Patents

U.S. Supreme Court Delves Into What Is and Isn’t Patentable

For more than a decade,two entrepreneurs have been battling without success to win a U.S. patent on their method of doing commodity deals. Last week, the U.S. Supreme Court agreed to hear their plea, signaling that it may pounce on the case to clarify rules about what is, or is not, patentable.Patent attorneys say a decision could affect not just business methods but some biotech claims and process inventions. The business duo, Bernard Bilski and Rand Warsaw, have been jousting with the U.S. Patent and Trademark Office (PTO) since the late 1990s because it refuses to award them a patent on their idea for buying and selling bulk materials, such as coal, while hedging their bets with contracts at different prices. PTO rejected this "invention” as too abstract—it doesn’t even include an algorithm—and the top U.S. patent court, the Court of Appeals for the Federal Circuit (CAFC), upheld the rejection.
The news that the Supreme Court has agreed to hear this case jolted legal experts
last week. Hans Sauer, associate counsel for the Biotechnology Industry Association
(BIO) in Washington, D.C., says it’s a “big deal” and has snapped “most patent attorneys in the country” to attention. For BIO members, Sauer sees a risk that the
Supreme Court—which hasn’t ventured into the territory of what is patentable in a
couple of decades—could come up with a new definition that excludes certain diagnostic procedures or techniques to analyze genes, chemicals, or other natural phenomena.
Physicians’ groups, on the other hand, view such restrictions more favorably
because they fear patents may limit access to diagnostics.
The biotech industry’s concern is justified, says Christopher Holman, a law professor
at the University of Missouri, Kansas City, and former pharma biochemist. He notes that the Bilski patent was rejected by CAFC because the judges said it did not
involve a machine or a process that transforms a material from one thing to another.
Since then, this logic has been used by a lower court to reject a biotech patent on vaccination scheduling; the court said simply that it violated the Bilski rule. Now CAFC is poised to decide about another biotech patent, this one held by Prometheus
Laboratories of San Diego, California, on setting doses for the immune suppressant
drug azathioprine. It’s been challenged on grounds that it violates Bilski and is based on natural phenomena. Holman has joined four academics in an amicus brief to CAFC saying that judges need to be cautious in knocking down such patents: They should not call a person’s response to azathioprine a natural phenomenon, for example, because the drug itself isn’t natural. BIO also weighed in with a brief to CAFC, arguing that “significant and important sectors of the biotechnology
industry” could be harmed if the Bilski logic is applied too broadly. Meanwhile, the American Medical Association and six other medical groups have filed a brief on the opposite side, arguing that the Prometheus patent should be rejected because it is abstract and based on natural phenomena.
The Supreme Court’s review of the Bilski case could set the ground rules for deciding
this case and others involving biotech and analytical process inventions. The court hasn’t set a date for accepting briefs but could do so as soon as this fall.
–ELIOT MARSHALL

Source
Science 324, 1374, 2009