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.)

Beyond that, the Supreme Court leaned heavily on its prior patent rulings and, rather than clarifying the scope of  § 101 and its three acknowledged exceptions (laws of nature, physical phenomena, and abstract ideas,” the Court suggested that others look to the “guideposts” of past precedent. Which means that the Supreme Court effectively kicked the issue back to the lower courts. Or, as Justice Stevens put it in concurrence, the Bilski “analysis (or lack thereof) may have led to the correct outcome in this case, but it also means that the Court’s musings on this issue stand for very little.”

The day after Bilski was decided, the Supreme Court granted certiorari in Prometheus and immediately vacated the Federal Circuit’s prior decision and remanded the case for reconsideration in light of Bilski. We wondered, in light of what the Court had said (or failed to say) in Bilski, how much there really was for the Federal Circuit to reconsider in Prometheus.

Fast forward to today and the answer, unsurprisingly, is “not much.” Here’s just about all you need to know from the Federal Circuit’s most recent opinion in Prometheus:

We do not think that either the Supreme Court’s GVR Order or the Court’s Bilski decision dictates a wholly different analysis or a different result on remand…The Supreme Court’s decision in Bilski did not undermine our preemption analysis of Prometheus’s claims and it rejected the machine-or-transformation test only as a definitive test…Thus, the Court did not disavow the machine-or-transformation test. And, as applied to the present claims, the “useful and important clue, an investigative tool,” leads to a clear and compelling conclusion, viz., that the present claims pass muster under § 101. They do not encompass laws of nature or preempt natural correlations. (15)

Because the Supreme Court didn’t tell the Federal Circuit that it had to use a test other than machine-or-transformation – only that it could – the Federal Circuit ultimately applied the same test and reached the same result (and, indeed, lifted multiple sections verbatim from its prior Prometheus ruling (pdf)). Prometheus’s claimed inventions – which involve 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 that drug – continue to constitute patentable subject matter. (For a substantive analysis of the Federal Circuit’s reasoning in Prometheus, which is largely unchanged despite the case having traveled to the Supreme Court and back, see Prometheus and Medical Method Patents.)

What’s Next for Prometheus and Medical Method Patents? If you’re trying to figure out what comes next in the biotechnology patent cycle, here is what to watch for:

While the Federal Circuit has provided no hints about when it will decide Myriad, its ruling in Prometheus does offer additional clues as to how the court may decide Myriad.

The Federal Circuit’s reasoning in Prometheus (which, again, is substantively unchanged from its 2009 opinion) adopts an expansive interpretation of the machine-or-transformation test in the context of medical method patents. In both 2009 and today, the Federal Circuit wrote that “methods of treatment…are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” (17, emphasis added) That leaves a potentially enormous opening through which to push all manner of personalized medicine patents replete with diagnostic, measurement, correlation and other interpretive or mental steps, provided that the claim language can be framed as describing a “method of treatment.”

A year ago, we wrote that the broad reading of the machine-or-transformation test in Prometheus might ultimately cause the Federal Circuit to “have second thoughts about just how widely it has opened the subject matter door” in the area of medical method patents, and to worry about the impact of such patents on medical practice and research. But after a year of reflection and a Supreme Court-mandated opportunity to reconsider, the Federal Circuit appears to have had no such second thoughts.

Indeed, in reviewing Prometheus in light of Bilski the Federal Circuit unambiguously rejected the argument that the current Supreme Court had somehow expressed support for Justice Breyer’s 2006 dissent in Lab. Corp, in which three Justices made a strong statement about the dangers of patents that claim simple biomedical associations.  The Prometheus court noted that even if “five Justices in two concurrences cited Lab. Corp with approval in Bilski, … such citations fail to transform a dissent into controlling law” (16) and, in any event, neither Lab. Corp nor Prometheus, unlike Bilski, involve business method patents.

The Federal Circuit’s reluctance to narrow its view of permissible medical method patents is consistent with an emerging theme we noted most recently in our discussion of RCT earlier in the week. The court appears to be relaxing (or least not tightening) the scope of patentable subject matter (§ 101), focusing instead on more strictly interpreting other patentability requirements, particularly that an invention must be novel (§ 102), non-obvious (§ 103) and fully and specifically described (§ 112). The broad reading of § 101 affirmed by the Federal Circuit in today’s Prometheus decision does nothing to discourage that analysis.

What This May Mean for Myriad. Between Bilski, RCT and Prometheus, it’s hardly a stretch to think that Myriad remains headed for at least a partial reversal. In particular jeopardy is Judge Sweet’s finding that Myriad’s diagnostic claims fail to satisfy § 101. Those claims, which involve the process of analyzing or comparing genetic sequences in the BRCA-1 and BRCA-2 genes to detect mutations, were ruled by Judge Sweet to have failed the machine-or-transformation test. That analysis, which relied on a far narrower reading of the machine-or-transformation test than the Federal Circuit has employed in Prometheus, seems increasingly unlikely to hold up at the Federal Circuit level.

As for Myriad’s patents on isolated sequences of DNA (the so-called “gene patents”), a reversal is certainly possible there, too. But that is a tougher call, in part because the patentability of genes has become one of the most polarizing questions of patent law in recent memory, with numerous heavyweights including the Department of Justice all too eager to offer their opinions to the court. To think that the policy and politics surrounding gene patents will have no bearing on the courts, including the Federal Court, is naïve.

With the Supreme Court failing to send a strong message in Bilski, about biotechnology patents or otherwise, there was little reason to believe that the Federal Circuit would change course and alter their established rules of gene and medical method patenting. Today’s decision in Prometheus confirms that thinking and suggests that a reversal in Myriad remains the more likely outcome.

The Prometheus decision also continues to highlight the need for the Supreme Court – whether in Prometheus, Myriad or elsewhere – to tackle biotechnology patents head-on. As Justice Kennedy wrote in Bilski, the Court faces a “great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover” independently. Perhaps nowhere is that challenge greater than in the field of biotechnology, particularly personalized medicine. It is a challenge that must be faced. Whether the Supreme Court, Congress or industry will be the first to do so remains to be seen.

Filed under: General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation
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