[Insight-users] U.S. Supreme Court Delves Into What Is and Isn't Patentable

Luis Ibanez luis.ibanez at kitware.com
Sat Jul 11 20:48:27 EDT 2009


http://www.sciencemag.org/cgi/content/full/sci;324/5933/1374
Science Magazine
*Science* 12 June 2009:
Vol. 324. no. 5933, p. 1374
DOI: 10.1126/science.324_1374

Patents:  U.S. Supreme Court Delves Into What Is and Isn't Patentable
*Eliot Marshall
* 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.
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