Court throws
out Prometheus drug patent
By Jesse J. Holland
Associated Press
WASHINGTON (AP) — The U.S. Supreme Court unanimously tossed out medical patent claims for Prometheus Laboratories on Tuesday for a test that could help doctors set drug doses for autoimmune diseases like Crohn’s disease, a decision that could affect the burgeoning field of personalized medicine.
The justices unanimously agreed that the patents held by the company — owned by Switzerland-based Nestle — were invalid because they were based on the laws of nature, which are unpatentable.
The patent in question covers a blood test that helps doctors determine the proper dosage for a drug, thiopurine, to treat gastrointestinal and non-gastrointestinal autoimmune illnesses. The patent covers methods of administering thiopurine to a patient and then determining the levels of the drug or the drug’s metabolites — what’s left after it breaks down in the body — in the patient’s red blood cells. That observation is used to adjust the amount of medicine needed for that patient.
“The question before us is whether the claims do significantly more than simply describe these natural relations,” said Justice Stephen Breyer, who wrote the opinion. “To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural law? We believe the answer to this question is no.”
The Mayo Clinic formerly used the Prometheus test, but its doctors announced in 2004 that they had come up with their own test and would put that one on the market. Prometheus sued to stop Mayo, but a federal judge invalidated their original patent.
Natural phenomenon cannot be patented, a lower court judge said. That decision was overturned by the U.S. Court of Appeals for the Federal Circuit, leading Mayo to appeal to the Supreme Court.
“The unanimous decision of the U.S. Supreme Court will enable physicians and other health care providers to offer and use tailored diagnostic tests to benefit patients,” said John Noseworthy, president & chief executive officer of the Mayo Clinic.
Personalized medicine is becoming big business in the United States, with companies trying to find the best way to use a person’s genetic makeup to help tailor care and find the most effective individualized treatments for cancer and other illnesses.
Officials at Prometheus Laboratories Inc., in San Diego said they were disappointed in the court’s ruling. “We believe that strong patent protection is important to encourage the investment of energy and resources to develop lifesaving diagnostic tests and treatment protocols,” a company statement said. “Without the availability of patent protection, future healthcare will suffer as companies may opt out of new research and development. This decision will, in our view, encourage imitation, not innovation.”
The court’s decision could affect other companies fighting for their personal medicine patents in court, said attorney Gerald Flattmann of the law firm Paul Hastings.
“One danger ... will be that courts misapply the decision as broadly requiring the invalidation of any claim that recites a law of nature as one of its steps,” Flattman said. “Such misapplication would have a profound negative impact on innovation in the field of personalized medicine and beyond since, of course, all invention is on some level based on the practical application of natural discoveries.”
Breyer noted that Albert Einstein would not have been able to patent his discovery of mass-energy equivalence or “by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa.)”
“If a law of nature is not patentable, than neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself,” Breyer said.
Justices say state can’t be sued
over sick leave
By Jesse J. Holland
Associated Press
WASHINGTON (AP) — The Supreme Court ruled Tuesday that states cannot be sued under the Family and Medical Leave Act for refusing to give an employee time off to recover from an illness. One justice said the decision “dilutes the force” of the law that allows millions of working Americans time off to care for sick family members or to have children.
The high court refused to let Daniel Coleman sue the Maryland state Court of Appeals for damages for firing him after he asked for sick leave, blaming Congress for not equating family care and self-care when lawmakers wrote the Family and Medical Leave Act.
Justice Anthony Kennedy, who wrote the controlling opinion, said Congress did not investigate self-care the way it did family care when it passed the FMLA, leaving little “widespread evidence of sex discrimination or sex stereotyping in the administration of sick leave.”
“Documented discrimination against women in the general workplace is a persistent unfortunate reality, and we must assume, a still prevalent wrong. An explicit purpose of the Congress in adopting the FMLA was to improve workplace conditions for women. But states may not be subject to suits for damages based on violations of a comprehensive statute unless Congress has identified a specific pattern of constitutional violations by state employers,” said Kennedy, who was joined in his opinion by Chief Justice John Roberts and Justices Clarence Thomas and Samuel Alito.
Coleman asked for a 10-day medical leave to deal with hypertension and diabetes in 2007, and said he was wrongfully fired after his request was denied. He sued for $1.1 million in damages under the Family and Medical Leave Act, but his lawsuit was thrown out, with the 4th U.S. Circuit Court of Appeals saying states could not be sued under the FMLA.
The 1993 Family and Medical Leave Act grants eligible workers up to a total of 12 weeks of unpaid leave during any 12-month period for such things as caring for a newborn or a sick family member, or because the employee has a serious health condition. It generally covers employers with 50 or more employees, which means it covers just about half of the U.S. workforce. Seven million of the 77.1 million FMLA-eligible people took leave in 2005.
Coleman argued to justices that he and some 5 million state workers like him should be able to sue for money damages for FMLA self-care violations but Maryland and 26 other states disagreed. They acknowledge they’re bound by the Family and Medical Leave Act and must grant time off. But the states say that unlike private employers, states are protected by the Constitution from monetary damage suits that could drain a state’s finances.
Kennedy agreed. For states to be sued under FMLA, “Congress must identify a pattern of constitutional violations and tailor a remedy congruent and proportional to the documented violations,” Kennedy said. “It failed to do so when it allowed employees to sue state for violations of the FMLA’s self-care provision.”
Justice Antonin Scalia did not join Kennedy’s opinion but agreed with the judgment. The way the other justices made their decision “make no sense,” Scalia said, but he said failing to grant a state employee leave for self-care “or any other purpose, for that matter” does not violate the Constitution’s equal protection clause.
Four justices dissented, including Ruth Bader Ginsburg, who in an unusual move read her dissent aloud in court. Ginsburg reiterated the Act’s intention was to end discrimination against women in the workplace based on their potential to become pregnant.
“The court’s judgment dilutes the force of the Act and that is regrettable,” she said. “But at least the damage is contained. The self-care provision remains valid Commerce Clause legislation and therefore applies, undiluted, in the private sector.”
Ginsburg also said employees can still ask a judge to reverse any potential violation. “And the Department of Labor has authority to sue a state employer for violating the self-care provision, and to gain monetary relief for adversely-affected employees,” she said.
Ginsburg said she would have also taken the opportunity in this case to conclusively overturn a Supreme Court position in 1974’s Geduldig v. Aiello decision that “discrimination on the basis of pregnancy is not discrimination on the basis of gender.” “I would hold that Aiello was egregiously wrong,” she said.
The case is Coleman v. Court of Appeals of Maryland, 10-1016.
