Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”.
23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical devotion to providing individuals with “unfettered access to their genomes” and its desire to commercialize the genomic information so many of those very same individuals have shared, free of charge, with 23andMe. With its new patent, 23andMe also injected itself into the middle of what Wojcicki herself described as the “hot debate” surrounding the patentability of “inventions related to genetics.” Wojcicki’s announcement appeared to catch more than a few of the company’s customers by surprise, sparking concern about the company’s intentions on 23andMe’s blog, Twitter and elsewhere, along with rapid and pointed commentaries from Stuart Hogarth and Madeleine Ball, among others.
Of the various questions asked of and about 23andMe and its new patent, these may be the three most common: Where did this patent come from, and why didn’t I hear about it before? What does 23andMe’s patent cover? How is 23andMe going to use its patent? Let’s take each question in turn.
Prometheus Patents Struck Down, 9-0: Mayo Collaborative Services v. Prometheus Laboratories, Inc. Analysis
In a strong rebuke to the Federal Circuit, a unanimous U.S. Supreme Court held (pdf), on March 20, 2012, that Prometheus Laboratories’ claims to methods of administering drugs to treat gastrointestinal autoimmune diseases do not meet the patentable subject matter standard of section 101 of the Patent Act. The representative claim quoted by the Court recites, “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder” comprising two steps: (a) administering one of a class of drugs (thiopurines) and (b) determining the level of a specified metabolite, “wherein” a level below a given threshold “indicates a need to increase the amount of said drug subsequently administered” [to improve efficacy], and a level above the threshold “indicates a need to decrease the amount of said drug subsequently administered” [to avoid toxicity].
History of the Case. Mayo originally bought and used Prometheus test kits that employed the patented method, but it then decided to sell and market its own test, which was similar, but not identical. Prometheus sued for patent infringement. The district court found that Mayo’s test would infringe the Prometheus patents, but it then held the patents invalid as essentially claiming unpatentable laws of nature–in this case, the relationship between the levels of the specified metabolite and the efficacy or toxicity of the relevant drugs.
The Federal Circuit’s long-awaited decision (pdf) in Association for Molecular Pathology v. USPTO (the Myriad gene patent litigation) was issued this past Friday. As we were writing, with the economy having slowed to a barely perceptible crawl and a government default looming more likely by the hour, there were plenty of reasons to believe that the sky was falling. But the Myriad decision was not, and is not, one of them.
For the most part, the Federal Circuit’s 2-1 decision returned the law to the state it was in before District Judge Sweet’s opinion turned things upside-down last March. Although full of interesting rhetoric, the court’s three lengthy opinions (a total of 105 pages) are less remarkable for what they decide than for what they invite higher authorities—the Supreme Court and the Congress—to decide down the road.
First, the scorecard. The court’s judgment—that is, the holding, or outcome—was joined by Judges Lourie and Moore. A third member of the panel, Judge Bryson, dissented in part, meaning that he joined only a portion of the judgment (more on that below) and disagreed with another part.
While everyone has been busy speculating about whether the Supreme Court will ultimately take the Myriad case, the justices (at least four of them—see below) sprung a surprise this week by deciding to review the Federal Circuit’s decision in another biomedical patent case, Prometheus v. Mayo.
The patents at issue in Prometheus involve a method of administering a drug (specifically thiopurine drugs used to treat gastrointestinal and other autoimmune diseases), measuring the drug’s level in a patient’s body, and then adjusting the dosage of the drug. The Supreme Court will hear the case this fall and should (see below) issue a ruling by next summer, thus drawing to a close a legal journey that began more than three years ago in a California district court.
Yesterday the Supreme Court issued its decision in the highly anticipated patent case, Bilski v. Kappos. Contrary to some expectations, the Court decided Bilski on narrow grounds, leaving the state of biotechnology patents largely untouched. Here is part of what we wrote yesterday:
Although the Court’s narrow ruling left a direct treatment of the difficult issues surrounding biotechnology patents for another day, those issues continue to loom large. As of this writing, a petition for certiorari in the Prometheus case is currently pending before the Supreme Court. In Prometheus, the Federal Circuit court applied the MoT test in a biotechnology context, upholding a patent on a method for improving administration of a drug. If the court grants review of the Prometheus decision, the biotechnology world will have another Supreme Court nail-biter on its hands, beginning with the oral argument next fall. Even if the Court denies certiorari in Prometheus, a number of alternate channels for biotechnology patent reform remain open, including the ongoing Myriad gene patent litigation (which itself might eventually reach the Supreme Court), the SACGHS gene patent recommendations and even private, industry-driven discussions (of which rumors abound).
The Court wasted no time resolving the will-they-or-won’t-they Prometheus question. In an order issued today (pdf) the Supreme Court granted certiorari and then immediately vacated the decision and remanded the case to the Federal Circuit for consideration in light of Bilski. With Bilski in the rearview, and Prometheus back to the Federal Circuit, speculation will now shift to the question of what, if anything, the Federal Circuit will do differently with Prometheus the second time around. Let the waiting begin anew.
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.
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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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.
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.
The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS) convened again on Friday for a snow-shortened session. One of several items on the Committee’s agenda was a report that the GLR has covered several times (see here and here): Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. With the threat of a blizzard looming, the meeting was unexpectedly short, with only a pair of public comments followed by the Committee’s vote to approve the report.
The report itself will not be available for several weeks, but the six recommendations on gene patenting and licensing approved by the Committee this past October continue to provoke a heated response. The Biotechnology Industry Organization (BIO), along with former Senator Birch Bayh (of Bayh-Dole Act fame) and others, held a Friday press conference to denounce – again – the report’s recommendations.
The SACGHS Recommendations. Most of the recommendations are uncontroversial, urging the Secretary of HHS to convene stakeholders to “explore” and “encourage” strategies to improve access to genetic testing, enhance patent licensing and ensure that the USPTO is “kept current with the latest scientific and technological developments related to genetic testing and technology.”
So what prompted Bayh’s charge that the recommendations represent “an attempt to send us back to a time when it appeared that American innovation was on its last legs and our economy was in deep distress”?
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