A high-stakes dispute

WASHINGTON, D.C.—With the U.S. Food and Drug Administration(FDA) looking on with renewed interest in pairing new drugs and companiondiagnostics, the U.S. Supreme Court on Dec. 7 heard oral arguments in the caseof Mayo Collaborative Services v. Prometheus Laboratories.

The high-profile dispute centers on the question of whetherlaws of nature and/or abstract ideas can be patented. At issue in this matteris a Prometheus patent on a method that assists doctors in figuring outeffective dosing of immunosuppressive drugs for patients based on varyinglevels of the drug's metabolic products as confirmed by tests with a Prometheuspatented kit.

Prometheus has sued Mayo for infringement of this patent,and Mayo has claimed that the patents involve a natural occurring phenomenon—the body's reaction to dosing levels—and should therefore be nullified.

As reported in ddn'sNovember issue, Mayo states in its appeal that no patent should be issued onobservations of how varying a dosage of a medicine alters a patient'ssubjective reactions. Those kinds of observations are what doctors doroutinely, the Mayo group has contended, and bottling up that process insomeone's exclusive patent rights would stifle normal medical practice, thecompany says.

Jim Mullen, a San Diego-based patent prosecutor (andmolecular biologist) with Morrison & Foerster, is a strategic patentadvisor who counsels clients in the diagnostics, therapeutics andclean-technology fields regarding patent procurement and IP due-diligenceactions, as well as infringement issues. He confesses to being troubled anytimethe Supreme Court decides to take up a patent case, and he notes the court hasbeen "loath to take up patent cases in the past. But, hopefully, we'll get helpon 101," he says.

For example, in Bilski,et al. v. Kappos, theSupreme Court affirmed the use of the Federal Circuit's"machine-or-transformation" test as one test for patentability of processes,but held that it is not the only test for patentability under 35 U.S.C. §101.The court left open the possibility for new tests to be defined to determinewhether business methods and other processes are patentable.

What does an applicant need to demonstrate to satisfy 101?Mullen thinks it should be a low threshold, and Mayo is attempting to elevatethe threshold with a broad interpretation of preemption. The "thresholdquestion" was asked by Justice Stephen Breyer during the oral arguments. Asother observers have also pointed out, Mullen notes that due to tacticalconsiderations, neither Mayo nor Prometheus wanted to commit under questioningby the justices as to "how much do you need to add to a law of nature to makeit patent eligible."

From an economic perspective, Mullen believes that a rulingin favor of Mayo would put all companion diagnostics in danger, with theresultant exodus of technology from the United States to lesspatent-restrictive nations. The FDA's interest in companion diagnostics—and arelated Draft Guidance the agency issued in July—sharpens the importance ofsettling the legal squabble in his view. And the continuing emergence ofpersonalized medicine, as represented by FDA's August approval of Zelboraf andits companion diagnostic test for late-stage skin cancer, underscores what isat stake, Mullen notes.

Jonas Anderson, an assistantprofessor at American University Washington College of Law who attended thesession, reported that Justice Antonin Scalia seemed genuinelydismissive of the court's precedents which have held that laws of nature (ornatural phenomenon) are not patentable.

"Tell me why you can't patent nature?" he asked Mayo's counsel early in theproceeding. "Doesn't any medical patent rely on natural processes? Even ifyou invent a new drug, what that new drug does is natural. What is thedifference [from this case]?"

When Mayo's counsel responded that the specificity would be the key test forpreemption, Justice Anthony Kennedy responded, "I thought your answer toJustice Scalia would be … that [the claims here cover] the measurement of aresult. That's how I would have answered the question. But that'sobviously not the right way to do it."

"Predicting the outcome of Supreme Court rulings in patentcases is a treacherous hobby," Anderson notes. "If anything, the argument todayrevealed a court troubled by the fact that both sides have urged an applicationof Section 101 that centers on preemption, but with little guidance on how toapply such a test. While I would expect a ruling to have some mention ofpreemption, none of the justices seemed comfortable with either side'ssuggested application of such a test, while Justice Scalia was dismissive ofsuch an idea."