Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis
Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of the Myriad holding: that isolated DNA sequences are not necessarily patentable.
Judge Dyk’s comments were a bolt out of the blue, as he raised an issue that had not been addressed by the parties or the lower court. Because he is a member of the court that will decide Myriad in the next year or so, Judge Dyk’s comments might be more significant than the district court opinion itself. (The case is Intervet Inc. v. Merial Ltd., Fed. Cir. 8/4/2010.)
European Court Issues Gene Patent Ruling Against Monsanto—A Myriad Connection?
In another significant international development, on July 6, the Court of Justice of the European Union (more commonly known by its old name, the European Court of Justice or ECJ) ruled against Monsanto Technology LLC (pdf) in its suit against an Argentine company called Cetera and several other parties.
The Court sat in a 13-member Grand Chamber, which is eurojargon for “really big deal,” and issued a ruling which leaves gene patents essentially intact but warns national courts to construe them carefully. (Travel advisory aside: If you ever have a chance to visit the Court in Luxembourg, do. Its magnificently robed judges sit in medieval splendor in a hideous modern building. Lawyers (usually several per case), robed almost as magnificently, read long and pompous arguments that are translated into many languages. The judges, apparently having already decided the case, ask no questions and seem to pay no attention. The rulings are logically convoluted and delivered in baroque language. Everyone seems immensely pleased with the spectacle.)
Bilski and Biotech: Business As Usual, For Now
Earlier today the Supreme Court handed down its opinion in what some patent observers have termed “the most highly anticipated patent decision of all time“: Bilski v. Kappos (pdf). The Bilski case was widely watched not for the significance of the particular patent at issue but for the far-reaching effect on patent law that the case might have.
Would the Court treat Bilski as a referendum on the patentability of so-called “business methods”? Would it speak more broadly still, using Bilski as an opportunity to clarify the patentability of a range of emerging technologies, particularly in the areas of software and biotechnology? These questions took on added significance for biotechnology companies, investors, researchers and observers earlier this spring when a federal court in New York used Bilski’s machine-or-transformation test to invalidate several of Myriad Genetics’ diagnostic method claims.
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 . . .
Read the rest of this entry »
Myriad Gene Patent Litigation Goes Down Under
On Tuesday, June 9, 2010, several plaintiffs, including a breast cancer patient and a cancer advocacy group, sued in a Sydney, Australia federal court to invalidate Myriad Genetics’ patents on the breast cancer susceptibility genes BRCA-1 and 2. According to published reports and comments by Australian patent law experts, the suit substantially tracks the much-publicized one filed in New York by the American Civil Liberties Union. In particular, this suit is also a frontal attack on the Myriad patents, seeking a judgment that genes in isolation from the body are products of nature and thus not patentable inventions.
The factual background in Australia seems a bit different. Myriad has granted an exclusive license to perform BRCA gene tests to a Melbourne company called Genetic Technologies Limited, which is a co-defendant in the case. But GTL has been reported to have “gifted” its patent rights to health care institutions, and not to charge royalties. Nonetheless, the plaintiffs’ lawyers have expressed concern about the possibility of GTL exploiting their monopoly as in the U.S., where the tests cost over $3,000. They note that on two earlier occasions GTL sent letters to hospitals telling them to stop testing. A number of Australian sources have also worried aloud about the implications of the patents for medical research.
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.
Final Words from the Sidelines as Courtroom Arguments Begin in Gene Patent Litigation
Yesterday, on the eve of summary judgment arguments in the Myriad case, The Boston Globe editorialized—strongly—against patenting isolated genes. This is an issue in which the Globe has a natural interest, given the concentration of biotech companies in and around Boston. The Globe’s editorialists may or may not be right on the merits, but they are surely too glib.
First, they wrongly blame the Patent Office for what they see as bad policy: “The US patent office assumes that granting one firm the exclusive right to profit off of a gene is the best way to encourage further research.” No, the Patent Office doesn’t “assume” this—it’s in the U.S. Constitution (Art. I, sec. 8, cl. 8), which allows Congress to grant exclusive rights to inventors to promote the progress of science and the useful arts. That is, the Constitution states an economic rationale for patents: the Framers believed that the promise of monopoly returns was the best way to motivate inventors to invent and then to disclose their technology (which you have to do to get a patent). So even if you disagree with this policy, you shouldn’t say that the Patent Office dreamed it up or has any authority to change it.
