WASHINGTON, D.C. -- One year after vacating and remanding a Federal Circuit U.S. Court of Appeals determination that medical treatment protocol steps are patentable, the U.S. Supreme Court heard oral argument on Dec. 7 in the same case (Mayo Collaborative Services and Mayo Clinic Rochester v. Prometheus Laboratories Inc., No. 10-1150, U.S. Sup.).
(Transcript. Document #16-111219-003T.)
Patient safety will be jeopardized should respondent Prometheus Laboratories Inc.'s patent be allowed to stand, Stephen M. Shapiro warned the high court on behalf of petitioners Mayo Collaborative Services and Mayo Clinic Rochester.
Shapiro said "[35 U.S. Code Section 101] is the only provision under which this Court has issued decision after decision for 150 years protecting the public domain. It's not some rough gauge; it's the critical test defining what's in the storehouse of information for medical researchers to use. And [to] reduce it to a dead letter here would be just contrary to this Court's precedence, and very harmful to the medical community. This is very important to -- to doctors around the country."
At issue in the dispute between the Mayo parties and Prometheus is a patented method for determining the proper dosage of thiopurine drugs commonly used to treat gastrointestinal and autoimmune disorders. Because thiopurine is potentially harmful when administered in large doses and because each individual possesses a unique threshold for thiopurine exposure, patent licensee Prometheus sells a "Pro-Predict" test kit to measure metabolites that naturally occur when the drug is internally converted by a patient's chemistry.
The Mayo parties purchased and used Pro-Predict before announcing in 2004 their intent to sell a competing test. Prometheus responded by filing the instant lawsuit in the U.S. District Court for the Southern District of California, and the Mayo parties counterclaimed for declaratory relief of noninfringement and patent invalidity. On cross-motions for summary judgment, the District Court granted the Mayo parties' motion to invalidate the patents under 35 U.S. Code Section 101. The District Court held that Mayo's test literally infringed but that the patents' steps of administering the drug and measuring the metabolite levels impermissibly claim natural phenomena -- the correlation between thiopurine drug metabolite levels and efficacy and toxicity that resulted from a natural body process.
On appeal, the Federal Circuit U.S. Court of Appeals reversed the ruling after applying the machine-or-transformation test, under which a claimed process is patent eligible if it is tied to a particular machine or apparatus or if it transforms a particular article into a different state or thing. The court held that the administering and determining steps of the patents were transformative. The Mayo parties filed a petition for writ of certiorari with the U.S. Supreme Court, and while the petition was pending, the Supreme Court decided Bilski v. Kappos (561 U.S. 130 S. Ct. 3218 ), in which it rejected the machine-or-transformation test as the sole method for determining patent eligibility under 35 U.S. Code Section 101.
In light of its ruling in Bilski, the Supreme Court in June 2010 vacated the Federal Circuit's decision on Prometheus' patents and remanded the case for further consideration. In December 2010, the Federal Circuit again upheld the patentability of Prometheus' medical treatment claims that include steps that are "part of a treatment protocol," finding that such steps are transformative and not merely for the purpose of gathering data. The appellate panel concluded that the claims at issue were drawn to a particular application of a natural phenomenon, not the natural law itself. It further agreed with Prometheus that the claims involve a particular transformation of a patient's body and bodily sample and recite specific means of treating specific diseases with specific drugs.
The Mayo parties again filed a petition for certiorari, which the Supreme Court granted June 20, asking "whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve 'transformations' of body chemistry." On Oct. 26, the U.S. solicitor general moved for leave to participate in oral argument as amicus curiae and for divided argument.
Shapiro argued Dec. 7 that the petitioner's test represents an improvement over Pro-Predict in that it offers "more accurate results." Upholding the Federal Circuit therefore presents "a huge practical problem for patients," Shapiro said. Later, Shapiro opined that "pieces of nature can't be monopolized [and] neither can formulas," lamenting that the numerical calibration ranges claimed by Pro-Predict "extend up to infinity, and preclude every other blood test." Justice Elena Kagan then asked Shapiro whether there is any patent that Prometheus could have written to satisfy the Mayo parties' definition of patentability. "Certainly," replied Shapiro, ""They could have said: When you reach 400, a real number, a specific number, you adjust the dosage by 20 percent. That's a treatment patent."
"What makes it different, is that leaves room for Mayo Clinic to come up with different numbers that it believes are more accurate and more helpful for patients that are suffering from these life-threatening diseases. We shouldn't require Americans to get one opinion from Prometheus when they want an opinion from Mayo Clinic," he continued.
Justice Ruth Bader Ginsburg later questioned Shapiro on why the Mayo parties failed to assert invalidity pursuant to Sections 102 and 103 of the Patent Act in response to Prometheus' infringement claims and focus its defense solely on the issue of patentability pursuant to Section 101. Justice Anthony Kennedy concurred, noting that "it's hard to resist the temptation to peek into the obvious component or the nonobvious component and then go back and apply it to 101."
In agreement was Solicitor General Donald B. Verrilli Jr., representing the U.S. Department of Justice as amicus curiae. In his arguments before the high court, Verrilli conceded that "each party in this case has got a valid point." Though the Mayo parties are "correct that you can't get a patent by tacking a mental step onto an utterly conventional process for administering drugs and testing their effects," Verrilli maintained that their position "is an issue under sections 102 and 103 of the Patent Act." Importing a novelty and obviousness analysis in Section 101 cases could be "very destabilizing," Verrilli warned, and although the patent in suit might not withstand a Section 102 or 103 challenge, it nonetheless passes the standard for Section 101.
"[Section] 101, as Bilski said, is a threshold eligibility test and the question is whether there is a process. Here there is a process. It's the administration of a drug that changes the body chemistry and there is then a test to determine the extent of the change and then there is an end of the test. That's a process," Verrilli said.
Richard P. Bress, representing Prometheus, was questioned by Justice Samuel A. Alito Jr. on what the respondent considers a natural phenomenon. To that end, Justice Alito questioned Bress on whether a patent should be issued for photosynthesis induced by a lamp inside a building. "I think you could probably get a patent . . . on the use of a lamp to induce photosynthesis," Bress replied, "but you couldn't claim the underlying process . . . of photosynthesis."
Bress' position was closely scrutinized by Justice Kagan, who questioned Prometheus' failure to offer guidance on specific treatments based on specific test results. "Why didn't you file a patent like that?" she asked. "Because that clearly would have been patentable."
"I think that the difference that people are noting or some people are noting is that this is not a treatment protocol, it's not a treatment regimen, all you have done is pointed out a set of facts that exist in the world, and are claiming protection for something that anybody can try to make use of in any way and you are saying you have to pay us," Justice Kagan continued.
The Mayo parties are represented by Shapiro, Timothy S. Bishop and Jeffrey W. Sarles of Mayer Brown in Chicago; Charles Rothfeld of Mayer Brown in Washington; Jonathan Singer, John Dragseth and Deanna Reichel of Fish & Richardson in Minneapolis; Eugene Volokh in Los Angeles; and Joseph M. Colaiano and James A. Rogers III of Mayo Clinic in Rochester, Minn. Bress, J. Scott Ballenger, Maximilian A. Grant, Matthew J. Moore and Gabriel K. Bell of Latham & Watkins in Washington represent Prometheus.
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