Classen: Has the Federal Circuit Lost Interest in Patentable Subject Matter?
Allison Williams Dobson is an attorney, scientist and lecturer in the Norfolk, Virginia area and is a regular GLR contributor.
But First: The Federal Circuit Has Denied the Plaintiff’s Motion for Rehearing in Myriad: This week, the Federal Circuit issued a one-word order—“Denied”—turning down both parties’ requests for rehearing by the three-judge panel that decided that case originally. The parties now have 90 days to file a certiorari petition asking for Supreme Court review.
This news is not surprising considering the Federal Circuit’s most recent treatment of patent-eligible subject matter under § 101 of the Patent Act. On August 31, 2011, another 2-1 divided panel issued its opinion (three very strong opinions, really) in Classen Immunotherapies, Inc. v Biogen Idec (pdf).
The majority finds that two of the three method patents in dispute claim subject matter that is patent-eligible under § 101. However, the court also emphasizes repeatedly that the two patents “may not” meet the other requirements for patentability imposed by §§ 102 (novelty), 103 (nonobviousness), and/or 112 (adequate written description). The thrust of the majority’s message is becoming a familiar mantra–the statutory role of § 101 is to act as a “coarse eligibility filter”–a gateway to the real tests–and not the “final arbiter of patentability.”
Pigs Return to Earth: Federal Circuit Reinstates Most—But Not All—of Myriad’s Patents
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.
Prometheus Returns to the Supreme Court, Medical Method Patent Speculation Intensifies
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.
Prometheus Unbound—Again
The latest news from the field of biotechnology patents is in: the Federal Circuit has handed down its opinion (again) in Prometheus v. Mayo (pdf), the closely watched diagnostic method case. The verdict is the same as before: Prometheus’s patents satisfy the § 101 test for patentable subject matter.
On Monday, we wrote about the Federal Circuit’s first post-Bilski method patent decision: Research Corporation Technology v. Microsoft. In analyzing RCT we argued that it was “a good bet that the Prometheus and Myriad patents, and others like them, will survive § 101.” That bet paid off today in Prometheus and, based on the signals the Federal Circuit sent in that opinion, we think it is increasingly likely to pay off again in Myriad in the form of at least a partial reversal (more on this below).
Applying Bilski means Business as Usual. Way back in June, when the Supreme Court decided Bilski, it not only failed to provide lower courts (including the Federal Circuit) with meaningful guidance for biotechnology method patents, it arguably failed to provide meaningful guidance about anything at all. Despite predictions that Bilski might fundamentally reshape the patent landscape, the Court’s fractured opinions produced little in the way of binding law. The clearest statement from the Court was that the machine-or-transformation test for method patentability, which the Federal Circuit had previously deemed an exclusive test, was in fact only a “useful and important tool.” (Other useful and important tools were not, however, enumerated.)
Swine Soar Higher in Myriad Thanks to US Government’s Amicus Brief
This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC).
After several months of courtroom quiet, the briefs began rolling in to the CAFC last week. Most, including Myriad’s own appellant brief (pdf), presented the argument we would expect. Myriad and its supporters frame Judge Sweet’s ruling as an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” (pdf) for the continued development of biotechnology.
And then there is the United States government. In an amicus brief filed on Friday (pdf) the Department of Justice (DOJ), on behalf of the United States, dropped a minor bombshell. Contradicting the longstanding policy of the United States Patent and Trademark Office (PTO), the government’s brief argues that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under § 101 of the Patent Act.
Breaking: Biotech and the Supremes: Prometheus Follows Bilski to Highest Court (For Just a Moment)
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.
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 . . .
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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.
