alleles, of the two genes that people carry will significantly sharpen geneticists’ ability to predict susceptibility to Alzheimer’s. Those predictions might prove especially useful in both diagnosing Alzheimer’s disease and in developing future Alzheimer’s drugs.
One of the first questions on everyone’s mind, particularly in light of the high-profile lawsuit by the ACLU and others against Myriad Genetics, is whether this newly discovered Alzheimer’s gene could be patented. In principle, yes. Going back at least to the early 1980s, the U.S. Patent and Trademark Office (US PTO) and the federal courts have repeatedly taken the position that genes in isolation from their natural environment (that is, outside the body) are patentable subject matter, just like any other chemical compound. Individual cases have turned on such specifics as whether others had previously identified the gene, or whether and when the patent applicant or others had first disclosed the gene. But there is no general prohibition against patenting genes.
“Three Generations of Imbeciles Are Enough”
So wrote Justice Oliver Wendell Holmes, Jr. in Buck v. Bell, a 1927 Supreme court case upholding a Virginia law that authorized the state to surgically sterilize certain “mental defectives” without their consent. The fascinating and disturbing history of the case is covered in a recent USA Today article.
Carrie Buck was a patient in the Virginia State Colony for Epileptics and Feeble-minded. Upon a finding that she was “the probable potential parent of socially inadequate offspring, likewise afflicted, that she may be sexually sterilized without detriment to her general health, and that her welfare and that of society will be promoted by her sterilization,” the Court upheld her involuntary tubal ligation. The Court infamously justified its decision as follows:
We have seen more than once that the public welfare may call upon the best citizens for their lives. It would be strange if it could not call upon those who already sap the strength of the State for these lesser sacrifices, often not felt to be such by those concerned, in order to prevent our being swamped with incompetence. It is better for all the world if, instead of waiting to execute degenerate offspring for crime or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind. . . . Three generations of imbeciles are enough.
The ACLU v. Myriad Genetics Suit: Legitimate Challenge or Publicity Stunt?
By now everyone has heard of the ACLU-instigated suit against Myriad’s patents on the breast cancer susceptibility genes BRCA1 and BRCA2 (read: ACLU release; the complaint). These patents emerged from research at the University of Utah and were assigned to Myriad, a private spinoff. The broadest product claims cover “an isolated DNA coding for a BRCA1 [or 2] polypeptide [protein], said polypeptide having the amino acid sequence” listed in the patent. Related patents also challenged in the suit cover methods for screening for genetic mutations. As a result of these patents, research and diagnostic testing involving BRCA1/2 must be done by or with the approval of Myriad, usually at some cost.
The ACLU has assembled a broad coalition of authoritative and sympathetic plaintiff. They include medical and scientific organizations, individual researchers and physicians, the women’s health cooperative that publishes Our Bodies, Ourselves, and cancer patients who allege that they need but cannot afford (and cannot get their insurers to pay for) BRCA1/2 testing. The defendants are Myriad, the U.S. Patent and Trademark Office, and several directors of the University of Utah Research Foundation.
The suit comes against the background of some recent decisions that nibble around the edges of gene patentability. Earlier this year, in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), the Federal Circuit affirmed the PTO’s obviousness rejection of a patent on polynucleotides that encode natural killer cell activation proteins (the NK cells help fight infections and cancer). The holding was that it would have been obvious to try to isolate these nucleotide sequences in light of existing knowledge of the proteins in question and the sequencing methods. Back in 1995, in In re Deuel, the Federal Circuit had had rejected this “obvious to try” objection to a generally comparable gene patent. But now the same court took the view that the Deuel had been “discredited” by the Supreme Court’s 2007 obviousness decision, KSR International v. Teleflex.
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