Wednesday, December 17, 2014

Supreme Court juggles molecular structure, cookie recipes and baseball bats in gene therapy case

WASHINGTON - Molecules, cookie recipes and baseball bats were discussed and debated at the U.S. Supreme Court Monday as the nine justices wrestled with a case based on the question of whether you should be able to get a patent for a human gene.

Supreme Court juggles molecular structure, cookie recipes and baseball bats in gene therapy case

WASHINGTON - Molecules and chocolate chip cookies, baseball bats and Amazonian tree sap were all part of a spirited Supreme Court discussion Monday as the nine justices wrestled with the question of whether you should be able to get a patent for a human gene.

If you slice up pieces of microscopic molecules, have you created new ones or just separated existing body parts, not unlike kidneys or livers, which are products of nature and not usually granted patents? And, more importantly in this matter, can you profit by preventing others from researching those molecules or providing lower-cost testing services?

The justices seemed to be looking for a compromise in the case of Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398. AMP was part of the original group of plaintiffs that represented researchers, including two from the University of Pennsylvania, patient groups and six women, including one from Williamsport, with breast or ovarian cancer or family history of it. The plaintiffs say Myriad's patent-provided monopoly on the BRCA1 and BRCA2 genes has stifled research because of Myriad's threats of lawsuits and less access to affordable testing for those cancers.

The U.S. Patent Office has dispensed thousands of gene-oriented patents. Justice Samuel Alito wondered by the court had to "jump" into this situation, but others seemed to think the patent office went too far.

"The Patent Office seems very patent happy," Justice Elena Kagan said, speaking to Myriad's attorney Greg Castanias. "You have a plant. You uproot it and carry it away and isolate it. Can you now patent it?"

Plaintiff's attorney Chris Hansen later answered Kagan's question: "We do not think you should be able to get a patent on that plant you pulled from the ground."

A decision is likely before the court's term ends in June. Pharmaceutical companies and other industries with similar kinds of patents are hoping that Myriad wins. Besides arguing for deference to the wisdom of patent office officials, Myriad argues that its human intervention takes molecules beyond what nature provides and it has suggested a baseball bat is an analogy. Baseball bats are not found naturally, but are born of inventive cutting of natural wood.

"For millions of years, trees have existed," Alito said, pondering aloud. "But if a limb falls off, ends up in the water, is manipulated by waves and washes up on shore and what you have is a baseball bat?"

As Chief Justice John Roberts said on the baseball bat point, "You have invented something."

However, like Kagan, Stephen Breyer and Sonia Sotomayor did not seem comfortable that Myriad would retain control of the still healthy trees in such an analogy. Breyer said he was fine with a man-made formulation that includes sap dripping from trees in the Amazon, but not the sap itself.

"I create a chocolate chip cookie recipe and maybe I can get a patent on the recipe," Sotomayor said. "I can't imagine getting a patent on the basic elements - salt, flour, sugar."

 

 

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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